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1. Factors associated with satisfaction with social roles and activities among people with systemic sclerosis: a Scleroderma Patient-centered Intervention Network (SPIN) cohort cross-sectional study

Author

Arsène Mekinian, Thierry Martin, Eric Hachulla, Carter Thorne, Danielle Rice, Andrea Benedetti, Brooke Levis, Virginia Steen, Paul R Fortin, Vincent Poindron, Aurélien Guffroy, David Launay, Luc Mouthon, Mandana Nikpour, John Varga, Benjamin Chaigne, Sindhu R Johnson, Sébastien Rivière, Michael Hughes, Daphna Harel, Marie-Eve Carrier, Karen Nielsen, Susan J Bartlett, Karen Gottesman, Ghassan El-Baalbaki, Kim Fligelstone, Catherine Fortune, Tracy Frech, Marie Hudson, Maggie Larche, Catarina Leite, Janet Pope, Anne A Schouffoer, Maria E Suarez-Almazor, Christian Agard, Marc André, Sabine Berthier, Lyne Bissonnette, Alessandra Bruns, Patricia Carreira, Marion Casadevall, Lorinda Chung, Christopher Denton, Robyn Domsic, James V Dunne, Bertrand Dunogue, Regina Fare, Dominique Farge-bancel, Jessica Gordon, Brigitte Granel-Rey, Genevieve Gyger, Monique Hinchcliff, Alena Ikic, Niall Jones, Suzanne Kafaja, Nader Khalidi, Marc Lambert, Hélène Maillard, Joanne Manning, Ariel Masetto, François Maurier, Susanna Proudman, Alexis Régent, David Robinson, Sophie Roux, Perrine Smets, Vincent Sobanski, Robert Spiera, Evelyn Sutton, Pearce Wilcox, Laurent Alric, Grégory Pugnet, François Rannou, Amy Gietzen, Christelle Nguyen, Michelle Richard, Nancy Maltez, Isabelle Marie, Mara Cañedo Ayala, Geneviève Guillot, Elana J Bernstein, Brett Thombs, Paul Legendre, Thylbert Deltombe, Sabrina Hoa, Laura K Hummers, Sophie Blaise, Yvonne C Lee, Louis Olagne, Marie-Claude Geoffroy, Richard S Henry, Robyn Wojeck, Maureen Mayes, Tiffany Dal Santo, Kimberly Lakin, Gabrielle Virgili-Gervais, Vanessa Malcarne, Claire E Adams, Rodriguez-Reyna Tatiana Sofia, Floryan Beaslay, Eva Bories, Carlotta Cacciatore, Benjamin Crichi, Tannvir Desroche, Loraine Gauzère, Anne Gerber, Maria Martin Lopez, Sheila Melchor Díaz, Morgane Mourguet, Loïc Raffray, Frederic Renou, Esther Rodríguez Almazar, Damien Vagner, Vanessa Cook, Sophie Hu, Elsa-Lynn Nassar, Marieke Alexandra Neyer, and Sabrina Provencher

Subjects
Medicine
Abstract

Objective The objectives were to (1) compare satisfaction with social roles and activities in a large multinational systemic sclerosis (SSc) cohort to general population normative data and (2) identify sociodemographic, lifestyle and SSc disease factors associated with satisfaction with social roles and activities.Methods Participants in the Scleroderma Patient-centered Intervention Network Cohort completed the Patient Reported Outcomes Information System Version 2 satisfaction with social roles and activities domain questionnaire. Multivariable regression was used to assess associations with sociodemographic, lifestyle and disease factors.Results Among 2385 participants, mean satisfaction with social roles and activities T-score (48.1, SD=9.9) was slightly lower than the US general population (mean=50, SD=10). Factors independently associated with satisfaction were years of education (0.54 per SD, 95% CI 0.14 to 0.93); non-White race or ethnicity (−1.13, 95% CI −2.18 to –0.08); living in Canada (−1.33, 95% CI −2.40 to –0.26 (reference USA)) or the UK (−2.49, 95% CI −3.92 to –1.06); body mass index (−1.08 per SD, 95% CI −1.47 to –0.69); gastrointestinal involvement (−3.16, 95% CI −4.27 to –2.05); digital ulcers (−1.90, 95% CI −3.05 to –0.76); moderate (−1.62, 95% CI −2.78 to –0.45) or severe (−2.26, 95% CI −3.99 to –0.52) small joint contractures; interstitial lung disease (−1.11, 95% CI −1.97 to –0.25); pulmonary arterial hypertension (−2.69, 95% CI −4.08 to –1.30); rheumatoid arthritis (−2.51, 95% CI −4.28 to –0.73); and Sjogren’s syndrome (−2.42, 95% CI −3.96 to –0.88).Conclusion Mean satisfaction with social roles and activities is slightly lower in SSc than the general population and associated with multiple sociodemographic and disease factors.

Published
2024
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2. A prognostic score to identify women at increased risk for abnormal uterine bleeding during anticoagulation for venous thromboembolism

Author

Gabrielle Sarlon-Bartoli, Juan Criado, Saskia Middeldorp, José Antonio Nieto, María del Carmen Díaz-Pedroche, Farès Moustafa, Nuria Ruiz-Giménez, Benjamin Brenner, Manuel Monreal, Pierpaolo DI Micco, Paolo Prandoni, Dominique Farge-Bancel, Raquel Barba, Pierpaolo Di Micco, Laurent Bertoletti, Sebastian Schellong, Inna Tzoran, Abilio Reis, Marijan Bosevski, Henri Bounameaux, Radovan Malý, Peter Verhamme, Joseph A. Caprini, Hanh My Bui, M.D. Adarraga, P. Agudo, C. Amado, J.I. Arcelus, A. Ballaz, J. Bascuñana, R. Barba, C. Barbagelata, M. Barrón, B. Barrón-Andrés, A. Blanco-Molina, F. Beddar Chaib, E. Botella, I. Cañas, R. Carrero-Arribas, I. Casado, P. Cerdá, L. Chasco, J. Criado, C. de Ancos, J. de Miguel, J. del Toro, P. Demelo-Rodríguez, A.M. Díaz-Brasero, M.C. Díaz-Pedroche, J.A. Díaz-Peromingo, I.M. Domínguez, A. Dubois-Silva, J.C. Escribano, F. Espósito, A.I. Farfán-Sedano, C. Falgá, C. Fernández-Capitán, B. Fernández-Jiménez, J. Fernández-Muixi, J.L. Fernández-Reyes, C. Font, I. Francisco, F. Galeano-Valle, M.A. García, F. García-Bragado, M. García de Herreros, O. Gavín-Blanco, A. Gil-Díaz, C. Gómez-Cuervo, A.M. Gómez-Mosquera, M. Gonzalez-Moreno, E. Grau, L. Guirado, J. Gutiérrez, L. Hernández-Blasco, L. Jara-Palomares, M.J. Jaras, D. Jiménez, I. Jou, M.D. Joya, B. Lacruz, S. Lainez-Justo, Latorre A, Lima J, Lobo Jl, M. López-De la Fuente, L. López-Jiménez, M. López-Meseguer, P. López-Miguel, J.J. López-Núñez, R. López-Reyes, J.B. López-Sáez, M.A. Lorente, A. Lorenzo, O. Madridano, A. Maestre, P.J. Marchena, J.M. Martín-Guerra, F. Martín-Martos, M. Mellado, E. Mena, J. Moisés, M.I. Mercado, M. Monreal, A. Muñoz-Blanco, G. Muñoz-Gamito, M.V. Morales, J.A. Nieto, E. Noguera-Gras, M.J. Núñez-Fernández, M. Olid-Velilla, J. Osorio, S. Otalora, R. Otero, D. Paredes-Ruiz, P. Parra, V. Parra, J.M. Pedrajas, M. Pérez-López, M.L. Peris, M.L. Pesce, J.A. Porras, J. Poyo-Molina, R. Puchades, A. Riera-Mestre, F. Rivera-Civico, A. Rivera-Gallego, M. Roca, V. Rosa, A. Rodríguez-Cobo, C. Rodríguez-Matute, P. Ruiz-Artacho, N. Ruiz-Giménez, J. Ruiz-Ruiz, G. Salgueiro, T. Sancho, V. Sendín, P. Sigüenza, S. Soler, B. Suárez-Rodríguez, J.M. Suriñach, G. Tiberio, M.I. Torres, A. Torres-Sánchez, J. Trujillo-Santos, F. Uresandi, E. Usandizaga, R. Valle, J.F. Varona, L. Vela, J.R. Vela, A. Villalobos, P. Villares, C. Ay, S. Nopp, I. Pabinger, M.M. Engelen, C. Martens, P. Verhamme, H.H.B. Yoo, J.D. Arguello, A.C. Montenegro, J. Roa, J. Hirmerova, R. Malý, S. Accassat, L. Bertoletti, A. Bura-Riviere, J. Catella, R. Chopard, F. Couturaud, O. Espitia, S. El Harake, R. Le Mao, I. Mahé, F. Moustafa, L. Plaisance, G. Sarlon-Bartoli, P. Suchon, E. Versini, S. Schellong, A. Braester, B. Brenner, G. Kenet, I. Tzoran, P. Sadeghipour, M. Basaglia, F. Bilora, C. Bortoluzzi, B. Brandolin, M. Ciammaichella, A. De Angelis, F. Dentali, P. Di Micco, E. Imbalzano, S. Merla, R. Pesavento, P. Prandoni, C. Siniscalchi, A. Tufano, A. Visonà, N. Vo Hong, B. Zalunardo, D. Kigitovica, E. Rusa, A. Skride, S. Fonseca, M. Manuel, J. Meireles, M. Bosevski, A. Eftimova, M. Zdraveska, H. Bounameaux, L. Mazzolai, A. Aujayeb, J.A. Caprini, I. Weinberg, and H.M. Bui

Subjects
Anticoagulants, Venous thromboembolism, Uterine bleeding, Prognostic score, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Introduction: Little is known about the clinical characteristics of women at increased risk for abnormal uterine bleeding (UB) during anticoagulation for venous thromboembolism (VTE). Methods: We used the RIETE registry to identify the baseline characteristics of women developing abnormal UB during anticoagulation. We used logistic regression analysis to identify independent predictors for abnormal UB. Then, we built a prognostic score to identify at-risk women. Results: From March 2001 through October 2022, there were 54,372 women with VTE. During anticoagulation (median, 181 days), 318 (0.6%) developed abnormal UB (major bleeding = 88, clinically relevant non-major (CRNM) = 230). On multivariable analysis, women aged 70 kg, with uterine cancer, recent UB, anemia, estrogen-related VTE, or receiving rivaroxaban or apixaban were at increased risk for abnormal UB. Using the prognostic score, 42,273 women (78%) were at low-risk, 8,828 (16%) intermediate-, and 3,271 (6.1%) at high-risk for abnormal UB. Their rates of abnormal UB were: 0.28 (95%CI: 0.23–0.35), 1.32 (95%CI: 1.07–1.61) and 7.12 (95%CI: 5.98–8.41) bleeds per 100 patient-years, respectively. The c-statistic was 0.80 (95%CI: 0.77–0.83). The rates of major UB were: 0.06 (95%CI: 0.04–0.09), 0.43 (95%CI: 0.30–0.60) and 1.85 (95%CI: 1.31–2.53) per 100 patient-years, respectively (c-statistic: 0.84; 95%CI: 0.80–0.89). The rates of CRNM uterine bleeding were: 0.21 (95%CI: 0.17–0.26), 0.85 (95%CI: 0.65–1.08), and 5.02 (95%CI: 4.09–6.10) bleeds per 100 patient-years, respectively (c-statistic: 0.78; 95%CI: 0.75–0.82). Conclusions: Using 7 variables easily available at admission, we built a prognostic score that reliably identified women with VTE at increased risk for abnormal UB during anticoagulation.

Published
2023
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3. Patterns of patient-reported symptoms and association with sociodemographic and systemic sclerosis disease characteristics: a scleroderma Patient-centered Intervention Network (SPIN) Cohort cross-sectional studyResearch in context

Author

Robyn K. Wojeck, Mitchell R. Knisely, Donald E. Bailey, Tamara J. Somers, Linda Kwakkenbos, Marie-Eve Carrier, Warren R. Nielson, Susan J. Bartlett, Vanessa L. Malcarne, Marie Hudson, Brooke Levis, Andrea Benedetti, Luc Mouthon, Brett D. Thombs, Susan G. Silva, Claire E. Adams, Richard S. Henry, Catherine Fortuné, Karen Gottesman, Geneviève Guillot, Laura K. Hummers, Amanda Lawrie-Jones, Maureen D. Mayes, Michelle Richard, Maureen Sauvé, Shervin Assassi, Ghassan El-Baalbaki, Kim Fligelstone, Tracy Frech, Amy Gietzen, Daphna Harel, Monique Hinchcliff, Sindhu R. Johnson, Maggie Larche, Catarina Leite, Christelle Nguyen, Karen Nielsen, Janet Pope, François Rannou, Tatiana Sofia Rodriguez-Reyna, Anne A. Schouffoer, Maria E. Suarez-Almazor, Christian Agard, Nassim Ait Abdallah, Marc André, Elana J. Bernstein, Sabine Berthier, Lyne Bissonnette, Alessandra Bruns, Patricia Carreira, Marion Casadevall, Benjamin Chaigne, Lorinda Chung, Benjamin Crichi, Christopher Denton, Robyn Domsic, James V. Dunne, Bertrand Dunogue, Regina Fare, Dominique Farge-Bancel, Paul R. Fortin, Jessica Gordon, Brigitte Granel-Rey, Aurélien Guffroy, Genevieve Gyger, Eric Hachulla, Sabrina Hoa, Alena Ikic, Suzanne Kafaja, Nader Khalidi, Kimberly Lakin, Marc Lambert, David Launay, Yvonne C. Lee, Hélène Maillard, Nancy Maltez, Joanne Manning, Isabelle Marie, Maria Martin Lopez, Thierry Martin, Ariel Masetto, François Maurier, Arsene Mekinian, Sheila Melchor Díaz, Mandana Nikpour, Louis Olagne, Vincent Poindron, Susanna Proudman, Alexis Régent, Sébastien Rivière, David Robinson, Esther Rodríguez Almazar, Sophie Roux, Perrine Smets, Vincent Sobanski, Robert Spiera, Virginia Steen, Evelyn Sutton, Carter Thorne, John Varga, Pearce Wilcox, Mara Cañedo Ayala, Vanessa Cook, Sophie Hu, Bianca Matthews, Elsa-Lynn Nassar, Marieke Alexandra Neyer, Julia Nordlund, and Sabrina Provencher

Subjects
Systemic sclerosis, Patient-reported symptoms, Symptom cluster, Medicine (General), R5-920
Abstract

Summary: Background: Systemic sclerosis is a heterogenous disease in which little is known about patterns of patient-reported symptom clusters. We aimed to identify classes of individuals with similar anxiety, depression, fatigue, sleep disturbance, and pain symptoms and to evaluate associated sociodemographic and disease-related characteristics. Methods: This multi-centre cross-sectional study used baseline data from Scleroderma Patient-centered Intervention Network Cohort participants enrolled from 2014 to 2020. Eligible participants completed the PROMIS-29 v2.0 measure. Latent profile analysis was used to identify homogeneous classes of participants based on patterns of anxiety, depression, fatigue, sleep disturbance, and pain scores. Sociodemographic and disease-related characteristics were compared across classes. Findings: Among 2212 participants, we identified five classes, including four classes with “Low” (565 participants, 26%), “Normal” (651 participants, 29%), “High” (569 participants, 26%), or “Very High” (193 participants, 9%) symptom levels across all symptoms. Participants in a fifth class, “High Fatigue/Sleep/Pain and Low Anxiety/Depression” (234 participants, 11%) had similar levels of fatigue, sleep disturbance, and pain as in the “High” class but low anxiety and depression symptoms. There were significant and substantive trends in sociodemographic characteristics (age, education, race or ethnicity, marital or partner status) and increasing disease severity (diffuse disease, tendon friction rubs, joint contractures, gastrointestinal symptoms) across severity-based classes. Disease severity and sociodemographic characteristics of “High Fatigue/Sleep/Pain and Low Anxiety/Depression” class participants were similar to the “High” severity class. Interpretation: Most people with systemic sclerosis can be classified by levels of patient-reported symptoms, which are consistent across symptoms and highly associated with sociodemographic and disease-related variables, except for one group which reports low mental health symptoms despite high levels of other symptoms and substantial disease burden. Studies are needed to better understand resilience in systemic sclerosis and to identify and facilitate implementation of cognitive and behavioural strategies to improve coping and overall quality of life. Funding: National Institute of Nursing Research (F31NR019007), Canadian Institutes of Health Research, Arthritis Society Canada, the Lady Davis Institute for Medical Research, the Jewish General Hospital Foundation, McGill University, Scleroderma Society of Ontario, Scleroderma Canada, Sclérodermie Québec, Scleroderma Manitoba, Scleroderma Atlantic, Scleroderma Association of BC, Scleroderma SASK, Scleroderma Australia, Scleroderma New South Wales, Scleroderma Victoria, and Scleroderma Queensland.

Published
2023
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4. Enoxaparin versus dalteparin or tinzaparin in patients with cancer and venous thromboembolism: The RIETECAT study

Author

Javier Trujillo‐Santos, Dominique Farge‐Bancel, José María Pedrajas, Covadonga Gómez‐Cuervo, Aitor Ballaz, Andrei Braester, Isabelle Mahé, Aurora Villalobos, José Antonio Porras, Manuel Monreal, and The RIETE Investigators

Subjects
cancer, cohort, dalteparin, enoxaparin, LMWH, recurrences, Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

Abstract Background Venous thromboembolism (VTE) is a frequent complication in patients with cancer and a leading cause of morbidity and death. Objectives The objective of the RIETECAT study was to compare the long‐term effectiveness and safety of enoxaparin versus dalteparin or tinzaparin for the secondary prevention of VTE in adults with active cancer. Methods We used the data from the multicenter, multinational RIETE registry to compare the rates of VTE recurrences, major bleeding, or death over 6 months in patients with active cancer and acute VTE using full doses of enoxaparin versus dalteparin or tinzaparin, and a multivariable Cox proportional hazard model was used to analyze the primary end point. Results From January 2009 to June 2018, 4451 patients with active cancer received full doses of the study drugs: enoxaparin, 3526 patients; and dalteparin or tinzaparin, 925 (754 + 171) patients. There was limited difference in VTE recurrences (2.0% vs 2.5%) and mortality rate (19% vs 17%) between the enoxaparin and dalteparin or tinzaparin subgroups. However, there was a slight numerical increase in major bleeding (3.1% vs 1.9%). Propensity score matching confirmed that there were no differences in the risk for VTE recurrences (adjusted hazard ratio [aHR], 0.81; 95% confidence interval [CI], 0.48‐1.38), major bleeding (aHR, 1.40; 95% CI, 0.80‐2.46), or death (aHR, 1.07; 95% CI, 0.88‐1.30) between subgroups. Conclusions In RIETECAT, in patients with cancer and VTE receiving full‐dose enoxaparin or dalteparin or tinzaparin, no statistically significant differences were observed regarding effectiveness and safety outcomes over a 6‐month period.

Published
2022
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5. Different Types of Statins and All-Cause Mortality during Anticoagulation for Venous Thromboembolism: Validation Study from RIETE Registry

Author

Carmine Siniscalchi, José M. Suriñach, Adriana Visonà, José L. Fernández-Reyes, Covadonga Gómez-Cuervo, Peter Verhamme, Pablo J. Marchena, Dominique Farge-Bancel, Jorge Moisés, and Manuel Monreal

Subjects
atorvastatin, simvastatin, rosuvastatin, venous thromboembolism, death, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Introduction We previously reported that during the course of anticoagulation for venous thromboembolism (VTE) patients using statins were at a lower risk to die than nonusers. Methods We used the Registro Informatizado Enfermedad TromboEmbólica (RIETE) registry to validate our previous findings in a subsequent cohort of patients and to compare the risk of death according to the use of different types of statins. Results From January 2018 to December 2019, 19,557 patients with VTE were recruited in RIETE. Of them, 4,065 (21%) were using statins (simvastatin, 1,406; atorvastatin, 1,328; rosuvastatin, 246; and others, 1,085). During anticoagulation (192 vs.182 days, for statin and no statin users respectively), 500 patients developed a VTE recurrence, 519 suffered major bleeding, and 1,632 died (fatal pulmonary embolism [PE], 88 and fatal bleeding, 78). On multivariable analysis, statin users were at a lower risk to die (hazard ratio [HR] = 0.68; 95% confidence interval [CI]: 0.59–0.79) than nonusers. When separately analyzing the drugs, on multivariable analysis, patients using simvastatin (HR = 0.64; 95% CI: 0.52–0.80), atorvastatin (HR 0.72; 95% CI: 0.58–0.89), or other statins (HR = 0.67; 95% CI: 0.52–0.87) were at a lower risk to die than nonusers. For those using rosuvastatin, difference was not statistically significant (HR = 0.77; 95% CI: 0.50–1.19), maybe due to the sample size. Conclusion Our data validate previous findings and confirm that VTE patients using statins at baseline are at a lower risk to die than nonusers. No statistically differences were found according to type of statins.

Published
2020
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6. Prognostic Factors for Clinical Response in Systemic Lupus Erythematosus Patients Treated by Allogeneic Mesenchymal Stem Cells

Author

Lihui Wen, Myriam Labopin, Manuela Badoglio, Dandan Wang, Lingyun Sun, and Dominique Farge-Bancel

Subjects
Internal medicine, RC31-1245
Abstract

Systemic lupus erythematosus (SLE) is an autoimmune disease with a broad range of clinical manifestations and a heterogeneous disease course. There is no cure for SLE, but current standard pharmacotherapies can improve disease prognosis in most patients. However, some patients are refractory to conventional treatments and require alternative treatment options. The present study is aimed at identifying predictors of clinical response to allogeneic bone marrow-derived or umbilical cord-derived mesenchymal stem cell (BM-/UC-MSC) transplant in SLE. All adult patients identified in the Nanjing database with an SLE Disease Activity Index (SLEDAI) score≥8 at baseline that had undergone MSC transplant and who had at least 1 year of follow-up after one or two successive intravenous injections of allogeneic BM-/UC-MSCs (1 million/kg) were analyzed. SLE symptoms and SLEDAI were assessed at baseline and during follow-up to determine low disease activity (LDA) and clinical remission (CR) at 1, 3, 6, and 12 months. Sixty-nine patients were included in the study, with a median (range) SLEDAI of 13 (8-34) at baseline. Among the 69 patients, 40 (58%) achieved LDA and 16 (23%) achieved CR with a SLEDAI of 9 (4–20), 8 (0-16), 6 (0-18), and 5 (0-18) after 1, 3, 6, and 12 months, respectively. Older age (p=0.006) and no arthralgia/arthritis at baseline (p=0.03) were associated with a higher rate of LDA. Achieving CR was associated with older age (p=0.033), no arthralgia/arthritis at baseline (p=0.001), and no prior use of cyclophosphamide (p=0.003) or hydroxychloroquine (p=0.016). Future studies using unique immunosuppressive regimens and allogeneic MSC sources will further elucidate determinants of clinical response to MSC transplant in SLE.

Published
2019
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7. Soluble HLA-G Expression Inversely Correlates With Fetal Microchimerism Levels in Peripheral Blood From Women With Scleroderma

Author

Julie Di Cristofaro, Karlin R. Karlmark, Sami B. Kanaan, Doua F. Azzouz, Marina El Haddad, Lucas Hubert, Dominique Farge-Bancel, Brigitte Granel, Jean Robert Harlé, Eric Hachulla, Etienne Pardoux, Jean Roudier, Christophe Picard, and Nathalie C. Lambert

Subjects
human leukocyte antigen-G, microchimerism, scleroderma, systemic sclerosis, pregnancy, fetal, Immunologic diseases. Allergy, RC581-607
Abstract

Women with scleroderma (SSc) maintain significantly higher quantities of persisting fetal microchimerism (FMc) from complete or incomplete pregnancies in their peripheral blood compared to healthy women. The non-classical class-I human leukocyte antigen (HLA) molecule HLA-G plays a pivotal role for the implantation and maintenance of pregnancy and has often been investigated in offspring from women with pregnancy complications. However data show that maternal HLA-G polymorphisms as well as maternal soluble HLA-G (sHLA-G) expression could influence pregnancy outcome. Here, we aimed to investigate the underlying role of maternal sHLA-G expression and HLA-G polymorphisms on the persistence of FMc. We measured sHLA-G levels by enzyme linked immunosorbent assay in plasma samples from 88 healthy women and 74 women with SSc. Male Mc was quantified by DYS14 real-time PCR in blood samples from 58 women who had previously given birth to at least one male child. Furthermore, eight HLA-G 5′URR/3′UTR polymorphisms, previously described as influencing HLA-G expression, were performed on DNA samples from 96 healthy women and 106 women with SSc. Peripheral sHLA-G was at lower concentration in plasma from SSc (76.2 ± 48.3 IU/mL) compared to healthy women (117.5 ± 60.1 IU/mL, p

Published
2018
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8. Analysis of clinical factors affecting the rates of fatal pulmonary embolism and bleeding in cancer patients with venous thromboembolism

Author

Javier Trujillo-Santos, Francisco Martín Martos, Carme Font, Dominique Farge-Bancel, Vladimir Rosa, Alicia Lorenzo, Manuel Barrón, Manuel Alejandro Lorente, José María Pedrajas, and Manuel Monreal

Subjects
Health Sciences, Medicine, Science (General), Q1-390, Social sciences (General), H1-99
Abstract

Background: In cancer patients with symptomatic venous thromboembolism (VTE) (deep-vein thrombosis (DVT) and/or pulmonary embolism (PE)), clinical factors that influence the benefit-risk balance of anticoagulation need to be identified so treatment intensity and duration can be optimally adjusted for the individual patient. Methods: Using clinical data for cancer patients with VTE obtained from the RIETE registry, we compared how rates of fatal PE and fatal bleeding during and after anticoagulation vary depending on patients‘ clinical characteristics. Results: Data were analysed from the 10,962 cancer patients with VTE (5,740 with PE with or without DVT; 5,222 with DVT alone) in RIETE registry as of March 2016. Fatal PE occurred in 2.18% of patients, while fatal bleedings occurred in 1.55%. During the 12 months from initial VTE, fatal PE was the most common cause of death, after disseminating cancer, and bleeding the fourth most common. In patients initially presenting with PE, fatal PE during anticoagulation was 4-fold more frequent than fatal bleeding (204 vs 51 deaths) and occurred mostly during the first month of treatment (196/223, 88%). In patients initially presenting with DVT, fatal PE was 3-fold lower than fatal bleeding during (25 vs 85 deaths) and after anticoagulation treatment (8 vs 37 deaths). During the 12-month follow-up, other characteristics of cancer patients with VTE were identified as more common in fatal cases of PE and/or bleeding than in surviving cases. Interpretation: Baseline clinical characteristics may determine anticoagulation outcomes in cancer patients with VTE and should be further investigated as possible factors for guiding changes in current practices of anticoagulation, such as adjusting anticoagulation intensity and duration in selected patients.

Published
2017
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9. Glutathione S Transferases Polymorphisms Are Independent Prognostic Factors in Lupus Nephritis Treated with Cyclophosphamide.

Author

Alexandra Audemard-Verger, Nicolas Martin Silva, Céline Verstuyft, Nathalie Costedoat-Chalumeau, Aurélie Hummel, Véronique Le Guern, Karim Sacré, Olivier Meyer, Eric Daugas, Cécile Goujard, Audrey Sultan, Thierry Lobbedez, Lionel Galicier, Jacques Pourrat, Claire Le Hello, Michel Godin, Rémy Morello, Marc Lambert, Eric Hachulla, Philippe Vanhille, Guillaume Queffeulou, Jacky Potier, Jean-Jacques Dion, Pierre Bataille, Dominique Chauveau, Guillaume Moulis, Dominique Farge-Bancel, Pierre Duhaut, Bernadette Saint-Marcoux, Alban Deroux, Jennifer Manuzak, Camille Francès, Olivier Aumaitre, Holy Bezanahary, Laurent Becquemont, and Boris Bienvenu

Subjects
Medicine, Science
Abstract

OBJECTIVE:To investigate association between genetic polymorphisms of GST, CYP and renal outcome or occurrence of adverse drug reactions (ADRs) in lupus nephritis (LN) treated with cyclophosphamide (CYC). CYC, as a pro-drug, requires bioactivation through multiple hepatic cytochrome P450s and glutathione S transferases (GST). METHODS:We carried out a multicentric retrospective study including 70 patients with proliferative LN treated with CYC. Patients were genotyped for polymorphisms of the CYP2B6, CYP2C19, GSTP1, GSTM1 and GSTT1 genes. Complete remission (CR) was defined as proteinuria ≤0.33g/day and serum creatinine ≤124 µmol/l. Partial remission (PR) was defined as proteinuria ≤1.5g/day with a 50% decrease of the baseline proteinuria value and serum creatinine no greater than 25% above baseline. RESULTS:Most patients were women (84%) and 77% were Caucasian. The mean age at LN diagnosis was 41 ± 10 years. The frequency of patients carrying the GST null genotype GSTT1-, GSTM1-, and the Ile→105Val GSTP1 genotype were respectively 38%, 60% and 44%. In multivariate analysis, the Ile→105Val GSTP1 genotype was an independent factor of poor renal outcome (achievement of CR or PR) (OR = 5.01 95% CI [1.02-24.51]) and the sole factor that influenced occurrence of ADRs was the GSTM1 null genotype (OR = 3.34 95% CI [1.064-10.58]). No association between polymorphisms of cytochrome P450s gene and efficacy or ADRs was observed. CONCLUSION:This study suggests that GST polymorphisms highly impact renal outcome and occurrence of ADRs related to CYC in LN patients.

Published
2016
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10. Anti-Ephrin Type-B Receptor 2 (EphB2) and Anti-Three Prime Histone mRNA EXonuclease 1 (THEX1) Autoantibodies in Scleroderma and Lupus.

Author

Doua F Azzouz, Gabriel V Martin, Fanny Arnoux, Nathalie Balandraud, Thierry Martin, Sylvain Dubucquoi, Eric Hachulla, Dominique Farge-Bancel, Kiet Tiev, Jean Cabane, Nathalie Bardin, Laurent Chiche, Marielle Martin, Eléonore C Caillet, Sami B Kanaan, Jean Robert Harlé, Brigitte Granel, Elisabeth Diot, Jean Roudier, Isabelle Auger, and Nathalie C Lambert

Subjects
Medicine, Science
Abstract

In a pilot ProtoArray analysis, we identified 6 proteins out of 9483 recognized by autoantibodies (AAb) from patients with systemic sclerosis (SSc). We further investigated the 6 candidates by ELISA on hundreds of controls and patients, including patients with Systemic Lupus Erythematosus (SLE), known for high sera reactivity and overlapping AAb with SSc. Only 2 of the 6 candidates, Ephrin type-B receptor 2 (EphB2) and Three prime Histone mRNA EXonuclease 1 (THEX1), remained significantly recognized by sera samples from SSc compared to controls (healthy or with rheumatic diseases) with, respectively, 34% versus 14% (P = 2.10-4) and 60% versus 28% (P = 3.10-8). Above all, EphB2 and THEX1 revealed to be mainly recognized by SLE sera samples with respectively 56%, (P = 2.10-10) and 82% (P = 5.10-13). As anti-EphB2 and anti-THEX1 AAb were found in both diseases, an epitope mapping was realized on each protein to refine SSc and SLE diagnosis. A 15-mer peptide from EphB2 allowed to identify 35% of SLE sera samples (N = 48) versus only 5% of any other sera samples (N = 157), including SSc sera samples. AAb titers were significantly higher in SLE sera (P

Published
2016
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11. Implementing Thrombosis Guidelines in Cancer Patients: A Review

Author

Dominique Farge-Bancel, Henri Bounameaux, Benjamin Brenner, Harry R. Büller, Ajay Kakkar, Ingrid Pabinger, Michael Streiff, and Philippe Debourdeau

Subjects
Anticoagulants, cancer, guidelines, thrombosis, Medicine, Medicine (General), R5-920
Abstract

Venous thromboembolism is a frequent and serious complication in patients with cancer. It is an independent prognostic factor of death in cancer patients and the second leading cause of death, but physicians often underestimate its importance, as well as the need for adequate prevention and treatment. Management of venous thromboembolism in patients with cancer requires the coordinated efforts of a wide range of clinicians, highlighting the importance of a multidisciplinary approach. However, a lack of consensus among various national and international clinical practice guidelines has contributed to knowledge and practice gaps among practitioners, and inconsistent approaches to venous thromboembolism. The 2013 international guidelines for thrombosis in cancer have sought to address these gaps by critically re-evaluating the evidence coming from clinical trials and synthesizing a number of guidelines documents. An individualized approach to prophylaxis is recommended for all patients.

Published
2014
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12. Comparing HLA shared epitopes in French Caucasian patients with scleroderma.

Author

Doua F Azzouz, Justyna M Rak, Isabelle Fajardy, Yannick Allanore, Kiet Phong Tiev, Dominique Farge-Bancel, Marielle Martin, Sami B Kanaan, Philippe P Pagni, Eric Hachulla, Jean Robert Harlé, Rémi Didelot, Brigitte Granel, Jean Cabane, Jean Roudier, and Nathalie C Lambert

Subjects
Medicine, Science
Abstract

Although many studies have analyzed HLA allele frequencies in several ethnic groups in patients with scleroderma (SSc), none has been done in French Caucasian patients and none has evaluated which one of the common amino acid sequences, (67)FLEDR(71), shared by HLA-DRB susceptibility alleles, or (71)TRAELDT(77), shared by HLA-DQB1 susceptibility alleles in SSc, was the most important to develop the disease. HLA-DRB and DQB typing was performed for a total of 468 healthy controls and 282 patients with SSc allowing FLEDR and TRAELDT analyses. Results were stratified according to patient's clinical subtypes and autoantibody status. Moreover, standardized HLA-DRß1 and DRß5 reverse transcriptase Taqman PCR assays were developed to quantify ß1 and ß5 mRNA in 20 subjects with HLA-DRB1*15 and/or DRB1*11 haplotypes. FLEDR motif is highly associated with diffuse SSc (χ(2) = 28.4, p

Published
2012
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13. Statin use and 30‐day mortality in patients with acute symptomatic pulmonary embolism

Author

Carmine Siniscalchi, Alfonso Muriel, Jose Maria Suriñach Caralt, Behnood Bikdeli, David Jiménez, José Luis Lobo, Cristina Amado, Aída Gil‐Díaz, Egidio Imbalzano, Manuel Monreal, Paolo Prandoni, Benjamin Brenner, Dominique Farge‐Bancel, Raquel Barba, Pierpaolo Di Micco, Laurent Bertoletti, Sebastian Schellong, Inna Tzoran, Abilio Reis, Marijan Bosevski, Henri Bounameaux, Radovan Malý, Peter Verhamme, Joseph A Caprini, and Hanh My Bui

Subjects
Neoplasms, Acute Disease, Humans, Registries, Hematology, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Pulmonary Embolism
Abstract

Statins possess antithrombotic and profibrinolytic properties. The association between statin use and short-term outcomes in patients with acute pulmonary embolism (PE) remains unknown.We used the data from the Registro Informatizado de Pacientes con Enfermedad TromboEmbólica registry to compare the 30-day all-cause mortality in patients with acute PE according to the use of statins. Secondary outcome was fatal PE. We used cancer-related mortality as a falsification endpoint.From January 2009 to April 2021, 31 169 patients with PE were recruited. Of these, 5520 (18%) were using statins at baseline: low intensity: 829, moderate: 3636, high intensity: 1055. Statin users were older and had a higher frequency of diabetes, hypertension, or atherosclerotic disease than non-users (P0.001 for all comparisons). During the first 30 days, 1475 patients died (fatal PE, 255). On multivariable analysis, statin users had a lower risk of all-cause death (odds ratio [OR]: 0.65; 95% confidence interval [CI]: 0.56-0.76) and fatal PE (OR: 0.42; 95% CI: 0.28-0.62) than non-users. The risk for death was lower in patients using either low- (OR: 0.51; 95% CI: 0.34-0.77), moderate- (OR: 0.68; 95% CI: 0.57-0.81), or high-intensity statins (OR: 0.68; 95% CI: 0.51-0.92). Results did not change in mixed effects logistic regression models with hospitals as a random effect. Statins were not associated with a significant chance in cancer mortality (falsification endpoint).PE patients using statins at baseline had a significantly lower risk of dying within the first 30 days than non-users. Randomized trials are needed to confirm these data.

Published
2022

14. Use of platelet inhibitors for digital ulcers related to systemic sclerosis: EUSTAR study on derivation and validation of the DU-VASC model

Author

Alexandru Garaiman 1, Klaus Steigmiller 2, Catherine Gebhard 3, Carina Mihai 1, Rucsandra Dobrota 1, Cosimo Bruni 4, Marco Matucci-Cerinic 5, Joerg Henes 6, Jeska de Vries-Bouwstra 7, Vanessa Smith 8, Andrea Doria 9, Yannick Allanore 10, Lorenzo Dagna 11, Branimir Anić 12, Carlomaurizio Montecucco 13, Otylia Kowal-Bielecka 14, Mickael Martin 15, Yoshiya Tanaka 16, Anna-Maria Hoffmann-Vold 17, Ulrike Held 2, Oliver Distler 1, Mike Oliver Becker 1, EUSTAR Silvia Bellando Randone, Gemma Lepri, Ulrich Walker, Florenzo Iannone, Suzana Jordan, Radim Becvar, Ewa Gindzienska-Sieskiewicz, Katarzyna Karaszewska, Maurizio Cutolo, Giovanna Cuomo, Elise Siegert, Simona Rednic, Jérome Avouac, Carole Desbas, Roberto Caporali, Lorenzo Cavagna, Patricia E Carreira, Srdan Novak, László Czirják, Michele Iudici, Eugene J Kucharz, Elisabetta Zanatta, Bernard Coleiro, Gianluca Moroncini, Dominique Farge Bancel, Paolo Airò, Roger Hesselstr, Mislav Radic, Alexandra Balbir-Gurman, Nicolas Hunzelmann, Raffaele Pellerito, Alessandro Giollo, Jadranka Morovic-Vergles, Christopher Denton, Nemanja Damjanov, Ann-Christian Pecher, Vera Ortiz Santamaria, Stefan Heitmann, Dorota Krasowska, Paul Hasler, Ivan Foeldvari, Maria João Salvador, Bojana Stamenkovic, Carlo Francesco Selmi, Lidia P Ananieva, Ariane Herrick, Ulf Müller-Ladner, Raffaele De Palma, Merete Engelhart, Gabriela Szücs, Carlos de la Puente, Øyvind Midtvedt, Torhild Garen, Håvard Fretheim, Eric Hachulla, Valeria Riccieri, Ruxandra Maria Ionescu, Ana Maria Gheorghiu, Cord Sunderkötter, Jörg Distler, Francesca Ingegnoli, Luc Mouthon, Francesco Paolo Cantatore, Susanne Ullman, Maria Rosa Pozzi, Kilian Eyerich, Piotr Wiland, Marie Vanthuyne, Juan Jose Alegre-Sancho, Kristine Herrmann, Ellen De Langhe, Marko Baresic, Miroslav Mayer, Sule Yavuz, Brigitte Granel, Carolina de Souza Müller, Svetlana Agachi, Simon Stebbings, D'Alessandro Mathieu, Alessandra Vacca, Kamal Solanki, Douglas Veale, Esthela Loyo, Carmen Tineo, Mengtao Li, Edoardo Rosato, Fahrettin Oksel, Figen Yargucu, Cristina-Mihaela Tanaseanu, Rosario Foti, Codrina Ancuta, Britta Maurer, Jacob van Laar, Marzena Olesinska, Cristiane Kayser, Nihal Fathi, Paloma García de la Peña Lefebvre, Jorge Juan Gonzalez Martin, Jean Sibilia, Ira Litinsky, Francesco Del Galdo, Lesley Ann Saketkoo, Eduardo Kerzberg, Washington Bianch, Breno Valdetaro Bianchi, Ivan Castellví, Massimiliano Limonta, Doron Rimar, Maura Couto, François Spertini, Antonella Marcoccia, Sarah Kahl, Ivien M Hsu, Thierry Martin, Sergey Moiseev, Pavel Novikov, Lorinda S Chung, Tim Schmeiser, Dominik Majewski, Zbigniew Zdrojewski, Julia Martínez-Barrio, Vera Bernardino, Gabriela Riemekasten, Yair Levy, Elena Rezus, Omer Nuri Pamuk, Piercarlo Sarzi Puttini, Hadi Poormoghim, Ina Kötter, Francis Gaches, Laura Belloli, Petros Sfikakis, Daniel Furst, Ana-Maria Ramazan, H U Scherer, Tom W J Huizinga, Marie-Elise Truchetet, Alain Lescoat, Giacomo De Luca, Corrado Campochiaro, J M van Laar, Lidia Rudnicka, Susana Oliveira, Fabiola Atzeni, Masataka Kuwana, Arsene Mekinian, Cédric L, Mathieu Puyade, Pascal Roblot, Satoshi Kubo, Yasuyuki Todoroki, 1, Alexandru Garaiman, 2, Klaus Steigmiller, 3, Catherine Gebhard, 1, Carina Mihai, 1, Rucsandra Dobrota, 4, Cosimo Bruni, 5, Marco Matucci-Cerinic, 6, Joerg Hene, 7, Jeska de Vries-Bouwstra, 8, Vanessa Smith, 9, Andrea Doria, Allanore 10, Yannick, Dagna 11, Lorenzo, Anić 12, Branimir, Montecucco 13, Carlomaurizio, Kowal-Bielecka 14, Otylia, Martin 15, Mickael, Tanaka 16, Yoshiya, Hoffmann-Vold 17, Anna-Maria, 2, Ulrike Held, 1, Oliver Distler, 1, Mike Oliver Becker, Silvia Bellando Randone, Eustar, Lepri, Gemma, Walker, Ulrich, Iannone, Florenzo, Jordan, Suzana, Becvar, Radim, Gindzienska-Sieskiewicz, Ewa, Karaszewska, Katarzyna, Cutolo, Maurizio, Cuomo, Giovanna, Siegert, Elise, Rednic, Simona, Avouac, Jérome, Desbas, Carole, Caporali, Roberto, Cavagna, Lorenzo, E Carreira, Patricia, Novak, Srdan, Czirják, László, Iudici, Michele, J Kucharz, Eugene, Zanatta, Elisabetta, Coleiro, Bernard, Moroncini, Gianluca, Farge Bancel, Dominique, Airò, Paolo, Hesselstr, Roger, Radic, Mislav, Balbir-Gurman, Alexandra, Hunzelmann, Nicola, Pellerito, Raffaele, Giollo, Alessandro, Morovic-Vergles, Jadranka, Denton, Christopher, Damjanov, Nemanja, Pecher, Ann-Christian, Ortiz Santamaria, Vera, Heitmann, Stefan, Krasowska, Dorota, Hasler, Paul, Foeldvari, Ivan, João Salvador, Maria, Stamenkovic, Bojana, Francesco Selmi, Carlo, P Ananieva, Lidia, Herrick, Ariane, Müller-Ladner, Ulf, DE PALMA, Raffaele, Engelhart, Merete, Szücs, Gabriela, de la Puente, Carlo, Midtvedt, Øyvind, Garen, Torhild, Fretheim, Håvard, Hachulla, Eric, Riccieri, Valeria, Maria Ionescu, Ruxandra, Maria Gheorghiu, Ana, Sunderkötter, Cord, Distler, Jörg, Ingegnoli, Francesca, Mouthon, Luc, Paolo Cantatore, Francesco, Ullman, Susanne, Rosa Pozzi, Maria, Eyerich, Kilian, Wiland, Piotr, Vanthuyne, Marie, Jose Alegre-Sancho, Juan, Herrmann, Kristine, De Langhe, Ellen, Baresic, Marko, Mayer, Miroslav, Yavuz, Sule, Granel, Brigitte, de Souza Müller, Carolina, Agachi, Svetlana, Stebbings, Simon, Mathieu, D'Alessandro, Vacca, Alessandra, Solanki, Kamal, Veale, Dougla, Loyo, Esthela, Tineo, Carmen, Li, Mengtao, Rosato, Edoardo, Oksel, Fahrettin, Yargucu, Figen, Tanaseanu, Cristina-Mihaela, Foti, Rosario, Ancuta, Codrina, Maurer, Britta, van Laar, Jacob, Olesinska, Marzena, Kayser, Cristiane, Fathi, Nihal, García de la Peña Lefebvre, Paloma, Juan Gonzalez Martin, Jorge, Sibilia, Jean, Litinsky, Ira, Del Galdo, Francesco, Ann Saketkoo, Lesley, Kerzberg, Eduardo, Bianch, Washington, Valdetaro Bianchi, Breno, Castellví, Ivan, Limonta, Massimiliano, Rimar, Doron, Couto, Maura, Spertini, Françoi, Marcoccia, Antonella, Kahl, Sarah, M Hsu, Ivien, Martin, Thierry, Moiseev, Sergey, Novikov, Pavel, S Chung, Lorinda, Schmeiser, Tim, Majewski, Dominik, Zdrojewski, Zbigniew, Martínez-Barrio, Julia, Bernardino, Vera, Riemekasten, Gabriela, Levy, Yair, Rezus, Elena, Nuri Pamuk, Omer, Sarzi Puttini, Piercarlo, Poormoghim, Hadi, Kötter, Ina, Gaches, Franci, Belloli, Laura, Sfikakis, Petro, Furst, Daniel, Ramazan, Ana-Maria, U Scherer, H, J Huizinga, Tom W, Truchetet, Marie-Elise, Lescoat, Alain, De Luca, Giacomo, Campochiaro, Corrado, M van Laar, J, Rudnicka, Lidia, Oliveira, Susana, Atzeni, Fabiola, Kuwana, Masataka, Mekinian, Arsene, L, Cédric, Puyade, Mathieu, Roblot, Pascal, Kubo, Satoshi, Todoroki, Yasuyuki, and University of Zurich

Subjects
prognostic prediction model, Rheumatology, 10051 Rheumatology Clinic and Institute of Physical Medicine, digital ulcers, platelets inhibitors, 610 Medicine & health, Pharmacology (medical), SSc, 10060 Epidemiology, Biostatistics and Prevention Institute (EBPI)
Abstract

Objective To develop and validate the prognostic prediction model DU-VASC to assist the clinicians in decision-making regarding the use of platelet inhibitors (PIs) for the management of digital ulcers in patients with systemic sclerosis. Secondly, to assess the incremental value of PIs as predictor. Methods We analysed patient data from the European Scleroderma Trials and Research group registry (one time point assessed). Three sets of derivation/validation cohorts were obtained from the original cohort. Using logistic regression, we developed a model for prediction of digital ulcers (DUs). C-Statistics and calibration plots were calculated to evaluate the prediction performance. Variable importance plots and the decrease in C-statistics were used to address the importance of the predictors. Results Of 3710 patients in the original cohort, 487 had DUs and 90 were exposed to PIs. For the DU-VASC model, which includes 27 predictors, we observed good calibration and discrimination in all cohorts (C-statistic = 81.1% [95% CI: 78.9%, 83.4%] for the derivation and 82.3% [95% CI: 779.3%, 85.3%] for the independent temporal validation cohort). Exposure to PIs was associated with absence of DUs and was the most important therapeutic predictor. Further important factors associated with absence of DUs were lower modified Rodnan skin score, anti-Scl-70 negativity and normal CRP. Conversely, the exposure to phosphodiesterase-5 inhibitor, prostacyclin analogues or endothelin receptor antagonists seemed to be associated with the occurrence of DUs. Nonetheless, previous DUs remains the most impactful predictor of DUs. Conclusion The DU-VASC model, with good calibration and discrimination ability, revealed that PI treatment was the most important therapy-related predictor associated with reduced DU occurrence.

Published
2022

15. A qualitative interview study exploring the psychological health impacts of the SPIN-CHAT program among people with systemic sclerosis at the onset of COVID-19: Perceptions of trial participants and research team members

Author

Amanda Wurz, Delaney Duchek, Kelsey Ellis, Mannat Bansal, Marie-Eve Carrier, Lydia Tao, Laura Dyas, Linda Kwakkenbos, Brooke Levis, Ghassan El-Baalbaki, Danielle B. Rice, Yin Wu, Richard S. Henry, Laura Bustamante, Sami Harb, Shannon Hebblethwaite, Scott B. Patten, Susan J. Bartlett, John Varga, Luc Mouthon, Sarah Markham, Brett D. Thombs, S. Nicole Culos-Reed, Catherine Fortuné, Amy Gietzen, Geneviève Guillot, Karen Nielsen, Nancy Lewis, Michelle Richard, Maureen Sauvé, Joep Welling, Lacey Battaglio, Tina Burger, Adrienne Burleigh, Peggy Collins, Jacob Davila, Louise Inglese, Franny Kaplan, Violet Konrad, Silvia Petrella, Audrey Potvin, Natalie Puccio, Karen Gottesman, Marie Hudson, Laura K. Hummers, Amanda Lawrie-Jones, Vanessa L. Malcarne, Maureen D. Mayes, Warren R. Nielson, Shervin Assassi, Carolyn Ells, Kim Fligelstone, Tracy Frech, Daphna Harel, Monique Hinchcliff, Sindhu R. Johnson, Maggie Larche, Catarina Leite, Christelle Nguyen, Janet Pope, François Rannou, Tatiana Sofia Rodriguez-Reyna, Anne A. Schouffoer, Maria E. Suarez-Almazor, Christian Agard, Nassim Ait Abdallah, Marc André, Elana J. Bernstein, Sabine Berthier, Lyne Bissonnette, Alessandra Bruns, Patricia Carreira, Marion Casadevall, Benjamin Chaigne, Lorinda Chung, Benjamin Crichi, Christopher Denton, Robyn Domsic, James V. Dunne, Bertrand Dunogue, Regina Fare, Dominique Farge-Bancel, Paul R. Fortin, Jessica Gordon, Brigitte Granel-Rey, Aurélien Guffroy, Genevieve Gyger, Eric Hachulla, Ariane L. Herrick, Sabrina Hoa, Alena Ikic, Niall Jones, Nader Khalidi, Marc Lambert, David Launay, Yvonne C. Lee, Hélène Maillard, Nancy Maltez, Joanne Manning, Isabelle Marie, Maria Martin Lopez, Thierry Martin, Ariel Masetto, François Maurier, Arsene Mekinian, Sheila Melchor Díaz, Mandana Nikpour, Louis Olagne, Vincent Poindron, Susanna Proudman, Alexis Régent, Sébastien Rivière, David Robinson, Esther Rodríguez Almazar, Sophie Roux, Perrine Smets, Vincent Sobanski, Robert Spiera, Virginia Steen, Evelyn Sutton, Carter Thorne, Pearce Wilcox, Mara Cañedo Ayala, Marie-Nicole Discepola, Laury Montemurro, Elsa Lynn Nassar, Marieke Alexandra Neyer, Julia Nordlund, Nora Østbø, and Sabrina Provencher

Subjects
Experimental Psychopathology and Treatment, Rehabilitation
Abstract

Explore trial participants’ and research team members’ perceptions of the impact of the videoconference-based, supportive care program (SPIN-CHAT Program) during early COVID-19 for individuals with systemic sclerosis (SSc). Data were collected cross-sectionally. A social constructivist paradigm was adopted, and one-on-one videoconference-based, semi-structured interviews were conducted with SPIN-CHAT Trial participants and research team members. A hybrid inductive-deductive approach and reflexive thematic analysis were used. Of the 40 SPIN-CHAT Trial participants and 28 research team members approached, 30 trial participants (Mean age = 54.9; SD = 13.0 years) and 22 research team members agreed to participate. Those who took part in interviews had similar characteristics to those who declined. Five themes were identified: (1) The SPIN-CHAT Program conferred a range of positive psychological health outcomes, (2) People who don’t have SSc don’t get it: The importance of SSc-specific programming, (3) The group-based format of the SPIN-CHAT Program created a safe space to connect and meet similar others, (4) The structure and schedule of the SPIN-CHAT Program reduced feelings of boredom and contributed to enhanced psychological health, (5) The necessity of knowledge, skills, and tools to self-manage SSc and navigate COVID-19. Participants’ and research team members’ perspectives elucidated SPIN-CHAT Program benefits and how these benefits may have been realized. Results underscore the importance of social support from similar others, structure, and self-management to enhance psychological health during COVID-19. clinicaltrials.gov (NCT04335279)IMPLICATIONS FOR REHABILITATIONThe videoconference-based, supportive care SPIN-CHAT Program enhanced psychological health amongst individuals affected by systemic sclerosis.SPIN-CHAT Program participants and research team members shared that being around similar others, program structure, and self-management support were important and may have contributed to enhanced psychological health.Further efforts are required to explore experiences within supportive care programs to better understand if and how psychological health is impacted. The videoconference-based, supportive care SPIN-CHAT Program enhanced psychological health amongst individuals affected by systemic sclerosis. SPIN-CHAT Program participants and research team members shared that being around similar others, program structure, and self-management support were important and may have contributed to enhanced psychological health. Further efforts are required to explore experiences within supportive care programs to better understand if and how psychological health is impacted.

Published
2023

16. Phenotype of limited cutaneous systemic sclerosis patients with positive anti-topoisomerase I antibodies: data from the EUSTAR cohort

Author

Elisabetta Zanatta 1, Dörte Huscher 2, Augusta Ortolan 1, Jérôme Avouac 3, Paolo Airò 4, Alexandra Balbir-Gurman 5, Elise Siegert 6, Marco Matucci Cerinic 7, Franco Cozzi 8, Gabriela Riemekasten 9, Anna-Maria Hoffmann-Vold 10, Oliver Distler 11, Armando Gabrielli 12, Stefan Heitmann 13, Nicolas Hunzelmann 14, Carlomaurizio Montecucco 15, Jadranka Morovic-Vergles 16, Camillo Ribi 17, Andrea Doria 1, Yannick Allanore 3, EUSTAR collaborators, Giovanna Cuomo, Gianluca Moroncini, Jiri Stork, Fiorenzo Iannone, Ulrich Walker, Eugenia Bertoldo, Dorota Krasowska, Maria João Salvador, Mohammed Tikly, Eric Hachulla, Valeria Riccieri, Ami Sha, Ana Maria Gheorghiu, Cord Sunderkötter, Francesca Ingegnoli, Luc Mouthon, Vanessa Smith, Francesco Paolo Cantatore, Kilian Eyerich, Piotr Wiland, Marie Vanthuyne, Branimir Anic, Maria Üprus, Brigitte Granel, Alessandra Vacca, Cristina-Mihaela Tanaseanu, Paloma García de la Peña Lefebvre, Jean Sibilia, Ira Litinsky, Lesley Ann Saketkoo, Eduardo Kerzberg, Massimiliano Limonta, Doron Rimar, Petros Sfikakis, Maurizio Cutolo, Patricia E Carreira, Rosario Foti, Srdan Novak, Michele Iudici, Mislav Radic, Raffaele Pellerito, Carlo Francesco Selmi, Lidia P Ananieva, Gabriela Szücs, Carlos de la Puente, Ruxandra Maria Ionescu, Jörg Distler, Maria Rosa Pozzi, Juan Jose Alegre-Sancho, Kristine Herrmann, Ellen De Langhe, Sule Yavuz, Carolina de Souza Müller, Svetlana Agachi, Douglas Veale, Esthela Loyo, Mengtao Li, Edoardo Rosato, Britta Maurer, Ivan Castellví, François Spertini, Kamal Solanki, Nicoletta Del Papa, Gerard Espinosa, László Czirják, Bernard Coleiro, Dominique Farge Bancel, Christopher Denton, Nemanja Damjanov, Jörg Henes, Vera Ortiz Santamaria, Michaela Kohm, Bojana Stamenkovic, 1, Elisabetta Zanatta, 2, Dörte Huscher, 1, Augusta Ortolan, 3, Jérôme Avouac, 4, Paolo Airò, 5, Alexandra Balbir-Gurman, 6, Elise Siegert, 7, Marco Matucci Cerinic, 8, Franco Cozzi, 9, Gabriela Riemekasten, Hoffmann-Vold 10, Anna-Maria, Distler 11, Oliver, Gabrielli 12, Armando, Heitmann 13, Stefan, Hunzelmann 14, Nicola, Montecucco 15, Carlomaurizio, Morovic-Vergles 16, Jadranka, Ribi 17, Camillo, 1, Andrea Doria, 3, Yannick Allanore, Collaborators, Eustar, Cuomo, Giovanna, Moroncini, Gianluca, Stork, Jiri, Iannone, Fiorenzo, Walker, Ulrich, Bertoldo, Eugenia, Krasowska, Dorota, João Salvador, Maria, Tikly, Mohammed, Hachulla, Eric, Riccieri, Valeria, Sha, Ami, Maria Gheorghiu, Ana, Sunderkötter, Cord, Ingegnoli, Francesca, Mouthon, Luc, Smith, Vanessa, Paolo Cantatore, Francesco, Eyerich, Kilian, Wiland, Piotr, Vanthuyne, Marie, Anic, Branimir, Üprus, Maria, Granel, Brigitte, Vacca, Alessandra, Tanaseanu, Cristina-Mihaela, García de la Peña Lefebvre, Paloma, Sibilia, Jean, Litinsky, Ira, Ann Saketkoo, Lesley, Kerzberg, Eduardo, Limonta, Massimiliano, Rimar, Doron, Sfikakis, Petro, Cutolo, Maurizio, E Carreira, Patricia, Foti, Rosario, Novak, Srdan, Iudici, Michele, Radic, Mislav, Pellerito, Raffaele, Francesco Selmi, Carlo, P Ananieva, Lidia, Szücs, Gabriela, de la Puente, Carlo, Maria Ionescu, Ruxandra, Distler, Jörg, Rosa Pozzi, Maria, Jose Alegre-Sancho, Juan, Herrmann, Kristine, De Langhe, Ellen, Yavuz, Sule, de Souza Müller, Carolina, Agachi, Svetlana, Veale, Dougla, Loyo, Esthela, Li, Mengtao, Rosato, Edoardo, Maurer, Britta, Castellví, Ivan, Spertini, Françoi, Solanki, Kamal, Del Papa, Nicoletta, Espinosa, Gerard, Czirják, László, Coleiro, Bernard, Farge Bancel, Dominique, Denton, Christopher, Damjanov, Nemanja, Henes, Jörg, Ortiz Santamaria, Vera, Kohm, Michaela, and Stamenkovic, Bojana

Subjects
interstitial lung disease, Scleroderma, Systemic, Hypertension, Pulmonary, disease subset, anti-topoisomerase I, Scleroderma, Systemic sclerosis, cutaneous form, outcome, Phenotype, Rheumatology, Scleroderma, Limited, Antibodies, Antinuclear, Scleroderma, Diffuse, Humans, Pharmacology (medical), Lung Diseases, Interstitial
Abstract

Objectives To characterize patients with positive anti-topoisomerase I (ATA) in lcSSc. Methods SSc patients enrolled in the EUSTAR cohort with a disease duration of ≤3 years at database entry were considered. We assessed the risk of major organ involvement in the following groups: ATA-lcSSc vs ACA-lcSSc and vs ANA without specificity (ANA)-lcSSc, and ATA-lcSSc vs ATA-dcSSc. Cox regression models with time-dependent covariates were performed with the following outcomes: new-onset interstitial lung disease (ILD), ILD progression [forced vital capacity (FVC) decline ≥10% and ≥5% vs values at ILD diagnosis), primary myocardial involvement (PMI), pulmonary hypertension (PH), any organ involvement and all-cause mortality. Results We included 1252 patients [194 ATA-lcSSc (15.5%)], with 7.7 years (s.d. 3.5) of follow-up. ILD risk was higher in ATA-lcSSc vs ACA- and ANA-lcSSc and similar to ATA-dcSSc, although with less frequent restrictive lung disease. The risk of FVC decline ≥10% (35% of ATA-lcSSc) was lower in ATA-lcSSc than in ATA-dcSSc, whereas FVC decline ≥5% occurs similarly between ATA-lcSSc (58% of patients) and other SSc subsets, including ATA-dcSSc. The risk of PMI was similar in ATA-lcSSc and ANA-lcSSc but lower than in ACA-lcSSc; no difference in PH and mortality risk was observed among lcSSc subsets. The risk of any organ involvement, PMI and PH was lower and the mortality tended to be lower in ATA-lcSSc vs ATA-dcSSc. Conclusion ATA-lcSSc patients have a high risk of ILD, albeit with a lower risk of progression compared with ATA-dcSSc, supporting careful screening for ILD in this subgroup.

Published
2022

17. The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial

Author

Evelyn Sutton, Lorinda Chung, Sophie Roux, Robert Spiera, Maria E. Suarez-Almazor, Thierry Martin, Shadi Gholizadeh, Carolyn Ells, Isabelle Marie, Louis Olagne, Monique Hinchcliff, Karen Nielsen, Geneviève Guillot, Alena Ikic, Jessica K. Gordon, Christian Agard, Maria Gagarine, Hélène Maillard, Julie Cumin, Angelica Bourgeault, David Robinson, Susanna Proudman, Amy Gietzen, Maureen D. Mayes, François Rannou, Dan Bilsker, Joanne Manning, Richard S. Henry, Ariel Masetto, Isabelle Boutron, Catherine Fortune, Elana J. Bernstein, Carter Thorne, Cornelia H. M. van den Ende, Christopher P. Denton, Sindhu R. Johnson, Regina Fare, Nassim Ait Abdallah, Alexander W. Levis, Maria Martin, Sabrina Hoa, Eric Hachulla, Anne A. Schouffoer, Susan J. Bartlett, Marie Hudson, Sébastien Rivière, Pearce G. Wilcox, Mara Cañedo Ayala, Sheila Melchor, Ariane L. Herrick, Tracy M. Frech, Andrea Benedetti, Laura Dyas, Janet E. Pope, Dominique Farge-Bancel, Andrea Carboni Jiménez, Maggie Larché, Perrine Smets, Vanessa L. Malcarne, Julia Nordlund, Marie-Nicole Discepola, Lyne Bissonnette, Maureen Sauve, Christelle Nguyen, Marion Casadevall, Brett D. Thombs, Karen Gottesman, Patricia Carreira, Marie-Eve Carrier, Sabine Berthier, Mandana Nikpour, Alexandra Albert, Luc Mouthon, Alessandra Bruns, Claire Fedoruk, John Varga, Linda Kwakkenbos, Vincent Poindron, Brooke Levis, Shervin Assassi, Amanda Wurz, Benjamin Crichi, Daphna Harel, Suzanne Kafaja, Esther Rodriguez, Nancy Maltez, Vincent Sobanski, Catarina Leite, Marc André, François Maurier, Ghassan El-Baalbaki, Lisa R. Jewett, Nora Østbø, Marc Lambert, Michelle Richard, James V. Dunne, Niall Jones, Robyn T. Domsic, Kimberly A. Turner, Chase Correia, Joep Welling, Nicole Culos-Reed, Benjamin Chaigne, Kim Fligelstone, Tatiana Sofia Rodriguez-Reyna, Paul R. Fortin, Bertrand Dunogue, Virginia D. Steen, Warren R. Nielson, Ward van Breda, Arsene Mekinian, Nader Khalidi, Brigitte Granel-Rey, David Launay, Pamela Piotrowski, Alexis Régent, Genevieve Gyger, Robert Riggs, Lydia Tao, and Organizational Psychology

Subjects
medicine.medical_specialty, Medicine (General), Medicine (miscellaneous), law.invention, Scleroderma, Experimental Psychopathology and Treatment, Study Protocol, 03 medical and health sciences, All institutes and research themes of the Radboud University Medical Center, 0302 clinical medicine, R5-920, Randomized controlled trial, law, Patient-Centered Care, Intervention (counseling), Self-management, Humans, Medicine, Pharmacology (medical), 030212 general & internal medicine, Disease management (health), Randomized Controlled Trials as Topic, 030203 arthritis & rheumatology, Self-efficacy, Protocol (science), Scleroderma, Systemic, business.industry, COVID-19, Patient activation, Women's cancers Radboud Institute for Health Sciences [Radboudumc 17], 3. Good health, Cohort, e-Health, Physical therapy, Feasibility Studies, Anxiety, Systemic sclerosis, medicine.symptom, business
Abstract

Background Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. We completed an initial feasibility trial of an online self-administered version of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program using the cohort multiple randomized controlled trial (RCT) design. Due to low intervention offer uptake, we will conduct a new feasibility trial with progression to full-scale trial, using a two-arm parallel, partially nested RCT design. The SPIN-SELF Program has also been revised to include facilitator-led videoconference group sessions in addition to online material. We will test the group-based intervention delivery format, then evaluate the effect of the SPIN-SELF Program on disease management self-efficacy (primary) and patient activation, social appearance anxiety, and functional health outcomes (secondary). Methods This study is a feasibility trial with progression to full-scale RCT, pending meeting pre-defined criteria, of the SPIN-SELF Program. Participants will be recruited from the ongoing SPIN Cohort (http://www.spinsclero.com/en/cohort) and via social media and partner patient organizations. Eligible participants must have SSc and low to moderate disease management self-efficacy (Self-Efficacy for Managing Chronic Disease (SEMCD) Scale score ≤ 7.0). Participants will be randomized (1:1 allocation) to the group-based SPIN-SELF Program or usual care for 3 months. The primary outcome in the full-scale trial will be disease management self-efficacy based on SEMCD Scale scores at 3 months post-randomization. Secondary outcomes include SEMCD scores 6 months post-randomization plus patient activation, social appearance anxiety, and functional health outcomes at 3 and 6 months post-randomization. We will include 40 participants to assess feasibility. At the end of the feasibility portion, stoppage criteria will be used to determine if the trial procedures or SPIN-SELF Program need important modifications, thereby requiring a re-set for the full-scale trial. Otherwise, the full-scale RCT will proceed, and outcome data from the feasibility portion will be utilized in the full-scale trial. In the full-scale RCT, 524 participants will be recruited. Discussion The SPIN-SELF Program may improve disease management self-efficacy, patient activation, social appearance anxiety, and functional health outcomes in people with SSc. SPIN works with partner patient organizations around the world to disseminate its programs free-of-charge. Trial registration ClinicalTrials.govNCT04246528. Registered on 27 January 2020

Published
2021

18. Stratification in systemic sclerosis according to autoantibody status versus skin involvement: a study of the prospective EUSTAR cohort

Author

Muriel Elhai, Nanthara Sritharan, Marouane Boubaya, Alexandra Balbir-Gurman, Elise Siegert, Eric Hachulla, Jeska de Vries-Bouwstra, Gabriela Riemekasten, Jörg H W Distler, Edoardo Rosato, Francesco Del Galdo, Fabian A Mendoza, Daniel E Furst, Carlos de la Puente, Anna-Maria Hoffmann-Vold, Armando Gabrielli, Oliver Distler, Coralie Bloch-Queyrat, Yannick Allanore, Marco Matucci Cerinic, Ulrich Walker, Florenzo Iannone, Suzana Jordan, Radim Becvar, Otylia Kowal Bielecka, Maurizio Cutolo, Giovanna Cuomo, Claudia Kedor, Simona Rednic, Jérome Avouac, P. Vlachoyiannopoulos, C. Montecucco, Jiri Stork, Murat Inanc, Patricia E. Carreira, Srdan Novak, László Czirják, Michele Iudici, Eugene J. Kucharz, Elisabetta Zanatta, Katja Perdan-Pirkmajer, Bernard Coleiro, Gianluca Moroncini, Dominique Farge Bancel, Paolo Airò, Roger Hesselstrand, Mislav Radic, Yolanda Braun-Moscovici, Andrea Lo Monaco, Nicolas Hunzelmann, Raffaele Pellerito, Alessandro Giollo, Jadranka Morovic-Vergles, Christopher Denton, Madelon Vonk, Nemanja Damjanov, Jörg Henes, Vera Ortiz Santamaria, Stefan Heitmann, Dorota Krasowska, Paul Hasler, Michaela Kohm, Ivan Foeldvari, Gianluigi Bajocchi, Maria João Salvador, Bojana Stamenkovic, Carlo Francesco Selmi, Mohammed Tikly, Lidia P. Ananieva, Ariane Herrick, Ulf Müller-Ladner, Raffaele De Palma, Merete Engelhart, Gabriela Szücs, Cristina Sobrino Grande, Øyvind Midtvedt, David Launay, Valeria Riccieri, Ruxandra Maria Ionescu, Ami Sha, Ana Maria Gheorghiu, Cord Sunderkötter, Francesca Ingegnoli, Luc Mouthon, Vanessa Smith, Francesco Paolo Cantatore, Susanne Ullman, Carlos Alberto von Mühlen, Maria Rosa Pozzi, Kilian Eyerich, Piotr Wiland, Marie Vanthuyne, Juan Jose Alegre-Sancho, Kristine Herrmann, Ellen De Langhe, Branimir Anic, Maria Üprus, Sule Yavuz, Brigitte Granel, Carolina de Souza Müller, Joanna Busquets, Svetlana Agachi, Simon Stebbings, D'Alessandro Mathieu, Percival D. Sampaio-Barros, Lisa Stamp, Kamal Solanki, Douglas Veale, Esthela Loyo, Mengtao Li, Walid Ahmed Abdel Atty Mohamed, Antonietta Gigante, Fahrettin Oksel, Cristina-Mihaela Tanaseanu, Rosario Foti, Codrina Ancuta, Britta Maurer, Jacob van Laar, Cristiane Kayser, Nihal Fathi, Paloma García de la Peña Lefebvre, Jean Sibilia, Ira Litinsky, Giuseppina Abignano, Goda Seskute, Lesley Ann Saketkoo, Eduardo Kerzberg, Washington Bianchi, Ivan Castellví, Massimiliano Limonta, Doron Rimar, Maura Couto, François Spertini, Antonella Marcoccia, Sarah Kahl, Ivien M. Hsu, Thierry Martin, Sergey Moiseev, Lorinda S. Chung, Tim Schmeiser, Dominik Majewski, Zbigniew Zdrojewski, Julia Martínez-Barrio, Vera Bernardino, Sabine Sommerlatte, Yair Levy, Elena Rezus, Omer Nuri Pamuk, Piercarlo Sarzi Puttini, Hadi Poormoghim, Ina Kötter, Francis Gaches, Laura Belloli, Petros Sfikakis, Juliana Markus, Gary R Feldman, Ana-Maria Ramazan, H.U. Scherer, Marie-Elise Truchetet, Alain Lescoat, Lorenzo Dagna, J.M. van Laar, Lidia Rudnicka, Susana Oliveira, Fabiola Atzeni, Masataka Kuwana, Arsene Mekinian, Mickaël Martin, Yoshiya Tanaka, Elhai, M., Sritharan, N., Boubaya, M., Balbir-Gurman, A., Siegert, E., Hachulla, E., de Vries-Bouwstra, J., Riemekasten, G., Distler, J. H. W., Rosato, E., Del Galdo, F., Mendoza, F. A., Furst, D. E., de la Puente, C., Hoffmann-Vold, A. -M., Gabrielli, A., Distler, O., Bloch-Queyrat, C., Allanore, Y., Matucci Cerinic, M., Walker, U., Iannone, F., Jordan, S., Becvar, R., Kowal Bielecka, O., Cutolo, M., Cuomo, G., Kedor, C., Rednic, S., Avouac, J., Vlachoyiannopoulos, P., Montecucco, C., Stork, J., Inanc, M., Carreira, P. E., Novak, S., Czirjak, L., Iudici, M., Kucharz, E. J., Zanatta, E., Perdan-Pirkmajer, K., Coleiro, B., Moroncini, G., Farge Bancel, D., Airo, P., Hesselstrand, R., Radic, M., Braun-Moscovici, Y., Lo Monaco, A., Hunzelmann, N., Pellerito, R., Giollo, A., Morovic-Vergles, J., Denton, C., Vonk, M., Damjanov, N., Henes, J., Ortiz Santamaria, V., Heitmann, S., Krasowska, D., Hasler, P., Kohm, M., Foeldvari, I., Bajocchi, G., Salvador, M. J., Stamenkovic, B., Selmi, C. F., Tikly, M., Ananieva, L. P., Herrick, A., Muller-Ladner, U., De Palma, R., Engelhart, M., Szucs, G., Sobrino Grande, C., Midtvedt, O., Launay, D., Riccieri, V., Ionescu, R. M., Sha, A., Gheorghiu, A. M., Sunderkotter, C., Ingegnoli, F., Mouthon, L., Smith, V., Cantatore, F. P., Ullman, S., Alberto von Muhlen, C., Pozzi, M. R., Eyerich, K., Wiland, P., Vanthuyne, M., Alegre-Sancho, J. J., Herrmann, K., De Langhe, E., Anic, B., Uprus, M., Yavuz, S., Granel, B., de Souza Muller, C., Busquets, J., Agachi, S., Stebbings, S., Mathieu, D. A., Sampaio-Barros, P. D., Stamp, L., Solanki, K., Veale, D., Loyo, E., Li, M., Abdel Atty Mohamed, W. A., Gigante, A., Oksel, F., Tanaseanu, C. -M., Foti, R., Ancuta, C., Maurer, B., van Laar, J., Kayser, C., Fathi, N., Garcia de la Pena Lefebvre, P., Sibilia, J., Litinsky, I., Abignano, G., Seskute, G., Saketkoo, L. A., Kerzberg, E., Bianchi, W., Castellvi, I., Limonta, M., Rimar, D., Couto, M., Spertini, F., Marcoccia, A., Kahl, S., Hsu, I. M., Martin, T., Moiseev, S., Chung, L. S., Schmeiser, T., Majewski, D., Zdrojewski, Z., Martinez-Barrio, J., Bernardino, V., Sommerlatte, S., Levy, Y., Rezus, E., Nuri Pamuk, O., Sarzi Puttini, P., Poormoghim, H., Kotter, I., Gaches, F., Belloli, L., Sfikakis, P., Markus, J., Feldman, G. R., Ramazan, A. -M., Scherer, H. U., Truchetet, M. -E., Lescoat, A., Dagna, L., van Laar, J. M., Rudnicka, L., Oliveira, S., Atzeni, F., Kuwana, M., Mekinian, A., Martin, M., and Tanaka, Y.

Subjects
Rheumatology, Immunology, Immunology and Allergy
Abstract

Background: The current subclassification of systemic sclerosis into cutaneous subtypes does not fully capture the heterogeneity of the disease. We aimed to compare the performances of stratification into LeRoy's cutaneous subtypes versus stratification by autoantibody status in systemic sclerosis. Methods: For this cohort study, we assessed people with systemic sclerosis in the multicentre international European Scleroderma Trials and Research (EUSTAR) database. Individuals positive for systemic-sclerosis autoantibodies of two specificities were excluded, and remaining individuals were classified by cutaneous subtype, according to their systemic sclerosis-specific autoantibodies, or both. We assessed the performance of each model to predict overall survival, progression-free survival, disease progression, and different organ involvement. The three models were compared by use of the area under the curve (AUC) of the receiver operating characteristic and the net reclassification improvement (NRI). Missing data were imputed. Findings: We assessed the database on July 26, 2019. Of 16 939 patients assessed for eligibility, 10 711 patients were included: 1647 (15·4%) of 10 709 were male, 9062 (84·6%) were female, mean age was 54·4 (SD 13·8) years, and mean disease duration was 7·9 (SD 8·2) years. Information regarding cutaneous subtype was available for 10 176 participants and antibody data were available for 9643 participants. In the prognostic analysis, there was no difference in AUC for overall survival (0·82, 95% CI 0·81–0·84 for cutaneous only vs 0·84, 0·82–0·85 for antibody only vs 0·84, 0·83–0·86 for combined) or for progression-free survival (0·70, 0·69–0·71 vs 0·71, 0·70–0·72 vs 0·71, 0·70–0·72). However, at 4 years the NRI showed substantial improvement for the antibody-only model compared with the cutaneous-only model in prediction of overall survival (0·57, 0·46–0·71 for antibody only vs 0·29, 0·19–0·39 for cutaneous only) and disease progression (0·36, 0·29–0·46 vs 0·21, 0·14–0·28). The antibody-only model did better than the cutaneous-only model in predicting renal crisis (AUC 0·72, 0·70–0·74 for antibody only vs 0·66, 0·64–0·69 for cutaneous only) and lung fibrosis leading to restrictive lung function (AUC 0·76, 0·75–0·77 vs 0·71, 0·70–0·72). The combined model improved the prediction of digital ulcers and elevated systolic pulmonary artery pressure, but did poorly for cardiac involvement. Interpretation: The autoantibody-only model outperforms cutaneous-only subsetting for risk stratifying people with systemic sclerosis in the EUSTAR cohort. Physicians should be aware of these findings at the time of decision making for patient management. Funding: World Scleroderma Foundation.

Published
2022

19. Association Between Preexisting Versus Newly Identified Atrial Fibrillation and Outcomes of Patients With Acute Pulmonary Embolism

Author

Behnood Bikdeli, David Jiménez, Jorge del Toro, Gregory Piazza, Agustina Rivas, José Luis Fernández‐Reyes, Ángel Sampériz, Remedios Otero, José María Suriñach, Carmine Siniscalchi, Javier Miguel Martín‐Guerra, Joaquín Castro, Alfonso Muriel, Gregory Y. H. Lip, Samuel Z. Goldhaber, Manuel Monreal, Paolo Prandoni, Benjamin Brenner, Dominique Farge‐Bancel, Raquel Barba, Pierpaolo Di Micco, Laurent Bertoletti, Sebastian Schellong, Inna Tzoran, Abilio Reis, Marijan Bosevski, Henri Bounameaux, Radovan Malý, Peter Verhamme, Joseph A. Caprini, Hanh My Bui, María Dolores Adarraga, María Agud, Jesús Aibar, Miguel Ángel Aibar, Cristina Amado, Juan Ignacio Arcelus, Carlos Baeza, Aitor Ballaz, Cristina Barbagelata, Manuel Barrón, Belén Barrón‐Andrés, Ángeles Blanco‐Molina, Ernesto Botella, Ana María Camon, Inmaculada Cañas, Ignacio Casado, Leyre Chasco, Juan Criado, Cristina de Ancos, Javier de Miguel, Pablo Demelo‐Rodríguez, José Antonio Díaz‐Peromingo, Mario Virgilio Di Campli, Javier Díez‐Sierra, Irene Milagros Domínguez, José Carlos Escribano, Conxita Falgá, Ana Isabel Farfán‐Sedano, Carmen Fernández‐Capitán, Jose Luis Fernández‐Reyes, María Ángeles Fidalgo, Katia Flores, Carme Font, Llorenç Font, Iria Francisco, Cristina Gabara, Francisco Galeano‐Valle, David Galindo, María Angelina García, Ferrán García‐Bragado, Marta García de Herreros, Raquel García‐Hernáez, María Mar García‐Mullor, Arantxa García‐Raso, Olga Gavín‐Sebastián, Aida Gil‐Díaz, Covadonga Gómez‐Cuervo, Enric Grau, Leticia Guirado, Javier Gutiérrez, Luis Hernández‐Blasco, Elena Hernando, Miguel Herreros, Luis Jara‐Palomares, María Jesús Jaras, Rafael Jiménez, Maria Dolores Joya, José Manuel León, Jorge Lima, Pilar Llamas, José Luis Lobo, Luciano López‐Jiménez, Patricia López‐Miguel, Juan José López‐Núñez, Raquel López‐Reyes, Antonio López‐Ruiz, Juan Bosco López‐Sáez, Alicia Lorenzo, Olga Madridano, Ana Maestre, Pablo Javier Marchena, Mar Martín del Pozo, Francisco Martín‐Martos, Carmen Mella, Meritxell Mellado, Maria Isabel Mercado, Jorge Moisés, María del Valle Morales, Arturo Muñoz‐Blanco, Nuria Muñoz‐Rivas, María Sierra Navas, Jose Antonio Nieto, Manuel Jesús Núñez‐Fernández, Berta Obispo, Mónica Olid, María Carmen Olivares, José Luis Orcastegui, Clara Ortega‐Michel, Jeisson Osorio, Sonia Otalora, Pedro Parra, Virginia Parra, José María Pedrajas, Galadriel Pellejero, José Antonio Porras, José Portillo, Antoni Riera‐Mestre, Francisco Rivera‐Civico, Diego Agustín Rodríguez‐Chiaradía, Ana Rodríguez‐Cobo, Consolación Rodríguez‐Matute, Jacobo Rogado, Sonia Roig, Vladimir Rosa, Pedro Ruiz‐Artacho, Nuria Ruiz‐Giménez, Justo Ruiz‐Ruiz, Pablo Ruiz‐Sada, Giorgina Salgueiro, Rosario Sánchez‐Martínez, Juan Francisco Sánchez‐Muñoz‐Torrero, Teresa Sancho, Merçe Sirisi, Silvia Soler, Raimundo Tirado, María Isabel Torres, Carles Tolosa, Javier Trujillo‐Santos, Fernando Uresandi, Beatriz Valero, Reina Valle, Jerónimo Ramón Vela, Gemma Vidal, Paula Villares, Carles Zamora, Paula Gutiérrez, Fernando Javier Vázquez, Matthias Engelen, Thomas Vanassche, Jana Hirmerova, Estuardo Salgado, Nassim Ait Abdallah, Alessandra Bura‐Riviere, Benjamin Crichi, Philippe Debourdeau, Espitia Olivier, Nicolas Falvo, Silvia Galliazzo, Hélène Helfer, Isabelle Mahé, Farès Moustafa, Geraldine Poenou, Andrei Braester, Franca Bilora, Eugenio Bucherini, Maurizio Ciammaichella, Egidio Imbalzano, Rosa Maida, Daniela Mastroiacovo, Federica Pace, Raffaele Pesavento, Fulvio Pomero, Roberto Quintavalla, Anna Rocci, Roberta Romualdi, Antonella Tufano, Adriana Visonà, Beniamino Zalunardo, Valdis Gibietis, Dana Kigitovica, Andris Skride, Samuel Fonseca, Filipa Martins, Jose Meireles, Lucia Mazzolai, Alfonso J. Tafur, Cassius Iyad Ochoa‐Chaar, Ido Weinberg, Hannah Wilkins, Institut Català de la Salut, [Bikdeli B] Cardiovascular Medicine Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA. Yale/YNHH Center for Outcomes Research & Evaluation, New Haven, CT. Cardiovascular Research Foundation (CRF), New York, NY. [Jiménez D] Respiratory Department, Hospital Ramón y Cajal (IRYCIS), Madrid, Spain. Medicine Department, Universidad de Alcalá (IRYCIS), Madrid, Spain. CIBER de Enfermedades Respiratorias (CIBERES), Madrid, Spain. [Del Toro J] Department of Internal Medicine, Hospital General Universitario Gregorio Marañón, Madrid, Spain. [Piazza G] Cardiovascular Medicine Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA. [Rivas A] Department of Pneumonology, Hospital Universitario Araba, Álava, Spain. [Fernández-Reyes JL] Department of Internal Medicine, Complejo Hospitalario de Jaén, Jaén, Spain. [Suriñach JM] Servei de Medicina Interna, Vall d’Hebron Hospital Universitari, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus, Bikdeli, B., Jimenez, D., Toro, J. D., Piazza, G., Rivas, A., Fernandez-Reyes, J. L., Samperiz, A., Otero, R., Surinach, J. M., Siniscalchi, C., Martin-Guerra, J. M., Castro, J., Muriel, A., Lip, G. Y. H., Goldhaber, S. Z., Monreal, M., and Tufano, A

Subjects
Registrie, medicine.medical_specialty, Embolism, enfermedades cardiovasculares::enfermedades cardíacas::arritmias cardíacas::fibrilación atrial [ENFERMEDADES], Otros calificadores::/diagnóstico [Otros calificadores], Vascular Medicine, Risk Factors, Internal medicine, Other subheadings::Other subheadings::Other subheadings::/mortality [Other subheadings], Atrial Fibrillation, medicine, Other subheadings::/diagnosis [Other subheadings], Diseases of the circulatory (Cardiovascular) system, Humans, Registries, Cor - Malalties - Diagnòstic, Mortality, Original Research, Outcome, Otros calificadores::Otros calificadores::Otros calificadores::/mortalidad [Otros calificadores], business.industry, Risk Factor, Pulmonary embolism, Thrombosis, Atrial fibrillation, medicine.disease, Cardiovascular Diseases::Vascular Diseases::Embolism and Thrombosis::Embolism::Pulmonary Embolism [DISEASES], Stroke, Embòlia pulmonar - Mortalitat, RC666-701, Acute Disease, Cardiology, Avaluació de resultats (Assistència sanitària), Cardiology and Cardiovascular Medicine, business, enfermedades cardiovasculares::enfermedades vasculares::embolia y trombosis::embolia::embolia pulmonar [ENFERMEDADES], Cardiovascular Diseases::Heart Diseases::Arrhythmias, Cardiac::Atrial Fibrillation [DISEASES], Human
Abstract

Background Atrial fibrillation (AF) may exist before or occur early in the course of pulmonary embolism (PE). We determined the PE outcomes based on the presence and timing of AF. Methods and Results Using the data from a multicenter PE registry, we identified 3 groups: (1) those with preexisting AF, (2) patients with new AF within 2 days from acute PE (incident AF), and (3) patients without AF. We assessed the 90‐day and 1‐year risk of mortality and stroke in patients with AF, compared with those without AF (reference group). Among 16 497 patients with PE, 792 had preexisting AF. These patients had increased odds of 90‐day all‐cause (odds ratio [OR], 2.81; 95% CI, 2.33–3.38) and PE‐related mortality (OR, 2.38; 95% CI, 1.37–4.14) and increased 1‐year hazard for ischemic stroke (hazard ratio, 5.48; 95% CI, 3.10–9.69) compared with those without AF. After multivariable adjustment, preexisting AF was associated with significantly increased odds of all‐cause mortality (OR, 1.91; 95% CI, 1.57–2.32) but not PE‐related mortality (OR, 1.50; 95% CI, 0.85–2.66). Among 16 497 patients with PE, 445 developed new incident AF within 2 days of acute PE. Incident AF was associated with increased odds of 90‐day all‐cause (OR, 2.28; 95% CI, 1.75–2.97) and PE‐related (OR, 3.64; 95% CI, 2.01–6.59) mortality but not stroke. Findings were similar in multivariable analyses. Conclusions In patients with acute symptomatic PE, both preexisting AF and incident AF predict adverse clinical outcomes. The type of adverse outcomes may differ depending on the timing of AF onset.

Published
2021

20. Prognostic Factors for Clinical Response in Systemic Lupus Erythematosus Patients Treated by Allogeneic Mesenchymal Stem Cells

Author

Manuela Badoglio, Lingyun Sun, Lihui Wen, Myriam Labopin, Dandan Wang, and Dominique Farge-Bancel

Subjects
0301 basic medicine, lcsh:Internal medicine, medicine.medical_specialty, Article Subject, Cyclophosphamide, Arthritis, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Refractory, Internal medicine, medicine, skin and connective tissue diseases, lcsh:RC31-1245, Molecular Biology, Disease prognosis, 030203 arthritis & rheumatology, Autoimmune disease, business.industry, Mesenchymal stem cell, Hydroxychloroquine, Cell Biology, medicine.disease, Alternative treatment, 3. Good health, 030104 developmental biology, business, Research Article, medicine.drug
Abstract

Systemic lupus erythematosus (SLE) is an autoimmune disease with a broad range of clinical manifestations and a heterogeneous disease course. There is no cure for SLE, but current standard pharmacotherapies can improve disease prognosis in most patients. However, some patients are refractory to conventional treatments and require alternative treatment options. The present study is aimed at identifying predictors of clinical response to allogeneic bone marrow-derived or umbilical cord-derived mesenchymal stem cell (BM-/UC-MSC) transplant in SLE. All adult patients identified in the Nanjing database with an SLE Disease Activity Index (SLEDAI) score≥8 at baseline that had undergone MSC transplant and who had at least 1 year of follow-up after one or two successive intravenous injections of allogeneic BM-/UC-MSCs (1 million/kg) were analyzed. SLE symptoms and SLEDAI were assessed at baseline and during follow-up to determine low disease activity (LDA) and clinical remission (CR) at 1, 3, 6, and 12 months. Sixty-nine patients were included in the study, with a median (range) SLEDAI of 13 (8-34) at baseline. Among the 69 patients, 40 (58%) achieved LDA and 16 (23%) achieved CR with a SLEDAI of 9 (4–20), 8 (0-16), 6 (0-18), and 5 (0-18) after 1, 3, 6, and 12 months, respectively. Older age (p=0.006) and no arthralgia/arthritis at baseline (p=0.03) were associated with a higher rate of LDA. Achieving CR was associated with older age (p=0.033), no arthralgia/arthritis at baseline (p=0.001), and no prior use of cyclophosphamide (p=0.003) or hydroxychloroquine (p=0.016). Future studies using unique immunosuppressive regimens and allogeneic MSC sources will further elucidate determinants of clinical response to MSC transplant in SLE.

Published
2019

21. COVID-19 in the context of autologous hematopoietic stem cell transplantation for a patient with autoimmune disease

Author

Tamim Alsuliman, Nicolas Stocker, Zoé Van de Wyngaert, Souhila Ikhlef, Cyrine Ellouz, Elise Corre, Anne Banet, Laure Ricard, Rémy Dulery, Jean-Luc Meynard, Florent Malard, Bruno Stankoff, Dominique Farge-Bancel, Eolia Brissot, Mohamad Mohty, and Zora Marjanovic

Subjects
SARS-CoV-2, Hematopoietic Stem Cell Transplantation, COVID-19, Humans, General Medicine, Transplantation, Autologous, Letter to the Editor, General Biochemistry, Genetics and Molecular Biology, Autoimmune Diseases
Published
2022

22. Comparative clinical prognosis of massive and non-massive pulmonary embolism: A registry-based cohort study

Author

Marc Blondon, David Jimenez, Helia Robert‐Ebadi, Jorge Del Toro, Luciano Lopez‐Jimenez, Conxita Falga, Andris Skride, Llorenç Font, Fernando Javier Vazquez, Henri Bounameaux, Manuel Monreal, Paolo Prandoni, Benjamin Brenner, Dominique Farge‐Bancel, Raquel Barba, Pierpaolo Di Micco, Laurent Bertoletti, Sebastian Schellong, Inna Tzoran, Abilio Reis, Marijan Bosevski, Radovan Malý, Peter Verhamme, Joseph A Caprini, Hanh My Bui, MD Adarraga, M Agud, J Aibar, MA Aibar, J Alfonso, C Amado, JI Arcelus, C Baeza, A Ballaz, R Barba, C Barbagelata, M Barrón, B Barrón‐Andrés, A Blanco‐Molina, E Botella, AM Camon, J Castro, MA Caudevilla, P Cerdà, L Chasco, J Criado, C de Ancos, J de Miguel, P Demelo‐Rodríguez, JA Díaz‐Peromingo, J Díez‐Sierra, R Díaz‐Simón, IM Domínguez, M Encabo, JC Escribano, C Falgá, AI Farfán, C Fernández‐Capitán, JL Fernández‐Reyes, MA Fidalgo, K Flores, C Font, I Francisco, C Gabara, F Galeano‐Valle, MA García, F García‐Bragado, MM García‐Mullor, O Gavín‐Blanco, O Gavín‐Sebastián, A Gil‐Díaz, C Gómez‐Cuervo, J González‐Martínez, E Grau, L Guirado, J Gutiérrez, L Hernández‐Blasco, L Jara‐Palomares, MJ Jaras, D Jiménez, MD Joya, I Jou, B Lacruz, R Lecumberri, J Lima, JL Lobo, H López‐Brull, L López‐Jiménez, P López‐Miguel, JJ López‐Núñez, R López‐Reyes, JB López‐Sáez, MA Lorente, A Lorenzo, M Loring, O Madridano, A Maestre, PJ Marchena, M Martín del Pozo, F Martín‐Martos, C Martínez‐Baquerizo, C Mella, M Mellado, MI Mercado, J Moisés, MV Morales, A Muñoz‐Blanco, D Muñoz‐Guglielmetti, N Muñoz‐Rivas, E Nart, JA Nieto, MJ Núñez, MC Olivares, C Ortega‐Michel, MD Ortega‐Recio, J Osorio, S Otalora, R Otero, P Parra, V Parra, JM Pedrajas, G Pellejero, A Pérez‐Jacoiste, ML Peris, D Pesántez, JA Porras, J Portillo, L Reig, A Riera‐Mestre, A Rivas, A Rodríguez‐Cobo, C Rodríguez‐Matute, J Rogado, V Rosa, CM Rubio, P Ruiz‐Artacho, N Ruiz‐Giménez, J Ruiz‐Ruiz, P Ruiz‐Sada, JC Sahuquillo, G Salgueiro, A Sampériz, JF Sánchez‐Muñoz‐Torrero, T Sancho, P Sigüenza, M Sirisi, S Soler, S Suárez, JM Suriñach, G Tiberio, MI Torres, C Tolosa, J Trujillo‐Santos, F Uresandi, E Usandizaga, R Valle, JR Vela, G Vidal, C Vilar, P Villares, C Zamora, P Gutiérrez, FJ Vázquez, T Vanassche, C Vandenbriele, P Verhamme, J Hirmerova, R Malý, E Salgado, I Benzidia, L Bertoletti, A Bura‐Riviere, B Crichi, P Debourdeau, O Espitia, D Farge‐Bancel, H Helfer, I Mahé, F Moustafa, G Poenou, S Schellong, A Braester, B Brenner, I Tzoran, M Amitrano, F Bilora, C Bortoluzzi, B Brandolin, M Ciammaichella, D Colaizzo, F Dentali, P Di Micco, E Giammarino, E Grandone, S Mangiacapra, D Mastroiacovo, R Maida, N Mumoli, F Pace, R Pesavento, F Pomero, P Prandoni, R Quintavalla, A Rocci, C Siniscalchi, A Tufano, A Visonà, N Vo Hong, B Zalunardo, RV Kalejs, K Maķe, M Ferreira, S Fonseca, F Martins, J Meireles, M Bosevski, M Zdraveska, L Mazzolai, JA Caprini, AJ Tafur, I Weinberg, H Wilkins, HM Bui, Blondon, M., Jimenez, D., Robert-Ebadi, H., Del Toro, J., Lopez-Jimenez, L., Falga, C., Skride, A., Font, L., Vazquez, F. J., Bounameaux, H., Monreal, M., Prandoni, P., Brenner, B., Farge-Bancel, D., Barba, R., Di Micco, P., Bertoletti, L., Schellong, S., Tzoran, I., Reis, A., Bosevski, M., Maly, R., Verhamme, P., Caprini, J. A., My Bui, H., Adarraga, M. D., Agud, M., Aibar, J., Aibar, M. A., Alfonso, J., Amado, C., Arcelus, J. I., Baeza, C., Ballaz, A., Barbagelata, C., Barron, M., Barron-Andres, B., Blanco-Molina, A., Botella, E., Camon, A. M., Castro, J., Caudevilla, M. A., Cerda, P., Chasco, L., Criado, J., de Ancos, C., de Miguel, J., Demelo-Rodriguez, P., Diaz-Peromingo, J. A., Diez-Sierra, J., Diaz-Simon, R., Dominguez, I. M., Encabo, M., Escribano, J. C., Farfan, A. I., Fernandez-Capitan, C., Fernandez-Reyes, J. L., Fidalgo, M. A., Flores, K., Font, C., Francisco, I., Gabara, C., Galeano-Valle, F., Garcia, M. A., Garcia-Bragado, F., Garcia-Mullor, M. M., Gavin-Blanco, O., Gavin-Sebastian, O., Gil-Diaz, A., Gomez-Cuervo, C., Gonzalez-Martinez, J., Grau, E., Guirado, L., Gutierrez, J., Hernandez-Blasco, L., Jara-Palomares, L., Jaras, M. J., Joya, M. D., Jou, I., Lacruz, B., Lecumberri, R., Lima, J., Lobo, J. L., Lopez-Brull, H., Lopez-Miguel, P., Lopez-Nunez, J. J., Lopez-Reyes, R., Lopez-Saez, J. B., Lorente, M. A., Lorenzo, A., Loring, M., Madridano, O., Maestre, A., Marchena, P. J., Martin del Pozo, M., Martin-Martos, F., Martinez-Baquerizo, C., Mella, C., Mellado, M., Mercado, M. I., Moises, J., Morales, M. V., Munoz-Blanco, A., Munoz-Guglielmetti, D., Munoz-Rivas, N., Nart, E., Nieto, J. A., Nunez, M. J., Olivares, M. C., Ortega-Michel, C., Ortega-Recio, M. D., Osorio, J., Otalora, S., Otero, R., Parra, P., Parra, V., Pedrajas, J. M., Pellejero, G., Perez-Jacoiste, A., Peris, M. L., Pesantez, D., Porras, J. A., Portillo, J., Reig, L., Riera-Mestre, A., Rivas, A., Rodriguez-Cobo, A., Rodriguez-Matute, C., Rogado, J., Rosa, V., Rubio, C. M., Ruiz-Artacho, P., Ruiz-Gimenez, N., Ruiz-Ruiz, J., Ruiz-Sada, P., Sahuquillo, J. C., Salgueiro, G., Samperiz, A., Sanchez-Munoz-Torrero, J. F., Sancho, T., Siguenza, P., Sirisi, M., Soler, S., Suarez, S., Surinach, J. M., Tiberio, G., Torres, M. I., Tolosa, C., Trujillo-Santos, J., Uresandi, F., Usandizaga, E., Valle, R., Vela, J. R., Vidal, G., Vilar, C., Villares, P., Zamora, C., Gutierrez, P., Vanassche, T., Vandenbriele, C., Hirmerova, J., Salgado, E., Benzidia, I., Bura-Riviere, A., Crichi, B., Debourdeau, P., Espitia, O., Helfer, H., Mahe, I., Moustafa, F., Poenou, G., Braester, A., Amitrano, M., Bilora, F., Bortoluzzi, C., Brandolin, B., Ciammaichella, M., Colaizzo, D., Dentali, F., Giammarino, E., Grandone, E., Mangiacapra, S., Mastroiacovo, D., Maida, R., Mumoli, N., Pace, F., Pesavento, R., Pomero, F., Quintavalla, R., Rocci, A., Siniscalchi, C., Tufano, A., Visona, A., Vo Hong, N., Zalunardo, B., Kalejs, R. V., Maie, K., Ferreira, M., Fonseca, S., Martins, F., Meireles, J., Zdraveska, M., Mazzolai, L., Tafur, A. J., Weinberg, I., Wilkins, H., and Bui, H. M.

Subjects
Registrie, medicine.medical_specialty, pulmonary embolism, Prognosi, Hemodynamics, 030204 cardiovascular system & hematology, Cohort Studies, 03 medical and health sciences, Clinical prognosis, 0302 clinical medicine, Recurrence, Internal medicine, Case fatality rate, medicine, Humans, hemorrhage, mortality, prognosis, thrombolytic therapy, Registries, cardiovascular diseases, business.industry, Anticoagulant, Anticoagulants, Hematology, Venous Thromboembolism, Prognosis, medicine.disease, Confidence interval, Pulmonary embolism, Discontinuation, Cohort Studie, business, Venous thromboembolism, Cohort study, Human
Abstract

Aims Little is known about the prognosis of patients with massive pulmonary embolism (PE) and its risk of recurrent venous thromboembolism (VTE) compared with non-massive PE, which may inform clinical decisions. Our aim was to compare the risk of recurrent VTE, bleeding, and mortality after massive and non-massive PE during anticoagulation and after its discontinuation. Methods and results We included all participants in the RIETE registry who suffered a symptomatic, objectively confirmed segmental or more central PE. Massive PE was defined by a systolic hypotension at clinical presentation (

Published
2021

23. Pain levels and associated factors in the Scleroderma Patient-centered Intervention Network (SPIN) cohort: A multicentre cross-sectional study

Author

Suzanne Kafaja, Jessica K. Gordon, Nader Khalidi, Esther Rodriguez, Ariel Masetto, Anne A. Schouffoer, Nancy Maltez, Geneviève Guillot, Virginia D. Steen, Joep Welling, Tatiana Sofia Rodriguez-Reyna, Paul R. Fortin, Bertrand Dunogue, Niall Jones, Robyn T. Domsic, Eric Hachulla, Arsene Mekinian, Warren R. Nielson, Joanne Manning, Sindhu R. Johnson, Chase Correia, Evelyn Sutton, Nassim Ait Abdallah, David Robinson, Benjamin Chaigne, Susanna Proudman, Geneviève Gyger, Karen Gottesman, Mara Cañedo Ayala, Christian Agard, Susan J. Bartlett, Yvonne C. Lee, Kim Fligelstone, Carter Thorne, Mandana Nikpour, Marie Hudson, Catherine Fortune, Thierry Martin, Maggie Larché, Laura K. Hummers, Benjamin Crichi, Carolyn Ells, Sabine Berthier, Angelica Bourgeault, Marie-Nicole Discepola, Ariane L. Herrick, Tracy M. Frech, Andrea Benedetti, Brett D. Thombs, Sébastien Rivière, Marion Casadevall, Sheila Melchor, Janet E. Pope, Maria E. Suarez-Almazor, Regina Fare, Alessandra Bruns, John Varga, Vincent Poindron, Rina S. Fox, Lyne Bissonnette, Vanessa L. Malcarne, Richard S. Henry, Hélène Maillard, Maureen Sauve, Maria Martin, Lorinda Chung, Marc Lambert, Marie-Eve Carrier, Louis Olagne, Sophie Roux, Maria Gagarine, François Rannou, Elana J. Bernstein, Andrea Carboni Jiménez, Monique Hinchcliff, Amy Gietzen, Alena Ikic, Christelle Nguyen, Julia Nordlund, Brigitte Granel-Rey, Alexis Régent, Robert Riggs, David Launay, Sabrina Hoa, Michelle Richard, Robert Spiera, Isabelle Marie, James V. Dunne, Brooke Levis, Shervin Assassi, Catarina Leite, Daphna Harel, Marc André, Ghassan El-Baalbaki, François Maurier, Nora Østbø, Vincent Sobanski, Karen Nielsen, Patricia Carreira, Alexandra Albert, Luc Mouthon, Linda Kwakkenbos, Christopher Denton, Maureen D. Mayes, Pearce G. Wilcox, Dominique Farge-Bancel, and Perrine Smets

Subjects
medicine.medical_specialty, business.industry, Cross-sectional study, Immunology, Disease, medicine.disease, Rheumatology, Scleroderma, Women's cancers Radboud Institute for Health Sciences [Radboudumc 17], Experimental Psychopathology and Treatment, All institutes and research themes of the Radboud University Medical Center, Quality of life, Rheumatoid arthritis, Internal medicine, Cohort, Immunology and Allergy, Medicine, business, Rheumatism
Abstract

Summary Background Pain is an important and detrimental feature of systemic sclerosis but is often overlooked or deprioritised in research and clinical care. Raynaud's phenomenon, arthritis, and cutaneous ulcers are among the commonly reported disease manifestations of systemic sclerosis that could be associated with pain. We aimed to assess levels of pain intensity and interference and to evaluate disease factors associated with pain intensity and interference. Methods In this multicentre cross-sectional study, participants from the Scleroderma Patient-centered Intervention Network cohort who completed pain intensity and interference measures (Patient Reported Outcomes Information System-29 profile, version 2·0) as part of baseline assessments were included. Patients were recruited from 46 centres in Australia, Canada, France, Mexico, Spain, the UK, and the USA between April 15, 2014, and Jan 7, 2020. Eligible patients included those aged 18 years or older who met the criteria for systemic sclerosis devised by the American College of Rheumatology and the European League Against Rheumatism. Associations of pain intensity and pain interference with systemic sclerosis-related variables and overlap syndromes, controlling for sociodemographic variables, were assessed with multiple linear regression. Continuous independent variables were standardised. Findings Among 2157 participants with systemic sclerosis (268 [12%] males and 1889 [88%] females), 1870 (87%) reported mild, moderate, or severe pain (defined as ≥1 on a 0 to 10 scale), and 815 (38%) reported moderate or severe pain (defined as ≥5). Moreover, 757 (35%) participants reported moderate or severe pain interference. Greater pain intensity was independently associated with female sex (0·58 points [95% CI 0·26–0·90]), non-White race or ethnicity (0·50 points [0·21–0·79]), fewer years in formal education (0·30 points per SD [0·19–0·41]), country (reference: USA; Canada: 0·29 points [0·01–0·57] and UK: 0·58 points [0·21–0·95]), greater body-mass index (0·35 points per SD [0·24–0·45]); joint contractures (0·67 points [0·39–0·94]), digital ulcers (0·33 points [0·10–0·55]), gastrointestinal involvement (0·66 points [0·33–0·98]), skin involvement (measured using modified Rodnan skin score; 0·22 points per SD [0·10–0·35]), rheumatoid arthritis (0·96 points [0·50–1·43]), and Sjogren's syndrome (0·42 points [0·01–0·83]). Pain interference results were similar. Interpretation Pain is common among people with systemic sclerosis. Controlling for sociodemographic variables, greater pain was associated with multiple systemic sclerosis-related manifestations, including joint contractures, digital ulcers, gastrointestinal involvement, skin involvement, and the presence of overlap syndromes. Health-care providers should work with patients to address pain, including identifying and addressing systemic sclerosis manifestations associated with their pain, and supporting behavioural approaches to minimise impact on function and quality of life. Funding Canadian Institutes of Health Research, Arthritis Society, The Lady Davis Institute for Medical Research of the Jewish General Hospital, Jewish General Hospital Foundation, McGill University, Scleroderma Society of Ontario, Scleroderma Canada, Sclerodermie Quebec, Scleroderma Manitoba, Scleroderma Atlantic, Scleroderma Association of BC, Scleroderma SASK, Scleroderma Australia, Scleroderma New South Wales, Scleroderma Victoria, and Scleroderma Queensland.

Published
2021

24. Factors associated with fears due to COVID-19: A Scleroderma Patient-centered Intervention Network (SPIN) COVID-19 cohort study

Author

Yin Wu, Linda Kwakkenbos, Richard S. Henry, Marie-Eve Carrier, Maria Gagarine, Sami Harb, Angelica Bourgeault, Lydia Tao, Andrea Carboni-Jiménez, Zelalem Negeri, Scott Patten, Susan J. Bartlett, Luc Mouthon, John Varga, Andrea Benedetti, Brett D. Thombs, Catherine Fortuné, Amy Gietzen, Geneviève Guillot, Nancy Lewis, Michelle Richard, Maureen Sauvé, Joep Welling, Kim Fligelstone, Karen Gottesman, Catarina Leite, Elisabet Pérez, Murray Baron, Vanessa Malcarne, Maureen D. Mayes, Warren R. Nielson, Robert Riggs, Shervin Assassi, Carolyn Ells, Cornelia van den Ende, Tracy Frech, Daphna Harel, Monique Hinchcliff, Marie Hudson, Sindhu R. Johnson, Maggie Larche, Christelle Nguyen, Janet Pope, François Rannou, Tatiana Sofia Rodriguez Reyna, Anne A. Schouffoer, Maria E. Suarez-Almazor, Christian Agard, Alexandra Albert, Elana J. Bernstein, Sabine Berthier, Lyne Bissonnette, Alessandra Bruns, Patricia Carreira, Benjamin Chaigne, Lorinda Chung, Chase Correia, Christopher Denton, Robyn Domsic, James V. Dunne, Bertrand Dunogue, Dominique Farge-Bancel, Paul R. Fortin, Jessica Gordon, Brigitte Granel-Rey, Pierre-Yves Hatron, Ariane L. Herrick, Sabrina Hoa, Niall Jones, Artur Jose de B. Fernandes, Suzanne Kafaja, Nader Khalidi, David Launay, Joanne Manning, Isabelle Marie, Maria Martin, Arsene Mekinian, Sheila Melchor, Mandana Nikpour, Louis Olagne, Susanna Proudman, Alexis Régent, Sébastien Rivière, David Robinson, Esther Rodriguez, Sophie Roux, Vincent Sobanski, Virginia Steen, Evelyn Sutton, Carter Thorne, Pearce Wilcox, Mara Cañedo Ayala, Julia Nordlund, Nora Østbø, Danielle B. Rice, Kimberly A. Turner, Nicole Culos-Reed, Laura Dyas, Ghassan El-Baalbaki, Shannon Hebblethwaite, Laura Bustamante, Delaney Duchek, Kelsey Ellis, and Medicine

Subjects
Adult, Male, medicine.medical_specialty, Canada, Population, Psychological intervention, Context (language use), Anxiety, Article, Scleroderma, Experimental Psychopathology and Treatment, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Intervention (counseling), Patient-Centered Care, Surveys and Questionnaires, Medicine, Humans, 030212 general & internal medicine, Psychiatry, education, Aged, education.field_of_study, Scleroderma, Systemic, business.industry, COVID-19, Fear, Middle Aged, Mental health, United Kingdom, United States, 3. Good health, Psychiatry and Mental health, Clinical Psychology, Cohort, Chronic Disease, Systemic sclerosis, Chronic medical condition, Female, France, medicine.symptom, business, 030217 neurology & neurosurgery, Cohort study
Abstract

Introduction No studies have examined factors associated with fear in any group of people vulnerable during COVID-19 due to pre-existing medical conditions. Objective To investigate factors associated with fear of consequences of COVID-19 among people living with a pre-existing medical condition, the autoimmune disease systemic sclerosis (SSc; scleroderma), including country. Methods Pre-COVID-19 data from the Scleroderma Patient-centered Intervention Network (SPIN) Cohort were linked to COVID-19 data collected in April 2020. Multivariable linear regression was used to assess factors associated with continuous scores of the 10-item COVID-19 Fears Questionnaire for Chronic Medical Conditions, controlling for pre-COVID-19 anxiety symptoms. Results Compared to France (N = 156), COVID-19 Fear scores among participants from the United Kingdom (N = 50) were 0.12 SD (95% CI 0.03 to 0.21) higher; scores for Canada (N = 97) and the United States (N = 128) were higher, but not statistically significant. Greater interference of breathing problems was associated with higher fears due to COVID-19 (Standardized regression coefficient = 0.12, 95% CI 0.01 to 0.23). Participants with higher financial resources adequacy scores had lower COVID-19 Fear scores (Standardized coefficient = −0.18, 95% CI −0.28 to −0.09). Conclusions Fears due to COVID-19 were associated with clinical and functional vulnerabilities in this chronically ill population. This suggests that interventions may benefit from addressing specific clinical issues that apply to specific populations. Financial resources, health policies and political influences may also be important. The needs of people living with chronic illness during a pandemic may differ depending on the social and political context in which they live., Highlights • People with chronic diseases may experience high levels of fear due to COVID-19. • We examined factors associated with fears due to COVID-19 in an at-risk population. • We used the validated COVID-19 Fears Questionnaire for Chronic Medical Conditions. • Fears due to COVID-19 among people with SSc differed substantially by country. • Interference of breathing problems and financial adequacy were related to fears.

Published
2020

25. The Survey on Cellular and Tissue-Engineered Therapies in Europe in 2016 and 2017

Author

Max H P, Gay, Helen, Baldomero, Dominique, Farge-Bancel, Pamela G, Robey, Scott, Rodeo, Jakob, Passweg, Magdalena, Müller-Gerbl, and Ivan, Martin

Subjects
Tissue engineered, Tissue Engineering, business.industry, Biomedical Engineering, Cell- and Tissue-Based Therapy, Hematopoietic stem cell, Bioengineering, Mesenchymal Stem Cells, Original Articles, Mesenchymal Stem Cell Transplantation, Biochemistry, Regenerative medicine, Biomaterials, Cell therapy, Clinical trial, Europe, medicine.anatomical_structure, Tissue engineering, Cancer research, Medicine, Humans, business
Abstract

This report describes activity in Europe for the years 2016 and 2017 in the area of cellular and tissue-engineered therapies, excluding hematopoietic stem cell treatments for the reconstitution of hematopoiesis. It is the eighth of its kind and is supported by five established scientific organizations. In 2016 and 2017, a combined 234 teams from 29 countries responded to the cellular and engineered tissue therapy survey; 227 teams reported treating 8236 patients in these 2 years. Indications were categorized in hematology/oncology (40%; predominantly prevention or treatment of graft vs. host disease and hematopoietic graft enhancement), musculoskeletal/rheumatological disorders (29%), cardiovascular disorders (6%), neurological disorders (4%), gastrointestinal disorders (

Published
2020

26. Patient-Level, Institutional, and Temporal Variations in Use of Imaging Modalities to Confirm Pulmonary Embolism

Author

Ghazaleh Mehdipoor, David Jimenez, Laurent Bertoletti, Ángeles Fidalgo, Juan Francisco Sanchez Muñoz-Torrero, José Pedro Gonzalez-Martinez, Ángeles Blanco-Molina, Miguel Ángel Aibar, Pierre-Benoît Bonnefoy, Ramin Khorasani, Martin R. Prince, Behnood Bikdeli, Manuel Monreal, María Dolores Adarraga, María Agud, Pedro Azcarate-Agüero, Jesús Aibar, Joaquín Alfonso, Cristina Amado, Juan Ignacio Arcelus, Aitor Ballaz, Raquel Barba, Cristina Barbagelata, Manuel Barrón, Belén Barrón-Andrés, Ana María Camon, Inmaculada Cañas, Juan Criado, Cristina de Ancos, Javier de Miguel, Jorge del Toro, Pablo Demelo-Rodríguez, Carmen Díaz-Pedroche, José Antonio Díaz-Peromingo, Raquel Díaz-Simón, Javier Díez-Sierra, Irene Milagros Domínguez, José Carlos Escribano, Ana Isabel Farfán, Carmen Fernández-Capitán, José Luis Fernández-Reyes, Katia Flores, Carme Font, Llorenç Font, Iria Francisco, Cristina Gabara, Francisco Galeano-Valle, María Ángeles García, Ferran García-Bragado, María García-García, Aránzazu García-Raso, Olga Gavín-Blanco, Olga Gavín-Sebastián, María Carmen Gayol, Aída Gil-Díaz, Covadonga Gómez-Cuervo, Enric Grau, Javier Gutiérrez-Guisado, Luis Hernández-Blasco, Marina Iglesias, Luis Jara-Palomares, María Jesús Jaras, María Dolores Joya, Inés Jou, Beatriz Lacruz, Antonio Lalueza, Ramón Lecumberri, Jorge Lima, Pilar Llamas, José Luis Lobo, Luciano López-Jiménez, Patricia López-Miguel, Juan José López-Núñez, Raquel López-Reyes, Juan Bosco López-Sáez, Manuel Alejandro Lorente, Alicia Lorenzo, Mónica Loring, Marina Lumbierres, Olga Madridano, Ana Maestre, Pablo Javier Marchena, Miguel Martín-Fernández, Javier Miguel Martín-Guerra, Francisco Martín-Martos, Meritxel Mellado, María Isabel Mercado, Jorge Moisés, María del Valle Morales, Arturo Muñoz-Blanco, Diego Muñoz-Guglielmetti, José Antonio Nieto, Manuel Jesús Núñez, María Carmen Olivares, Clara Ortega-Michel, María Dolores Ortega-Recio, Jeisson Osorio, Remedios Otero, Diana Paredes, Pedro Parra, Virginia Parra, José María Pedrajas, Galadriel Pellejero, Cristina Pérez-Ductor, María Asunción Pérez-Jacoíste, David Pesántez, José Antonio Porras, José Portillo, Lluis Reig, Antoni Riera-Mestre, Agustina Rivas, Ana Rodríguez-Cobo, Irene Rodríguez-Galán, Consolación Rodríguez-Matute, Vladimir Rosa, Carmen María Rubio, Pedro Ruiz-Artacho, Nuria Ruiz-Giménez, Justo Ruiz-Ruiz, Pablo Ruiz-Sada, Paloma Ruiz-Torregrosa, Joan Carles Sahuquillo, Giorgina Salgueiro, Ángel Sampériz, Teresa Sancho, Silvia Soler, Susana Suárez, José María Suriñach, Gregorio Tiberio, María Isabel Torres, Carlos Tolosa, Javier Trujillo-Santos, Fernando Uresandi, Esther Usandizaga, Reina Valle, Jeronimo Ramón Vela, Gemma Vidal, Paula Villares, Carles Zamora, Paula Gutiérrez, Fernando Javier Vázquez, Thomas Vanassche, Christophe Vandenbriele, Peter Verhamme, Jana Hirmerova, Radovan Malý, Estuardo Salgado, Ilham Benzidia, Alessandra Bura-Riviere, Benjamin Crichi, Philippe Debourdeau, Dominique Farge-Bancel, Hélène Helfer, Isabelle Mahé, Farès Moustafa, Geraldine Poenou, Sebastian Schellong, Andrei Braester, Benjamin Brenner, Inna Tzoran, María Amitrano, Franca Bilora, Cristiano Bortoluzzi, Barbara Brandolin, Eugenio Bucherini, Maurizio Ciammaichella, Donatella Colaizzo, Francesco Dentali, Pierpaolo Di Micco, Eliana Giammarino, Elvira Grandone, Fabio Maggi, Sara Mangiacapra, Daniela Mastroiacovo, Rosa Maida, Federica Pace, Raffaele Pesavento, Fulvio Pomero, Paolo Prandoni, Roberto Quintavalla, Anna Rocci, Carmine Siniscalchi, Eros Tiraferri, Antonella Tufano, Adriana Visonà, Ngoc Vo Hong, Beniamino Zalunardo, Roberts V. Kalejs, Dana Kigitovica, Andris Skride, Melanie Ferreira, Jose Meireles, Abilio Reis, Marijan Bosevski, Gorjan Krstevski, Marija Zdraveska, Henri Bounameaux, Lucia Mazzolai, Joseph A. Caprini, Alfonso J. Tafur, Ido Weinberg, Hannah Wilkins, and Hanh My Bui

Subjects
Diagnostic Imaging, Male, medicine.medical_specialty, pulmonary embolism, Hospitals, Low-Volume, Time Factors, Computed Tomography Angiography, Health Status, Perfusion Imaging, Comorbidity, Imaging modalities, Predictive Value of Tests, Pregnancy, medicine, Humans, Radiology, Nuclear Medicine and imaging, angiography, Prospective Studies, Registries, Healthcare Disparities, Practice Patterns, Physicians', thrombosis, Computed tomography angiography, Aged, Ultrasonography, Aged, 80 and over, Venous Thrombosis, Modality (human–computer interaction), medicine.diagnostic_test, business.industry, Ventilation/perfusion scan, Phlebography, Venous Thromboembolism, Middle Aged, medicine.disease, Thrombosis, Pulmonary embolism, Hospitalization, ventilation-perfusion scan, Angiography, Female, Radiology, Cardiology and Cardiovascular Medicine, business, Pulmonary Embolism, Hospitals, High-Volume, Magnetic Resonance Angiography
Abstract

Background: The choice of the imaging modality for diagnosis of pulmonary embolism (PE) could be influenced by provider, patient or hospital characteristics, or over time. However, little is known about the choice of the diagnostic modalities in practice. The aim of this study was to evaluate the variations in the use of imaging modalities for patients with acute PE. Methods: Using the data from Registro Informatizado Enfermedad TromboEmbolica (RIETE), a prospective international registry of patients with venous thromboembolism (March 2001–January 2019), we explored the imaging modalities used in patients with acute PE. The imaging modalities included computed tomography pulmonary angiography, ventilation/perfusion scanning, pulmonary angiography, a combination of these tests, or PE signs and symptoms plus imaging-confirmed proximal deep vein thrombosis but no chest imaging. Results: Among 38 025 patients with confirmed PE (53.1% female, age: 67.3±17 years), computed tomography pulmonary angiography was the dominant modality of diagnosis in all RIETE enrollees (78.2% [99% CI, 77.6–78.7]); including pregnant patients (58.9% [99% CI, 47.7%–69.4%]) and patients with severe renal insufficiency (62.5% [99% CI, 59.9–65.0]). A greater proportion of patients underwent ventilation/perfusion scanning in larger hospitals compared with smaller hospitals (13.1% versus 7.3%, P P Conclusions: In a large multinational PE registry, variations were observed in the use of imaging modalities according to patient or institutional factors and over time. However, computed tomography pulmonary angiography was the dominant modality of diagnosis, even in pregnancy and severe renal insufficiency. The safety, costs, and downstream effects of these tests on PE-related and non-PE-related outcomes warrant further investigation.

Published
2020

27. Incidence of major adverse cardiovascular events among patients with provoked and unprovoked venous thromboembolism: Findings from the Registro Informatizado de Enfermedad Tromboembólica Registry

Author

Fernando J. Vazquez, Hanh My Bui, R. Maida, Alicia Lorenzo, Iva Golemi, Remedios Otero, R. Otero, G. Pellejero, Pilar Llamas, M.J. Soto, J. del Toro, Inna Tzoran, K. Sablinskis, Carmine Siniscalchi, E. Bucherini, G. Vidal, Juan J. López-Núñez, N. Mumoli, J.M. Suriñach, S. Ruiz-Alcaraz, H. Bounameaux, Jose Gutierrez, E. Salgado, C. Carrasco, I. Gaya, R. Parisi, M.D. Adarraga, Peter Verhamme, Meritxell Mellado, N. Vo Hong, I. Jou, M.C. Gayol, M. García-Morillo, Marco Fresa, Luis Jara-Palomares, Daniela Mastroiacovo, M. Sablinskis, A. Rodríguez-Hernández, R. Díaz-Simón, Miguel Ángel Aibar, David Jiménez, Ángel Sampériz, Raquel López-Reyes, Isabelle Mahé, P. Ruiz-Sada, Martin Ellis, J.A. Porras, Omer Iftikhar, Ángeles Blanco-Molina, J. Aibar, R. Malý, M. Pérez-Pinar, Adriana Visonà, L. Guirado, Carme Font, M. Encabo, M.A. Lorente, María del Carmen Díaz-Pedroche, F. García-Bragado, Gianfranco Lessiani, P. Prandoni, T. Sancho, I. Sanoja, A. Tafur, Manuel Monreal, M.J. Jaras, Alessandra Bura-Rivière, Javier Trujillo-Santos, E. Grau, J. Castro, E. Imbalzano, P. Demelo, A.M. Camon, P. López-Miguel, R. Quintavalla, Alfonso Tafur, Laurent Bertoletti, N. Falvo, J. Ruiz-Ruiz, M. Pinelli, M.A. Fidalgo, Pablo Javier Marchena, Anna Rocci, Aitor Ballaz, José González-Martínez, Andrei Braester, J.F. Sánchez-Muñoz-Torrero, J. Bascuñana, Philippe Debourdeau, J.M. Pedrajas, Giovanni Barillari, C. Vandenbriele, H.M. Bui, M. Iglesias, M. Bosevski, Raffaele Pesavento, Barry M. Brenner, Antonella Tufano, Silvia Soler, F. Pace, Paolo Prandoni, L. Font, L. Bertoletti, A. García-Raso, G. Pérez-Rus, V. Salazar, Juan I. Arcelus, Barbara Ney, Lauren Cote, Raquel Barba, B. Brandolin, Luciano López-Jiménez, Pierpaolo Di Micco, C. Fernández-Capitán, M. Martín Fernández, M.A. García, R. Barba, R. Valle, Carmen Fernández-Capitán, M.L. Pesce, J.M. Martín-Guerra, D. Farge-Bancel, Conxita Falga, M. Lumbierres, Fernando Uresandi, Benjamin Brenner, Elvira Grandone, Mónica Loring, Dominique Farge-Bancel, A. Lalueza, Cristiano Bortoluzzi, M.J. Núñez, M.C. Olivares, Maurizio Ciammaichella, M.D. Joya, Agustina Rivas, Joan Carles Sahuquillo, C.M. Rubio, Abílio Reis, A. Vilaseca, P. Di Micco, Jana Hirmerova, M. Monreal, José María Pedrajas, M.L. Peris, M.A. Rodríguez-Dávila, S. Otalora, F. Bilora, E. Usandizaga, C. Amado, Pedro Ruiz-Artacho, Roberto Quintavalla, B. Barrón-Andrés, P.M. Azcarate, I. Benzidia, Lucia Mazzolai, P. Gutiérrez, Jorge Lima, O. Gavín, Thomas Vanassche, Farès Moustafa, V. Gómez, Andris Skride, Joseph A. Caprini, A. Gil-Díaz, Behnood Bikdeli, A. Hij, L. Rodríguez-Fernández, Olga Madridano, C. Rodríguez-Martín, C. de Ancos, Ana Maestre, M.C. Fernández-Criado, Henri Bounameaux, M.I. Torres, Radovan Malý, A.I. Farfán, I. Tzoran, J.A. Díaz-Peromingo, J.B. López-Sáez, M. Barrón, C. Tolosa, José Luis Lobo, Francesco Dentali, M. Zdraveska, Marijan Bosevski, L.M. Hernández Blasco, J.A. Nieto, Ma Morales, J. Caprini, Golemi, I., Cote, L., Iftikhar, O., Brenner, B., Tafur, A., Bikdeli, B., Fernandez-Capitan, C., Pedrajas, J. M., Otero, R., Quintavalla, R., Monreal, M., Prandoni, P., Farge-Bancel, D., Barba, R., Di Micco, P., Bertoletti, L., Tzoran, I., Reis, A., Bounameaux, H., Maly, R., Verhamme, P., Bosevski, M., Caprini, J. A., Bui, H. M., Adarraga, M. D., Aibar, M. A., Aibar, J., Amado, C., Arcelus, J. I., Azcarate, P. M., Ballaz, A., Barron, M., Barron-Andres, B., Bascunana, J., Blanco-Molina, A., Camon, A. M., Carrasco, C., Castro, J., de Ancos, C., del Toro, J., Demelo, P., Diaz-Pedroche, M. C., Diaz-Peromingo, J. A., Diaz-Simon, R., Encabo, M., Falga, C., Farfan, A. I., Fernandez-Criado, M. C., Fidalgo, M. A., Font, C., Font, L., Garcia, M. A., Garcia-Bragado, F., Garcia-Morillo, M., Garcia-Raso, A., Gavin, O., Gaya, I., Gayol, M. C., Gil-Diaz, A., Guirado, L., Gomez, V., Gonzalez-Martinez, J., Grau, E., Gutierrez, J., Hernandez Blasco, L. M., Iglesias, M., Jara-Palomares, L., Jaras, M. J., Jimenez, D., Jou, I., Joya, M. D., Lalueza, A., Lima, J., Llamas, P., Lobo, J. L., Lopez-Jimenez, L., Lopez-Miguel, P., Lopez-Nunez, J. J., Lopez-Reyes, R., Lopez-Saez, J. B., Lorente, M. A., Lorenzo, A., Loring, M., Lumbierres, M., Madridano, O., Maestre, A., Marchena, P. J., Martin-Guerra, J. M., Martin Fernandez, M., Mellado, M., Morales, M. V., Nieto, J. A., Nunez, M. J., Olivares, M. C., Otalora, S., Pellejero, G., Perez-Pinar, M., Perez-Rus, G., Peris, M. L., Pesce, M. L., Porras, J. A., Rivas, A., Rodriguez-Davila, M. A., Rodriguez-Fernandez, L., Rodriguez-Hernandez, A., Rodriguez-Martin, C., Rubio, C. M., Ruiz-Alcaraz, S., Ruiz-Artacho, P., Ruiz-Ruiz, J., Ruiz-Sada, P., Sahuquillo, J. C., Salazar, V., Samperiz, A., Sanchez-Munoz-Torrero, J. F., Sancho, T., Sanoja, I., Soler, S., Soto, M. J., Surinach, J. M., Tolosa, C., Torres, M. I., Trujillo-Santos, J., Uresandi, F., Usandizaga, E., Valle, R., Vidal, G., Gutierrez, P., Vazquez, F. J., Vilaseca, A., Vanassche, T., Vandenbriele, C., Hirmerova, J., Salgado, E., Benzidia, I., Bura-Riviere, A., Debourdeau, P., Falvo, N., Hij, A., Mahe, I., Moustafa, F., Braester, A., Ellis, M., Barillari, G., Bilora, F., Bortoluzzi, C., Brandolin, B., Bucherini, E., Ciammaichella, M., Dentali, F., Grandone, E., Imbalzano, E., Lessiani, G., Maida, R., Mastroiacovo, D., Mumoli, N., Vo Hong, N., Pace, F., Parisi, R., Pesavento, R., Pinelli, M., Rocci, A., Siniscalchi, C., Tufano, A., Visona, A., Skride, A., Sablinskis, K., Sablinskis, M., Zdraveska, M., Fresa, M., Ney, B., Mazzolai, L., and Caprini, J.

Subjects
Registrie, Male, Time Factors, Databases, Factual, Major adverse cardiovascular event, 030204 cardiovascular system & hematology, Coronary artery disease, 0302 clinical medicine, Retrospective Studie, Cardiovascular Disease, Major adverse limb events, Medicine, Registries, 030212 general & internal medicine, Myocardial infarction, Stroke, Incidence, Incidence (epidemiology), Hazard ratio, Major adverse limb event, Heart Disease Risk Factor, Middle Aged, Prognosis, Cardiovascular Diseases, Major adverse cardiovascular events, Female, VTE, Cardiology and Cardiovascular Medicine, Human, Provoked, Venous thromboembolism, medicine.medical_specialty, Time Factor, Prognosi, Risk Assessment, 03 medical and health sciences, Internal medicine, Humans, cardiovascular diseases, Aged, Retrospective Studies, business.industry, Unstable angina, medicine.disease, equipment and supplies, Confidence interval, Heart Disease Risk Factors, Surgery, business, Mace
Abstract

Registro Informatizado de Enfermedad Tromboembólica Investigators., [Objective] Overlap exists between the risk factors for coronary artery disease and venous thromboembolism (VTE). However, a paucity of data is available on the incidence of major acute cardiovascular events (MACE) and major adverse limb events (MALE) among patients presenting with VTE. Moreover, it is unknown whether the rate of cardiovascular outcomes differs among patients with unprovoked vs provoked VTE., [Methods] We analyzed the data from 2009 to 2017 in the Registro Informatizado de Enfermedad Tromboembólica registry, an ongoing, multicenter, international registry of consecutive patients with a diagnosis of objectively confirmed VTE. The query was restricted it to patients with data entry for the arterial outcomes. The baseline prevalence of coronary artery disease risk factors was compared between patients with provoked (ie, immobility, cancer, surgery, travel >6 hours, hormonal causes) and unprovoked VTE. After the initial VTE event, we followed up patients for the composite primary outcome of incident MACE (ie, stroke, myocardial infarction, unstable angina) and/or MALE (ie, major limb events). We used the χ2 test for baseline associations and a Cox proportional hazard for multivariate analysis. We used IBM SPSS, version 24 (IBM Corp, Armonk, NY) for statistical analysis. A P value of, [Results] We analyzed the data from 41,259 patients with VTE, of whom 22,633 (55.6%) had experienced a provoked VTE. During follow-up, the patients with provoked VTE were more likely to develop MACE or MALE than were patients with unprovoked VTE (hazard ratio [HR], 1.3; 95% confidence interval [CI], 1.1-1.5). The association of arterial events with recent immobility (HR, 1.4; 95% CI, 1.5-12.1) and cancer (HR, 1.7; 95% CI, 1.4-1.9) was strong. After adjusting for multiple conventional cardiovascular risk factors, provoked VTE, compared with unprovoked VTE, was significantly associated with an increased hazard for MACE (HR, 1.4; 95% CI, 1.1-1.7). Cancer remained a significant adjusted predictor for both MACE (HR, 1.7; 95% CI, 1.4-2.1) and MALE (HR, 2.1; 95% CI 1.01-4.6) in those with provoked VTE., [Conclusions] Among patients with VTE, provoked cases, specifically those with cancer-associated VTE, have an increased risk of major arterial events.

Published
2020

28. Significant weight loss in systemic sclerosis: a study from the EULAR Scleroderma Trials and Research (EUSTAR) database

Author

Michael Hughes, Calvin Heal, Elise Siegert, Eric Hachulla, Paolo Airó, Antonella Riccardi, Oliver Distler, Marco Matucci-Cerinic, Andrea Doria, Lorenzo Baretta, Alexandra Balbir-Gurman, Patricia E Carreira, Vanessa Smith, Carlos Alberto, Jörg Distler von Mühlen, Ulf Müller-Ladner, Lidia P Ananieva, László Czirják, Jörg Henes, Jeska de Vries-Bouwstra, Mengtao Li, Fabian Mendoza, Nemanja Damjanov, Ivan Castellví, Alessandro Giollo, Stefan Heitmann, Edoardo Rosato, Lorenzo Dagna, Christopher P Denton, Marie Vanthuyne, Fabio Cacciapaglia, Valeria Riccieri, Nicolas Hunzelmann, Ami Shah, Carlomaurizio Montecucco, Raffaele Pellerito, Ruxandra Maria Ionescu, Simona Rednic, Ulrich Walker, Maria Rosa Pozzi, Anna-Maria Hoffmann-Vold, Marie-Elise Truchetet, Susanne Ullman, Carolina de Souza Müller, Juan Jose Alegre-Sancho, Eduardo Kerzberg, Francesco Del Galdo, Gabriela Riemekasten, Branimir Anic, Marko Baresic, Miroslav Mayer, Fahrettin Oksel, Figen Yargucu, Ellen De Langhe, Ina Kötter, Mohammed Tikly, Radim Becvar, Douglas Veale, Dorota Krasowska, Andrea Lo Monaco, Lidia Rudnicka, Ana Maria Gheorghiu, Piercarlo Sarzi Puttini, Mislav Radic, Armando Gabrielli, Maria João Salvador, Carlos de la Puente, Gabriela Szücs, Sule Yavuz, Rosario Foti, Otylia Kowal Bielecka, Codrina Ancuta, Peter Villiger, Sabine Adler, Patrick Jego, Michaela Kohm, Eugene J Kucharz, Dominique Farge Bancel, Tim Schmeiser, Alberto Cauli, Alessandra Vacca, Kamal Solanki, Piotr Wiland, Paloma García de la Peña Lefebvre, Jorge Juan Gonzalez Martin, Sergio Jimenez, Lesley Ann Saketkoo, Roger Hesselstrand, Francesca Ingegnoli, Jean Sibilia, Merete Engelhart, Esthela Loyo, Carmen Tineo, Francesco Paolo Cantatore, Brigitte Krummel-Lorenz, Petros Sfikakis, Cristiane Kayser, Vera Ortiz Santamaria, Bojana Stamenkovic, Giovanna Cuomo, Francesco Puppo, Thierry Zenone, Nihal Fathi, Ira Litinsky, Carlo Chizzolini, Monika Swacha, Washington Bianchi, Breno Valdetaro Bianchi, Maria Üprus, Kati Otsa, Masataka Kuwana, Panayiotis Vlachoyiannopoulos, Sarah Kahl, Bernard Coleiro, François Spertini, Walid Ahmed Abdel Atty Mohamed, Sergey Moiseev, Pavel Novikov, Dominik Majewski, Simon Stebbings, Svetlana Agachi, Massimiliano Limonta, Carlo Francesco Selmi, Elena Rezus, Kristine Herrmann, Brigitte Granel, Goda Seskute, Matthias Seidel, Paul Hasler, Maurizio Cutolo Vera Bernardino, Carmen Pizzorni, Jadranka Morovic-Vergles, Daniel Furst, Ana-Maria Ramazan, Gianluigi Bajocchi, Lisa Stamp, Doron Rimar, Antonella Marcoccia, Srdan Novak, Luc Mouthon, Jiri Stork, Lorinda S Chung, Hadi Poormoghim, Francis Gaches, Laura Belloli, Cristina-Mihaela Tanaseanu, Fabiola Atzeni, Kilian Eyerich, Ivien M Hsu, Jacob van Laar, Mary Ellen Csuka, Omer Nuri Pamuk, Maura Couto, Arsene Mekinian, Murat Inanc, Ivan Foeldvari, Julia Martínez-Barrio, Yair Levy, Juliana Markus, Susana Oliveira, Hughes, Michael, Heal, Calvin, Siegert, Elise, Hachulla, Eric, Airó, Paolo, Riccardi, Antonella, Distler, Oliver, Matucci-Cerinic, Marco, Doria, Andrea, Baretta, Lorenzo, Balbir-Gurman, Alexandra, E Carreira, Patricia, Smith, Vanessa, Alberto, Carlo, Distler von Mühlen, Jörg, Müller-Ladner, Ulf, P Ananieva, Lidia, Czirják, László, Henes, Jörg, de Vries-Bouwstra, Jeska, Li, Mengtao, Mendoza, Fabian, Damjanov, Nemanja, Castellví, Ivan, Giollo, Alessandro, Heitmann, Stefan, Rosato, Edoardo, Dagna, Lorenzo, P Denton, Christopher, Vanthuyne, Marie, Cacciapaglia, Fabio, Riccieri, Valeria, Hunzelmann, Nicola, Shah, Ami, Montecucco, Carlomaurizio, Pellerito, Raffaele, Maria Ionescu, Ruxandra, Rednic, Simona, Walker, Ulrich, Rosa Pozzi, Maria, Hoffmann-Vold, Anna-Maria, Truchetet, Marie-Elise, Ullman, Susanne, de Souza Müller, Carolina, Jose Alegre-Sancho, Juan, Kerzberg, Eduardo, Del Galdo, Francesco, Riemekasten, Gabriela, Anic, Branimir, Baresic, Marko, Mayer, Miroslav, Oksel, Fahrettin, Yargucu, Figen, De Langhe, Ellen, Kötter, Ina, Tikly, Mohammed, Becvar, Radim, Veale, Dougla, Krasowska, Dorota, Lo Monaco, Andrea, Rudnicka, Lidia, Maria Gheorghiu, Ana, Sarzi Puttini, Piercarlo, Radic, Mislav, Gabrielli, Armando, João Salvador, Maria, de la Puente, Carlo, Szücs, Gabriela, Yavuz, Sule, Foti, Rosario, Kowal Bielecka, Otylia, Ancuta, Codrina, Villiger, Peter, Adler, Sabine, Jego, Patrick, Kohm, Michaela, J Kucharz, Eugene, Farge Bancel, Dominique, Schmeiser, Tim, Cauli, Alberto, Vacca, Alessandra, Solanki, Kamal, Wiland, Piotr, García de la Peña Lefebvre, Paloma, Juan Gonzalez Martin, Jorge, Jimenez, Sergio, Ann Saketkoo, Lesley, Hesselstrand, Roger, Ingegnoli, Francesca, Sibilia, Jean, Engelhart, Merete, Loyo, Esthela, Tineo, Carmen, Paolo Cantatore, Francesco, Krummel-Lorenz, Brigitte, Sfikakis, Petro, Kayser, Cristiane, Ortiz Santamaria, Vera, Stamenkovic, Bojana, Cuomo, Giovanna, Puppo, Francesco, Zenone, Thierry, Fathi, Nihal, Litinsky, Ira, Chizzolini, Carlo, Swacha, Monika, Bianchi, Washington, Valdetaro Bianchi, Breno, Üprus, Maria, Otsa, Kati, Kuwana, Masataka, Vlachoyiannopoulos, Panayioti, Kahl, Sarah, Coleiro, Bernard, Spertini, Françoi, Ahmed Abdel Atty Mohamed, Walid, Moiseev, Sergey, Novikov, Pavel, Majewski, Dominik, Stebbings, Simon, Agachi, Svetlana, Limonta, Massimiliano, Francesco Selmi, Carlo, Rezus, Elena, Herrmann, Kristine, Granel, Brigitte, Seskute, Goda, Seidel, Matthia, Hasler, Paul, Cutolo Vera Bernardino, Maurizio, Pizzorni, Carmen, Morovic-Vergles, Jadranka, Furst, Daniel, Ramazan, Ana-Maria, Bajocchi, Gianluigi, Stamp, Lisa, Rimar, Doron, Marcoccia, Antonella, Novak, Srdan, Mouthon, Luc, Stork, Jiri, S Chung, Lorinda, Poormoghim, Hadi, Gaches, Franci, Belloli, Laura, Tanaseanu, Cristina-Mihaela, Atzeni, Fabiola, Eyerich, Kilian, M Hsu, Ivien, van Laar, Jacob, Ellen Csuka, Mary, Nuri Pamuk, Omer, Couto, Maura, Mekinian, Arsene, Inanc, Murat, Foeldvari, Ivan, Martínez-Barrio, Julia, Levy, Yair, Markus, Juliana, and Oliveira, Susana

Subjects
Adult, Male, 0301 basic medicine, medicine.medical_specialty, weight loss, systemic sclerosis, nutrition, Immunology, Disease, computer.software_genre, General Biochemistry, Genetics and Molecular Biology, Scleroderma, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Risk Factors, Weight loss, Internal medicine, Weight Loss, Epidemiology, medicine, Humans, Immunology and Allergy, 610 Medicine & health, Aged, 030203 arthritis & rheumatology, Scleroderma, Systemic, Database, business.industry, Middle Aged, medicine.disease, 030104 developmental biology, Mood, Databases as Topic, Female, Outcomes research, medicine.symptom, business, computer, Rheumatism
Abstract

Gastrointestinal (GI) involvement is almost universal in patients with systemic sclerosis (SSc) and is associated with significant disease-related morbidity and mortality.1 The entire GI tract can be involved and other disease features (eg, low mood, terminal organ failure and functional hand impairment) can result in significant nutritional impairment. Severe GI involvement has been reported to occur in ~10% of patients with SSc and often occurs early in the course of the disease.2 However, identification of patients at high risk of clinically significant weight loss is extremely challenging, including from the high prevalence of GI symptoms in patients with SSc. Therefore, there is a need to understand high-risk patients including potentially modifiable risk factors, with a view to early intervention strategies. Against this background, the aim of this study was to examine potential clinical risk factors of significant weight loss in patients with SSc. We performed an analysis of patients with SSc enrolled in the multinational, longitudinal European League Against Rheumatism (EULAR) Scleroderma Trials and Research (EUSTAR) database. In our study, we defined significant weight loss as 4.5 kg and/or least 5% of their body weight at 5 months onwards.3 Patients with a recorded second visit after 3 months and before 12 months were included in the analysis. We adopted a pragmatic approach (relevant to clinical practice) in …

Published
2020
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29. Protocol for a partially nested randomised controlled trial to evaluate the effectiveness of the scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program to reduce anxiety among at-risk scleroderma patients

Author

Brett D. Thombs, Linda Kwakkenbos, Marie-Eve Carrier, Angelica Bourgeault, Lydia Tao, Sami Harb, Maria Gagarine, Danielle Rice, Laura Bustamante, Kelsey Ellis, Delaney Duchek, Yin Wu, Parash Mani Bhandari, Dipika Neupane, Andrea Carboni-Jiménez, Richard S. Henry, Ankur Krishnan, Ying Sun, Brooke Levis, Chen He, Kimberly A. Turner, Andrea Benedetti, Nicole Culos-Reed, Ghassan El-Baalbaki, Shannon Hebblethwaite, Susan J. Bartlett, Laura Dyas, Scott Patten, John Varga, Catherine Fortuné, Amy Gietzen, Geneviève Guillot, Nancy Lewis, Karen Nielsen, Michelle Richard, Maureen Sauvé, Joep Welling, Murray Baron, Daniel E. Furst, Karen Gottesman, Vanessa Malcarne, Maureen D. Mayes, Luc Mouthon, Warren R. Nielson, Robert Riggs, Fredrick Wigley, Shervin Assassi, Isabelle Boutron, Carolyn Ells, Cornelia van den Ende, Kim Fligelstone, Tracy Frech, Dominique Godard, Daphna Harel, Monique Hinchcliff, Marie Hudson, Sindhu R. Johnson, Maggie Larche, Catarina Leite, Christelle Nguyen, Janet Pope, Alexandra Portales, François Rannou, Tatiana Sofia Rodriguez Reyna, Anne A. Schouffoer, Maria E. Suarez-Almazor, Christian Agard, Alexandra Albert, Marc André, Guylaine Arsenault, Ilham Benzidia, Elana J. Bernstein, Sabine Berthier, Lyne Bissonnette, Gilles Boire, Alessandra Bruns, Patricia Carreira, Marion Casadevall, Benjamin Chaigne, Lorinda Chung, Pascal Cohen, Chase Correia, Pierre Dagenais, Christopher Denton, Robyn Domsic, Sandrine Dubois, James V. Dunne, Bertrand Dunogue, Regina Fare, Dominique Farge-Bancel, Paul R. Fortin, Anna Gill, Jessica Gordon, Brigitte Granel-Rey, Genevieve Gyger, Eric Hachulla, Pierre-Yves Hatron, Ariane L. Herrick, Adrian Hij, Sabrina Hoa, Alena Ikic, Niall Jones, Artur Jose de B. Fernandes, Suzanne Kafaja, Nader Khalidi, Marc Lambert, David Launay, Patrick Liang, Hélène Maillard, Nancy Maltez, Joanne Manning, Isabelle Marie, Maria Martin, Thierry Martin, Ariel Masetto, François Maurier, Arsene Mekinian, Sheila Melchor, Mandana Nikpour, Louis Olagne, Vincent Poindron, Susanna Proudman, Alexis Régent, Sébastien Rivière, David Robinson, Esther Rodriguez, Sophie Roux, Perrine Smets, Doug Smith, Vincent Sobanski, Robert Spiera, Virginia Steen, Wendy Stevens, Evelyn Sutton, Benjamin Terrier, Carter Thorne, Pearce Wilcox, Mara Cañedo Ayala, Nora Ostbo, Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte (M2iSH), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)

Subjects
Research design, Program evaluation, medicine.medical_specialty, Pneumonia, Viral, Psychological intervention, Health Promotion, Anxiety, Risk Assessment, Article, Trial, law.invention, Scleroderma, Experimental Psychopathology and Treatment, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Intervention (counseling), Patient-Centered Care, Medicine, Humans, 030212 general & internal medicine, Pandemics, Scleroderma, Systemic, business.industry, COVID-19, [SDV.BBM.BM]Life Sciences [q-bio]/Biochemistry, Molecular Biology/Molecular biology, Mental health, [SDV.MP.BAC]Life Sciences [q-bio]/Microbiology and Parasitology/Bacteriology, 3. Good health, Coronavirus, Psychiatry and Mental health, Clinical Psychology, Social Isolation, Research Design, Cohort, Physical therapy, Videoconferencing, Systemic sclerosis, medicine.symptom, business, Coronavirus Infections, 030217 neurology & neurosurgery, RCT, Program Evaluation
Abstract

Objective Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions. No randomised controlled trials (RCTs) have tested interventions to reduce mental health consequences of contagious disease outbreaks. The primary objective of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate the effect of a videoconference-based program on symptoms of anxiety. Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction. Methods The SPIN-CHAT Trial is a pragmatic RCT that will be conducted using the SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score ≥ 55), not working from home, and not receiving current counselling or psychotherapy. We will randomly assign 162 participants to intervention groups of 7 to 10 participants each or waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support. Intervention participants will receive the 4-week (3 sessions per week) SPIN-CHAT Program via videoconference. The primary outcome is PROMIS Anxiety 4a score immediately post-intervention. Ethics and dissemination The SPIN-CHAT Trial will test whether a brief videoconference-based intervention will improve mental health outcomes among at-risk individuals during contagious disease outbreak., Highlights • No RCTs have tested mental health interventions in contagious disease outbreaks. • People with scleroderma face fear and isolation during COVID-19. • SPIN-CHAT is designed to improve mental health in SSc patients during COVID-19. • SPIN-CHAT provides 12 group sessions over 4 weeks. • The SPIN-CHAT trial will randomize 162 participants to intervention or waitlist.

Published
2020

30. Anti-Ephrin Type-B Receptor 2 (EphB2) and Anti-Three Prime Histone mRNA EXonuclease 1 (THEX1) Autoantibodies in Scleroderma and Lupus

Author

Gabriel V. Martin, Kiet Tiev, Brigitte Granel, Laurent Chiche, Elisabeth Diot, Eleonore C. Caillet, Marielle Martin, Nathalie C. Lambert, Isabelle Auger, Doua F. Azzouz, Fanny Arnoux, Jean Robert Harlé, Sami B. Kanaan, Thierry Martin, Jean Cabane, Nathalie Bardin, Sylvain Dubucquoi, Jean Roudier, Nathalie Balandraud, Eric Hachulla, Dominique Farge-Bancel, Arthrites autoimmunes (AA), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Rhumatologie [Sainte- Marguerite - APHM] ( Hôpitaux Sud), Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital Sainte-Marguerite [CHU - APHM] (Hôpitaux Sud ), Service d'Immunologie Clinique, CHU Strasbourg, Immunopathologie et chimie thérapeutique (ICT), Centre National de la Recherche Scientifique (CNRS)-Institut de biologie moléculaire et cellulaire (IBMC), Université de Strasbourg (UNISTRA)-Centre National de la Recherche Scientifique (CNRS)-Université de Strasbourg (UNISTRA)-Centre National de la Recherche Scientifique (CNRS), Laboratoire d'Immunologie (EA 2686), Université de Lille, Droit et Santé, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Hôpital Claude Huriez [Lille], CHU Lille, Centre national de référence des maladies auto-immunes systémiques rares (sclérodermie systémique) [Lille], Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Bases Moleculaires de l'Homeostasie Cutanee : Inflammation, Reparation et Cancer, Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Vascular research center of Marseille (VRCM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU), Centre d'Immunologie de Marseille - Luminy (CIML), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre de Compétence PACA Ouest pour la prise en charge des maladies auto-immunes systémiques, Assistance Publique-Hôpitaux de Marseille (AP-HM), Hôpital Bretonneau, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), VAFFIDES, Chantal, Institut de biologie moléculaire et cellulaire (IBMC), Université de Strasbourg (UNISTRA)-Centre National de la Recherche Scientifique (CNRS)-Université de Strasbourg (UNISTRA)-Centre National de la Recherche Scientifique (CNRS)-Centre National de la Recherche Scientifique (CNRS), Assistance Publique - Hôpitaux de Marseille (APHM), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7)

Subjects
0301 basic medicine, Male, Serum Proteins, Physiology, [SDV]Life Sciences [q-bio], Aucun, lcsh:Medicine, Biochemistry, Epitope, Scleroderma, 0302 clinical medicine, Immune Physiology, Medicine and Health Sciences, Lupus Erythematosus, Systemic, Enzyme-Linked Immunoassays, lcsh:Science, skin and connective tissue diseases, Connective Tissue Diseases, Multidisciplinary, Systemic lupus erythematosus, Immune System Proteins, Middle Aged, Blood proteins, 3. Good health, [SDV] Life Sciences [q-bio], Titer, [SDV.IMM]Life Sciences [q-bio]/Immunology, Female, Ephrin Type-B Receptor 2, Research Article, [SDV.IMM] Life Sciences [q-bio]/Immunology, Receptor, EphB2, Immunology, Rheumatoid Arthritis, Enzyme-Linked Immunosorbent Assay, Biology, Research and Analysis Methods, Systemic Lupus Erythematosus, Sensitivity and Specificity, Antibodies, Autoimmune Diseases, 03 medical and health sciences, Exonuclease 1, Rheumatology, Diagnostic Medicine, medicine, Humans, Immunoassays, Autoantibodies, 030203 arthritis & rheumatology, Scleroderma, Systemic, Lupus Erythematosus, Arthritis, lcsh:R, Autoantibody, Biology and Life Sciences, Proteins, medicine.disease, Molecular biology, 030104 developmental biology, Epitope mapping, Exoribonucleases, Immunologic Techniques, lcsh:Q, Clinical Immunology, Clinical Medicine, Epitope Mapping
Abstract

International audience; In a pilot ProtoArray analysis, we identified 6 proteins out of 9483 recognized by autoantibodies (AAb) from patients with systemic sclerosis (SSc). We further investigated the 6 candidates by ELISA on hundreds of controls and patients, including patients with Systemic Lupus Erythematosus (SLE), known for high sera reactivity and overlapping AAb with SSc. Only 2 of the 6 candidates, Ephrin type-B receptor 2 (EphB2) and Three prime Histone mRNA EXonuclease 1 (THEX1), remained significantly recognized by sera samples from SSc compared to controls (healthy or with rheumatic diseases) with, respectively, 34% versus 14% (P = 2.10(-4)) and 60% versus 28% (P = 3.10(-8)). Above all, EphB2 and THEX1 revealed to be mainly recognized by SLE sera samples with respectively 56%, (P = 2.10(-10)) and 82% (P = 5.10(-13)). As anti-EphB2 and anti-THEX1 AAb were found in both diseases, an epitope mapping was realized on each protein to refine SSc and SLE diagnosis. A 15-mer peptide from EphB2 allowed to identify 35% of SLE sera samples (N = 48) versus only 5% of any other sera samples (N = 157), including SSc sera samples. AAb titers were significantly higher in SLE sera (P< 0.0001) and correlated with disease activity (p< 0.02). We could not find an epitope on EphB2 protein for SSc neither on THEX1 for SSc or SLE. We showed that patients with SSc or SLE have AAb against EphB2, a protein involved in angiogenesis, and THEX1, a 3'-5' exoribonuclease involved in histone mRNA degradation. We have further identified a peptide from EphB2 as a specific and sensitive tool for SLE diagnosis.

Published
2016

31. Juvenile and young adult-onset systemic sclerosis share the same organ involvement in adulthood: data from the EUSTAR database

Author

Ulf Müller-Ladner, Dominique Farge Bancel, László Czirják, Christopher P. Denton, Ottilia Kowal-Bielecka, Marco Matucci-Cerinic, Alan Tyndall, Ivan Foeldvari, and Francesco Zulian

Subjects
Adult, Male, Databases, Factual, Adolescent, Juvenile systemic sclerosis, Disease, computer.software_genre, Systemic scleroderma, Scleroderma, Databases, Rheumatology, Antibody Profile, medicine, Humans, Juvenile, Pharmacology (medical), Age of Onset, Child, Preschool, Factual, Outcome, EUSTAR, Scleroderma, Systemic, Database, business.industry, Systemic, Organ involvement, Prognosis, medicine.disease, Antibody profile, Diffuse subtype, Juvenile scleroderma, Limited subtype, Systemic sclerosis, Child, Preschool, Female, Cohort, Age of onset, business, computer
Abstract

Objective. The aim of the present study was to explore the long-term outcome and clinical characteristics of adult patients with juvenile onset in the EULAR Scleroderma Trials and Research (EUSTAR) cohort and compare them with adult patients with onset between 20 and 40 years of age. Methods. From the EUSTAR SSc cohort two patient groups were analysed: patients with juvenile SSc (jSSc) who are adults at present, and patients diagnosed between the age of 20 and 40 years (aSSc). Demographic data of the patients, organ involvement and outcome of the disease were examined using the Minimal Essential Data Set database system. Results. From 5000 patients in the EUSTAR cohort, 60 patients (1.2%) with jSSc and 910 patients (18%) with aSSc were selected according the inclusion criteria. In the jSSc group, the mean age of disease onset was 12.4 years (range 2-15.9 years), and in the aSSc group, the mean age was 32 years (range 20-40 years). Disease subsets were similar. The antibody profile was also comparable except for ACAs, which were positive in 5% of the jSSc group and 26.9% of the aSSc group (P

Published
2012

32. Efficacy of sildenafil on ischaemic digital ulcer healing in systemic sclerosis: the placebo-controlled SEDUCE study

Author

Eric, Hachulla, Pierre-Yves, Hatron, Patrick, Carpentier, Christian, Agard, Emmanuel, Chatelus, Patrick, Jego, Luc, Mouthon, Viviane, Queyrel, Anne-Laure, Fauchais, Ulrique, Michon-Pasturel, Roland, Jaussaud, Alexis, Mathian, Brigitte, Granel, Elisabeth, Diot, Dominique, Farge-Bancel, Arsène, Mekinian, Jérôme, Avouac, Hélène, Desmurs-Clavel, Pierre, Clerson, Jacques, Ninet, Service de médecine interne [Lille], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Service de médecine interne, European Synchrotron Radiation Facility (ESRF), unité de recherche de l'institut du thorax UMR1087 UMR6291 (ITX), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), Service de médecine interne [Nantes], Université de Nantes (UN)-Hôtel-Dieu-Centre hospitalier universitaire de Nantes (CHU Nantes), Service de Rhumatologie, Les Hôpitaux Universitaires de Strasbourg (HUS)-Centre National de Référence pour les Maladies Systémiques Autoimmunes Rares, GIRC Thrombose, Service de Médecine interne et immunologie clinique [Rennes] = internal medicine and clinical immunology [Rennes], CHU Pontchaillou [Rennes], Service de médecine interne et centre de référence des maladies rares [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Médecine interne A et polyclinique médicale [CHU Limoges], CHU Limoges, Université de Reims Champagne-Ardenne (URCA), Institut E3M [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre d'Immunologie et de Maladies Infectieuses (CIMI), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hôpital Nord [CHU - APHM], Physiopathologie de l'Endothelium, Vascular research center of Marseille (VRCM), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Département d'Oncologie (Dep Oncol - AVIGNON), Institut Ste Catherine, CHU Saint-Antoine [AP-HP], Laboratoire de géophysique, CEA, Service de Médecine Interne, Hospices Civils de Lyon (HCL), Orgamétrie biostatistiques, Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU), Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Unité de recherche de l'institut du thorax (ITX-lab), Centre Hospitalier Régional Universitaire [Lille] ( CHRU Lille ), European Synchrotron Radiation Facility ( ESRF ), unité de recherche de l'institut du thorax UMR1087 UMR6291 ( ITX ), Université de Nantes ( UN ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), Université de Nantes ( UN ) -Hôtel-Dieu-Centre hospitalier universitaire de Nantes ( CHU Nantes ), Université de Rennes 1 ( UR1 ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Hôpital Sud, Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Cochin [AP-HP], Université de Reims Champagne-Ardenne ( URCA ), CHU Pitié-Salpêtrière [APHP], Centre d'Immunologie et de Maladies Infectieuses ( CIMI ), Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), Vascular research center of Marseille ( VRCM ), Aix Marseille Université ( AMU ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Aix Marseille Université ( AMU ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Aix Marseille Université ( AMU ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Département d'Oncologie ( Dep Oncol - AVIGNON ), CHU Saint-Antoine [APHP], Hospices Civils de Lyon ( HCL ), Hôpital Cochin [AP-HP], Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-hôpital Sud, Sorbonne Université-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université

Subjects
Ulcer healing, Adult, Male, medicine.medical_specialty, Time Factors, Sildenafil, [SDV]Life Sciences [q-bio], Vasodilator Agents, Immunology, Placebo, Gastroenterology, General Biochemistry, Genetics and Molecular Biology, Sildenafil Citrate, Autoimmune Diseases, Fingers, Patient perspective, chemistry.chemical_compound, Rheumatology, Double-Blind Method, Ischemia, Internal medicine, Skin Ulcer, medicine, Immunology and Allergy, Humans, Longitudinal Studies, Prospective Studies, Proportional Hazards Models, Scleroderma, Systemic, [ SDV ] Life Sciences [q-bio], business.industry, Middle Aged, Clinical and Epidemiological Research, medicine.disease, Connective tissue disease, 3. Good health, Surgery, Intention to Treat Analysis, Treatment, Treatment Outcome, chemistry, cGMP-specific phosphodiesterase type 5, Female, business
Abstract

ObjectiveTo assess the effect of sildenafil, a phosphodiesterase type 5 inhibitor, on digital ulcer (DU) healing in systemic sclerosis (SSc).MethodsRandomised, placebo-controlled study in patients with SSc to assess the effect of sildenafil 20 mg or placebo, three times daily for 12 weeks, on ischaemic DU healing. The primary end point was the time to healing for each DU. Time to healing was compared between groups using Cox models for clustered data (two-sided tests, p=0.05).ResultsIntention-to-treat analysis involved 83 patients with a total of 192 DUs (89 in the sildenafil group and 103 in the placebo group). The HR for DU healing was 1.33 (0.88 to 2.00) (p=0.18) and 1.27 (0.85 to 1.89) (p=0.25) when adjusted for the number of DUs at entry, in favour of sildenafil. In the per protocol population, the HRs were 1.49 (0.98 to 2.28) (p=0.06) and 1.43 (0.93 to 2.19) p=0.10. The mean number of DUs per patient was lower in the sildenafil group compared with the placebo group at week (W) 8 (1.23±1.61 vs 1.79±2.40 p=0.04) and W12 (0.86±1.62 vs 1.51±2.68, p=0.01) resulting from a greater healing rate (p=0.01 at W8 and p=0.03 at W12).ConclusionsThe primary end point was not reached in intention-to-treat, partly because of an unexpectedly high healing rate in the placebo group. We found a significant decrease in the number of DUs in favour of sildenafil compared with placebo at W8 and W12, confirming a sildenafil benefit.Trial registration numberNCT01295736.

Published
2014

33. Implementing thrombosis guidelines in cancer patients: a review

Author

Philippe Debourdeau, Ingrid Pabinger, Harry R. Büller, Ajay K. Kakkar, Michael B. Streiff, Dominique Farge-Bancel, Benjamin Brenner, Henri Bounameaux, Amsterdam Cardiovascular Sciences, and Vascular Medicine

Subjects
medicine.medical_specialty, venous thromboembolism, Alternative medicine, lcsh:Medicine, Bioinformatics, Multidisciplinary approach, medicine, cancer, In patient, guidelines, Intensive care medicine, thrombosis, Cause of death, lcsh:R5-920, business.industry, lcsh:R, Cancer, Anticoagulants, General Medicine, Current Clinical Practice, medicine.disease, Thrombosis, 3. Good health, Clinical trial, business, lcsh:Medicine (General), Venous thromboembolism
Abstract

Venous thromboembolism is a frequent and serious complication in patients with cancer. It is an independent prognostic factor of death in cancer patients and the second leading cause of death, but physicians often underestimate its importance, as well as the need for adequate prevention and treatment. Management of venous thromboembolism in patients with cancer requires the coordinated efforts of a wide range of clinicians, highlighting the importance of a multidisciplinary approach. However, a lack of consensus among various national and international clinical practice guidelines has contributed to knowledge and practice gaps among practitioners, and inconsistent approaches to venous thromboembolism. The 2013 international guidelines for thrombosis in cancer have sought to address these gaps by critically re-evaluating the evidence coming from clinical trials and synthesizing a number of guidelines documents. An individualized approach to prophylaxis is recommended for all patients.

Published
2014

34. Erectile dysfunction is frequent in systemic sclerosis and associated with severe disease : a study of the EULAR Scleroderma Trial and Research group

Author

Dominique Farge-Bancel, Ulrich A. Walker, Jean Sibilia, Oliver Distler, José António Pereira da Silva, Paola Caramaschi, Vanessa Smith, Thomas Hügle, Paloma García de la Peña Lefebvre, Starovojtova M Nikolaevna, Yannick Allanore, Eric Hachulla, Paolo Airò, Piotr Wiland, Chingching Foocharoen, Edoardo Rosato, Anna T Onken, Gabriela Riemekasten, Bojana Stamenkovic, Ingo H. Tarner, Simona Rednic, Alan Tyndall, Andrea Himsel, Walid Ahmed Abdel Atty Mohamed, and Jadranka Morović-Vergles

Subjects
IMPOTENCE, Male, Databases, Factual, Vasodilator Agents, Severity of Illness Index, Scleroderma, Piperazines, chemistry.chemical_compound, Erectile Dysfunction, Surveys and Questionnaires, Medicine and Health Sciences, Medicine, Immunology and Allergy, Prospective Studies, Sulfones, Prospective cohort study, skin and connective tissue diseases, integumentary system, MEN, Erectile dysfunction (ED), systemic sclerosis (SSc), Middle Aged, PREVALENCE, Treatment Outcome, Kidney Diseases, Psychosocial, Research Article, Adult, medicine.medical_specialty, Sildenafil, Immunology, Skin Diseases, Sildenafil Citrate, Rheumatology, Muscular Diseases, Internal medicine, Severity of illness, Humans, Restrictive lung disease, ddc:610, Scleroderma, Systemic, HYPERTENSION, business.industry, medicine.disease, Erectile dysfunction, chemistry, Purines, systemic sclerosis, erectile dysfunction, RISK-FACTORS, Physical therapy, business
Abstract

Introduction: Erectile dysfunction (ED) is common in men with systemic sclerosis (SSc) but the demographics, risk factors and treatment coverage for ED are not well known. Method: This study was carried out prospectively in the multinational EULAR Scleroderma Trial and Research database by amending the electronic data-entry system with the International Index of Erectile Function-5 and items related to ED risk factors and treatment. Centres participating in this EULAR Scleroderma Trial and Research substudy were asked to recruit patients consecutively. Results: Of the 130 men studied, only 23 (17.7%) had a normal International Index of Erectile Function-5 score. Thirty-eight per cent of all participants had severe ED (International Index of Erectile Function-5 score

Published
2012

35. Effects and safety of rituximab in systemic sclerosis : An analysis from the European Scleroderma Trial and Research (EUSTAR) group

Author

Veronica Codullo, Thierry Zenone, Ulrich A. Walker, Dominique Farge-Bancel, Jacob M van Laar, Matija Tomšič, Simona Rednic, Francesco Paolo Cantatore, Sule Yavuz, Tore K Kvien, Sergiu Popa, Lidia Ananjeva, Suzana Jordan, Marco Matucci-Cerinic, Gabriela Szucs, Paolo Airò, Paola Caramaschi, Armando Gabrielli, Emmanuel Chatelus, Codrina Michaela Ancuta, Agneta Scheja, Francesca Ingegnoli, Gabriela Riemekasten, Gabriele Valentini, Vanessa Smith, Edoardo Rosato, Esthela Loyo, Martin Aringer, Alexandra Balbir-Gurman, Ulf Müller-Ladner, I. Herrgott, Britta Maurer, Yannick Allanore, Juan José Alegre Sancho, Dörte Huscher, Rosario Foti, Rene Westhovens, Øyvind Palm, Jörg H W Distler, Oliver Distler, M. Saracco, Carina Mihai, Jörg Henes, Florenzo Iannone, Walid Ahmed Abdel Atty Mohamed, Jordan, Suzana, Distler, Jörg H. W., Maurer, Britta, Huscher, Dörte, Van Laar, Jacob M., Allanore, Yannick, Distler, Oliver, Kvien, Tore K., Airo, Paolo, Sancho, Juan José Alegre, Ananjeva, Lidia, Ancuta, Codrina Michaela, Aringer, Martin, Balbir Gurman, Alexandra, Cantatore, Francesco Paolo, Caramaschi, Paola, Chatelus, Emmanuel, Codullo, Veronica, Farge Bancel, Dominique, Foti, Rosario, Gabrielli, Armando, Henes, Jörg, Herrgott, Ilka, Iannone, Florenzo, Ingegnoli, Francesca, Loyo, Esthela, Matucci Cerinić, Marco, Mohamed, Walid Ahmed Abdel Atty, Müller Ladner, Ulf, Palm, Øyvind, Popa, Sergiu, Riemekasten, Gabriela, Rednic, Simona, Rosato, Edoardo, Saracco, Marta, Scheja, Agneta, Smith, Vanessa, Mihai, Carina, Szucs, Gabriela, Tomšić, Matija, Valentini, Gabriele, Walker, Ulrich A., Westhovens, Rene, Yavuz, Sule Kurhan, and Zenone, Thierry

Subjects
Male, Vital capacity, Databases, Factual, Fibrosi, Vital Capacity, Gastroenterology, Severity of Illness Index, Biochemistry, Scleroderma, Cohort Studies, Antibodies, Monoclonal, Murine-Derived, Immunosuppressive Agent, Immunology and Allergy, Lung, Skin, Medicine(all), B cell, integumentary system, Medicine (all), Interstitial lung disease, Antirheumatic Agent, Orvostudományok, Middle Aged, Connective tissue disease, Rheumatoid arthritis, Antirheumatic Agents, Rituximab, Female, Case-Control Studie, Immunosuppressive Agents, medicine.drug, Human, medicine.medical_specialty, Immunology, Observational Study, Klinikai orvostudományok, General Biochemistry, Genetics and Molecular Biology, FEV1/FVC ratio, Rheumatology, Internal medicine, medicine, Journal Article, Humans, Systemic Sclerosi, Scleroderma, Systemic, Biochemistry, Genetics and Molecular Biology (all), business.industry, Biochemistry, Genetics and Molecular Biology(all), medicine.disease, Fibrosis, Treatment, Case-Control Studies, Cohort Studie, business, Lung Diseases, Interstitial, Genetics and Molecular Biology(all)
Abstract

ObjectivesTo assess the effects of Rituximab (RTX) on skin and lung fibrosis in patients with systemic sclerosis (SSc) belonging to the European Scleroderma Trial and Research (EUSTAR) cohort and using a nested case-control design.MethodsInclusion criteria were fulfilment of American College of Rheumatology classification criteria for SSc, treatment with RTX and availability of follow-up data. RTX-treated patients were matched with control patients from the EUSTAR database not treated with RTX. Matching parameters for skin/lung fibrosis were the modified Rodnan Skin Score (mRSS), forced vital capacity (FVC), follow-up duration, scleroderma subtype, disease duration and immunosuppressive co-treatment. The primary analysis was mRSS change from baseline to follow-up in the RTX group compared with the control group. Secondary analyses included change of FVC and safety measures.Results63 patients treated with RTX were included in the analysis. The case-control analysis in patients with severe diffuse SSc showed that mRSS changes were larger in the RTX group versus matched controls (N=25; −24.0±5.2% vs −7.7±4.3%; p=0.03). Moreover, in RTX-treated patients, the mean mRSS was significantly reduced at follow-up compared with baseline (26.6±1.4 vs 20.3±1.8; p=0.0001). In addition, in patients with interstitial lung disease, RTX prevented significantly the further decline of FVC compared with matched controls (N=9; 0.4±4.4% vs −7.7±3.6%; p=0.02). Safety measures showed a good profile consistent with previous studies in autoimmune rheumatic diseases.ConclusionsThe comparison of RTX treated versus untreated matched-control SSc patients from the EUSTAR cohort demonstrated improvement of skin fibrosis and prevention of worsening lung fibrosis, supporting the therapeutic concept of B cell inhibition in SSc.

Published
2015

36. 828 Prolonged Regression of Ileocolonic Crohn's Disease Following Autologous Haemopoetic Stem Cell Transplantation: Presentation on Behalf of the Astic Trialists

Author

Miranda Clark, Dominique Farge-Bancel, Christopher J. Hawkey, Gerhard Rogler, James O. Lindsay, Matthieu Allez, Jack Satsangi, and Myriam Labopin

Subjects
Crohn's disease, medicine.medical_specialty, Hepatology, business.industry, Gastroenterology, Eldelumab, medicine.disease, Placebo, Surgery, Transplantation, Internal medicine, medicine, Clinical efficacy, Stem cell, Adverse effect, business, INDUCTION TREATMENT
Abstract

TNF-naive and -failure subgroups. Adverse events were comparable across treatment groups; serious adverse events were more common in the eldelumab 10 and 20 mg/kg groups (7.5% and 9.8%, respectively) compared with placebo (5.0%), driven by infusion-related events. Rates of infection were similar across all groups. Conclusion: Induction treatment with eldelumab 10 or 20 mg/kg IV demonstrated trends towards efficacy as assessed by both clinical and endoscopic endpoints. Safety signals were consistent with those reported previously for eldelumab.1,2 1. Sandborn WJ, et al. Gastroenterology 2014;146(Suppl 1):S-55. 2. Mayer L, et al. Gut 2014;63:442-50. Clinical efficacy

Published
2015

37. Expression of transforming growth factor β receptor II in mesenchymal stem cells from systemic sclerosis patients

Author

Laurence Michel, Franck Verrecchia, Jérôme Larghero, Séverine Lecourt, Dominique Farge-Bancel, J Baraut, Valérie Vanneaux, Cécilia Brun, Francette Jean-Louis, and Audrey Cras

Subjects
Pathology, medicine.medical_specialty, Dermatology, SMAD, 03 medical and health sciences, 0302 clinical medicine, Fibrosis, Internal Medicine, medicine, 030304 developmental biology, 030203 arthritis & rheumatology, 0303 health sciences, integumentary system, business.industry, Research, Mesenchymal stem cell, General Medicine, medicine.disease, 3. Good health, Transplantation, Haematopoiesis, medicine.anatomical_structure, Bone marrow, Stem cell, business, Transforming growth factor
Abstract

Objectives The present work aimed to evaluate the expression of transforming growth factor-β (TGF-β) receptors on bone marrow-derived multipotent mesenchymal stromal cells (MSCs) in patients with systemic sclerosis (SSc) and the consequences of TGF-β activation in these cells, since MSC have potential therapeutic interest for SSc patients and knowing that TGF-β plays a critical role during the development of fibrosis in SSc. Design This is a prospective research study using MSC samples obtained from SSc patients and compared with MSC from healthy donors. Setting One medical hospital involving collaboration between an internal medicine department for initial patient recruitment, a clinical biotherapeutic unit for MSC preparation and an academic laboratory for research. Participants 9 patients with diffuse SSc for which bone marrow (BM) aspiration was prescribed by sternum aspiration before haematopoietic stem cell transplantation, versus nine healthy donors for normal BM. Primary and secondary outcome measures TGF-β, TGF-β receptor types I (TBRI) and II (TBRII) mRNA and protein expression were assessed by quantitative PCR and flow cytometry, respectively, in MSC from both SSc patients and healthy donors. MSC were exposed to TGF-β and assessed for collagen 1α2 synthesis and Smad expression. As positive controls, primary cultures of dermal fibroblasts were also analysed. Results Compared with nine controls, MSC from nine SSc patients showed significant increase in mRNA levels (p

Published
2013

38. Comparing HLA Shared Epitopes in French Caucasian Patients with Scleroderma

Author

Yannick Allanore, Philippe P. Pagni, Kiet Tiev, Sami B. Kanaan, Brigitte Granel, I. Fajardy, Marielle Martin, Jean Roudier, Justyna Rak, Jean Robert Harlé, Nathalie C. Lambert, Rémi Didelot, Jean Cabane, Eric Hachulla, Dominique Farge-Bancel, and Doua F. Azzouz

Subjects
Male, Genetic Screens, Linkage disequilibrium, lcsh:Medicine, Gene Expression, Peptide binding, Linkage Disequilibrium, Scleroderma, Major Histocompatibility Complex, Epitopes, Gene Frequency, HLA Antigens, Pathology, HLA-DQ beta-Chains, lcsh:Science, skin and connective tissue diseases, HLA-DRB1, Multidisciplinary, Middle Aged, Medicine, Female, Research Article, Human leukocyte antigen, Biology, White People, Autoimmune Diseases, Molecular Genetics, Diagnostic Medicine, Genetics, Humans, Gene Regulation, Genetic Predisposition to Disease, RNA, Messenger, Allele, Allele frequency, Alleles, Scleroderma, Systemic, lcsh:R, Haplotype, Autoantibody, Computational Biology, HLA-DRB5 Chains, Haplotypes, Genetics of Disease, Immunology, lcsh:Q, Clinical Immunology, Biomarkers, General Pathology, HLA-DRB1 Chains
Abstract

Although many studies have analyzed HLA allele frequencies in several ethnic groups in patients with scleroderma (SSc), none has been done in French Caucasian patients and none has evaluated which one of the common amino acid sequences, (67)FLEDR(71), shared by HLA-DRB susceptibility alleles, or (71)TRAELDT(77), shared by HLA-DQB1 susceptibility alleles in SSc, was the most important to develop the disease. HLA-DRB and DQB typing was performed for a total of 468 healthy controls and 282 patients with SSc allowing FLEDR and TRAELDT analyses. Results were stratified according to patient's clinical subtypes and autoantibody status. Moreover, standardized HLA-DRß1 and DRß5 reverse transcriptase Taqman PCR assays were developed to quantify ß1 and ß5 mRNA in 20 subjects with HLA-DRB1*15 and/or DRB1*11 haplotypes. FLEDR motif is highly associated with diffuse SSc (χ(2) = 28.4, p

Published
2012

39. Clinical images: Voluminous ectopic tumoral calcinosis of the spine in systemic sclerosis

Author

Dominique Farge-Bancel and Cécile Durant

Subjects
Male, medicine.medical_specialty, Systemic disease, Pathology, Immunology, Scleroderma, Rheumatology, Immunopathology, Internal medicine, medicine, Humans, Immunology and Allergy, Pharmacology (medical), Cyclophosphamide, Rachis, Incidental Findings, Scleroderma, Systemic, business.industry, Nerve Compression Syndromes, Calcinosis, Middle Aged, medicine.disease, Connective tissue disease, Spine, Radiography, Spinal Nerves, Tumoral calcinosis, Spinal Diseases, business, Immunosuppressive Agents, Calcification
Published
2011

40. Case report: French West Indies - a tourist destination at risk for Plasmodium falciparum transmission?

Author

Catherine Arfi, Dominique Farge-Bancel, Yves Poinsignon, Claudine Sarfati, and Christian Raccurt

Subjects
Caribbean island, biology, Public Health, Environmental and Occupational Health, Plasmodium falciparum, macromolecular substances, biology.organism_classification, medicine.disease, law.invention, Infectious Diseases, Transmission (mechanics), Geography, law, Falciparum infection, parasitic diseases, medicine, Parasitology, Socioeconomics, Martinique, Malaria, Tourism, West indies
Abstract

Summary We report a case of P. falciparum infection observed in Paris and presumably acquired in Guadeloupe, a French Caribbean island where malaria has been considered to be eradicated since 1970.

Published
1999

41. Effectiveness and safety of tocilizumab in patients with systemic sclerosis: a propensity score matched controlled observational study of the EUSTAR cohort

Author

Pavel I Novikov, Thierry Martin, Eric Hachulla, Vanessa Smith, Maurizio Cutolo, Yannick Allanore, Camillo Ribi, Oliver Distler, Britta Maurer, Paolo Airo, Cosimo Bruni, Veronica Codullo, Luc Mouthon, Marie Vanthuyne, Elisabetta Zanatta, Simona Rednic, Ulf Müller-Ladner, Nemanja Damjanov, Anna-Maria Hoffmann-Vold, Michele Iudici, Suzana Jordan, Jean Sibilia, Mengtao Li, Roger Hesselstrand, Elise Siegert, László Czirják, Armando Gabrielli, Dominique Farge Bancel, Yolanda Braun-Moscovici, Nicolas Hunzelmann, Raffaele Pellerito, Jörg Henes, Bojana Stamenkovic, Carlo Francesco Selmi, Mohammed Tikly, Merete Engelhart, Valeria Riccieri, Cord Sunderkötter, Francesca Ingegnoli, Francesco Paolo Cantatore, Susanne Ullman, Maria Rosa Pozzi, Piotr Wiland, Juan Jose Alegre-Sancho, Brigitte Krummel-Lorenz, Ellen De Langhe, Branimir Anic, Carolina de Souza Müller, Simon Stebbings, Alessandra Vacca, Lisa Stamp, Kamal Solanki, Douglas Veale, Esthela Loyo, Edoardo Rosato, Cristina-Mihaela Tanaseanu, Rosario Foti, Codrina Ancuta, Ira Litinsky, Lesley Ann Saketkoo, Eduardo Kerzberg, Tim Schmeiser, Piercarlo Sarzi Puttini, Fabio Cacciapaglia, Marie-Elise Truchetet, Muriel Elhai, Juan José Alegre Sancho, Ivan Castellví, Serena Vettori, Vivien M Hsu, Masataka Kuwana, Sule Yavuz, Radim Becvar, Patricia E Carreira, Eugene J Kucharz, Bernard Coleiro, Paul Hasler, Carlos de la Puente, Svetlana Agachi, Thierry Zenone, Francesco Del Galdo, Doron Rimar, Alessandro Giollo, Lidia P Ananieva, Ina Kötter, Mislav Radic, Dominik Majewski, Kristine Herrmann, Goda Seskute, Lorinda S Chung, Laura Belloli, Ulrike Held, FJ López-Longo, Joerg H W Distler, Maria João Salvador, Simon Kuster, Klaus Steigmiller, Ana-Maria Gheorghiu, Katarzyna Romanowska-Prochnicka, Yuichiro Shirai, Chris Denton, Ruxandra M Ionescu, Stefan Heitmann Vera Ortiz-Santamaria, Walid Ahmed Abdel Atty Mohamed, Paloma Garcíadela Peña Lefebvre, and Vera Bernardino

Subjects
Medicine
Abstract

Objectives Tocilizumab showed trends for improving skin fibrosis and prevented progression of lung fibrosis in systemic sclerosis (SSc) in randomised controlled clinical trials. We aimed to assess safety and effectiveness of tocilizumab in a real-life setting using the European Scleroderma Trial and Research (EUSTAR) database.Methods Patients with SSc fulfilling the American College of Rheumatology (ACR)/EULAR 2013 classification criteria, with baseline and follow-up visits at 12±3 months, receiving tocilizumab or standard of care as the control group, were selected. Propensity score matching was applied. Primary endpoints were the modified Rodnan skin score (mRSS) and FVC at 12±3 months compared between the groups. Secondary endpoints were the percentage of progressive/regressive patients for skin and lung at 12±3 months.Results Ninety-three patients with SSc treated with tocilizumab and 3180 patients with SSc with standard of care fulfilled the inclusion criteria. Comparison between groups did not show significant differences, but favoured tocilizumab across all predefined primary and secondary endpoints: mRSS was lower in the tocilizumab group (difference −1.0, 95% CI −3.7 to 1.8, p=0.48). Similarly, FVC % predicted was higher in the tocilizumab group (difference 1.5 (−6.1 to 9.1), p=0.70). The percentage of progressive/regressive patients favoured tocilizumab over controls. These results were robust regarding the sensitivity analyses. Safety analysis confirmed previously reported adverse event profiles.Conclusion Although this large, observational, controlled, real-life EUSTAR study did not show significant effectiveness of tocilizumab on skin and lung fibrosis, the consistency of direction of all predefined endpoints generates hypothesis for potential effectiveness in a broader SSc population.

Published
2022
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