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1. Colposcopy Accuracy and Diagnostic Performance: A Quality Control and Quality Assurance Survey in Italian Tertiary-Level Teaching and Academic Institutions—The Italian Society of Colposcopy and Cervico-Vaginal Pathology (SICPCV)

Author

Origoni, M, Cantatore, F, Sopracordevole, F, Clemente, N, Spinillo, A, Gardella, B, De Vincenzo, R, Ricci, C, Landoni, F, Di Meo, M, Ciavattini, A, Di Giuseppe, J, Preti, E, Iacobone, A, Carriero, C, Dellino, M, Capodanno, M, Perino, A, Miglioli, C, Insolia, L, Barbero, M, Candiani, M, Origoni M., Cantatore F., Sopracordevole F., Clemente N., Spinillo A., Gardella B., De Vincenzo R., Ricci C., Landoni F., Di Meo M. L., Ciavattini A., Di Giuseppe J., Preti E., Iacobone A. D., Carriero C., Dellino M., Capodanno M., Perino A., Miglioli C., Insolia L., Barbero M., Candiani M., Origoni, M, Cantatore, F, Sopracordevole, F, Clemente, N, Spinillo, A, Gardella, B, De Vincenzo, R, Ricci, C, Landoni, F, Di Meo, M, Ciavattini, A, Di Giuseppe, J, Preti, E, Iacobone, A, Carriero, C, Dellino, M, Capodanno, M, Perino, A, Miglioli, C, Insolia, L, Barbero, M, Candiani, M, Origoni M., Cantatore F., Sopracordevole F., Clemente N., Spinillo A., Gardella B., De Vincenzo R., Ricci C., Landoni F., Di Meo M. L., Ciavattini A., Di Giuseppe J., Preti E., Iacobone A. D., Carriero C., Dellino M., Capodanno M., Perino A., Miglioli C., Insolia L., Barbero M., and Candiani M.

Abstract

Quality Control (QC) and Quality Assurance (QA) principles are essential for effective cervical cancer prevention. Being a crucial diagnostic step, colposcopy’s sensitivity and specificity improvements are strongly advocated worldwide since inter- and intra-observer differences are the main limiting factors. The objective of the present study was the evaluation of colposcopy accuracy through the results of a QC/QA assessment from a survey in Italian tertiary-level academic and teaching hospitals. A web-based, user-friendly platform based on 100 colposcopic digital images was forwarded to colposcopists with different levels of experience. Seventy-three participants were asked to identify colposcopic patterns, provide personal impressions, and indicate the correct clinical practice. The data were correlated with a panel of experts’ evaluation and with the clinical/pathological data of the cases. Overall sensitivity and specificity with the threshold of CIN2+ accounted for 73.7% and 87.7%, respectively, with minor differences between senior and junior candidates. Identification and interpretation of colposcopic patterns showed full agreement with the experts’ panel, ranging from 50% to 82%, in some instances with better results from junior colposcopists. Colposcopic impressions correlated with a 20% underestimation of CIN2+ lesions, with no differences linked to level of experience. Our results demonstrate the good diagnostic performance of colposcopy and the need for improving accuracy through QC assessments and adhesion to standard requirements and recommendations.

Published
2023

2. Survival and prognostic factors from a multicentre large cohort of unselected Italian systemic sclerosis patients

Author

Cacciapaglia, F., Airo, P., Fornaro, M., Trerotoli, Paolo, De Lorenzis, E., Corrado, A., Lazzaroni, M. G., Natalello, G., Montini, F., Altomare, Annamaria, Urso, L., Verardi, Lucrezia, Bosello, Silvia Laura, Cantatore, F. P., Iannone, F., Trerotoli P., Altomare A., Verardi L., Bosello S. L. (ORCID:0000-0002-4837-447X), Cacciapaglia, F., Airo, P., Fornaro, M., Trerotoli, Paolo, De Lorenzis, E., Corrado, A., Lazzaroni, M. G., Natalello, G., Montini, F., Altomare, Annamaria, Urso, L., Verardi, Lucrezia, Bosello, Silvia Laura, Cantatore, F. P., Iannone, F., Trerotoli P., Altomare A., Verardi L., and Bosello S. L. (ORCID:0000-0002-4837-447X)

Abstract

Objectives: Survival and death prognostic factors of SSc patients varied during the past decades. We aimed to update the 5- and 10-year survival rates and identify prognostic factors in a multicentre cohort of Italian SSc patients diagnosed after 2009. Material and methods: Patients who received a diagnosis of SSc after 1 January 2009 and were longitudinally followed up in four Italian rheumatologic centres were retrospectively assessed up to 31 December 2020. Overall survival of SSc patients was described using the Kaplan–Meier method. Predictors of mortality at 10-year follow-up were assessed by the Cox regression model. A comparison of our cohort with the Italian general population was performed by determining the standardized mortality ratio (SMR). Results: A total of 912 patients (91.6% females, 20% dcSSc) were included. Overall survival rates at 5 and 10 years were 94.4% and 89.4%, respectively. The SMR was 0.96 (95% CI 0.81, 1.13), like that expected in the Italian general population. Pulmonary arterial hypertension (PAH) and interstitial lung disease (ILD) associated with pulmonary hypertension (PH) significantly reduced survival (P < 0.0001). Main death predictors were male gender (HR 1⁄4 2.76), diffuse cutaneous involvement (HR 1⁄4 3.14), older age at diagnosis (HR 1⁄4 1.08), PAH (HR 1⁄4 3.21), ILD-associated PH (HR 1⁄4 4.11), comorbidities (HR 1⁄4 3.53) and glucocorticoid treatment (HR1⁄4 2.02). Conclusions: In the past decade, SSc patients have reached similar mortality of that expected in the Italian general population. Male gender, diffuse cutaneous involvement, comorbidities and PAH with or without ILD represent the main poor prognostic factors.

Published
2023

3. Late Skin Fibrosis in Systemic Sclerosis: A Study from the EUSTAR Cohort

Author

Michael Hughes 1 2, Suiyuan Huang 3 4, Juan Jose Alegre-Sancho 5, Patricia E Carreira 6, Merete Engelhart 7, Eric Hachulla 8, Joerg Henes 9, Eduardo Kerzberg 10, Maria Rosa Pozzi 11, Gabriela Riemekasten 12, Vanessa Smith 13, Gabriella Szücs 14, Marie Vanthuyne 15, Elisabetta Zanatta 16, Oliver Distler 17, Armando G Gabrielli 18, Anna-Maria Hoffmann-Vold 19, Virginia D Steen 20, Dinesh Khanna 3 21, EUSTAR Airò P, Allanore A, Ananieva Lp, Anic B, Balbir-Gurman A, Becvar R, Benvenuti F, Cantatore F P, Chung L S, Cuomo G, Cutolo M, Czirják L, Damjanov N, de Vries-Bouwstra J, Del Galdo F, Distler J, Eyerich K, Farge D, Foti R, Gheorghiu A M, Giollo A, Heitmann S, Herrick A, Hesselstrand R, Hsu I M, Hunzelmann N, Iannone F, Iudici M, Ionescuc M R, Ingegnoli F, Jose J, Joven B E, Kerzberg E, Kucharz E J, Kuwana M, Langhe E D, Launay D, Lefebvre P, Litinsky I, García de la Peña Lefebvre P, González-Martín J J, Li M, Loyo E, Martin T, Matucci-Cerinic M, Maurer B, Moroncini G, Mouthon L, Müller Cs, Müller-Ladner U, Novak S, Pastor P, Pecher A-C, Pellerito R, Pozzi M R, Oksel F, Rednic S, Rezus E, Riccieri V, Rosato E, Saketkoo L A, Salvador M J, Schmeiser T, Selmi C F, Sibilia J, Siegert E, Solanki K, Sommerlatte S, Spertini F, Stamenkovic B, Stamp L, Tanaseanu C-M, Tikly M, Tineo C, Ullman S, Üprus M, Vanthuyne M, Veale D, Walker U, Wiland P, Yargucu F, Yavuz S, University of Zurich, Michael Hughes, 1 2, Suiyuan Huang, 3 4, Juan Jose Alegre-Sancho, 5, Patricia, E Carreira 6, Merete Engelhart, 7, Eric Hachulla, 8, Joerg Henes, 9, Eduardo Kerzberg, 10, Maria Rosa Pozzi, 11, Gabriela Riemekasten, 12, Vanessa Smith, 13, Gabriella Szücs, 14, Marie Vanthuyne, 15, Elisabetta Zanatta, 16, Oliver Distler, 17, Armando, G Gabrielli 18, Anna-Maria Hoffmann-Vold, 19, Virginia, D Steen 20, Dinesh Khanna, 3 21, EUSTAR Airò, P, Allanore, A, Ananieva, Lp, Anic, B, Balbir-Gurman, A, Becvar, R, Benvenuti, F, Cantatore, F P, Chung, L S, Cuomo, G, Cutolo, M, Czirják, L, Damjanov, N, de Vries-Bouwstra, J, Del Galdo, F, Distler, J, Eyerich, K, Farge, D, Foti, R, Gheorghiu, A M, Giollo, A, Heitmann, S, Herrick, A, Hesselstrand, R, Hsu, I M, Hunzelmann, N, Iannone, F, Iudici, M, Ionescuc, M R, Ingegnoli, F, Jose, J, Joven, B E, Kerzberg, E, Kucharz, E J, Kuwana, M, Langhe, E D, Launay, D, Lefebvre, P, Litinsky, I, García de la Peña Lefebvre, P, González-Martín, J J, Li, M, Loyo, E, Martin, T, Matucci-Cerinic, M, Maurer, B, Moroncini, G, Mouthon, L, Müller, C, Müller-Ladner, U, Novak, S, Pastor, P, Pecher, A-C, Pellerito, R, Pozzi, M R, Oksel, F, Rednic, S, Rezus, E, Riccieri, V, Rosato, E, Saketkoo, L A, Salvador, M J, Schmeiser, T, Selmi, C F, Sibilia, J, Siegert, E, Solanki, K, Sommerlatte, S, Spertini, F, Stamenkovic, B, Stamp, L, Tanaseanu, C-M, Tikly, M, Tineo, C, Ullman, S, Üprus, M, Vanthuyne, M, Veale, D, Walker, U, Wiland, P, Yargucu, F, and Yavuz, S

Subjects
Rheumatology, Cohort enrichment, 10051 Rheumatology Clinic and Institute of Physical Medicine, Late disease, Systemic sclerosis, Pharmacology (medical), 610 Medicine & health, Fibrosis, Clinical trial design, Scleroderma, Skin
Abstract

Objectives The early trajectory of skin fibrosis provides insights into the disease course of systemic sclerosis (SSc) including mortality; however, little is known about late skin fibrosis. The aims of our study were to ascertain the prevalence and characteristics of late skin fibrosis in SSc. Methods We developed and tested three conceptual scenarios of late (>5 years after first non-RP feature) skin fibrosis including new worsening of skin disease, and failure to improve after worsening within 5-year window. We defined skin worsening as change in modified Rodnan skin score (mRSS) ≥5 units or ≥25%. Using strict inclusion criteria including complete mRSS, we identified 1,043 (out of 19 115) patients within the EUSTAR database for our analysis. We further restricted analysis within 887 (out of 1043) patients who had lcSSc or dcSSc at baseline. Results One-fifth of patients among the whole cohort (n = 208/1043, 19.9%) experienced mRSS worsening, including in patients with lcSSc or dcSSc at baseline (n = 193/887, 21.8%). This was largely due to new skin worsening after the 5-year window or failure to improve with worsening within the 5-year window. Patients with lower baseline mRSS and lcSSc were more likely to develop late skin fibrosis. Anti-Scl-70 was associated with progression from baseline lcSSc to dcSSc, and anticentromere was protective. Conclusions Late skin fibrosis is not uncommon in SSc. We have identified different patterns relevant to clinical practice and trial design. Late skin fibrosis is a neglected manifestation of SSc and warrants further investigation including to determine clinical outcomes and optimal therapeutic strategy.

Published
2022

5. Hysterectomy for cervical intraepithelial neoplasia: A retrospective observational multi-institutional study

Author

Ciavattini, A., Di Giuseppe, J., Marconi, C., Giannella, L., Delli Carpini, G., Paolucci, M., Fichera, M., De Vincenzo, R. P., Scambia, G., Evangelista, M. T., Bogani, G., Bertolina, F., Raspagliesi, F., Gardella, B., Spinillo, A., Dominoni, M., Monti, E., Liverani, C. A., Vercellini, P., Iorio, M., Vitobello, D., Portuesi, R., Bresciani, G., Origoni, M., Cantatore, F., Pellegri, A. M., Moriconi, L., Serri, M., Chiari, A., Sopracordevole, F., Barbero, M., Parazzini, F., De Vincenzo R. P. (ORCID:0000-0001-7408-0435), Scambia G. (ORCID:0000-0003-2758-1063), Ciavattini, A., Di Giuseppe, J., Marconi, C., Giannella, L., Delli Carpini, G., Paolucci, M., Fichera, M., De Vincenzo, R. P., Scambia, G., Evangelista, M. T., Bogani, G., Bertolina, F., Raspagliesi, F., Gardella, B., Spinillo, A., Dominoni, M., Monti, E., Liverani, C. A., Vercellini, P., Iorio, M., Vitobello, D., Portuesi, R., Bresciani, G., Origoni, M., Cantatore, F., Pellegri, A. M., Moriconi, L., Serri, M., Chiari, A., Sopracordevole, F., Barbero, M., Parazzini, F., De Vincenzo R. P. (ORCID:0000-0001-7408-0435), and Scambia G. (ORCID:0000-0003-2758-1063)

Abstract

Objective: To analyze the clinical management, the outcomes, and the trend in hysterectomy rates (HR) in patients who underwent this procedure for cervical intraepithelial neoplasia (CIN). Methods: Multicentric retrospective observational study conducted on 242 patients who underwent hysterectomy for CIN between 2010 and 2020 in nine Italian institutions. Hysterectomy for invasive or micro-invasive neoplasia, sub-total hysterectomy, or trachelectomy were excluded. Results: A significant increase in the trend of HR for CIN was recorded (P = 0.002, r = 0.81; C.I. 95%: 0.415–0.949); HR increased from 0.46% in the year 2010 to 3.32% in 2020. The mortality rate was 0.4%, and 5% had operative complications. On definitive histopathology examination, a CIN of any grade was recorded in 71.5% of cases, and an occult invasive cancer in 1.24%. No pathology or CIN1 was found in 26.8% of cases, suggesting over treatment. During follow-up, a vaginal lesion was recorded in 5% of cases. Conclusion: A significant increase in the number of hysterectomies performed for CIN in the last 10 years was recorded. Hysterectomy for CIN can lead to complications, risk of the onset of vaginal lesions, and risk of overtreatment, and remains, in the first instance, an unacceptable treatment, to be proposed only after adequate counseling.

Published
2022

6. Author Correction: Visual field loss and vision-related quality of life in the Italian Primary Open Angle Glaucoma Study

Author

Rulli, Eliana, Quaranta, Luciano, Riva, Ivano, Poli, Davide, Hollander, Lital, Galli, Fabio, Katsanos, Andreas, Oddone, Francesco, Torri, Valter, Weinreb, N Varano L, Robert, Carchedi, T, Talarico, S, Frezzotti, P, Parravano, F, Motolese, I, Bagaglia, Sa, Rossi, Gcm, Lateri, S, Bossolesi, L, Carmassi, L, Rolle, T, Piccini, R, Ratiglia, R, Rossi, A, Gandolfi, S, Tagliavini, V, Ungaro, N, Fossarello, M, Cucca, A, Zucca, I, Uva, M, Bonacci, E, Cardarella, G, Tognetto, D, Vattovani, O, Vallon, P, Iannacone, F, Fontana, L, Marchi, S, Manni, Gl, Jannetta, D, Roberti, G, Rossetti, L, Maggiolo, E, Oneta, O, Sborgia, C, Cantatore, F, Mastropasqua, L, Agnifili, L, Campos, E, Gizzi, C, Giannaccare, G, Pucci, V, Cassamali, M, Costagliola, C, Traverso, C, Scotto, R, Musolino, M, Landi, L, Bagnis, A., Rulli, Eliana, Quaranta, Luciano, Riva, Ivano, Poli, Davide, Hollander, Lital, Galli, Fabio, Katsanos, Andrea, Oddone, Francesco, Torri, Valter, Weinreb, Robert, N Varano L, Carchedi, T, Talarico, S, Frezzotti, P, Parravano, F, Motolese, I, Bagaglia, Sa, Rossi, Gcm, Lateri, S, Bossolesi, L, Carmassi, L, Rolle, T, Piccini, R, Ratiglia, R, Rossi, A, Gandolfi, S, Tagliavini, V, Ungaro, N, Fossarello, M, Cucca, A, Zucca, I, Uva, M, Bonacci, E, Cardarella, G, Tognetto, D, Vattovani, O, Vallon, P, Iannacone, F, Fontana, L, Marchi, S, Manni, Gl, Jannetta, D, Roberti, G, Rossetti, L, Maggiolo, E, Oneta, O, Sborgia, C, Cantatore, F, Mastropasqua, L, Agnifili, L, Campos, E, Gizzi, C, Giannaccare, G, Pucci, V, Cassamali, M, Costagliola, C, Traverso, C, Scotto, R, Musolino, M, Landi, L, and Bagnis, A.

Subjects
Multidisciplinary, Open angle glaucoma, business.industry, Published Erratum, lcsh:R, MEDLINE, lcsh:Medicine, Italian Study Group on QoL in Glaucoma, Eye, Quality of life (healthcare), Medicine, Optometry, lcsh:Q, Visual field loss, business, lcsh:Science
Abstract

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Published
2020

7. Golimumab effectiveness in biologic inadequate responding patients with rheumatoid arthritis, psoriatic arthritis and spondyloarthritis in real-life from the Italian registry GISEA

Author

Iannone, F., Favalli, E. G., Caporali, R., D'Angelo, S., Cantatore, F. P., Sarzi-Puttini, P., Foti, Roberta, Conti, Francesco, Carletto, A., Gremese, Elisa, Cauli, A., Ramonda, R., Palermo, A., Epis, O., Priora, M., Bergossi, F., Frediani, B., Salaffi, F., Lopalco, G., Cacciapaglia, F., Marchesoni, A., Biggioggiero, M., Bugatti, S., Balduzzi, S., Carriero, Alessandro, Corrado, A., Bongiovanni, S., Benenati, A., Miranda, F., Fracassi, E., Perra, D., Ferraccioli, Gianfranco, Lapadula, G., Foti R., Conti F., Gremese E. (ORCID:0000-0002-2248-1058), Carriero A., Ferraccioli G. (ORCID:0000-0001-6246-2428), Iannone, F., Favalli, E. G., Caporali, R., D'Angelo, S., Cantatore, F. P., Sarzi-Puttini, P., Foti, Roberta, Conti, Francesco, Carletto, A., Gremese, Elisa, Cauli, A., Ramonda, R., Palermo, A., Epis, O., Priora, M., Bergossi, F., Frediani, B., Salaffi, F., Lopalco, G., Cacciapaglia, F., Marchesoni, A., Biggioggiero, M., Bugatti, S., Balduzzi, S., Carriero, Alessandro, Corrado, A., Bongiovanni, S., Benenati, A., Miranda, F., Fracassi, E., Perra, D., Ferraccioli, Gianfranco, Lapadula, G., Foti R., Conti F., Gremese E. (ORCID:0000-0002-2248-1058), Carriero A., and Ferraccioli G. (ORCID:0000-0001-6246-2428)

Abstract

Objective: To evaluate the clinical effectiveness of golimumab in biologic inadequate responder (IR) patients with Rheumatoid arthritis (RA), Spondyloarthritis (SpA), and Psoriatic arthritis (PsA). Methods: We analyzed 1424 patients on golimumab from the GISEA registry. Drug survival was estimated by Kaplan-Meier analysis in biologic-naïve, 1-biologic IR, ≥ 2-biologics IR patients. Hazard ratios (HRs) of discontinuing golimumab at 2 years were assessed by multivariate Cox regression. Patients achieving CDAI based low disease activity (LDA) or BASDAI < 4 were calculated at 6 and 12 months. Results: In RA (n.370), the 2-years survival on golimumab was 61.4% in 1-biologic IR, 51.9% in ≥ 2-biologics IR, and 73.1% in biologic-naive patients (P = 0.002 vs ≥ 2-biologics IR). In SpA (n.502), the survival was similar among 1-biologic IR (80%), ≥ 2-biologics IR (76.5%), and biologic-naive (74.6%) patients (P > 0.05). In PsA (n.552) the survival was 72% in 1-biologic IR, 72.5% in ≥ 2-biologics IR, and 71.8% in naïve-biologic (P > 0.05). Predictors of golimumab discontinuation were monotherapy (HR 1.65) for RA, female gender for SpA (HR 2.48) and PsA (HR 1.57). In RA, patients on CDAI-LDA were lower in 1-biologic IR (40%) or ≥ 2 biologics IR (40%) than in biologic-naïve (60%) group at 6 months (P = 0.02), but no difference was observed at 12 months. In PsA and SpA, the percentage of patients on CDAI-LDA or BASDAI < 4 at 6 months was almost identical across the subgroups. Conclusions: Golimumab had similar effectiveness in biologic-failure and biologic-naïve SpA and PsA, but seems to be less effective in multi-failure RA patients, especially as monotherapy. The best outcomes were seen in male patients.

Published
2021

9. Vision-related quality of life and symptom perception change over time in newly-diagnosed primary open angle glaucoma patients

Author

Riva, I, Legramandi, L, Rulli, E, Konstas, Ag, Katsanos, A, Oddone, F, Weinreb, Rn, Quaranta, L, Varano, L, Carchedi, T, Talarico, S, Parravano, F, Motolese, I, Bagaglia, Sa, Rossi, Gcm, Lateri, S, Bossolesi, L, Carmassi, L, Rolle, T, Piccini, R, Ratiglia, R, Rossi, A, Gandolfi, S, Tagliavini, Ungaro, N, Fossarello, M, Cuccu, A, Zucca, I, Uva, M, Bonacci, E, Cardarella, G, Tognetto, D, Vattovani, O, Vallon, P, Iannacone, F, Fontana, L, Marchi, S, Manni, G, Iannetta, D, Roberti, G, Rossetti, L, Maggiolo, E, Oneta, O, Sborgia, C, Cantatore, F, Mastropasqua, L, Agnifili, L, Campos, E, Gizzi, C, Giannaccare, G, Pucci, Cassamali, M, Costagliola, C, Traverso, C, Scotto, R, Musolino, M, Landi, L, Bagnis, A, Riva I, Legramandi L, Rulli E, Konstas AG, Katsanos A, Oddone F, Weinreb RN, Quaranta L, Italian Study Group on QoL in Glaucoma: L Varano, T Carchedi, S Talarico, F Parravano, I Motolese, SA Bagaglia, GCM Rossi, S Lateri, L Bossolesi, L Carmassi, T Rolle, R Piccini, R Ratiglia, A Rossi, S Gandolfi, V Tagliavini, N Ungaro, M Fossarello, A Cuccu, I Zucca, M Uva, E Bonacci, G Cardarella, D Tognetto, O Vattovani, P Vallon, F Iannacone, L Fontana, S Marchi, GL Manni, D Jannetta, G Roberti, L Rossetti, E Maggiolo, O Oneta, C Sborgia, F Cantatore, L Mastropasqua, L Agnifili, E Campos, C Gizzi, G Giannaccare, V Pucci, M Cassamali, C Costagliola, C Traverso, R Scotto, M Musolino, L Landi, A Bagnis, Riva, Ivano, Legramandi, Lorenzo, Rulli, Eliana, Konstas, Anastasios G, Katsanos, Andrea, Oddone, Francesco, Weinreb, Robert N, Quaranta, Luciano, Varano, L, Carchedi, T, Talarico, S, Parravano, F, Motolese, I, Bagaglia, Sa, Rossi, Gcm, Lateri, S, Bossolesi, L, Carmassi, L, Rolle, T, Piccini, R, Ratiglia, R, Rossi, A, Gandolfi, S, Tagliavini, Ungaro, N, Fossarello, M, Cuccu, A, Zucca, I, Uva, M, Bonacci, E, Cardarella, G, Tognetto, D, Vattovani, O, Vallon, P, Iannacone, F, Fontana, L, Marchi, S, Manni, Gl, Jannetta, D, Roberti, G, Rossetti, L, Maggiolo, E, Oneta, O, Sborgia, C, Cantatore, F, Mastropasqua, L, Agnifili, L, Campos, E, Gizzi, C, Giannaccare, G, Pucci, Cassamali, M, Costagliola, C, Traverso, C, Scotto, R, Musolino, M, Landi, L, and Bagnis, A.

Subjects
0301 basic medicine, Change over time, medicine.medical_specialty, Aging, Visual acuity, Open angle glaucoma, genetic structures, Population, lcsh:Medicine, Glaucoma, Diseases, Italian Study Group on QoL in Glaucoma, Neurodegenerative, Eye, Article, 03 medical and health sciences, Medical research, 0302 clinical medicine, Quality of life, Clinical Research, Settore MED/30, Internal medicine, medicine, POAG, lcsh:Science, education, Prospective cohort study, Author Correction, Eye Disease and Disorders of Vision, education.field_of_study, Multidisciplinary, business.industry, lcsh:R, Neurosciences, medicine.disease, primary open angle glaucoma, humanities, eye diseases, 030104 developmental biology, Symptom perception, glaucoma, quality of life, lcsh:Q, sense organs, medicine.symptom, business, 030217 neurology & neurosurgery
Abstract

To evaluate the change over time of vision-related quality of life (QoL) and glaucoma symptoms in a population of newly-diagnosed primary open angle glaucoma (POAG) patients. Multicenter, prospective study. Consecutive newly-diagnosed POAG patients were enrolled and followed-up for one year. Follow-up visits were scheduled at 6 and 12 months from baseline. At each visit, vision-related QoL and glaucoma-related symptoms were assessed by the means of the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) and the Glaucoma Symptom Scale (GSS), respectively. Trends over time for NEI-VFQ-25 and GSS scores were evaluated with longitudinal linear mixed models. One-hundred seventy-eight patients were included in the analysis. At baseline, early to moderate glaucoma stages were associated with higher scores for most GSS and NEI-VFQ-25 items, while lower best-corrected visual acuity was associated with lower scores for 4 of the 12 NEI-VFQ-25 items. During the follow-up, all the GSS scores, the NEI-VFQ-25 total score, and 7 of the 12 NEI-VFQ-25 scores significantly improved (p

Published
2019

11. Do we trust scientific evidence? A multicentre retrospective analysis of first IVF/ICSI cycles before and after the OPTIMIST trial

Author

Papaleo, E, primary, Revelli, A, additional, Costa, M, additional, Bertoli, M, additional, Zaffagnini, S, additional, Tomei, F, additional, Manno, M, additional, Rebecchi, A, additional, Villanacci, R, additional, Vanni, V S, additional, Cantatore, F, additional, Ruffa, A, additional, Colia, D, additional, Sironi, M, additional, Tessari, T, additional, Parissone, F, additional, Romanello, I, additional, Reschini, M, additional, Dallagiovanna, C, additional, and Somigliana, E, additional

Published
2021
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12. Author Correction: Vision-related quality of life and symptom perception change over time in newly-diagnosed primary open angle glaucoma patients (Scientific Reports, (2019), 9, 1, (6735), 10.1038/s41598-019-43203-9)

Author

Riva, I., Legramandi, L., Rulli, E., Konstas, A. G., Katsanos, A., Oddone, F., Weinreb, R. N., Quaranta, L., Varano, L., Carchedi, T., Talarico, S., Frezzotti, P., Parravano, F., Motolese, I., Bagaglia, S. A., Rossi, G. C. M., Lateri, S., Bossolesi, L., Carmassi, L., Rolle, T., Piccini, R., Ratiglia, R., Rossi, A., Gandolfi, S., Tagliavini, V., Ungaro, N., Fossarello, M., Cuccu, A., Zucca, I., Uva, M., Bonacci, E., Cardarella, G., Tognetto, D., Vattovani, O., Vallon, P., Iannacone, F., Fontana, L., Marchi, S., Manni, G. L., Jannetta, D., Roberti, G., Rossetti, L., Maggiolo, E., Oneta, O., Sborgia, C., Cantatore, F., Mastropasqua, L., Agnifili, L., Campos, E., Gizzi, C., Giannaccare, G., Pucci, V., Cassamali, M., Costagliola, C., Traverso, C., Scotto, R., Musolino, M., Landi, L., and Bagnis, A.

Subjects
Settore MED/30
Published
2020

13. Author Correction: Visual field loss and vision-related quality of life in the Italian Primary Open Angle Glaucoma Study (Scientific Reports, (2018), 8, 1, (619), 10.1038/s41598-017-19113-z)

Author

Rulli, E., Quaranta, L., Riva, I., Poli, D., Hollander, L., Galli, F., Katsanos, A., Oddone, F., Torri, V., Weinreb, R. N., Varano, L., Carchedi, T., Talarico, S., Frezzotti, P., Parravano, F., Motolese, I., Bagaglia, S. A., Rossi, G. C. M., Lateri, S., Bossolesi, L., Carmassi, L., Rolle, T., Piccini, R., Ratiglia, R., Rossi, A., Gandolfi, S., Tagliavini, V., Ungaro, N., Fossarello, M., Cucca, A., Zucca, I., Uva, M., Bonacci, E., Cardarella, G., Tognetto, D., Vattovani, O., Vallon, P., Iannacone, F., Fontana, L., Marchi, S., Manni, G. L., Jannetta, D., Roberti, G., Rossetti, L., Maggiolo, E., Oneta, O., Sborgia, C., Cantatore, F., Mastropasqua, L., Agnifili, L., Campos, E., Gizzi, C., Giannaccare, G., Pucci, V., Cassamali, M., Costagliola, C., Traverso, C., Scotto, R., Musolino, M., Landi, L., and Bagnis, A.

Subjects
Settore MED/30
Published
2020

14. Predictors of disease worsening defined by progression of organ damage in diffuse systemic sclerosis: a European Scleroderma Trials and Research (EUSTAR) analysis

Author

Becker M, Graf N, Sauter R, Curram J, Denton C, Khanna D, Pena J, Pope J, Distler O, Matucci-Cerinic M, Guiducci S, Walker U, Jaeger V, Bannert B, Lapadula G, Becvarare R, Cutolo M, Valentini G, Siegert E, Rednic S, Allanore Y, Montecucco C, Carreira P, Novak S, Czirjak L, Varju C, Chizzolini C, Allai D, Kucharz E, Cozzi F, Rozman B, Mallia C, Gabrielli A, Bancel D, Airo P, Hesselstrand R, Martinovic D, Balbir-Gurman A, Braun-Moscovici Y, Hunzelmann N, Pellerito R, Caramaschi P, Black C, Damjanov N, Henes J, Santamaria V, Heitmann S, Seidel M, Da Silva J, Stamenkovic B, Selmi C, Tikly M, Denisov L, Muller-Ladner U, Engelhart M, Hachulla E, Riccieri V, Ionescu R, Mihai C, Sunderkotter C, Kuhn A, Schett G, Distler J, Meroni P, Ingegnoli F, Mouthon L, De Keyser F, Smith V, Cantatore F, Corrado A, Ullman S, Iversen L, Pozzi M, Eyerich K, Hein R, Knott E, Wiland P, Szmyrka-Kaczmarek M, Sokolik R, Morgiel E, Madej M, Alegre-Sancho J, Krummel-Lorenz B, Saar P, Aringer M, Gunther C, Anne E, Westhovens R, De Langhe E, Lenaerts J, Anic B, Baresic M, Mayer M, Uprus M, Otsa K, Yavuz S, Radominski S, Muller C, Azevedo V, Popa S, Zenone T, Stebbings S, Highton J, Mathieu A, Vacca A, Stamp L, Chapman P, O'Donnell J, Solanki K, Doube A, Veale D, O'Rourke M, Loyo E, Li M, Rosato E, Amoroso A, Gigante A, Oksel F, Yargucu F, Tanaseanu C, Popescu M, Dumitrascu A, Tiglea I, Foti R, Visalli E, Benenati A, Amato G, Ancuta C, Chirieac R, Villiger P, Adler S, Dan D, Lefebvre P, Rubio S, Exposito M, Sibilia J, Chatelus E, Gottenberg J, Chifflot H, Litinsky I, Del Galdo F, Venalis A, Saketkoo L, Lasky J, Kerzberg E, Montoya F, Cosentino V, Limonta M, Brucato A, Lupi E, Spertini F, Ribi C, Buss G, Martin T, Guffroy A, Poindron V, Chung L, Schmeiser T, Zebryk P, Riso N, Riemekasten G, Rezus E, Puttini P, and EUSTAR Collaborators

Abstract

Objectives Mortality and worsening of organ function are desirable endpoints for clinical trials in systemic sclerosis (SSc). The aim of this study was to identify factors that allow enrichment of patients with these endpoints, in a population of patients from the European Scleroderma Trials and Research group database. Methods Inclusion criteria were diagnosis of diffuse SSc and follow-up over 12 +/- 3 months. Disease worsening/organ progression was fulfilled if any of the following events occurred: new renal crisis; decrease of lung or heart function; new echocardiography-suspected pulmonary hypertension or death. In total, 42 clinical parameters were chosen as predictors for the analysis by using (1) imputation of missing data on the basis of multivariate imputation and (2) least absolute shrinkage and selection operator regression. Results Of 1451 patients meeting the inclusion criteria, 706 had complete data on outcome parameters and were included in the analysis. Of the 42 outcome predictors, eight remained in the final regression model. There was substantial evidence for a strong association between disease progression and age, active digital ulcer (DU), lung fibrosis, muscle weakness and elevated C-reactive protein (CRP) level. Active DU, CRP elevation, lung fibrosis and muscle weakness were also associated with a significantly shorter time to disease progression. A bootstrap validation step with 10 000 repetitions successfully validated the model. Conclusions The use of the predictive factors presented here could enable cohort enrichment with patients at risk for overall disease worsening in SSc clinical trials.

Published
2019

17. Prevalence and incidence of osteoporotic fractures in patients on long-term glucocorticoid treatment for rheumatic diseases: The glucocorticoid induced OsTeoporosis TOol (GIOTTO) study

Author

Rossini, M., Viapiana, O., Vitiello, M., Malavolta, N., La Montagna, G., Maddali Bongi, S., Di Munno, O., Nuti, R., Manzini, C. U., Ferri, C., Bogliolo, L., Mathieu, A., Cantatore, F., Del Puente, A., Muratore, M., Grassi, W., Frediani, B., Saviola, G., Delvino, P., Mirone, L., Ferraccioli, G., Tripi, G., Piazza, I., Gatti, D., Rossini M. (ORCID:0000-0003-2665-534X), Muratore M., Mirone L. (ORCID:0000-0001-5820-5533), Ferraccioli G. (ORCID:0000-0001-6246-2428), Rossini, M., Viapiana, O., Vitiello, M., Malavolta, N., La Montagna, G., Maddali Bongi, S., Di Munno, O., Nuti, R., Manzini, C. U., Ferri, C., Bogliolo, L., Mathieu, A., Cantatore, F., Del Puente, A., Muratore, M., Grassi, W., Frediani, B., Saviola, G., Delvino, P., Mirone, L., Ferraccioli, G., Tripi, G., Piazza, I., Gatti, D., Rossini M. (ORCID:0000-0003-2665-534X), Muratore M., Mirone L. (ORCID:0000-0001-5820-5533), and Ferraccioli G. (ORCID:0000-0001-6246-2428)

Abstract

Osteoporosis and fractures are common and invalidating consequences of chronic glucorticoid (GC) treatment. Reliable information regarding the epidemiology of GC induced osteoporosis (GIOP) comes exclusively from the placebo group of randomized clinical trials while observational studies are generally lacking data on the real prevalence of vertebral fractures, GC dosage and primary diagnosis. The objective of this study was to evaluate the prevalence and incidence of osteoporotic fractures and to identify their major determinants (primary disease, GC dosage, bone mineral density, risk factors, specific treatment for GIOP) in a large cohort of consecutive patients aged >21 years, on chronic treatment with GC (≥5 mg prednisone - PN - equivalent) and attending rheumatology centers located all over Italy. Glucocorticoid Induced OsTeoporosis TOol (GIOTTO) is a national multicenter cross-sectional and longitudinal observational study. 553 patients suffering from Rheumatoid Arthritis (RA), Polymyalgia Rheumatica (PMR) and Connective Tissue Diseases (CTDs) and in chronic treatment with GCs were enrolled. Osteoporotic BMD values (T score <-2.5) were observed in 28%, 38% and 35% of patients with CTDs, PMR or RA at the lumbar spine, and in 18%, 29% and 26% at the femoral neck, respectively. Before GC treatment, prevalent clinical fractures were reported by 12%, 37% and 17% of patients with CTDs, PMR, or RA, respectively. New clinical fragility fractures during GC treatment were reported by 12%, 10% and 23% of CTDs, PMR and RA patients, respectively. Vertebral fractures were the prevailing type of fragility fracture. More than 30% of patients had recurrence of fracture. An average of 80% of patients were in supplementation with calcium and/or vitamin D during treatment with GCs. Respectively, 64%, 80%, and 72% of the CTDs, PMR and RA patients were on pharmacological treatment for GIOP, almost exclusively with bisphosphonates. The GIOTTO study might provide relevant contri

Published
2017

18. The Italian observational study on severe osteoporosis (ISSO): 24-month results on incidence of fractures and adherence to treatment

Author

Window, Trova@UniTO(opens in a. new, Export, Download | Add to List | More,, Rheumatology, Clinical, Experimental, Volume 34, Issue 2, The Italian observational study on severe osteoporosis: 24 month results on incidence of fractures, adherence to treatment Idolazzi, L. Abb, Maugeri, D. B, Monti, S. C, Massarotti, M. D, Osella, G. E, Barbagallo, M. F, Del Fiacco, R. G, Silvestri, S. G, Adami, S. H, Altomonte, L. I, Bardoscia, A. J, Bertoldo, F. K, Bevilacqua, M. L, Bianchi, G. M, Brancati, A. N, Cagnoni, C. O, Cantatore, F. P. P, Capone, A. Q, Costanzo, G. R, D'Avola, G. S, De Giorgi, G. T, Di Matteo, L. U, Di Munno, O. V, Filipponi, P. W, Frisina, N. X, Fusco, A. Y, Giannini, S. Z, Guiducci, S. Aa, Iolascon, G. Ab, Isaia, Giovanni Carlo, Lombardi, G. Ad, Malavolta, N. Ae, Marcocci, C. Af, Migliaccio, S. Ag, Migliore, A. Ah, Muratore, M. Ai, Nardi, A. Aj, Ortolani, S. Ak, Pasquali, R. Al, Petto, H. Am, Pietrogrande, L. An, Pola, E. Ao, Previti, B. Ap, Resmini, G. Aq, Rubinacci, A. Ar, Russo, E. As, Scillitani, A. At, Silveri, F. Au, Leali, P. T. Av, Trotta, F. Aw, Ulivieri, M. Ax, Verdoia, C. Ay, Versace, F. Az, Vinicola, V. Ba, Idolazzi, Luca, Maugeri, Domenico, Monti, Salvatore, Massarotti, Marco, Osella, Giangiacomo, Barbagallo, Mario, Del Fiacco, Romano, Silvestri, Sandra, Adami, S, Altomonte, L, Barbagallo, M, Bardoscia, A, delle Murge, C, Bertoldo, F, Bevilacqua, M, Bianchi, G, Brancati, A, Cagnoni, C, Cantatore, Fp, Capone, A, DI COSTANZO, Gennaro, D'Avola, G, De Giorgi, G, Di Matteo, L, Di Munno, O, Filipponi, P, Frisina, N, Fusco, A, Giannini, S, Guiducci, S, Iolascon, G, Isaia, G, Lombardi, G, Malavolta, N, Marcocci, C, Migliaccio, S, Migliore, A, Muratore, M, Nardi, A, Ortolani, S, Osella, G, Pasquali, R, Petto, H, Pietrogrande, L, Pola, E, Previti, B, Resmini, G, Rubinacci, A, Russo, Pina Elvira, Scillitani, A, Silveri, F, Leali, Pt, Trotta, F, Ulivieri, M, Verdoia, C, Versace, F, and Vinicola, V.

Subjects
Aged, 80 and over, Male, Spinal fracture, Incidence, Osteoporosi, Middle Aged, Parathyroid hormone, Spine, Medication Adherence, Fracture, Observational study, Osteoporosis therapy, Teriparatide, 80 and over, Settore MED/33 - Malattie Apparato Locomotore, Humans, Osteoporosis, Female, Prospective Studies, Aged, Osteoporotic Fractures
Abstract

Objective To estimate the proportion of patients with very severe osteoporosis (those covered by the reimbursement criteria of the Italian National Health Service) experiencing new vertebral and non-vertebral fragility fractures in the first 24 months of a new anti-osteoporosis treatment. Methods Prospective observational study in men and post-menopausal women (aged > 21 years) initiating anti-osteoporosis treatment for very severe osteoporosis. Eligibility was based on teriparatide (TPD) reimbursement criteria in Italy: Incident of vertebral or hip fracture during anti-resorptive treatment (minimum 1 year), or at least three prevalent severe vertebral fractures, or two prevalent severe vertebral fractures and a historical proximal hip fracture. Incidence of new clinical vertebral and non-vertebral fractures was documented by original x-rays and/or radiological reports, and a post-hoc analysis compared data from the TPD monotherapy population versus the total treated group. Results Overall, 767 patients (mean age 72.8 years, 90.7% women) were enrolled in the study, of whom 628, 538, 419 and 424 attended visits at 6, 12, 18 and 24 months, respectively. The most commonly prescribed therapy was TPD (single-agent; 64.5%), then bisphosphonates and other anti-resorptives (33.3%). A combination of different oral treatments was given to 22.5% of the patients. Overall treatment adherence at 24 months was 65.7%. In a post-hoc analysis, the overall incidence of new clinical vertebral and non-vertebral fractures in the total treated population was, respectively, 4.7% and 2.3% in the first 6 months; 1.8% and 1.6% in the 6-12 month period; 2.9% and 1.4% in the 12-18 month period; and 2.2% and 1.0% in the 18-24 month period. Conclusion In patients with very severe osteoporosis, the risk of new vertebral and non-vertebral fractures declined after the first 6 months and remained low throughout the study. Objective To estimate the proportion of patients with very severe osteoporosis (those covered by the reimbursement criteria of the Italian National Health Service) experiencing new vertebral and non-vertebral fragility fractures in the first 24 months of a new anti-osteoporosis treatment. Methods Prospective observational study in men and post-menopausal women (aged > 21 years) initiating anti-osteoporosis treatment for very severe osteoporosis. Eligibility was based on teriparatide (TPD) reimbursement criteria in Italy: Incident of vertebral or hip fracture during anti-resorptive treatment (minimum 1 year), or at least three prevalent severe vertebral fractures, or two prevalent severe vertebral fractures and a historical proximal hip fracture. Incidence of new clinical vertebral and non-vertebral fractures was documented by original x-rays and/or radiological reports, and a post-hoc analysis compared data from the TPD monotherapy population versus the total treated group. Results Overall, 767 patients (mean age 72.8 years, 90.7% women) were enrolled in the study, of whom 628, 538, 419 and 424 attended visits at 6, 12, 18 and 24 months, respectively. The most commonly prescribed therapy was TPD (single-agent; 64.5%), then bisphosphonates and other anti-resorptives (33.3%). A combination of different oral treatments was given to 22.5% of the patients. Overall treatment adherence at 24 months was 65.7%. In a post-hoc analysis, the overall incidence of new clinical vertebral and non-vertebral fractures in the total treated population was, respectively, 4.7% and 2.3% in the first 6 months; 1.8% and 1.6% in the 6-12 month period; 2.9% and 1.4% in the 12-18 month period; and 2.2% and 1.0% in the 18-24 month period. Conclusion In patients with very severe osteoporosis, the risk of new vertebral and non-vertebral fractures declined after the first 6 months and remained low throughout the study.

Published
2016

19. Gastrointestinal symptoms and association with medication use patterns, adherence, treatment satisfaction, quality of life, and resource use in osteoporosis: baseline results of the MUSIC-OS study

Author

Modi, A., Sen, S., Adachi, J., Adami, S., Cortet, B., Cooper, A., Geusens, P., Mellström, D., Weaver, J., van den Bergh, J., Nguyen, A., Sajjan, S., Khan, A., Schweitzer, B., Saunders, K., Du Preez, M., Bayly, K., Lichtenstein, T., Boroditsky, R., Corey, J., Sinha, J., Kooy, J., Nayar, A., Arndt, S., Mohamed, I., Olszynski, W., Legroux, I., Guinamand, S., De Vernejoul, M., Roux, C., Thomas, E., Lévy-Weil, F., Ursu, C., Barucq, F., Bisch, O., Bouche, P., Breton, N., Lacoin, F., Makridis, G., Marmor, P., Ruetsch, M., Taminau, D., Bismuth, M., Bourgoin, M., Sacareau, D., Scellier, C., Wurtz, J., Le Mouel, S., Bortolotti, C., Lauer, B., Amar, H., Cadinot, D., Thorngren, K., Akesson, K., Gandolini, G., Barbagallo, M., Nuti, R., Di Monaco, M., Bonaccorsi, G., Giannini, S., Del Puente, A., Minisola, S., Tarantino, U., Brandi, M., Di Munno, O., D'Avola, G., Caminiti, M., Frediani, B., Marcocci, C., Grimaldi, F., Falaschi, P., Biondi, M., Mauro, G., Cantatore, F., Muratore, M., den Heijer, N., Hamdy, N., Franke, H., Boermans, T., Kooy, A., Valk, N., Eavis, P., Brownlie, R., Brunskill, J., Gumbley, M., Gaunt, R., Litchfield, J., Martin, G., Mcconnell, B., Mccormack, T., Annamalai, N., Srinivasan, D., Takhar, A., Gooding, T., Conn, P., Parker, I., Redmond, M., Calvert, J., Cookson, N., Ainsworth, P., Heer, A., Wyatt, N., Modi, A., Sen, S, Adachi, J., Adami, S., Cortet, B, Cooper, A., Geusens, P., Mellstrom, D., Weaver, J., VAn den Berghe, J., Nguyen, A., Sajjan, S., MUSIC-OS Study Group, Barbagallo, M, Letizia Mauro, G, RS: CAPHRI School for Public Health and Primary Care, RS: CAPHRI - R3 - Functioning, Participating and Rehabilitation, Interne Geneeskunde, and RS: NUTRIM - R3 - Chronic inflammatory disease and wasting

Subjects
Gastrointestinal Diseases, Endocrinology, Diabetes and Metabolism, Health-related quality of life, Osteoporosis, FRACTURE RISK, RISEDRONATE, 0302 clinical medicine, Endocrinology, Quality of life, Back pain, 030212 general & internal medicine, Prospective Studies, HEALTH PLAN, Prospective cohort study, ALENDRONATE, Osteoporosis, Postmenopausal, POPULATION, education.field_of_study, Bone Density Conservation Agents, Diphosphonates, BISPHOSPHONATE THERAPY, Settore MED/34 - Medicina Fisica E Riabilitativa, TRACT SAFETY, Bisphosphonates, Middle Aged, Europe, Diabetes and Metabolism, POSTMENOPAUSAL WOMEN, Patient Satisfaction, Health Resources, Female, Original Article, Postmenopausal, medicine.symptom, Gastrointestinal, Treatment satisfaction, Aged, Canada, Humans, Medication Adherence, Psychometrics, Quality of Life, medicine.medical_specialty, Population, 030209 endocrinology & metabolism, NO, 03 medical and health sciences, Internal medicine, medicine, education, business.industry, PERSISTENCE, bisphosphonates, gastrointestyinal, osteoporosis, postmenopausal, treatment satisfaction, medicine.disease, Rheumatology, CLINICAL-PRACTICE, Orthopedic surgery, Observational study, business
Abstract

The Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study (MUSIC-OS) is a prospective, observational study of women with osteoporosis in Europe and Canada. At baseline, patients with gastrointestinal symptoms reported lower adherence to osteoporosis treatment, treatment satisfaction, and health-related quality of life, than those without gastrointestinal symptoms. INTRODUCTION: The aim of the study was to examine gastrointestinal (GI) symptoms and the association between GI symptoms and treatment adherence, treatment satisfaction, and health-related quality of life (HRQoL) among osteoporotic women in Europe and Canada. METHODS: Baseline results are reported here for a prospective study which enrolled postmenopausal, osteoporotic women who were initiating (new users) or continuing (experienced users) osteoporosis treatment at study entry (baseline). A patient survey was administered at baseline and included the occurrence of GI symptoms during 6-month pre-enrolment, treatment adherence (adherence evaluation of osteoporosis (ADEOS), score 0-22), treatment satisfaction (Osteoporosis Treatment Satisfaction Questionnaire for Medications (OPSAT-Q), score 0-100) and HRQoL (EuroQol-5 dimension (EQ-5D) utility, score 0-1; OPAQ-SV, score 0-100). The association between GI symptoms and ADEOS (experienced users), OPSAT-Q (experienced users), and HRQoL (new and experienced users) was assessed by general linear models adjusted for patient characteristics. RESULTS: A total of 2959 patients (2275 experienced and 684 new users) were included. Overall, 68.1 % of patients experienced GI symptoms in the past 6 months. Compared with patients without GI symptoms, patients with GI symptoms had lower mean baseline scores on most measures. The mean adjusted differences were ADEOS, -0.43; OPSAT-Q, -5.68; EQ-5D, -0.04 (new users) and -0.06 (experienced users), all P < 0.01. GI symptoms were also associated with lower OPAQ-SV domain scores: physical function, -4.17 (experienced users); emotional status, -4.28 (new users) and -5.68 (experienced users); back pain, -5.82 (new users) and -11.33 (experienced users), all P < 0.01. CONCLUSIONS: Patients with GI symptoms have lower treatment adherence and treatment satisfaction and worse HRQoL than patients without GI symptoms.

Published
2016

20. Determinants of Bone Turnover Markers in Healthy Premenopausal Women

Author

Silvano, Adami, Gerolamo, Bianchi, Maria Luisa Brandi, Sandro, Giannini, Sergio, Ortolani, Ombretta, Dimunno, Bruno, Frediani, Maurizio, Rossini, Group Bevilacqua, Bonturno Study M., Bianchi, G., Bosello, O., Cantatore, F., Di Munno, O., Fiore, E., Frediani, B., Frisina, N., Gandolini, G., Giannini, S., Lo Cascio, V., Luisetto, G., Marcocci, C., Minisola, Salvatore, Muratore, M., Nuti, R., Ortolani, S., Rini, G. B., Rossini, M., and Massimo, F.

Subjects
Adult, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, Osteocalcin, Osteoporosis, Reference range, body weight, bone turnover marker, contraceptive pill, normative value, serum phosphate, Bone and Bones, Collagen Type I, Phosphates, Bone remodeling, chemistry.chemical_compound, Endocrinology, Reference Values, Internal medicine, medicine, Humans, Magnesium, Orthopedics and Sports Medicine, Creatinine, biology, business.industry, Confounding, Middle Aged, medicine.disease, Peptide Fragments, Premenopause, chemistry, biology.protein, Calcium, Female, Bone Remodeling, Follicle Stimulating Hormone, Peptides, business, Body mass index, Biomarkers, Procollagen, Hormone
Abstract

Bone turnover markers (BTMs) are widely used for the management of osteoporosis, and the premenopausal reference range is the target value for the treatment of postmenopausal osteoporosis with antiresorbing agents. Three serum BTMs (serum C-telopeptide of type I collagen [CTX], osteocalcin [OC], and N-terminal propeptide of type I procollagen [P1NP]), serum calcium, creatinine, phosphate, magnesium, and follicle-stimulating hormone (FSH) were measured in 638 healthy premenopausal women aged 20-50 years. In 83 women on the contraceptive pill (CP), the levels of the three BTMs adjusted for all confounding factors were 14-26% lower (P0.005) than in non-CP users. In 18 women considered perimenopausal for serum FSH levels30 IU/mL despite having regular menses, BTM levels were significantly higher than in age-matched women. This group of subjects and the women on the CP were excluded from further analysis. The three BTMs significantly decreased with advancing age and were negatively and independently correlated with body mass index (P0.001) and serum phosphate. In conclusion, we confirm that CP use is associated with significantly lower BTM values. An increase in BTM concentrations can be observed in perimenopausal women, i.e., women with normal menses but FSH levels30 IU/mL. BTMs decrease substantially with advancing age, and this appears to be associated with changes in body weight and serum phosphate. New normative ranges for serum OC, CTX, and P1NP were identified; and our findings in general impose a redefinition of the criteria for establishing the normal ranges for BTMs.

Published
2008
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21. Prevalence and incidence of osteoporotic fractures in patients on long-term glucocorticoid treatment for rheumatic diseases: the Glucocorticoid Induced OsTeoporosis TOol (GIOTTO) study

Author

Rossini, M., primary, Viapiana, O., additional, Vitiello, M., additional, Malavolta, N., additional, La Montagna, G., additional, Maddali Bongi, S., additional, Di Munno, O., additional, Nuti, R., additional, Manzini, C.U., additional, Ferri, C., additional, Bogliolo, L., additional, Mathieu, A., additional, Cantatore, F., additional, Del Puente, A., additional, Muratore, M., additional, Grassi, W., additional, Frediani, B., additional, Saviola, G., additional, Delvino, P., additional, Mirone, L., additional, Ferraccioli, G., additional, Tripi, G., additional, Piazza, I., additional, and Gatti, D., additional

Published
2017
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23. Characteristics of joint involvement and relationships with systemic inflammation in systemic sclerosis: results from the EULAR Scleroderma Trial and Research Group (EUSTAR) database

Author

Avouac, Jerome, Walker, Ulrich, Tyndall, Alan, Kahan, André, Matucci Cerinic, Marco, Allanore, Yannick, Miniati, I., Müller, A., Iannone, F., Giacomelli, R., Distler, O., Becvar, R., Sierakowsky, S., Kowal Bielecka, O., Coelho, P., Cabane, J., Cutolo, M., Shoenfeld, Y., Rovensky, J., Riemekasten, G., Nicoara, I., Vlachoyiannopoulos, P., Caporali, R., Jiri, S., Inanc, M., Gorska, I. Zimmermann, Carreira, P., Novak, S., Czirjak, L., Ramos, F. Oliveira, Jendro, M., Chizzolini, C., Kucharz, E. J., Richter, J., Cozzi, F., Rozman, B., Mallia, C. M., Gabrielli, A., Farge, D., Kiener, H. P., Schöffel, D., Sticherling, M., Airo, P., Wollheim, F., Martinovic, D., Trotta, F., Hunzelmann, N., Jablonska, S., Reich, K., Bombardieri, S., Siakka, P., Pellerito, R., Bambara, L. M., Morovic Vergles, J., Denton, C., Hinrichs, R., Van Den Hoogen, F., Damjanov, N., Kötter, I., Ortiz, V., Heitmann, S., Krasowska, D., Seidel, M., Hasler, P., Van Laar, J. M., Kaltwasser, J. P., Foeldvari, I., Juan Mas, A., Bajocchi, G., Wislowska, M., Pereira Da Silva, J. A., Jacobsen, S., Worm, M., Graniger, W., Kuhn, A., Stankovic, A., Cossutta, R., Majdan, M., Rajcevska, L. Damjanovska, Tikly, M., Nasonov, E. L., Steinbrink, K., Herrick, A., Müller Ladner, U., Dinc, A., Scorza, R., Sondergaard, K., Indiveri, F., Nielsen, H., Szekanecz, Z., Silver, R. M., Antivalle, M., Espinosa, I. B., García De La Pena Lefebvre, P., Midtvedt, O., Launay, D., Valesini, F., Tuvik, P., Ionescu, R. M., Del Papa, N., Pinto, S., Wigley, F., Mihai, C., Capranu, M. Sinziana, Sunderkötter, C., Jun, J. B., Derk, C., Alhasani, S., Distler, J. H., Ton, E., Soukup, T., Seibold, J., Zeni, S., Nash, P., Mouthon, L., De Keyser, F., Duruöz, M. T., Cantatore, F. P., Strauss, G., Von Mülhen, C. A., Pozzi, M. R., Eyerich, K., Szechinski, J., Keiserman, M., Houssiau, F. A., Rom Ivorra, J. A., Krummel Lorenz, B., Aringer, M., Westhovens, R., Bellisai, F., Mayer, M., Stoeckl, F., Üprus, M., Volpe, A., Buslau, M., Yavuz, S., Granel, B., Feijó, A. Valderílio, Del Galdo, F., Popa, S., Zenone, T., Machado, X. Ricardo, Pileckyte, M., Stebbings, S., Mathieu, A., Tulli, A., Tourinho, T., Souza, R., Acayaba De Toledo, R., Stamp, L., Solanki, K., Veale, D., Neto, J. Francisco Marques, Bagnato, G. F., Loyo, E., Toloza, S., Li, M., Mohamed, W. Ahmed Abdel Atty, Cobankara, V., Olas, J., Salsano, F., Oksel, F., Tanaseanu, C. M., Foti, R., Ancuta, C., Vonk, M., Caramashi, P., Beretta, L., Balbir, A., Shine, B., Chiàla, A., Simic, K. Pasalic, Ghio, M., Stamenkovic, B., Rednic, S., Host, N., Hachulla, E., Furst, D. E., VALENTINI, Gabriele, Avouac, Jerome, Walker, Ulrich, Tyndall, Alan, Kahan, André, Matucci Cerinic, Marco, Allanore, Yannick, Miniati, I., Müller, A., Iannone, F., Giacomelli, R., Distler, O., Becvar, R., Sierakowsky, S., Kowal Bielecka, O., Coelho, P., Cabane, J., Cutolo, M., Shoenfeld, Y., Valentini, Gabriele, Rovensky, J., Riemekasten, G., Nicoara, I., Vlachoyiannopoulos, P., Caporali, R., Jiri, S., Inanc, M., Gorska, I. Zimmermann, Carreira, P., Novak, S., Czirjak, L., Ramos, F. Oliveira, Jendro, M., Chizzolini, C., Kucharz, E. J., Richter, J., Cozzi, F., Rozman, B., Mallia, C. M., Gabrielli, A., Farge, D., Kiener, H. P., Schöffel, D., Sticherling, M., Airo, P., Wollheim, F., Martinovic, D., Trotta, F., Hunzelmann, N., Jablonska, S., Reich, K., Bombardieri, S., Siakka, P., Pellerito, R., Bambara, L. M., Morovic Vergles, J., Denton, C., Hinrichs, R., Van Den Hoogen, F., Damjanov, N., Kötter, I., Ortiz, V., Heitmann, S., Krasowska, D., Seidel, M., Hasler, P., Van Laar, J. M., Kaltwasser, J. P., Foeldvari, I., Juan Mas, A., Bajocchi, G., Wislowska, M., Pereira Da Silva, J. A., Jacobsen, S., Worm, M., Graniger, W., Kuhn, A., Stankovic, A., Cossutta, R., Majdan, M., Rajcevska, L. Damjanovska, Tikly, M., Nasonov, E. L., Steinbrink, K., Herrick, A., Müller Ladner, U., Dinc, A., Scorza, R., Sondergaard, K., Indiveri, F., Nielsen, H., Szekanecz, Z., Silver, R. M., Antivalle, M., Espinosa, I. B., García De La Pena Lefebvre, P., Midtvedt, O., Launay, D., Valesini, F., Tuvik, P., Ionescu, R. M., Del Papa, N., Pinto, S., Wigley, F., Mihai, C., Capranu, M. Sinziana, Sunderkötter, C., Jun, J. B., Derk, C., Alhasani, S., Distler, J. H., Ton, E., Soukup, T., Seibold, J., Zeni, S., Nash, P., Mouthon, L., De Keyser, F., Duruöz, M. T., Cantatore, F. P., Strauss, G., Von Mülhen, C. A., Pozzi, M. R., Eyerich, K., Szechinski, J., Keiserman, M., Houssiau, F. A., Rom Ivorra, J. A., Krummel Lorenz, B., Aringer, M., Westhovens, R., Bellisai, F., Mayer, M., Stoeckl, F., Üprus, M., Volpe, A., Buslau, M., Yavuz, S., Granel, B., Feijó, A. Valderílio, Del Galdo, F., Popa, S., Zenone, T., Machado, X. Ricardo, Pileckyte, M., Stebbings, S., Mathieu, A., Tulli, A., Tourinho, T., Souza, R., Acayaba De Toledo, R., Stamp, L., Solanki, K., Veale, D., Neto, J. Francisco Marque, Bagnato, G. F., Loyo, E., Toloza, S., Li, M., Mohamed, W. Ahmed Abdel Atty, Cobankara, V., Olas, J., Salsano, F., Oksel, F., Tanaseanu, C. M., Foti, R., Ancuta, C., Vonk, M., Caramashi, P., Beretta, L., Balbir, A., Shine, B., Chiàla, A., Simic, K. Pasalic, Ghio, M., Stamenkovic, B., Rednic, S., Host, N., Hachulla, E., Furst, D. E., Chizzolini, Carlo, and Westhovens, Rene

Subjects
Male, Systemic disease, Databases, Factual, Cross-sectional study, Joint Diseases/etiology/pathology/physiopathology, Systemic inflammation, Joint involvement, Scleroderma, systemic sclrosis, systemic inflemmetion, joint involvement, Tendons, Systemic sclerosi, Scleroderma, Localized, 0302 clinical medicine, data base, Immunopathology, joint radiography, Immunology and Allergy, Joints/pathology, scleroderma, 030212 general & internal medicine, nuclear magnetic resonance imaging, Range of Motion, Articular, skin and connective tissue diseases, rheumatic disease, ddc:616, interstitial lung disease, Joint contracture, Clinical Trials as Topic, Synovitis, Inflammation/etiology/pathology/physiopathology, integumentary system, article, Tendons/pathology, Middle Aged, musculoskeletal system, cohort analysis, Connective tissue disease, priority journal, Joint, Synoviti, Systemic sclerosis, Female, medicine.symptom, Joint Diseases, Human, musculoskeletal diseases, Adult, medicine.medical_specialty, hand radiography, Immunology, Scleroderma, Localized/etiology/*pathology, Auto-immunity, transplantation and immunotherapy [N4i 4], 03 medical and health sciences, SYSTEMIC SCLEROSIS, JOINT INVOLVEMENT, SYNOVITIS, JOINT CONTRACTURE, TENDON FRICTION RUB, Tendon friction rub, Rheumatology, Internal medicine, medicine, Humans, Health care ethics [NCEBP 5], Tendon, Aged, 030203 arthritis & rheumatology, Cross-Sectional Studie, Inflammation, skin disease, Scleroderma, Systemic, business.industry, echography, medicine.disease, major clinical study, tenosynovitis, Synovitis/etiology/pathology, clinical feature, body regions, Cross-Sectional Studies, Evaluation of complex medical interventions [NCEBP 2], Scleroderma, Systemic/complications/pathology/physiopathology, Joints, disease duration, business, Joint Disease, disease activity
Abstract

Objective.To determine the prevalence of and independent factors associated with joint involvement in a large population of patients with systemic sclerosis (SSc).Methods.This study was cross-sectional, based on data collected on patients included in the European League Against Rheumatism (EULAR) Scleroderma Trials and Research (EUSTAR) registry. We queried this database to extract data regarding global evaluation of patients with SSc and the presence of any clinical articular involvement: synovitis (tender and swollen joints), tendon friction rubs (rubbing sensation detected as the tendon was moved), and joint contracture (stiffness of the joints that decreased their range of motion). Overall joint involvement was defined by the occurrence of synovitis and/or joint contracture and/or tendon friction rubs.Results.We recruited 7286 patients with SSc; their mean age was 56 ± 14 years, disease duration 10 ± 9 years, and 4210 (58%) had a limited cutaneous disease subset. Frequencies of synovitis, tendon friction rubs, and joint contractures were 16%, 11%, and 31%, respectively. Synovitis, tendon friction rubs, and joint contracture were more prevalent in patients with the diffuse cutaneous subset and were associated together and with severe vascular, muscular, renal, and interstitial lung involvement. Moreover, synovitis had the highest strength of association with elevated acute-phase reactants taken as the dependent variable.Conclusion.Our results highlight the striking level of articular involvement in SSc, as evaluated by systematic examination in a large cohort of patients with SSc. Our data also show that synovitis, joint contracture, and tendon friction rubs are associated with a more severe disease and with systemic inflammation.

Published
2010
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25. Prediction of worsening of skin fibrosis in patients with diffuse cutaneous systemic sclerosis using the EUSTAR database

Author

Maurer, B., Graf, N., Michel, B. A., Muller Ladner, U., Czirjak, L., Denton, C. P., Tyndall, A., Metzig, C., Lanius, V., Khanna, D., Distler, O., Arner, I. H., Cerinic, M. M., Guiducci, S., Walker, U., Lapadula, G., Iannone, F., Becvar, R., Sierakowsky, S., Bielecka, O. K., Cutolo, M., Sulli, A., Valentini, G., Cuomo, G., Vettori, S., Riemekasten, G., Rednic, S., Nicoara, I., Kahan, A., Allanore, Y., Vlachoyiannopoulos, P., Montecucco, C., Caporali, R., Carreira, P. E., Novak, S., Varju, C., Chizzolini, C., Kucharz, E. J., Kotulska, A., Kopec Medrek, M., Widuchowska, M., Cozzi, F., Rozman, B., Mallia, C., Coleiro, B., Gabrielli, A., Farge, D., Hij, A., Airo, P., Hesselstrand, R., Scheja, A., Wollheim, F., Martinovic, D., Gurman, A. B., Braun Moscovici, Y., Govoni, Marcello, LO MONACO, Andrea, Hunzelmann, N., Pellerito, R., Bambara, L. M., Caramaschi, P., Black, C., Damjanov, N., Santamaria, V. O., Heitmann, S., Krasowska, D., Seidel, M., Oleszowsky, M., Burkhardt, H., Himsel, A., Salvador, M. J., Stamenkovic, B., Stankovic, A., Tikly, M., Starovoytova, M. N., Ananieva, L. P., Scorza, R., Engelhart, M., Strauss, G., Nielsen, H., Damgaard, K., Szucs, G., Mendoza, A. Z., Buijdos, C. d. l. P., Sifuentes Giraldo, W. A., Midtvedt, O., Garen, T., Hachulla, E., Launay, D., Valesini, G., Riccieri, V., Ionescu, R. M., Opris, D., Groseanu, L., Wigley, F. M., Mihai, C. M., Cornateanu, R. S., Ionitescu, R., Gherghe, A. M., Gorga, M., Dobrota, R., Bojinca, M., Schett, G., Distler, J. H., Meroni, P., Zeni, P., Mouthon, L., Keyser, F. D., Cantatore, F. P., Corrado, A., Ullman, S., Iversen, L., Pozzi, M. R., Eyerich, K., Hein, R., Knott, E., Szechinski, J., Wiland, P., Szmyrka Kaczmarek, M., Sokolik, R., Morgiel, E., Krummel Lorenz, B., Saar, P., Aringer, M., Gunther, C., Anic, B., Baresic, M., Mayer, M., Radominski, S. C., Muller, C. d. S., Azevedo, V. F., Agachi, S., Groppa, L., Chiaburu, L., Russu, E., Zenone, T., Highton, J., Stamp, L., Chapman, P., O'Donnell, J., Solanki, K., Doube, A., Veale, D., O'Rourke, M., Loyo, E., Li, M., Rosato, E., Pisarri, S., Tanaseanu, C. M., Popescu, M., Dumitrascu, A., Tiglea, I., Chirieac, R., Ancuta, C., Furst, D. E., Kafaja, S., Lefebvre, P. G. d. l. P., Rubio, S. R., Exposito, M. V., Sibilia, J., Chatelus, E., Gottenberg, J. E., Chifflot, H., Litinsky, I., Venalis, A., Butrimiene, I., Venalis, P., Rugiene, R., Karpec, D., Kerzberg, E., Montoya, F., Cosentino, V., Chizzolini, Carlo, Maurer, Britta, Graf, Nicole, Michel, Beat A, Müller Ladner, Ulf, Czirják, László, Denton, Christopher P, Tyndall, Alan, Metzig, Carola, Lanius, Vivian, Khanna, Dinesh, Distler, Oliver, Tarner, Ingo H, Cerinic, Marco Matucci, Guiducci, Serena, Walker, Ulrich, Lapadula, Giovanni, Iannone, Florenzo, Becvar, Radim, Sierakowsky, Stanislaw, Bielecka, Otylia Kowal, Cutolo, Maurizio, Sulli, Alberto, Valentini, Gabriele, Cuomo, Giovanna, Vettori, Serena, Riemekasten, Gabriele, Rednic, Simona, Nicoara, Ileana, Kahan, André, Allanore, Yannick, Vlachoyiannopoulos, P, Montecucco, Carlomaurizio, Caporali, Roberto, Carreira, Patricia E, Novak, Srdan, Varju, Cecilia, Kucharz, Eugene J, Kotulska, Anna, Kopec Medrek, Magdalena, Widuchowska, Malgorzata, Cozzi, Franco, Rozman, Blaz, Mallia, Carmel, Coleiro, Bernard, Gabrielli, Armando, Farge, Dominique, Hij, Adrian, Airò, Paolo, Hesselstrand, Roger, Scheja, Agneta, Wollheim, Frank, Martinovic, Duska, Gurman, Alexandra Balbir, Braun Moscovici, Yolanda, Govoni, M, Monaco, Andrea Lo, Hunzelmann, Nicola, Pellerito, Raffaele, Bambara, Lisa Maria, Caramaschi, Paola, Black, Carol, Damjanov, Nemanja, Santamaria, Vera Ortiz, Heitmann, Stefan, Krasowska, Dorota, Seidel, Matthia, Oleszowsky, Mara, Burkhardt, Harald, Himsel, Andrea, Salvador, Maria J, Stamenkovic, Bojana, Stankovic, Aleksandra, Tikly, Mohammed, Starovoytova, Maya N, Ananieva, Lidia P, Scorza, Raffaella, Engelhart, Merete, Strauss, Gitte, Nielsen, Henrik, Damgaard, Kirsten, Szücs, Gabriella, Mendoza, Antonio Zea, Buijdos, Carlos de la Puente, Giraldo, Walter A. Sifuente, Midtvedt, Øyvind, Garen, Torhild, Hachulla, Eric, Launay, David, Valesini, Guido, Riccieri, Valeria, Ionescu, Ruxandra Maria, Opris, Daniela, Groseanu, Laura, Wigley, Fredrick M, Mihai, Carmen M, Cornateanu, Roxana Sfrent, Ionitescu, Razvan, Gherghe, Ana Maria, Gorga, Marilena, Dobrota, Rucsandra, Bojinca, Mihai, Schett, Georg, Distler, Jörg HW, Meroni, Pierluigi, Zeni, Silvana, Mouthon, Luc, Keyser, Filip De, Cantatore, Francesco P, Corrado, Ada, Ullman, Susanne, Iversen, Line, Pozzi, Maria R, Eyerich, Kilian, Hein, Rüdiger, Knott, Elisabeth, Szechinski, Jacek, Wiland, Piotr, Szmyrka Kaczmarek, Magdalena, Sokolik, Renata, Morgiel, Ewa, Krummel Lorenz, Brigitte, Saar, Petra, Aringer, Martin, Günther, Claudia, Anic, Branimir, Baresic, Marko, Mayer, Miroslav, Radominski, Sebastião C, Müller, Carolina de Souza, Azevedo, Valderílio F, Agachi, Svetlana, Groppa, Liliana, Chiaburu, Lealea, Russu, Eugen, Zenone, Thierry, Highton, John, Stamp, Lisa, Chapman, Peter, O'Donnell, John, Solanki, Kamal, Doube, Alan, Veale, Dougla, O’Rourke, Marie, Loyo, Esthela, Li, Mengtao, Rosato, Edoardo, Pisarri, Simonetta, Tanaseanu, Cristina Mihaela, Popescu, Monica, and University of Zurich

Subjects
Genetics and Molecular Biology (all), Male, Time Factors, Databases, Factual, systemic sclerosis, 2745 Rheumatology, computer.software_genre, Biochemistry, Severity of Illness Index, Outcomes Research, Qualitative Research, Systemic Sclerosis, Adult, Cohort Studies, Creatine Kinase, Decision Support Techniques, Deglutition Disorders, Dyspnea, Female, Fibrosis, Humans, Logistic Models, Middle Aged, Multivariate Analysis, Scleroderma, Diffuse, Sex Factors, Skin, Synovitis, Disease Progression, Rheumatology, Immunology, Biochemistry, Genetics and Molecular Biology (all), Immunology and Allergy, Medicine (all), Scleroderma, skin fibrosis, skin and connective tissue diseases, ddc:616, EUSTAR, Univariate analysis, Database, integumentary system, 10051 Rheumatology Clinic and Institute of Physical Medicine, Orvostudományok, Diffuse, Connective tissue disease, Cohort, 2723 Immunology and Allergy, Cohort study, medicine.medical_specialty, 610 Medicine & health, Klinikai orvostudományok, General Biochemistry, Genetics and Molecular Biology, NO, outcomes research, qualitative research, Databases, 1300 General Biochemistry, Genetics and Molecular Biology, Internal medicine, Severity of illness, medicine, Factual, 2403 Immunology, business.industry, medicine.disease, business, computer
Abstract

ObjectivesTo identify predictive parameters for the progression of skin fibrosis within 1 year in patients with diffuse cutaneous SSc (dcSSc).MethodsAn observational study using the EUSTAR database was performed. Inclusion criteria were dcSSc, American College of Rheumatology (ACR) criteria fulfilled, modified Rodnan skin score (MRSS) ≥7 at baseline visit, valid data for MRSS at 2nd visit, and available follow-up of 12±2 months. Worsening of skin fibrosis was defined as increase in MRSS >5 points and ≥25% from baseline to 2nd visit. In the univariate analysis, patients with progressive fibrosis were compared with non-progressors, and predictive markers with pResultsA total of 637 dcSSc patients were eligible. Univariate analyses identified joint synovitis, short disease duration (≤15 months), short disease duration in females/patients without creatine kinase (CK) elevation, low baseline MRSS (≤22/51), and absence of oesophageal symptoms as potential predictors for progressive skin fibrosis. In the multivariate analysis, by employing combinations of the predictors, 17 models with varying prediction success were generated, allowing cohort enrichment from 9.7% progressive patients in the whole cohort to 44.4% in the optimised enrichment cohort. Using a second validation cohort of 188 dcSSc patients, short disease duration, low baseline MRSS and joint synovitis were confirmed as independent predictors of progressive skin fibrosis within 1 year resulting in a 4.5-fold increased prediction success rate.ConclusionsOur study provides novel, evidence-based criteria for the enrichment of dcSSc cohorts with patients who experience worsening of skin fibrosis which allows improved clinical trial design.

Published
2014

26. Effect of cyclosporine A on bone density in female rheumatoid arthritis patients: results from a multicenter, cross-sectional study

Author

Mazzantini M, Di Munno O, Sinigaglia L, Bianchi G, Rossini M, Mela Q, Frediani B, Cantatore F, Adami S., DEL PUENTE, ANTONIO, Mazzantini, M, Di Munno, O, Sinigaglia, L, Bianchi, G, Rossini, M, Mela, Q, DEL PUENTE, Antonio, Frediani, B, Cantatore, F, and Adami, S.

Subjects
Bone loss, ciclosporina, Arthritis, Rheumatoid, Cyclosporine A, Absorptiometry, Photon, Bone Density, Predictive Value of Tests, cyclosporine A, rheumatoid arthritis, Humans, Rheumatoid arthritis, Aged, Lumbar Vertebrae, Dose-Response Relationship, Drug, Femur Neck, Densità minerale ossea, Middle Aged, Health Surveys, artrite reumatoide, Cross-Sectional Studies, Logistic Models, Antirheumatic Agents, Multivariate Analysis, Cyclosporine, Osteoporosis, Female, Bone loss, Cyclosporine A, Osteoporosis, Rheumatoid arthritis
Abstract

To analyze the influence of cyclosporine A (CYA) on bone using data from a large multicenter, cross-sectional study on bone mineral density (BMD) in rheumatoid arthritis (RA).We selected 558 female patients with RA and divided them into two groups on the basis of CYA use: those who had never used CYA (n = 467) and CYA users (n = 91; users for24 months n = 50; users for24 months n = 41). Demographic, disease and treatment-related variables were collected for each patient. BMD was measured at the lumbar spine and proximal femur using dual x-ray absorptiometry. Data was analyzed by means of a univariate and multivariate statistical procedure. Osteoporosis (OP) was defined as BMD-2.5 T score.The frequency of OP among non-CYA users and CYA users was 28.2% and 33.3% (p=NS) for the lumbar spine, and 34.2% and 31.3% (p=NS) for the femoral neck, respectively. The prevalence of fragility fractures was not significantly different between the two groups. Mean values for the T-score at either the lumbar spine or the femoral neck were comparable in the two groups, even after adjustment for age, menopausal status, body mass index (BMI), Health Assessment Questionnaire (HAQ) score and steroid use. The generalized linear model showed that age, BMI and the HAQ score were significant independent predictors of BMD at the lumbar and femoral levels, whereas CYA use was not. Logistic analysis showed that only age, the HAQ score and BMI were significantly associated with the risk of OP. However, the duration of CYA therapy24 months was associated with an adjusted decreased lumbar BMD and a significantly decreased femoral neck BMD (p = 0.01). The frequency of femoral neck OP in patients on CYA for24 months was significantly higher than in patients on CYA for24 months: 46.4% vs. 19.44% (p=0.03), while the prevalence of fragility fractures did not differ significantly: 23.1% vs. 16.6%, respectively (p=NS). Logistic analysis showed that CYA use was an independent predictor of osteoporosis at the femoral site.Long-term CYA therapy may have negative effects on BMD in female RA patients.

Published
2007

27. Regional differences of vitamin D deficiency in rheumatoid arthritis patients in Italy

Author

Rossini, M, D'Avola, G, Muratore, M, Malavolta, N, Silveri, F, Bianchi, G, Frediani, B, Minisola, G, Sorgi, Ml, Varenna, M, Foti, Rosario, Tartarelli, G, Orsolini, G, Adami, S, Study Group on Osteoporosis, Metabolic Skeletal Diseases of the Italian Society of Rheumatology CollaboratorsAdami, Study Group on Osteoporosis, CollaboratorsAdami S, Metabolic Skeletal Diseases of the Italian Society of R. h. e. u. m. a. t. o. l. o. g. y., Bagnato, G, Cacace, E, Caminiti, M, Cantatore, F, Del Puente, A, Di Munno, O, Ferri, Clodoveo, Iagnocco, Am, La Montagna, G, Maddali Bongi, S, Sinigaglia, L, Tartarelli, G., Rossini, M, D'Avola, G, Muratore, M, Malavolta, N, Silveri, F, DEL PUENTE, Antonio, Bianchi, G, Frediani, B, Minisola, G, Sorgi, Ml, Varenna, M, Foti, R, Tartarelli, G, Orsolini, G, and Adami, S.

Subjects
Male, rheumatoid arthritis, lcsh:Internal medicine, medicine.medical_specialty, vitamin D, disease activity, lcsh:Medicine, Arthritis, Disease, Severity of Illness Index, vitamin D deficiency, Arthritis, Rheumatoid, Rheumatology, Rheumatoid, Internal medicine, Severity of illness, Prevalence, Vitamin D and neurology, Humans, Medicine, Disease activity, Vitamin D, lcsh:RC31-1245, Body mass index, Disability, Nrheumatoid arthritis, Female, Italy, Middle Aged, Vitamin D Deficiency, business.industry, lcsh:R, VITAMIN-D METABOLISM, medicine.disease, Rheumatoid arthritis, Rheumatoid arthritis, Vitamin D, Disease activity, Disability, Body mass index, Physical therapy, business
Abstract

Vitamin D deficiency is very common in patients with rheumatoid arthritis (RA). Aim of this study was to evaluate the prevalence of vitamin D deficiency among the different Italian regions and whether these variations are associated with different severity of the disease. The study includes 581 consecutive RA patients (464 women), not taking vitamin D supplements, from 22 Italian rheumatology centres uniformly distributed across Italy. Together with parameters of disease activity (disease activity score 28), functional impairment (activities of daily living and health assessment questionnaire disability index) and mean sun exposure time, all patients had serum 25-hydroxyvitamin D (25OHD) measured in a centralized laboratory. Vitamin D deficiency (25OHD level

Published
2013
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28. Differenze regionali della carenza di vitamina D in pazienti affetti da artrite reumatoide in Italia

Author

Rossini, M, D'Avola, G, Muratore, M, Malavolta, N, Silveri, F, Bianchi, G, Frediani, B, Minisola, G, Sorgi, Ml, Varenna, M, Foti, R, Tartarelli, G, Orsolini, G, Adami, S, Bagnato, G, Cacace, E, Caminiti, M, Cantatore, F, G, Del Puente, A, Di Munno, O, Ferri, C, Iagnocco, Am, La Montagna, G, Maddali Bongi, Susanna, and Sinigaglia, L

Subjects
Arthritis, Rheumatoid, Female, Humans, Italy, Male, Middle Aged, Prevalence, Severity of Illness Index, Vitamin D Deficiency
Published
2013

29. A comparison of the nutritional status between adult celiac patients on a long-term, strictly gluten-free diet and healthy subjects

Author

Barone, M, primary, Della Valle, N, additional, Rosania, R, additional, Facciorusso, A, additional, Trotta, A, additional, Cantatore, F P, additional, Falco, S, additional, Pignatiello, S, additional, Viggiani, M T, additional, Amoruso, A, additional, De Filippis, R, additional, Di Leo, A, additional, and Francavilla, R, additional

Published
2015
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31. Studio vitamina D ed artrite reumatoide (VITAR): trattamento con vitamina D

Author

Rossini, M., Adami, S., Antonelli, M., Bagnato, F., Bianchi, G., Cacace, E., Caminiti, M., Cantatore, F. P., Davola, G., DEL PUENTE, A., DI MUNNO, O., Ferri, C., Foti, R., Fracassi, E., Frediani, B., Iagnocco, A., LA MONTAGNA, G., MADDALI BONGI, S., Malavolta, N., Muratore, M., Silveri, F., Sinigaglia, L., Sorgi, Maria Laura, Tartarelli, G., and Minisola, G.

Published
2009

32. The effect of cyclosporine A on bone density in female rheumatoid arthritis patients: Results from a multicenter, cross-sectional study

Author

Mazzantini, M., Di Munno, O., Sinigaglia, L., Bianchi, G., Maurizio Rossini, Mela, Q., Del Puente, A., Frediani, B., Cantatore, F., Adami, S., Bartolone, S., Girasole, G., Rovetta, G., Broggini, M., Citi, M., Canesi, B., Meneghin, M., Ciocci, A., Consoli, G., Di Matteo, G., Oriente, P., Ferraris, M., Delvino, P. G., Marcolongo, R., Fumagalli, M., Gandolini, G., La Corte, R., Trotta, F., La Montagna, G., Tirri, G., Perpignano, G., Minisola, G., Muratore, M., Nervetti, A., Pellerito, R., Varenna, M., Binelli, L., Ghiringhelli, D., and Zucchi, F.

Subjects
Rhaumtoid Arthritis, BMD, CYA, BMD, Rhaumtoid Arthritis, CYA
Published
2007

33. Vascular risk factors in glaucoma: The results of a national survey

Author

Orzalesi, N, Rossetti, L., Omboni, S., Sborgia, C., Vetrugno, M., Cantatore, F., Campos, E., Baldi, A., Quaranta, L., Serra, A., Zucca, I., Mura, M., Malocci, M., Uva, M., Longo, A., Lombardo, A., Scorcia, G., Moschettini, R., Gallenga, P. E., Mastropasqua, L, Ciancaglini, Marco, Carpineto, P., Lobefalo, L., Perri, P., Paduano, B., Alfieri, G., Menchini, U., Campana, F., Giansanti, F., Delle, Noci, Balducci, N., Calabria, F., Saccà, G., Sanna, S., Camicione, G., Mastromarino, P., Balestrazzi, A., DI STASO, Silvio, Ferreri, S., D’Andrea, G., Orzalesi, A., Rossetti, N., Fogagnolo, L., Mazzolani, P., Brancato, F., Carassa, R., Bettin, R., Fiori, P., Guerra, M., Martini, R., Scarale, E., Campi, G., Bonavolontà, L., Rinaldi, G., Meo, Di, Fusco, A., Dorigo, R., Doro, M. T., Grgic, D., Lodato, V., Morreale, Bubella, Signorelli, D., Gandolfi, F., Trimarchi, S., Milano, F., Fiore, G., Carolis, De, Sbordone, A., Nardi, G., Bartolomei, M., Figus, M. P., Guidi, M., Scullica, G., Salgarello, L., Colotto, T., Bucci, A., Cerulli, M. G., Manni, L., Centofanti, G. L., Parravano, M., Scuderi, M., Nucci, G., Carta, C., Pinna, F., Caporossi, A., Frezzotti, A., Grignolo, P., Brogliatti, F., Rolle, B., Ravalico, T., Vattovani, G., Tritto, O., Canziani, D., Marchini, T., Marraffa, G., ORZALESI N, ROSSETTI L, OMBONI S, LODATO G, and COMPROSO

Subjects
Male, medicine.medical_specialty, Intraocular pressure, genetic structures, Diastole, Glaucoma, Blood Pressure, Risk factors, Survey, Aged, Cardiovascular Diseases, Family Health, Female, Glaucoma, Open-Angle, Humans, Intraocular Pressure, Italy, Risk Factors, Surveys and Questionnaires, Visual Fields, Health Surveys, Ophthalmology, Sensory Systems, Cellular and Molecular Neuroscience, NO, Settore MED/30, medicine, Medical history, Family history, Settore MED/30 - Malattie Apparato Visivo, business.industry, Intraocular pressure, Glaucoma, Odds ratio, medicine.disease, eye diseases, Blood pressure, Open-Angle, Population study, sense organs, business
Abstract

Background The role of vascular risk factors in glaucoma is still being debated. To assess the importance of vascular risk factors in patients with primary open-angle glaucoma (POAG), data from the medical history of 2,879 POAG patients and 973 age-matched controls were collected and analyzed. Methods Design: observational survey. Setting: 35 Italian academic centers. Study population: POAG patients and age-matched controls. In order to reduce bias consecutive patients were included. Observation procedures: data concerning vascular risk factors were collected for all patients with a detailed questionnaire. A complete ophthalmological examination with assessment of intraocular pressure (IOP), visual field, optic disc, and systemic blood pressure was performed. Main outcome measures: the ESH-ESC (European Society of Hypertension-European Society of Cardiology) guidelines were used to calculate the level of cardiovascular risk. Crude and adjusted estimates of the odds ratios (OR) were calculated for all cardiovascular risk factors in POAG and controls. Results The study included 2,879 POAG patients and 973 controls. POAG cases had a significantly higher systolic and diastolic blood pressure (p=0.001) and systolic perfusion pressure (p=0.02) as compared with controls. Also mean IOP was significantly higher in the POAG group (p=0.01), while diastolic perfusion pressure was not significantly different in the two groups. Myopia was more prevalent in the POAG group (23 vs 18%, p=0.005) as well as a positive family history for glaucoma (26 vs 12%, p= 0.004). POAG patients tended to have a higher cardiovascular risk than controls: 63% of glaucoma cases vs 55% of controls (OR: 1.38, p=0.005) had a “high” or “very high” cardiovascular risk. Conclusions The level of cardiovascular risk was significantly higher in glaucoma patients than in controls.

Published
2007

34. Vascular risk factors in glaucoma: the results of a national survey

Author

Orzalesi, N., Rossetti, L., Omboni, S., OPTIME study group, Sborgia, C, Vetrugno, M, Cantatore, F, Campos, E, Baldi, A, Quaranta, Luciano, University of Cagliari, University of Catania Uva, M, Longo, A, Lombardo, A, Scorcia, G, Moschettini, R, Gallenga, Pe, Mastropasqua, L, Ciancaglini, M, Carpineto, P, Lobefalo, L, University of Ferrara, University of Firenze (Alfieri, G, Menchini, U, Campana, F, Giansanti, F, Delle Noci, N, Balducci, F, Calabria, G, Saccà, S, Sanna, G, Camicione, P, Mastromarino, A, Balestrazzi, E, Di Staso, S, Ferreri, G, D’Andrea, A, Orzalesi, N, Rossetti, L, Fogagnolo, P, Mazzolani, F, Brancato, R, Carassa, R, Bettin, P, Fiori, M, Guerra, R, Martini, E, Scarale, G, Campi, L, Bonavolontà, G, Rinaldi, E, Di Meo, A, Fusco, R, Dorigo, Mt, Doro, D, Grgic, V, Lodato, G, Morreale Bubella, D, Signorelli, F, Gandolfi, S, Trimarchi, F, Milano, G, Fiore, C, De Carolis, A, Sbordone, G, Nardi, M, Bartolomei, Mp, Figus, M, Guidi, G, Scullica, L, Salgarello, T, Colotto, A, Bucci, Mg, Cerulli, L, Manni, Gl, Centofanti, M, Parravano, M, Scuderi, G, Nucci, C, Carta, F, Pinna, A, Caporossi, A, Frezzotti, P, Grignolo, F, Brogliatti, B, Rolle, T, Ravalico, G, Vattovani, O, Tritto, D, Canziani, T, Marchini, G, and Marraffa, M.

Subjects
glaucoma, genetic structures, risk factors, sense organs, eye diseases
Published
2007

35. Interleukin-10 and interleukin-10 receptor in human osteoarthritic and healthy chondrocytes

Author

Iannone, F., Bari, C., Accio, F., Covelli, M., Cantatore, F. P., Patella, V., Lo Bianco, G., and Giovanni Lapadula

Subjects
Cartilage, Articular, Male, Gene Expression, Receptors, Interleukin, Middle Aged, Osteoarthritis, Knee, Interleukin-10, Chondrocytes, Fetus, Humans, Female, Receptors, Interleukin-10, RNA, Messenger, Aged
Abstract

To evaluate the expression of interleukin-10 (IL-10) and interleukin-10 receptor (IL-10R) on chondrocytes from healthy, osteoarthritic, and foetal cartilage from human subjects.Articular cartilage was obtained from 12 patients with osteoarthritis (OA) undergoing surgical knee replacement. Chondrocytes were isolated from the two zones of cartilage showing macroscopically and histologically the lowest (MIN) and highest (MAX) extent of osteoarthritic damage. Additional specimens of cartilage were obtained from 3 healthy donors and 3 human foetuses. IL-10 mRNA expression was determined by a reverse transcriptase-polymerase chain reaction (RT-PCR). For detection of intracellular IL-10 protein, chondrocytes were permeabilized and then incubated with R-phycoerythrin (PE) conjugated rat anti-human IL-10 mAb. Cell surface IL-10R was detected by incubation with biotinylated recombinant human IL-10; after washing, bound IL-10 was revealed by fluorescein (FITC) conjugated streptavidin. Positive chondrocytes were analysed by flowcytometry.IL-10 mRNA expression was higher in osteoarthritic than in normal chondrocytes. IL-10 protein intracellular levels were significantly higher in MAX than in MIN osteoarthritic cartilage or in healthy cartilage. Cell surface IL-10R was expressed on osteoarthritic chondrocytes with no difference in the degree of cartilage damage. The highest levels of IL-10 protein and IL-10R were found in foetal cartilage.Human chondrocytes synthesise IL-10 and express on their surface IL-10R. Since IL-10 inhibits IL-1 and TNF-alpha expression, its upregulation in osteoarthritic chondrocytes may counteract the detrimental effects of these catabolic cytokines. However, the functions of IL-10 in cartilage may go beyond those activities established in the immunological setting. The high levels of IL-10 and IL-10R in foetal cartilage, an active growing tissue, suggest that IL-10 may play a role in controlling chondrocyte metabolism under physiological conditions.

Published
2001

36. Imaging of chondrocalcinosis: calcium pyrophosphate dihydrate (CPPD) crystal deposition disease -- imaging of common sites of involvement

Author

Magarelli, Nicola, Amelia, Rosanna, Melillo, N, Nasuto, M, Cantatore, F, Guglielmi, Gaspare, Magarelli, Nicola (ORCID:0000-0002-2521-086X), Magarelli, Nicola, Amelia, Rosanna, Melillo, N, Nasuto, M, Cantatore, F, Guglielmi, Gaspare, and Magarelli, Nicola (ORCID:0000-0002-2521-086X)

Abstract

Calcium pyrophosphate dihydrate (CPPD) crystal deposition disease is characterised by the accumulation of pyrophosphate dihydrate crystals in articular and periarticular tissues and it can be classified as sporadic, hereditary or secondary. The diagnosis frequently rests on radiographic findings. Computed tomography scanning can detect well mineralised deposits in joints and also ultrasound may be useful in detecting CPPD crystal deposits. About MRI recent studies have demonstrated the utility of high field in depiction of CPPD crystal deposits. The aim of this review is to focus on the clinical-classificative and radiological aspects of CPPD, particularly the contribution of the different imaging techniques.

Published
2012

37. Intraocular pressure lowering effect of latanoprost monotherapy vs. latanoprost or pilocarpine in combination with timolol: a randomized, observer masked multicenter study in patients with open angle glaucoma

Author

Bucci, M. G., Manni, G. L., Schiavonc, M., Brancato, R., Carassa, R., Cardia, L., Cantatore, F., Frezzotti, R., Ciappetta, R., Frezzotti, P., De Marco, D., Cian, R., Menchini, U., Ferrari, E., Miglior, M., Troiano, P., Rama, G., Zampini, A., Rapizzi, A., Daniotti, E., Reibaldi, A., Uva, Maurizio Giacinto, Prosdocimo, G., Zingirian, M., and Calabria, G.

Published
1999

45. Anti-angiogenic effects of biotechnological therapies in rheumatic diseases

Author

Cantatore FP, Maruotti N, Corrado A, and Ribatti D

Subjects
angiogenesis, biotechnological therapy, rheumatic disease, Medicine (General), R5-920
Abstract

Francesco Paolo Cantatore,1 Nicola Maruotti,1 Addolorata Corrado,1 Domenico Ribatti2,3 1Rheumatology Clinic, Department of Medical and Surgical Sciences, University of Foggia Medical School, Foggia, 2Department of Basic Medical Sciences, Neurosciences and Sensory Organs, University of Bari Medical School, 3National Cancer Institute “Giovanni Paolo II”, Bari, Italy Introduction: Angiogenesis plays a key role in the pathogenesis of numerous rheumatic diseases, such as rheumatoid arthritis, psoriatic arthritis, and vasculitides. Therefore, the inhibition of pathological angiogenesis may be considered a useful therapeutical approach in these rheumatic diseases. Methods: This review article is based on a literature research about the role of biotechnological therapies in angiogenesis inhibition. Results and conclusions: Several evidences have demonstrated a role for biotechnological therapies in angiogenesis inhibition. Nevertheless, further research and clinical trials are needed to better quantify the real impact of biotechnological therapies on pathological angiogenesis. Keywords: abatacept, anakinra, angiogenesis, rituximab, TNF-α, tocilizumab

Published
2017

46. C-reactive protein is independently associated with total body fat, central fat, and insulin resistance in adult women.

Author

Pannacciulli, N, Cantatore, F P, Minenna, A, Bellacicco, M, Giorgino, R, and De Pergola, G

Subjects
*C-reactive protein, *HUMAN body composition, *INSULIN resistance, *ADIPOSE tissues
Abstract

OBJECTIVE:: To investigate whether C-reactive protein (CRP) concentrations are influenced by body composition, insulin resistance, and body fat distribution in healthy women. DESIGN:: Cross-sectional study of CRP plasma levels in adult women. SUBJECTS:: A total of 201 apparently healthy normal weight, overweight, and obese women, aged 18–60 y. MEASUREMENTS:: CRP plasma levels, several fatness and body fat distribution parameters (by bioimpedance analysis and anthropometry), and insulin resistance (HOMAIR), as calculated by homeostatic model assessment. RESULTS:: CRP was positively correlated with age, body mass index (BMI), waist, fasting glucose and insulin, HOMAIR, fat-free mass (FFM) and fat mass (FM). After multivariate analyses, age, HOMAIR, waist and FM maintained their independent association with CRP. CONCLUSION:: Our study has shown an independent relationship of central fat accumulation and insulin resistance with CRP plasma levels, thus suggesting that mild, chronic inflammation may be a further component of the metabolic syndrome and a mediator of the atherogenic profile of this syndrome.International Journal of Obesity (2001) 25, 1416–1420 [ABSTRACT FROM AUTHOR]

Published
2001
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47. Functional impairment of systemic scleroderma patients with digital ulcerations: results from the DUO Registry

Author

Guillevin, L, Hunsche, E, Denton, Cp, Krieg, T, Schwierin, B, Rosenberg, D, Matucci-Cerinic, M, Raffier, B, Hirschi, M, Trautinger, F, Schmidt, P, Stetter, M, Hundstorfer, M, Reinhart, V, Monshi, B, Pirkhammer, D, Richter, L, Hamberger, N, Metz, S, Feldmann, R, Semmelweis, K, Lackner, K, Tomi, N, Kolle, H, Hafner, F, Brodmann, M, Kuen-Spiegel, M, Minmair, G, Heil, Pm, Broil, H, Holzer, G, Illmer, X, Rintelen, B, Sautner, J, Takacs, M, Thun, M, Zemanova, I, Soukup, T, Smrzova, A, Bohmova, J, Prochazkova, L, Nemec, P, Fojtik, Z, Suchy, D, Becvar, R, Olsen, Ab, Sondergaard, Kh, Luosu jarvi, R, Vidqvist, Kl, Madaule, S, Beneton, N, Maillard, H, Charlanne, H, Granelbrocard, F, Hachulla, E, Hatron, Py, Jourdain, N, Lambert, M, Launay, D, Morell, S, Woijtasik, G, Skowron, F, Zenone, T, Dadban, A, Lok, C, Ferrandiz, D, Magybertrand, N, Moiton, Mp, Taieb, A, Balquiere, S, Belin, E, Droitcourt, C, Julien, S, Prey, S, Boulon, C, Constans, J, Doutre, Ms, Kostrzwewa, E, Richez, C, Greco, M, Misery, L, Sassolas, B, Collet, E, Berthier, S, Leguy-Seguin, V, Imbert, B, Carpentier, P, Blaise, S, Couraud, A, Doeffel-Hantz, V, Spars, A, Bezanahary, H, Boussely, N, Dumonteil, S, Fauchais, Al, Goudran, G, Loustaud-Ratti, V, Manea, P, Vidal, E, Coppere, B, Desmursclavel, H, Girard-Madoux, Mh, Hot, A, Ninet, J, Granel, B, Cohen, Jd, Keynote, A, Khau van Kien, A, Le Quellec, A, Riviere, S, Rullier, P, Bessis, D, Farcas, C, Bravetti, V, Moline, T, Wahl, D, Zuily, S, Granel-Brocard, F, Agard, C, Durant, C, Fuzibet, Jg, Queyrel, V, Berezne, A, Mouthon, L, Cabane, J, Tiev, K, Toledano, C, Lazareth, I, Michon-Pasturel, U, Priollet, P, Reguiai, Z, Cazaletslacoste, C, Jego, P, Letremy, A, Perlat, A, Duval-Modeste, Ab, Chatelus, E, Chiffot, H, Sibillia, J, Sordet, C, Adoue, D, Couret, B, Moulis, G, Pugnet, G, Sailler, L, Diot, E, Gaches, F, Farge, D, Keshtmand, H, Frances, C, von Elling, A, Bora, D, Ebel, J, Ahmadi-Simab, K, Klein, E, Hahn, K, Schulze, K, Rasche, C, Riemekasten, G, Lee, Hh, Deuschle, K, Mattat, K, Becker, M, Worm, M, Mensing, C, Klings, D, Mensing, H, Messall, J, Zuper, R, Eilbacher, P, Saar, P, Kaufmann, P, Hallermann, C, Schmidt, K, Wahn, H, Schildt, K, Schuart, T, Kaczmarczyk, A, Kellner, C, von Oelhafen, J, Baron von Bildering, P, Kunze, S, Kleiner, Hj, Alsheimer, B, Schuetz, N, Miirker-Hermann, E, Gottl, Kh, Weiss, E, Reischel, N, Kern, S, Goettl, Kh, Goetheuniversitiitsklinikum, Jw, Himsel, A, Henkemeier, U, Schwarting, A, Hazenbiller, A, Nichelmann, V, Rumbaur, C, Boesenberg, I, Schmeiser, T, Mueller-Ladner, U, Unholzer, A, Starz, H, Welzel, J, Plaumann, K, Stoeckl, F, Sperling, S, Podda, M, Wagner, N, Rapprich, H, Niedermeier, A, Messer, G, Sardy, M, Bekou, V, Dill-MUller, D, Wlodarz, M, Belloni, B, Huettig, B, Ziai, M, Hein, R, Kneitz, C, Federow, I, Schneider, K, Semmler, M, Hapke, S, Metzler, C, Stein, T, Enderlein, M, Kayser, M, Werthmann, M, Guenther, Cu, Neul, S, Hellmich, B, Loeffler, C, Pflugfelder, J, Karaenke, P, Mueglich, C, Tony, Hp, Marina, P, Popp, M, Mittag, M, Baumann, C, Scheib, Eg, Brand, H, Wilhelm, Hu, Bohm, J, Dyballa, J, Boehm, J, Taggeselle, J, Luthke, K, Wuerzburg, I, Niefanger, K, Mayer, L, Drabek, J, Harmuth, W, Dietl, S, Moritz, D, Gause, A, Gaubitz, M, Hallecker, A, Krupp, E, Rumpel, H, Moosig, F, Frey, P, Kahl, S, Linke, M, Merk, B, Bloching, Hh, Ochs, W, Kurthen, R, Eiden, E, Guertler, I, Aries, Pm, Kirchberg, S, Jahnke, K, Mettler, S, Toeller, S, Zwenger, S, Langer, He, Deininger, F, Hartmann, F, Neeck, G, Neek, G, Wernitzsch, H, Meier, L, Herr, U, Meier, U, Aaig, W, Bruckner, L, Sheikh, N, Wollenhaupt, J, Krog, B, Wollersdorfer, E, Hall, R, Diehm, C, Tiggers, C, Peters, J, Kirschke, J, Schroeder, Jo, Zeuner, R, Uhlig, S, Barth, S, Huegel, R, Glaeser, R, Schaefer, C, Monshausen, M, Mengden, T, Funkert, A, Blank, N, Lupaschko, S, Voss, B, Megahed, M, Sadeghlar, F, Seidel, M, Wasmuth, Jc, Kreuter, A, Vosswinkel, J, Pfoehler, C, Gerber, A, Haust, M, Hoff, Np, Mota, R, Akanay-Diesel, S, Homey, B, Katzemich, A, Erfurt-Berge, C, Sticherling, M, Beyer, C, Distler, J, Mitchell, A, Freundlieb, C, Rushentsova, U, Hermanns, G, Blaschke, S, Fiene, M, Wessel, C, Norgauer, J, Rabe, B, Schuster, J, Scholz, J, Kremer, K, Robakidze-Torbahn, M, Moinzadeh, P, Dohse, A, Muhlack, A, Schultz, L, Schult, S, Frambach, Y, Kruse, S, Kettenbach, A, Fell, I, Schweda, K, Steinbrink, K, Podobinska, M, Fieri beck, G, Schanz, S, Pfeiffer, C, Hassel, R, Herrgott, I, Sunderkoetter, C, Guenzel, J, Athanassiou, P, Dimitroulas, T, Settas, L, Kritikos, I, Tsifetaki, N, Garyfallos, A, Vasilopoulos, D, Boura, P, Kamali, S, Aslanidis, S, Vlachoyannopoulos, P, Galanopoulo, V, Sakkas, L, Koutroubas, A, Elezoglou, T, Galanopoulos, N, Grier, A, Murray, M, O'Rourke, M, Del Papa, N, Maglione, W, Zeni, S, Foti, R, Benenati, A, De Vita, S, Ferraccioli, G, Grassi, W, de Angeli, R, Pomponio, G, Mussi, A, Colonna, L, Airo, P, Zingarelli, S, Scorza, R, Serverino, A, Puppo, F, Negrini, S, Roma, I, Salsano, F, Triolo, G, Mazzuca, S, Carignola, R, Gatti, S, Lunardi, G, Riccieri, V, Salvarani, C, Bajocchi, G, Varcasia, G, Marasini, B, Belloll, L, de Luca, R, Stisi, S, Bellissimo, S, Fusaro, E, Pellerito, R, Cozzi, F, Rizzo, M, Bartoluzzi, A, Trotta, F, Cantatore, F, Corrado, A, Ferri, C, Colaci, M, Malavolta, N, Mule, R, Galeazzi, M, Lapadula, G, Mathieu, A, Vacca, A, Giacomelli, R, Cipriani, P, Montecucco, Cm, Codullo, V, Bucci, R, Battaglia, E, Valentini, G, Cuomo, G, Terlizzi, N, Serafino, L, Reumatologia, Uo, Bombardieri, S, Della Rossa, A, Doveri, M, Perricone, R, de Mattia, M, Pallotta, S, Groenendael, Jh, Seys, P, Goekoop, Rj, Han, Kh, Wlarvens, M, Bonte-Mineur, F, de Bois MH, de Beus WM, van Zeben, D, Vonk, M, Knaapen, Hk, Smit, A, Bootsma, H, Ton, E, Voskuyl, A, Dutmer, Ea, Stalk, Jn, Madland, Tm, Seip, M, Hoffmann Vold AM, Bitter, H, Stocklund Thomsen, R, Resende, C, Ponte, C, Martinho, S, Silva, F, Ferreira, P, Grilo, A, Riso, N, Santos, C, Camara, I, Costa, J, Alves, J, Oliveira, S, Almeida, I, Silva, I, Cordeiro, A, Coelho, P, Lukac, J, Dolnicar, As, Espinosa, G, Mejia, Jc, Ramos, M, Plasin Rodriguez MA, Mera, A, Blanco, Js, Diaz, Jj, Losada, L, Perez, E, Maneiro, Jr, Caamano, M, Fermindez, S, Insua, Sa, Barbado, J, Fonseca, Em, Nufio, Fj, Castellvi, I, Garcia de Ia Pena, P, Bellido, D, Paulino, M, Garcia, Pv, Salas, V, Minguez, Md, Sanchez, Ma, Urrego, C, Martin, I, Rueda, A, Calvo, J, Ripoll, Mm, Torres, Mc, Corteguera, M, Maceiras, F, Cruz, J, Mosquera, Ja, Gomez, R, Area, B, Carrio, I, Rubio, M, Castellvi Barranco, I, Santos, P, Simeon, Cp, Fonollosa, V, Egurbide, Mv, Garcia de Vicuna, R, Vicente, E, Villaverde, V, Fernandez, C, Garcia, E, Uson, J, Miguelez, R, Callejas, Jl, Ortego, N, Roman, J, Alegre-Sancho, Jj, Robles, A, Rios, Jj, Bonilla, Mg, Sanchez Andrade, A, Vazquez, Tr, Miranda, Ja, Saez, L, Zea, A, De la Puente, C, Martinez, Fg, Aguirre, Ma, Collado, P, Cruz, A, Crespo, M, Sanchez-Roman, J, Castillo, Mj, Garcia, Am, Muniz, G, Hedin, Pj, Stahl, C, Bracin, T, Nordin, A, Albertsson, K, Rydvald, Y, Thorsson, C, Hermansson, E, Maurer, B, Verner, D, Schmidt Bosshard, R, Hall, F, Murphy, K, Lamb, J, Anderson, M, Moots, R, Buch, M, Bissell, L, Madhok, R, Hampson, R, D'Cruz, D, Choong, Lm, Gordon, P, Dobson, J, Salerno, R, Nisar, M, Williams, C, Wilcox, L, Denton, C, Ochiel, R, Ngcozana, T, Parker, L, Vincent, R, Mchugh, N, Cole, S, Brown, S, James, J, Herrick, A, Manning, J, Moore, T, Faizal, A, Skyes, H, Smythe, A, Hamilton, A., L., Guillevin, E., Hunsche, C. P., Denton, T., Krieg, B., Schwierin, D., Rosenberg, DUO Registry Group: B Raffier, Matucci-Cerinic M., Hirschi, M, Trautinger, F, Schmidt, P, Stetter, M, Hundstorfer, M, Reinhart, V, Monshi, B, Pirkhammer, D, Richter, L, Hamberger, N, Metz, S, Feldmann, R, Semmelweis, K, Lackner, K, Tomi, N, Kolle, H, Hafner, F, Brodmann, M, Kuen-Spiegel, M, Minmair, G, M Heil, P, Broil, H, Holzer, G, Illmer, X, Rintelen, B, Sautner, J, Takacs, M, Thun, M, Zemanova, I, Soukup, T, Smrzova, A, Bohmova, J, Prochazkova, L, Nemec, P, Fojtik, Z, Suchy, D, Becvar, R, B Olsen, A, H Sondergaard, K, Luosu jarvi, R, Vidqvist, K-L, Madaule, S, Beneton, N, Maillard, H, Charlanne, H, Granelbrocard, F, Hachulla, E, Y Hatron, P, Jourdain, N, Lambert, M, Launay, D, Morell, S, Woijtasik, G, Skowron, F, Zenone, T, Dadban, A, Lok, C, Ferrandiz, D, Magybertrand, N, P Moiton, M, Taieb, A, Balquiere, S, Belin, E, Droitcourt, C, Julien, S, Prey, S, Boulon, C, Constans, J, S Doutre, M, Kostrzwewa, E, Richez, C, Greco, M, Misery, L, Sassolas, B, Collet, E, Berthier, S, Leguy-Seguin, V, Imbert, B, Carpentier, P, Blaise, S, Couraud, A, Doeffel-Hantz, V, Spars, A, Bezanahary, H, Boussely, N, Dumonteil, S, L Fauchais, A, Goudran, G, Loustaud-Ratti, V, Manea, P, Vidal, E, Coppere, B, Desmursclavel, H, H Girard-Madoux, M, Hot, A, Ninet, J, Granel, B, D Cohen, J, Keynote, A, Khau van Kien, A, Le Quellec, A, Riviere, S, Rullier, P, Bessis, D, Farcas, C, Bravetti, V, Moline, T, Wahl, D, Zuily, S, Granel-Brocard, F, Agard, C, Durant, C, G Fuzibet, J, Queyrel, V, Berezne, A, Guillevin, L, Mouthon, L, Cabane, J, Tiev, K, Toledano, C, Lazareth, I, Michon-Pasturel, U, Priollet, P, Reguiai, Z, Cazaletslacoste, C, Jego, P, Letremy, A, Perlat, A, B Duval-Modeste, A, Chatelus, E, Chiffot, H, Sibillia, J, Sordet, C, Adoue, D, Couret, B, Moulis, G, Pugnet, G, Sailler, L, Diot, E, Gaches, F, Farge, D, Keshtmand, H, Frances, C, von Elling, A, Bora, D, Ebel, J, Ahmadi-Simab, K, Klein, E, Hahn, K, Schulze, K, Rasche, C, Riemekasten, G, H Lee, H, Deuschle, K, Mattat, K, Becker, M, Worm, M, Mensing, C, Klings, D, Mensing, H, Messall, J, Zuper, R, Eilbacher, P, Saar, P, Kaufmann, P, Hallermann, C, Schmidt, K, Wahn, H, Schildt, K, Schuart, T, Kaczmarczyk, A, Kellner, C, von Oelhafen, J, Baron von Bildering, P, Kunze, S, J Kleiner, H, Alsheimer, B, Schuetz, N, Miirker-Hermann, E, Gottl, K-H, Weiss, E, Reischel, N, Kern, S, H Goettl, K, Goetheuniversitiitsklinikum, J-W, Himsel, A, Henkemeier, U, Schwarting, A, Hazenbiller, A, Nichelmann, V, Rumbaur, C, Boesenberg, I, Schmeiser, T, Mueller-Ladner, U, Unholzer, A, Starz, H, Welzel, J, Plaumann, K, Stoeckl, F, Sperling, S, Podda, M, Wagner, N, Rapprich, H, Niedermeier, A, Messer, G, Sardy, M, Bekou, V, Dill-MUller, D, Wlodarz, M, Belloni, B, Huettig, B, Ziai, M, Hein, R, Kneitz, C, Federow, I, Schneider, K, Semmler, M, Hapke, S, Metzler, C, Stein, T, Enderlein, M, Kayser, M, Werthmann, M, U Guenther, C, Neul, S, Hellmich, B, Loeffler, C, Pflugfelder, J, Karaenke, P, Mueglich, C, P Tony, H, Marina, P, Popp, M, Mittag, M, Baumann, C, G Scheib, E, Brand, H, U Wilhelm, H, Bohm, J, Dyballa, J, Boehm, J, Taggeselle, J, Luthke, K, Wuerzburg, I, Niefanger, K, Mayer, L, Drabek, J, Harmuth, W, Dietl, S, Moritz, D, Gause, A, Gaubitz, M, Hallecker, A, Krupp, E, Rumpel, H, Moosig, F, Frey, P, Kahl, S, Linke, M, Merk, B, H Bloching, H, Ochs, W, Kurthen, R, Eiden, E, Guertler, I, M Aries, P, Kirchberg, S, Jahnke, K, Mettler, S, Toeller, S, Zwenger, S, E Langer, H, Deininger, F, Hartmann, F, Neeck, G, Neek, G, Wernitzsch, H, Meier, L, Herr, U, Meier, U, Aaig, W, Bruckner, L, Sheikh, N, Wollenhaupt, J, Krog, B, Wollersdorfer, E, Hall, R, Diehm, C, Tiggers, C, Peters, J, Kirschke, J, O Schroeder, J, Zeuner, R, Uhlig, S, Barth, S, Huegel, R, Glaeser, R, Schaefer, C, Monshausen, M, Mengden, T, Funkert, A, Blank, N, Lupaschko, S, Voss, B, Megahed, M, Sadeghlar, F, Seidel, M, C Wasmuth, J, Kreuter, A, Vosswinkel, J, Pfoehler, C, Gerber, A, Haust, M, P Hoff, N, Mota, R, Akanay-Diesel, S, Homey, B, Katzemich, A, Erfurt-Berge, C, Sticherling, M, Beyer, C, Distler, J, Mitchell, A, Freundlieb, C, Rushentsova, U, Hermanns, G, Blaschke, S, Fiene, M, Wessel, C, Norgauer, J, Rabe, B, Schuster, J, Scholz, J, Kremer, K, Robakidze-Torbahn, M, Moinzadeh, P, Dohse, A, Muhlack, A, Schultz, L, Schult, S, Frambach, Y, Kruse, S, Kettenbach, A, Fell, I, Schweda, K, Steinbrink, K, Podobinska, M, Fieri beck, G, Schanz, S, Pfeiffer, C, Hassel, R, Herrgott, I, Sunderkoetter, C, Guenzel, J, Athanassiou, P, Dimitroulas, T, Settas, L, Kritikos, I, Tsifetaki, N, Garyfallos, A, Vasilopoulos, D, Boura, P, Kamali, S, Aslanidis, S, Vlachoyannopoulos, P, Galanopoulo, V, Sakkas, L, Koutroubas, A, Elezoglou, T, Galanopoulos, N, Grier, A, Murray, M, O'Rourke, M, Del Papa, N, Maglione, W, Zeni, S, Foti, R, Benenati, A, De Vita, S, Ferraccioli, G, Grassi, W, de Angeli, R, Pomponio, G, Mussi, A, Colonna, L, Airo, P, Zingarelli, S, Scorza, R, Serverino, A, Puppo, F, Negrini, S, Roma, I, Salsano, F, Triolo, G, Mazzuca, S, Carignola, R, Gatti, S, Lunardi, G, Riccieri, V, Salvarani, C, Bajocchi, G, Varcasia, G, Marasini, B, Belloll, L, Matucci-Cerinic, M, de Luca, R, Stisi, S, Bellissimo, S, Fusaro, E, Pellerito, R, Cozzi, F, Rizzo, M, Bartoluzzi, A, Trotta, F, Cantatore, F, Corrado, A, Ferri, C, Colaci, M, Malavolta, N, Mule, R, Galeazzi, M, Lapadula, G, Mathieu, A, Vacca, A, Giacomelli, R, Cipriani, P, M Montecucco, C, Codullo, V, Bucci, R, Battaglia, E, Valentini, G, Cuomo, G, Terlizzi, N, Serafino, L, O Reumatologia, U, Bombardieri, S, Della Rossa, A, Doveri, M, Perricone, R, de Mattia, M, Pallotta, S, M Groenendael, J H L, Seys, P, J Goekoop, R, H Han, K, Wlarvens, M, Bonte-Mineur, F, and W de Bois, M H

Subjects
Adult, Employment, Male, Registrie, Scleroderma, Systemic, Systemic, Middle Aged, Scleroderma, Fingers, Disability Evaluation, Cost of Illness, Skin Ulcer, Activities of Daily Living, Finger, Humans, Female, Registries, Self Report, Human
Abstract

Digital ulcers (DUs) are frequent manifestations of systemic scleroderma (SSc). This study assessed functional limitations due to DUs among patients enrolled in the Digital Ulcer Outcome (DUO) Registry, an international, multicentre, observational registry of SSc patients with DU disease.Patients completed at enrolment a DU-specific functional assessment questionnaire with a 1-month recall period, measuring impairment in work and daily activities, and hours of help needed from others. Physician-reported clinical parameters were used to describe the population. For patients who completed at least part of the questionnaire, descriptive analyses were performed for overall results, and stratified by number of DUs at enrolment.This study included 2327 patients who completed at least part of the questionnaire. For patients with 0, 1-2, and ≥3 DUs at enrolment, mean overall work impairment during the prior month among employed/self-employed patients was 28%, 42%, and 48%, respectively. Across all included patients, ability to perform daily activities was impaired on average by 35%, 54%, and 63%, respectively. Patients required a mean of 2.0, 8.7, and 8.8 hours of paid help and 17.0, 35.9, and 63.7 hours of unpaid help, respectively, due to DUs in the prior month. Patients with DUs had more complications and medication use than patients with no DUs.With increasing number of DUs, SSc patients reported more impairment in work and daily activities and required more support from others.

49. Latanoprost 0.005% in POAG: effects on IOP and ocular blood flow

Author

Vetrugno, M., Cantatore, F., Gigante, G., and Cardia, L.

Abstract

The scope of this work was to evaluate the effect on ocular pressure and on ocular blood flow of latanoprost 0.005% eye‐drops. Included in the study were 12 patients (24 eyes) with POAG, aged between 37 and 48 years, non‐smokers, refractions between ±3D, Haemorrheological parameters within normal, not in ocular or systemic vasoactive therapy. Each patient had one eye treated with latanoprost 0.005% and the other with timolol 0.05%. The choroidal perfusion was measured by Langham's POBF system during the first day of therapy and then after 7, 15, 30, 60, 90 and 180 days. The maximum pressure decrease after the first administration of latanoprost was at the twelfth hour; after 6 months of therapy, mean IOP reduction was 32.6%. POBF values increased up to 55.8% in the first day and then settled at 22.6% at the end of the study. Timolol showed a similar pressure progress, but its haematic perfusion values were distinctly lower. In conclusion, latanoprost is efficacious in POAG therapy since it unites a positive optic nerve head perfusion effect with hypotensive efficacy.

Published
1998
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50. 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

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