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2. Profile of atacicept and its potential in the treatment of systemic lupus erythematosus

Author

Cogollo E, Silva MA, and Isenberg D

Subjects
Therapeutics. Pharmacology, RM1-950
Abstract

Estafania Cogollo,1,* Marta Amaral Silva,2,* David Isenberg3 1Department of Internal Medicine, Hospital Principe de Asturias, Alcala de Henares, Madrid, Spain; 2Department of Internal Medicine, Hospital Distrital da Figueira da Foz, Coimbra, Portugal; 3Centre for Rheumatology, Department of Medicine, University College London, London, UK *These authors are regarded as equal first authors Abstract: The importance of B cell activating factors in the generation of autoantibodies in patients with systemic lupus erythematosus (SLE) is now recognized. The two key factors, known as BAFF and APRIL, produced by a variety of cells including monocytes, dendritic cells and T cells, also help to regulate B cell maturation, function and survival. Biologic agents that block these factors have now been developed and tried out in large scale clinical trials in SLE patients. Benlysta which blocks BAFF has met some of its end points in clinical trials and is approved for use in patients with skin and joint disease who have failed conventional drugs. In contrast, clinical trials using atacicept which blocks both BAFF and APRIL have been more challenging to interpret. An early study in lupus nephritis was, mistakenly, abandoned due to serious infections thought to be linked to the biologic when in fact the dramatic fall in the immunoglobulin levels took place when the patients were given mycophenolate, prior to the introduction of the atacicept. Likewise the higher dose arm (150 mgm) of a flare prevention study was terminated prematurely when 2 deaths occurred. However, the mortality rate in this study was identical to that seen in the Benlysta studies and a post hoc analysis found a highly significant benefit for the 150mgm arm compared to the lower dose (75 mgm) and placebo arms. Other trials with both Benlysta and atacicept are on-going. Keywords: cytokines, lupus nephritis, BLyS, APRIL

Published
2015

5. Mortality risk factors in primary Sjögren syndrome: a real-world, retrospective, cohort study

Author

Arends, S., Treppo, E., Longhino, S., Manfrè, V., Rizzo, M., Baldini, C., Bombardieri, S., Bandeira, M., Silvéiro-António, M., Seror, R., Mariette, X., Nordmark, G., Danda, D., Wiland, P., Gerli, R., Kwok, S.K., Park, S.H., Kvarnstrom, M., Wahren-Herlenius, M., Downie-Doyle, S., Sene, D., Isenberg, D., Valim, V., Devauchelle-Pensec, V., Saraux, A., Morel, J., Morcillo, C., Díaz Cuiza, P.E., Herrera, B.E., González-de-Paz, L., Sisó-Almirall, A., Brito-Zerón, Pilar, Flores-Chávez, Alejandra, Horváth, Ildiko Fanny, Rasmussen, Astrid, Li, Xiaomei, Olsson, Peter, Vissink, Arjan, Priori, Roberta, Armagan, Berkan, Hernandez-Molina, Gabriela, Praprotnik, Sonja, Quartuccio, Luca, Inanç, Nevsun, Özkızıltaş, Burcugül, Bartoloni, Elena, Sebastian, Agata, Romão, Vasco C., Solans, Roser, Pasoto, Sandra G., Rischmueller, Maureen, Galisteo, Carlos, Suzuki, Yasunori, Trevisani, Virginia Fernandes Moça, Fugmann, Cecilia, González-García, Andrés, Carubbi, Francesco, Jurcut, Ciprian, Shimizu, Toshimasa, Retamozo, Soledad, Atzeni, Fabiola, Hofauer, Benedikt, Melchor-Díaz, Sheila, Gheita, Tamer, López-Dupla, Miguel, Fonseca-Aizpuru, Eva, Giacomelli, Roberto, Vázquez, Marcos, Consani, Sandra, Akasbi, Miriam, Nakamura, Hideki, Szántó, Antónia, Farris, A. Darise, Wang, Li, Mandl, Thomas, Gattamelata, Angelica, Kilic, Levent, Pirkmajer, Katja Perdan, Abacar, Kerem, Tufan, Abdurrahman, de Vita, Salvatore, Bootsma, Hendrika, and Ramos-Casals, Manuel

Published
2023
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7. POS1247 CHARACTERIZATION OF 284 PATIENTS PRESENTING WITH CENTRAL NERVOUS SYSTEM INVOLVEMENT AT DIAGNOSIS OF SJÖGREN DISEASE: RESULTS FROM THE SJÖGREN BIG DATA REGISTRY

Author

Alunno, A., primary, Brito-Zerón, P., additional, Carubbi, F., additional, Ng, W. F., additional, Flores-Chávez, A., additional, Szántó, A., additional, Li, X., additional, Rasmussen, A., additional, Dong, X., additional, Priori, R., additional, Olsson, P., additional, Baldini, C., additional, Seror, R., additional, Bootsma, H., additional, Armagan, B., additional, Kaya, B., additional, Gottenberg, J. E., additional, Praprotnik, S., additional, Suzuki, Y., additional, Quartuccio, L., additional, Leavis, H., additional, Hernandez-Molina, G., additional, Inanc, N., additional, Danda, D., additional, Bartoloni, E., additional, Rischmueller, M., additional, Sebastian, A., additional, Silvério-António, M., additional, Reis de Oliveira, F., additional, Kwok, S. K., additional, Kvarnstrom, M., additional, Solans-Laqué, R., additional, Fernandes Moça Trevisani, V., additional, Galisteo, C., additional, Sene, D., additional, Jurcut, C., additional, Fugmann, C., additional, Hofauer, B., additional, Isenberg, D., additional, Atzeni, F., additional, Shimuzu, T., additional, Valim, V., additional, Pasoto, S., additional, González García, A., additional, Retamozo, S., additional, Cipriani, P., additional, Devauchelle-Pensec, V., additional, Melchor Díaz, S., additional, Gheita, T. A., additional, Morcillo, C., additional, Fonseca-Aizpuru, E., additional, Lopez-Dupla, J. M., additional, Giacomelli, R., additional, Nakamura, H., additional, Vázquez, M., additional, Morel, J., additional, Consani-Fernández, S., additional, Akasbi Montalvo, M., additional, Diaz Cuiza, P. E., additional, De Miguel-Campo, B., additional, Lee, A. Y. S., additional, and Ramos-Casals, M., additional

Published
2024
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8. Cardiovascular events prior to or early after diagnosis of systemic lupus erythematosus in the systemic lupus international collaborating clinics cohort

Author

Urowitz, MB, Gladman, DD, Anderson, NM, Su, J, Romero-Diaz, J, Bae, SC, Fortin, PR, Sanchez-Guerrero, J, Clarke, A, Bernatsky, S, Gordon, C, Hanly, JG, Wallace, DJ, Isenberg, D, Rahman, A, Merrill, J, Ginzler, E, Alarcón, GS, Fessler, BF, Petri, M, Bruce, IN, Khamashta, M, Aranow, C, Dooley, M, Manzi, S, Ramsey-Goldman, R, Sturfelt, G, Nived, O, Steinsson, K, Zoma, A, Ruiz-Irastorza, G, Lim, S, Kalunian, KC, Ỉnanç, M, van Vollenhoven, R, Ramos-Casals, M, Kamen, DL, Jacobsen, S, Peschken, C, Askanase, A, and Stoll, T

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Prevention, Atherosclerosis, Lupus, Cardiovascular, Autoimmune Disease, Clinical Research, Evaluation of treatments and therapeutic interventions, 4.1 Discovery and preclinical testing of markers and technologies, Detection, screening and diagnosis, 6.1 Pharmaceuticals, Inflammatory and immune system, Cardiovascular Disease, Inflammation, Systemic Lupus Erythematosus, Clinical sciences, Immunology
Abstract

ObjectiveTo describe the frequency of myocardial infarction (MI) prior to the diagnosis of systemic lupus erythematosus (SLE) and within the first 2 years of follow-up.MethodsThe systemic lupus international collaborating clinics (SLICC) atherosclerosis inception cohort enters patients within 15 months of SLE diagnosis. MIs were reported and attributed on a specialised vascular event form. MIs were confirmed by one or more of the following: abnormal ECG, typical or atypical symptoms with ECG abnormalities and elevated enzymes (≥2 times upper limit of normal), or abnormal stress test, echocardiogram, nuclear scan or angiogram. Descriptive statistics were used.Results31 of 1848 patients who entered the cohort had an MI. Of those, 23 patients had an MI prior to SLE diagnosis or within the first 2 years of disease. Of the 23 patients studied, 60.9% were female, 78.3% were Caucasian, 8.7% black, 8.7% Hispanic and 4.3% other. The mean age at SLE diagnosis was 52.5±15.0 years. Of the 23 MIs that occurred, 16 MIs occurred at a mean of 6.1±7.0 years prior to diagnosis and 7 occurred within the first 2 years of follow-up. Risk factors associated with early MI in univariate analysis are male sex, Caucasian, older age at diagnosis, hypertension, hypercholesterolaemia, family history of MI and smoking. In multivariate analysis only age (OR=1.06 95% CI 1.03 to 1.09), hypertension (OR=5.01, 95% CI 1.38 to 18.23), hypercholesterolaemia (OR=4.43, 95% CI 1.51 to 12.99) and smoking (OR=7.50, 95% CI 2.38 to 23.57) remained significant risk factors.ConclusionsIn some patients with lupus, MI may develop even before the diagnosis of SLE or shortly thereafter, suggesting that there may be a link between autoimmune inflammation and atherosclerosis.

Published
2016

9. Efficacy and safety of Atacicept for prevention of flares in patients with moderate-to-severe systemic lupus erythematosus (SLE):52-week data (April-SLE randomised trial)

Author

Wofsy, David, Isenberg, D, Gordon, C, Licu, D, Copt, S, and Rossi, CP

Abstract

Objectives: Despite advances in systemic lupus erythematosus (SLE) treatment, many patients suffer from the disease and side effects. Atacicept is a fusion protein that blocks B-lymphocyte stimulator and a proliferationinducing ligand, which are increased

Published
2015

10. Breast Cancer in Systemic Lupus Erythematosus

Author

Cloutier, B Tessier, Clarke, AE, Ramsey-Goldman, R, Wang, Y, Foulkes, W, Gordon, C, Hansen, JE, Yelin, E, Urowitz, MB, Gladman, D, Fortin, PR, Wallace, DJ, Petri, M, Manzi, S, Ginzler, EM, Labrecque, J, Edworthy, S, Dooley, MA, Senécal, JL, Peschken, CA, Bae, SC, Isenberg, D, Rahman, A, Ruiz-Irastorza, G, Hanly, JG, Jacobsen, S, Nived, O, Witte, T, Criswell, LA, Barr, SG, Dreyer, L, Sturfelt, G, and Bernatsky, S

Subjects
Clinical Research, Breast Cancer, Cancer, Lupus, Autoimmune Disease, Adult, Aged, Breast Neoplasms, Carcinoma, Ductal, Breast, Carcinoma, Lobular, Cohort Studies, Disease Susceptibility, Female, Humans, Logistic Models, Lupus Erythematosus, Systemic, Middle Aged, Multivariate Analysis, Odds Ratio, Risk Factors, Breast cancer, Systemic lupus erythematosus, Histopathology, Epidemiology, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

ObjectiveEvidence points to a decreased breast cancer risk in systemic lupus erythematosus (SLE). We analyzed data from a large multisite SLE cohort, linked to cancer registries.MethodsInformation on age, SLE duration, cancer date, and histology was available. We analyzed information on histological type and performed multivariate logistic regression analyses of histological types according to age, SLE duration, and calendar year.ResultsWe studied 180 breast cancers in the SLE cohort. Of the 155 cases with histology information, 11 were referred to simply as 'carcinoma not otherwise specified'. In the remaining 144 breast cancers, the most common histological type was ductal carcinoma (n = 95; 66%) followed by lobular adenocarcinoma (n = 11; 8%), 15 cancers were of mixed histology, and the remaining ones were special types. In our regression analyses, the independent risk factors for lobular versus ductal carcinoma was age [odds ratio (OR) 1.07, 95% confidence interval (CI) 1.01-1.14] and for the 'special' subtypes it was age (OR 1.06, 95% CI 1.01-1.10) and SLE duration (OR 1.05, 95% CI 1.00-1.11).ConclusionsGenerally, up to 80% of breast cancers are ductal carcinomas. Though our results are not definitive, in the breast cancers that occur in SLE, there may be a slight decrease in the ductal histological type. In our analyses, age and SLE duration were independent predictors of histological status.

Published
2013

12. Mortality risk factors in primary Sjögren syndrome: a real-world, retrospective, cohort study

Author

Brito-Zerón, Pilar, primary, Flores-Chávez, Alejandra, additional, Horváth, Ildiko Fanny, additional, Rasmussen, Astrid, additional, Li, Xiaomei, additional, Olsson, Peter, additional, Vissink, Arjan, additional, Priori, Roberta, additional, Armagan, Berkan, additional, Hernandez-Molina, Gabriela, additional, Praprotnik, Sonja, additional, Quartuccio, Luca, additional, Inanç, Nevsun, additional, Özkızıltaş, Burcugül, additional, Bartoloni, Elena, additional, Sebastian, Agata, additional, Romão, Vasco C., additional, Solans, Roser, additional, Pasoto, Sandra G., additional, Rischmueller, Maureen, additional, Galisteo, Carlos, additional, Suzuki, Yasunori, additional, Trevisani, Virginia Fernandes Moça, additional, Fugmann, Cecilia, additional, González-García, Andrés, additional, Carubbi, Francesco, additional, Jurcut, Ciprian, additional, Shimizu, Toshimasa, additional, Retamozo, Soledad, additional, Atzeni, Fabiola, additional, Hofauer, Benedikt, additional, Melchor-Díaz, Sheila, additional, Gheita, Tamer, additional, López-Dupla, Miguel, additional, Fonseca-Aizpuru, Eva, additional, Giacomelli, Roberto, additional, Vázquez, Marcos, additional, Consani, Sandra, additional, Akasbi, Miriam, additional, Nakamura, Hideki, additional, Szántó, Antónia, additional, Farris, A. Darise, additional, Wang, Li, additional, Mandl, Thomas, additional, Gattamelata, Angelica, additional, Kilic, Levent, additional, Pirkmajer, Katja Perdan, additional, Abacar, Kerem, additional, Tufan, Abdurrahman, additional, de Vita, Salvatore, additional, Bootsma, Hendrika, additional, Ramos-Casals, Manuel, additional, Arends, S., additional, Treppo, E., additional, Longhino, S., additional, Manfrè, V., additional, Rizzo, M., additional, Baldini, C., additional, Bombardieri, S., additional, Bandeira, M., additional, Silvéiro-António, M., additional, Seror, R., additional, Mariette, X., additional, Nordmark, G., additional, Danda, D., additional, Wiland, P., additional, Gerli, R., additional, Kwok, S.K., additional, Park, S.H., additional, Kvarnstrom, M., additional, Wahren-Herlenius, M., additional, Downie-Doyle, S., additional, Sene, D., additional, Isenberg, D., additional, Valim, V., additional, Devauchelle-Pensec, V., additional, Saraux, A., additional, Morel, J., additional, Morcillo, C., additional, Díaz Cuiza, P.E., additional, Herrera, B.E., additional, González-de-Paz, L., additional, and Sisó-Almirall, A., additional

Published
2023
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18. PO145 Strange rheuminations

Author

Ward, V, Parsons, G, Buchanan, S, Grote, H, Dahdelah, S, Farmer, S, Grieve, J, Jaunmuktane, Z, Shah, S, Isenberg, D, Zandi, M, and Gandhi, S

Published
2017
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20. Machine learning identifies clusters of longitudinal autoantibody profiles predictive of systemic lupus erythematosus disease outcomes.

Author

Choi, M. Y., Hanly, J., Bae, S.-C., Romero-Diaz, J., Sanchez-Guerrero, J., Bernatsky, S., Wallace, D. J., Isenberg, D. A., Rahman, A., Merrill, J. T., Fortin, P. R., Ramsey-Goldman, R., Manzi, S., Jönsen, A., Alarcón, G. S., van Vollenhoven C. Aranow M. Mackay, R. F., Ruiz-Irastorza, G., Kalunian, K., Kamen, D. L., and Askanase, A.

Published
2023
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21. Genome-wide association study identifies HLA 8.1 ancestral haplotype alleles as major genetic risk factors for myositis phenotypes

Author

Miller, F W, Chen, W, O'Hanlon, T P, Cooper, R G, Vencovsky, J, Rider, L G, Danko, K, Wedderburn, L R, Lundberg, I E, Pachman, L M, Reed, A M, Ytterberg, S R, Padyukov, L, Selva-O'Callaghan, A, Radstake, T R, Isenberg, D A, Chinoy, H, Ollier, W E R, Scheet, P, Peng, B, Lee, A, Byun, J, Lamb, J A, Gregersen, P K, and Amos, C I

Published
2015
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22. Childhood-onset of primary Sjögren’s syndrome: phenotypic characterization at diagnosis of 158 children

Author

Ramos-Casals, M., Acar-Denizli, N., Vissink, A., Brito-Zeron, P., Li, X., Carubbi, F., Priori, R., Toplak, N., Baldini, C., Faugier-Fuentes, E., Kruize, A. A., Mandl, T., Tomiita, M., Gandolfo, S., Hashimoto, K., Hernandez-Molina, G., Hofauer, B., Mendieta-Zeron, S., Rasmussen, A., Sandhya, P., Sene, D., Trevisani, V. F. M., Isenberg, D., Sundberg, E., Pasoto, S. G., Sebastian, A., Suzuki, Y., Retamozo, S., Xu, B., Giacomelli, R., Gattamelata, A., Bizjak, M., Bombardieri, S., Loor-Chavez, R. -E., Hinrichs, A., Olsson, P., Bootsma, H., Lieberman, S. M., Kostov, B., Horvath, I. -F., Szanto, A., Seror, R., Mariette, X., Kvarnstrom, M., Wahren-Herlenius, M., Praprotnik, S., Solans, R., Nordmark, G., Hammenfors, D., Brun, J. G., Gheita, T. A., Atzeni, F., Armagan, B., Kilic, L., Kalyoncu, U., Nakamura, T., Takagi, Y., Consani, S., Solorzano, F. O., Translational Immunology Groningen (TRIGR), Personalized Healthcare Technology (PHT), Universitat Politècnica de Catalunya. Departament d'Estadística i Investigació Operativa, and Universitat Politècnica de Catalunya. ADBD - Anàlisi de Dades Complexes per a les Decisions Empresarials

Subjects
Male, Systemic disease, Anti-nuclear antibody, Epidemiology, Autoimmune diseases, Matemàtiques i estadística::Matemàtica aplicada a les ciències [Àrees temàtiques de la UPC], Disease, Severity of Illness Index, Parotid Gland, Medicine, CLASSIFICATION CRITERIA, Pharmacology (medical), Registries, Age of Onset, biology, 92 Biology and other natural sciences::92B Mathematical biology in general [Classificació AMS], Dry eyes, Phenotype, Sjogren's syndrome, Female, epidemiology, Antibody, medicine.symptom, PAROTITIS, medicine.medical_specialty, Biomatemàtica, Adolescent, 62 Statistics::62D05 Sampling theory, sample surveys [Classificació AMS], Childhood, Paediatrics, Humans, Sjogren's Syndrome, paediatrics, AGE, Rheumatology, Peripheral nerve, Rheumatoid factor, autoimmune diseases, Sampling (Statistics), Primary Sjögren Syndrome, childhood, Biomathematics, Matemàtiques i estadística::Estadística aplicada::Estadística biosanitària [Àrees temàtiques de la UPC], business.industry, CLINICAL-FEATURES, medicine.disease, Dry mouth, Dermatology, stomatognathic diseases, biology.protein, Sjogren’s syndrome, CONSENSUS, business, Mostreig (Estadística), Parotitis
Abstract

Objectives To characterize the phenotypic presentation at diagnosis of childhood-onset primary SS. Methods The Big Data Sjögren Project Consortium is an international, multicentre registry using worldwide data-sharing cooperative merging of pre-existing clinical SS databases from the five continents. For this study, we selected those patients in whom the disease was diagnosed below the age of 19 years according to the fulfilment of the 2002/2016 classification criteria. Results Among the 12 083 patients included in the Sjögren Big Data Registry, 158 (1.3%) patients had a childhood-onset diagnosis (136 girls, mean age of 14.2 years): 126 (80%) reported dry mouth, 111 (70%) dry eyes, 52 (33%) parotid enlargement, 118/122 (97%) positive minor salivary gland biopsy and 60/64 (94%) abnormal salivary US study, 140/155 (90%) positive ANA, 138/156 (89%) anti-Ro/La antibodies and 86/142 (68%) positive RF. The systemic EULAR Sjögren’s syndrome disease activity index (ESSDAI) domains containing the highest frequencies of active patients included the glandular (47%), articular (26%) and lymphadenopathy (25%) domains. Patients with childhood-onset primary SS showed the highest mean ESSDAI score and the highest frequencies of systemic disease in 5 (constitutional, lymphadenopathy, glandular, cutaneous and haematological) of the 12 ESSDAI domains, and the lowest frequencies in 4 (articular, pulmonary, peripheral nerve and CNS) in comparison with patients with adult-onset disease. Conclusions Childhood-onset primary SS involves around 1% of patients with primary SS, with a clinical phenotype dominated by sicca features, parotid enlargement and systemic disease. Age at diagnosis plays a key role in modulating the phenotypic expression of the disease.

Published
2021
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24. PO.6.126 Anti-rituximab antibodies demonstrate neutralising capacity, associate with lower circulating drug levels and early relapse in patients undergoing treatment for systemic lupus erythematosus

Author

Wincup, C, primary, Dunn, N, additional, Ruetsch-Chelli, C, additional, Manouchehrinia, A, additional, Kharlamova, N, additional, Naja, M, additional, Seitz-Polski, B, additional, Isenberg, D, additional, Fogdell-Hahn, A, additional, Ciurtin, C, additional, and Jury, E, additional

Published
2022
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25. Use of Glomerular CD68+ Cells as a Surrogate Marker for Endocapillary Hypercellularity in Lupus Nephritis

Author

Bos, E.M.J., Sangle, S.R., Wilhelmus, S., Wolterbeek, R., Jordan, N., D'Cruz, D., Isenberg, D., Cook, H.T., Bruijn, J.A., and Bajema, I.M.

Subjects
lupus nephritis, Nephrology, activity index, endocapillary hypercellularity, glomerular CD68+ cells
Abstract

Introduction: Lupus nephritis (LN) class III or IV is strongly related to patient mortality and morbidity. The interobserver agreement of endocapillary hypercellularity by routine light microscopy, one of the most important lesions determining whether class III or IV is present, is moderate. In IgA nephropathy (IgAN), the presence of glomerular CD68+ cells was found to be a good surrogate marker for endocapillary hypercellularity. We investigated whether the presence of glomerular CD68+ cells could serve as a surrogate marker for endocapillary hypercellularity as well in LN.Methods: A total of 92 LN biopsies were scored for the number of glomerular CD68+ cells using CD68 staining, including endocapillary hypercellularity and the activity index (AI). A new AI was calculated in which CD68+ cells replaced endocapillary hypercellularity. Clinical parameters were obtained from time of biopsy, 1 year after, and 2 years after.Results: The number of glomerular CD68+ cells significantly correlated with endocapillary hypercellularity. A cutoff value of 7 for the maximum number of CD68+ cells within 1 glomerulus in a biopsy yielded a sensitivity of 88% and a specificity of 67% for the presence of endocapillary hypercellularity. Both endocapillary hypercellularity and CD68+ cells correlated with renal function during follow-up. The current and the new AI correlated equally well with the clinical outcome.Conclusion: In LN, CD68+cells can be used as a surrogate marker for endocapillary hypercellularity.

Published
2022
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26. Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus: the PISCOS study

Author

Piga, M. Chessa, E. Morand, E.F. Ugarte-Gil, M.F. Tektonidou, M. van Vollenhoven, R. Petri, M. Arnaud, L. Appenzeller, S. Aranow, C. Askanase, A. Avcin, T. Bae, S.-C. Bertsias, G. Bonfa, E. Cairoli, E. Cardiel, M.H. Cervera, R. Chasset, F. Chizzolini, C. Clarke, A.E. Conti, F. Costedoat-Chalumeau, N. Czirják, L. Doria, A. Dörner, T. Espinosa, G. Fischer-Betz, R. Garcìa, M. Gladman, D.D. González, L.A. Gunnarsson, I. Hamijoyo, L. Hanly, J.G. Hasni, S.A. Houssiau, F.A. Inanç, M. Inês, L.S. Isenberg, D. Jacobsen, S. Jan Wu, Y.-J. Kaneko, Y. Katsumata, Y. Lau, C.S. Legge, A.C. Lerang, K. Limper, M. Louthrenoo, W. Luo, S.-F. Marinho, A. Massardo, L. Mathian, A. Mosca, M. Nikpour, M. Pego-Reigosa, J.M. Peschken, C.A. Pons-Estel, B.A. Pons-Estel, G.J. Rahman, A. Rednic, S. Ribi, C. Ruiz-Irastorza, G. Sato, E.I. Saxena, A. Schneider, M. Sebastiani, G.D. Strand, V. Svenungsson, E. Tanaka, Y. Tazi Mezalek, Z. Tee, M.L. Tincani, A. Touma, Z. Troldborg, A. Vasconcelos, C. Vinet, É. Vital, E.M. Voskuyl, A.E. Voss, A. Wallace, D. Ward, M. Zamora, L.D. PISCOS Investigator Group and Piga, M. Chessa, E. Morand, E.F. Ugarte-Gil, M.F. Tektonidou, M. van Vollenhoven, R. Petri, M. Arnaud, L. Appenzeller, S. Aranow, C. Askanase, A. Avcin, T. Bae, S.-C. Bertsias, G. Bonfa, E. Cairoli, E. Cardiel, M.H. Cervera, R. Chasset, F. Chizzolini, C. Clarke, A.E. Conti, F. Costedoat-Chalumeau, N. Czirják, L. Doria, A. Dörner, T. Espinosa, G. Fischer-Betz, R. Garcìa, M. Gladman, D.D. González, L.A. Gunnarsson, I. Hamijoyo, L. Hanly, J.G. Hasni, S.A. Houssiau, F.A. Inanç, M. Inês, L.S. Isenberg, D. Jacobsen, S. Jan Wu, Y.-J. Kaneko, Y. Katsumata, Y. Lau, C.S. Legge, A.C. Lerang, K. Limper, M. Louthrenoo, W. Luo, S.-F. Marinho, A. Massardo, L. Mathian, A. Mosca, M. Nikpour, M. Pego-Reigosa, J.M. Peschken, C.A. Pons-Estel, B.A. Pons-Estel, G.J. Rahman, A. Rednic, S. Ribi, C. Ruiz-Irastorza, G. Sato, E.I. Saxena, A. Schneider, M. Sebastiani, G.D. Strand, V. Svenungsson, E. Tanaka, Y. Tazi Mezalek, Z. Tee, M.L. Tincani, A. Touma, Z. Troldborg, A. Vasconcelos, C. Vinet, É. Vital, E.M. Voskuyl, A.E. Voss, A. Wallace, D. Ward, M. Zamora, L.D. PISCOS Investigator Group

Abstract

The Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus (PISCOS) study aimed to obtain an evidence-based and expert-based consensus standardisation of the Physician Global Assessment (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). An international panel of 79 SLE experts participated in a three-round Delphi consensus process, in which 41 statements related to the PGA in SLE were rated, using a 0 (strongly disagree) to 10 (strongly agree) numerical rating scale. Statements with agreement of 75% or greater were selected and further validated by the expert panel. Consensus was reached on 27 statements, grouped in 14 recommendations, for the use of the PGA in SLE, design of the PGA scale, practical considerations for PGA scoring, and the relationship between PGA values and levels of disease activity. Among these recommendations, the expert panel agreed that the PGA should consist of a 0–3 visual analogue scale for measuring disease activity in patients with SLE in the preceding month. The PGA is intended to rate the overall disease activity, taking into account the severity of active manifestations and clinical laboratory results, but excluding organ damage, serology, and subjective findings unrelated to disease activity. The PGA scale ranges from “no disease activity” (0) to the “most severe disease activity” (3) and incorporates the values 1 and 2 as inner markers to categorise disease activity as mild (≥0·5 to 1), moderate (>1 and ≤2) and severe (>2 to 3). Only experienced physicians can rate the PGA, and it should be preferably scored by the same rater at each visit. The PISCOS results will allow for increased homogeneity and reliability of PGA ratings in routine clinical practice, definitions of remission and low disease activity, and future SLE trials. © 2022 Elsevier Ltd

Published
2022

27. 2021 DORIS definition of remission in SLE: Final recommendations from an international task force.

Author

van Vollenhoven R.F., Bertsias G., Doria A., Isenberg D., Morand E., Petri M.A., Pons-Estel B.A., Rahman A., Ugarte-Gil M.F., Voskuyl A., Arnaud L., Bruce I.N., Cervera R., Costedoat-Chalumeau N., Gordon C., Houssiau F.A., Mosca M., Schneider M., Ward M.M., Alarcon G., Aringer M., Askenase A., Bae S.-C., Bootsma H., Boumpas D.T., Brunner H., Clarke A.E., Coney C., Czirjak L., Dorner T., Faria R., Fischer R., Fritsch-Stork R., Inanc M., Jacobsen S., Jayne D., Kuhn A., van Leeuw B., Limper M., Mariette X., Navarra S., Nikpour M., Olesinska M.H., Pons-Estel G., Romero-Diaz J., Rubio B., Schoenfeld Y., Bonfa E., Smolen J., Teng Y.K.O., Tincani A., Tsang-A-Sjoe M., Vasconcelos C., Voss A., Werth V.P., Zakharhova E., Aranow C., van Vollenhoven R.F., Bertsias G., Doria A., Isenberg D., Morand E., Petri M.A., Pons-Estel B.A., Rahman A., Ugarte-Gil M.F., Voskuyl A., Arnaud L., Bruce I.N., Cervera R., Costedoat-Chalumeau N., Gordon C., Houssiau F.A., Mosca M., Schneider M., Ward M.M., Alarcon G., Aringer M., Askenase A., Bae S.-C., Bootsma H., Boumpas D.T., Brunner H., Clarke A.E., Coney C., Czirjak L., Dorner T., Faria R., Fischer R., Fritsch-Stork R., Inanc M., Jacobsen S., Jayne D., Kuhn A., van Leeuw B., Limper M., Mariette X., Navarra S., Nikpour M., Olesinska M.H., Pons-Estel G., Romero-Diaz J., Rubio B., Schoenfeld Y., Bonfa E., Smolen J., Teng Y.K.O., Tincani A., Tsang-A-Sjoe M., Vasconcelos C., Voss A., Werth V.P., Zakharhova E., and Aranow C.

Abstract

Objective To achieve consensus on a definition of remission in SLE (DORIS). Background Remission is the stated goal for both patient and caregiver, but consensus on a definition of remission has been lacking. Previously, an international task force consisting of patient representatives and medical specialists published a framework for such a definition, without reaching a final recommendation. Methods Several systematic literature reviews were performed and specific research questions examined in suitably chosen data sets. The findings were discussed, reformulated as recommendations and voted on. Results Based on data from the literature and several SLE-specific data sets, a set of recommendations was endorsed. Ultimately, the DORIS Task Force recommended a single definition of remission in SLE, based on clinical systemic lupus erythematosus disease activitiy index (SLEDAI)=0, Evaluator's Global Assessment <0.5 (0-3), prednisolone 5 mg/day or less, and stable antimalarials, immunosuppressives, and biologics. Conclusion The 2021 DORIS definition of remission in SLE is recommended for use in clinical care, education, and research including clinical trials and observational studies.Copyright © 2021 BMJ Publishing Group. All rights reserved.

Published
2022

31. AB0433 ANTI-RITUXIMAB ANTIBODIES DEMONSTRATE NEUTRALISING CAPACITY, ASSOCIATE WITH LOWER CIRCULATING DRUG LEVELS AND EARLY RELAPSE IN PATIENTS UNDERGOING TREATMENT FOR SYSTEMIC LUPUS ERYTHEMATOSUS

Author

Wincup, C., primary, Dunn, N., additional, Ruetsch-Chelli, C., additional, Manouchehrinia, A., additional, Kharlamova, N., additional, Naja, M., additional, Seitz-Polski, B., additional, Isenberg, D., additional, Fogdell-Hahn, A., additional, Ciurtin, C., additional, and Jury, E., additional

Published
2022
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34. AB0571 DERIVATION AND INDEPENDENT VALIDATION OF THE LUPUS ARTHRITIS AND MUSCULOSKELETAL DISEASE ACTIVITY SCORE (LAMDA): A MORE SENSITIVE, SPECIFIC AND RESPONSIVE TOOL FOR LUPUS ARTHRITIS

Author

Mahmoud, K., primary, Zayat, A., additional, MD Yusof, M. Y., additional, Teh, L. S., additional, Khan, S., additional, Yee, C. S., additional, D’cruz, D., additional, Ng, N., additional, Isenberg, D., additional, Ciurtin, C., additional, Conaghan, P. G., additional, Emery, P., additional, Edwards, C. J., additional, Hensor, E., additional, and Vital, E., additional

Published
2022
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35. Efficacy and Safety of Epratuzumab in Moderately to Severely Active Systemic Lupus Erythematosus: Results From Two Phase III Randomized, Double‐Blind, Placebo‐Controlled Trials

Author

Clowse, Megan E. B., Wallace, Daniel J., Furie, Richard A., Petri, Michelle A., Pike, Marilyn C., Leszczyński, Piotr, Neuwelt, C. Michael, Hobbs, Kathryn, Keiserman, Mauro, Duca, Liliana, Kalunian, Kenneth C., Galateanu, Catrinel, Bongardt, Sabine, Stach, Christian, Beaudot, Carolyn, Kilgallen, Brian, Gordon, Caroline, Batalov, A., Bojinca, M., Djerassi, R., Duca, L., Horak, P., Kolarov, Z., Milasiene, R., Monova, D., Otsa, K., Pileckyte, M., Popova, T., Radulescu, F., Rashkov, R., Rednic, S., Repin, M., Stoilov, R., Tegzova, D., Vezikova, N., Vitek, P., Zainea, C., East, Far, Baek, H., Chen, Y., Chiu, Y., Cho, C., Chou, C., Choe, J., Huang, C., Kang, Y., Kang, S., Lai, N., Lee, S., Park, W., Shim, S., Suh, C., Yoo, W., Armengol, H. Avila, Zapata, F. Avila, Santiago, M. Barreto, Cavalcanti, F., Chahade, W., Costallat, L., Keiserman, M., Alcala, J. Orozco, Remus, C. Ramos, Roimicher, L., AbuShakra, M., Agarwal, V., AgmonLevin, N., Kadel, J., Levy, Y., Mevorach, D., Paran, D., Reitblat, T., Rosner, I., Shobha, V., Sthoeger, Z., Zisman, D., Ayesu, K., Berney, S., Box, J., Busch, H., Buyon, J., Carter, J., Chi, J., Clowse, M., Collins, R., Dao, K., Diab, I., Dikranian, A., ElShahawy, M., Gaylis, N., Grossman, J., Halpert, E., Huff, J., Jarjour, W., Kao, A., Katz, R., Kennedy, A., Khan, M., Kivitz, A., Kohen, M., LawrenceFord, T., Lawson, J., Levesque, M., Lowenstein, M., Majjhoo, A., Mcarthur, R., McLain, D., Merrill, J., Murillo, A., Neucks, S., Niemer, G., Noaiseh, G., Parker, C., Pantojas, C., Pattanaik, D., Petri, M., Pickrell, P., Reveille, J., RomanMiranda, A., Rothfield, N., Sankoorikal, A., Sayers, M., Singhal, A., Snyder, A., Striebich, C., Vo, Q., von Feldt, J., Wallace, D., Wasko, M., Young, C., Adelstein, S., Hall, S., Littlejohn, G., Nicholls, D., Suranyi, M., Amoura, Z., Bannert, B., Behrens, F., Perez, L.Carreno, Chakravarty, K., Gonzales, F. Diaz, Davies, K., Doria, A., Emery, P., FernándezNebro, A., Govoni, M., Hachulla, E., Hellmich, B., Houssiau, F., Malaise, M., Margaux, J., Maugars, Y., MuñozFernández, S., Navarro, F., OrdiRos, J., Pellerito, R., PenaSagredo, J., Roussou, E., Schmidt, R. E., UcarAngulo, E., Viallard, JF., Westhovens, R., Worm, M., Yee, C. S., Nayiager, S., Reuter, H., Spargo, C., Bazela, B., Brzosko, M., Chudzik, D., Gasztonyi, B., Geher, P., Ionescu, R., Jeka, S., Kemeny, L., Kiss, E., Kotyla, P., Kovacs, L., Kovalenko, V., Kucharz, E., Kwiatkowska, B., Leszczynski, P., Levchenko, E., Lysenko, G., Majdan, M., Mihailov, C., Nalotov, S., Nedelciu, M., Pavel, M., Raskina, T., Rebrov, B., Rezus, E., Semen, T., Smakotina, S., Stanislavchuk, M., Stanislav, M., Szombati, I., Szucs, G., Udrea, G., Zajdel, J., ZonGiebel, A., Bonfiglioli, R., Bustamante, R., Klumb, E., Ramirez, G. Medrano, Neiva, C., Olguin, M., Gonzaga, J.Reyes, Scotton, A., Ayala, S. Sicsik, Ximenes, A., Sharma, R., Srikantiah, C., Aelion, J., Aranow, C., Baker, M., Chadha, A., Chao, J., Chatham, W., Chow, A., Clay, C., CohenGadol, S., Conaway, D., Denburg, J., Escalante, A., Espinoza, L., Fiechtner, J., Fortin, I., Fraser, A., Furie, R., Gladman, D., Goddard, D., Goldberg, M., GonzalezRivera, R., Gorman, J., Griffin, R., Haaland, D., Halter, D., Hemaiden, A., Hobbs, K., Joshi, V., Lim, S., Kalunian, K., Karpouzas, G., Khraishi, M., Lafyatis, R., Lee, S., Lidman, R., Lue, C., Mohan, M., Mease, P., Mehta, C., Mizutani, W., Nami, A., Nascimento, J., Neuwelt, C., Pappas, J., Pope, J., Porges, A., Roane, G., Rosenberg, D., Ross, S., Saadeh, C., Scoville, C., Sherrer, Y., Solomon, M., Surbeck, W., Valenzuela, G., Waller, P., Alten, R., Baerwald, C., Bienvenu, B., Bombardieri, S., Braun, J., Dival, L., Espinosa, G., Fernandez, I. Figueroa, GomezReino, J., Gordon, C., Hiepe, F., Hopkinson, N., Isenberg, D., Jacobi, A., Jorgensen, C., Guern, V. Le, Paul, C., PegoReigosa, J. M., Heredia, J. Rodriguez, RubbertRoth, A., Sabbadini, M., Schroeder, J., Schwarting, A., Spieler, W., Valesini, G., Wollenhaupt, J., Mendoza, A. Zea, and Zouboulis, C.

Published
2017
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37. Influence of the age at diagnosis in the disease expression of primary Sjögren's syndrome: Analysis of 12,753 patients from the Sjögren Big Data Consortium

Author

Retamozo, S., Acar-Denizli, N., Horváth, I. F., Ng, W. -F, Rasmussen, A., Dong, X., Li, X., Baldini, C., Olsson, P., Priori, R., Seror, R., Gottenberg, J. -E, Kruize, A. A., Hernandez-Molina, G., Vissink, A., Sandhya, P., Armagan, B., Quartuccio, L., Sebastian, A., Praprotnik, S., Bartoloni, E., Kwok, S. -K, Kvarnstrom, M., Rischmueller, M., Soláns-Laqué, R., Sene, D., Pasoto, S. G., Suzuki, Y., Isenberg, D. A., Valim, V., Nordmark, G., Nakamura, H., Virginia Trevisani, Hofauer, B., Sisó-Almirall, A., Giacomelli, R., Devauchelle-Pensec, V., Bombardieri, M., Atzeni, F., Hammenfors, D., Maure, B., Carsons, S. E., Gheita, T., Sánchez-Berná, I., López-Dupla, M., Morel, J., Inanç, N., Fonseca-Aizpuru, E., Morcillo, C., Vollenweider, C., Melchor, S., Vázquez, M., Díaz-Cuiza, E., Consani-Fernández, S., De-Miguel-Campo, B., Szántó, A., Bombardieri, S., Gattamelata, A., Hinrichs, A., Sánchez-Guerrero, J., Danda, D., Kilic, L., Vita, S., Wiland, P., Gerli, R., Park, S. -H, Wahren-Herlenius, M., Bootsma, H., Mariette, X., Ramos-Casals, M., Brito-Zerón, P., Translational Immunology Groningen (TRIGR), and Personalized Healthcare Technology (PHT)

Subjects
immunological markers, MANIFESTATIONS, age, Sjogren's syndrome, ONSET, YOUNG, MANAGEMENT, LYMPHOMA, disease phenotype, CLASSIFICATION CRITERIA, CONSENSUS, PROJECT, SALIVARY FLOW
Abstract

Objective. To analyse how the main components of the disease phenotype (sicca symptoms, diagnostic tests, immunological markers and systemic disease) can be driven by the age at diagnosis of primary Sjogren's syndrome (pSS). Methods. By January 2021, the participant centres had included 12,753 patients from 25 countries that fulfilled the 2002/2016 classification criteria for pSS. The age at diagnosis was defined as the time when the attending physician confirmed fulfilment of the criteria. Patients were clustered according to age at diagnosis. 50 clusters with more than 100 observations (from 27 to 76 years) were used to study the influence of the age at diagnosis in the disease expression. Results. There was a consistent increase in the frequency of oral dryness according to the age at diagnosis, with a frequency of 95% in those diagnosed at the oldest ages. The smooth curves that best fitted a linear model were the frequency of dry mouth (adjusted R-2 0.87) and the frequency of abnormal oral tests (adjusted R-2 0.72). Therefore, for each 1-year increase in the age at diagnosis, the frequency of dry mouth increased by 0.13%, and the frequency of abnormal oral diagnostic tests by 0.11%. There was a consistent year-by-year decrease in the frequency of all autoantibodies and immunological markers except for cryoglobulins. According to the linear models, for each 1-year increase in the age at diagnosis, the frequency of a positive result decreased by 0.57% (for anti-Ro antibodies), 0.47% (for RF) and 0.42% (for anti-La antibodies). The ESSDAI domains which showed a more consistent decrease were glandular and lymph node involvement (for each 1-year increase in the age at diagnosis, the frequency of activity decreased by 0.18%), and constitutional, cutaneous, and haematological involvements (the frequency decreased by 0.09% for each 1-year increase). In contrast, other domains showed an ascending pattern, especially pulmonary involvement (for each 1-year increase in the age at diagnosis, the frequency of activity increased by 0.22%), and peripheral nerve involvement (the frequency increased by 0.09% for each 1-year increase). Conclusion. The influence of the age at diagnosis on the key phenotypic features of pSS is strong, and should be considered critical not only for designing a personalised diagnostic approach, but also to be carefully considered when analysing the results of diagnostic tests and immunological parameters, and when internal organ involvement is suspected at diagnosis.

Published
2021

42. 2021 DORIS definition of remission in SLE: Final recommendations from an international task force

Author

van Vollenhoven, R.F. Bertsias, G. Doria, A. Isenberg, D. Morand, E. Petri, M.A. Pons-Estel, B.A. Rahman, A. Ugarte-Gil, M.F. Voskuyl, A. Arnaud, L. Bruce, I.N. Cervera, R. Costedoat-Chalumeau, N. Gordon, C. Houssiau, F.A. Mosca, M. Schneider, M. Ward, M.M. Alarcon, G. Aringer, M. Askenase, A. Bae, S.-C. Bootsma, H. Boumpas, D.T. Brunner, H. Clarke, A.E. Coney, C. Czirják, L. Dörner, T. Faria, R. Fischer, R. Fritsch-Stork, R. Inanc, M. Jacobsen, S. Jayne, D. Kuhn, A. van Leeuw, B. Limper, M. Mariette, X. Navarra, S. Nikpour, M. Olesinska, M.H. Pons-Estel, G. Romero-Diaz, J. Rubio, B. Schoenfeld, Y. Bonfá, E. Smolen, J. Teng, Y.K.O. Tincani, A. Tsang-A-Sjoe, M. Vasconcelos, C. Voss, A. Werth, V.P. Zakharhova, E. Aranow, C.

Subjects
skin and connective tissue diseases
Abstract

Objective To achieve consensus on a definition of remission in SLE (DORIS). Background Remission is the stated goal for both patient and caregiver, but consensus on a definition of remission has been lacking. Previously, an international task force consisting of patient representatives and medical specialists published a framework for such a definition, without reaching a final recommendation. Methods Several systematic literature reviews were performed and specific research questions examined in suitably chosen data sets. The findings were discussed, reformulated as recommendations and voted on. Results Based on data from the literature and several SLE-specific data sets, a set of recommendations was endorsed. Ultimately, the DORIS Task Force recommended a single definition of remission in SLE, based on clinical systemic lupus erythematosus disease activitiy index (SLEDAI)=0, Evaluator’s Global Assessment

Published
2021

43. DORIS definition of remission in SLE: final recommendations from an international task force

Author

van Vollenhoven RF, Bertsias, G, Doria, A, Isenberg, D, Morand, E, Petri, Ma, Pons-Estel, Ba, Rahman, A, Ugarte-Gil, Mf, Voskuyl, A, Arnaud, L, Bruce, In, Cervera, R, Costedoat-Chalumeau, N, Gordon, C, Houssiau, Fa, Mosca, M, Schneider, M, Ward, Mm, Alarcon, G, Aringer, M, Askenase, A, Bae, Sc, Bootsma, H, Boumpas, Dt, Brunner, H, Clarke, Ae, Coney, C, Czirják, L, Dörner, T, Faria, R, Fischer, R, Fritsch-Stork, R, Inanc, M, Jacobsen, S, Jayne, D, Kuhn, A, van Leeuw, B, Limper, M, Mariette, X, Navarra, S, Nikpour, M, Olesinska, Mh, Pons-Estel, G, Romero-Diaz, J, Rubio, B, Schoenfeld, Y, Bonfá, E, Smolen, J, Teng, Yko, Tincani, A, Tsang-A-Sjoe, M, Vasconcelos, C, Voss, A, Werth, Vp, Zakharhova, E, and Aranow, C

Published
2021

44. SARS-CoV-2 infection in patients with primary Sjögren syndrome: characterization and outcomes of 51 patients

Author

Brito-Zerón, Pilar, Melchor, Sheila, Seror, Raphaèle, Priori, Roberta, Solans, Roser, Kostov, Belchin, Baldini, Chiara, Carubbi, Francesco, Callejas, Jose Luis, Guisado-Vasco, Pablo, Hernández-Molina, Gabriela, Pasoto, Sandra G, Valim, Valeria, Sisó-Almirall, Antoni, Mariette, Xavier, Carreira, Patricia, Ramos-Casals, Manuel, Brito-Zerón, P, Morcillo, C, Flores-Chávez, A, Ramos-Casals, M, Acar-Denizli, N, Horvath, I F, Szanto, A, Tarr, T, Seror, R, Mariette, X, Mandl, T, Olsson, P, Li, X, Xu, B, Baldini, C, Bombardieri, S, Gottenberg, J E, Gandolfo, S, De Vita, S, Priori, R, Giardina, F, Hernandez-Molina, G, Sánchez-Guerrero, J, Kruize, A A, Hinrichs, A, Valim, V, Isenberg, D, Solans, R, Rischmueller, M, Downie-Doyle, S, Kwok, S-K, Park, S-H, Nordmark, G, Suzuki, Y, Kawano, M, Giacomelli, R, Devauchelle-Pensec, V, Saraux, A, Hofauer, B, Knopf, A, Bootsma, H, Vissink, A, Morel, J, Vollenveider, C, Atzeni, F, Retamozo, S, Moça Trevisano, V, Armagan, B, Kilic, L, Kalyoncu, U, Pasoto, S G, Kostov, B, Sisó-Almirall, A, Consani-Fernández, S, Carubbi, F, Callejas, J L, López-Dupla, M, Pérez-Alvarez, R, Akasbi, M, Guisado-Vasco, P, Sánchez, I, Hospital Universitario 12 de Octubre [Madrid], EULAR standing committee of People with Arthritis/Rheumatism in Europe (PARE), H. CIMA-Sanitas, Barcelona, CELLEX-IDIBAPS Department of Autoimmune Diseases, Barcelona, Instituto Mexicano del Seguro Social [Mexico City, Mexico] (IMSS), Universidad de Colima [Mexico], Hospital Clinic [Barcelona, Spain], İstanbul Üniversitesi, İstanbul, Medical and Health Science Center, University of Debrecen, Debrecen, Hungary, MTA-Debreceni Egyetem, Immunologie des maladies virales, auto-immunes, hématologiques et bactériennes (IMVA-HB), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Center for Immunology of Viral Infections and Autoimmune Diseases, Le Kremlin Bicêtre, Skåne University Hospital [Malmö, Suède], Stockholm University, Wuhan University [China], Pisa University Hospital, Nuclear Medicine Unit, Humanitas Gavazzeni, Bergamo, Italy, University Hospitals, Strasbourg, Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome] (UNIROMA), Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán - National Institute of Medical Science and Nutrition Salvador Zubiran [Mexico], Federal University of Espírito Santo, University Hospital Vall d’Hebròn [Barcelona, Spain], Lymphocytes B, Autoimmunité et Immunothérapies (LBAI), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-LabEX IGO Immunothérapie Grand Ouest, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut de Génétique Moléculaire de Montpellier (IGMM), Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Institut d'Investigaciones Biomèdiques August Pi i Sunye (IDIBAPS), Università degli studi di Palermo - University of Palermo, Hospitales Universitarios de Granada/Universidad de Granada, Hospital Universitario Quironsalud, Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome], Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Rheumatology Unit, Department of Internal Medicine, University of Palermo, Palermo, Italy, and Michel, Geneviève

Subjects
Male, medicine.medical_specialty, Multivariate analysis, [SDV.IMM] Life Sciences [q-bio]/Immunology, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Comorbidity, Laboratory abnormality, comorbidities, outcomes, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Risk Factors, Internal medicine, medicine, Humans, In patient, Pharmacology (medical), 030212 general & internal medicine, Registries, Risk factor, Primary Sjögren Syndrome, AcademicSubjects/MED00360, ComputingMilieux_MISCELLANEOUS, 030203 arthritis & rheumatology, business.industry, SARS-CoV-2, COVID-19, Primary SS, SARS-Cov-2, Middle Aged, medicine.disease, 3. Good health, Hospitalization, Sjogren's Syndrome, [SDV.IMM]Life Sciences [q-bio]/Immunology, Original Article, Female, business
Abstract

Objective To analyse the prognosis and outcomes of SARS-CoV-2 infection in patients with primary SS. Methods We searched for patients with primary SS presenting with SARS-CoV-2 infection (defined following and according to the European Centre for Disease Prevention and Control guidelines) among those included in the Big Data Sjögren Registry, an international, multicentre registry of patients diagnosed according to the 2002/2016 classification criteria. Results A total of 51 patients were included in the study (46 women, mean age at diagnosis of infection of 60 years). According to the number of patients with primary SS evaluated in the Registry (n = 8211), the estimated frequency of SARS-CoV-2 infection was 0.62% (95% CI 0.44, 0.80). All but two presented with symptoms suggestive of COVID-19, including fever (82%), cough (57%), dyspnoea (39%), fatigue/myalgias (27%) and diarrhoea (24%), and the most frequent abnormalities included raised lactate dehydrogenase (LDH) (88%), CRP (81%) and D-dimer (82%) values, and lymphopenia (70%). Infection was managed at home in 26 (51%) cases and 25 (49%) required hospitalization (five required admission to ICU, four died). Compared with patients managed at home, those requiring hospitalization had higher odds of having lymphopenia as laboratory abnormality (adjusted OR 21.22, 95% CI 2.39, 524.09). Patients with comorbidities had an older age (adjusted OR 1.05, 95% CI 1.00, 1.11) and showed a risk for hospital admission six times higher than those without (adjusted OR 6.01, 95% CI 1.72, 23.51) in the multivariate analysis. Conclusion Baseline comorbidities were a key risk factor for a more complicated COVID-19 in patients with primary SS, with higher rates of hospitalization and poor outcomes in comparison with patients without comorbidities.

Published
2020
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45. What Does It Mean to Be a BICLA (BILAG-Based Composite Lupus Assessment) Responder? Post Hoc Analysis of the Phase 3 TULIP-1 and TULIP-2 Trials.

Author

Van Vollenhoven R., Isenberg D., Abreu G., Tummala R., Pineda L., Furie R., Morand E., Bruce I., Van Vollenhoven R., Isenberg D., Abreu G., Tummala R., Pineda L., Furie R., Morand E., and Bruce I.

Abstract

Background/Purpose: BICLA is a validated composite global measure of SLE disease activity that incorporates BILAG, an instrument that distinguishes between partial and complete improvement. BICLA was an endpoint in the phase 3 TULIP-1 and TULIP-2 trials of anifrolumab.1,2 This study investigated the relationships between BICLA response and SLE clinical and laboratory assessments in TULIP-1 and -2, irrespective of treatment assignment. Method(s): This was a post hoc analysis of pooled data from the 52-week (wk), double-blind TULIP-1 and -2 trials. Patients with moderately to severely active SLE, despite standard of care, were randomized to receive anifrolumab (150 or 300 mg IV Q4W) or placebo for 48 wks. BICLA responses were defined by the following: reduction of all baseline BILAG-2004 A and B domain scores to B/C/D and C/D, respectively, and no worsening in any organ system; no worsening of SLEDAI-2K score; and no worsening >=0.3 points in Physician's Global Assessment (range 0-3).3 Attempts to taper oral corticosteroids (OCS) to <=7.5 mg/day between Wks 8 and 40 were required for patients receiving OCS >=10 mg/day at baseline. Sustained OCS dosage reduction was defined as OCS dosage <=7.5 mg/day achieved by Wk 40 and sustained through Wk 52. Result(s): Baseline characteristics were generally similar between BICLA responders (n=318) and nonresponders (n=501). Overall, improved outcomes were observed in BICLA responders vs nonresponders, including numerically greater improvements in SLEDAI-2K (-7.4 [SD: 3.64] vs -4.2 [SD: 4.28]) from baseline to Wk 52 (Table 1). Greater mean daily OCS dosage reduction was observed in BICLA responders vs nonresponders (-5.41 [SD: 6.84] vs -1.67 [SD: 8.08] mg/day) from baseline to Wk 52, and sustained OCS dosage reduction was achieved by more BICLA responders vs nonresponders (79.2% vs 19.1%). A >=50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score, for patients with baseline score >

Published
2021

46. 2021 DORIS definition of remission in SLE: Final recommendations from an international task force.

Author

van Vollenhoven R.F., Bertsias G., Doria A., Isenberg D., Morand E., Petri M.A., Pons-Estel B.A., Rahman A., Ugarte-Gil M.F., Voskuyl A., Arnaud L., Bruce I.N., Cervera R., Costedoat-Chalumeau N., Gordon C., Houssiau F.A., Mosca M., Schneider M., Ward M.M., Alarcon G., Aringer M., Askenase A., Bae S.-C., Bootsma H., Boumpas D.T., Brunner H., Clarke A.E., Coney C., Czirjak L., Dorner T., Faria R., Fischer R., Fritsch-Stork R., Inanc M., Jacobsen S., Jayne D., Kuhn A., van Leeuw B., Limper M., Mariette X., Navarra S., Nikpour M., Olesinska M.H., Pons-Estel G., Romero-Diaz J., Rubio B., Schoenfeld Y., Bonfa E., Smolen J., Teng Y.K.O., Tincani A., Tsang-A-Sjoe M., Vasconcelos C., Voss A., Werth V.P., Zakharhova E., Aranow C., van Vollenhoven R.F., Bertsias G., Doria A., Isenberg D., Morand E., Petri M.A., Pons-Estel B.A., Rahman A., Ugarte-Gil M.F., Voskuyl A., Arnaud L., Bruce I.N., Cervera R., Costedoat-Chalumeau N., Gordon C., Houssiau F.A., Mosca M., Schneider M., Ward M.M., Alarcon G., Aringer M., Askenase A., Bae S.-C., Bootsma H., Boumpas D.T., Brunner H., Clarke A.E., Coney C., Czirjak L., Dorner T., Faria R., Fischer R., Fritsch-Stork R., Inanc M., Jacobsen S., Jayne D., Kuhn A., van Leeuw B., Limper M., Mariette X., Navarra S., Nikpour M., Olesinska M.H., Pons-Estel G., Romero-Diaz J., Rubio B., Schoenfeld Y., Bonfa E., Smolen J., Teng Y.K.O., Tincani A., Tsang-A-Sjoe M., Vasconcelos C., Voss A., Werth V.P., Zakharhova E., and Aranow C.

Abstract

Objective To achieve consensus on a definition of remission in SLE (DORIS). Background Remission is the stated goal for both patient and caregiver, but consensus on a definition of remission has been lacking. Previously, an international task force consisting of patient representatives and medical specialists published a framework for such a definition, without reaching a final recommendation. Methods Several systematic literature reviews were performed and specific research questions examined in suitably chosen data sets. The findings were discussed, reformulated as recommendations and voted on. Results Based on data from the literature and several SLE-specific data sets, a set of recommendations was endorsed. Ultimately, the DORIS Task Force recommended a single definition of remission in SLE, based on clinical systemic lupus erythematosus disease activitiy index (SLEDAI)=0, Evaluator's Global Assessment <0.5 (0-3), prednisolone 5 mg/day or less, and stable antimalarials, immunosuppressives, and biologics. Conclusion The 2021 DORIS definition of remission in SLE is recommended for use in clinical care, education, and research including clinical trials and observational studies.Copyright © 2021 BMJ Publishing Group. All rights reserved.

Published
2021

47. 2021 DORIS definition of remission in SLE: final recommendations from an international task force

Author

van Vollenhoven, RF, Bertsias, G, Doria, A, Isenberg, D, Morand, E, Petri, MA, Pons-Estel, BA, Rahman, A, Ugarte-Gil, MF, Voskuyl, A, Arnaud, L, Bruce, IN, Cervera, R, Costedoat-Chalumeau, N, Gordon, C, Houssiau, FA, Mosca, M, Schneider, M, Ward, MM, Alarcon, G, Aringer, M, Askenase, A, Bae, S-C, Bootsma, H, Boumpas, DT, Brunner, H, Clarke, AE, Coney, C, Czirjak, L, Doerner, T, Faria, R, Fischer, R, Fritsch-Stork, R, Inanc, M, Jacobsen, S, Jayne, D, Kuhn, A, van Leeuw, B, Limper, M, Mariette, X, Navarra, S, Nikpour, M, Olesinska, MH, Pons-Estel, G, Romero-Diaz, J, Rubio, B, Schoenfeld, Y, Bonfa, E, Smolen, J, Teng, YKO, Tincani, A, Tsang-A-Sjoe, M, Vasconcelos, C, Voss, A, Werth, VP, Zakharhova, E, Aranow, C, van Vollenhoven, RF, Bertsias, G, Doria, A, Isenberg, D, Morand, E, Petri, MA, Pons-Estel, BA, Rahman, A, Ugarte-Gil, MF, Voskuyl, A, Arnaud, L, Bruce, IN, Cervera, R, Costedoat-Chalumeau, N, Gordon, C, Houssiau, FA, Mosca, M, Schneider, M, Ward, MM, Alarcon, G, Aringer, M, Askenase, A, Bae, S-C, Bootsma, H, Boumpas, DT, Brunner, H, Clarke, AE, Coney, C, Czirjak, L, Doerner, T, Faria, R, Fischer, R, Fritsch-Stork, R, Inanc, M, Jacobsen, S, Jayne, D, Kuhn, A, van Leeuw, B, Limper, M, Mariette, X, Navarra, S, Nikpour, M, Olesinska, MH, Pons-Estel, G, Romero-Diaz, J, Rubio, B, Schoenfeld, Y, Bonfa, E, Smolen, J, Teng, YKO, Tincani, A, Tsang-A-Sjoe, M, Vasconcelos, C, Voss, A, Werth, VP, Zakharhova, E, and Aranow, C

Abstract

OBJECTIVE: To achieve consensus on a definition of remission in SLE (DORIS). BACKGROUND: Remission is the stated goal for both patient and caregiver, but consensus on a definition of remission has been lacking. Previously, an international task force consisting of patient representatives and medical specialists published a framework for such a definition, without reaching a final recommendation. METHODS: Several systematic literature reviews were performed and specific research questions examined in suitably chosen data sets. The findings were discussed, reformulated as recommendations and voted on. RESULTS: Based on data from the literature and several SLE-specific data sets, a set of recommendations was endorsed. Ultimately, the DORIS Task Force recommended a single definition of remission in SLE, based on clinical systemic lupus erythematosus disease activitiy index (SLEDAI)=0, Evaluator's Global Assessment <0.5 (0-3), prednisolone 5 mg/day or less, and stable antimalarials, immunosuppressives, and biologics. CONCLUSION: The 2021 DORIS definition of remission in SLE is recommended for use in clinical care, education, and research including clinical trials and observational studies.

Published
2021

48. SARS-CoV-2 infection in patients with primary Sjögren syndrome: Characterization and outcomes of 51 patients

Author

Medicina i Cirurgia, Universitat Rovira i Virgili, Brito-Zerón P; Brito-Zerón P; Melchor S; Seror R; Seror R; Priori R; Priori R; Solans R; Solans R; Kostov B; Kostov B; Baldini C; Carubbi F; Carubbi F; Callejas JL; Guisado-Vasco P; Hernández-Molina G; Hernández-Molina G; Pasoto SG; Pasoto SG; Valim V; Valim V; Sisó-Almirall A; Sisó-Almirall A; Mariette X; Carreira P; Ramos-Casals M; Brito-Zerón P; Morcillo C; Flores-Chávez A; Acar-Denizli N; Horvath IF; Szanto A; Tarr T; Mandl T; Olsson P; Li X; Xu B; Baldini C; Bombardieri S; Gottenberg JE; Gandolfo S; De Vita S; Giardina F; Sánchez-Guerrero J; Kruize AA; Hinrichs A; Isenberg D; Rischmueller M; Downie-Doyle S; Kwok SK; Park SH; Nordmark G; Suzuki Y; Kawano M; Giacomelli R; Devauchelle-Pensec V; Saraux A; Hofauer B; Knopf A; Bootsma H; Vissink A; Morel J; Vollenveider C; Atzeni F; Retamozo S; Moça Trevisano V; Armagan B; Kilic L; Kalyoncu U; Consani-Fernández S; Callejas JL; López-Dupla M; Pérez-Alvarez R; Akasbi M; Sánchez I, Medicina i Cirurgia, Universitat Rovira i Virgili, and Brito-Zerón P; Brito-Zerón P; Melchor S; Seror R; Seror R; Priori R; Priori R; Solans R; Solans R; Kostov B; Kostov B; Baldini C; Carubbi F; Carubbi F; Callejas JL; Guisado-Vasco P; Hernández-Molina G; Hernández-Molina G; Pasoto SG; Pasoto SG; Valim V; Valim V; Sisó-Almirall A; Sisó-Almirall A; Mariette X; Carreira P; Ramos-Casals M; Brito-Zerón P; Morcillo C; Flores-Chávez A; Acar-Denizli N; Horvath IF; Szanto A; Tarr T; Mandl T; Olsson P; Li X; Xu B; Baldini C; Bombardieri S; Gottenberg JE; Gandolfo S; De Vita S; Giardina F; Sánchez-Guerrero J; Kruize AA; Hinrichs A; Isenberg D; Rischmueller M; Downie-Doyle S; Kwok SK; Park SH; Nordmark G; Suzuki Y; Kawano M; Giacomelli R; Devauchelle-Pensec V; Saraux A; Hofauer B; Knopf A; Bootsma H; Vissink A; Morel J; Vollenveider C; Atzeni F; Retamozo S; Moça Trevisano V; Armagan B; Kilic L; Kalyoncu U; Consani-Fernández S; Callejas JL; López-Dupla M; Pérez-Alvarez R; Akasbi M; Sánchez I

Abstract

Objective: To analyse the prognosis and outcomes of SARS-CoV-2 infection in patients with primary SS. Methods: We searched for patients with primary SS presenting with SARS-CoV-2 infection (defined following and according to the European Centre for Disease Prevention and Control guidelines) among those included in the Big Data Sjögren Registry, an international, multicentre registry of patients diagnosed according to the 2002/2016 classification criteria. Results: A total of 51 patients were included in the study (46 women, mean age at diagnosis of infection of 60 years). According to the number of patients with primary SS evaluated in the Registry (n = 8211), the estimated frequency of SARS-CoV-2 infection was 0.62% (95% CI 0.44, 0.80). All but two presented with symptoms suggestive of COVID-19, including fever (82%), cough (57%), dyspnoea (39%), fatigue/myalgias (27%) and diarrhoea (24%), and the most frequent abnormalities included raised lactate dehydrogenase (LDH) (88%), CRP (81%) and D-dimer (82%) values, and lymphopenia (70%). Infection was managed at home in 26 (51%) cases and 25 (49%) required hospitalization (five required admission to ICU, four died). Compared with patients managed at home, those requiring hospitalization had higher odds of having lymphopenia as laboratory abnormality (adjusted OR 21.22, 95% CI 2.39, 524.09). Patients with comorbidities had an older age (adjusted OR 1.05, 95% CI 1.00, 1.11) and showed a risk for hospital admission six times higher than those without (adjusted OR 6.01, 95% CI 1.72, 23.51) in the multivariate analysis. Conclusion: Baseline comorbidities were a key risk factor for a more complicated COVID-19 in patients with primary SS, with higher rates of hospitalization and poor outcomes in comparison with patients without co

Published
2021

49. Lung cancer in systemic lupus erythematosus

Author

Bin, J., Bernatsky, S., Gordon, C., Boivin, J.-F., Ginzler, E., Gladman, D., Fortin, P.R., Urowitz, M., Manzi, S., Isenberg, D., Rahman, A., Petri, M., Nived, O., Sturfeldt, G., Ramsey-Goldman, R., and Clarke, A.E.

Published
2007
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50. POS0746 THE ARTHRITIS COMPONENT OF THE SLEDAI SHOULD ONLY BE SCORED IF THERE IS JOINT SWELLING

Author

Mahmoud, K., primary, Zayat, A., additional, MD Yusof, M. Y., additional, Dutton, K., additional, Teh, L. S., additional, Yee, C. S., additional, D’cruz, D., additional, Ng, N., additional, Isenberg, D., additional, Ciurtin, C., additional, Conaghan, P. G., additional, Emery, P., additional, Edwards, C. J., additional, Hensor, E., additional, and Vital, E., additional

Published
2021
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