Objectives To analyze activity and response to therapies in a large multicenter sample of patients with systemic lupus erythematosus (SLE).
Methods Study design: national, multicenter, cross-sectional. Patients: SLE patients according to ACR criteria. Data collected: demographics, comorbidities, disease characteristics: activity (SELENA-SLEDAI), damage, severity, hospitalizations, mortality and treatments. Data about activity were collected in a cumulative way (at some stage) and at the time of the last evaluation. SLE was considered refractory if at least one of these criteria were present at some stage of the disease: ineffectiveness of cyclophosphamide, ineffectiveness of at least 2 non-biological immunosuppressants other than cyclophosphamide, use of rituximab or splenectomy. A multivariate analysis of the factors associated with refractory disease was performed.
Results 3,658 patients (90% female; median age[IR]: 46.8 years[20.8]; 93% Caucasians; median SLE duration[IR]:124 months) were included in 45 centers. At the time of their last evaluation, 14.7% of the patients had moderate-severe SLE (SELENA-SLEDAI score ≥6). 1,954 (53.4%) patients were hospitalized due to activity at least once over the course of the disease. Activity was the main cause of death (26%) among the deceased patients. At some stage, 84.6% of the patients received corticosteroids. Due to either toxicity or ineffectiveness, cyclophosphamide was withdrawn in 21.5% of the cases, mycophenolate mofetil in 24.9%, azathioprine in 40.2% and methotrexate in 46.8%. 898 (24.5%) patients had refractory SLE at some stage. Renal, neuropsychiatric, vasculitic, hematological and musculoskeletal involvement, a younger age at diagnosis and male sex are associated with refractory disease.
Conclusions A significant percentage of patients have moderately-to-severely active SLE at some stage. Disease activity has a big impact in terms of need for treatments, cause of hospitalization and death. The effectiveness of the standard therapies for reducing disease activity is clearly insufficient.
Acknowledgements RELESSER is supported by the Spanish Society of Rheumatology. Dr. Pego-Reigosa is supported by the grant 316265 (BIOCAPS) from the European Union 7th Framework Programme (FP7/REGPOT-2012-2013.1).
We thank Juan Manuel Barrio, Sabina Pérez and our colleagues in the Research Unit of the Spanish Society of Rheumatology who helped establish the database and provided excellent statistical support. The authors would like to thank all the investigators who participated in this study.
Disclosure of Interest J. M. Pego-Reigosa Grant/research support: Grants from GSK, Roche, UCB and Novartis contributed to the support of the cross-sectional stage of the Registry. These study sponsors were not involved in the study design, in the collection, analysis and interpretation data, in the writing of the report or in the decision to submit the abstract to the meeting., I. Rúa: None declared, V. del Campo: None declared, M. J. García-Yébenes: None declared, F. J. Lόpez-Longo: None declared, M. Galindo: None declared, J. Calvo: None declared, E. Loza: None declared, A. Olivé: None declared, R. Blanco: None declared, P. Vela: None declared, M. Rodríguez: None declared, C. Mouriño: None declared, T. Oton: None declared, E. Tornero: None declared, E. Uriarte: None declared, M. Freire: None declared, C. Fito: None declared, A. Fernández-Nebro: None declared, J. Narvaez: None declared, A. Zea: None declared, J. C. Rosas: None declared, J. A. Hernández: None declared, B. Hernández: None declared, A. Sánchez: None declared, M. Ibáñez: None declared, J. J. Pérez-Venegas: None declared
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