Evaluation of belimumab use in routine clinical practice: observations in France

Trial description: Systemic Lupus Erythematosus (SLE) is a complex and severe autoimmune disease, with extremely variable clinical manifestations. Belimumab is indicated in subjects with active SLE, with the presence of autoantibodies and a high level of disease activity despite undergoing standard treatment. Belimumab has been marketed in France since September 2012. Although the clinical efficacy of belimumab has been demonstrated in randomized controlled clinical trials, its use and clinical benefits in real clinical practice have not been studied in France. Thus, a better understanding of the use of belimumab and its clinical benefit could support improved management of SLE in clinical practice. The primary objective of this retrospective, cohort study is to describe the therapeutic management and changes in activity of SLE in subjects treated with belimumab in routine clinical practice in France. Subjects treated with belimumab for a period of <6 months will be included in cohort 1 and those treated with belimumab for a period of >=6 months, collecting follow-up data for 24 months following initiation of treatment or until discontinuing belimumab in the event of early discontinuation, will be included in cohort 2. Data will be collected retrospectively from subject medical records for a maximum period of 30 months, including 6 months before initiation of belimumab to a maximum of 24 months follow-up. The reference date will be defined as the date of initiating belimumab treatment. In total, 150 subjects will be included in cohort 2 whereas the number of subjects in cohort 1 will be unlimited.