Background Our clinical research center have been conducting evaluation for innovative therapies in patients with Systemic Lupus Erythematosus during the past 15 years. In the present study we combined the results observed on extension studies from four different trials in patients receiving either intravenous or subcutaneous, belimumab and evaluated for activity, adverse events, in Caucasian and Black Brazilian patients.
Methods Seventy four patients were part of the combined study.The Lupus Low Disease Activity State(LLDAS) that has been shown to be a valuable tool to detect response or failure in trials were used in this study and statistical comparisons between the different result groups were determined.The period of evaluation ranged from 12 to 48 months
Results Seventy four patients completed the initial study. Four refused to continue the extension evaluation. Seven belonged to the black group(10%), sixty three were Caucasian.(90%)One patient was discontinued due to pregnancy.Nine received the subcutaneous presentation.(12.8%) In subgroup analysis analysis one patient in the black group had flare (14.2%) five in the intravenous administration had severe flares(8.1%) and were discontinued.During the evaluation ten had flares that were adjusted with steroids (eight articular or skin reactivation) and two with renal disease.On the five severe flares two required hospitalization.The mean time duration to achieve LLDAS was six months.Twenty seven achieved steroid free status and remained two patients on 2.5 mg and seventeen stable on daily 5.0 mg of prednisone.
Conclusions Using the LLDAS criteria response, it was possible to show that the majority of patients with active SLE on all three groups studied intravenous, subcutaneous and black race receiving belimumab for prolonged periods go into remission steroid free or in low disease activity in association with the correspondent immunosuppressive treatment.
Funding Source(s): Funding source Institutional and GSK.
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