ABSTRACT
INTRODUCTION: We have been conducting an evaluation of innovative therapies in patients with SLE during the past 15 years. We combine the results observed on extension studies from four different trials in patients receiving either intravenous or subcutaneous belimumab, and evaluated, in Caucasian and Black Brazilian patients. METHODS: Seventy-four patients were part of the study. The Lupus Low Disease Activity State (LLDAS) shown to be an available tool to detect a response in trials was used in this study and statistical comparisons between the different result groups were determined. The period of evaluation was 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 a subcutaneous presentation (12.8%). In the subgroup analysis, one patient in the black group had flare (14.2%); five in the intravenous administration had severe flares (8.1%) and were discontinued. Ten had flares adjusted with steroids (eight articular or skin reactivation) and two with renal disease. Of the five severe flares, two required hospitalization. The mean time duration to achieve LLDAS was 6 months. Twenty-seven achieved a steroid-free status and the remaining two patients on 2.5 mg and seventeen were stable on daily 5.0 mg of prednisone. CONCLUSIONS: Using the LLDAS, it was possible to show that the majority of patients receiving belimumab for prolonged periods go into remission steroid-free or in low disease activity in association with the corresponding immunosuppressive treatment. Key Points ⢠Prolonged real-life evaluation confirms the efficacy and steroid-sparing of Belimumab in SLE patients with active disease.
