The objective was to systematically review and conduct a meta-analysis of the spontaneous remission percentage in the placebo arm in order to get a better estimation of the needed patients for future clinical trials of biotherapies for systemic erythematosus and nephritis lupus.	Among 180 studies screened, 36 studies were included in the meta-analysis. 16 studies are from phase II, 15 from phase III and 5 of them are also post hoc studies. Most of the studies were evaluated belimumab (anti-BAFF mAb), abatacept (CTLA4-Ig), rituximab (anti-CD20 mAb) and tabalumab (anti-BAFF mAb). Only belimumab met his primary objective and obtained the marketing authorisation in Europe, United States and Canada. Final results will be available at the beginning of 2019. The expected results would show that the spontaneous remission percentage in the controlled arm of selected trials is higher than expected at the start of the studies. The meta-analysis would allow to a better estimation of the effect size and could increase the strength of future trials The needed number of subjects will be consequently more precise for future studies and could lead to more successful trials. Furthermore, it will will play a key role in estimating trial cost.

Meta-analysis of spontaneous remission percentage in placebo arm of biologic agents in randomized controlled trials for lupus

DIA Europe 2019

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