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BAFF/BLyS, a pivotal cytokine in B-cell development, survival and proliferation,1 became a trusted target in systemic lupus erythematosus (SLE) more than 15 years ago when the growth factor was shown to be involved in the pathogenesis of both preclinical models and human SLE.2 ,3
Anti-BLyS monoclonal antibody belimumab (BEL) was licensed in 2011 for the treatment of SLE based on the results of the BLISS 52 and 76 phase III trials, which showed superiority compared with placebo, based on the percentage of patients achieving the SLE Responder Index 4 (SRI-4), a composite endpoint requiring (a) a reduction of ≥4 points in SELENA-SLEDAI score, (b) no new British Isles Lupus Assessment Group 2004 (BILAG) index score A or no more than 1 new BILAG B score and (c) no worsening (increase ≥0.3 points from baseline) in Physician's Global Assessment. At week 52, the delta efficacy between BEL and placebo (both on top of standard of care) was 14.0% and 9.7% in favour of the study drug in BLISS 52 and 76, respectively.4 ,5 …