Belimumab plus standard therapy superior to standard therapy
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A 2-year randomized controlled trial has found that belimumab plus standard therapy is superior to standard therapy alone in patients with lupus nephritis, according to data published in the New England Journal of Medicine. To examine the efficacy and safety of intravenous belimumab (Benlysta, GlaxoSmithKline) plus standard therapy, compared with a placebo, among patients with active lupus nephritis, Furie and colleagues conducted the phase 3 BLISS-LN study, a randomized, double-blind, 104-week trial. Investigators randomly assigned 448 adults with SLE and biopsy-confirmed lupus nephritis — recruited from 107 sites in 21 countries — to receive either 10 mg/kg of belimumab or placebo alongside standard therapy. The efficacy analysis included 223 participants in each group, while the safety analysis featured 224 in each group.

According to the researchers, 43% of patients who received belimumab alongside standard therapy achieved PERR at week 104, compared with 32% of those in the placebo group. In addition, 30% of those in the belimumab group experienced a complete renal response, compared with 20% of those in the placebo group.

Regarding safety, 95.5% of patients in the belimumab, and 94.2% of those in the placebo group, demonstrated one or more adverse event, with 25.9% and 29.9% patients, respectively, developing one or more serious adverse event. The discontinuation rate due to adverse events was 12.9% in both groups, with fatal adverse-event rates of 1.8% in the belimumab group and 1.3% in the placebo group. The risk of renal-related event or death was lower among participants who received belimumab compared with those in the placebo group.