Phase III/IV, randomized, fifty‐two–week study of the efficacy and safety of belimumab in patients of Black African ancestry with systemic lupus erythematosus
Arthritis & Rheumatism — Ginzler E, Barbosa LSG, D'Cruz D, et al. | January 21, 2022
Intravenous (IV) belimumab plus standard therapy was tested for efficacy and safety in patients of self-identified Black race with systemic lupus erythematosus (SLE), findings revealed that although the primary endpoint was not met, belimumab conferred improvements than placebo. This indicates that belimumab continues to be an appropriate therapeutic choice for SLE treatment in patients of Black African ancestry.
In a 52-week multicenter, double-blind, placebo-controlled trial (EMBRACE), adults of self-identified Black race with active SLE who were treated with monthly belimumab 10 mg/kg IV, or placebo, plus standard therapy, were analyzed (n=448 in modified intent-to-treat population).
The primary endpoint was SLE Responder Index (SRI) response rate at week 52 with modified proteinuria scoring adapted from the SLE Disease Activity Index 2000 (SLEDAI-2K) (SRI–SLEDAI-2K).
Primary endpoint was not achieved (belimumab 48.7%, placebo 41.6%; odds ratio 1.40); however, numerical improvements favoring belimumab were noted.
Belimumab was associated with higher SRI–SLEDAI-2K response rates vs placebo, especially in patients with SLE who had high disease activity or renal manifestations at baseline.
A safety profile, generally consistent with that observed in previous SLE trials, was identified for belimumab.
The main reason for double-blind phase withdrawals was adverse events (belimumab 5.4%, placebo 6.7%).