Ginzler E, Barbosa LSG, D'Cruz D, et al. - Although the primary endpoint was not met, belimumab conferred improvements than placebo, indicating belimumab is an appropriate treatment choice for systemic lupus erythematosus (SLE) management in patients of Black African ancestry.

• A 52-week multicenter, double-blind, placebo-controlled trial (EMBRACE) included adults of self-identified Black race with active SLE who received monthly belimumab 10 mg/kg intravenous, or placebo, plus standard therapy.

• 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, observed numerical improvements favored belimumab, in which higher SRI–SLEDAI-2K response rates were noted in cases treated with belimumab than placebo, especially in SLE cases with high disease activity or renal manifestations at baseline.

• Belimumab’s safety profile was generally consistent with that seen in previous SLE trials.

• The main reasons for double-blind phase withdrawals were adverse events (belimumab 5.4%, placebo 6.7%).