The Food and Drug Administration (FDA) has approved belimumab (Benlysta; GlaxoSmithKline), for the treatment of adults with active lupus nephritis (LN) who are receiving standard therapy.

Belimumab is a B-Lymphocyte stimulator (BLyS)-specific inhibitor already indicated for the treatment of active, autoantibody-positive systemic lupus erythematosus in individuals aged 5 years and over receiving standard therapy.

Approval for the new indication was based on results from the phase 3 ‘BLISS-LN’ study, which included 448 adult patients with LN. Results showed that the belimumab arm met the primary end point with a significantly greater number of patients achieving primary efficacy renal response (PERR) over 2 years compared with placebo (43% vs 32%; odds ratio [95% CI] 1.55 [1.04, 2.32]; P =.0311).

Statistical significance was also found across the major secondary endpoints, which included complete renal response after 2 years, ordinal renal response after 2 years, PERR after 1 year, and the time to death or renal-related event.

Serious infections occurred in 14% of patients with active LN receiving belimumab intraveously, and in 17% of the placebo group. Adverse reactions in over 3% of adults in the belimumab group were consistent with its known safety profile in SLE patients.

Dr Richard Furie, Chief of the Division of Rheumatology and Professor at the Feinstein Institutes for Medical Research at Northwell Health and Lead Investigator of the BLISS-LN study, said, “The data from the BLISS-LN study show that Benlysta added to standard therapy not only increased response rates over two years, but it also prevented worsening of kidney disease in patients with active lupus nephritis compared to standard therapy alone.”

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FDA approves GSK’s BENLYSTA as the first medicine for adult patients with active lupus nephritis in the US. [press release]. London, England: GlaxoSmithKline; December 17, 2020.