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

The approval is based on results from the 104-week randomized, placebo-controlled BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) study, the largest and longest phase 3 trial conducted in active LN. The study, which included 448 patients, met its primary end point showing that a significantly greater proportion of patients treated with belimumab plus standard therapy achieved the primary efficacy renal response (PERR) at 104 weeks compared with placebo plus standard therapy (43% vs 32%). Belimumab treatment was significantly associated with 1.5-fold increased odds of achieving the PERR compared with placebo.

“The overarching goal in the management of patients with lupus nephritis is to delay the need for kidney replacement therapies, such as dialysis and transplantation,” Brad Rovin, MD, director of the Division of Nephrology and medical director of the Center for Clinical Research Management at the Ohio State University Wexner Medical Center in Columbus, said in a GlaxoSmithKline press release.

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Besides showing that the addition of belimumab to standard therapy significantly increased the PERR, the trial demonstrated that patients had a 49% decreased risk for renal-related events. “I’m encouraged by the progress we’re making in lupus nephritis,” he said.

“The FDA’s approval of Benlysta for lupus nephritis represents an important milestone in treating one of the most serious consequences of lupus,” Stevan W. Gibson, president and CEO of the Lupus Foundation of America, said in a press release issued by the foundation.

Noting that end-stage kidney disease or kidney failure will develop in 10% to 30% of patients with LN, Gibson said effective treatment “can greatly improve health outcomes and reduce the long-term costs associated with managing lupus-related kidney disease.”


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