We are thrilled to report more great news about a potential new treatment for lupus-related kidney disease (lupus nephritis). Please see our statement below for more information.

Today, GSK announced positive headline results for a two-year clinical trial of Benlysta® (belimumab) for treating lupus-related kidney disease. The phase 3 study met all of its designated endpoints while demonstrating a favorable safety profile. The U.S. Food and Drug Administration (FDA) has already approved Benlysta for use in treating mild to moderate lupus. This new trial specifically examined its effectiveness for treating lupus-related kidney disease. The company news release has more information about the study results.

“This is the second study in as many weeks to report positive results for a potential treatment for lupus nephritis,” said Susan Manzi, MD, MPH, Board Chair and Medical Director for the Lupus Foundation of America and Chair, Allegheny Health Network Medicine Institute and Director, Lupus Center of Excellence. “The results for this trial of Benlysta are the latest in a string of successful outcomes to be reported this year about potential new treatments for lupus. As a lupus clinician-scientist, this is an exciting time for our community."

“I’ve been waiting for treatments that provide a greater reward with less risk ever since being diagnosed with lupus nephritis, and the news today from GSK gives me hope that an effective treatment is on the horizon,” shared Monique Gore-Massy, Lupus Foundation of America advocate living with lupus nephritis. “Today, I take a cocktail of medications to manage my symptoms with an abundance of side effects that are typical from prolonged steroid use. I’m excited for the potential of a better treatment for lupus nephritis — it’s something myself, lupus warriors and family members have dreamed of.”

“People with lupus have reasons for optimism about the future for managing lupus,” said Stevan W. Gibson, President and CEO, Lupus Foundation of America. “The Benlysta trial results demonstrate real progress to secure additional treatment options for lupus-related kidney disease. We're proud of our long-standing collaboration with GSK in the fight against lupus. The Foundation has a strong commitment to supporting all efforts to develop new treatments for lupus, including working with the FDA to improve how potential new treatments are tested and evaluated, and educating people with lupus about the importance of participation in lupus clinical studies. We applaud GSK and the doctors and volunteers who participated in this very important trial of Benlysta."

GSK is on-track for FDA submission during the first half of 2020. We will report additional information to our constituents as it becomes available.

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