Identifying B-cell Depleting Agents for Lupus Nephritis, with Richard Furie, MD

Obinutuzumab (Gazya/Gazyvaro) was found to be superior to standard of care therapy alone for achieving a complete renal response in patients with active lupus nephritis, according to results from the phase 3 REGENCY trial.

REGENCY evaluated obinutuzumab for efficacy in patients with active lupus nephritis with a primary endpoint of complete renal response compared with placebo. Investigators found that obinutuzumab was associated with a statistically significant and clinically meaningful improvement in complete renal response, with 46.4% achieving complete renal response at 76 weeks compared to just 33.1% of people treated with standard therapy alone (adjusted difference, 13.4%; 95% CI, 2.0 to 24.8; P = .0232). Investigators pointed out there were no unexpected safety signals identified in the trial, but more serious adverse events, mainly infections and events related to coronavirus disease 2019, occurred among the obinutuzumab group.

HCPLive spoke with primary investigator Richard Furie, MD, the Marilyn and Barry Rubenstein Chair in Rheumatology and Chief of the Division of Rheumatology at Northwell Health, to learn more about obinutuzumab’s use for treating lupus nephritis and other forms of lupus. He shared his experience investigating B-cell depleting agents for lupus, beginning with rituximab and continuing to obinutuzumab.

“I first heard about obinutuzumab probably some 10 years ago, and it was approved for chronic lymphocytic leukemia in 2013, so they had safety data. And the question was, should we do another study, much like LUNAR the rituximab lupus nephritis trial, but with a more potent antibody? And I said, sure, let's do a study. And the condensed version of that whole story with the NOBILITY trial in lupus nephritis… was that it was a positive study,” Furie said.

REFERENCE

Furie RA, Rovin BH, Garg JP. Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis. New England Journal of Medicine. Published online February 7, 2025. doi:10.1056/NEJMoa2410965