Richard Furie, MD

Furie shared how Obinutuzumab could enrich the treatment landscape of LN.

Anticipating Obinutuzumab’s Approval for Lupus Nephritis, with Richard Furie, MD

Patients with active lupus nephritis treated with obinutuzumab (Gazya/Gazyvaro) achieved achieving more complete renal responses than those receiving standard therapy alone.

These findings are from the phase 3 REGENCY trial, which has met its primary end point, with 46.4% of patients treated with obinutuzmab achieving complete renal response at 76 weeks compared to 33.1% of people treated with standard therapy alone (adjusted difference, 13.4%; 95% CI, 2.0 to 24.8; 

The data primary investigator Richard Furie, MD, the Marilyn and Barry Rubenstein Chair in Rheumatology and Chief of the Division of Rheumatology at Northwell Health, and colleagues found no unexpected safety signals identified in the trial, but the obinutuzumab group did have a higher incidence of serious adverse events of mainly infections and events related to coronavirus disease 2019, emphasizing the importance of up-to-date vaccinations for this population.

 spoke Furie to learn more about the REGENCY trial and new questions that the findings may have prompted. He stressed that while the benefits of obinutuzumab may not be dramatic, they are clinically meaningful, and compared it to other milestone approvals of belimumab and voclosporin.

“I do think it will get an approval, and I do think people will be using it. We have been using it off label, because it's been approved since 2013 so for a patient with refractory disease, that's our go-to medicine. But we'll use it more extensively than just for that sub population,” Furie said.

Furie's relevant disclosures include Alexion Pharmaceuticals, Amgen, AstraZeneca, Biogen, Bristol-Myers Squibb, Eli Lilly, EMD Serono, galapagos, Genentech, GlaxoSmithKline, Janssen, Kezar Life Sciences. Kyowa Kirin, Kyverna Therapeutics, Merck, Novartis, Remegen, Sanofi, Takeda, and UCB.

Furie RA, Rovin BH, Garg JP. Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis. 

 Published online February 7, 2025. doi:10.1056/NEJMoa2410965

FDA accepts supplemental Biologics License Application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis. News release. Roche. March 5, 2025. Accessed March 17, 2025.

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Furie discussed topline data from the REGENCY trial and key secondary endpoints.

Achieving Complete Renal Response and Reducing Corticosteroid Use in Lupus Nephritis Treatment With Obinutuzmab, with Richard Furie, MD

The phase 3 REGENCY trial met its primary endpoint of achieving more complete renal responses in patients with active lupus nephritis treated with obinutuzumab (Gazya/Gazyvaro) than standard therapy alone, in data published in 

Investigators in the trial, including primary investigator Richard Furie, MD, the Marilyn and Barry Rubenstein Chair in Rheumatology and Chief of the Division of Rheumatology at Northwell Health, found that 46.4% of patients treated with obinutuzmab achieved complete renal response at 76 weeks compared to 33.1% of people treated with standard therapy alone (adjusted difference, 13.4%; 95% CI, 2.0 to 24.8; P = .0232). They found no unexpected safety signals identified in the trial, but the obinutuzumab group did have a higher incidence of serious adverse events of mainly infections and events related to coronavirus disease 2019, underscoring the importance of up-to-date vaccinations for this population.

 spoke Furie to learn more about the REGENCY trial and topline data published. He went over the positive primary and secondary end point week 76 findings and stressed that there are more data to come with the week 104 data. He highlighted a key secondary endpoint that obinutuzumab-treated patients were able to achieve of complete renal response at 1.5 years with the ability to taper prednisone to below or 7.5 milligrams or below for the last 12 weeks of the study, and why reducing corticosteroid exposure is important for patients.

“We've had a love hate relationship since 1948 when compound E or cortisone was discovered. It has definitely transformed our inflammatory diseases and the outcomes for these patients, but there are a lot of potential side effects: increased cardiovascular risk, osteoporosis, cataracts, infections, I mean, the list goes on and on. So, we are always trying to lower the prednisone dose. That's why that is a very key secondary endpoint to see success with,” Furie told 

Furie RA, Rovin BH, Garg JP. Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis.

Furie discussed his experiences in evaluating therapies such as rituximab and now obinutuzumab for lupus nephritis.

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; 

 = .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.

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.

Furie RA, Rovin BH, Garg JP. Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis. 

. Published online February 7, 2025. doi:10.1056/NEJMoa2410965

Richard Furie, MD

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