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 New England Journal of Medicine earlier this month.

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.

HCPLive® 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 HCPLive.

REFERENCE

Furie RA, Rovin BH, Garg JP. Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis. N Eng J Med. Published online February 7, 2025. doi:10.1056/NEJMoa2410965