Obinutuzumab Efficacious for Renal Response in Lupus Nephritis
By Elana Gotkine HealthDay Reporter
WEDNESDAY, Feb. 26, 2025 -- For patients with active lupus nephritis, obinutuzumab, a humanized type II anti-CD20 monoclonal antibody plus standard therapy is more efficacious for providing a complete renal response than standard therapy alone, according to a study published online Feb. 7 in the New England Journal of Medicine. The research was published to coincide with the International Society of Nephrology annual World Congress of Nephrology, held from Feb. 6 to 9 in New Delhi.
Richard A. Furie, M.D., from Northwell Health in Great Neck, New York, and colleagues randomly assigned adults with biopsy-proven active lupus nephritis to receive obinutuzumab in one of two dose schedules or placebo (135 and 136 participants, respectively). In addition, all patients received standard therapy with mycophenolate mofetil plus oral prednisone. The primary end point was a complete renal response at week 76, defined by a urinary protein-to-creatinine ratio of less than 0.5, an estimated glomerular filtration rate of at least 85 percent of the baseline value, and no intercurrent event.
The researchers found that 46.4 and 33.1 percent of patients in the obinutuzumab and placebo groups had a complete renal response at week 76. More patients in the obinutuzumab group than the placebo group had a complete renal response at week 76 with a prednisone dose of 7.5 mg per day or lower between weeks 64 and 76 (42.7 versus 30.9 percent). A urinary protein-to-creatinine ratio lower than 0.8 without an intercurrent event was more common in the obinutuzumab group than the placebo group (55.5 versus 41.9 percent). There were no unexpected safety signals noted. More serious adverse events occurred with obinutuzumab than with placebo, and the adverse events reported were mainly infections and events related to COVID-19.
"These findings, and those from the NOBILITY trial, support the hypothesis that deep B-cell depletion with obinutuzumab is an effective treatment for patients with lupus nephritis," the authors write.
Several authors disclosed ties to biopharmaceutical companies, including F. Hoffmann-La Roche, which manufactures obinutuzumab and funded the study.
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Posted February 2025
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