TUESDAY, March 10, 2026 (HealthDay News) -- For patients with systemic lupus erythematosus (SLE), obinutuzumab, a glycoengineered type II anti-CD20 monoclonal antibody, is superior to placebo, according to a study published online March 6 in the New England Journal of Medicine.
Richard A. Furie, M.D., from Northwell in New Hyde Park, New York, and colleagues conducted a phase 3 trial involving adults with active SLE without proliferative or membranous lupus nephritis who were receiving standard therapy. Patients were randomly assigned to receive obinutuzumab (1,000 mg) or placebo on day 1 and weeks 2, 24, and 26 (151 and 152 patients, respectively). A response on the SLE Responder Index 4 (SRI-4) was the primary end point at week 52 in the prespecified analysis.
The researchers found an SRI-4 response in 76.7 and 53.5 percent of patients in the obinutuzumab and placebo groups, respectively, at week 52. In an additional analysis where response status was not affected by nonfatal intercurrent events, the corresponding percentages were 85.4 and 68.5 percent. With respect to all key secondary end points, obinutuzumab was superior to placebo. Adverse events were reported in 88.7 and 81.5 percent of those in the obinutuzumab and placebo groups, respectively, and serious adverse events were reported in 15.9 and 11.9 percent, respectively. During the double-blind period, one patient in the obinutuzumab group and three in the placebo group died.
"These findings complement those of the phase 3 REGENCY trial involving patients with active proliferative lupus nephritis, whereby treatment with obinutuzumab led to clinically meaningful improvements," the authors write.
Several authors disclosed ties to biopharmaceutical companies, including F. Hoffmann La Roche, which manufactures obinutuzumab and funded the study.