Obinutuzumab

TUESDAY, March 10, 2026 -- 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. Abstract/Full Text (subscription or payment may be required)

TUESDAY, March 10, 2026 — An already-approved IV drug significantly reduces the symptoms of lupus , a new clinical trial showed. More than three-quarters of lupus patients taking obinutuzumab ( Gazvya ) had a significant improvement in their symptoms after a year on the drug, researchers reported March 6 in The New England Journal of Medicine . The drug also improved time between lupus flares, and had a more than doubled remission rate compared to placebo, researchers said. Gazvya already is approved to treat lupus-caused kidney inflammation. The drug prompts the immune system to attack and destroy B-cells, which produce the antibodies that cause lupus. The clinical trial “represents one of the most compelling late-stage successes in years for the treatment of patients with systemic lupus erythematosus (SLE), showing important evidence that targeting B cells can deliver significant reductions in disease activity,” said lead researcher Dr. Richard Furie , chief of rheumatology at Northwell Health in New Hyde Park, New York. “We are seeing the potential to deliver more robust and sustained disease control with less reliance on steroids,” Furie said in a news release. “These benefits matter profoundly to patients, physicians and families, marking Gazyva as an important step forward in the treatment of this autoimmune disease.” Lupus is a chronic autoimmune disease that causes the immune system to turn on the body, attacking primarily the skin, joints and internal organs like the kidneys or the heart, according to the Lupus Foundation of America. Lupus affects more than 3 million people worldwide, mostly women diagnosed between ages 15 and 45, researchers said in background notes. Frequent lupus flares can cause irreversible organ damage. About half of lupus patients develop lupus nephritis – the kidney complication for which Gazvya is approved – within five years of diagnosis. For the new study, researchers recruited more than 300 patients with lupus receiving standard therapy for the disease, and randomly assigned half to take Gazvya and the rest a placebo. The patients received IV infusions of either Gazvya or a placebo on day one of the trial, followed with repeat doses at weeks two, 24 and 26. After a year, 77% of patients with Gazvya had a significant reduction in their lupus, compared with 54% of those on placebo. About 35% of those on Gazvya went into remission, compared with 14% of those on placebo, results showed. Patients taking Gazvya had a higher rate of serious side effects, 17% versus 14%, researchers found. The most common adverse events were pneumonia, upper respiratory tract infection and urinary tract infection, researchers reported. One death occurred among the Gazvya patients, and three deaths among patients on placebo. The Gazvya death involved pneumonia. “For decades, people living with SLE have faced a cycle of unpredictable disease activity, limited treatment options and long-term steroid burden,” Dr. Levi Garraway , chief medical officer for the Roche Group, said in a news release. The Roche Group makes Gazvya and funded the clinical trial. “These results … show that Gazyva can provide significant, clinically meaningful and sustained disease control, which is critical to preventing life-threatening damage to major organs,” Garraway said. “We look forward to working with health authorities around the world to bring this potentially transformative new treatment to patients with lupus as quickly as possible.” Sources Roche Group, news release, March 6, 2026 The New England Journal of Medicine, March 6, 2026