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 is already approved to treat lupus-related 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 by repeat doses at weeks two, 24, and 26.
After a year, 77 percent of patients with Gazvya had a significant reduction in their lupus, compared with 54 percent of those on placebo.
About 35 percent of those on Gazvya went into remission, compared with 14 percent of those on placebo, results showed.
Patients taking Gazvya had a higher rate of serious side effects, 17 percent versus 14 percent, 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.”
The findings from the clinical trial are especially important for Black patients, who continue to experience disproportionately high rates of systemic lupus erythematosus (SLE) and lupus-related complications. Black women are estimated to develop lupus at rates up to three times higher than white women and are more likely to experience earlier onset, greater disease severity, and higher rates of organ damage, particularly lupus nephritis.
Research also shows that Black patients with lupus have higher hospitalization and mortality rates, often driven by delayed diagnosis, barriers to specialty care, and inequities in treatment access. Socioeconomic factors, insurance limitations, and gaps in culturally responsive healthcare can further complicate disease management and contribute to worse long-term outcomes.
For clinicians, the emergence of additional biologic treatments may present an opportunity to improve disease control in populations who have a higher risk of developing severe lupus complications.
Despite the disproportionate impact of the chronic condition in Black communities, racial and ethnic minority populations remain underrepresented in many autoimmune disease clinical trials. This lack of representation continues to raise concerns about the generalizability of trial findings and whether therapies are being adequately evaluated in the populations most affected by lupus.
Diversifying lupus research remains critical for advancing equitable care. Providers play a crucial role in increasing clinical trial participation through patient education, community engagement, and referral to the appropriate research opportunities.
As more therapies emerge for lupus management, ensuring equitable access to both clinical trials and newly approved treatments will remain an important part of reducing disparities in autoimmune disease outcomes.
The latest findings on obinutuzumab add to the growing momentum in lupus treatment, especially as providers seek more effective steroid-sparing therapies for patients with moderate to severe disease. For Black patients, who continue to face disproportionately high rates of lupus complications, delayed diagnosis, and barriers to specialty care, expanding targeted treatment options could help improve long-term outcomes and quality of life.
More information
The Lupus Foundation of America has more on lupus.
SOURCES: Roche Group, news release, March 6, 2026; The New England Journal of Medicine, March 6, 2026
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