Existing IV Drug Shows Strong Results in Reducing Lupus Symptoms, Clinical Trial Finds
A medication already approved for intravenous use has shown significant potential in reducing symptoms of Systemic Lupus Erythematosus, according to results from a new clinical trial published on March 6 in The New England Journal of Medicine.
Researchers found that more than three-quarters of patients treated with the drug Obinutuzumab, marketed as Gazyva, experienced a notable improvement in disease symptoms after one year of treatment. The therapy also helped extend the time between disease flare-ups and more than doubled the remission rate compared with patients receiving a placebo.
The drug is already approved for treating kidney inflammation caused by lupus, known as Lupus Nephritis. It works by prompting the immune system to target and destroy B-cells, which produce the antibodies responsible for triggering lupus-related immune attacks.
Lead investigator Dr. Richard Alan Furie, chief of rheumatology at Northwell Health in New Hyde Park, New York, described the findings as one of the most promising advances in lupus treatment in recent years.
“The study represents one of the most compelling late-stage successes for patients with systemic lupus erythematosus,” Furie said in a statement. “Targeting B cells appears to significantly reduce disease activity and may allow patients to rely less on steroid treatments.”
Lupus is a chronic autoimmune condition in which the body’s immune system mistakenly attacks its own tissues. The disease most commonly affects the skin and joints but can also damage internal organs such as the kidneys and heart. According to the Lupus Foundation of America, more than three million people worldwide live with the condition, with most diagnoses occurring in women between the ages of 15 and 45.
Repeated disease flare-ups can cause permanent organ damage. Approximately half of lupus patients develop lupus-related kidney disease within five years of diagnosis.
The clinical trial involved more than 300 patients who were already receiving standard lupus therapies. Participants were randomly assigned to receive either Gazyva or a placebo through intravenous infusion on the first day of the trial, with additional doses administered during weeks two, 24 and 26.
After 12 months, 77 percent of patients receiving Gazyva showed significant reductions in disease activity compared with 54 percent in the placebo group. In addition, about 35 percent of those treated with the drug achieved remission, compared with just 14 percent of those given a placebo.
However, researchers noted a slightly higher rate of serious side effects among patients taking the drug—17 percent compared with 14 percent in the placebo group. The most commonly reported complications included pneumonia, upper respiratory infections and urinary tract infections.
One death was reported among patients receiving Gazyva due to pneumonia, while three deaths occurred in the placebo group.
Dr. Levi Garraway, chief medical officer of the Roche Group, which manufactures Gazyva and funded the study, said the results could mark an important step forward for lupus care.
“For decades, people living with systemic lupus erythematosus have faced unpredictable disease activity and limited treatment options,” Garraway said. “These findings show that Gazyva may offer meaningful and sustained disease control, helping prevent serious organ damage.”
Roche said it plans to work with health authorities worldwide to expand access to the treatment for lupus patients if regulatory approvals are granted.
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