HealthDay News — The addition of belimumab vs placebo to standard therapy increases the likelihood of a primary efficacy renal response in patients with active lupus nephritis, according to a study published in the New England Journal of Medicine.
Richard Furie, MD, from Northwell Health and the Feinstein Institutes for Medical Research in Great Neck, New York, and colleagues conducted a 104-week trial at 107 sites in 21 countries involving adults with biopsy-proven, active lupus nephritis. A total of 448 participants were randomly assigned to receive either intravenous belimumab or matching placebo in addition to standard therapy in a 1:1 ratio.
The researchers found that significantly more patients in the belimumab vs placebo group had a primary efficacy renal response (43% vs 32%; odds ratio, 1.6; 95% confidence interval, 1.0 to 2.3; P =.03) and a complete renal response (30% vs 20%; odds ratio, 1.7; 95% confidence interval, 1.1 to 2.7; P =.02) at week 104. Compared with those who received placebo, patients who received belimumab had a lower risk for a renal-related event or death (hazard ratio, 0.51; 95% confidence interval, 0.34 to 0.77; P =.001).
“This history-making clinical trial is the first successful study after decades of attempts with other lupus nephritis therapies,” Furie said in a statement. “This trial will hopefully lead to the US Food and Drug Administration’s approval to extend belimumab’s use to lupus nephritis, which represents the greatest unmet need for patients with systemic lupus erythematosus.”
Several authors disclosed financial ties to pharmaceutical companies, including GlaxoSmithKline, which manufactures belimumab and funded the study.