MONDAY, Dec. 5 (HealthDay News) -- For patients with systemic lupus erythematosus (SLE) receiving standard therapy, belimumab is well tolerated and significantly improves the SLE Responder Index (SRI) response rate, according to a study published in the December issue of Arthritis & Rheumatism.
Richard Furie, M.D., from the North Shore-Long Island Jewish Health System in Lake Success, N.Y., and colleagues compared the safety and efficacy of belimumab with placebo in 819 patients with active SLE receiving standard therapy. Participants had a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) version of the SLE Disease Activity Index (SLEDAI) score of ≥6. They were randomized to receive either 1 or 10 mg/kg belimumab or placebo for 72 weeks. The SRI response rate at week 52 was the primary efficacy end point.
The investigators found that the primary efficacy end point was met with belimumab 10 mg/kg plus standard therapy, which generated a significantly greater week-52 SRI response rate than placebo (43.2 versus 33.5 percent). This rate was 40.6 percent (P = 0.089) for belimumab 1 mg/kg. At week 76, the placebo, 1 mg/kg belimumab, and 10 mg/kg belimumab groups had response rates of 32.4, 39.1, and 38.5 percent, respectively. Belimumab 10 mg/kg showed better discrimination at weeks 52 and 76 during post hoc sensitivity analyses of higher SELENA-SLEDAI score thresholds. Belimumab at 1 and 10 mg/kg showed reduced severe flare risk over 76 weeks (34 percent [P = 0.023] and 23 percent [P = 0.13], respectively). All groups had comparable serious and severe adverse events.
"Belimumab plus standard therapy significantly improved SRI response rate," the authors write.
Several authors disclosed financial relationships with pharmaceutical companies, including Human Genome Sciences and GlaxoSmithKline, both of which funded the study and manufacture belimumab.
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