HealthDay News — Weekly belimumab is associated with greater benefit than placebo for patients with hypocomplementemic/anti-double stranded (ds)DNA-positive systemic lupus erythematosus (SLE), according to a study published online in Arthritis & Rheumatology.
Andrea Doria, M.D., from the University of Padua in Italy, and colleagues examined the efficacy and safety of belimumab in a subset of patients with SLE who were hypocomplementemic (C3 and/or C4) and anti-dsDNA-positive at baseline (356 of 836 patients). Patients were randomized to weekly subcutaneous (SC) belimumab or placebo (248 and 108 patients, respectively), plus standard SLE therapy for 52 weeks. SLE Responder Index (SRI4) at week 52 was assessed as the primary end point.
The researchers found that the belimumab group contained more SIR4 responders than the placebo group (64.6 versus 47.2 percent; P = 0.0014), and they had lower incidence of severe SLE Flare Index flare (14.1 versus 31.5 percent). Furthermore, more patients in the belimumab group were able to reduce corticosteroid use by ≥25 percent to ≤7.5 mg/day during weeks 40 to 52 (20.7 versus 11.4 percent; P = 0.0844). The treatment groups had similar adverse events.
“In patients with hypocomplementemic/anti-dsDNA-positive SLE, weekly belimumab 200 mg SC significantly improved SRI4 response, decreased severe flare incidence, and reduced corticosteroid use, versus placebo,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including GlaxoSmithKline, which manufacturers belimumab and funded the study.