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Safety and efficacy of intravenous belimumab in children with systemic lupus erythematosus: Results from a randomised, placebo-controlled trial

Annals of Rheumatic Diseases Jul 26, 2020

Brunner HI, Abud-Mendoza C, Viola DO, et al. - Researchers conducted ongoing Phase-2, randomized, placebo-controlled, double-blind study to analyze the efficacy, safety, and pharmacokinetics of intravenous belimumab in childhood-onset systemic lupus erythematosus (cSLE). They randomized patients (5 to 17 years) to belimumab 10 mg/kg intravenous or placebo every 4 weeks, plus standard SLE therapy. Researchers randomized a total of 93 patients (belimumab, n=53; placebo, n=40). It was reported that in cSLE, the belimumab intravenous pharmacokinetics and benefit-risk profile are consistent with adult belimumab studies, and the 10 mg/kg every 4 weeks dose is appropriate.

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