Belimumab paediatric trial results ‘consistent with adult studies’

Intravenous belimumab 10mg/kg every four weeks was safe and effective in childhood-onset systemic lupus erythematosus (SLE) say the authors of a phase-2 placebo-controlled trial.
US researchers randomised 93 children between the ages of 5-17 (median 14.5 years, 45% female) to 10mg/kg IV belimumab or placebo every four weeks, plus standard SLE therapy.
At week 52, there were more SLE Responder Index responders with belimumab versus placebo (53% vs 44%), although the results for this primary end point did not achieve statistical significance.
More belimumab patients attained Paediatric Rheumatology International Trials Organisation/American College of Rheumatology responses using alternative definitions of 30 (53% vs 28%) and 50 (60% vs 35%), both statistically significant results.