SAFETY AND EFFICACY OF BELIMUMAB IN THE TREATMENT OF ADULT IDIOPATHIC INFLAMMATORY MYOSITIS (POLYMYOSITIS AND DERMATOMYOSITIS)
Authors: P. Chadha al.
Intravenous (IV) belimumab was investigated for adult patients with refractory IIM in a 40-week multicenter randomized, double blind, placebo controlled clinical trial with a 24-week open label extension. Refractory IIM was defined as inadequate response/ intolerance to 3 months of glucocorticoids and/or at least one immunosuppressive agent (IS). Numerically higher proportions of patients improved on belimumab vs. standard of care. A higher proportion of patients on belimumab achieved sustained moderate or major total improvement scores at 40 and 64 weeks compared to standard of care. Detected differences were not statistically significant; however, the sample size was small (n=15).
This small study and its encouraging result justifies a larger randomized trial of Belimumab in patients with refractory idiopathic inflammatory myositis (of which there are many).