Belimumab in Idiopathic Inflammatory Myositis

Summary

The goal of the trial is to evaluate the efficacy and safety of belimumab as a maintenance therapy in adults with refractory Idiopathic inflammatory myositis (IIM) as compared with standard of care. This is a multicentre double-blind, placebo-controlled trial.

Timeline

Start

2015-01

Primary completion

2020-11

Completion

2020-11

Outcome

Missed primary endpoint

paper The study did not meet the primary endpoint and no statistically significant differences were observed in clinical responses between arms. PMID 37326854 ↗

registry p = 0.60; Risk Ratio (RR) 0.5 (95% CI 0.08 to 2.65); ANOVA NCT02347891 ↗

registry p = 0.92; ANOVA NCT02347891 ↗

Publications

• Marder G, Quach T, Chadha P, Nandkumar P, Tsang J, Levine T, Schiopu E, Furie R, Davidson A, Narain S. Belimumab treatment of adult idiopathic inflammatory myopathy. Rheumatology (Oxford). 2024 Mar 1;63(3):742-750. doi: 10.1093/rheumatology/kead281.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Belimumab	Monoclonal antibody	10 mg/kg	Intravenous

Indications