Safety and efficacy of intravenous bimagrumab in inclusion body myositis (RESILIENT): a randomised, double-blind, placebo-controlled phase 2b trial

MG Hanna; UA Badrising; O Benveniste; TE Lloyd; M Needham; H Chinoy; M Aoki; PM Machado; C Liang; KA Reardon; M de Visser; DP Ascherman; RJ Barohn; MM Dimachkie; JAL Miller; JT Kissel; B Oskarsson; NC Joyce; P Van den Bergh; J Baets; JL De Bleecker; C Karam; WS David; M Mirabella; SP Nations; HH Jung; E Pegoraro; L Maggi; C Rodolico; M Filosto; AI Shaibani; K Sivakumar; NA Goyal; M Mori-Yoshimura; S Yamashita; N Suzuki; M Katsuno; K Murata; H Nodera; I Nishino; CD Romano; VSL Williams; J Vissing; LZ Auberson; M Wu; A de Vera; DA Papanicolaou; AA Amato

Journal article

Safety and efficacy of intravenous bimagrumab in inclusion body myositis (RESILIENT): a randomised, double-blind, placebo-controlled phase 2b trial

MG Hanna, UA Badrising, O Benveniste, TE Lloyd, M Needham, H Chinoy, M Aoki, PM Machado, C Liang, KA Reardon, M de Visser, DP Ascherman, RJ Barohn, MM Dimachkie, JAL Miller, JT Kissel, B Oskarsson, NC Joyce, P Van den Bergh, J Baets Show all

Lancet Neurology | ELSEVIER SCIENCE INC | Published : 2019

DOI: 10.1016/S1474-4422(19)30200-5

Abstract

Background: Inclusion body myositis is an idiopathic inflammatory myopathy and the most common myopathy affecting people older than 50 years. To date, there are no effective drug treatments. We aimed to assess the safety, efficacy, and tolerability of bimagrumab—a fully human monoclonal antibody—in individuals with inclusion body myositis. Methods: We did a multicentre, double-blind, placebo-controlled study (RESILIENT) at 38 academic clinical sites in Australia, Europe, Japan, and the USA. Individuals (aged 36–85 years) were eligible for the study if they met modified 2010 Medical Research Council criteria for inclusion body myositis. We randomly assigned participants (1:1:1:1) using a bloc..

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