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

Michael G Hanna; Umesh A Badrising; Olivier Benveniste; Thomas E Lloyd; Merrilee Needham; Hector Chinoy; Masashi Aoki; Pedro M Machado; Christina Liang; Katrina A Reardon; Marianne de Visser; Dana P Ascherman; Richard J Barohn; Mazen M Dimachkie; James AL Miller; John T Kissel; Bjoern Oskarsson; Nanette C Joyce; Peter Van den Bergh; Jonathan Baets; Jan L De Bleecker; Chafic Karam; William S David; Massimiliano Mirabella; Sharon P Nations; Hans H Jung; Elena Pegoraro; Lorenzo Maggi; Carmelo Rodolico; Massimiliano Filosto; Aziz Shaibani; Kumaraswamy Sivakumar; Namita A Goyal; Madoka Mori-Yoshimura; Satoshi Yamashita; Naoki Suzuki; Masahisa Katsuno; Kenya Murata; Hiroyuki Nodera; Carla D Romano; Valerie SL Williams; John Vissing; Lixin Zhang Auberson; Min Wu; Ana de Vera; Dimitris A Papanicolaou; Anthony A Amato; Ichizo Nishino

Journal article

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

Michael G Hanna, Umesh A Badrising, Olivier Benveniste, Thomas E Lloyd, Merrilee Needham, Hector Chinoy, Masashi Aoki, Pedro M Machado, Christina Liang, Katrina A Reardon, Marianne de Visser, Dana P Ascherman, Richard J Barohn, Mazen M Dimachkie, James AL Miller, John T Kissel, Bjoern Oskarsson, Nanette C Joyce, Peter Van den Bergh, Jonathan 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..

View full abstract