Rooks, Daniel, Swan, Therese, Filosa, Lee Anne, Bunte, Ola, Panchaud, Nicolas, Coleman, Laura, Miller, Ram, Garcia Garayoa, Elisa, Praestgaard, Jens, Laurent, Didier, Petricoul, Olivier, Trifilieff, Estelle, Papanicolaou, Dimitris and Roubenoff, Ronenn (2020) Bimagrumab for treatment of sarcopenia in community-dwelling older adults: a phase II, randomized, controlled trial. JAMA Network Open, 3 (10). ISSN 2574-3805

Abstract

Background: The potential benefit of novel skeletal muscle anabolic agents to improve physical function in people with sarcopenia and other muscle wasting diseases is unknown.
Objective: To confirm the safety and efficacy of bimagrumab on skeletal muscle mass, strength, and physical function in community-dwelling older adults with sarcopenia.
Design: Randomized, double-blind, placebo-controlled.
Setting: 38 sites in 13 countries.
Participants: 180 community-dwelling, men and women aged ≥70 years meeting gait speed and skeletal muscle criteria for sarcopenia.
Intervention: Bimagrumab 700 mg (n=113) or placebo (n=67) monthly for 6-months with appropriate diet and home-based exercise.
Measurements: Short Physical Performance Battery (SPPB), 6-minute walk distance (6MWD), gait speed, handgrip strength, total lean body mass (LBM), and standard safety parameters.
Results: 159/180 (88.3%) participants (mean age: 79.1 years; 60.6% women) completed the study. Bimagrumab was safe, well-tolerated and increased LBM by 6.0% over placebo (P<0.001). The mean SPPB score increased by 1.34 (0.90–1.77, mean, 95%CI) with bimagrumab versus 1.03 (0.53–1.52) with placebo (P=0.134); 6MWD increased by 24.60 m (7.65–41.56 m) versus 14.30 m (−4.64–33.23 m; P=0.163); and gait speed increased by 0.14 m/s (0.09–0.18 m/s) versus 0.11 m/s (0.05–0.16 m/s; P=0.161). Handgrip strength did not change.
Limitation: Powered only for key functional endpoints.
Conclusion: Bimagrumab treatment over 6-months was safe, well-tolerated and increased LBM in community-dwelling older adults with sarcopenia. Appropriate nutrition and exercise improved physical performance in this vulnerable population; bimagrumab did not significantly enhance this effect. At the completion of the study, a majority of participants in both treatment groups no longer met sarcopenia criteria. Sarcopenia, an increasing cause of disability in the elderly, is reversible with proper diet and exercise.
ClinicalTrials.gov identifier: NCT02333331
Keywords: bimagrumab; sarcopenia; muscle; lean body mass; SPPB; gait speed;
6-minute walk test

Item Type:	Article
Keywords:	bimagrumab; sarcopenia; muscle; lean body mass; SPPB; gait speed; 6-minute walk test
Date Deposited:	24 Nov 2020 00:45
Last Modified:	24 Nov 2020 00:45
URI:	https://oak.novartis.com/id/eprint/41948