Rinsho Shinkeigaku (Clinical Neurology)

Original Article

Late phase II/III study of BYM338 in patients with sporadic inclusion body myositis (RESILIENT): Japanese cohort data

Madoka Mori-Yoshimura, M.D., Ph.D.1), Satoshi Yamashita, M.D., Ph.D.2), Naoki Suzuki, M.D., Ph.D.3), Masahisa Katsuno, M.D., Ph.D.4), Kenya Murata, M.D., Ph.D.5), Hiroyuki Nodera, M.D.6), Rie Teshima7), Tatsumi Inamura7), Ichizo Nishino, M.D., Ph.D.8) and Masashi Aoki, M.D., Ph.D.3)

1)Department of Neurology, National Center Hospital, National Center of Neurology and Psychiatry
2)Department of Neurology, Kumamoto University Hospital
3)Department of Neurology, Tohoku University Hospital
4)Department of Neurology, Nagoya University Hospital
5)Department of Neurology, Wakayama Medical University Hospital
6)Department of Neurology, Tokushima University Hospital
7)Development Division, Novartis Pharma K.K.
8)Department of Neuromuscular Research, National Institute of Neuroscience, National Center of Neurology and Psychiatry

A global, randomized, double-blind placebo-controlled study was conducted to confirm that BYM338 (bimagrumab), an anti-activin type II receptor antibody, improves motor function in patients with sporadic inclusion body myositis after 52 weeks' treatment consisting of intravenous administration every 4 weeks at doses of 10, 3, and 1 mg/kg. In a Japanese sub-population (20 patients in total, 5 per dose group), no significant differences in the change from baseline of the 6-minute walking distance at Week 52 (primary endpoint) were observed between the placebo group and each BYM338 dose group. Furthermore, the lean body mass as an indicator of skeletal muscle mass increased in all BYM338 groups compared with the placebo group and the effects were dose-dependent. Overall, the Japanese sub-population showed similar trends as observed in the entire population (251 patients in total).
Full Text of this Article in Japanese PDF (613K)

(CLINICA NEUROL, 59: 806|813, 2019)
key words: sporadic inclusion body myositis, BYM338, bimagrumab, activin type II receptor, phase III

(Received: 24-Mar-19)