Efficacy and Safety of Bimagrumab in Sporadic Inclusion Body Myositis - Archive ouverte HAL
Article Dans Une Revue Neurology Année : 2021

Efficacy and Safety of Bimagrumab in Sporadic Inclusion Body Myositis

Anthony Amato
  • Fonction : Auteur
Umesh Badrising
  • Fonction : Auteur
Hector Chinoy
Thomas Lloyd
  • Fonction : Auteur
Ananda Krishna Karanam
  • Fonction : Auteur
Min Wu
  • Fonction : Auteur
László Tankó
  • Fonction : Auteur
Dimitris Papanicolaou
  • Fonction : Auteur
Christina Liang
  • Fonction : Auteur
Katrina Reardon
  • Fonction : Auteur
Dana Ascherman
  • Fonction : Auteur
Mazen Dimachkie
James A.L. Miller
  • Fonction : Auteur
John Kissel
  • Fonction : Auteur
Björn Oskarsson
Nanette Joyce
  • Fonction : Auteur
Peter van den Bergh
  • Fonction : Auteur
Jonathan Baets
  • Fonction : Auteur
Jan de Bleecker
  • Fonction : Auteur
Chafic Karam
  • Fonction : Auteur
William David
  • Fonction : Auteur
Massimiliano Mirabella
Sharon Nations
  • Fonction : Auteur
Hans Jung
  • Fonction : Auteur
Elena Pegoraro
  • Fonction : Auteur
Lorenzo Maggi
  • Fonction : Auteur
Carmelo Rodolico
  • Fonction : Auteur
Massimiliano Filosto
  • Fonction : Auteur
Aziz Shaibani
  • Fonction : Auteur
Kumaraswamy Sivakumar
  • Fonction : Auteur
Namita Goyal
  • Fonction : Auteur
Madoka Mori-Yoshimura
  • Fonction : Auteur
Satoshi Yamashita
Naoki Suzuki
  • Fonction : Auteur
Masashi Aoki
  • Fonction : Auteur
Masahisa Katsuno
Hirokazu Morihata
  • Fonction : Auteur
Kenya Murata
  • Fonction : Auteur
Hiroyuki Nodera
  • Fonction : Auteur
Ichizo Nishino
Carla Romano
  • Fonction : Auteur
Valerie S.L. Williams
John Vissing
  • Fonction : Auteur
Lixin Zhang Auberson
  • Fonction : Auteur

Résumé

Objective To assess long-term (2 years) effects of bimagrumab in participants with sporadic inclusion body myositis (sIBM). Methods Participants (aged 36–85 years) who completed the core study (RESILIENT [Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients]) were invited to join an extension study. Individuals continued on the same treatment as in the core study (10 mg/kg, 3 mg/kg, 1 mg/kg bimagrumab or matching placebo administered as IV infusions every 4 weeks). The co–primary outcome measures were 6-minute walk distance (6MWD) and safety. Results Between November 2015 and February 2017, 211 participants entered double-blind placebo-controlled period of the extension study. Mean change in 6MWD from baseline was highly variable across treatment groups, but indicated progressive deterioration from weeks 24–104 in all treatment groups. Overall, 91.0% (n = 142) of participants in the pooled bimagrumab group and 89.1% (n = 49) in the placebo group had ≥1 treatment-emergent adverse event (AE). Falls were slightly higher in the bimagrumab 3 mg/kg group vs 10 mg/kg, 1 mg/kg, and placebo groups (69.2% [n = 36 of 52] vs 56.6% [n = 30 of 53], 58.8% [n = 30 of 51], and 61.8% [n = 34 of 55], respectively). The most frequently reported AEs in the pooled bimagrumab group were diarrhea 14.7% (n = 23), involuntary muscle contractions 9.6% (n = 15), and rash 5.1% (n = 8). Incidence of serious AEs was comparable between the pooled bimagrumab and the placebo group (18.6% [n = 29] vs 14.5% [n = 8], respectively). Conclusion Extended treatment with bimagrumab up to 2 years produced a good safety profile and was well-tolerated, but did not provide clinical benefits in terms of improvement in mobility. The extension study was terminated early due to core study not meeting its primary endpoint. Clinical Trial Registration Clinicaltrials.gov identifier NCT02573467 . Classification of Evidence This study provides Class IV evidence that for patients with sIBM, long-term treatment with bimagrumab was safe, well-tolerated, and did not provide meaningful functional benefit. The study is rated Class IV because of the open-label design of extension treatment period 2.

Dates et versions

hal-03830946 , version 1 (26-10-2022)

Identifiants

Citer

Anthony Amato, Michael Hanna, Pedro Machado, Umesh Badrising, Hector Chinoy, et al.. Efficacy and Safety of Bimagrumab in Sporadic Inclusion Body Myositis. Neurology, 2021, 96 (12), pp.e1595-e1607. ⟨10.1212/WNL.0000000000011626⟩. ⟨hal-03830946⟩
99 Consultations
0 Téléchargements

Altmetric

Partager

More