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Long-term efficacy and safety of eculizumab in Japanese patients with generalized myasthenia gravis: A subgroup analysis of the REGAIN open-label extension study

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

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  • Hiroyuki Murai
  • Akiyuki Uzawa
  • Yasushi Suzuki
  • Tomihiro Imai
  • Hirokazu Shiraishi
  • Hidekazu Suzuki
  • Meinoshin Okumura
  • Fanny O'Brien
  • Jing-Jing Wang
  • Kenji P Fujita
  • Kimiaki Utsugisawa
  • REGAIN Study Group
  • John Vissing (Medlem af forfattergruppering)
Vis graf over relationer

The terminal complement inhibitor eculizumab was shown to improve myasthenia gravis-related symptoms in the 26-week, phase 3, randomized, double-blind, placebo-controlled REGAIN study (NCT01997229). In this 52-week sub-analysis of the open-label extension of REGAIN (NCT02301624), eculizumab's efficacy and safety were assessed in 11 Japanese and 88 Caucasian patients with anti-acetylcholine receptor antibody-positive refractory generalized myasthenia gravis. For patients who had received placebo during REGAIN, treatment with open-label eculizumab resulted in generally similar outcomes in the Japanese and Caucasian populations. Rapid improvements were maintained for 52 weeks, assessed by change in score from open-label extension baseline to week 52 (mean [standard error]) using the following scales (in Japanese and Caucasian patients, respectively): Myasthenia Gravis Activities of Daily Living (-2.4 [1.34] and - 3.3 [0.65]); Quantitative Myasthenia Gravis (-2.9 [1.98] and - 4.3 [0.79]); Myasthenia Gravis Composite (-4.5 [2.63] and - 4.9 [1.19]); and Myasthenia Gravis Quality of Life 15-item questionnaire (-8.6 [5.68] and - 6.5 [1.93]). Overall, the safety of eculizumab was consistent with its known safety profile. In this interim sub-analysis, the efficacy and safety of eculizumab in Japanese and Caucasian patients were generally similar, and consistent with the overall REGAIN population.

OriginalsprogEngelsk
TidsskriftJournal of the Neurological Sciences
Vol/bind407
Sider (fra-til)e116419
ISSN0022-510X
DOI
StatusUdgivet - 15 dec. 2019

Bibliografisk note

Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.

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