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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.
Murai, Hiroyuki; Uzawa, Akiyuki; Suzuki, Yasushi; Imai, Tomihiro; Shiraishi, Hirokazu; Suzuki, Hidekazu; Okumura, Meinoshin; O'Brien, Fanny; Wang, Jing-Jing; Fujita, Kenji P; Utsugisawa, Kimiaki.
Afiliação
  • Murai H; Department of Neurology, International University of Health and Welfare, Tokyo, Japan. Electronic address: murai@iuhw.ac.jp.
  • Uzawa A; Department of Neurology, Graduate School of Medicine, Chiba University, Chiba, Japan. Electronic address: auzawa@chiba-u.jp.
  • Suzuki Y; Department of Neurology, National Hospital Organization Sendai Medical Center, Sendai, Japan.
  • Imai T; Department of Neurology, Sapporo Medical University Hospital, Sapporo, Japan. Electronic address: toimai@sapmed.ac.jp.
  • Shiraishi H; Department of Neurology, Nagasaki University Hospital, Nagasaki, Japan.
  • Suzuki H; Department of Neurology, Kindai University Hospital, Osaka, Japan.
  • Okumura M; Osaka Toneyama Medical Center, Toyonaka, Japan. Electronic address: meinosin@toneyama.go.jp.
  • O'Brien F; Alexion Pharmaceuticals, Boston, MA, United States. Electronic address: fanny.obrien@alexion.com.
  • Wang JJ; Formerly of Alexion Pharmaceuticals, Boston, MA, United States.
  • Fujita KP; Formerly of Alexion Pharmaceuticals, Boston, MA, United States.
  • Utsugisawa K; Department of Neurology, Hanamaki General Hospital, Hanamaki, Japan. Electronic address: kutsugi@s4.dion.ne.jp.
J Neurol Sci ; 407: 116419, 2019 Dec 15.
Article em En | MEDLINE | ID: mdl-31698177
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Inativadores do Complemento / Anticorpos Monoclonais Humanizados / Miastenia Gravis Tipo de estudo: Clinical_trials Limite: Adult / Aged / Female / Humans / Male / Middle aged País/Região como assunto: Asia Idioma: En Revista: J Neurol Sci Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Inativadores do Complemento / Anticorpos Monoclonais Humanizados / Miastenia Gravis Tipo de estudo: Clinical_trials Limite: Adult / Aged / Female / Humans / Male / Middle aged País/Região como assunto: Asia Idioma: En Revista: J Neurol Sci Ano de publicação: 2019 Tipo de documento: Article