Long-term efficacy and safety of eculizumab in Japanese patients with generalized myasthenia gravis: A subgroup analysis of the REGAIN open-label extension study
Jazyk angličtina Země Nizozemsko Médium print-electronic
Typ dokumentu časopisecké články
PubMed
31698177
DOI
10.1016/j.jns.2019.08.004
PII: S0022-510X(19)30340-5
Knihovny.cz E-zdroje
- Klíčová slova
- Eculizumab, Japanese patients, MG-ADL, MG-QoL15, Myasthenia gravis, Open-label extension study,
- MeSH
- Asijci MeSH
- dospělí MeSH
- humanizované monoklonální protilátky škodlivé účinky terapeutické užití MeSH
- inhibitory komplementu škodlivé účinky terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- myasthenia gravis farmakoterapie MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Japonsko MeSH
- Názvy látek
- eculizumab MeSH Prohlížeč
- humanizované monoklonální protilátky MeSH
- inhibitory komplementu MeSH
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.
Alexion Pharmaceuticals Boston MA United States
Department of Neurology Graduate School of Medicine Chiba University Chiba Japan
Department of Neurology Hanamaki General Hospital Hanamaki Japan
Department of Neurology International University of Health and Welfare Tokyo Japan
Department of Neurology Kindai University Hospital Osaka Japan
Department of Neurology Nagasaki University Hospital Nagasaki Japan
Department of Neurology National Hospital Organization Sendai Medical Center Sendai Japan
Department of Neurology Sapporo Medical University Hospital Sapporo Japan