Muscle & nerve · 2019
Long-term safety and efficacy of eculizumab in generalized myasthenia gravis.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Muppidi Srikanth, Utsugisawa Kimiaki, Benatar Michael, Murai Hiroyuki, Barohn Richard J, Illa Isabel, Jacob Saiju, Vissing John, Burns Ted M, Kissel John T, Nowak Richard J, Andersen Henning, Casasnovas Carlos, de Bleecker Jan L, Vu Tuan H, Mantegazza Renato, O'Brien Fanny L, Wang Jing Jing, Fujita Kenji P, Howard James F, Regain Study Group
Аннотация
INTRODUCTION: Eculizumab is effective and well tolerated in patients with antiacetylcholine receptor antibody-positive refractory generalized myasthenia gravis (gMG; REGAIN; NCT01997229). We report an interim analysis of an open-label extension of REGAIN, evaluating eculizumab's long-term safety and efficacy.
METHODS: Eculizumab (1,200 mg every 2 weeks for 22.7 months [median]) was administered to 117 patients.
RESULTS: The safety profile of eculizumab was consistent with REGAIN; no cases of meningococcal infection were reported during the interim analysis period. Myasthenia gravis exacerbation rate was reduced by 75% from the year before REGAIN (P < 0.0001). Improvements with eculizumab in activities of daily living, muscle strength, functional ability, and quality of life in REGAIN were maintained through 3 years; 56% of patients achieved minimal manifestations or pharmacological remission. Patients who had received placebo during REGAIN experienced rapid and sustained improvements during open-label eculizumab (P < 0.0001).
DISCUSSION: These findings provide evidence for the long-term safety and sustained efficacy of eculizumab for refractory gMG. Muscle Nerve 2019.
METHODS: Eculizumab (1,200 mg every 2 weeks for 22.7 months [median]) was administered to 117 patients.
RESULTS: The safety profile of eculizumab was consistent with REGAIN; no cases of meningococcal infection were reported during the interim analysis period. Myasthenia gravis exacerbation rate was reduced by 75% from the year before REGAIN (P < 0.0001). Improvements with eculizumab in activities of daily living, muscle strength, functional ability, and quality of life in REGAIN were maintained through 3 years; 56% of patients achieved minimal manifestations or pharmacological remission. Patients who had received placebo during REGAIN experienced rapid and sustained improvements during open-label eculizumab (P < 0.0001).
DISCUSSION: These findings provide evidence for the long-term safety and sustained efficacy of eculizumab for refractory gMG. Muscle Nerve 2019.
Предметные рубрики MeSH
Activities of Daily LivingAdultAngioedemaAntibodies, Monoclonal, HumanizedAspergillosisComplement Inactivating AgentsDisease ProgressionFemaleHeart DiseasesHumansInjection Site ReactionLongitudinal StudiesMaleMeningococcal InfectionsMeningococcal VaccinesMiddle AgedMuscle StrengthMyasthenia GravisQuality of LifeTreatment Outcome