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Long-term safety and efficacy of eculizumab in generalized myasthenia gravis.


ABSTRACT:

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?DiscussionThese findings provide evidence for the long-term safety and sustained efficacy of eculizumab for refractory gMG. Muscle Nerve 2019.

SUBMITTER: Muppidi S 

PROVIDER: S-EPMC6619057 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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<h4>Introduction</h4>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.<h4>Methods</h4>Eculizumab (1,200 mg every 2 weeks for 22.7 months [median]) was administered to 117 patients.<h4>Results</h4>The safety profile of eculizumab was consistent with REGA  ...[more]

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