Dataset Information
Long-term safety and efficacy of eculizumab in generalized myasthenia gravis.
Ontology highlight
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
Publications
Long-term safety and efficacy of eculizumab in generalized myasthenia gravis.
Muscle & nerve 20190308 1
<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]