Journal article
Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study
Lancet neurology, Vol.16(12), pp.976-986
12/2017
DOI: 10.1016/S1474-4422(17)30369-1
PMID: 29066163
Abstract
Complement is likely to have a role in refractory generalised myasthenia gravis, but no approved therapies specifically target this system. Results from a phase 2 study suggested that eculizumab, a terminal complement inhibitor, produced clinically meaningful improvements in patients with anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis. We further assessed the efficacy and safety of eculizumab in this patient population in a phase 3 trial.
Details
- Title: Subtitle
- Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study
- Creators
- James F Howard Jr - Department of Neurology, University of North Carolina, Chapel Hill, NC, USA. Electronic address: howardj@neurology.unc.eduKimiaki Utsugisawa - Department of Neurology, Hanamaki General Hospital, Hanamaki, JapanMichael Benatar - Department of Neurology, University of Miami Miller School of Medicine, Miami, FL, USAHiroyuki Murai - Department of Neurology, International University of Health and Welfare, Narita, JapanRichard J Barohn - Department of Neurology, University of Kansas Medical Center, Kansas City, KA, USAIsabel Illa - Neurology Department, Hospital Sant Pau, Universitat Autònoma Barcelona, Barcelona, SpainSaiju Jacob - Queen Elizabeth Neuroscience Centre, Wellcome Trust Clinical Research Facility, University Hospitals of Birmingham, Birmingham, UKJohn Vissing - Rigshospitalet, Department of Neurology, University of Copenhagen, Copenhagen, DenmarkTed M Burns - Department of Neurology, University of Virginia Health System, Charlottesville, VA, USAJohn T Kissel - Department of Neurology, Ohio State University, Columbus, OH, USASrikanth Muppidi - Department of Neurology and Neurosciences, Stanford University School of Medicine, Stanford, CA, USARichard J Nowak - Department of Neurology, Yale University School of Medicine, New Haven, CT, USAFanny O'Brien - Alexion Pharmaceuticals, New Haven, CT, USAJing-Jing Wang - Alexion Pharmaceuticals, New Haven, CT, USARenato Mantegazza - Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, ItalyREGAIN Study Group
- Contributors
- Laurie Gutmann (Contributor) - University of Iowa, Neurology
- Resource Type
- Journal article
- Publication Details
- Lancet neurology, Vol.16(12), pp.976-986
- DOI
- 10.1016/S1474-4422(17)30369-1
- PMID
- 29066163
- NLM abbreviation
- Lancet Neurol
- ISSN
- 1474-4422
- eISSN
- 1474-4465
- Publisher
- England
- Grant note
- DOI: 10.13039/100000065, name: National Institute of Neurological Disorders and Stroke; DOI: 10.13039/100006396, name: Alexion Pharmaceuticals; DOI: 10.13039/100000002, name: National Institutes of Health; DOI: 10.13039/100000030, name: Centers for Disease Control and Prevention
- Language
- English
- Date published
- 12/2017
- Academic Unit
- Neurology
- Record Identifier
- 9984013164702771
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