Journal article
Eculizumab improves fatigue in refractory generalized myasthenia gravis
Quality of life research, Vol.28(8), pp.2247-2254
08/15/2019
DOI: 10.1007/s11136-019-02148-2
PMCID: PMC6620379
PMID: 30905021
Abstract
To evaluate the effect of eculizumab on perceived fatigue in patients with anti-acetylcholine receptor antibody-positive, refractory, generalized myasthenia gravis (MG) using the Quality of Life in Neurological Disorders (Neuro-QOL) Fatigue subscale, and to evaluate correlations between improvements in Neuro-QOL Fatigue and other clinical endpoints.Neuro-QOL Fatigue, MG Activities of Daily Living (MG-ADL), Quantitative MG (QMG), and the 15-item MG Quality of Life (MG-QOL15) scales were administered during the phase 3, randomized, placebo-controlled REGAIN study (eculizumab, n = 62; placebo, n = 63) and subsequent open-label extension (OLE). Data were analyzed using repeated-measures models. Correlations between changes in Neuro-QOL Fatigue and in MG-ADL, QMG, and MG-QOL15 scores were determined at REGAIN week 26.At REGAIN week 26, eculizumab-treated patients showed significantly greater improvements in Neuro-QOL Fatigue scores than placebo-treated patients (consistent with improvements in MG-ADL, QMG, and MG-QOL15 scores previously reported in REGAIN). Improvements with eculizumab were sustained through OLE week 52. Correlations between Neuro-QOL Fatigue and MG-QOL15, MG-ADL, and QMG scores were strong for eculizumab-treated patients at REGAIN week 26, and strong, moderate, and weak, respectively, for placebo-treated patients.Compared with placebo, eculizumab was associated with improvements in perceived fatigue that strongly correlated with improvements in MG-specific outcome measures.
Details
- Title: Subtitle
- Eculizumab improves fatigue in refractory generalized myasthenia gravis
- Creators
- Henning Andersen - 0000 0004 0512 597X grid.154185.c Department of Neurology Aarhus University Hospital Indgang J, Plan 5, Krydspunkt 504, Palle Juul-Jensens Boulevard 8200 Aarhus N DenmarkRenato Mantegazza - grid.414603.4 Foundation of the Carlo Besta Neurological Institute IRCCS Milan ItalyJing Wang - 0000 0004 0408 0730 grid.422288.6 Formerly of Alexion Pharmaceuticals, Inc. New Haven CT USAFanny O’Brien - 0000 0004 0408 0730 grid.422288.6 Alexion Pharmaceuticals, Inc. New Haven CT USAKaushik Patra - 0000 0004 0408 0730 grid.422288.6 Alexion Pharmaceuticals, Inc. New Haven CT USAJames Howard Jr - 0000000122483208 grid.10698.36 Department of Neurology, UNC School of Medicine University of North Carolina at Chapel Hill Chapel Hill NC USA
- Contributors
- Laurie Gutmann (Contributor) - University of Iowa, NeurologyLudwig Gutmann (Contributor) - University of Iowa, NeurologyThe REGAIN Study Group (Institution)
- Resource Type
- Journal article
- Publication Details
- Quality of life research, Vol.28(8), pp.2247-2254
- DOI
- 10.1007/s11136-019-02148-2
- PMID
- 30905021
- PMCID
- PMC6620379
- NLM abbreviation
- Qual Life Res
- ISSN
- 0962-9343
- eISSN
- 1573-2649
- Publisher
- Springer International Publishing; Cham
- Grant note
- Alexion Pharmaceuticals (http://dx.doi.org/10.13039/100006396)
- Language
- English
- Date published
- 08/15/2019
- Academic Unit
- Neurology
- Record Identifier
- 9984020798402771
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