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Eculizumab improves fatigue in refractory generalized myasthenia gravis.

Publication ,  Journal Article
Andersen, H; Mantegazza, R; Wang, JJ; O'Brien, F; Patra, K; Howard, JF; REGAIN Study Group,
Published in: Qual Life Res
August 2019

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Compared with placebo, eculizumab was associated with improvements in perceived fatigue that strongly correlated with improvements in MG-specific outcome measures. Trial ID Registration: NCT01997229, NCT02301624.

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Published In

Qual Life Res

DOI

EISSN

1573-2649

Publication Date

August 2019

Volume

28

Issue

8

Start / End Page

2247 / 2254

Location

Netherlands

Related Subject Headings

  • Receptors, Cholinergic
  • Quality of Life
  • Placebos
  • Outcome Assessment, Health Care
  • Myasthenia Gravis
  • Middle Aged
  • Male
  • Humans
  • Health Policy & Services
  • Female
 

Citation

APA
Chicago
ICMJE
MLA
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Andersen, H., Mantegazza, R., Wang, J. J., O’Brien, F., Patra, K., Howard, J. F., & REGAIN Study Group, . (2019). Eculizumab improves fatigue in refractory generalized myasthenia gravis. Qual Life Res, 28(8), 2247–2254. https://doi.org/10.1007/s11136-019-02148-2
Andersen, Henning, Renato Mantegazza, Jing Jing Wang, Fanny O’Brien, Kaushik Patra, James F. Howard, and James F. REGAIN Study Group. “Eculizumab improves fatigue in refractory generalized myasthenia gravis.Qual Life Res 28, no. 8 (August 2019): 2247–54. https://doi.org/10.1007/s11136-019-02148-2.
Andersen H, Mantegazza R, Wang JJ, O’Brien F, Patra K, Howard JF, et al. Eculizumab improves fatigue in refractory generalized myasthenia gravis. Qual Life Res. 2019 Aug;28(8):2247–54.
Andersen, Henning, et al. “Eculizumab improves fatigue in refractory generalized myasthenia gravis.Qual Life Res, vol. 28, no. 8, Aug. 2019, pp. 2247–54. Pubmed, doi:10.1007/s11136-019-02148-2.
Andersen H, Mantegazza R, Wang JJ, O’Brien F, Patra K, Howard JF, REGAIN Study Group. Eculizumab improves fatigue in refractory generalized myasthenia gravis. Qual Life Res. 2019 Aug;28(8):2247–2254.
Journal cover image

Published In

Qual Life Res

DOI

EISSN

1573-2649

Publication Date

August 2019

Volume

28

Issue

8

Start / End Page

2247 / 2254

Location

Netherlands

Related Subject Headings

  • Receptors, Cholinergic
  • Quality of Life
  • Placebos
  • Outcome Assessment, Health Care
  • Myasthenia Gravis
  • Middle Aged
  • Male
  • Humans
  • Health Policy & Services
  • Female