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Eculizumab Improves Fatigue in Refractory Generalized Myasthenia Gravis
- Source :
- Andersen, H, Mantegazza, R, Wang, J J, O’Brien, F, Patra, K, Howard, J F & The REGAIN Study Group 2019, ' Eculizumab improves fatigue in refractory generalized myasthenia gravis ', Quality of Life Research, vol. 28, no. 8, pp. 2247-2254 . https://doi.org/10.1007/s11136-019-02148-2, Quality of Life Research, QUALITY OF LIFE RESEARCH
- Publication Year :
- 2019
-
Abstract
- 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.
- Subjects :
- Male
Activities of daily living
Outcome Assessment
Myasthenia Gravis/drug therapy
Myasthenia gravi
Placebos
0302 clinical medicine
Quality of life
QUALITY-OF-LIFE
Outcome Assessment, Health Care
Monoclonal
Receptors
Activities of Daily Living
Medicine and Health Sciences
Clinical endpoint
Receptors, Cholinergic
Fatigue/drug therapy
Myasthenia gravis
Humanized
Fatigue
Cholinergic
Public, Environmental & Occupational Health
030503 health policy & services
Terminal complement inhibition
Eculizumab
Middle Aged
humanities
Antibodies, Monoclonal, Humanized/therapeutic use
030220 oncology & carcinogenesis
Health Policy & Services
Female
0305 other medical science
Life Sciences & Biomedicine
medicine.drug
medicine.medical_specialty
Complement
Brief Communication
Antibodies, Monoclonal, Humanized
Placebo
Antibodies
03 medical and health sciences
Neuro-QOL Fatigue
Refractory
Internal medicine
Myasthenia Gravis
medicine
Humans
Generalized myasthenia
Placebos/therapeutic use
Quality of Life
Receptors, Cholinergic/immunology
Science & Technology
business.industry
Public Health, Environmental and Occupational Health
Correction
medicine.disease
Health Care
Health Care Sciences & Services
business
Subjects
Details
- Language :
- English
- ISSN :
- 09629343 and 15732649
- Database :
- OpenAIRE
- Journal :
- Andersen, H, Mantegazza, R, Wang, J J, O’Brien, F, Patra, K, Howard, J F & The REGAIN Study Group 2019, ' Eculizumab improves fatigue in refractory generalized myasthenia gravis ', Quality of Life Research, vol. 28, no. 8, pp. 2247-2254 . https://doi.org/10.1007/s11136-019-02148-2, Quality of Life Research, QUALITY OF LIFE RESEARCH
- Accession number :
- edsair.doi.dedup.....7c1280ef9d422ed0f1faa7d939ffdf5a
- Full Text :
- https://doi.org/10.1007/s11136-019-02148-2