Browsing by Author "Wang, Jing Jing"
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Item Open Access Correction to: Eculizumab improves fatigue in refractory generalized myasthenia gravis.(Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2019-08) Andersen, Henning; Mantegazza, Renato; Wang, Jing Jing; O'Brien, Fanny; Patra, Kaushik; Howard, James F; REGAIN Study GroupThe article "Eculizumab improves fatigue in refractory generalized myasthenia gravis", written by "Henning Andersen, Renato Mantegazza, Jing Jing Wang, Fanny O'Brien, Kaushik Patra, James F. Howard Jr. and The REGAIN Study Group" was originally published electronically on the publisher's internet portal (currently SpringerLink) on 23 March 2019 without open access.Item Open Access Eculizumab improves fatigue in refractory generalized myasthenia gravis.(Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2019-08) Andersen, Henning; Mantegazza, Renato; Wang, Jing Jing; O'Brien, Fanny; Patra, Kaushik; Howard, James F; REGAIN Study GroupPURPOSE: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.Item Open Access Long-term safety and efficacy of eculizumab in generalized myasthenia gravis.(Muscle & nerve, 2019-07) Muppidi, Srikanth; Utsugisawa, Kimiaki; Benatar, Michael; Murai, Hiroyuki; Barohn, Richard J; Illa, Isabel; Jacob, Saiju; Vissing, John; Burns, Ted M; Kissel, John T; Nowak, Richard J; Andersen, Henning; Casasnovas, Carlos; de Bleecker, Jan L; Vu, Tuan H; Mantegazza, Renato; O'Brien, Fanny L; Wang, Jing Jing; Fujita, Kenji P; Howard, James F; Regain Study GroupIntroduction
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 < 0.0001). Improvements with eculizumab in activities of daily living, muscle strength, functional ability, and quality of life in REGAIN were maintained through 3 years; 56% of patients achieved minimal manifestations or pharmacological remission. Patients who had received placebo during REGAIN experienced rapid and sustained improvements during open-label eculizumab (P < 0.0001).Discussion
These findings provide evidence for the long-term safety and sustained efficacy of eculizumab for refractory gMG. Muscle Nerve 2019.