P.053 雷珠单抗治疗抗ACHR抗体阳性gMG成人患者同时使用皮质类固醇:CHAMPION MG开放标签扩展研究的结果

MW Nicolle, D Annane, A Meisel, T. Vu, R. Mantegazza, M Katsuno, V. Bril, R Aguzzi, G Frick, J. Howard
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引用次数: 0

摘要

背景:减少类固醇剂量治疗全身性肌无力(gMG)可最大限度地减少类固醇相关的不良反应。在对抗性乙酰胆碱受体抗体阳性(AChRAb+)成人重症肌无力患者进行的为期26周的CHAMPION MG研究中,不允许改变皮质类固醇的剂量。完成研究的参与者可在开放标签扩展研究(OLE;NCT03920293)中接受雷珠单抗治疗;允许调整皮质类固醇用量。研究方法患者可接受静脉注射雷珠单抗(之前接受过安慰剂或雷珠单抗治疗的患者可分别在第26周[OLE开始]接受盲诱导剂量或桥接剂量,然后在第28周接受3000-3600毫克的雷珠单抗,此后每8周一次),持续时间不超过4年。研究结果在161名进入OLE并接受雷珠单抗治疗≤164周的患者(78名雷珠单抗患者,83名安慰剂患者)中,有113名患者在OLE期间接受了口服或肠内皮质类固醇治疗;接受>10毫克/天皮质类固醇治疗的患者比例从OLE首次用药时的58%(66人)下降到最后一次用药时的37%(42人)(35人[31%]接受>5毫克/天皮质类固醇治疗,71人[63%]接受>10毫克/天皮质类固醇治疗)。14名患者(12%)停用了皮质类固醇。每位患者的皮质类固醇平均剂量(标度)从首次服用 OLE 时的 17.5(11.9)毫克/天降至最后一次评估时的 11.7(10.9)毫克/天。结论雷珠单抗减少了 AChRAb+ gMG 患者的皮质类固醇用量,表明雷珠单抗具有节省类固醇的作用。
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P.053 Concomitant corticosteroid use in ravulizumab-treated adults with anti-AChR antibody-positive gMG: results from the CHAMPION MG open-label extension
Background: Treatment of generalized myasthenia gravis (gMG) with reduced steroid dosages may minimize steroid-associated AEs. Corticosteroid dosage changes were not permitted during the 26-week, CHAMPION MG study of ravulizumab in adults with anti-acetylcholine receptor antibody-positive (AChRAb+) gMG. Participants who completed the study could receive ravulizumab in the open-label extension (OLE; NCT03920293); corticosteroid adjustments were permitted. Methods: Patients could receive intravenous ravulizumab (blind induction or bridging dose at Week 26 [OLE start] for those previously receiving placebo or ravulizumab, respectively, then 3000–3600 mg at Week 28 and every 8 weeks thereafter) for ≤4 years. Results: Among 161 patients (78 ravulizumab, 83 placebo) who entered the OLE and received ravulizumab for ≤164 weeks, 113 received oral or enteral corticosteroids during the OLE; the proportion treated with >10 mg/day corticosteroids decreased from 58% (n=66) at first OLE dose to 37% (n=42) (35 [31%] received ≤5 mg/day and 71 [63%] received ≤10 mg/day) at last reported dose. Fourteen patients (12%) discontinued corticosteroids. The mean (SD) corticosteroid dosage/patient decreased from 17.5 (11.9) mg/day at first OLE dose to 11.7 (10.9) mg/day at last assessment. Conclusions: Ravulizumab decreased corticosteroid use in patients with AChRAb+ gMG, suggesting a steroid-sparing role for ravulizumab.
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