库用促肾上腺皮质激素注射液(HP Acthar凝胶)作为阿仑单抗输注前处理的回顾性研究

C. Kutz
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摘要

背景:阿仑单抗治疗多发性硬化患者与细胞因子释放相关,导致输注相关反应(IARs)。治疗前通常使用皮质类固醇以减轻iar的风险,但类固醇预处理在一些患者中是不可行的。本研究调查了使用库促肾上腺皮质激素注射(RCI)作为阿仑单抗输注的预处理的真实世界经验。方法:采用电子问卷对处方RCI作为预防阿仑单抗IARs的预处理的患者进行回顾性研究。数据在收集时已去标识化。结果:收集并分析了175例患者的完整信息。175例患者的阿仑单抗1疗程输注数据;其中23例也有疗程2输注的可用数据。患者中62%为白种人,21%为黑人,15%为西班牙裔,诊断为复发型多发性硬化症(60%)或进行性多发性硬化症(40%)。在阿仑单抗治疗前使用RCI的原因包括类固醇不耐受史(第1期:37%,第2期:59%),类固醇不良反应史(20%,27%)和合并症(20%,27%)。RCI最常用于皮下注射,剂量为80单位。在RCI预处理后,56%(疗程1)和61%(疗程2)的患者未发生iar。在第1和第2疗程中,分别有72%和91%的患者未发现RCI引起的不良事件。结论:RCI是一种安全、有效、耐受性良好的皮质类固醇替代预处理,可减轻MS患者阿仑单抗相关输注反应的风险。
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A Retrospective Study of Utilization of Repository Corticotropin Injection (HP Acthar Gel) as Pretreatment for Alemtuzumab Infusion
Background: Alemtuzumab treatment of patients with MS is associated with cytokine release, resulting in infusion-associated reactions (IARs). Premedication with corticosteroids is typically administered to alleviate the risk of IARs, but steroid pretreatment is not feasible in some patients. This study investigated real-world experience using repository corticotropin injection (RCI) as a pretreatment for alemtuzumab infusion. Methods: A retrospective study of patients who were prescribed RCI as pretreatment for the prevention of alemtuzumab IARs was conducted using an electronic questionnaire. Data were de-identified at the time of collection. Results: Complete information on 175 patients was collected and analyzed. Data for alemtuzumab Course 1 infusions were available for 175 patients; 23 of these also had data available for Course 2 infusions. Patients were 62% Caucasian, 21% black, 15% Hispanic, and were diagnosed with relapsing forms of MS (60%) or progressive forms of MS (40%). Reasons for using RCI prior to alemtuzumab included history of steroid intolerance (Course 1: 37%, Course 2: 59%), history of poor response to steroids (20%, 27%), and comorbidities (20%, 27%). RCI was most frequently administered subcutaneously at a dose of 80 units. No IARs occurred in 56% (Course 1) and 61% (Course 2) of patients after RCI pretreatment. No adverse events attributed to RCI were seen in 72% and 91% of patients treated with Course 1 and 2, respectively. Conclusion: RCI is a safe, effective, and well-tolerated pretreatment alternative to corticosteroids to alleviate the risk of alemtuzumab-associated infusion reaction in patients with MS.
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