从原始药物阿达利木马布转换为生物类似药物的影响:一项追溯队列研究
W H A van Poecke1, N E F Hooi2, T K Mossel2
1Department of Internal Medicine, Allergy and Clinical Immunology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
BMC immunology
|July 3, 2025
概括
切换到阿达利穆马布生物类似药Hyrimoz显示与原始生物药物相比的爆发率相当. 然而,患者在转换后报告了更多的副作用和主观投诉.
科学领域:
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
- 临床医学 临床医学
背景情况:
- 阿达利穆马布是对自身免疫和炎症性疾病的关键单克隆抗体.
- 希里莫兹是已批准的阿达利穆马布生物类似药,需要对其临床有效性和安全性进行评估.
- 从阿达利穆马布转换为Hyrimoz后评估患者的结果对于临床实践至关重要.
研究的目的:
- 通过比较从阿达利姆巴切换之前和之后的爆发率来评估Hyrimoz的有效性.
- 为了识别和量化使用Hyrimoz.患者经历的不良影响.
- 评估患者在转换为Hyrimoz后的体验和主观投诉.
主要方法:
- 研究了一组185名在2021年2月至2023年2月期间在伊拉斯医疗中心接受阿达利穆马布治疗的患者.
- 数据收集涉及电子患者档案和患者问卷.
- 主要结局:与转换前相比,转换后出现了爆发;次要结局:不良反应和患者体验.
主要成果:
- 在阿达利穆马布和Hyrimoz (P=0.456) 之间没有观察到明显的发作发生差异.
- 24.9%的患者报告了副作用,注射部位疼痛是最常见的 (13.5%).
- 32.4%的患者因爆发,不良反应或主观投诉而停止治疗.
结论:
- 在爆发率方面,Hyrimoz的有效性与阿达利穆马布相美.
- 在转换为Hyrimoz后,显著比例的患者经历了不良反应和主观投诉的增加.
- 这些发现凸显了需要仔细监测患者切换到阿达利姆巴生物类似药的必要性.
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