波兰高活性复发性缓解性多发性硬化症的克拉德里宾片:在COVID-19大流行期间的现实世界,多中心,回顾性,队列研究
Adam Stępień1, Aleksandra Pogoda-Wesołowska2, Elżbieta Tokarz-Kupczyk3
1Department of Neurology, Military Institute of Medicine, Warsaw, Poland. astepien@wim.mil.pl.
Neurologia i neurochirurgia polska
|July 25, 2023
概括
克拉迪片在经过治疗的复发性复发性多发性硬化症 (RRMS) 患者中显示出现实世界的安全性和有效性. 疗效略低于临床试验,这可能是由于研究的患者群体.
科学领域:
- 神经学 神经学
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
背景情况:
- 高活性复发性复发性多发性硬化症 (RRMS) 适用于克拉德里宾片.
- 关键的CLARITY试验证明了克拉迪宾的安全性和有效性,主要是在以前没有接受过治疗的患者中.
- 现实世界的数据至关重要,因为克拉迪宾通常用于以前治疗失败的患者.
研究的目的:
- 在RRMS患者中调查克拉迪宾片的真实安全性和有效性.
- 评估一组主要由治疗经验丰富的个体组成的队列中的治疗结果.
主要方法:
- 从波兰9个多发性硬化症临床中心收集的数据.
- 包括RRMS患者,他们在2019年12月至2022年6月期间开始服用克拉迪宾片.
- 随访数据分析长达两年的时间.
主要成果:
- 招募了140名患者,94%的患者是经验丰富的治疗者.
- 年复发率 (ARR) 从1.49显著下降到0.33 (第一年) 和0.25 (第二年).
- 没有疾病活性的证据 (NEDA-3) 达到42.7% (第一年) 和66.7% (第二年).
- 在超过83%的患者中,EDSS得分保持稳定或改善.
- 严重淋巴缺血的发病率低 (0.72% 4 级) 和可管理的不良事件 (3 VZV 感染).
结论:
- 克拉迪布林片在现实世界,经过治疗的RRMS队列中证明了安全性和有效性.
- 与CLARITY试验相比,疗效结局略显较差.
- 经过治疗的患者比例较高可能解释了观察到的疗效差异.
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