对抗TNF生物相似切换-现实世界的临床有效性和安全性的更新
Susanna Meade1, Elizabeth Squirell1, Thomas Tam Hoang1
1University of British Columbia, Vancouver, BC V6T 1Z4, Canada.
Journal of the Canadian Association of Gastroenterology
|February 5, 2024
概括
在加拿大,切换到生物类似抗TNF药物治疗炎症性肠病 (IBD) 显示出与原始产品相比的临床有效性和安全性. 这些发现支持降低医疗保健成本,同时保持患者的结果.
科学领域:
- 胃肠病学 胃肠病学
- 药物经济学 药物经济学
- 免疫学 免疫学 免疫学
背景情况:
- 炎症性肠病 (IBD) 的生物疗法对省级医疗保健预算造成了相当大的成本.
- 加拿大将在2023年底前在全国范围内转向生物类似抗TNF药物,以管理这些成本.
- 生物相似的调节途径与原始途径不同,这引发了关于现实世界的性能的问题.
研究的目的:
- 在成年IBD患者中,系统地审查从原始药物转换为生物类似抗TNF疗法的临床有效性和安全性的现实证据.
- 评估二次结果,包括反应丧失,治疗持久性,停止和免疫性.
主要方法:
- 一个系统的回顾现实世界的观察性研究,涉及IBD的成年患者.
- 主要结局:切换到生物类似抗TNF的临床有效性和/或安全性.
- 二次结局:反应丧失,治疗持续/停止,免疫性.
主要成果:
- 包括43项研究 (7,462名患者),重点关注克罗恩病 (70%) 和性结肠炎 (30%).
- 与原始药物 (78%) 相比,因弗利克西马布生物类似药物转换显示了持续缓解率 (75%在12个月内).
- 转换至阿达利穆马布仿生药物显示了较高的缓解率 (82%在6个月). 注射部位疼痛在含有酸盐的阿达利穆马布 (Adalimumab) 中被注意到. 其他结果与发起人相似.
结论:
- 现实数据表明,在IBD中切换到生物类似抗TNF药物是安全有效的.
- 这些发现对患者和临床医生来说令人放心,支持转向生物类似药.
- 预计生物类似药的广泛采用将大大降低加拿大的医疗保健支出.
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