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托法西提尼布在耐火轴性脊柱炎中的有效性:剂量升级研究
Abdul Mahin Tazbir1, Mohammad Abul Kalam Azad2, Abul Khair Ahmedullah2
1Rheumatology, Enam Medical College Hospital, Dhaka, BGD.
Cureus
|November 10, 2025
概括
在对10毫克不充分反应的轴性脊椎关节炎患者中,提升托法西提尼布到每天15毫克,导致疾病活性和生活质量显著改善. 这种剂量升级显示出与较低剂量相比的安全性,提供了可行的治疗选择.
科学领域:
- 类风湿病学 类风湿病学
- 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:
- 轴性脊柱关节炎 (ax-SpA) 是一种影响脊柱的慢性炎症状况.
- 托法西提尼布是一种用于治疗炎症性疾病的Janus激酶抑制剂.
- 优化托法西提尼布剂量对于那些对标准剂量反应不足的患者至关重要.
研究的目的:
- 评估tofacitinib在ax-SpA患者中每天从10毫克升级到15毫克的疗效和安全性.
- 为了评估12周内对10毫克托法西提尼布的反应不足的患者的结局.
- 确定剂量升级是否是一种可行的治疗到目标策略.
主要方法:
- 这是一项实用性的,开放的,单臂的,持续24周的剂量升级研究.
- 101名患者开始每天服用10毫克的托法西提尼布;第12周没有反应的患者升级到15毫克.
- 评估结果包括ASDAS-CRP,ASAS 20/40,BASDAI,BASFI,BASMI,ASQoL和SF-36,并进行安全监测.
主要成果:
- 在88名可评估患者中,31人 (35.2%) 升级到15毫克托法西提尼.
- 升级到15毫克导致ASDAS-CRP,BASDAI和ASAS响应标准在第24周显著改善.
- 副作用导致六名患者停止治疗;鼻炎在15毫克时更频繁,但没有发生结核病,静脉动脉突发症或MACE等严重事件.
结论:
- 将托法西提尼布升至每天15毫克为ax-SpA患者提供了额外的临床益处,这些患者在10毫克的剂量下无法实现治疗目标.
- 15毫克剂量的安全性概况与10毫克剂量的安全性概况相似.
- 选择性剂量升级是当治疗替代方案有限时管理ax-SpA的可行策略.
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