在患有活跃类风湿性关节炎且对甲醇治疗反应不充分的患者中,用upadacitinib作为单疗法 (SELECT- MONOTHERAPY):一项随机对照,双盲的第三期研究
Josef S Smolen1, Aileen L Pangan2, Paul Emery3
1Medical University of Vienna, Vienna, Austria.
Lancet (London, England)
|May 28, 2019
概括
与持续使用甲状腺素相比,单独使用upadacitinib可显著改善类风湿性关节炎的治疗结果. 安全性概况与之前的研究相似,表明这种JAK1抑制剂的风险益处平衡有利.
科学领域:
- 关节病学
- 免疫学
- 药理学
背景情况:
- 乌帕达西尼布是一种口服的Janus激酶 (JAK) 1选择性抑制剂.
- 之前的研究证明了其在类风湿性关节炎 (RA) 组合治疗中的有效性.
- 这项研究评估了阿巴迪西尼布作为单一治疗的 RA 患者对甲醇的反应不足.
研究的目的:
- 在 RA 患者中,评估upadacitinib 单一治疗的安全性和有效性与持续使用甲状腺素相比.
- 将治疗组之间的临床和功能结果进行比较.
主要方法:
- 在SELECT- MONOTHERAPY试验中,尽管接受了稳定的甲醇治疗,但仍有活跃的RA患者.
- 患者被随机分为上达西提尼布 (15 mg 或 30 mg) 或继续使用甲状腺素.
- 主要终点包括第14周的ACR20反应和低疾病活性 (DAS28-CRP≤3. 2).
主要成果:
- 在第14周 (p< 0. 0001) 与继续服用甲状腺素 (41%) 相比,阿巴达西尼布 (15 mg 和 30 mg) 的ACR20反应率显著更高.
- 显著更多的患者获得了较低的疾病活性 (45%和53%) 与甲状腺素 (19%) (p< 0. 0001).
- 各组的不良事件发生率相似;特殊事件如疹,恶性瘤和心血管事件是罕见的.
结论:
- 在甲状腺炎患者中,单独治疗乌帕达西丁可以显著改善临床和功能结果.
- 乌帕达西尼布单一治疗的安全性与先前的RA研究结果一致.
- 转换为upadacitinib单一治疗是这种患者群体的可行的治疗选择.
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