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使用移动应用程序进行现实世界的有效性研究,以评估在风湿性关节炎中使用乌帕达西提尼布的早期结果
Leslie R Harrold1,2, Patrick Zueger3, W Benjamin Nowell4
1CorEvitas, LLC, 300 5th Avenue, Waltham, MA, 02451, USA. lharrold@corevitas.com.
Rheumatology and therapy
|September 20, 2023
概括
在12周内,upadacitinib迅速改善了类风湿性关节炎症状,包括疼痛和疲劳. 患者在疾病活动和日常功能方面报告了显著的好处,证明了早期和持续的治疗效果.
科学领域:
- 类风湿病学 类风湿病学
- 临床试验 临床试验
- 患者报告的结果
背景情况:
- 类风湿性关节炎 (RA) 管理通常涉及评估患者报告的结果 (PRO).
- 移动健康应用程序为在现实环境中收集PRO提供了一种新的方式.
研究的目的:
- 通过移动健康应用程序收集的PROs来评估upadacitinib对RA症状的影响.
- 评估upadacitinib在12周的早期和持续治疗效果.
主要方法:
- 一项前性观察队列研究 (CorEvitas RA Registry) 招募了开始使用upadacitinib的RA患者.
- 包括RAPID3在内的PROs,早晨硬和疲劳,在基线和各种后续点使用ArthritisPower应用程序收集.
- 卡普兰-梅尔估计分析了RAPID3对疾病活动改善和临床重要差异最小 (MCID) 的反应.
主要成果:
- 51.4%的患者完成了为期12周的研究,提供基于应用程序的PRO数据.
- 在第1周观察到RAPID3,疼痛,硬和疲劳的显著改善,并持续到第12周.
- 到第12周,59.6%的患者实现了低疾病活性 (RAPID3) 和59.8%达到MCID.
结论:
- 在现实环境中,upadacitinib在 RA 症状和 PRO 中表现出早期和显著的改善.
- 无论之前的TNF抑制剂 (TNFi) 经验如何,都观察到治疗效益.
- 患者报告的疾病活性在临床上有意义的改善早在第1周就显而易见.
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