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在缺乏头对头试验的情况下,真实世界研究告诉了我们什么有关生物制剂在克罗恩病中的比较疗效的信息。

In the absence of head-to-head trials, what do real world studies tell us about the comparative effectiveness of biologics in Crohn's disease.

机构信息

University of California San Diego, Division of Gastroenterology and Hepatology, 9500, Gilman Drive, #0956, La Jolla, San Diego, CA, USA.

出版信息

Best Pract Res Clin Gastroenterol. 2019 Feb-Apr;38-39:101619. doi: 10.1016/j.bpg.2019.05.006. Epub 2019 May 29.

Abstract

Head-to-head clinical trials are the highest quality of evidence to support comparative effectiveness. However, there are currently no head-to-head phase 3 clinical trials of biologics in Crohn's Disease. With a need for direct comparisons but lagging RCTs, Real World Data (RWD) can provide evidence on the comparative effectiveness of biologics for a diverse population that is more generalizable to routine practice. The majority of available real-world comparative analyses show no significant difference in effectiveness outcomes-primarily clinical remission and CD related complications. Real-world data is limited by its susceptibility to bias and clinicians must critically evaluate the methods and data sources utilized. Moving forward, it is important to note that comparisons including newer biologics may be limited by significant prior biologic exposure. Additionally, shared decision making incorporates efficacy, safety, and tolerability with patient preference and clinicians should use data from real-world comparative analyses as a part of this equation.

摘要

头对头临床试验是支持比较有效性的最高质量证据。然而,目前在克罗恩病中还没有生物制剂的头对头 3 期临床试验。由于需要直接比较但 RCT 滞后,真实世界数据(RWD)可以为更广泛应用于常规实践的生物制剂的比较有效性提供证据,这些证据来自多样化的人群。大多数现有的真实世界比较分析显示,在有效性结果方面没有显著差异-主要是临床缓解和 CD 相关并发症。真实世界的数据容易受到偏差的影响,临床医生必须批判性地评估所使用的方法和数据源。向前看,重要的是要注意,包括新型生物制剂在内的比较可能受到先前生物制剂暴露的显著限制。此外,共同决策将疗效、安全性和耐受性与患者偏好结合起来,临床医生应该将真实世界比较分析的数据作为该方程的一部分。

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