在临床实践中采用一种可扩展的方法来评估最近上市的特应性皮炎系统治疗方法的安全性。

Maria C Schneeweiss, Robert J Glynn, Richard Wyss, Priyanka Anand, Yinzhu Jin, Joan Landon, Arash Mostaghimi, Joseph F Merola, Jonathan I Silverberg, David M Rosmarin, Robert Sidbury, Sebastian Schneeweiss
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引用次数: 0

摘要

治疗特应性皮炎(AD)的靶向性全身免疫调节药物(IMDs)在随机试验中疗效显著。但受试者人数有限的试验对其安全性提出了质疑。我们介绍了一种数据和分析结构,用于及时提供高质量的证据,说明最近批准的 IMDs 在临床实践中对 AD 患者的安全性比较。我们建立了一系列连续的倾向得分(PS)平衡队列,其规模随着每年数据的更新而扩大。我们确定了九种相关的健康结果以及作为阳性示踪结果的结膜炎。最初的治疗比较是白细胞介素-4/13抑制剂杜必鲁单抗或白细胞介素-13抑制剂曲妥珠单抗与阿罗西替尼/乌帕他替尼(均为JAK抑制剂)。第一个分析周期(2021年12月至2023年2月)比较了269名开始使用JAK抑制剂的患者和2650名开始使用IL-4/IL-13抑制剂的患者。经过 PS 匹配后,患者特征非常均衡。JAK-1抑制剂启动者在180天内发生门诊感染的比例为18%,而杜比鲁单抗/曲妥珠单抗启动者为12%(RR=1.50;0.96-2.33),而痤疮风险分别为7%和3%(RR=2.29,0.96-5.46)。基于对临床实践中观察到的患者进行的研究规模不断扩大,这一连续监测系统将为IMDs治疗AD的安全性提供重要知识。
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A scalable approach to assess the safety of recently marketed systemic treatments for atopic dermatitis in clinical practice.

Targeted systemic immune-modulating drugs (IMDs) to treat atopic dermatitis (AD) were highly efficacious in randomized trials. Trials with limited number of subjects leave questions about their safety. We describe a data and analytics structure for the production of timely, high-quality evidence on the comparative safety of recently approved IMDs in patients with AD in clinical practice. We established a series of sequential propensity score (PS)-balanced cohorts that grow in size with each annual data refresh. Nine health outcomes of interest plus conjunctivitis as a positive tracer outcome were identified. The initial treatment comparison was dupilumab, an interleukin-4/13 inhibitor, or tralokinumab, an interleukin-13 inhibitor, versus abrocitinib/upadacitinib, both JAK inhibitors. The first analysis cycle (December 2021-February 2023) compared 269 patients initiating JAK inhibitors and 2,650 initiating IL-4/IL-13 inhibitors. Patient characteristics were well balanced after PS-matching. Outpatient infections within 180 days occurred in 18% of JAK-1 inhibitor initiators versus 12% of dupilumab/ tralokinumab initiators (RR=1.50; 0.96 to 2.33) whereas acne risks were 7% vs. 3%, respectively (RR=2.29, 0.96 to 5.46). This sequential monitoring system will produce essential knowledge on the safety of IMDs to treat AD based on its growing study size of patients observed in clinical practice.

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