研究动态
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安全数据发布后,开始和停止类风湿关节炎先进疗法的患者特征发生变化。

Changes in Characteristics of Patients Initiating and Discontinuing Advanced Therapies for Rheumatoid Arthritis Following the Release of Safety Data.

发表日期:2023 Nov 01
作者: Stephanie Song, Bryant R England, Brian Sauer, Michael D George, Thomas R Riley, Beth Wallace, Grant W Cannon, Ted R Mikuls, Joshua F Baker
来源: ARTHRITIS RESEARCH & THERAPY

摘要:

通过描述 2021 年 1 月前后开始和停止类风湿性关节炎 (RA) 先进疗法的患者特征,确定新出现的安全性数据对实践模式的影响。这项队列研究评估了 2019 年 4 月至 2022 年 9 月期间患有 RA 的美国退伍军人。该时期分为2021年1月前后两个664天的时期。符合条件的患者具有≥1个RA诊断代码,并开始使用肿瘤坏死因子抑制剂(TNFi)、非TNFi生物制剂或Janus激酶抑制剂(JAKi)。我们测试了回归模型内的相互作用,以确定托法替布使用者的患者特征变化是否与其他疗法观察到的变化不同。我们还在 Cox 模型中评估了与治疗中止相关的因素,根据年龄、性别和治疗持续时间进行调整,包括效果修改评估。比较 2021 年 1 月之前 (N=2111) 和之后 (N=1664) 开始使用托法替布的 RA 患者,平均年龄(64.1 vs 63.0)和心血管合并症比例有所下降(全部 p<0.01)。这些变化与开始使用 TNFi 或非 TNFi 生物制剂的患者观察到的变化显着不同。在积极的高级治疗使用者中,托法替布停药的可能性高于 TNFi(HR:1.18 [1.10,1.26],p<0.001)。在存在心血管合并症的情况下,托法替布停药率较高(p<0.05)。最近的安全性数据显着影响了先进疗法的处方实践,老年患者和老年人中 JAKi 起始剂量减少,JAKi 停药次数增加。高心血管风险。本文受版权保护。保留所有权利。© 2023 美国风湿病学院。
To determine the impact of emerging safety data on practice patterns by describing the characteristics of patients initiating and discontinuing advanced therapies for rheumatoid arthritis (RA) before and after January 2021.This cohort study evaluated U.S. Veterans with RA between April 2019 and September 2022. This period was divided into two 664-day periods before and after January 2021. Eligible patients had ≥1 diagnosis code for RA and initiated a tumor necrosis factor inhibitor (TNFi), non-TNFi biologic, or Janus kinase inhibitor (JAKi). We tested for interaction within regression models to determine whether changes in patient characteristics for tofacitinib users were different from changes observed for other therapies. We also evaluated factors associated with therapy discontinuation in Cox models adjusted for age, sex, and duration on therapy, including assessment for effect modification.When comparing patients with RA initiating tofacitinib before (N=2111) and after (N=1664) January 2021, there was a decrease in mean age (64.1 vs 63.0) and in the proportion with cardiovascular comorbidities (all p<0.01). These changes were significantly different from those observed for patients initiating TNFi or non-TNFi biologics. Among active advanced therapy users, the likelihood of discontinuation was higher for tofacitinib than TNFi (HR: 1.18 [1.10,1.26], p<0.001). The higher rate of tofacitinib discontinuation was more pronounced in the presence of cardiovascular comorbidities (p<0.05).Recent safety data significantly affected prescribing practices for advanced therapies, with a reduction in JAKi initiation and an increase in JAKi discontinuation among older patients and those at high cardiovascular risk. This article is protected by copyright. All rights reserved.© 2023 American College of Rheumatology.