Adverse events of special interest in clinical trials of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and psoriasis with 37 066 patient-years of tofacitinib exposure.
Adverse events of special interest in clinical trials of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and psoriasis with 37 066 patient-years of tofacitinib exposure.
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DOI：
10.1136/rmdopen-2021-001595
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发表时间：
2021-05
期刊：
影响因子：
6.2
通讯作者：
Cohen SB
中科院分区：
文献类型：
--
作者：
Burmester GR;Nash P;Sands BE;Papp K;Stockert L;Jones TV;Tan H;Madsen A;Valdez H;Cohen SB
分析托法替布在类风湿性关节炎（RA）、银屑病关节炎（PsA）、溃疡性结肠炎（UC）和银屑病（PsO）临床项目中特别关注的不良事件（AE），并确定这些事件的发生率（IR;每100患者-年发生事件的独特患者）在不同疾病中是否一致。该分析包括在RA（23项试验）、PsA（3项试验）、UC（5项试验）和PsO（7项试验）的1、2、3或3b/4期临床试验和长期扩展（LTE）研究（38项试验）中暴露于≥1剂托法替布的患者的数据。所有研究均在2019年7月或之前完成，但一项正在进行的UC LTE研究除外（数据截止日期为2019年5月）。获得特别关注AE的IR。分析中纳入了13567例患者（RA：n=7964; PsA：n=783; UC：n=1157; PsO：n=3663），代表37066患者年的暴露量。最长暴露持续时间为10.5年（RA）。“感染和侵扰”系统器官类别中的AE是所有疾病中最常见的。在特别关注的AE中，带状疱疹（非严重和严重; RA、PsA、UC和PsO分别为3.6、1.8、3.5和2.4）和严重感染（RA、PsA、UC和PsO分别为2.5、1.2、1.7和1.3）的IR最高。各队列的经性别校正和经年龄校正的死亡率比（按国家加权）≤0.2。与既往分析相比，该分析中托法替布的安全性特征在不同疾病之间基本一致，且随访时间更长。
To analyse adverse events (AEs) of special interest across tofacitinib clinical programmes in rheumatoid arthritis (RA), psoriatic arthritis (PsA), ulcerative colitis (UC) and psoriasis (PsO), and to determine whether the incidence rates (IRs; unique patients with events per 100 patient-years) of these events are consistent across diseases. The analysis included data from patients exposed to ≥1 dose of tofacitinib in phase 1, 2, 3 or 3b/4 clinical trials and long-term extension (LTE) studies (38 trials) in RA (23 trials), PsA (3 trials), UC (5 trials) and PsO (7 trials). All studies were completed by or before July 2019, except for one ongoing UC LTE study (data cut-off May 2019). IRs were obtained for AEs of special interest. 13 567 patients were included in the analysis (RA: n=7964; PsA: n=783; UC: n=1157; PsO: n=3663), representing 37 066 patient-years of exposure. Maximum duration of exposure was 10.5 years (RA). AEs within the ‘infections and infestations’ System Organ Class were the most common in all diseases. Among AEs of special interest, IRs were highest for herpes zoster (non-serious and serious; 3.6, 1.8, 3.5 and 2.4 for RA, PsA, UC and PsO, respectively) and serious infections (2.5, 1.2, 1.7 and 1.3 for RA, PsA, UC and PsO, respectively). Age-adjusted and sex-adjusted mortality ratios (weighted for country) were ≤0.2 across cohorts. The tofacitinib safety profile in this analysis was generally consistent across diseases and with longer term follow-up compared with previous analyses.
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