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接受托法替布治疗的类风湿关节炎或银屑病关节炎患者带状疱疹的临床管理

Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment.

作者信息

Winthrop Kevin L, Curtis Jeffrey R, Yamaoka Kunihiro, Lee Eun Bong, Hirose Tomohiro, Rivas Jose L, Kwok Kenneth, Burmester Gerd R

机构信息

OHSU-PSU School of Public Health, Oregon Health and Science University, OHSU Mail Code GH1043181 S.W. Sam Jackson Rd, Portland, OR, 97239, USA.

The University of Alabama at Birmingham, Birmingham, AL, USA.

出版信息

Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.

Abstract

INTRODUCTION

Risk of herpes zoster (HZ) is increased with Janus kinase inhibitor use. We evaluated clinical study data relating to HZ management in patients with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) receiving tofacitinib.

METHODS

This post hoc analysis included data from 21 RA and 3 PsA clinical studies; data were pooled for tofacitinib doses. Outcomes of HZ events (serious and non-serious) and tofacitinib treatment changes were evaluated in response to first and second HZ events. Median time to resolution was stratified by dermatomal involvement, history of HZ prior to tofacitinib, changes to tofacitinib treatment, anti-viral and corticosteroid use, and tofacitinib dose.

RESULTS

Seven hundred eighty-three (11.1%, N = 7061) patients with RA experienced ≥ 1 HZ event, 63 (8.0%) of whom had ≥ 2 HZ events. In patients with PsA, 36 (4.6%, N = 783) experienced ≥ 1 HZ event, 1 (2.8%) of whom had ≥ 2 HZ events. For most HZ events, tofacitinib treatment was unchanged or temporarily discontinued. The majority of patients received anti-viral treatment, most within 3 days of onset. Post-herpetic neuralgia developed in 6.9% and 3.2% of patients with RA with first and second events, respectively, and in 2.8% of patients with PsA with a first event. Most first and second events resolved (RA: 97.6% and 96.8%, respectively; PsA: 94.4% and 100%, respectively). Median time to resolution was 22.0 days for first and 15.0 days for second events for RA and 20.5 days for first and 11.0 days for second events (n = 1) for PsA. Time to resolution of first events for RA and PsA was generally numerically shorter for patients with single dermatomal HZ, history of HZ, or anti-viral use versus those without.

CONCLUSION

Among patients receiving tofacitinib, recurrent events were more common in patients with RA versus PsA; HZ duration was shorter for repeat events.

TRIAL REGISTRATION

NCT01262118, NCT01484561, NCT00147498, NCT00413660, NCT00550446, NCT00603512, NCT00687193, NCT01164579, NCT00976599, NCT01059864, NCT01359150, NCT02147587, NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT01039688, NCT02187055, NCT00413699, NCT00661661, NCT01877668, NCT01882439, NCT01976364.

摘要

引言

使用Janus激酶抑制剂会增加带状疱疹(HZ)的风险。我们评估了接受托法替布治疗的类风湿关节炎(RA)或银屑病关节炎(PsA)患者中与HZ管理相关的临床研究数据。

方法

这项事后分析纳入了21项RA和3项PsA临床研究的数据;将托法替布各剂量的数据进行汇总。针对首次和第二次HZ事件,评估HZ事件(严重和非严重)的结局以及托法替布治疗的变化。根据皮节受累情况、托法替布治疗前的HZ病史、托法替布治疗的变化、抗病毒和皮质类固醇的使用情况以及托法替布剂量,对缓解的中位时间进行分层。

结果

783例(11.1%,N = 7061)RA患者发生≥1次HZ事件,其中63例(8.0%)发生≥2次HZ事件。在PsA患者中,36例(4.6%,N = 783)发生≥1次HZ事件,其中1例(2.8%)发生≥2次HZ事件。对于大多数HZ事件,托法替布治疗未改变或暂时中断。大多数患者接受了抗病毒治疗,大多数在发病后3天内。带状疱疹后神经痛在首次和第二次事件的RA患者中分别有6.9%和3.2%发生,在首次事件的PsA患者中有2.8%发生。大多数首次和第二次事件得到缓解(RA:分别为97.6%和96.8%;PsA:分别为94.4%和100%)。RA患者首次事件缓解的中位时间为22.0天,第二次事件为15.0天;PsA患者首次事件为20.5天,第二次事件为11.0天(n = 1)。与无单一皮节HZ、HZ病史或使用抗病毒药物的患者相比,RA和PsA患者首次事件的缓解时间在数值上通常更短。

结论

在接受托法替布治疗的患者中,RA患者的复发事件比PsA患者更常见;重复事件的HZ持续时间更短。

试验注册

NCT01262118、NCT01484561、NCT00147498、NCT00413660、NCT00550446、NCT00603512、NCT00687193、NCT01164579、NCT00976599、NCT01059864、NCT01359150、NCT02147587、NCT00960440、NCT00847613、NCT00814307、NCT00856544、NCT00853385、NCT01039688、NCT02187055、NCT00413699、NCT00661661、NCT01877668、NCT01882439、NCT01976364。

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