Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib

托法替尼 医学 溃疡性结肠炎 内科学 皮肤病科 胃肠病学 结肠炎 类风湿性关节炎 疾病
作者
Kevin Winthrop,Séverine Vermeire,Millie D. Long,Julián Panés,Siew C. Ng,Nicole Kulisek,Rajiv Mundayat,Nervin Lawendy,Ivana Vranić,Irene Modesto,Chinyu Su,Gil Y. Melmed
出处
期刊:Inflammatory Bowel Diseases [Oxford University Press]
卷期号:29 (1): 85-96 被引量:18
标识
DOI:10.1093/ibd/izac063
摘要

Abstract Background Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We report herpes zoster (HZ) incidence and risk factors in the tofacitinib UC clinical program (up to 7.8 years). Methods Proportions and incidence rates (IRs; unique patients with events/100 patient-years) of HZ were evaluated in 4 cohorts: Induction (phase 2 and 3 induction study data), Maintenance (phase 3 maintenance study data), Overall (data from all phase 2, 3, and open-label, long-term extension studies), and Overall plus interim 6-month phase 3b and 4 data. Herpes zoster risk factors were assessed by Cox regression analysis. Results In the Induction and Maintenance Cohorts, IRs for HZ (nonserious and serious) were numerically higher with tofacitinib 10 mg twice daily (BID) vs placebo and tofacitinib 10 vs 5 mg BID, respectively. With all tofacitinib doses (5 or 10 mg BID), IRs (95% confidence intervals) for HZ in the Overall and Overall plus phase 3b/4 Cohorts (total exposure, 2814.4 and 2999.7 patient-years, respectively) were 3.38 (2.73-4.15) and 3.30 (2.67-4.04), respectively. In the Overall plus phase 3b/4 Cohort, >90% of HZ were nonserious; >90% were mild/moderate; >90% resolved without discontinuing tofacitinib; 0.6% of patients had multiple HZ events. Herpes zoster IRs were stable when analyzed by 6-month intervals up to >30 months. Herpes zoster risk factors included older age, lower weight, geographic region, and prior tumor necrosis factor inhibitor (TNFi) failure. Conclusions Most HZ events were mild/moderate. Herpes zoster IRs remained stable over 7.8 years of exposure. Older age, lower weight, geographic region, and prior TNFi failure were associated with increased HZ risk. ClinicalTrials.gov NCT00787202;NCT01465763;NCT01458951;NCT01458574;NCT01470612;NCT03281304
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
lyy完成签到 ,获得积分10
1秒前
4秒前
myuniv完成签到,获得积分10
4秒前
专注鸵鸟完成签到,获得积分10
4秒前
专注之双完成签到,获得积分10
5秒前
Zircon完成签到 ,获得积分10
6秒前
Much完成签到 ,获得积分10
7秒前
7秒前
充电宝应助颠覆乾坤采纳,获得10
8秒前
9秒前
无花果应助pz采纳,获得10
9秒前
zheng完成签到 ,获得积分10
11秒前
量子星尘发布了新的文献求助10
12秒前
星辰大海应助荔枝采纳,获得10
12秒前
LJL发布了新的文献求助10
13秒前
meng发布了新的文献求助10
13秒前
无私的颤完成签到,获得积分10
13秒前
lucky完成签到 ,获得积分10
14秒前
Zel博博完成签到,获得积分10
14秒前
谷粱诗云完成签到,获得积分10
14秒前
yar应助myuniv采纳,获得10
14秒前
xc完成签到 ,获得积分10
15秒前
15秒前
干净的天与完成签到,获得积分10
15秒前
哈基米德应助毅诚菌采纳,获得10
17秒前
铁甲小杨完成签到,获得积分0
17秒前
18秒前
卡机了完成签到,获得积分10
19秒前
平淡绿柏完成签到,获得积分10
21秒前
架子猫发布了新的文献求助10
21秒前
21秒前
颠覆乾坤发布了新的文献求助10
22秒前
乔乔完成签到,获得积分10
23秒前
学术小白完成签到,获得积分10
23秒前
min完成签到,获得积分10
23秒前
23秒前
汉堡包应助slin_sjtu采纳,获得10
23秒前
czx完成签到,获得积分10
24秒前
szxnb666发布了新的文献求助30
24秒前
MRJJJJ完成签到,获得积分10
24秒前
高分求助中
【提示信息,请勿应助】关于scihub 10000
Les Mantodea de Guyane: Insecta, Polyneoptera [The Mantids of French Guiana] 3000
徐淮辽南地区新元古代叠层石及生物地层 3000
The Mother of All Tableaux: Order, Equivalence, and Geometry in the Large-scale Structure of Optimality Theory 3000
Handbook of Industrial Diamonds.Vol2 1100
Global Eyelash Assessment scale (GEA) 1000
Picture Books with Same-sex Parented Families: Unintentional Censorship 550
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 4038235
求助须知:如何正确求助?哪些是违规求助? 3575992
关于积分的说明 11374009
捐赠科研通 3305760
什么是DOI,文献DOI怎么找? 1819276
邀请新用户注册赠送积分活动 892662
科研通“疑难数据库(出版商)”最低求助积分说明 815022