Real-world experience with tofacitinib in ulcerative colitis: a systematic review and meta-analysis.
Real-world experience with tofacitinib in ulcerative colitis: a systematic review and meta-analysis.
复制标题
DOI：
10.1177/17562848211064004
复制
发表时间：
2021
影响因子：
4.2
通讯作者：
Lees CW
中科院分区：
文献类型：
--
作者：
Lucaciu LA;Constantine-Cooke N;Plevris N;Siakavellas S;Derikx LAAP;Jones GR;Lees CW
托法替尼是一种Janus激酶抑制剂（JAKi），基于OCTAVE临床试验的稳健疗效和安全性数据，最近获批用于治疗中度至重度溃疡性结肠炎（UC）。需要关于托法替尼治疗在真实世界UC患者中的结局的证据，因为这些患者中的一些患者将被认为不符合临床试验的条件。因此，我们总结了来自托法替尼在中重度UC患者中的有效性和安全性的观察性、真实世界证据（RWE）研究的数据。我们检索了PubMed、EMBASE、Scopus、Web of Science和科克伦数据库中2018年5月30日至2021年1月24日期间发表的关于UC患者使用托法替尼的观察性研究。使用随机效应模型计算合并的诱导（8-14周）和维持（16-26周）临床应答和缓解率，以及报告的不良事件比例。纳入了9项研究，包括830例患者，其中81%既往接受过抗肿瘤坏死因子（TNF）治疗，57%接受过Vedolizumab治疗。在中位随访8周后，51%（95%置信区间，41-60%）和37%（26-45%）的患者实现了诱导临床应答和缓解。在中位随访24周结束时，分别有40%（31-50%）和29%（23-36%）的患者达到临床应答和缓解的维持。32%的患者至少有一次不良事件，最常见的是轻度感染（13%）和UC恶化，需要结肠切除术（13%）。三分之一的患者（35%）停用托法替尼，最常见的原因是原发性无应答（51%）。如先前临床试验所报告，托法替尼在现实世界的UC患者中是一种安全有效的治疗。
Tofacitinib is a Janus kinase inhibitor (JAKi) recently approved for the treatment of moderate to severe ulcerative colitis (UC) based on robust efficacy and safety data derived from OCTAVE clinical trials. Evidence on the outcomes of tofacitinib therapy in real-world UC patients is needed, as a number of these patients would be deemed ineligible for clinical trials. We have therefore summarised data derived from observational, real-world evidence (RWE) studies on the effectiveness and safety of tofacitinib in moderate to severe UC patients. We searched the PubMed, EMBASE, Scopus, Web of Science and Cochrane databases for observational studies on the use of tofacitinib in UC patients, published between 30 May 2018 and 24 January 2021. Pooled induction (8–14 weeks) and maintenance (16–26 weeks) clinical response and remission rates were calculated, as well as the proportion of reported adverse events using random effects models. Nine studies were included, comprising 830 patients, of which 81% were previously treated with anti-tumour necrosis factor (TNF) and 57% with vedolizumab. Induction of clinical response and remission were achieved in 51% (95% confidence interval, 41–60%) and 37% (26–45%) of patients, after a median follow-up of 8 weeks. At the end of a median follow-up of 24 weeks, maintenance of clinical response and remission were met in 40% (31–50%) and 29% (23–36%) of patients, respectively. Thirty-two percent of the patients had at least one adverse event, the most commonly reported being mild infection (13%) and worsening of UC, requiring colectomy (13%). A third of the patients (35%) discontinued tofacitinib, most frequently due to primary non-response (51%). Tofacitinib is a safe and effective therapy in real-world UC patients, as previously reported by clinical trials.
登录
查看更多内容
影响因子：
7.6
作者：
Sandborn, William J.;Panes, Julian;Danese, Silvio
通讯作者：
Danese, Silvio
影响因子：
12.6
作者：
Sandborn, William J.;Panes, Julian;Chan, Gary
通讯作者：
Chan, Gary
影响因子：
7.6
作者：
Biemans, Vince B. C.;Sleutjes, Jasmijn A. M.;Pierik, Marieke J.
通讯作者：
Pierik, Marieke J.
DOI：
10.1016/j.cgh.2020.06.050
发表时间：
2021-08
期刊：
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
影响因子：
--
作者：
Deepak P;Alayo QA;Khatiwada A;Lin B;Fenster M;Dimopoulos C;Bader G;Weisshof R;Jacobs M;Gutierrez A;Ciorba MA;Christophi GP;Patel A;Hirten RP;Colombel JF;Rubin DT;Ha C;Beniwal-Patel P;Ungaro RC;Syal G;Pekow J;Cohen BL;Yarur A
通讯作者：
Yarur A
DOI：
10.1016/0197-2456(86)90046-2
发表时间：
1986-09-01
期刊：
CONTROLLED CLINICAL TRIALS
影响因子：
--
作者：
DERSIMONIAN, R;LAIRD, N
通讯作者：
LAIRD, N