Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting.
Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting.
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DOI：
10.1093/ibd/izac121
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发表时间：
2023-04-03
影响因子：
4.9
通讯作者：
Herfarth, Hans H.
中科院分区：
文献类型：
--
作者：
Long, Millie D.;Afzali, Anita;Fischer, Monika;Hudesman, David;Abdalla, Maisa;McCabe, Robert;Cohen, Benjamin L.;Ungaro, Ryan C.;Harlan, Will;Hanson, John;Konijeti, Gauree;Polyak, Steven;Ritter, Timothy;Salzberg, Bruce;Seminerio, Jennifer;English, Emily;Zhang, Xian;Sharma, Puza P.;Herfarth, Hans H.
托法替尼是一种口服小分子JAK抑制剂，用于治疗溃疡性结肠炎（UC）。使用一种新颖的电子报告工具，我们的目的是在现实世界的研究中前瞻性地描述诱导治疗期间托法替尼疗效的开始。每天收集患者报告的结果数据（PROs），包括简单临床结肠炎活动指数（SCCAI）、PRO测量识别系统（PROMIS）测量和不良事件，包括前14天、第28天和第56天。使用配对t检验和趋势P来比较SCCAI随时间的变化。采用双变量分析和logistic回归模型描述临床因素对缓解（SCCAI <5）和缓解（SCCAI≤2）的影响。在所有纳入的患者（n = 96）中，67%的患者使用≥2种生物制剂失败，61.5%的患者同时使用类固醇。从第3天开始，PROs的SCCAI平均值持续显著下降（- 1.1,P < 000.1），包括排便频率（- 0.3,P < 0.003）、出血（- 0.3,P < 0.002）和急症（- 0.2,P < 0.001）的SCCAI亚评分显著降低。在第14、28和56天，分别有25%、30.2%和29.2%的患者实现了无类固醇缓解。在多变量模型中，既往生物制剂和内镜严重程度都不能独立预测反应或缓解。在第56天，所有PROMIS测量（焦虑、抑郁、社会满意度）的数值都有所改善。由于不良事件而停药的比率很低。在这项前瞻性现实世界研究中，托法替尼导致UC疾病活动性pro的快速和持续改善。安全性研究结果与托法替尼的既定安全性一致。
Tofacitinib is an oral, small-molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Using a novel electronic reporting tool, we aimed to prospectively describe the onset of tofacitinib efficacy during induction therapy in a real-world study. Patient-reported outcome data (PROs) including the simple clinical colitis activity index (SCCAI), PRO Measurement Identification Systems (PROMIS) measures, and adverse events were collected daily for the first 14 days and at day 28 and 56. Paired t tests and P for trend were utilized to compare changes in SCCAI over time. Bivariate analyses and logistic regression models were performed to describe response (SCCAI <5) and remission (SCCAI ≤2) by clinical factors. Of all included patients (n = 96), 67% had failed ≥2 biologics, and 61.5% were on concomitant steroids. Starting at day 3, PROs showed significant and persistent decline of the mean SCCAI (−1.1, P < 000.1) including significantly lower SCCAI subscores for stool frequency (−0.3; P < .003), bleeding (−0.3; P < .0002) and urgency (−0.2; P < .001). Steroid-free remission at day 14, 28, and 56 was achieved in 25%, 30.2%, and 29.2% of patients, respectively. Neither prior biologics nor endoscopic severity were independently predictive of response or remission in multivariate models. Numeric improvements in all PROMIS measures (anxiety, depression, social satisfaction) were seen through day 56. Rates of discontinuation due to adverse events were low. In this prospective real-world study, tofacitinib resulted in a rapid and persistent improvement in UC disease activity PROs. The safety findings were consistent with the established safety profile of tofacitinib.
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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.
影响因子：
9.8
作者：
Lichtenstein, GR;Yan, SK;Hanauer, S
通讯作者：
Hanauer, S
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
影响因子：
1.9
作者：
Jowett, SL;Seal, CJ;Welfare, MR
通讯作者：
Welfare, MR
影响因子：
9.8
作者：
Kochar, Bharati;Martin, Christopher F.;Long, Millie D.
通讯作者：
Long, Millie D.