与维多珠单抗相比，托法替布在接受过抗TNF治疗的溃疡性结肠炎患者中疗效更佳：一项荷兰全国性注册研究。

Superior Effectiveness of Tofacitinib Compared to Vedolizumab in Anti-TNF-experienced Ulcerative Colitis Patients: A Nationwide Dutch Registry Study.

作者信息

Straatmijer Tessa, Biemans Vince B C, Visschedijk Marijn, Hoentjen Frank, de Vries Annemarie, van Bodegraven Adriaan A, Bodelier Alexander, de Boer Nanne K H, Dijkstra Gerard, Festen Noortje, Horjus Carmen, Jansen Jeroen M, Jharap Bindia, Mares Wout, van Schaik Fiona D M, Ponsioen Cyriel, Romkens Tessa, Srivastava Nidhi, van der Voorn Michael M P J A, West Rachel, van der Woude Janneke, Wolvers Marije D J, Pierik Marieke, van der Meulen-de Jong Andrea E, Duijvestein Marjolijn

机构信息

Amsterdam UMC, University of Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research Institute, Amsterdam, the Netherlands; Leiden University Medical Centre, Department of Gastroenterology and Hepatology, Leiden, The Netherlands.

St Antonius ziekenhuis, Nieuwegein, the Netherlands.

出版信息

Clin Gastroenterol Hepatol. 2023 Jan;21(1):182-191.e2. doi: 10.1016/j.cgh.2022.04.038. Epub 2022 May 26.

DOI:10.1016/j.cgh.2022.04.038

PMID:35644343

Abstract

BACKGROUND & AIMS: Clinicians face difficulty in when and in what order to position biologics and Janus kinase inhibitors in patients with anti-tumor necrosis factor-alpha (TNF) refractory ulcerative colitis (UC). We aimed to compare the effectiveness and safety of vedolizumab and tofacitinib in anti-TNF-exposed patients with UC in our prospective nationwide Initiative on Crohn and Colitis Registry.

METHODS

Patients with UC who failed anti-TNF treatment and initiated vedolizumab or tofacitinib treatment were identified in the Initiative on Crohn and Colitis Registry in the Netherlands. We selected patients with both clinical as well as biochemical or endoscopic disease activity at initiation of therapy. Patients previously treated with vedolizumab or tofacitinib were excluded. Corticosteroid-free clinical remission (Simple Clinical Colitis Activity Index ≤2), biochemical remission (C-reactive protein ≤5 mg/L or fecal calprotectin ≤250 μg/g), and safety outcomes were compared after 52 weeks of treatment. Inverse propensity score-weighted comparison was used to adjust for confounding and selection bias.

RESULTS

Overall, 83 vedolizumab- and 65 tofacitinib-treated patients were included. Propensity score-weighted analysis showed that tofacitinib-treated patients were more likely to achieve corticosteroid-free clinical remission and biochemical remission at weeks 12, 24, and 52 compared with vedolizumab-treated patients (odds ratio [OR], 6.33; 95% confidence interval [CI], 3.81-10.50; P < .01; OR, 3.02; 95% CI, 1.89-4.84; P < .01; and OR, 1.86; 95% CI, 1.15-2.99; P = .01; and OR, 3.27; 95% CI, 1.96-5.45; P < .01; OR, 1.87; 95% CI, 1.14-3.07; P = .01; and OR, 1.81; 95% CI, 1.06-3.09; P = .03, respectively). There was no difference in infection rate or severe adverse events.

CONCLUSIONS

Tofacitinib was associated with superior effectiveness outcomes compared with vedolizumab in anti-TNF-experienced patients with UC along with comparable safety outcomes.

摘要

背景与目的

临床医生在确定何时以及按何种顺序为抗肿瘤坏死因子-α（TNF）难治性溃疡性结肠炎（UC）患者使用生物制剂和 Janus 激酶抑制剂时面临困难。我们旨在通过我们全国性的前瞻性克罗恩病和结肠炎登记倡议，比较维多珠单抗和托法替布在接受过 TNF 治疗的 UC 患者中的有效性和安全性。

方法

在荷兰的克罗恩病和结肠炎登记倡议中，识别出抗 TNF 治疗失败并开始使用维多珠单抗或托法替布治疗的 UC 患者。我们选择了治疗开始时具有临床以及生化或内镜下疾病活动的患者。排除先前接受过维多珠单抗或托法替布治疗的患者。比较治疗 52 周后的无皮质类固醇临床缓解（简单临床结肠炎活动指数≤2）、生化缓解（C 反应蛋白≤5mg/L 或粪便钙卫蛋白≤250μg/g）和安全性结果。使用逆倾向评分加权比较来调整混杂因素和选择偏倚。

结果

总体而言，纳入了 83 例接受维多珠单抗治疗和 65 例接受托法替布治疗的患者。倾向评分加权分析显示，与接受维多珠单抗治疗的患者相比，接受托法替布治疗的患者在第 12、24 和 52 周更有可能实现无皮质类固醇临床缓解和生化缓解（优势比[OR]，6.33；95%置信区间[CI]，3.81 - 10.50；P <.01；OR，3.02；95%CI，1.89 - 4.84；P <.01；OR，1.86；95%CI，1.15 - 2.99；P =.01；OR，3.27；95%CI，1.96 - 5.45；P <.01；OR，1.87；95%CI，1.14 - 3.07；P =.01；OR，1.81；95%CI，1.06 - 3.09；P =.03）。感染率或严重不良事件没有差异。