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

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

*Corresponding author for this work

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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.

Original languageEnglish
Pages (from-to)182-191.e2
JournalClinical Gastroenterology and Hepatology
Volume21
Issue number1
Early online date25 May 2022
DOIs
Publication statusPublished - 1 Jan 2023

Bibliographical note

Funding
The Initiative on Crohn and Colitis is sponsered by Pfizer by an Independent
Investigator Sponsored Research Grant (Pfizer Tracking Number #57944353).
The Initiative on Crohn and Colitis fellowship is sponsored by AbbVie, Pfizer,
Takeda, Celgene, Janssen Pharmaceutica, Teva Pharmaceutical Industries,
Cablon Medical, Ferring Pharmaceuticals, Mundipharma, Dr Falk Pharma,
Sandoz, and Tramedico.

Publisher Copyright:
© 2023 The Authors

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