1. Superior effectiveness of tofacitinib compared to vedolizumab in anti-TNF experienced ulcerative colitis patients: a nationwide Dutch Registry study
- Author
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Tessa Straatmijer, Vince B.C. Biemans, 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 Voorn, Rachel West, Janneke van der Woude, Marije D.J. Wolvers, Marieke Pierik, Andrea E. van der Meulen-de Jong, Marjolijn Duijvestein, Malena Schlotter, Martine van Workum, Dirk de Jong, Willemijn van Dop, S. van der Marel, Hayat El Ghabzouri, Kamila Talhaoui, Bas Oldenburg, Nynke Boontje, Herma Fidder, Meike Hirdes, Rob H. Creemers, J. Hoekstra, Jael Smid, Zlatan Mujagic, Marthe François-Verweij, Toos Schakel- van den Berge, Jeroen Maljaars, Rosaline Theeuwen, Denise van den Berg, Suzanne Gerretsen, Xenia Yocarini, Geert D’Haens, Mark Lowenberg, Joep Grootjans, Krisztina Gecse, Gerd Bouma, Petra Waaijenberg, Bart Muskens, Groningen Institute for Organ Transplantation (GIOT), Translational Immunology Groningen (TRIGR), Groningen Institute for Gastro Intestinal Genetics and Immunology (3GI), Gastroenterology and hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Interne Geneeskunde, MUMC+: MA Maag Darm Lever (9), RS: NUTRIM - R2 - Liver and digestive health, Gastroenterology and Hepatology, Graduate School, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Clinical Research Unit, General Internal Medicine, Tytgat Institute for Liver and Intestinal Research, and Gastroenterology & Hepatology
- Subjects
All institutes and research themes of the Radboud University Medical Center ,Hepatology ,Tofacitinib ,Gastroenterology ,Ulcerative Colitis ,Other Research Radboud Institute for Molecular Life Sciences [Radboudumc 0] ,Real-world Data ,Inflammatory diseases Radboud Institute for Molecular Life Sciences [Radboudumc 5] ,Vedolizumab - 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.
- Published
- 2023