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

Autor: Straatmijer T; 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., Biemans VBC; St Antonius ziekenhuis, Nieuwegein, the Netherlands., Visschedijk M; University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Hoentjen F; Department of Gastroenterology, Radboud university medical centre, Nijmegen, The Netherlands; Division of Gastroenterology, University of Alberta, Edmonton, Canada., de Vries A; Erasmus Medical Centre, Rotterdam, The Netherlands., van Bodegraven AA; Department of Gastroenterology, Geriatrics, Internal, and Intensive Care Medicine (COMIK), Zuyderland Medical Centre, Heerlen-Sittard-Geleen, The Netherlands., Bodelier A; Amphia Hospital, Breda, The Netherlands., de Boer NKH; Amsterdam University Medical Centre, Vrije Universiteit Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research Institute, Amsterdam, The Netherlands., Dijkstra G; University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Festen N; University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Horjus C; Rijnstate, Arnhem, The Netherlands., Jansen JM; OLVG, Amsterdam, The Netherlands., Jharap B; Meander Medisch Centrum, Amersfoort, The Netherlands., Mares W; Ziekenhuis Geldersche Vallei, Ede, The Netherlands., van Schaik FDM; University Medical Centre Utrecht, Utrecht, The Netherlands., Ponsioen C; Amsterdam UMC, University of Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research Institute, Amsterdam, the Netherlands., Romkens T; Jeroen Bosch Ziekenhuis, Den Bosch, The Netherlands., Srivastava N; Haaglanden Medisch Centre, The Hague, The Netherlands., van der Voorn MMPJA; Haga Ziekenhuis, Den Haag, The Netherlands., West R; Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands., van der Woude J; Erasmus Medical Centre, Rotterdam, The Netherlands., Wolvers MDJ; Amsterdam UMC, department of Epidemiology and Data Science, Amsterdam, The Netherlands., Pierik M; Maastricht University Medical Centre, Maastricht, The Netherlands., van der Meulen-de Jong AE; Leiden University Medical Centre, Department of Gastroenterology and Hepatology, Leiden, The Netherlands., Duijvestein M; Department of Gastroenterology, Radboud university medical centre, Nijmegen, The Netherlands. Electronic address: marjolijn.duijvestein@radboudumc.nl.
Jazyk: angličtina
Zdroj: Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association [Clin Gastroenterol Hepatol] 2023 Jan; Vol. 21 (1), pp. 182-191.e2. Date of Electronic Publication: 2022 May 26.
DOI: 10.1016/j.cgh.2022.04.038
Abstrakt: 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.
(Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE