Superior Effectiveness of Tofacitinib Compared to Vedolizumab in Anti-TNF-experienced Ulcerative Colitis Patients: A Nationwide Dutch Registry Study
Initiative on Crohn and Colitis
(2023) Clinical Gastroenterology and Hepatology, volume 21, issue 1, pp. 182 - 191.e2
(Article)
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
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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.
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Keywords: Real-world Data, Tofacitinib, Ulcerative Colitis, Vedolizumab, Gastroenterology, Hepatology, Journal Article
ISSN: 1542-3565
Publisher: W.B. Saunders Ltd
Note: Funding Information: 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. Conflicts of interest These authors disclose the following: Alexander Bodelier has participated in advisory boards of Takeda, Janssen Pharmaceutica, Ferring, and Mundipharma. Adriaan A. van Bodegraven has served as consultant or speaker for AbbVie, ARENA, Ferring, Janssen, MSD, Pfizer, Takeda, TEVA, Tramedico, VIFOR, and Dutch Ministry of Health (ZonMW); has received (unrestricted) research grants from Aventis and Ferring, Pfizer, TEVA, and the Dutch Ministry of Health; and has performed as (local) principal investigator in studies sponsored by Schering-Plough, Roche, Teva, Janssen, MSD, Pfizer, ARENA and Centocor. Marijn Visschedijk has served on the advisory board for Janssen-Cilag and received a speakers fee from Takeda, outside the submitted work. Fiona van Schaik has served on advisory boards for Takeda and Galapagos. Janneke van der Woude received grant support from Falk Benelux, Ferring and Pfizer; received speaker fees from AbbVie, Takeda, Ferring, Dr Falk Pharma, Pfizer; and served as a consultant for Janssen. Nanne K. H. de Boer has served as a speaker for AbbVie and MSD and has served as consultant and/or principal investigator for TEVA Pharma BV and Takeda; has received a (unrestricted) research grant from Dr Falk, TEVA Pharma BV, MLDS and Takeda, all outside the submitted work. Frank Hoentjen has served on advisory boards or as speaker for Abbvie, Janssen-Cilag, MSD, Takeda, Celltrion, Teva, Sandoz, and Dr Falk; has received funding (grants/honoraria) from Dr Falk, Janssen-Cilag, and Abbvie; and has received consulting fees from Celgene. Marjolijn Duijvestein reports advisory fees from Echo Pharma and Robarts Clinical Trials, Inc; speaker fees from Janssen, Merck & Co., Inc., Pfizer, Takeda, and Tillotts Pharma; and nonfinancial support from Dr Falk Pharm. Gerard Dijkstra has received grant support from DSM nutritional products LTD and speaker's fees from Janssen Pharmaceuticals, Abbvie, and Takeda, outside of the submitted work. Andrea E van der Meulen-de Jong has received a presentation fee from Janssen and served on the advisory board of Takeda and Galapagos, outside of the submitted work. Rachel West has served on the advisory board and as an invited speaker for Janssen, Pfizer and Takeda, outside of the submitted work. Jeroen M. Jansen has served on advisory boards, or as speaker or consultant for Abbvie, Amgen, Ferring, Fresenius, Janssen, MSD, Pfizer, Takeda, and A.G.L. Annemarie C. de Vries has participated in advisory boards and/or received financial compensation from the following companies: Jansen, Takeda, Abbvie, and Tramedico. Marieke J. Pierik has served on advisory boards, or as speaker or consultant for Abbvie, Janssen-Cilag, MSD, Takeda, Ferring, Dr Falk, and Sandoz; and has received unrestricted grants from, Janssen-Cilag, Abbvie, and Takeda, outside the submitted work. Cyriel Ponsioen received grants or contracts from Takeda, Pliant, and Gilead Sciences; consulting fees from Pliant and Shire (Takeda); and payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events from Takeda, Tillotts Pharma, and Pfizer, outside of the submitted work. The remaining authors disclose no conflicts. Funding Information: Conflicts of interest These authors disclose the following: Alexander Bodelier has participated in advisory boards of Takeda, Janssen Pharmaceutica, Ferring, and Mundipharma. Adriaan A. van Bodegraven has served as consultant or speaker for AbbVie, ARENA, Ferring, Janssen, MSD, Pfizer, Takeda, TEVA, Tramedico, VIFOR, and Dutch Ministry of Health (ZonMW); has received (unrestricted) research grants from Aventis and Ferring, Pfizer, TEVA, and the Dutch Ministry of Health; and has performed as (local) principal investigator in studies sponsored by Schering-Plough, Roche, Teva, Janssen, MSD, Pfizer, ARENA and Centocor. Marijn Visschedijk has served on the advisory board for Janssen-Cilag and received a speakers fee from Takeda, outside the submitted work. Fiona van Schaik has served on advisory boards for Takeda and Galapagos. Janneke van der Woude received grant support from Falk Benelux, Ferring and Pfizer; received speaker fees from AbbVie, Takeda, Ferring, Dr Falk Pharma, Pfizer; and served as a consultant for Janssen. Nanne K. H. de Boer has served as a speaker for AbbVie and MSD and has served as consultant and/or principal investigator for TEVA Pharma BV and Takeda; has received a (unrestricted) research grant from Dr Falk, TEVA Pharma BV, MLDS and Takeda, all outside the submitted work. Frank Hoentjen has served on advisory boards or as speaker for Abbvie, Janssen-Cilag, MSD, Takeda, Celltrion, Teva, Sandoz, and Dr Falk; has received funding (grants/honoraria) from Dr Falk, Janssen-Cilag, and Abbvie; and has received consulting fees from Celgene. Marjolijn Duijvestein reports advisory fees from Echo Pharma and Robarts Clinical Trials, Inc; speaker fees from Janssen, Merck & Co., Inc., Pfizer, Takeda, and Tillotts Pharma; and nonfinancial support from Dr Falk Pharm. Gerard Dijkstra has received grant support from DSM nutritional products LTD and speaker's fees from Janssen Pharmaceuticals, Abbvie, and Takeda, outside of the submitted work. Andrea E van der Meulen-de Jong has received a presentation fee from Janssen and served on the advisory board of Takeda and Galapagos, outside of the submitted work. Rachel West has served on the advisory board and as an invited speaker for Janssen, Pfizer and Takeda, outside of the submitted work. Jeroen M. Jansen has served on advisory boards, or as speaker or consultant for Abbvie, Amgen, Ferring, Fresenius, Janssen, MSD, Pfizer, Takeda, and A.G.L. Annemarie C. de Vries has participated in advisory boards and/or received financial compensation from the following companies: Jansen, Takeda, Abbvie, and Tramedico. Marieke J. Pierik has served on advisory boards, or as speaker or consultant for Abbvie, Janssen-Cilag, MSD, Takeda, Ferring, Dr Falk, and Sandoz; and has received unrestricted grants from, Janssen-Cilag, Abbvie, and Takeda, outside the submitted work. Cyriel Ponsioen received grants or contracts from Takeda, Pliant, and Gilead Sciences; consulting fees from Pliant and Shire (Takeda); and payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events from Takeda, Tillotts Pharma, and Pfizer, outside of the submitted work. The remaining authors disclose no conflicts. Funding Information: 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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