Superior Effectiveness of Tofacitinib Compared to Vedolizumab in Anti-TNF-experienced Ulcerative Colitis Patients : A Nationwide Dutch Registry Study
Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved..
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.
| Errataetall: |
CommentIn: Clin Gastroenterol Hepatol. 2023 May;21(5):1372-1373. - PMID 35850410 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:21 |
|---|---|
| Enthalten in: |
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association - 21(2023), 1 vom: 01. Jan., Seite 182-191.e2 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Straatmijer, Tessa [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 11.01.2023 Date Revised 07.05.2023 published: Print-Electronic CommentIn: Clin Gastroenterol Hepatol. 2023 May;21(5):1372-1373. - PMID 35850410 Citation Status MEDLINE |
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| doi: |
10.1016/j.cgh.2022.04.038 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM341663883 |
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| 245 | 1 | 0 | |a Superior Effectiveness of Tofacitinib Compared to Vedolizumab in Anti-TNF-experienced Ulcerative Colitis Patients |b A Nationwide Dutch Registry Study |
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| 500 | |a Date Revised 07.05.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a CommentIn: Clin Gastroenterol Hepatol. 2023 May;21(5):1372-1373. - PMID 35850410 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a CONCLUSIONS: Tofacitinib was associated with superior effectiveness outcomes compared with vedolizumab in anti-TNF-experienced patients with UC along with comparable safety outcomes | ||
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Real-world Data | |
| 650 | 4 | |a Tofacitinib | |
| 650 | 4 | |a Ulcerative Colitis | |
| 650 | 4 | |a Vedolizumab | |
| 650 | 7 | |a Gastrointestinal Agents |2 NLM | |
| 650 | 7 | |a tofacitinib |2 NLM | |
| 650 | 7 | |a 87LA6FU830 |2 NLM | |
| 650 | 7 | |a Tumor Necrosis Factor Inhibitors |2 NLM | |
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| 650 | 7 | |a vedolizumab |2 NLM | |
| 650 | 7 | |a 9RV78Q2002 |2 NLM | |
| 650 | 7 | |a Janus Kinase Inhibitors |2 NLM | |
| 700 | 1 | |a Biemans, Vince B C |e verfasserin |4 aut | |
| 700 | 1 | |a Visschedijk, Marijn |e verfasserin |4 aut | |
| 700 | 1 | |a Hoentjen, Frank |e verfasserin |4 aut | |
| 700 | 1 | |a de Vries, Annemarie |e verfasserin |4 aut | |
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| 700 | 1 | |a Bodelier, Alexander |e verfasserin |4 aut | |
| 700 | 1 | |a de Boer, Nanne K H |e verfasserin |4 aut | |
| 700 | 1 | |a Dijkstra, Gerard |e verfasserin |4 aut | |
| 700 | 1 | |a Festen, Noortje |e verfasserin |4 aut | |
| 700 | 1 | |a Horjus, Carmen |e verfasserin |4 aut | |
| 700 | 1 | |a Jansen, Jeroen M |e verfasserin |4 aut | |
| 700 | 1 | |a Jharap, Bindia |e verfasserin |4 aut | |
| 700 | 1 | |a Mares, Wout |e verfasserin |4 aut | |
| 700 | 1 | |a van Schaik, Fiona D M |e verfasserin |4 aut | |
| 700 | 1 | |a Ponsioen, Cyriel |e verfasserin |4 aut | |
| 700 | 1 | |a Romkens, Tessa |e verfasserin |4 aut | |
| 700 | 1 | |a Srivastava, Nidhi |e verfasserin |4 aut | |
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| 700 | 1 | |a van der Woude, Janneke |e verfasserin |4 aut | |
| 700 | 1 | |a Wolvers, Marije D J |e verfasserin |4 aut | |
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| 700 | 0 | |a Initiative on Crohn and Colitis |e verfasserin |4 aut | |
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| 700 | 1 | |a van Workum, Martine |e investigator |4 oth | |
| 700 | 1 | |a de Jong, Dirk |e investigator |4 oth | |
| 700 | 1 | |a van Dop, Willemijn |e investigator |4 oth | |
| 700 | 1 | |a van der Marel, S |e investigator |4 oth | |
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| 700 | 1 | |a Oldenburg, Bas |e investigator |4 oth | |
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| 700 | 1 | |a Hirdes, Meike |e investigator |4 oth | |
| 700 | 1 | |a Creemers, Rob H |e investigator |4 oth | |
| 700 | 1 | |a Hoekstra, J |e investigator |4 oth | |
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