Effectiveness and safety of vedolizumab in anti-TNF-naïve patients with inflammatory bowel disease-a multicenter retrospective European study

U. Kopylov, B. Verstockt, L. Biedermann, S. Sebastian, D. Pugliese, E. Sonnenberg, P. Steinhagen, N. Arebi, Y. Ron, T. Kucharzik, X. Roblin, B. Ungar, A.B.-G. Shitrit, S. Ardizzone, P. Molander, M. Coletta, L. Peyrin-Biroulet, P. Bossuyt, I. Avni-Biron, E. TsoukaliM. Allocca, K. Katsanos, T. Raine, T. Sipponen, G. Fiorino, S. Ben-Horin, R. Eliakim, A. Armuzzi, B. Siegmund, D.C. Baumgart, N. Kamperidis, N. Maharshak, C. Maaser, G. Mantzaris, H. Yanai, D.K. Christodoulou, I. Dotan, M. Ferrante

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Background: Vedolizumab (VDZ) is effective for treatment of ulcerative colitis (UC) and Crohn's disease (CD). In GEMINI trials, anti-tumor necrosis factor (anti-TNF)-naïve patients had a superior response compared with anti-TNF-exposed patients. In real-world experience (RWE), the number of included anti-TNF-naïve patients was low. We aimed to evaluate the effectiveness and safety of VDZ in anti-TNF-naïve patients in an RWE setting. Methods: This retrospective multicenter European pooled cohort study included consecutive active anti-TNF-naïve IBD patients treated with VDZ. The primary end point was clinical response at week 14. Patients with follow-up beyond week 14 and those discontinuing VDZ at any time were included for maintenance outcomes analysis. Results: Since January 2015, 184 anti-TNF-naïve patients from 23 centers initiated VDZ treatment (Crohn's disease [CD], 50; ulcerative colitis [UC], 134). In CD, 42/50 (82%) patients responded by week 14 and 32 (64%) were in clinical remission; 26/50 (52%) achieved corticosteroid-free remission (CSFR). At last follow-up (44 weeks; interquartile range [IQR], 30-52 weeks), 27/35 (77.1%) patients with available data responded to treatment; 24/35 (68.6%) were in clinical remission, 21/35 (60%) were in CSFR. For UC, 116/134 (79.1%) responded to treatment by week 14, including 53 (39.5%) in clinical remission; 49/134 (36.6%) achieved CSFR. At last follow-up (42.5 weeks; IQR, 30-52 weeks), 79/103 (76.7%) patients responded to treatment, 69/103 (67.0%) were in remission, and 61/103 (59.2%) were in CSFR. Adverse effects were reported in 20 (11%) of the patients, leading to treatment discontinuation in 6 (3.3%). Conclusions: VDZ is similarly effective in ant-TNF-naïve CD and UC patients. The efficacy is higher than reported in anti-TNF-experienced patients and is comparable to that of anti-TNF biologics in this population. © 2018 Crohn's & Colitis Foundation. Published by Oxford University Press.
Original languageEnglish
Pages (from-to)2442-2451
Number of pages10
JournalInflammatory Bowel Diseases
Issue number11
Publication statusPublished - 2018


  • corticosteroid
  • mercaptopurine
  • methotrexate
  • vedolizumab, adult
  • aged
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  • cholestasis
  • cohort analysis
  • Crohn disease
  • drug efficacy
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  • European
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  • human
  • inflammatory bowel disease
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  • multicenter study
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  • neutropenia
  • observational study
  • priority journal
  • remission
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  • sarcoidosis
  • tinnitus
  • treatment duration
  • treatment response
  • ulcerative colitis


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