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

Uri Kopylov, Bram Verstockt, Luc Biedermann, Shaji Sebastian, Daniela Pugliese, Elena Sonnenberg, Peter Steinhagen, Naila Arebi, Yulia Ron, Torsten Kucharzik, Xavier Roblin, Bella Ungar, Ariella Bar Gil Shitrit, Sandro Ardizzone, Pauliina Molander, Marina Coletta, Laurent Peyrin-Biroulet, Peter Bossuyt, Irit Avni-Biron, Emmanouela TsoukaliMariangela Allocca, Konstantinos Katsanos, Tim Raine, Taina Sipponen, Gionata Fiorino, Shomron Ben-Horin, Rami Eliakim, Alessandro Armuzzi, Britta Siegmund, Daniel C. Baumgart, Nikolaos Kamperidis, Nitsan Maharshak, Christian Maaser, Gerassimos Mantzaris, Henit Yanai, Dimitrious K. Christodoulou, Iris Dotan, Marc Ferrante

Research output: Contribution to journalArticlepeer-review

54 Scopus citations


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.

Original languageEnglish
Pages (from-to)2442-2451
Number of pages10
JournalInflammatory Bowel Diseases
Issue number11
StatePublished - Nov 2018


FundersFunder number
Dr Falk
Dr Falk Benelux
Falk Foundation
Astellas Pharma US
Meso Scale Diagnostics
Takeda Pharmaceutical Company
Janssen Pharmaceuticals
Ferring Pharmaceuticals
Tillotts Pharma
Dr. Falk Pharma


    • Anti-TNF-naïve
    • Crohn's disease
    • Ulcerative colitis
    • Vedolizumab


    Dive into the research topics of 'Effectiveness and safety of vedolizumab in anti-TNF-naïve patients with inflammatory bowel disease-a multicenter retrospective European study'. Together they form a unique fingerprint.

    Cite this