Uri Kopylov1, Bram Verstockt2, Luc Biedermann3, Shaji Sebastian4, Daniela Pugliese5, Elena Sonnenberg6, Peter Steinhagen7, Naila Arebi8, Yulia Ron9, Torsten Kucharzik10, Xavier Roblin11, Bella Ungar1, Ariella Bar-Gil Shitrit12, Sandro Ardizzone13, Pauliina Molander14, Marina Coletta15, Laurent Peyrin-Biroulet16, Peter Bossuyt17, Irit Avni-Biron18, Emmanouela Tsoukali2, Mariangela Allocca19, Konstantinos Katsanos20, Tim Raine21, Taina Sipponen14, Gionata Fiorino22, Shomron Ben-Horin1, Rami Eliakim1, Alessandro Armuzzi5, Britta Siegmund6, Daniel C Baumgart7, Nikolaos Kamperidis8, Nitsan Maharshak9, Christian Maaser10, Gerassimos Mantzaris23, Henit Yanai7, Dimitrious K Christodoulou20, Iris Dotan7, Marc Ferrante2. 1. Sheba Medical Center, Gastroenterology, Tel Hashomer, and Sackler School of Medicine, Tel Aviv University, Israel. 2. Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium. 3. Division of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland. 4. IBD Unit, Hull & East Yorkshire Hospitals NHS Trust, Hull, United Kingdom. 5. IBD Unit, Presidio Columbus Fondazione Policlinico Gemelli Università Cattolica, Rome, Italy. 6. Department of Medicine (Gastroenterology, Infectious DIseases, Rheumatology), Campus Benjamin Franklin, Charité-Universitätsmedizin, Berlin, Germany. 7. Inflammatory Bowel Disease Center, Department of Gastroenterology and Hepatology, Charité Medical School, Humboldt-University of Berlin, Berlin, Germany. 8. Department of Inflammatory Bowel Disease, St Mark's Hospital, Harrow, London, United Kingdom. 9. IBD Center, Department of Gastroenterology and Liver Diseases, Tel Aviv Sourasky Medical Center, and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. 10. Department of Gastroenterology, Lüneburg Hospital, University of Hamburg, Lüneburg, Germany. 11. CHU de Saint-Etienne, Gastroenterology, Saint Etiennne, France. 12. Shaare Zedek Medical Center, Digestive Diseases Institute, Jerusalem, Israel. 13. Department of Gastroenterology, DIBIC, ASST Fatebenefratelli Sacco, Milan University, Milan, Italy. 14. Department of Gastroenterology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland. 15. Department of Pathophysiology and Transplantation, Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico,Università degli Studi di Milano, Milan, Italy. 16. Department of Hepatogastroenterology, Nancy University Hospital, Université de Lorraine, Vandoeuvre-lès-Nancy, France. 17. Imelda GI Clinical Research Center, Gastroenterology, Bonheiden, Belgium. 18. Division of Gastroenterology, Rabin Medical Center, Beilinson Campus, Petah Tikva, and Sackler School of Medicine, Tel Aviv University, Israel. 19. Gastroenterology, Humanitas Gradenigo, Turin, Italy. 20. Division of Gastroenterology, School of Health Sciences and Univeristy Hospital of Ioannina, Ioannina, Greece. 21. Department of Medicine, Addenbrooke's Hospital, University of Cambridge, Cambridge, United Kingdom. 22. IBD Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan, Italy. 23. Department of Gastroenterology, "Evaggelismos-Ophthalmiatreion Athinon-Polycliniki, Athens, Greece.
Abstract
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.
Background: Vedolizumab (VDZ) is effective for treatment of ulcerative colitis (UC) and Crohn's disease (CD). In GEMINI trials, anti-tumornecrosis 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 IBDpatients 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.
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