Effectiveness and Safety of Vedolizumab in Anti-TNF-Naïve Patients With Inflammatory Bowel Disease—A Multicenter Retrospective European Study. Issue 11 (18th May 2018)

• Record Type: Journal Article
• Authors: Kopylov, Uri; Verstockt, Bram; Biedermann, Luc; Sebastian, Shaji; Pugliese, Daniela; Sonnenberg, Elena; Steinhagen, Peter; Arebi, Naila; Ron, Yulia; Kucharzik, Torsten; Roblin, Xavier; Ungar, Bella; Shitrit, Ariella Bar-Gil; Ardizzone, Sandro; Molander, Pauliina; Coletta, Marina; Peyrin-Biroulet, Laurent; Bossuyt, Peter; Avni-Biron, Irit; Tsoukali, Emmanouela; Allocca, Mariangela; Katsanos, Konstantinos; Raine, Tim; Sipponen, Taina; Fiorino, Gionata; Ben-Horin, Shomron; Eliakim, Rami; Armuzzi, Alessandro; Siegmund, Britta; Baumgart, Daniel C; Kamperidis, Nikolaos; Maharshak, Nitsan; Maaser, Christian; Mantzaris, Gerassimos; Yanai, Henit; Christodoulou, Dimitrious K; Dotan, Iris; Ferrante, Marc;
• Is Part Of: Inflammatory bowel diseases. Volume 24:Issue 11(2018)
• Page Start: 2442
• Page End: 2451
• Publication Date: 2018-05-18
• Subjects: vedolizumab -- Crohn's disease -- ulcerative colitis -- anti-TNF-naïve; Inflammatory bowel diseases -- Periodicals; Colitis, Ulcerative -- Periodicals; Crohn Disease -- Periodicals; Inflammatory Bowel Diseases -- Periodicals; 616.344
• DOI: 10.1093/ibd/izy155
• Languages: English
• ISSNs: 1078-0998

Abstract

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.