ORIGINAL ARTICLE Efficacy and Safety of Vedolizumab for Induction of Remission in Inflammatory Bowel Disease—the Israeli Real-World Experience Uri Kopylov, MD,* ,‡‡ Yulia Ron, MD, † ,‡‡ Irit Avni-Biron, MD, ‡ ,‡‡ Benjamin Koslowsky, MD, §,§§ Matti Waterman, MD, k,kk Saleh Daher, MD, ¶,§§ Bella Ungar, MD,* ,‡‡ Henit Yanai, MD, †,‡‡ Nitsan Maharshak, MD, †,‡‡ Ofer Ben-Bassat, MD, ‡ ,‡‡ Lev Lichtenstein, MD, ‡,‡‡ Ariella Bar-Gil Shitrit, MD, §,§§ Eran Israeli, MD, ¶,§§ Doron Schwartz, MD,** ,¶¶ Eran Zittan, MD, †† ,kk Rami Eliakim, MD,* ,‡‡ Yehuda Chowers, MD, k ,kk Shomron Ben-Horin, MD,* ,‡‡ and Iris Dotan, MD †,‡‡ Background: Vedolizumab (VDZ) is an anti-integrin monoclonal antibody effective in ulcerative colitis (UC) and Crohn’s disease (CD). The aim of this study was to examine the “real world” efficacy and safety of VDZ in a large national patient cohort. Methods: Patients with inflammatory bowel disease treated with VDZ were prospectively followed for 14 weeks. Patients who completed the induction protocol (week 0/2/6/14) or discontinued the treatment before week 14 for adverse events (AEs) or primary nonresponse were included. The primary outcome was induction of clinical remission at week 14; secondary outcomes included clinical response and corticosteroid-free clinical remission. Results: A total of 204 patients (CD-130, UC-69, inflammatory bowel disease–unclassified-5) from 8 centers in Israel were included. Fifteen (7.4%) of the patients were anti–tumor necrosis factor naive and 46 (35.4%) had a previous surgery. For patients with CD, 69/130 (53.1%) responded to treatment; 45 (34.6%) achieved clinical remission; and 38 (29.2%) achieved corticosteroid-free remission at week 14. Fourteen (10.7%) patients discontinued VDZ before week 14 due to primary nonresponse or AEs. For UC, 32/74 (43.2%) responded to treatment; 20 (28.4%) achieved clinical remission, and 18 (24.3%) achieved corticosteroid-free remission at week 14. Fifteen (20.3%) patients with UC did not complete the induction due to primary nonresponse or AEs. AEs were reported by 29 (14.2%) patients (CD and UC combined), most common being nasopharyngitis and skin eruptions. Conclusions: In a large real-world Israeli cohort of anti–tumor necrosis factor–experienced patients with inflammatory bowel disease, VDZ was effective and safe in induction of clinical remission and steroid-free clinical remission. (Inflamm Bowel Dis 2017;23:404–408) Key Words: ulcerative colitis, Crohn’s disease, vedolizumab V edolizumab (VDZ) is a monoclonal antibody which blocks lymphocyte trafficking by binding to the a4b7 integrin. In clinical trials, VDZ was demonstrated to be effective in the induc- tion and maintenance of remission in both ulcerative colitis (UC) and Crohn’s disease (CD). 1,2 In GEMINI I study, patients with moderate-to-severe UC, who received 300 mg VDZ intrave- nously, had a significantly higher (47.1%) response rate at week 6 compared with 25.5% in the placebo arm (P , 0.001). Remis- sion rates at week 52 for patients continuing VDZ every 8 (41.8%) or 4 weeks (44.8%) were significantly higher compared with those switching to placebo after induction (15.9% P , 0.001). 1 In the GEMINI II study, clinical remission at week 6 in patients with active CD was 14.5% compared with 6.8% in the placebo arm (P ¼ 0.02). Remission rates at week 52 for patients continuing VDZ every 8 (39.0%) or 4 weeks (36.4%) were sig- nificantly higher compared with those switching to placebo after induction (21.6%). 2 By contrast, in the Gemini III study, results of induction of remission in anti–tumor necrosis factor (TNF)–- experienced patients with CD at week 6 did not demonstrate a definite benefit over placebo (primary outcome), although clin- ical superiority of VDZ over placebo was demonstrated for later time points at week 10 and beyond. 3 Thus, data on clinical effi- cacy of VDZ, especially with respect to anti-TNF–experienced patients with CD are scarce. The safety profile of VDZ seems to be favorable, as indicated by the pooled data from 6 VDZ trials; specifically, no increase in the prevalence of infectious complications in comparison with placebo was reported. 4 Several real-world data series have been published to date 5–8 demonstrat- Received for publication November 25, 2016; Accepted December 20, 2016. From the *Department of Gastroenterology, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel; † IBD Center, Department of Gastroenterology and Liver Diseases, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; ‡ Department of Gastroenterology, Rabin Medical Center, Petach Tikva, Israel; § Digestive Diseases Institute, Shaare Zedek Medical Center, Jerusalem, Israel; k Department of Gastroen- terology, Rambam Healthcare Campus, Haifa, Israel; ¶ Department of Gastroenterol- ogy, Hadassah Medical Center, Jerusalem, Israel; **Department of Gastroenterology, Soroka Medical Center, Beer Sheva, Israel; †† Department of Gastroenterology, Hae- mek Medical Center, Afula, Israel; ‡‡ Sackler Faculty of Medicine, Tel Aviv Univer- sity, Tel Aviv, Israel; §§ Faculty of Medicine, Hebrew University, Jerusalem, Israel; kk Bruce Rappoport Faculty of Medicine, Technion, Haifa, Israel; and ¶¶ Faculty of Medicine, Beer Sheba University, Beer Sheba, Israel. U. Kopylov and Y. Ron have contributed equally. Author disclosures are available in the Acknowledgments. Address correspondence to: Uri Kopylov, Department of Gastroenterology, Sheba Medical Center, Tel Hashomer, Ramat Gan, 52960 Israel (e-mail: ukopylov@gmail. com). Copyright © 2017 Crohn’s & Colitis Foundation of America, Inc. DOI 10.1097/MIB.0000000000001039 Published online 13 February 2017. 404 | www.ibdjournal.org Inflamm Bowel Dis  Volume 23, Number 3, March 2017 Copyright © 2017 Crohn’s & Colitis Foundation of America, Inc. Unauthorized reproduction of this article is prohibited.