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Efficacy and Safety of Vedolizumab for Induction of Remission in Inflammatory Bowel Disease—the Israeli Real-World Experience

2017; Oxford University Press; Volume: 23; Issue: 3 Linguagem: Inglês

10.1097/mib.0000000000001039

1536-4844

Uri Kopylov, Yulia Ron, Irit Avni‐Biron, Benjamin Koslowsky, Matti Waterman, Saleh Daher, Bella Ungar, Henit Yanai, Nitsan Maharshak, Ofer Ben–Bassat, Lev Lichtenstein, Ariella Bar‐Gil Shitrit, Eran Israeli, Doron Schwartz, Eran Zittan, Rami Eliakim, Yehuda Chowers, Shomron Ben‐Horin, Iris Dotan,

Pregnancy and Medication Impact

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.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.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.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.