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Inflamm Bowel Dis. 2017 Mar;23(3):404-408. doi: 10.1097/MIB.0000000000001039.

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

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  • 1*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; ‖Department of Gastroenterology, Rambam Healthcare Campus, Haifa, Israel; ¶Department of Gastroenterology, Hadassah Medical Center, Jerusalem, Israel; **Department of Gastroenterology, Soroka Medical Center, Beer Sheva, Israel; ††Department of Gastroenterology, Haemek Medical Center, Afula, Israel; ‡‡Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; §§Faculty of Medicine, Hebrew University, Jerusalem, Israel; ‖‖Bruce Rappoport Faculty of Medicine, Technion, Haifa, Israel; and ¶¶Faculty of Medicine, Beer Sheba University, Beer Sheba, Israel.

Abstract

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.

PMID:
28178003
DOI:
10.1097/MIB.0000000000001039
[PubMed - in process]
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