Efficacy and Safety of Vedolizumab for Induction of Remission in Inflammatory Bowel Disease-the Israeli Real-World Experience.
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.
*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.
Uri
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Kopylov
Yulia
Y
Ron
Irit
I
Avni-Biron
Benjamin
B
Koslowsky
Matti
M
Waterman
Saleh
S
Daher
Bella
B
Ungar
Henit
H
Yanai
Nitsan
N
Maharshak
Ofer
O
Ben-Bassat
Lev
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Lichtenstein
Ariella
A
Bar-Gil Shitrit
Eran
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Israeli
Doron
D
Schwartz
Eran
E
Zittan
Rami
R
Eliakim
Yehuda
Y
Chowers
Shomron
S
Ben-Horin
Iris
I
Dotan
D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D015331:Cohort Studies; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage*; D006801:Humans; D060828:Induction Chemotherapy / Q000379:methods; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D007557:Israel; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
D061067:Antibodies, Monoclonal, Humanized; D005765:Gastrointestinal Agents; D014409:Tumor Necrosis Factor-alpha; C543529:vedolizumab