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Medline ® Abstract for Reference 34

of 'Management of severe or refractory ulcerative colitis in children and adolescents'

Vedolizumab in pediatric inflammatory bowel disease: a retrospective multi-center experience from the Paediatric IBD Porto group of ESPGHAN.
Ledder O, Assa A, Levine A, Escher JC, de Ridder L, Ruemmele F, Shah N, Shaoul R, Wolters VM, Rodrigues A, Uhlig HH, Posovsky C, Kolho KL, Jakobsen C, Cohen S, Shouval DS, de Meij T, Martin-de-Carpi J, Richmond L, Bronsky J, Friedman M, Turner D
J Crohns Colitis. 2017;
Background: Vedolizumab, an anti-integrin antibody, has proven to be effective in adults with Inflammatory Bowel Disease (IBD), but the data in pediatrics are limited. We describe the short-term effectiveness and safety of vedolizumab in a European multi-center pediatric IBD cohort.
Method: Retrospective review of children (2-18 years) treated with vedolizumab from 19 centers affiliated with the Paediatric IBD Porto group of ESPGHAN. Primary outcome was week 14 corticosteroid-free remission (CFR).
Results: 64 children were included [32 (50%) male, mean age 14.5 ± 2.8 years, with a median follow-up 24 weeks (IQR 14-38; range 6-116)]; 41 (64%) UC/IBDU and 23 (36%) CD. All were previously treated with anti-TNF (28% primary failure, 53% secondary failure). Week 14 CFR was 37% in UC, and 14% in CD (p=0.06). CFR by last follow-up was 39% in UC and 24% in CD (p=0.24). Ten (17%) children required surgery, 6 of whom had colectomy for UC.Concomitant immunomodulatory drugs did not affect remission rate (42% vs 35%; p=0.35 at week 22). There were 3 minor drug-related adverse events. Overall 5% achieved endoscopic mucosal healing with 9% achieving stool calprotectin<100mcg/gm.
Conclusion: Vedolizumab was safe and effective in this cohort of pediatric refractory IBD. These data support previous findings of slow induction rate of vedolizumab in CD and a trend to be less effective compared to patients with UC.
Shaare Zedek Medical Center, Jerusalem, Israel.