Vedolizumab in Paediatric Inflammatory Bowel Disease: A Retrospective Multi-Centre Experience From the Paediatric IBD Porto Group of ESPGHAN. (9th June 2017)

• Record Type: Journal Article
• Authors: Ledder, Oren; Assa, Amit; Levine, Arie; Escher, Johanna C; de Ridder, Lissy; Ruemmele, Frank; Shah, Neil; Shaoul, Ron; Wolters, Victorien M; Rodrigues, Astor; Uhlig, Holm H; Posovszky, Carsten; Kolho, Kaija-Leena; Jakobsen, Christian; Cohen, Shlomi; Shouval, Dror S; de Meij, Tim; Martin-de-Carpi, Javier; Richmond, Lisa; Bronsky, Jiri; Friedman, Mira; Turner, Dan
• Is Part Of: Journal of Crohn's and colitis. Volume 11:Number 10(2017:Oct.)
• Page Start: 1230
• Page End: 1237
• Publication Date: 2017-06-09
• Subjects: Vedolizumab -- paediatric -- inflammatory bowel disease; Inflammatory bowel diseases -- Periodicals; 616.344005
• DOI: 10.1093/ecco-jcc/jjx082
• Languages: English
• ISSNs: 1873-9946

Abstract

Abstract: Background: Vedolizumab, an anti-integrin antibody, has proven to be effective in adults with inflammatory bowel disease [IBD], but the data in paediatrics are limited. We describe the short-term effectiveness and safety of vedolizumab in a European multi-centre paediatric IBD cohort. Method: Retrospective review of children [aged 2–18 years] treated with vedolizumab from 19 centres affiliated with the Paediatric IBD Porto group of ESPGHAN. Primary outcome was Week 14 corticosteroid-free remission [CFR]. Results: In all, 64 children were included (32 [50%] male, mean age 14.5 ± 2.8 years, with a median follow-up 24 weeks [interquartile range 14–38; range 6–116]); 41 [64%] cases of ulcerative colitis/inflammatory bowel disease unclassified [UC/IBD-U] and 23 [36%] Crohn's disease [CD]. All were previously treated with anti-tumour necrosis factor [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, six 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 three minor drug-related adverse events. Only 3 of 16 children who underwent endoscopic evaluation had mucosal healing after treatment (19%). Conclusions: Vedolizumab was safe and effective in this cohort of paediatric refractory IBD. These data support previous findings of slow induction rate of vedolizumab in CD and a trend to be less effective compared with patients with UC.