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Vedolizumab in Paediatric Inflammatory Bowel Disease: A Retrospective Multi-Centre Experience From the Paediatric IBD Porto Group of ESPGHAN
O. Ledder, A. Assa, A. Levine, JC. Escher, L. de Ridder, F. Ruemmele, N. Shah, R. Shaoul, VM. Wolters, A. Rodrigues, HH. Uhlig, C. Posovsky, KL. Kolho, C. Jakobsen, S. Cohen, DS. Shouval, T. de Meij, J. Martin-de-Carpi, L. Richmond, J. Bronsky,...
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články, multicentrická studie
PubMed
28605483
DOI
10.1093/ecco-jcc/jjx082
Knihovny.cz E-zdroje
- MeSH
- Crohnova nemoc farmakoterapie MeSH
- dítě MeSH
- humanizované monoklonální protilátky škodlivé účinky terapeutické užití MeSH
- idiopatické střevní záněty farmakoterapie MeSH
- lidé MeSH
- mladiství MeSH
- předškolní dítě MeSH
- retrospektivní studie MeSH
- ulcerózní kolitida farmakoterapie MeSH
- výsledek terapie MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- předškolní dítě MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
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.
Erasmus Medical Center Rotterdam The Netherlands
Great Ormond Street Hospital London UK
Helsinki University Central Hospital Helsinki Finland
Hopital Necker Enfants Malades Paris France
Hospital Sant Joan de Deu Barcelona Spain
Hvidovre University Hospital Copenhagen Denmark
Oxford University Children's Hospital Oxford UK
Rambam Medical Center Haifa Israel
Royal Hospital for Sick Children Glasgow Uk
Sackler Faculty of Medicine Tel Aviv University Tel Aviv Israel Wolfson Medical Center Holon Israel
Shaare Zedek Medical Center Jerusalem Israel
Shaare Zedek Medical Center Jerusalem Israel Hebrew University of Jerusalem Jerusalem Israel
University Hospital Motol Prague Czech Republic
University Medical Center Ulm Germany
Citace poskytuje Crossref.org
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- $a 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.
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