Oren Ledder1,2, Amit Assa3,4, Arie Levine4,5, Johanna C Escher6, Lissy de Ridder6, Frank Ruemmele7, Neil Shah8, Ron Shaoul9, Victorien M Wolters10, Astor Rodrigues11, Holm H Uhlig12,13, Carsten Posovszky14, Kaija-Leena Kolho15, Christian Jakobsen16, Shlomi Cohen4,17, Dror S Shouval4,18, Tim de Meij19, Javier Martin-de-Carpi20, Lisa Richmond21, Jiri Bronsky22, Mira Friedman1, Dan Turner1,2. 1. Shaare Zedek Medical Center, Jerusalem, Israel. 2. Hebrew University of Jerusalem, Jerusalem, Israel. 3. Schneider Medical Center, Petach Tikva, Israel. 4. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 5. Wolfson Medical Center, Holon, Israel. 6. Erasmus Medical Center, Rotterdam, The Netherlands. 7. Hopital Necker Enfants Malades, Paris, France. 8. Great Ormond Street Hospital, London, UK. 9. Rambam Medical Center, Haifa, Israel. 10. University Medical Center Utrecht, Utrecht, The Netherlands. 11. Oxford University Children's Hospital,Oxford, UK. 12. Oxford University Children's Hospital, Oxford, UK. 13. Translational Gastroenterology Unit, Oxford University, UK. 14. University Medical Center, Ulm, Germany. 15. Helsinki University Central Hospital, Helsinki, Finland. 16. Hvidovre University Hospital, Copenhagen, Denmark. 17. 'Dana-Dwek' Children's Hospital, Tel Aviv, Israel. 18. Edmond and Lily Safra Children's Hospital, Tel Hashomer, Israel. 19. VU Medical Centre, Amsterdam, The Netherlands. 20. Hospital Sant Joan de Deu, Barcelona, Spain. 21. Royal Hospital for Sick Children, Glasgow, Uk. 22. University Hospital Motol, Prague, Czech Republic.
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.
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.
Authors: Anna-Maria Schneider; Daniel Weghuber; Benjamin Hetzer; Andreas Entenmann; Thomas Müller; Georg Zimmermann; Sebastian Schütz; Wolf-Dietrich Huber; Judith Pichler Journal: BMC Gastroenterol Date: 2018-09-15 Impact factor: 3.067
Authors: David R Mack; Eric I Benchimol; Jeff Critch; Jennifer deBruyn; Frances Tse; Paul Moayyedi; Peter Church; Colette Deslandres; Wael El-Matary; Hien Huynh; Prévost Jantchou; Sally Lawrence; Anthony Otley; Mary Sherlock; Thomas Walters; Michael D Kappelman; Dan Sadowski; John K Marshall; Anne Griffiths Journal: J Can Assoc Gastroenterol Date: 2018-07-10
Authors: Jodie Ouahed; Elizabeth Spencer; Daniel Kotlarz; Dror S Shouval; Matthew Kowalik; Kaiyue Peng; Michael Field; Leslie Grushkin-Lerner; Sung-Yun Pai; Athos Bousvaros; Judy Cho; Carmen Argmann; Eric Schadt; Dermot P B Mcgovern; Michal Mokry; Edward Nieuwenhuis; Hans Clevers; Fiona Powrie; Holm Uhlig; Christoph Klein; Aleixo Muise; Marla Dubinsky; Scott B Snapper Journal: Inflamm Bowel Dis Date: 2020-05-12 Impact factor: 5.325