DOP037 Efficacy and safety of intravenous vedolizumab in paediatric patients with moderate-to-severe Ulcerative Colitis: Results from the KEPLER phase 3 trial

Abstract Background Approved treatment options for children and adolescents with ulcerative colitis (UC) are limited.1 The KEPLER phase 3 trial evaluated the efficacy, immunogenicity, pharmacokinetics (PK) and safety of vedolizumab (VDZ), an anti-α4β7 integrin biologic, administered as intravenous (IV) induction and maintenance therapy in children and adolescents with moderately to severely active UC. Methods This phase 3, single arm trial (NCT04779307) enrolled patients with moderate-to-severe UC (modified Mayo score of 5-9 with endoscopic subscore ≥2) aged 2-17 years and weighing ≥10kg with prior failure of conventional therapy such as steroids, immunomodulators, and/or tumour necrosis factor (TNF) antagonists. VDZ IV was administered during a 14-week, open-label induction period followed by a 40-week, randomised, double-blind maintenance period evaluating low- (LD) or high-dose (HD) VDZ (1:1) by body weight (10-15kg [100 vs 150mg]; >15-15-