Croft NM, Faubion WA, Kugathasan S, et al. - Researchers conducted the double-blind ENVISION I study at 24 hospitals in ten countries with the aim to determine the safety and efficacy of adalimumab in children with moderate-to-severe ulcerative colitis. They randomly assigned children (4–17 years) with moderate-to-severe ulcerative colitis, despite stable doses of concurrent treatment with oral corticosteroids or immunosuppressants, to receive either high-dose induction adalimumab (2·4 mg/kg [maximum 160 mg] at weeks 0 and 1) or standard-dose induction adalimumab (2·4 mg/kg at week 0 and placebo at week 1); at week 2, both groups were administered 1·2 mg/kg (maximum 80 mg) and at weeks 4 and 6, groups were administered 0·6 mg/kg (maximum 40 mg). Random assignment (2:2:1) of patients with partial Mayo score (PMS) response at week 8 (defined as a decrease of two or more points and a decrease of ≥ 30% from baseline in PMS) was done to receive either high-dose maintenance adalimumab (0·6 mg/kg weekly), standard-dose maintenance adalimumab (0·6 mg/kg every other week), or placebo up to week 52 (random assignment to the placebo group was ceased mid-trial, as was randomization in the induction phase with all subsequent patients receiving open-label high-dose induction adalimumab). Per outcomes, children who received adalimumab showed clinically meaningful rates of remission and response. Researchers recorded no new safety signals, indicating that adalimumab is an efficacious and safe therapeutic option for children with moderate-to-severe ulcerative colitis.