Adalimumab may be efficacious, safe treatment for children with ulcerative colitis
Adalimumab was an efficacious and safe treatment option for pediatric patients with moderate to severe ulcerative colitis, according to findings published in Lancet Gastroenterology and Hepatology.
“Before the initiation of the present study in 2014, clinical trials in pediatric patients with moderate to severe ulcerative colitis were scarce,” Nicholas M. Croft, MD, PhD, MBBS, professor of pediatric gastroenterology at the Center for Immunology, Blizard Institute, Barts and London School of Medicine, Queen Mary University of London and the Royal London Children’s Hospital, and colleagues wrote. “The aim of this study was to assess the safety and efficacy of adalimumab in children with moderate to severe ulcerative colitis.”
In the randomized, double-blind phase 3 study ENVISION I, Croft and colleagues analyzed data from 93 children (51% girls ) aged 4 years to 17 years with moderate to severe UC (83% received high-dose or standard-dose induction adalimumab; 17% received open-label high-dose induction adalimumab after study design change). Investigators recruited the participants between Oct. 13, 2014, and Sept. 5, 2018.
The participants received 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); both groups received 1.2 mg/kg (maximum 80 mg) at week 2 and 0.6 mg/kg (maximum 40 mg) at weeks 4 and 6. Those with partial Mayo score (PMS) response at week 8 in the study (defined as a decrease of two or more points and a decrease of 30% from baseline in PMS) received 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.
The co-primary efficacy endpoints of the study were the proportion of patients with PMS remission at week 8 and the proportion of week 8 PMS responders who were in full Mayo score (FMS) remission at week 52.
Croft and colleagues found that remission rates in the pooled adalimumab groups were better compared with external placebo (PMS remission at week 8: 53% of 77 patients; P < .0001; FMS remission at week 52: 37% of 62 patients; P = .0001).
“The findings of the study show that adalimumab treatment was efficacious and well tolerated in children with moderate to severe ulcerative colitis with clinically meaningful rates of remission and response, including corticosteroid-free remission and mucosal healing, observed up to 52 weeks,” Croft and colleagues concluded. “No new safety signals were observed, suggesting that adalimumab is an efficacious and safe treatment option for children with moderate to severe ulcerative colitis.”