Outcomes in adult infammatory bowel disease clinical trials: Assessment of similarity among participants with adolescent-onset and adult-onset disease

Abstract

Background and Aims: Most paediatric infammatory bowel disease [IBD] studies are performed after medications are approved in adults, and the majority of participants in these studies are adolescents. We hypothesised that adolescent-onset IBD is not fundamentally different from adult-onset IBD. If this is correct, the value of delaying access to novel drugs in adolescents becomes questioned. Methods: Data from 11 randomised, double-blind, placebo-controlled, adult Phases 2 and 3 trials of four biologics were analysed. Participants were categorised as having adolescent-or adult-onset disease [diagnosed 12 to <18 years old at diagnosis; 836 participants [32.4%] received placebo. Of 3708 participants with UC, 221 were 12-<18 years old at diagnosis; 1212 [33%] were receiving placebo. The majority of the ratios of ORs were within 2-fold, suggesting that responses in adolescent-and adult-onset participants are generally similar. Conclusion: Data presented lend support for extrapolating effcacy of biologics from adults to adolescents with IBD, which would facilitate earlier labelling and patient access.