Abstract
Objectives
Few approved treatments exist for children with Crohn’s disease (CD). The REALITI study retrospectively assessed the effectiveness and safety of ustekinumab in real-world clinical settings for children with CD.
Methods
Data were collected from the prospective ImproveCareNow (ICN) registry for pediatric patients (≥ 2 to <18 years old) and young adult patients (≥ 18 to <26 years old), regardless of baseline CD severity. Additional analyses were conducted for a subset of patients who had moderately-to-severely active CD (short pediatric CD activity index [sPCDAI] ≥30). Key Week-52 endpoints included clinical remission (sPCDAI ≤10) and corticosteroid-free (CF) clinical remission. Safety events of interest were assessed at Week 52.
