Randomized Trial Comparing 5-Year Follow-Up of First-Line Infliximab to Conventional Therapy in Pediatric Crohn’s Disease

BACKGROUND & AIMS: The TISKids study previously demonstrated that first-line infliximab was more effective than conventional treatment in achieving clinical remission without treatment escalation at 52 weeks in children with moderate-to-severe Crohn's disease. We investigated 5-year outcomes. METHODS: The TISKids study is a multicenter, open-label, randomized controlled trial in newly diagnosed, untreated patients with Crohn's disease aged 3 to 17 years (weighted Pediatric Crohn's Disease Activity Index >40). Patients were randomized to first-line infliximab (5 infliximab infusions, then stopped) or conventional treatment (exclusive enteral nutrition or prednisolone). Both groups received azathioprine maintenance. The primary outcome was sustained clinical remission (weighted Pediatric Crohn's Disease Activity Index