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

Area of Science:

• Pediatric Gastroenterology
• Immunology
• Clinical Therapeutics

Background:

• The TISKids study previously showed first-line infliximab (FL-IFX) superior to conventional therapy for pediatric Crohn's disease (CD) at 52 weeks.
• This study investigates the long-term 5-year outcomes of this cohort.

Purpose of the Study:

• To evaluate sustained clinical remission and treatment escalation at 5 years in children with moderate-to-severe CD treated with FL-IFX versus conventional therapy.
• To compare the time to initiation or re-initiation of biologic therapy between the two groups.

Main Methods:

• A multicenter, open-label randomized controlled trial involving newly diagnosed, untreated pediatric CD patients (aged 3-17 years).
• Patients were randomized to FL-IFX (5 infusions, then stopped) or conventional treatment, both with azathioprine maintenance.
• Primary outcome: sustained clinical remission without additional CD-related therapy at 5 years. Secondary outcome: time to (re)start biologic therapy.

Main Results:

• At 5 years, sustained remission without additional therapy was low in both groups (6% FL-IFX vs. 2% conventional; p=0.617).
• The majority of patients required additional CD-related treatment (88% FL-IFX vs. 86% conventional; p=0.271).
• FL-IFX significantly delayed the median time to (re)start biologic therapy (65 weeks vs. 31 weeks; p=0.037).

Conclusions:

• Nearly all pediatric patients with moderate-to-severe CD require additional CD-related treatment by 5 years, irrespective of initial therapy.
• FL-IFX induction therapy demonstrated a benefit by delaying the need for subsequent biologic treatments.
• Early and sustained treatment, potentially including infliximab, is crucial for managing moderate-to-severe pediatric Crohn's disease.