Long-term Outcome of Treatment with Infliximab in Pediatric-onset Crohn's Disease: A Population-Based Study

Background: We examined short-and long-term benefits and safety of infliximab (IFX) in a population-based cohort of Crohn's disease (CD) patients <17 years old at diagnosis. Methods: The following parameters were assessed: short- and long-term efficacy of IFX, impact of drug efficacy, and mode of administration on rate of resection surgery, growth and nutritional catch-up, and adverse events (AEs). Results: In all, 120 patients (69 female) required IFX with a median duration of 32 months (Q1 = 8-Q3 = 60). Median age at diagnosis was 14.5 years (12-16) and median interval between diagnosis and IFX initiation was 41 months (22-78). Median follow-up since CD diagnosis was 111 months (75-161). Fifty patients (42%) received episodic and 70 (58%) maintenance therapy. Sixty-five (54%) patients were in the IFX efficacy'' group: 38 (32%) still receiving IFX at the last visit and 27 (22%) stopping IFX while in remission. The IFX failure'' group included 55 (46%) patients: 17 (14%) who stopped IFX due to AEs and 38 (32%) nonresponders. The risk of surgery was reduced (P = 0.009) in the IFX efficacy'' group and lower (P = 0.03) in patients with scheduled versus episodic therapy. Patients in the IFX efficacy'' group had significant catch-up growth (P = 0.04), while those in the IFX failure'' group did not. Twenty-four patients presented AEs leading to cessation of IFX in 17 of them. Conclusions: In this population-based cohort of pediatric-onset CD, IFX treatment was effective in more than half of patients during a median follow-up of 32 months. Long-term IFX responders had a lower rate of surgery and improved catch-up in growth, especially when receiving scheduled IFX therapy.