Background: Infliximab therapy has short-term benefits in children with moderate-to-severe Crohn's disease (CD). We assessed the long-term outcome of infliximab maintenance therapy in children with CD.
Methods: We performed a multicenter cohort study of 729 pediatric patients with CD enrolled in the Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry. Children younger than 16 years and newly diagnosed with CD were eligible for this study. Disease and medication information were collected prospectively from the treating physician at diagnosis, 30 days, and quarterly thereafter. No interventions were specified, per protocol.
Results: In all, 202 of 729 patients received infliximab: 62%, 23%, and 15% within 1, 1-2, and >2 years of diagnosis, respectively. The mean age at infliximab initiation was 12.7 years. A total of 158 infliximab-treated patients received maintenance therapy, 29 episodic (8 converted to maintenance), and 15 had incomplete follow-up. Among 128 patients administered maintenance infliximab and followed for >or=1 year, concomitant medications at infliximab initiation included corticosteroids (52%) and immunomodulators (90%). By 1, 2, and 3 years, <10% of patients continuing on maintenance infliximab were receiving corticosteroids (P < 0.001). Following maintenance therapy initiation, 26%, 44%, and 33% of patients continuing on maintenance infliximab over 0-1, 1-2, and 2-3 years, respectively, had clinically inactive disease not requiring corticosteroids or surgery. The likelihood of continuing maintenance infliximab at 1, 2, and 3 years was 93%, 78%, and 67%, respectively.
Conclusions: Infliximab maintenance therapy was a durable and effective treatment that was associated with prolonged corticosteroid withdrawal over a 3-year period in children with CD.