Safety and Durability of Accelerated Infliximab Dosing Strategies in Pediatric IBD: A Single Center, Retrospective Study

Objectives: Infliximab (IFX) is commonly used to treat children with inflammatory bowel disease (IBD). We previously reported that patients with extensive disease started on IFX at a dose of 10 mg/kg had greater treatment durability at year one. The aim of this follow-up study is to assess the long-term safety and durability of this dosing strategy in pediatric IBD. Methods: We performed a retrospective single-center study of pediatric IBD patients started on IFX over a 10-year period. Results: Two hundred ninety-one patients were included (mean age = 12.61, 38% female) with a follow-up range of 0.1-9.7 years from IFX induction. One hundred fifty-five (53%) were started at a dose of 10 mg/kg. Only 35 patients (12%) discontinued IFX. The median duration of treatment was 2.9 years. Patients with ulcerative colitis (P <= 0.01) and patients with extensive disease (P = 0.01) had lower durability, despite a higher starting dose of IFX (P = 0.03). Adverse events (AEs) were observed to occur at a rate of 234 per 1000 patient-years. Patients with a higher serum IFX trough level (>= 20 mu g/mL) had a higher rate of AEs (P = 0.01). Use of combination therapy had no impact on risk of AEs (P = 0.78). Conclusions: We observed an excellent IFX treatment durability, with only 12% of patients discontinuing therapy over the observed timeframe. The overall rate of AEs was low, the majority being infusion reactions and dermatologic conditions. Higher IFX dose and serum trough level> 20 mu g/mL were associated with higher risk of AEs, the majority being mild and not resulting in cessation of therapy.

Automated summary

Objective: To assess the long-term safety and durability of Infliximab (IFX) treatment in pediatric inflammatory bowel disease (IBD). Results: Only 12% of patients discontinued IFX treatment and the majority of adverse events (AEs) were mild and did not result in cessation of therapy. Higher dose and serum trough level of IFX were associated with a higher risk of AEs. Conclusions: IFX has excellent treatment durability in pediatric IBD with low AEs rate and can be safely used for long-term treatment.