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 10mg/kg… Click to show full abstract
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 10mg/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 infliximab over a 10-year period. RESULTS 291 patients were included (mean age = 12.61, 38% female) with a follow-up range of 0.1 to 9.7 years from IFX induction. 155 (53%) were started at a dose of 10mg/kg. Only 35 patients (12%) discontinued IFX. The median duration of treatment was 2.9 years. Patients with UC (p=<0.01) and patients with extensive disease (p=0.01) had lower durability, despite a higher starting dose of infliximab (p=0.03). Adverse events (AEs) were observed to occur at a rate of 234 per 1,000 patient-years. Patients with a higher serum infliximab trough level (≥ 20 µg/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 infliximab dose and serum trough level> 20ug/ml were associated with higher risk of AEs, the majority being mild and not resulting in cessation of therapy.
               
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