Retrospective Review of Infliximab Use in Patients Less Than Six Years of Age

Abstract

The REACH study helped determine the efficacy and safety of infliximab in patients 6-17 years of age. The dosing, including induction, was found to be similar to adult dosing. This study also demonstrated an incidence of serious infections at 5.7%. The most prevalent adverse events were respiratory infections. In 2012, deBie et al. reviewed the literature on the use of anti-TNF medications in pediatric IBD and found adjustments in dosing between 27-49% of the time. The median time to dose adjustment was 6-9 months. After initiation of infliximab, intestinal surgery was performed in 25-35% of patients with Crohn's disease. There are no reports on the use of infliximab in patients less than 6 years of age. This was a descriptive, retrospective chart review of patients with IBD receiving infliximab as standard care for treatment of IBD from June 2002- July 2012. Since 2002, our institution has diagnosed 790 patients with IBD; 50 patients (6%) were under 6 years of age at the time of diagnosis. 13 (26%) of these patients with IBD received infliximab when they were less than 6 years of age; 8 diagnosed with Crohn's disease, 3 with UC, and 2 with indeterminant colitis. The age at diagnosis ranged from 11 months to 66 months with a mean of 37 months. 12 patients presented with bloody diarrhea. The age infliximab was initiated ranged from 15 months to 69 months with a mean of 46 months. 7 patients received monotherapy. Prior to 2008, infliximab was given in combination with mercaptopurine in one patient and azathioprine in 3 patients. Since 2008, methotrexate was given in combination with infliximab in two patients. The number of doses of infliximab given ranged from 2 to 38 with dosage ranges of 4.7 mg/kg to 13 mg/kg. The doses were adjusted in 6 patients, 4 with success. Two patients still on infliximab have not had dose adjustments due to high initial doses (9.3 mg/kg and 12.5 mg/kg). Seven patients had colectomies; two diagnosed with UC, two indeterminant colitis, two diagnosed with Crohn's after an initial diagnosis of UC, and one patient with severe perianal Crohn's disease. Six of the patients requiring colectomy were prior to 2008; only one out of 7 patients in the past 4 years required a colectomy. Two patients developed hives after 6-7 doses and one had an acute infusion reaction with facial swelling and desaturation. Other potential complications were limited to one patient with mycoplasma pneumonia, one with recurrent UTIs, and one with recurrent Clostridium difficile. The patient with severe perianal disease has since been diagnosed with IL10RA. Infliximab was used successfully in 6 out of 7 patients with IBD in the past 4 years. All six patients who received infliximab prior to 2008 went on to colectomy.