Infliximab in Pediatric Crohn Disease Patients With Enterovesicular Fistulas

Pediatric Gastroenterology and Nutrition, The Children's Hospital at Monmouth Medical Center, Long Branch, NJ 08008, USA.
Journal of pediatric gastroenterology and nutrition (Impact Factor: 2.63). 03/2007; 44(2):279-82. DOI: 10.1097/01.mpg.0000237933.38223.da
Source: PubMed
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    ABSTRACT: This review summarises the present knowledge of infliximab therapy in children with inflammatory bowel disease (IBD) based on the available published literature. Infliximab, the chimeric monoclonal IgG(1) antibody to tumour necrosis factor-alpha, is indicated for medically refractory luminal and fistulising paediatric Crohn's disease. Recently, ulcerative colitis case series in children and adolescents suggested that infliximab might also be effective for treatment of ulcerative colitis resistant to standard medical therapy. Induction therapy with infliximab 5 mg/kg at weeks 0, 2 and 6 is routinely used. Since the majority of patients will relapse if not re-treated, a long-term approach with systematic re-treatment with 5 mg/kg every 8-12 weeks is recommended. Maintenance therapy every 8 weeks was superior to 12 weeks' administration in maintaining response and remission in the largest-to-date paediatric randomised trial. Concomitant immunosuppressive therapy reduces the risk of infliximab antibody formation and infusion reactions, and prolongs the duration of treatment success. Severe reactions may not be an absolute contraindication to future infliximab therapy. Premedication does not prevent the development of infusion reactions; however, it is indicated for prevention of subsequent infusion reactions. Adverse events and safety findings in children are comparable to those observed in adults. Latent tuberculosis needs to be screened for. Malignancy rates in paediatric patients treated with infliximab do not seem to be increased. However, newly reported cases of hepatosplenic T-cell lymphoma in young patients with IBD treated with infliximab and mercaptopurine therapy raise concern, and long-term follow-up studies are necessary to determine the true malignancy risk.
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    ABSTRACT: Post hoc analyses evaluated the effect of infliximab upon concurrent perianal Crohn disease (CD) in a subpopulation of 31 patients from REACH, a randomized trial of 112 children with moderately to severely active luminal CD. The Pediatric Crohn Disease Activity Index perirectal subscore was used to assess perianal symptom activity and therapeutic response. Patients with no symptoms or asymptomatic tags received a score of 0; those with "1-2 indolent fistula, scant drainage, no tenderness" received a score of 5; and those with "active fistula, drainage, tenderness or abscess" received a score of 10. Initial perirectal subscores of 10 or 5 decreasing to 0 were considered complete response. Subscores of 10 decreasing to 5 were considered partial response. All patients were followed for efficacy and safety through week 54. Twenty-two patients with baseline perianal disease were randomized at week 10 following a 3-dose infliximab induction regimen. At week 2, 40.9% (9/22) of patients with signs and symptoms of perianal disease at baseline attained response (4 partial and 5 complete). At week 54, 72.7% (16/22) of patients with signs and symptoms of perianal disease attained response (1 partial and 15 complete). Nine patients developed perianal signs and symptoms during treatment; 7 had complete response and 2 had no response at week 54. The incidence of adverse events for patients with perianal symptoms at baseline and for those in the overall REACH population was similar (95.7% vs 94.6%). Infliximab rapidly reduced concurrent perianal disease signs and symptoms in this REACH cohort.
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