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Medline ® Abstract for Reference 17

of 'Management of severe or refractory ulcerative colitis in children and adolescents'

Use of infliximab in the treatment of Crohn's disease in children and adolescents.
Hyams JS, Markowitz J, Wyllie R
J Pediatr. 2000;137(2):192.
BACKGROUND: Crohn's disease is often poorly responsive to conventional therapy with corticosteroids and immunomodulators. A novel chimeric antibody to tumor necrosis factor-alpha, infliximab, has shown utility in the treatment of refractory Crohn's disease in adults.
PURPOSE: To evaluate the efficacy of open-label administration of infliximab in children and adolescents with active intestinal Crohn's disease.
METHODS: Chart review of the experience with 19 subjects (mean age 14.4 years, range 9 to 19 years) receiving 1 to 3 infusions of infliximab (5 mg/kg/dose) over a 12-week period for corticosteroid-resistant disease (n = 7) or corticosteroid dependence (n = 12). Disease activity was monitored by physician global assessment and the Pediatric Crohn's Disease Activity Index.
RESULTS: Significant initial improvement (first 4 weeks after infusion) was noted in all subjects, with Pediatric Crohn's Disease Activity Index values decreasing significantly (mean +/- SD, 42.1 +/- 13.7 to 10.0 +/- 5.6, P<.0001). Over the subsequent 8-week period, 8 of 19 treated subjects had worsening of symptoms, although none deteriorated to severe activity. The mean Pediatric Crohn's Disease Activity Index at 12 weeks was 26.8 +/- 16. 4. The mean daily prednisone dosages at baseline, 4 weeks, and 12 weeks were 28 +/- 14 mg, 20 +/- 12 mg, and 8 +/- 12 mg, respectively (P<.01). Adverse effects were noted in 3 patients during infusion (dyspnea, rash) and were self-limited.
CONCLUSIONS: Infliximab is associated with short-term clinical improvement in children and adolescents with severe Crohn's disease. The rapid return of disease activity in some patients suggests that additional dosing strategies may be required. Long-term safety necessitates close monitoring.
Departments of Pediatrics, Connecticut Children's Medical Center, Hartford, Connecticut, USA.