Infliximab (REMICADE) therapy in the treatment of pediatric Crohn’s disease

Baldassano, Robert; Braegger, Christian P.; Escher, Johanna C.; DeWoody, Kimberly; Hendricks, David F.; Keenan, Gregory F.; Winter, Harland S.
April 2003
American Journal of Gastroenterology;Apr2003, Vol. 98 Issue 4, p833
Academic Journal
: ObjectivesThe aim of this study was to assess the efficacy and safety of a single infusion of infliximab in the treatment of pediatric Crohn’s disease (CD).: MethodsA total of 21 pediatric CD patients were enrolled at seven study centers and randomized to receive a single infusion of infliximab 1 mg/kg (n = 6), 5 mg/kg (n = 7), or 10 mg/kg (n = 8) over at least 2 hrs at week 0 in this multicenter, open-label, dose-blinded trial. Efficacy assessments, including the Pediatric Crohn’s Disease Activity Index (PCDAI), modified CDAI, C-reactive protein concentration (CRP), and erythrocyte sedimentation rate (ESR) determinations, were made at screening and at weeks 1, 2, 4, 8, and 12. Adverse events were assessed throughout study participation.: ResultsImprovements in the PCDAI, modified CDAI, ESR, and CRP were observed with all infliximab doses, beginning at week 1. On average, all treated patients experienced approximately 50% improvement in the PCDAI by week 2. By week 12, the PCDAI remained approximately 30% improved from baseline. During the study, all 21 patients (100%) achieved a clinical response, and 10 patients (48%) achieved clinical remission. There were no infusion reactions in any of the treatment arms.: ConclusionsThe results of this trial suggest that infliximab may be safe and effective as short-term therapy of medically refractory moderate to severe CD in a pediatric population.


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