Clinical experience with infliximab for Crohn’s disease: MATERIALS AND METHODS Part 1

30 Apr

Crohn's diseaseInfliximab was available either through compassionate release or through clinical trials. All gastroenterologists in Edmonton were contacted to determine whether they had treated patients with infliximab. Records of patients who had received infliximab via compassionate release programs (n=101) were reviewed, as were the records of patients who had received an initial dose of infliximab as part of the Accent I and Accent II clinical trials initiated by Centocor Inc (USA) and then entered the compassionate release program (n=8). For patients who participated in these two clinical trials, no clinical trial data were used for the purposes of the present paper. Instead, the treating physician’s global clinical response assessment following a known infusion of infliximab 5 mg/kg was recorded.
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The charts of patients who had received at least one infusion of infliximab for the induction treatment of luminal inflammatory Crohn’s disease and three infusions for the induction treatment of fistulizing Crohn’s disease, and who had received at least one clinical follow-up visit were reviewed. Data were extracted for the following parameters: patient demographics, indication for infliximab infusion, duration of Crohn’s disease, immediate previous medical therapies for the management of Crohn’s disease and concurrent therapies (buy prednisone at beginning and end of therapy), disease distribution, previous surgery, surgery during infliximab therapy, type of infliximab induction (single- or triple-infusion induction), total number of infusions, requirements for premedication to prevent adverse infusion reactions, time to onset of clinical response, duration of clinical response and adverse events.