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Infliximab Reduces Pain From Crohn's Disease: Presented at ACG

By Mike Fillon

ORLANDO, FL -- November 4, 2004 -- Patients who are treated with a 3-dose induction regimen of infliximab (Remicade) appear to have a greater reduction in pain after 10 weeks than those who are treated with a single dose of the drug.

The results, based on a new subanalysis of the A Crohn's Disease Clinical Trial Evaluating Infliximab in a New Long-Term Treatment Regimen (ACCENT I), were presented in a poster session at the American College of Gastroenterology 69th Annual Scientific Meeting, held here October 29th to November 3rd.

According to lead researcher Gary R. Lichtenstein, MD, director, Center for Inflammatory Bowel Disease, University of Pennsylvania, Philadelphia, Pennsylvania, abdominal pain is a frequent complication of Crohn's disease. "This analysis examined the benefit of Remicade to patients with Crohn's disease, with respect to pain measures, from indices used to assess this debilitating condition."

In the ACCENT I study, the effect of infliximab treatment on pain was assessed with 4 pain questions. The main objective was to assess the early benefit in pain reduction with infliximab therapy.

In the 54-week trial, all subjects received a single infusion of 5 mg/kg infliximab at baseline. At week 2, patients were evaluated for a clinical response and, if present, were then randomized to 1 of 3 maintenance regimens to be followed until week 46: 1) placebo at weeks 2 and 6, followed by placebo every 8 weeks; 2) infliximab 5 mg/kg at weeks 2 and 6, followed by every 8 weeks thereafter; and 3) infliximab 5 mg/kg at weeks 2 and 6, increased to 10 mg/kg every 8 weeks.

The researchers used the Wilcoxon signed rank test to detect the change in pain measures in the Crohn's Disease Activity Index (CDAI), the Inflammatory Bowel Disease Questionnaire (IBDQ), and the SF-36. The IBDQ and the SF-36 are validated patient-reporting tools. The SF-36 is a measurement tool used to assess physical and mental health status. The IBDQ provides relevant data on bowel function and abdominal pain, systemic symptoms, social functioning, and emotional health. T-test on van der Waerden scores was used to compare the change from baseline to week 10 between the single-dose and the 3-dose induction regimens.

Among the patients who were responders at week 2, the median pain reduction at week 10 was significantly greater in the 3-dose regimen (P <.05) than in the single-dose regimen in abdominal pain and cramps ratings over a 7-day period (70% vs 57%); in abdominal pain over a 1-week period (40% vs 25%); in bodily pain over 4 weeks (25% vs 0%); and in the extent to which pain interfered with normal work over 4 weeks (33% vs 25%). There also was a reduction compared with baseline in each treatment group at weeks 10, 30, and 54 in all 4 pain measures.

The ACCENT I trial is the largest study of a biologic therapy ever conducted in Crohn's disease, involving 573 patients with moderate to severe disease at centers in North America, Europe, and Israel. The objective of the trial was to evaluate the safety and effectiveness of infliximab as a maintenance therapy. The study also evaluated the effect of maintenance regimen on steroid use and health-related quality of life.


[Presentation title: Infliximab Treatment Reduces Pain in Patients With Crohn's Disease. Abstract 203]

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