ACCENT I Study Reveals REMICADE May Offer
Crohn's Patients Remission in as Little
as Two Weeks

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ACCENT I study background

The ACCENT I study was one of the largest clinical studies ever conducted in Crohn's disease therapy. This study was designed to evaluate the safety and effectiveness of maintenance therapy with REMICADE over a 54-week period as compared to a single dose of REMICADE.

ACCENT I stands for "A Crohn's disease Clinical study Evaluating infliximab in a New long term Treatment regimen." FDA approval of REMICADE as maintenance therapy was based on data from this study.

• 545 patients with Crohn's disease were studied in clinical centers in North America, Europe, and Israel. These were patients with moderately to severely active Crohn's disease who had previously failed to respond to usual therapies, such as aminosalicylates, immunosuppressants, and steroids.
• A commonly used scale called the Crohn's Disease Activity Index (CDAI) was used to identify patients who had moderately to severely active Crohn's disease. Higher scores indicate more active or more severe Crohn’s disease; lower scores indicate less active or less severe Crohn’s disease.
• All participants were each given one dose of REMICADE to start (at Week 0). At Week 2, they were checked for a response that was measured as a change in their CDAI score.
• Patients who responded to the first dose of REMICADE (often called "responders") were placed into one of three groups:
• Group A was made up of patients who received a placebo (an inactive substance). Placebo patients were not given maintenance REMICADE therapy again. Instead, these patients were given an infusion that had no medical effect. These infusions were administered at Week 2, at Week 6, and then again every 8 weeks for the remainder of the study. This group was the “control group” that was used to compare the results of groups B and C.
• Group B was made up of patients who were given an additional dose of REMICADE at Week 2, at Week 6, and then once every 8 weeks for the remainder of the study. These patients were given 5 milligrams of REMICADE for each kilogram of their body weight (5 mg/kg)
• Group C was made up of patients who were also given REMICADE 5 mg/kg at Week 2 and Week 6. However, these patients were then given 10 mg/kg once every 8 weeks for the remainder of the study.
• This summary compares results of REMICADE 5 mg/kg (Group B) with placebo (Group A) because REMICADE 5 mg/kg is the most commonly used dose. Results for REMICADE 10 mg/kg (Group C) were at least as good as the 5 mg/kg group (Group B).

ACCENT I Study findings

FDA approval of REMICADE as maintenance therapy was based on the following data from the ACCENT I Study:

• REMICADE offers patients the possibility of remission in as little as two weeks. In fact, 46% of ACCENT I study patients who responded to the first infusion of REMICADE achieved remission.
• Patients on REMICADE showed significant improvement in “quality of life” scores compared to patients on placebo. Quality of life in Crohn's disease is measured by the Inflammatory Bowel Disease Questionnaire (IBDQ)*.
• 25% of patients who were initially on steroids were able to stop steroids and remain in remission when they were on REMICADE. This number compares to only 11% of patients who were given placebo. To put that into perspective, one out of every four patients who was initially on steroids was able to stop taking steroids and remain in remission when they were on REMICADE maintenance therapy.

ACCENT I is not the only study conducted on the effectiveness of REMICADE for Crohn’s disease. View the summary of the ACCENT II study and other clinical studies.

*Inflammatory Bowel Disease Questionnaire (IBDQ) is a copyright of McMasters University.