ACCENT II Clinical Study Overview

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The approval for REMICADE maintenance therapy in fistulizing Crohn’s disease was based on the results of the ACCENT II study. ACCENT II stands for "A Crohn’s disease Clinical study Evaluating infliximab in a New long-term Treatment regimen." in patients with fistulizing Crohn’s disease.

Who were the study participants?

A total of 296 patients with fistulizing Crohn’s disease were studied in clinical centers in North America, Europe, and Israel.  To enter the study, patients had to present with either single or multiple draining enterocutaneous fistulas, including perianal and abdominal fistulas, for at least 3 months.  Women with rectovaginal fistulas were also included as long as they had at least one other enterocutaneous fistula present.  Patients were evaluated for a fistula response.  A fistula response was defined as a reduction of at least 50 percent in the number of draining fistulas from the start of the study and maintained over a 4-week period of time.  Additionally, patients were assessed to see how long they could keep their response while on therapy.  All patients included in this study had never received REMICADE before, and many were taking other medications, such as steroids, 5-aminosalicylates (e.g. mesalamine), or antibiotics.

Which medications were given to study participants?

All participating patients were each given 3 doses of REMICADE 5 mg/kg.  The first dose was infused at the start of the study (Week 0) the second dose at Week 2, and the third dose at Week 6.  Patients were checked for a fistula response throughout the 54-week study period at specified time points.  Patients who achieved a fistula response with REMICADE at Week 10 and maintained that response at Week 14 were placed into one of 2 groups.

Group A was made up of patients that achieved a fistula response at Week 10 and maintained that response at Week 14.  These patients were given additional doses of REMICADE 5 mg/kg once every 8 weeks for the remainder of the study.  This means they were given 5 milligrams of REMICADE for each kilogram of their body weight (a kilogram is equivalent to 2.2 pounds).

Group B was also made up of patients that achieved a fistula response at Week 10 and maintained that response at Week 14.  These patients received placebo (an inactive substance).  Placebo patients were not given maintenance REMICADE therapy.  Instead these patients were given an infusion that had no medical effect on their fistulizing disease.  These infusions were given every 8 weeks through Week 46.  This group was the control group that was used to compare the results with group A. 

Results from the ACCENT II study:

1. REMICADE induced and maintained fistula response
At Week 14 of the study, almost two-thirds of all patients treated with the 3 initial doses REMICADE had a fistula response.  At Week 54, more patients in Group A (38%) had no draining fistulas compared to patients in Group B (22%).  Also, Patients in Group A had a longer time until they lost fistula response (greater than 40 weeks) compared to Group B (14 weeks).  In other words, patients in Group A experienced fistula closure for a longer duration than patients in Group B.
 
2. REMICADE reduced the number of hospitalizations and surgery
When looking at all patients that achieved and maintained a fistula response at Weeks 10 and 14, it was found that the average number of hospitalizations among those patients who received REMICADE maintenance therapy was less than that among the placebo maintenance treated patients.