Analysis shows Remicade reduces pain associated with Crohn's disease

Nov 2 2004

Remicade (infliximab), the only biologic approved for the treatment of Crohn's disease, was found to reduce pain associated with the disease.

According to a new sub-analysis from the ACCENT I (A Crohn's disease Clinical trial Evaluating infliximab in a New long-term Treatment regimen) trial patients who received a three-dose induction regimen of Remicade experienced a significantly greater reduction in pain as assessed by four different pain questions after ten weeks, compared with patients who received a single dose of Remicade.

Remicade is the only biologic indicated for reducing signs and symptoms and inducing and maintaining clinical remission in patients with moderately-to-severely active Crohn's disease who have had an inadequate response to conventional therapy. Remicade is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing Crohn's disease.

"In previous analyses of ACCENT I and ACCENT II, Remicade has been shown to have an impact on the reduction or elimination of steroid usage associated with Crohn's disease, mucosal healing, even a reduction in the need for surgeries and hospitalizations," said Dr. Gary Lichtenstein, Director of the Center for Inflammatory Bowel Disease, University of Pennsylvania. "This analysis from the ACCENT I trial further examines the benefit of Remicade to patients with Crohn's disease, with respect to pain measures from indices used to assess this debilitating condition."

Remicade is a monoclonal antibody that specifically targets and binds to tumor necrosis factor-alpha (TNF-alpha) on the cell membrane and in the blood. Overproduction of TNF-alpha is believed to play a role in rheumatoid arthritis (RA) and Crohn's disease (CD) and in a wide range of Immune-Mediated Inflammatory Disorders (I.M.I.D.) in which Remicade is currently being studied.

The ACCENT I Trial randomized 573 moderately-to-severely active CD patients to receive one of three different treatment regimens of Remicade during the 54-week trial. ACCENT I utilized three composite questionnaires to evaluate disease activity in CD patients. This analysis explored the impact of Remicade treatment on four pain independent questions (one in each of the CDAI and Inflammatory Bowel Disease Questionnaire (IBDQ), and two in the SF- 36), which were compared between the single-dose (5mg/kg IV at week 0) and the 3-dose (5 mg/kg at weeks 0, 2 and 6) Remicade induction regimens.

Among the patients randomized as responders at week 2, the median reduction at week 10 was significantly greater in the 3-dose regimen (p < 0.05) than in the single-dose regimen in abdominal pain and cramps ratings (from the CDAI) over a seven-day period (70 percent vs. 57 percent), in abdominal pain (from the IBDQ) over a one-week period (40 percent vs. 25 percent), in bodily pain (from the SF-36) over four weeks (25 percent vs. 0 percent), and in the extent to which pain interfered with normal work (from the SF-36) over four weeks (33 percent vs. 25 percent). A benefit was also observed when comparing the two groups based on all randomized patients. There was a reduction compared with baseline in each treatment group at weeks 10, 30, and 54 in all four pain measures.

In clinical trials, 26 percent of Crohn's disease patients receiving Remicade experienced abdominal pain reported as an adverse event. However, there was an insufficient number of patients not receiving Remicade to make a meaningful comparison.

CD is a chronic inflammatory bowel disorder that commonly affects the lower part of the small intestine and the large intestine and typically begins in late childhood or early adulthood. The disease causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain and weight loss. It is estimated that 500,000 Americans and more than 400,000 people in Europe and Canada suffer from this gastrointestinal disorder.