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Analysis Shows REMICADE Reduces Pain Associated With Crohn's Disease; Investigators Awarded 2004 Presidential Poster Award at the American College of Gastroenterology Meeting

Posted on: Tuesday, 2 November 2004, 09:00 CST

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.

About the ACCENT I Sub-analysis

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 (5mg/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 (less than) 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.

About Crohn's disease

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.

About REMICADE

REMICADE is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and the only agent approved for the treatment of both RA and Crohn's disease in North America, the European Union and Japan, and was the first biologic approved for ankylosing spondylitis in the European Union. In the EU, REMICADE is indicated for the treatment of ankylosing spondylitis in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.

In September, the European Commission gave approval for expanded labeling for REMICADE, in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to disease modifying anti-rheumatic drugs.

REMICADE is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting. In RA and CD patients, REMICADE is a two-hour infusion administered every eight weeks, following a standard induction regimen that requires treatment at weeks 0, 2 and 6. As a result, REMICADE patients may require as few as six treatments each year. The safety and efficacy of REMICADE have been well established in clinical trials over the past 12 years and through commercial experience with more than a half million patients treated worldwide.

Important Information

Many people with heart failure should not take REMICADE; so prior to treatment you should discuss any heart condition with your doctor.

Tell your doctor right away if you develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of your ankles or feet).

There are reports of serious infections, including tuberculosis (TB) and sepsis. Some of these infections have been fatal. Tell your doctor if you have had recent or past exposure to people with TB.

Your doctor will evaluate you for TB and perform a skin test. If you have latent (inactive) TB, your doctor should begin TB treatment before you start REMICADE. REMICADE can lower your ability to fight infections, so if you are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough, or the flu while taking REMICADE, tell your doctor right away. Also tell your doctor if you have lived in a region where histoplasmosis or coccidioidomycosis is common. Blood disorders have been reported, some fatal. Tell your doctor if you develop possible signs of blood disorders such as persistent fever, bruising, bleeding, or paleness while taking REMICADE. Nervous system disorders have also been reported. Tell your doctor if you have or have had a disease that affects the nervous system, or if you experience any numbness, weakness, tingling, or visual disturbances while taking REMICADE. Reports of lymphoma (a type of cancer) in patients on REMICADE and other TNF blockers are rare but occur more often than in the general population. Tell your doctor if you have or have had cancer.

Serious infusion reactions have been reported with REMICADE, including hives, difficulty breathing, and low blood pressure. Reactions have occurred during or after infusions. In clinical studies, some people experienced the following common side effects: respiratory infections (that may include sinus infections and sore throat), coughing, and stomach pain or mild reactions to infusion such as rash or itchy skin. (Please read accompanying patient information sheet)

About Centocor

Centocor is a leading biopharmaceutical company that creates, acquires and markets cost-effective therapies that yield long-term benefits for patients and the healthcare community. The company is dedicated to the research and development of treatments for a wide range of diseases including cancer, infectious diseases, cardiovascular and metabolic diseases and Immune-Mediated Inflammatory Disorders (I.M.I.D.), such as arthritis and inflammatory skin diseases. Centocor's products, developed primarily through monoclonal antibody technology, help physicians deliver innovative treatments to improve human health and restore patients' quality of life. Centocor is a wholly owned subsidiary of Johnson & Johnson, the worldwide manufacturer of healthcare products.

Centocor discovered REMICADE and has exclusive marketing rights to the product in the United States. Schering-Plough Corporation has rights to market REMICADE in all countries outside of the United States, except in Japan and parts of the Far East where Tanabe Seiyaku, Ltd. markets the product.

Source: Business Wire

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