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New REMICADE Safety Data Presented at the American College of Gastroenterology Annual Meeting

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

Data from TREAT Patient Registry, Largest Registry of its Kind, Suggest Crohn's Disease Medications Were Not Associated with a Risk of Intestinal Stricture, Stenosis or Obstruction

Centocor announced today that safety data from a sub-analysis of the Crohn's Disease Therapy, Evaluation and Assessment Tool (TREAT) registry indicate that while severity and duration of disease were associated with the development or exacerbation of intestinal strictures, stenosis or obstruction, the use of REMICADE(R) (infliximab) and other Crohn's disease medications did not appear to contribute to this risk. The research results were presented today at the 69th American College of Gastroenterology Annual Meeting and Postgraduate Course.

"These data help address the important question of whether the use of particular Crohn's disease medications increases a patient's risk of stricture. These results support what we know about the role of disease duration and severity in the development of strictures," said Gary R. Lichtenstein, MD, Professor of Medicine and Director, IBD Center, University of Pennsylvania School of Medicine, and study author. "The benefit of REMICADE in the treatment of Crohn's disease continues to be evident as we gather more important information for this and other Crohn's therapies from the TREAT patient registry," added Dr. Lichtenstein.

REMICADE, first approved for Crohn's disease in 1998, is used to treat patients with moderate-to-severe disease who have had an inadequate response to conventional therapies. The safety and efficacy of REMICADE have been well established in clinical trials over the past 12 years. REMICADE has been used to treat nearly 600,000 patients worldwide for autoimmune conditions such as rheumatoid arthritis (RA) and Crohn's disease (CD). 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 RA and CD and in a wide range of Immune-Mediated Inflammatory Disorders (I.M.I.D.) in which REMICADE is currently being studied.

About TREAT

As of February 2004, 6283 patients were enrolled in the TREAT registry with 4247 patient years (pt-yrs) of follow-up for those who received REMICADE (infliximab or IFX), and 3541 pt-yrs of follow-up for those who received treatments other than IFX. At enrollment, more IFX-treated patients had moderate-to-severe (33.9 percent vs 11.1 percent, p (less than) 0.0001) or severe-fulminant (2.9 percent vs 0.6 percent, p (less than) 0.0001) CD; more had been hospitalized (28.9 percent vs. 19.7 percent, p (less than) 0.0001) or undergone surgery (18.5 percent vs. 13.7 percent, p (less than) 0.0001) in the previous year; and more were taking corticosteroids (28.4 percent vs. 16.5 percent, p (less than) 0.0001), or immunomodulators (50.0 percent vs. 32.9 percent, p (less than) 0.0001).

A total of 93 strictures, stenosis or obstruction (SSO) events occurred in patients treated with infliximab, and 41 SSO events occurred in patients treated with other treatments (2.1 events per 100 pt-yrs vs 1.2; RR=1.89). The analysis suggested that moderate, severe or fulminant disease (RR=1.99, 95 percent CI 1.03-3.81, p (less than) 0.05), duration of CD (RR = 1.03, 95 percent CI 1.003-1.05, p (less than) 0.05) and ileal disease (RR=1.87, 95 percent CI 1.15-3.03, p (less than) 0.05) were associated with SSO events, but not prior IFX therapy (RR 1.06, 95 percent CI 0.63-1.79, p=NS), immunomodulator use (RR= 1.40, 95 percent CI 0.81-2.42, p=NS), or corticosteroid use (RR=1.62, 95 percent CI 0.98-2.70, p=NS).

Intestinal stenosis and obstruction have been reported in clinical trials; patient follow-up in the TREAT registry is ongoing and will be the subject of future reports.

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 CD 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 the only biologic indicated for the treatment of 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.

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.

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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