lots of room for improvement, this indication. emphasis is mine........
Wednesday May 22, 3:02 pm Eastern Time
Press Release
SOURCE: Centocor
Centocor Presents Long-Term Data From ACCENT II Trial With REMICADE(R) (infliximab) in Maintaining Fistula Closures In Crohn's Patients
Results Presented Today at Digestive Disease Week Meeting
SAN FRANCISCO, May 22 /PRNewswire-FirstCall/ -- New 54-week data from the ACCENT II clinical trial assessing the effectiveness of maintenance therapy with REMICADE® (infliximab) in sustaining closure of draining fistulas in Crohn's disease (CD) were reported today at the Digestive Disease Week meeting in San Francisco. Up to 30 percent of patients who have CD, a debilitating gastrointestinal disorder, can suffer from fistulas -- openings that burrow through the bowel wall into nearby organs or through the surface of the skin.
"There is a significant unmet medical need facing those who are living with fistulizing Crohn's disease," said Bruce Sands, M.D., Massachusetts General Hospital, and a principal investigator in the study. "These data add to the growing body of research on the use of REMICADE and the role of TNF-alpha within this treatment population."
About the Study
The ACCENT II study was the largest clinical trial of a biologic conducted in fistulizing CD. The study evaluated the effectiveness of maintenance dosing with REMICADE in sustaining fistula closure in patients suffering from single or multiple fistulas for at least three months immediately preceding screening, as compared to the effectiveness of a single, three-dose induction regimen of infliximab. The primary efficacy endpoint was defined as the time from randomization until loss of fistula response.
Of the 282 patients who completed the study through week 14, 69 percent had closure of at least 50 percent of draining fistulas sustained over one month after receiving a 5 mg/kg dose of REMICADE at weeks 0, 2 and 6. Responding patients (195) were then randomized to receive either placebo (99 patients) or 5 mg/kg of REMICADE (96 patients) every eight weeks through week 46.
According to researchers, results show that at week 30, almost half (48 percent) of REMICADE patients were in complete fistula response compared to 27 percent given placebo. At week 54, 36 percent of patients taking REMICADE maintained complete fistula response vs. 19 percent on placebo.
Adverse events reported for REMICADE maintenance therapy among patients with fistulizing CD treated for up to 46 weeks appeared consistent with other trial experience.
About REMICADE
It is believed that the monoclonal antibody REMICADE reduces inflammation in patients with CD by irreversibly binding to and neutralizing a key inflammatory mediator called tumor necrosis factor alpha (TNF-alpha) on the cell membrane and in the blood. REMICADE is the only biologic approved by the FDA for the short-term treatment of CD. It is indicated as a monotherapy for the reduction of signs and symptoms in moderately to severely active Crohn's disease in patients who have had an inadequate response to conventional therapy. It is also indicated for reducing the number of draining enterocutaneous fistulas in patients with fistulizing Crohn's disease. The safety and effectiveness of use of REMICADE beyond the recommended duration in Crohn's disease have not been established.
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. More than 500,000 Americans suffer from this gastrointestinal disorder.
Important Information
Many people with heart failure should not take REMICADE; so, prior to treatment, patients should discuss any heart condition with their doctor. Patients should tell their doctor right away if they develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of their feet).
There are reports of serious infections, including tuberculosis (TB) and sepsis. Some of these infections have been fatal. Patients should tell their doctor if they have had recent or past exposure to people with TB. Their doctor will evaluate them for TB and perform a skin test. If a patient has latent (inactive) TB, he or she should begin TB treatment before starting REMICADE. If a patient is prone to or has a history of infections, currently has one, or develops one while taking REMICADE, he or she should tell his or her doctor right away. Patients should also tell their doctor if they have lived in a region where histoplasmosis is common, or if they have or have had a disease that affects the nervous system, or if they experience any numbness, tingling, or visual disturbances.
There are also reports of serious infusion reactions with hives, difficulty breathing, and low blood pressure. In clinical studies, some people experienced the following common side effects: upper respiratory infections, headache, nausea, cough, sinusitis or mild reactions to the infusion such as rash or itchy skin. Please read important information about REMICADE, including full prescribing information, at remicade.com .
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. Its 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 (NYSE: JNJ - News).
Centocor has exclusive marketing rights to REMICADE in the United States. Schering-Plough Corporation (NYSE: SGP - News) has rights to market REMICADE in all other countries throughout the world, except in Japan and parts of the Far East where Tanabe Seiyaku, Ltd. will market the product.
Media Contact:
Bill Newbould
(610) 651-6122
SOURCE: Centocor |
