• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

CORRECTING AND REPLACING Study of Claims Data Finds REMICADE Dosing Remains Stable With Maintenance Therapy Over Two Year Period

Posted on: Tuesday, 2 November 2004, 12:00 CST

Headline of release should read: Study of Claims Data Finds REMICADE Dosing Remains Stable with Maintenance Therapy over Two Year Period (sted Study of Claims Data Finds REMICADE Dosing Remains Stable with Maintenace Therapy over Two Year Period).

The corrected release reads:

STUDY OF CLAIMS DATA FINDS REMICADE DOSING REMAINS STABLE WITH MAINTENANCE THERAPY OVER TWO YEAR PERIOD

Study Presented at 69th Annual American College of Gastroenterology Meeting Also Provides Information Relevant to Cost

A new study based on nearly 30,000 Crohn's disease cases, derived from a nationwide reimbursement database (2002-2003), observed that patients diagnosed with Crohn's disease taking REMICADE(R) (infliximab) every eight weeks only marginally increased their doses over time. The annual costs of maintenance therapy also remained relatively stable, with little variability by site of infusion or payer status.

"This is welcomed data by both physicians and insurers because we are always seeking information to estimate the costs of these treatments," said Dr. Russell Cohen, Associate Professor of Medicine at the University of Chicago and study author. "For payers especially, these data may provide a basis for forecasting the cost associated with treating the patients for whom they cover."

Among the 28,932 cases analyzed, 10,942 were initial infliximab infusions and 17,990 subsequent infusions. The mean dose per initial infusion and subsequent infusions were 5.56 mg/kg (SD= 0.93) and 5.71 mg/kg (SD=1.13), respectively, with the median number of vials 4 (IQR = 3-5) and 4 (IQR = 4-5). Across all cases, the average amount of infliximab administered was 423.81 mg, assuming 6.5 infusions per year, resulted in an annual average cost of maintenance therapy of $16,194.

From this database, it was estimated that the average dose is 2.7 percent higher for a subsequent infusion versus an initial infusion and 1.15 percent higher for those patients infused in 2003 versus 2002. The average dose for females was 0.9 percent less than males, while infusions in an office based setting were 1.99 percent higher than those in other settings. An increase in age by 1 year resulted in a dose decrease of 0.03 percent. Payer status did not have a statistically significant effect on dosing.

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 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.

In Crohn's disease, the recommended dose of REMICADE is 5 mg/kg given as an induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of moderately to severely active Crohn's disease or fistulizing disease. For patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg.

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 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

More News in this Category