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Results for Phase II Infliximab Study Show Significant Improvement on Quality of Life

MALVERN, Pa., Feb. 7 /PRNewswire/ -- A new analysis was presented today at the annual meeting of the American Academy of Dermatology (AAD) in Washington, DC from a Phase II study investigating the effect of treatment with REMICADE® on quality of life in 249 patients with severe plaque psoriasis. In this study, treatment with REMICADE resulted in significant improvement in quality of life from baseline to week 10 versus placebo as measured by the Dermatology Life Quality Index (DLQI). The median change from baseline was 84% for patients treated with REMICADE 3 mg/kg and 91% for patients treated with REMICADE 5mg/kg. The median change from baseline in the placebo group was 0%.

"Psoriasis is a chronic disease that severely impacts quality of life, affecting many aspects of a patient's life including work, family, sexual relations and physical and emotional well-being," said Steven R. Feldman, M.D., Wake Forest School of Medicine. "Patients often live with the condition, hoping for total clearance or relief of their symptoms and continued research into potential treatments for psoriasis is critical for patients with this difficult-to-treat disease."

REMICADE is a monoclonal antibody that specifically targets and irreversibly binds to tumor necrosis factor-alpha (TNF-a) on the cell membrane and in the blood. Overproduction of TNF-a is believed to play a role not only in psoriasis, psoriatic arthritis, rheumatoid arthritis (RA) and Crohn's disease, but also in a wide range of Immune-Mediated Inflammatory Disorders (I.M.I.D.). REMICADE is currently indicated for the treatment of rheumatoid arthritis and Crohn's disease and is being investigated in Phase III trials for the treatment of severe psoriasis.

Study Findings

This study was a phase II, double blind, placebo-controlled trial to investigate the safety and efficacy of REMICADE in 249 patients with extensive or severe plaque psoriasis. Patients were randomly assigned to infusions of 3 mg/kg or 5 mg/kg of REMICADE or placebo and were treated at weeks zero, two and six. The primary endpoint of the study was the percentage of patients achieving greater than or equal to 75% improvement in the Psoriasis Area and Severity Index (PASI) score from baseline at week 10. At week 10, significantly more patients treated with REMICADE achieved an improvement of greater than or equal to 75% in their PASI score compared to placebo-treated patients. The study also evaluated patient's health-related quality of life through the use of the Dermatology Life Quality Index (DLQI). The DLQI is a validated assessment of quality of life in adults with dermatologic disease(1). DLQI responses are a series of questions scored in increments of 0 to 3, with a maximum score of 30 indicating maximum disability. Patients completed the Dermatology Life Quality Index (DLQI) at baseline and week 10. The higher the DLQI score, the greater the impact on a patient's quality of life.

The median percent change from baseline in DLQI at week 10 was a reduction of 84 percent and 91 percent respectively for the 3 mg/kg and 5 mg/kg REMICADE groups compared with 0 percent reduction in the placebo group (p

During the ongoing clinical development program for REMICADE for this investigational use, adverse reactions observed have generally been consistent with those described in the prescribing information, including information concerning serious infections (see Important Information). Larger trials are necessary to establish a safety profile of infliximab in the treatment of psoriasis.

About Psoriasis

According to the National Psoriasis Foundation, psoriasis is a chronic skin disease that generally appears as patches of raised red skin covered by flaky white scales. While the exact cause is unknown, psoriasis is believed to be related to faulty inflammatory signals sent by the body's immune system that causes development of skin plaques. Psoriasis affects more than seven million Americans. This immune-mediated inflammatory disorder most commonly appears between the ages of 15 and 35.

About REMICADE®

REMICADE is a monoclonal antibody that specifically targets and irreversibly binds to tumor necrosis factor-alpha (TNF-a) on the cell membrane and in the blood. Overproduction of TNF-a is believed to play a role in RA, Crohn's disease (CD), a serious gastrointestinal disorder, and ankylosing spondylitis (AS), in addition to a wide range of Immune-Mediated Inflammatory Disorders (I.M.I.D.) in which REMICADE is currently being studied.

REMICADE is the only anti-TNF biologic therapy that has received marketing authorizations for the treatment of both RA and CD and, in the European Union, AS. In most countries, REMICADE, in combination with methotrexate, is indicated for the treatment of patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate alone. REMICADE is the only biologic indicated for the treatment of patients with moderate to severe, 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 received 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 conducted over the past 10 years and through commercial experience with more than 400,000 patients treated worldwide -- more patients treated than all other TNF inhibitors combined.

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 the ankles and 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, his or her doctor 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 or coccidioidomycosis is common, or if they have or have had a disease that affects the nervous system, or if they experience any numbness, weakness, 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: respiratory infections, (that may include sinus infections and sore throat) coughing and stomach pain or mild reactions to the infusion such as rash or itchy skin. Please read important information about REMICADE, including full prescribing information, at http://www.remicade.com/.

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