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Subset of Patients in SPIRIT Psoriasis Trial Shows Response to Infliximab

MALVERN, Pa., Feb. 10 /PRNewswire/ -- New data were presented at the annual meeting of the American Academy of Dermatology (AAD) in Washington, DC, from a Phase II study investigating the use of REMICADE(R) (infliximab) in patients suffering from severe plaque-type psoriasis. The data presented were from a retrospective analysis in a subset of patients who also had psoriatic arthritis (PsA) and who received a single induction of REMICADE(R) therapy. In this sub-analysis of 78 patients, more patients treated with REMICADE(R) showed a greater than or equal to 75 percent improvement from baseline to week 10 in the Psoriasis Area and Severity Index score (PASI 75 response) compared to placebo-treated patients. At week 10, 75 percent and 86 percent of patients treated with REMICADE(R) 3mg/kg and 5 mg/kg, respectively, achieved a PASI 75 response compared to 0 percent in the placebo group.

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. It is estimated that up to 23 percent of patients with psoriasis also have PsA, a chronic and often painful type of arthritis characterized by joint swelling and skin manifestations.

"The results of this study are very promising, especially when you consider that physicians and patients are looking at potential new therapies for psoriasis," said Cynthia Guzzo, Senior Director Clinical Research, Centocor, Inc. "Observations like these highlight the importance of continued research into potential treatments for difficult-to-treat psoriatic diseases."

REMICADE(R) 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 and Crohn's disease, but also in a wide range of Immune-Mediated Inflammatory Disorders (I.M.I.D.). REMICADE(R) 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 and psoriatic arthritis, ankylosing spondylitis, pediatric Crohn's disease and ulcerative colitis.

Study Findings
This retrospective subanalysis is from the SPIRIT trial - a Phase II, multicenter, randomized, double blind, placebo-controlled trial investigating the safety and efficacy of REMICADE(R) for the treatment of severe plaque-type psoriasis. The primary endpoint of the SPIRIT trial was the percentage of patients achieving greater than or equal to 75 percent improvement in the Psoriasis Area and Severity Index (PASI) score from baseline at week 10. The primary objective of this retrospective analysis was to assess the safety and efficacy of REMICADE(R) induction therapy in a subset of patients who also had psoriatic arthritis identified by medical history. Patients identified with PsA were treated with a placebo (n = 17) or either 3mg/kg (n = 32) or 5mg/kg (n = 29) of REMICADE(R) at weeks zero, two, and six. Improvement from baseline in psoriatic lesions was assessed using the PASI score and the Physician Global Assessment (PGA).

At week 10, improvement in the skin lesions of psoriasis was noted in patients treated with REMICADE(R) compared with those treated with placebo, with 69 percent and 90 percent of patients in the 3mg/kg and 5mg/kg groups, respectively, were rated as having minimal or clear disease compared with 0 patients in the placebo group. Additionally, 75 percent and 86 percent of patients in the 3mg/kg and 5mg/kg groups, respectively, were classified as PASI responders (greater than or equal to 75 percent improvement in PASI) compared with 0 patients in the placebo group. In this sub analysis, REMICADE(R) treatment was also shown to improve health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI). Median DLQI scores decreased greater than or equal to 80 percent from baseline to week 10 for patients treated with REMICADE(R).

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

About SPIRIT
SPIRIT is a multi-center, randomized, double blind, and placebo-controlled trial involving 249 patients with moderate-to-severe psoriasis. The primary objective was to evaluate safety and efficacy of REMICADE as compared to placebo through week 10. Patients were randomized to receive placebo (n=51) or either 3 mg/kg (n=99) or 5 mg/kg (n=99) REMICADE monotherapy at weeks zero, two, and six. Efficacy was assessed every two weeks through week 10 using the Psoriasis Area Severity Index (PASI), a scale for assessing the severity and extent of psoriasis.

At week 10, 88 percent and 72 percent of patients treated with 5 mg/kg and 3 mg/kg of REMICADE, respectively, experienced a >75 percent improvement from baseline in PASI score compared to 6 percent of those treated with placebo.

About Psoriatic Arthritis
Psoriatic arthritis affects men and women equally and can develop at any age, although it most commonly appears between the ages of 30 and 50. In most instances, psoriasis symptoms, such as scaly rashes, occur as long as 10 years before the patient begins to suffer from arthritis. Symptoms of PsA include stiffness, pain, swelling and tenderness of the joints and the soft tissue around them; reduced range of motion; morning stiffness and tiredness; nail changes; and redness and pain of the eye. Joints commonly affected by PsA are the hands, wrists, knees, ankles, lower back and neck.

About REMICADE(R)
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 www.remicade.com.

Source: Centocor

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