THOUSAND OAKS, Calif. & MADISON, N.J.--(BUSINESS WIRE)--Feb. 18, 2005--
Data Also Show Many ENBREL Patients Experienced Improvements in
Symptoms and the Impact of the Disease on Their Daily Life
At three months, nearly 30 percent of 311 patients with moderate-to-severe psoriasis who were taking Enbrel(R) (etanercept) reported that they were "not at all" bothered by their psoriasis, as indicated by their achieving a "zero" score on the Dermatology Life Quality Index (DLQI) measure. The data will be presented at the American Academy of Dermatology annual meeting in New Orleans, Louisiana.
The DLQI is a patient questionnaire widely used in clinical practice which measures the impact of their disease on patient's feelings, daily activities, leisure activities, work, school and personal relationships, as well as how they feel about treatment and their symptoms. The best possible DLQI score to achieve is zero, indicating that psoriasis did not interfere with their lives at all.
Many patients treated with ENBREL experienced improvements in their symptoms and how they felt about their disease as early as one week. Additionally, many patients also reported that the condition of their skin no longer affected social or leisure activities, prevented them from working or studying, or restricted intimacy. The group of patients on ENBREL therapy continued to experience improvements in their activities of daily living over the course of the 12-week study.
In addition to its significant physical symptoms, moderate-to-severe psoriasis can also affect people's feelings, behaviors and experiences. People with psoriasis often are fatigued, and feel depressed, self conscious and socially isolated.
"People with moderate-to-severe psoriasis may face a lifetime of physical and emotional challenges that can have a devastating impact on their personal lives, even leading to extreme embarrassment and social isolation," said Alice Gottlieb, M.D., of the UMDNJ-Robert Wood Johnson Medical School in New Brunswick, New Jersey. "We know that ENBREL can be extremely effective in treating the physical symptoms of the disease, and it is impressive to see that ENBREL treatment also helped improve important aspects of patients' personal lives."
In addition to DLQI data, statistically significant improvements were seen in many people treated with ENBREL across a variety of measurements including mean improvement from baseline in the Psoriasis Area and Severity Index (PASI), a measure of disease severity and in the patient's assessment of psoriasis and itching. These new psoriasis data on ENBREL are consistent with previous studies showing that ENBREL treatment provided significant relief of psoriasis symptoms.
In the Phase 3, double-blind, placebo-controlled, multicenter study conducted at 39 sites in the United States and Canada 620 patients were randomized to receive either 50 mg subcutaneous injections of ENBREL twice a week or placebo twice a week. Before study entry, patients had to discontinue previous psoriasis therapies. Patients were stratified at randomization into two groups: patients who previously received phototherapy or systemic psoriasis therapy, and patients who received neither therapy. The primary endpoint for this study was achievement of a 75 percent or greater improvement from baseline in the PASI 75 after 12 weeks of double-blind treatment. Secondary endpoints at week 12 included the DLQI response, a zero score in DLQI, the subject's assessment of itching, and improvements from baseline in skin pain. After 12 weeks, the double-blind phase was followed by an open-label treatment period where all patients received 50 mg of ENBREL twice a week.
ENBREL was generally well-tolerated during the 12-week double-blind portion of the study. The most commonly reported adverse event was injection site reaction.
Up to seven million people in the United States have psoriasis and 1.5 million have moderate-to-severe plaque psoriasis. The disease is characterized by chronic inflammation of the skin. This inflammation helps drive the formation of red, itchy skin plaques that are often painful and disfiguring. Tumor necrosis factor (TNF) is found at increased levels in psoriatic plaques and plays a critical role in their formation and continued existence.
ENBREL is the only soluble TNF receptor approved to reduce signs and symptoms, induce major clinical response, improve physical function, and inhibit the progression of structural damage in patients with moderately to severely active rheumatoid arthritis (RA). ENBREL can be initiated in combination with methotrexate or used alone.
ENBREL is the only treatment indicated to reduce the signs and symptoms and inhibit the progression of structural damage of active arthritis in patients with psoriatic arthritis. It is approved to reduce the signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis (JRA) in patients four years of age or older who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). It is also the first biologic approved to reduce the signs and symptoms in patients with active ankylosing spondylitis (AS). ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
ENBREL has been used by more than 280,000 patients worldwide across indications.
ENBREL acts by binding TNF, one of the dominant inflammatory cytokines or regulatory proteins that play an important role in both normal immune function and the cascade of reactions involved in the inflammatory process of RA, JRA, psoriasis, psoriatic arthritis, and AS. The binding of ENBREL to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity.
Since the product was first introduced, the following have been reported in patients using Enbrel(R) (etanercept): -- Serious Infections -- Many occurred in people prone to infection, such as those with advanced or poorly controlled diabetes -- Some serious infections were fatal -- Rare cases of tuberculosis -- What to do/Not to do -- Do not start ENBREL if you have an infection or are allergic to ENBREL or its components. -- Tell your doctor if you are prone to infection. -- Stop ENBREL if a serious infection occurs. -- Contact your doctor if you have questions about ENBREL or develop an infection. -- Tell your doctor if you have ever been treated for heart failure. -- Serious nervous system disorders such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes -- Tell your doctor if you have ever had any of these disorders or if you develop them after starting ENBREL. -- Rare reports of serious blood disorders (some fatal) -- Contact your doctor immediately if you develop symptoms such as persistent fever, bruising, bleeding, or paleness. -- In medical studies of all TNF inhibitors, a higher rate of lymphoma (a type of cancer) was seen compared to the general population; however, the risk of lymphoma may be up to several fold-higher in RA and psoriasis patients. -- The role of TNF inhibitors in the development of lymphoma is unknown. -- The incidence of other cancers has not increased with exposure to ENBREL and is similar to the expected rate. -- ENBREL can also cause injection site reactions. -- In a medical study of patients with JRA, infections, headaches, abdominal pain, vomiting, and nausea occurred more frequently than in adults. -- The kinds of infections reported were generally mild and similar to those usually seen in children. -- Other serious adverse reactions were reported rarely, including serious infections (2 percent) and depression/personality disorder (1 percent).
Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL in North America. Wyeth markets ENBREL outside of North America. Immunex Corporation, a wholly owned subsidiary of Amgen, manufactures ENBREL. Additional information about ENBREL, including full Prescribing Information, can be found on the Web site sponsored by the companies at www.enbrel.com or by calling toll free 888-4ENBREL (888-436-2735).
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