Positive Results From ENBREL Psoriasis Study to be Presented by RWJMS Researcher at American Academy of Dermatology Conference
Friday March 21, 8:01 am ET
NEW BRUNSWICK, N.J., March 21 /PRNewswire/ -- Alice Gottlieb, M.D., Ph.D., professor of medicine at the University of Medicine and Dentistry of New Jersey - Robert Wood Johnson Medical School, will present positive results from a pivotal Phase 3 study of ENBREL® (etanercept) in the treatment of psoriasis at the 61st Annual Meeting of the American Academy of Dermatology in San Francisco.
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"The study demonstrated that patients treated with ENBREL experienced rapid, significant, and sustained improvement in their symptoms," said Gottlieb. "Patients treated with ENBREL experienced an impressive response in skin lesions and quality of life in as early as two weeks, and nearly 60 percent of patients achieved at least a 75 percent improvement in their symptoms over the six month period."
In the study (n=652), 49 percent of patients treated with 50 mg of ENBREL twice weekly achieved at least a 75 percent improvement compared to placebo after three months of therapy. Continued improvement was seen throughout the study. Nearly 60 percent of patients receiving ENBREL 50 mg twice a week achieved at least a 75 percent improvement after six months of therapy. Similar results were seen among patients treated with 25 mg of ENBREL twice weekly, with 34 percent of patients achieving at least a 75 percent improvement after three months of therapy and 44 percent improving after six months.
These improvements were accompanied by significant and clinically important improvements in physician global assessment of psoriasis, patient global assessment, and in health-related quality of life as measured by the Dermatology Life Quality Index and EuroQoL 5D Feeling Thermometer.
"With ENBREL, patients benefited from a combination of dramatic clearing of the skin, improvement in subjective measures of quality of life and a proven safety record in more than 150,000 patients treated for rheumatoid arthritis and psoriatic arthritis," said Gottlieb.
ENBREL was generally well tolerated in the studies and adverse events were similar to those occurring in patients receiving placebo. The most frequent adverse events were injection site reactions.
Psoriasis is an inflammatory disease affecting nearly 7 million people in the United States, with approximately 1 million classified as appropriate for biologic therapy. It can significantly impact a patient's quality of life and is characterized by chronic inflammation of the skin. This inflammation drives the formation of skin plaques that are painful and disfiguring. Tumor necrosis factor (TNF) is found at high levels in psoriatic plaques, and plays a critical role in their formation and maintenance.
ENBREL is the only fully human anti-TNF receptor approved for use to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis, and to reduce the signs and symptoms and inhibit the structural damage in patients with moderately to severely active rheumatoid arthritis (RA). ENBREL is the only biologic therapy approved to treat newly diagnosed RA patients, and can be used alone. It is also approved to reduce the signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis (JRA) in patients who have had an inadequate response to disease-modifying medicines.
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 that causes the inflammatory process. The binding of ENBREL to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity. |
