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| |  AAD: Enbrel (Etanercept) Effective In Treating Psoriasis NEW BRUNSWICK, NJ -- February 22, 2002 -- The Phase 2 clinical study has demonstrated that 56 percent of patients treated with Enbrel® (etanercept) had at least a 75 percent improvement in their psoriasis over the six month period compared to 5 percent of patients receiving placebo. Enbrel was approved by the U.S. Food and Drug Administration (FDA) last month to treat psoriatic arthritis a disease with both joint and skin involvement. Alice Gottlieb, MD, Ph.D., Professor of Medicine at the University Medicine and Dentistry of New Jersey - Robert Wood Johnson Medical School, will present results from this clinical study of Enbrel for the treatment of psoriasis at the 60th Annual American Academy of Dermatology Conference in New Orleans. "We previously have seen the effectiveness of Enbrel on the psoriatic plaques of psoriatic arthritis patients," said Dr. Gottlieb. "This new psoriasis study provides data that show Enbrel, used without other medicines, may be a powerful new weapon against this life-impacting disease." Patients treated with Enbrel in this study experienced a significant improvement at three months, with 30 percent of patients on Enbrel achieving PASI 75, compared with 2 percent of those on placebo (p < 0.0001). Continued improvement was seen throughout the study. After six months of treatment, 56 percent of patients receiving Enbrel achieved PASI 75, compared with 5 percent of those receiving placebo at six months. Additionally, 21 percent of patients receiving Enbrel achieved PASI 90 compared to none of the patients who received placebo. These improvements in PASI score were accompanied by significant and clinically important improvements in psoriasis target lesions, physician global assessment of psoriasis, and in health-related quality of life as measured by the Dermatology Life Quality Index (DLQI). Enbrel treated patients experienced rapid onset in subjective improvement. The patient global assessment of psoriasis was significantly improved in patients receiving Enbrel compared with those receiving placebo after only two weeks of treatment. In this Phase 2 clinical study, 112 patients with moderate to severe plaque psoriasis were randomized evenly to receive 25 mg of Enbrel or placebo subcutaneously twice a week for six months. The primary endpoint of the study was the proportion of patients achieving a 75 percent improvement in Psoriasis Area and Severity Index (PASI 75) after three months. Enbrel was generally well tolerated in this study. Side effects seen more frequently in patients receiving Enbrel included mild infections. The majority of infections observed were mild upper respiratory infections and sinusitis. The overall tolerability profile in patients receiving Enbrel was similar to that in the placebo group. "Enbrel has an impressive tolerability profile which coupled with its ease of administration, will make it especially attractive to dermatologists who are considering using biologic therapy for their patients," said Dr. Gottlieb. "Further, the role of TNF (tumor necrosis factor) in psoriasis has emerged to validate that this protein is an important one to target for psoriasis therapy." Psoriasis is a non-contagious skin disease, beginning most often in people ages 10 to 40, in which the skin grows faster than normal and forms silvery layers, known as plaques. These plaques can flake off with red, inflamed skin underneath. More than 7,000,000 people in the United States have psoriasis, with 150,000 new cases occurring each year. Enbrel has been marketed since November 1998 and has been used by over 120,000 patients. Enbrel is indicated for reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active RA, and reducing signs and symptoms in patients four years of age and older with moderately to severely active polyarticular-course juvenile rheumatoid arthritis who have had an inadequate response to one or more disease modifying medicines. Enbrel is the only tumor necrosis factor (TNF) inhibitor that can be used as monotherapy (without methotrexate) and the only biologic response modifier approved for use as a first-line monotherapy for RA. Most recently, Enbrel was approved as the first therapy to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis. Enbrel is the only TNF receptor on the market. It 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 cause the inflammatory process of RA and psoriatic arthritis. The binding of Enbrel to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity.
SOURCE Robert Wood Johnson Medical School
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