NEW BRUNSWICK, N.J., Nov. 19 /PRNewswire/ -- A new study released today indicates people with moderate-to-severe plaque psoriasis treated with etanercept experienced significant clearing of skin lesions within the first two weeks of taking the medication.
The study which is published in the November 20th issue of The New England Journal of Medicine, followed patients with psoriasis who were treated with etanercept, also known by the brand name ENBREL.
“The study results show that ENBREL may be a safe and effective treatment and that its effects may be sustained and improved over time. This is great news for patients with psoriasis as patients report that this disease causes more physical and mental disability than many other major chronic diseases” said Alice Gottlieb, M.D., Ph.D., director of the Clinical Research Center at University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, and corresponding author of the journal article. “Over the past five years, ENBREL has had an exceptional safety and efficacy profile in treating adults and children with other diseases, which is why its effectiveness in treating psoriasis is an important and promising advance for patients with psoriasis.”
Nearly half (49 percent) of people taking a high dose of ENBREL (50 mg twice weekly) achieved clear or almost clear skin at week 12 (primary end point). Clear or almost clear skin is similar to an improvement of at least 75 percent from baseline in the PASI (a psoriasis severity scoring tool), also known as PASI 75. These results continued to improve with nearly 60 percent of patients taking this dose of ENBREL achieving clear or almost clear skin at six months.
ENBREL was also effective at other doses. More than one- third (34 percent) of patients taking the currently approved dose of 25 mg twice weekly achieved clear or almost clear skin compared with four percent of patients taking placebo at week 12. At week 24, responses continued to improve with 44 percent of patients taking this dose achieving clear or almost clear skin.
ENBREL also produced statistically significant and clinically meaningful improvement in quality of life in as early as two weeks, as measured by the Dermatology Life Quality Index (DLQI), a 10-item patient questionnaire that assesses the impact psoriasis has on various aspects of life. At week 12, the majority of patients taking either 25 mg twice weekly or 50 mg twice weekly of ENBREL (61 percent, 51 percent, respectively) experienced an improvement in quality of life compared with 11 percent of patients taking placebo. By week 24, nearly 40 percent of patients receiving 50 mg twice weekly of ENBREL reported that psoriasis was no longer impacting any aspect of their daily life.
“Patients with moderate to severe plaque psoriasis report a significant disease-related inability to participate in daily activities and may suffer from self image problems and depression,” Dr. Gottlieb said. “It is very encouraging as a physician to see that patients on ENBREL report a better quality of life because how a patient actually feels is an important aspect of effective psoriasis management.”
The study involved a total of 652 psoriasis patients who were randomized to receive either placebo or a low dose of ENBREL (25 mg once weekly), medium dose (25 mg twice weekly), or high dose (50 mg twice weekly) for 12 weeks. Patients in the placebo group were treated with ENBREL following week 12. The study followed patients for 24 weeks.
“Many people believe that psoriasis is just red itchy skin. In reality, it is a serious, chronic disease that, if not properly treated, can present a lifetime of physical and emotional challenges,” said Gail Zimmerman, president and chief executive officer of the National Psoriasis Foundation. “People with psoriasis need new treatment options that provide consistent relief of psoriasis symptoms. These results are exciting for psoriasis patients and show that ENBREL may improve their quality of life.”
ENBREL is the first therapy that targets tumor necrosis factor (TNF), the dominant inflammatory cytokine in psoriasis. TNF is found at high levels in psoriatic plaques, and plays a critical role in their formation and maintenance. This is the first large multi-center study to demonstrate the efficacy and tolerability of a TNF antagonist for the treatment of psoriasis.
“The results underscore the critical role TNF plays in the pathogenesis of psoriasis,” Dr. Gottlieb said.
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.
ENBREL was well-tolerated across all treatment groups. The side effects were similar to those taking placebo, and the most common side effects were mild and temporary injection site reactions.
About Psoriasis
It is estimated that nearly seven million Americans have psoriasis, a painful, chronic inflammatory disease, which generally appears as patches of raised, scaly, red skin covered by a flaky white buildup or plaque that are painful and disfiguring. Psoriasis can significantly impact a patient’s quality of life and many people with psoriasis report that they are unable to work, and may face discrimination, financial distress, or depression.
About UMDNJ-Robert Wood Johnson Medical School
As one of the nation’s leading comprehensive medical schools, UMDNJ-Robert Wood Johnson Medical School is dedicated to the pursuit of excellence in education, research, health care delivery and the promotion of community health for the residents of New Jersey. The school maintains educational programs at the undergraduate, graduate and postgraduate levels, as well as continuing education courses for health care professionals and community education programs.
The medical school encompasses 21 basic science and clinical departments and also integrates diverse clinical programs conducted at its 37 hospital affiliates and numerous ambulatory care sites in the region. The major institutes affiliated with UMDNJ-Robert Wood Johnson Medical School are the Cancer Institute of New Jersey, the Cardiovascular Institute, the Child Health Institute of New Jersey, the Center for Advanced Biotechnology and Medicine, and the Environmental and Occupational Health Sciences Institute.
The University of Medicine and Dentistry of New Jersey comprises the state’s only three medical schools, its only dental school, a graduate school of biomedical sciences, school of health related professions, school of nursing and a school of public health on campuses in Newark, Piscataway/New Brunswick, Scotch Plains, Camden and Stratford. UMDNJ also operates UMDNJ-University Hospital in Newark and University Behavioral HealthCare. It is affiliated with more than 200 health care and educational institutions throughout the state.
UMDNJ
CONTACT: Maura Bergen of Porter Novelli, +1-212-601-8220, for UMDNJ
