Contact: Susan Preston
At UMDNJ-Robert Wood Johnson Medical School
Psoriasis Study Results Presented at American Academy of Dermatology
Alice Gottlieb, M.D., Ph.D., professor of medicine at the University
of Medicine and Dentistry of New Jersey (UMDNJ)-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.
"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
"With ENBREL, dermatologists and patients benefit from a combination
of dramatic clearing of the skin, improvement in subjective measures
of quality of life and a proven safety record in the treatment
of more than 150,000 patients," 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.
Physicians have become familiar with the benefits and proven
long-term tolerability profile of ENBREL. It has been used to
treat over 150,000 patients worldwide since becoming commercially
available four years ago.
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.
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