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Friday February 22, 10:00 am Eastern Time
Press Release
SOURCE: University of Medicine & Dentistry of New Jersey
Long-Term Results Show Investigational Biologic Therapy Infliximab Provides A High Degree of Sustained Clinical Benefit in Psoriasis Patients
Landmark Data Presented at American Academy of Dermatology Meeting In New Orleans
NEW BRUNSWICK, N.J., Feb. 22 /PRNewswire/ -- The monoclonal antibody infliximab has been shown to provide a rapid, durable response and a high level of sustained efficacy for at least six months in patients with moderate-to-severe psoriasis, according to new long-term data presented today at the 60th Annual Meeting of the American Academy of Dermatology (AAD). Approximately one quarter of the seven million Americans with psoriasis suffer from moderate-to-severe disease, which can be both physically and emotionally debilitating.
``Our findings to date suggest that infliximab may be a safe and effective therapy for the long-term treatment of this devastating, life-impacting disorder,'' said Alice Gottlieb, M.D., Ph.D., principal investigator and professor of medicine at the University of Medicine & Dentistry of New Jersey-Robert Wood Johnson Medical School. ``With these promising results in psoriasis, we can now begin thinking about the possibility of a disease-modifying drug like infliximab that can achieve long-lived remission without the side effects of existing treatment options.''
Infliximab (also known as REMICADE®) is a monoclonal antibody that specifically targets and irreversibly binds to a key inflammatory mediator called tumor necrosis factor alpha (TNF-alpha), which is believed to play a pivotal role in psoriasis. Histology results have shown a high correlation between the clinical efficacy of infliximab and the cellular improvement in psoriasis plaques. These findings suggest that infliximab may treat underlying disease, as well as external symptoms of the skin.
Study Results
The purpose of this open-label extension trial was to determine whether or not those who had a favorable response to infliximab in the initial randomized 10-week study (The Lancet, June 9, 2001) could maintain the clinically-relevant benefits of a Psoriasis Area Severity Index (PASI) improvement of >/= 50 percent. In the original trial, 82 and 73 percent of patients (5 mg/kg and 10 mg/kg treatment groups, respectively) experienced a 75 percent improvement in their PASI rating at week 10, following three doses of infliximab (at weeks 0, 2, and 6).
A total of 29 patients (15 at 5 mg/kg, 14 at 10 mg/kg) who received the three doses of infliximab were observed in the open-label extension study through 26 weeks. The data showed that more than half (55 percent, 16 of 29 patients) of the two combined treatment groups sustained their response for six months without re-treatment and maintained a >/= 50 percent improvement in their PASI rating. In addition, 48 percent of patients maintained a 75 percent improvement in PASI over the same study period.
Infliximab was generally well tolerated, with no serious adverse events reported. Overall, the safety profile was consistent with rheumatoid arthritis (RA) and Crohn's disease (CD) trials using infliximab.
About Psoriasis
Psoriasis is a chronic skin disease that generally appears as patches of raised red skin covered by a flaky white buildup. The flaring and remittance of these plaques can be physically and psychologically debilitating. Although the exact cause is unknown, psoriasis is believed to be related to signals sent by the body's immune system, accelerating the growth cycle of skin cells, causing them to pile up on the surface when the body can't shed them fast enough.
Moderate-to-severe psoriasis is defined as involving five percent or more of the body surface. Although these patients are typically treated with systemic immunosuppressants, such as cyclosporine, long-term exposure can cause toxic side effects such as hypertension and irreversible renal insufficiency.
About UMDNJ
The University of Medicine & Dentistry of New Jersey is the largest university of its kind in the nation. It comprises the state's only three medical schools and dental school, and also has schools of nursing, public health, health-related professions, and graduate biomedical sciences. The University offers 27 academic programs in health sciences. Its four main academic health care campuses are located in Newark, Camden, Stratford and Piscataway/New Brunswick, and it also has affiliations with more than 200 academic and health care institutions throughout New Jersey. UMDNJ is dedicated to the pursuit of excellence in: the undergraduate, graduate, postgraduate and continuing education of health professionals and scientists; the conduct of basic biomedical, psychosocial, clinical and public health research; health promotion, disease prevention and the delivery of health care; and service to the citizens of New Jersey.
CONTACT: Susan Preston |
