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Clinical Trials to Explore Use of Humira™ in Psoriasis and Psoriatic Arthritis

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www.ProHealth.com • March 19, 2003


Abbott Laboratories, maker of the new rheumatoid arthritis drug Humira™, (adalimumab) recently announced the expansion of two clinical trials evaluating the potential of Humira in psoriasis and psoriatic arthritis.

Psoriasis and psoriatic arthritis are autoimmune disorders in which a human protein, tumor necrosis factor-alpha (TNF-á), has been suggested to play a role in the disease development. Data from clinical studies suggest that treatments that inhibit TNF-á may be effective in these disease states. Humira is an FDA approved human monoclonal antibody that resembles antibodies normally found in the body that works by specifically blocking TNF-á.

Humira reduces the signs and symptoms and inhibits the progression of structural damage in adults with moderately to severely active rheumatoid arthritis (RA) who have had insufficient response to one or more traditional disease modifying antirheumatic drugs (DMARDs) and can be used alone or in combination with methotrexate (MTX) or other DMARDs.

"Based on the recent approval of Humira for rheumatoid arthritis, we're excited to be initiating programs that will help us understand the effect of Humira in other autoimmune diseases as well," said Jim Lefkowith, M.D., divisional vice president, Immunosciences Development, Abbott Laboratories.

Psoriasis Trial

Humira will be studied in a randomized, multicenter, Phase II clinical trial that will assess safety and efficacy in adult patients with moderate to severe chronic-plaque psoriasis. Patient response to treatment will be assessed by using the Psoriasis Area Severity Index score, which is a measure of a patient's disease activity.

"We’re hoping that this trial will lead to an available treatment option for the more than four million Americans living with psoriasis," said Ken Gordon, M.D., associate professor of medicine, division of dermatology, Loyola University Medical Center. "Psoriasis can have a significant emotional and psychological impact on a patient's quality of life and by investigating the use of Humira in psoriasis, we’re hoping to see improvements in treating the disease."

Psoriasis is a non-contagious, chronic skin disease characterized by red plaques covered with white scales that presents in different forms and varying degrees of severity. The most common form of psoriasis is "plaque psoriasis," which accounts for approximately 80 percent of psoriasis cases. Plaque psoriasis can appear on any skin surface, although the knees, elbows, scalp, and trunk are the most common locations.

Psoriatic Arthritis Trial

A Phase III study has been initiated that will evaluate Humira in improving signs and symptoms of psoriatic arthritis in adult patients with moderate to severe disease. Patients in the trial will be randomized to receive Humira or placebo, and responses will be measured by improvements in signs and symptoms as measured by American College of Rheumatology response scores.

"Psoriatic arthritis patients experience the often unmanageable symptoms of arthritis combined with psoriasis," said Philip Mease, M.D., clinical professor of rheumatology at the University of Washington. "This trial is designed to assess the effect of Humira in the treatment of these patients and on the progression of the disease."

Flares and remissions characterize the course of psoriatic arthritis, which is an autoimmune disease. If left untreated it can be a progressively disabling disease. The arthritic manifestations often include not only debilitating disease of the hands and feet as is seen in rheumatoid arthritis, but also arthritis of the spine and painful inflammation of tendon insertions. Epidemiological studies indicate that psoriatic arthritis affects as many as 30 percent of the people who have psoriasis. Common symptoms include varying degrees of psoriasis activity along with stiffness, pain, swelling and tenderness of the joints that can lead to a reduced range of motion and potential severe joint destruction.

Additionally, clinical trials are currently underway evaluating the potential of Humira in juvenile rheumatoid arthritis (JRA) and Crohn's disease.

More information about Humira clinical trials can be obtained by calling Abbott Laboratories Medical Information at 1-800-633-9110.



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