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Adalimumab Undergoing Clinical Trial Program in Psoriatic Arthritis

ABBOTT PARK, Ill., Oct. 6 /PRNewswire-FirstCall/ -- Abbott Laboratories announced today the expansion of its immunology clinical trials program to include an additional Phase III study evaluating the potential of HUMIRA (adalimumab) in psoriatic arthritis. Psoriatic arthritis is an autoimmune disorder in which a human protein, tumor necrosis factor-alpha (TNF-a), has been suggested to play a role in the disease development. Data from clinical studies suggest that treatments that inhibit TNF-a may be effective in these disease states. HUMIRA, which is a human monoclonal antibody that resembles antibodies normally found in the body, works by specifically blocking TNF-a.

"Abbott is committed to exploring the full therapeutic potential of HUMIRA," said Jim Lefkowith, M.D., divisional vice president, Immunosciences Development, Abbott Laboratories. "Based on the recent approval of HUMIRA for rheumatoid arthritis, we're excited to be expanding programs that will help us understand the effect of HUMIRA in other autoimmune diseases, in addition to our continued programs in rheumatoid arthritis."

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 who have had inadequate response to disease modifying antirheumatic drugs (DMARDs). 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. This study is in addition to the Phase III study in psoriatic arthritis initiated earlier this year.

"Psoriatic arthritis patients experience symptoms of two often debilitating conditions, arthritis and psoriasis," said Mark Genovese, M.D., assistant professor of medicine at Stanford University School of Medicine. "This trial is designed to assess the effect of HUMIRA on both the joint and skin manifestations of the disease."

If left untreated, psoriatic arthritis 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 people who have psoriasis, a non-contagious, chronic skin disease characterized by red plaques covered with white scales. Common symptoms of psoriatic arthritis 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.

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

Important Safety Information

Cases of tuberculosis (TB), frequently disseminated or extra pulmonary at clinical presentation, have been observed in patients receiving HUMIRA. Serious infections and sepsis, including fatalities, have been reported with the use of TNF-blocking agents, including HUMIRA. Many of these infections occurred in patients on concomitant immunosuppressive therapy that in addition to their underlying disease could predispose them to infections. Other invasive opportunistic fungal infections have also been observed in patients treated with TNF-blocking agents, including HUMIRA.

TNF-blocking agents, including HUMIRA, have been associated in rare cases with exacerbation of demyelinating disease. The most frequent adverse events seen in the placebo-controlled clinical trials (HUMIRA vs. placebo) were upper respiratory infection (17 percent vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for HUMIRA and 4 percent for placebo. As with any treatment program, the benefits and risks of HUMIRA should be carefully considered before initiating therapy.

About HUMIRA

HUMIRA is the first human monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) for reducing the signs and symptoms and inhibiting 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. HUMIRA was created using phage display technology, resulting in an antibody with human-derived heavy and light chain variable regions and human IgG1:K constant regions.

Clinical trials are also currently underway evaluating the potential of HUMIRA in juvenile rheumatoid arthritis (JRA), psoriasis, Crohn's disease and early RA.

HUMIRA was discovered through a broad scientific collaboration between Abbott and Cambridge Antibody Technology (CAT). As part of the collaboration, Abbott had the right to select several target antigens for which a joint Abbott/CAT research team would discover human antibody therapeutics. HUMIRA was isolated and optimized by Abbott and CAT as part of this collaboration. Abbott owns exclusive worldwide rights to HUMIRA, including responsibility for clinical development, manufacturing, sales and marketing. Abbott will book all revenues for HUMIRA, and CAT will receive a royalty fee based on HUMIRA sales.

In September, the European Commission granted marketing authorization to HUMIRA for the treatment of adult rheumatoid arthritis (RA). With E.U. marketing authorization, HUMIRA became the first human monoclonal antibody approved in Europe for RA, and the first tumor necrosis factor alpha (TNF-a) antagonist approved with an indication for use with methotrexate or as monotherapy. HUMIRA is indicated for the treatment of moderate to severe active RA in adult patients when the response to disease modifying anti- rheumatic drugs (DMARDs), including methotrexate, has been inadequate.

Source: Abbott Laboratories

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