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Phase III Trial of Adalimumab in Ankylosing Spondylitis Launched

ABBOTT PARK, Ill., Feb. 4 /PRNewswire-FirstCall/ -- Abbott Laboratories (NYSE:ABT) announced today the initiation of a global Phase III study evaluating the potential of HUMIRA(R) (adalimumab) in treating ankylosing spondylitis (ANK-ki-low-sing spon-di-LIE-tis). Ankylosing spondylitis (AS), or arthritis of the spine, is an autoimmune disorder in which a human protein, tumor necrosis factor-alpha (TNF-a), appears to play a role in the disease development. Data from clinical studies suggest that inhibition of TNF-a may be active against this disease state. HUMIRA, which is a fully human monoclonal antibody that resembles antibodies normally found in the body, works by specifically blocking TNF-a.

Ankylosing spondylitis, one of the many forms of inflammatory arthritis known as spondyloarthropathies, is a chronic disease that primarily affects the spine but can also affect other joints and ligaments, resulting in severe joint and back stiffness and deformity over time. It is estimated that between 350,000 and one million people in the U.S. and more than three million in the European community are affected by AS or a related disease. Spondyloarthropathies may affect young adults and commonly begin before the age of 35.

"Biologic therapies, such as HUMIRA, are changing the way we treat devastating autoimmune diseases," said James B. Lefkowith, M.D., divisional vice president, Immunology Development, Abbott Laboratories. "We hope that this trial will yield information about whether HUMIRA will be an option in reducing the severe joint and back pain that affects AS patients."

Trial Information
A global Phase III study has been initiated that will evaluate the efficacy and safety of HUMIRA in ankylosing spondylitis in adult patients who have had inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs). Patients in the trial will be randomized to receive HUMIRA or placebo, and responses will be measured by improvements in signs and symptoms, disease progression and quality of life.

"AS patients can experience a range of clinical symptoms from occasional back pain to a chronic and progressive form of the disease that attacks the spine and other organs. This can often result in loss of motion and deformity as well as have a devastating impact on a patient's quality of life," said John Davis, M.D., University of California at San Francisco and co-lead investigator in the study.

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 injection site reactions (20 percent vs. 14 percent), 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.

HUMIRA is the first fully 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. HUMIRA offers convenient every other week dosing by subcutaneous injection (shot beneath the skin) via a specially designed pre-filled syringe.

On Sept. 10, 2003, Abbott announced that the European Commission granted marketing authorization to HUMIRA for the treatment of adult rheumatoid arthritis (RA). With European Union (EU) marketing authorization, HUMIRA became the first fully 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. In the EU, HUMIRA is indicated for the treatment of moderate to severe active RA in adult patients when the response to DMARDs including methotrexate, has been inadequate. To date, HUMIRA has been approved in 37 countries and launched in eight (including the U.S.).

On Oct. 1, 2003, Abbott submitted a supplemental Biologics Licensing Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of HUMIRA to improve physical function in patients with moderately to severely active rheumatoid arthritis.

Clinical trials are also currently underway evaluating the potential of HUMIRA in other autoimmune diseases.

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.

Source: Abbott Laboratories

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