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FDA Approves Humira (adalimumab) to Improve Physical Function in Rheumatoid Arthritis (RA) Patients

ABBOTT PARK, IL -- August 10, 2004 -- The U.S. Food and Drug Administration (FDA) has approved an expanded indication for Abbott Laboratories' rheumatoid arthritis (RA) treatment, Humira(R) (adalimumab), to include improvement in physical function for adult patients with moderately to severely active RA.

Improvement in physical function is an important goal of therapy for RA patients, who of10 experience disability and loss of function that can greatly reduce quality of life. Many people with RA are unable to groom or dress themselves and some cannot walk due to the crippling effects of their disease.

The FDA based its approval on a supplemental Biologics Licensing Application (sBLA) filed by Abbott on Sept. 30, 2003. In 2002, Humira was approved to reduce signs and symptoms and inhibit the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to 1 or more disease modifying antirheumatic drugs (DMARDs).

"It is not uncommon for RA patients to live with such debilitating pain and loss of function that they cannot perform simple activities such as bathing or even cutting up food," said Arthur Kavanaugh, MD, rheumatologist and professor of medicine at University of California, San Diego. "Now, with biologic treatment options like Humira, my patients aren't only experiencing a reduction in disease symptoms; they are seeing important gains in physical function and overall quality of life."

Improvements in Physical Function Maintained Over Two Years
The physical function approval was based on a 52-week open-label continuation study of 457 RA patients with inadequate response to methotrexate (MTX) who were previously enrolled in a double-blind placebo-controlled 52-week lead-in study. The continuation study was designed to assess the maintenance of improved physical function in patients treated with Humira.

Improvement in physical function was measured using the Health Assessment Questionnaire Disability Index (HAQ). HAQ is a measure of physical function that assesses a patient's ability to perform normal daily activities such as getting dressed, walking and climbing stairs.

In this study, meaningful improvements in HAQ were achieved as soon as 2 weeks following the first Humira dose, and improvements in physical function were maintained with Humira through 2 years of treatment. Sustained improvement in HAQ scores beyond 2 years has also been seen in other trials with Humira: in 1 long-term open-label study presented earlier this year, HAQ response was maintained for up to 5 years.

Improvement in physical function was also demonstrated using the Short
Form 36-item Health Survey (SF-36), a broad questionnaire that examines the physical and mental impact of RA on patients. SF-36 assesses several quality-of-life factors, including limitations in physical, social and emotional functioning, mental health, general health perceptions, bodily pain and vitality. Data showed that clinically meaningful improvements in SF-36 measures for Humira patients were sustained for 2 years.

"With Humira, rheumatologists have an important tool to enhance mobility and overall quality of life in patients who were previously limited or even incapacitated by their disease," said Jim Lefkowith, MD, divisional vice president, Development, Abbott Immunology. "This approval is the latest example of Abbott's ongoing commitment toward improving the lives of patients by expanding Humira's potential in RA and exploring its use in other
conditions."

Important Safety Information
Cases of tuberculosis (TB) 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 also taking other immunosuppressive agents that in addition to their underlying disease could predispose them to infections. The combination of Humira and anakinra is not recommended.

TNF-blocking agents, including Humira, have been associated in rare cases with demyelinating disease and severe allergic reactions. Rare reports of serious blood disorders and lymphoma have been reported with TNF-blocking agents. Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of TNF-blocking therapy in the development of malignancies is not known.

The most frequent adverse events seen in the placebo-controlled clinical trials in rheumatoid arthritis (Humira vs. placebo) were injection site reactions (20% vs. 14%), upper respiratory infection (17% vs. 13%), injection site pain (12% vs. 12%), headache (12% vs. 8%), rash (12% vs. 6%) and sinusitis (11% vs. 9%). Discontinuations due to adverse events were 7% for Humira and 4% for placebo. As with any treatment program, the benefits and risks of Humira should be carefully considered before initiating therapy.

About RA
More than 5 million people worldwide suffer from RA, a chronic autoimmune disease that causes pain, swelling and stiffness in the joints of the hands, feet and wrists, and of10 leads to the destruction of joints. Unlike osteoarthritis, the most common form of arthritis, RA is an autoimmune disease where joints are inflamed, resulting in eventual destruction of the joints interior and the surrounding bone.

More information on RA and current treatment options can be found at http://www.RA.com.

About Humira
Humira is the only fully human monoclonal antibody approved by the FDA for reducing the signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adults with moderately to severely active RA who have had insufficient response to 1 or more disease modifying antirheumatic drugs (DMARDs). Humira can be used al1 or in combination with methotrexate (MTX) or other DMARDs. The efficacy and safety of Humira have been studied in 23 clinical trials and in more than 2,300 patients, making it the most-studied TNF antagonist for RA at the time of regulatory submission. Humira was approved by the FDA on Dec. 31, 2002.

Humira offers convenient every-other-week dosing by subcutaneous injection (shot beneath the skin) via a specially designed pre-filled syringe. Humira is 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 April 2004, the European Medicines Evaluation Agency (EMEA) granted a positive opinion for a Humira label extension for reducing the rate of progression of joint damage as measured by X-ray and improving physical function in adults with RA. To date, Humira has been approved in 51 countries and prescribed to more than 75,000 patients suffering from rheumatoid arthritis worldwide.

Clinical trials are currently underway evaluating the potential of Humira in other autoimmune diseases, including juvenile rheumatoid arthritis (JRA), psoriasis, psoriatic arthritis, Crohn's disease and ankylosing spondylitis.

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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