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The U.S. Food and Drug Administration (FDA) will allow Abbott Labs to claim that its drug Humira® (adalimumab) can improve the physical function of adult patients with moderately to severe rheumatoid arthritis.
Many rheumatoid arthritis patients suffer a loss of physical function. Many cannot groom or dress themselves. Some cannot walk due to the crippling effects of their disease. Humira is already indicated to improve the signs and symptoms and to inhibit structural damaged of rheumatoid arthritis in such patients.
The new indication is based on a 52-week study of Humira that involved 457 rheumatoid arthritis patients who failed to adequately respond to treatment with the disease modifying antirheumatic drug methotrexate.
While undergoing treatment with Humira, the study participants were assessed on their ability to perform normal daily activities such as getting dressed, walking and climbing stairs. Meaningful physical function gains were achieved as soon as two weeks following the first Humira dose and maintained through two years of treatment.
"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, M.D., 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."
Source:
Medical Week Staff, week
of August 9, 2004
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