The US Food and Drug Administration (FDA) has approved an expanded indication for Abbott Laboratories' rheumatoid arthritis (RA) treatment, Humira (adalimumab), to include improvement in physical function for adult patients with moderately to severely active RA, an official release said.
Improvement in physical function is an important goal of therapy for RA patients, who often 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 one 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, 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."
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 two weeks following the first Humira dose, and improvements in physical function were maintained with Humira through two years of treatment. Sustained improvement in HAQ scores beyond two years has also been seen in other trials with Humira: in one long-term open-label study presented earlier this year, HAQ response was maintained for up to five 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 two 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, M.D., 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."