Abbott (NYSE: ABT) today announced five-year results from the open-label extension of the ATLAS study, which evaluated the long-term impact of treatment with HUMIRA® (adalimumab) on disease activity, including spinal mobility in patients with active ankylosing spondylitis (AS). Improvements in disease activity were measured from baseline through year five. At baseline and year five, the study showed mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores were 6.0 (+/-2.0) and 1.8 (+/-1.9), respectively. The BASDAI is a composite measure of disease activity that assesses the severity of fatigue, spinal and peripheral joint pain, localized tenderness, and morning stiffness on a 0-10 scale. For these patients receiving open-label HUMIRA treatment through year five, improvements were also observed for spinal mobility and quality of life.
ATLAS (Adalimumab Trial Evaluating Long-Term Safety and Efficacy for Ankylosing Spondylitis) is among the first tumor necrosis factor (TNF) inhibitor studies to evaluate five years of efficacy and safety data in AS. Results from ATLAS were presented at the American College of Rheumatology Annual Scientific Meeting (ACR) in Chicago.
Ankylosing spondylitis is an autoimmune disease that affects up to 1 percent of the worldwide population. AS affects the spine and large peripheral joints, including the hips, and can be associated with other inflammatory diseases of the skin, eyes and intestines. Typically, the first symptoms of AS are subtle and can include frequent pain and stiffness in the lower back and buttocks. In the most advanced cases, AS can lead to new bone formation on the spine, which may cause the spine to fuse in a fixed position with severely limited mobility. AS typically develops between the ages of 17 and 35, and men are two to three times more likely than women to develop the disease.
"AS is a potentially disabling disease that can go undiagnosed for up to 10 years, so it is important for people with symptoms to see a rheumatologist early to begin proper treatment," said Philip Mease, M.D., Chief, Swedish Hospital Rheumatology Clinical Research Division, Seattle, WA.