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.
In the ATLAS study, patients with active AS were randomized to HUMIRA 40 mg every other week or placebo for 24 weeks followed by an open-label extension of up to five years, during which time patients were allowed to escalate to weekly dosing. Of the 125 patients who completed five years of HUMIRA exposure, 30 (24 percent) received weekly dosing. The recommended dose of HUMIRA for the treatment of AS is 40 mg every other week by subcutaneous injection.
"The controlled portion of the ATLAS study demonstrated improvement in signs and symptoms and other disease measures with adalimumab," added Philip Mease, M.D.
"HUMIRA's efficacy and safety has been evaluated across six immune-mediated conditions and its use in rheumatoid arthritis has been evaluated in multiple studies during the past 14 years," said John Leonard, M.D., senior vice president, Global Pharmaceuticals Research and Development, Abbott. "HUMIRA has been approved for use in people with AS since 2006 and with the open-label extension of the ATLAS trial, HUMIRA is among the first TNF inhibitors to present five years of efficacy data in ankylosing spondylitis."