Abbott Reports Five-Year Data for Humira (Adalimumab) in Ankylosing Spondylitis
Results from ATLAS, a Long-Term, Open-Label Extension Study Presented at ACR, Highlight Impact of HUMIRA on Signs and Symptoms and Other Disease Measures in Patients with Active AS
ABBOTT PARK, Ill., Nov. 8, 2011 /PRNewswire/ -- 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.1 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.2,3
"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."
ATLAS is a Phase 3, multicenter, double-blind trial of patients with active AS. A total of 315 patients (208 HUMIRA/107 placebo) were randomized, of which 311 received at least one dose of HUMIRA. Results showed that HUMIRA was effective in reducing the signs and symptoms of active AS as measured by ASAS 20 Response Criteria (a composite measure of patient's global assessment of disease activity, total back pain visual analog scale (VAS) score, inflammation and Bath Ankylosing Spondylitis Functional Index - BASFI). Improvements in spinal mobility were evaluated using linear Bath Ankylosing Spondylitis Metrology Index (BASMI), which is a combined index comprising five assessments of spinal mobility in patients with AS including individual assessment of cervical rotation in degrees, lumbar flexion, lumbar side flexion, intermalleolar distance and tragus-to-wall distance in centimeters. Additional outcomes included BASDAI, C-reactive protein (CRP), BASFI, Short Form-36 Physical Component Summary (SF-36 PCS) and health-related quality of life as measured by the AS Quality of Life (ASQOL) questionnaire.
In the open-label extension of the ATLAS study, spinal mobility was measured by the BASMIln, which is a different version of the BASMI than what was used in the blinded portion of the trial, but comprises the same five assessments. Improvements in BASMIln were evaluated through five years. At year five, mean change from baseline in BASMIln was -0.6. Of the individual components, lumbar side flexion, cervical rotation and intermalleolar distance appeared to drive change in overall BASMIln. Improvements in disease activity, physical function, and quality of life were also measured from baseline through year five. At baseline and year five, mean BASDAI scores were 6.0 (+/-2.0) and 1.8 (+/-1.9), mean total back pain VAS scores were 62.0 (+/-23.9) and 16.4 (+/-20.5), mean SF-36 PCS scores were 32.6 (+/-8.0) and 44.4 (+/-10.0), and mean ASQOL scores were 10.3 (+/-4.4) and 4.8(+/-4.8).
HUMIRA (adalimumab) is a prescription medicine used to reduce the signs and symptoms of ankylosing spondylitis in adults.
HUMIRA is used alone, with methotrexate, or with certain other medicines to reduce the signs and symptoms of moderate to severe rheumatoid arthritis in adults. It may prevent future damage to bones and joints and may help with the ability to perform daily activities.
Important Safety Information
HUMIRA is a TNF blocker that affects the immune system and can lower the ability to fight infections.
People treated with HUMIRA are at an increased risk for developing serious infections that may lead to hospitalization or death. Reported serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy. People at risk of TB may be treated with medicine for TB. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection.
For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death.
Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus, allergic reactions, nervous system problems, blood problems, certain immune reactions, including a lupus-like syndrome, liver problems and new or worsening heart failure or psoriasis. The use of HUMIRA with anakinra or abatacept is not recommended. People using HUMIRA should not receive live vaccines. Common side effects of HUMIRA include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (including sinus infections), headaches, rash, and nausea.
As with any treatment program, the benefits and risks of HUMIRA should be carefully considered before starting therapy.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.
- Journal of the American Academy of Orthopaedic Surgeons.
- Spondylitis Association of America.
Posted: November 2011