ABBOTT PARK, Illinois, May 29, 2012 /PRNewswire/ -- Abbott (NYSE: ABT) scientists and independent researchers will highlight the latest investigational research findings on HUMIRA® (adalimumab) at the European League Against Rheumatism (EULAR) Congress in Berlin, Germany, from 6-9 June, 2012. The presentations include two of the longest open-label extension studies in rheumatoid arthritis (RA), featuring long-term data for disease activity and radiographic inhibition. Data will also be presented on investigational indications in axial and peripheral spondyloarthritis (SpA), moderate to severe polyarticular juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS) and health economics research.
"Data presented at this year's EULAR highlight Abbott's commitment to continue to expand our understanding of the efficacy and safety of HUMIRA and address the needs of patients and physicians across a broad spectrum of rheumatologic diseases," said John Medich, Ph.D., divisional vice president, Clinical Development, Immunology, Abbott. "Specifically, data highlighting the use of HUMIRA for long-term treatment of RA and new data in investigational indications like axial and peripheral SpA will be presented, reinforcing Abbott's ongoing investment in research in the rheumatology space."
Data being presented at EULAR include the comprehensive 10-year data for treatment of moderate to severe, long-standing RA in the DE019 trial and in the DE020 follow-up study. DE020 will be presented in a publication, while DE019 will be presented as a poster on 9 June.
Data will also be presented for ABILITY-I, the first, multi-national Phase 3 study evaluating the use of an anti-tumor necrosis factor (anti-TNF) medication in patients with active non-radiographic axial SpA – a debilitating condition closely related to AS that primarily presents with chronic back pain and stiffness, and can be accompanied by the presence of arthritis, and inflammation in the eye and/or gastrointestinal tract. There is currently no approved treatment for non-radiographic axial SpA. Results from 68 weeks of treatment with HUMIRA will be shown, highlighting not only the initial clinical responses in the 12-week, placebo-controlled trial, but also the responses over an additional year of treatment. These data will be presented as a poster on 7 June.
The initial results will be presented from ABILITY-2, the first Phase 3 study investigating the use of an anti-TNF medication in patients with active peripheral SpA that don't have a diagnosis of psoriatic arthritis (PsA). This patient population is characterized by peripheral arthritis (asymmetric, lower limb or both), enthesitis (painful inflammation where a tendon or ligament attaches to bone) or dactylitis (a painful and swollen digit), in addition to the presence of other features (family history of SpA, history of inflammation in the eye, diagnosis of other immune-mediated inflammatory diseases, sacroiliitis on MRI). There is currently no approved treatment for non-PsA peripheral SpA. Data following 12-weeks of treatment with HUMIRA will be shown as a poster on 7 June.
Additionally, clinical and patient-reported outcomes will be presented from OPTIMA, the first global prospective trial using a treat-to-target philosophy in the treatment of moderate to severe RA. Treat-to-target is focused on achieving a clearly defined treatment goal within a set duration of time and adjusting the treatment if the target is not met. This approach is aligned to EULAR and American College of Rheumatology (ACR) rheumatoid arthritis treatment recommendations.
A comprehensive list of EULAR abstracts is available at www.eular.org. Specific abstracts related to HUMIRA or the disease states that it helps to treat include the following (all times are CET):
Juvenile Idiopathic Arthritis
Long-Term Safety Across Diseases
Health and Economic Outcomes
General Disease State
Approved indications for HUMIRA vary worldwide by country or region.
About HUMIRA® (adalimumab)
HUMIRA in combination with methotrexate, is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate has been inadequate and for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. HUMIRA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
HUMIRA in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in children and adolescents aged 4 to 17 years who have had an inadequate response to one or more DMARDs. HUMIRA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
HUMIRA is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
HUMIRA is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
The medicine can only be obtained with a prescription.
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.
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