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Abbott 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."
Presentation Highlights:
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.
*Results from an Analysis Evaluating the Long-term Safety of Adalimumab in Patients with Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Psoriasis and Crohn's Disease; G. Burmester, et al
– Abstract SAT0130; Poster; 9 June, 2012; 10:15 a.m.; Location: Poster Area.
Source: prnewswire.com
"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."
Presentation Highlights:
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.
*Results from an Analysis Evaluating the Long-term Safety of Adalimumab in Patients with Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Psoriasis and Crohn's Disease; G. Burmester, et al
– Abstract SAT0130; Poster; 9 June, 2012; 10:15 a.m.; Location: Poster Area.
Source: prnewswire.com