Health Boards
Abbott scientists and independent researchers will highlight the latest research findings on HUMIRA® (adalimumab) at this year's American College of Rheumatology (ACR) Annual Scientific Meeting, scheduled for November 5-9 in Chicago. The presentations include data on rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS) and spondyloarthritis (SpA), as well as health economics research.
"At this year's ACR, taking place in our home town of Chicago, researchers will share a broad spectrum of compelling data for HUMIRA across approved and investigational indications," said John Leonard, M.D., senior vice president, Global Pharmaceutical Research and Development, Abbott. "These studies underscore our commitment to advancing treatment for rheumatologic diseases and meeting the needs of patients, physicians and payors around the world."
Presentation Highlights
Abbott data being presented at ACR include the first presentation of results from ABILITY-1, the first Phase 3 study to evaluate an anti-tumor necrosis factor medication (anti-TNF) in patients with non-radiographic axial spondyloarthritis. These data were selected for an oral presentation on November 8.
The company also will present clinical and patient-reported outcomes from OPTIMA, the first global prospective trial using a treat-to-target philosophy in the treatment of moderate to severe rheumatoid arthritis. 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. In OPTIMA, the treatment goal was a composite primary endpoint of low disease activity score (DAS28<3.2) and no radiographic progression (change from baseline in modified total Sharp score of less than or equal to 0.5).
Additionally, Abbott is presenting data from among the longest open-label extension studies in RA: 10-year data from the open-label extension of the DE019 trial of patients with moderate to severe long-standing RA and eight-year data from the open-label extension of the PREMIER trial of patients with early moderate to severe RA. Abbott also will present five-year results from the open-label extension of the ATLAS study. ATLAS is a Phase 3, multicenter, double-blind trial of patients with active AS randomized to HUMIRA 40 mg every other week or placebo for 24 weeks followed by an open-label extension up to five years.
Identified below are some HUMIRA abstracts of interest (all times are CST):
Rheumatoid Arthritis
Study Related to Clinical and Radiographic Implications of Time to Treatment Response in Early Rheumatoid Arthritis Patients with Baseline Levels of Disease Activity Reflective of a Clinical Practice Setting; E. Keystone, et al
Abstract 417; Poster Session; November 6, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Analysis of Genetic Influence of HLA-DRB1, IL4R and FcγRIIb on Radiographic Responses to Methotrexate Monotherapy or Adalimumab Plus Methotrexate Through 26 Weeks in Patients with Early Rheumatoid Arthritis; A. Skapenko, et al
Abstract 154; Poster Session; November 6, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Eight-Year Results of an Open-Label Extension of a Phase 3 Trial Related to Initial Combination Therapy with Adalimumab Plus Methotrexate in Patients with Early Rheumatoid Arthritis; F. Breedveld, et al
Abstract 1231; Poster Session; November 7, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Study Related to Baseline Levels of the Inflammatory Biomarker C-Reactive Protein Correlation with Magnetic Resonance Imaging Measures of Synovitis at Baseline and After 26 Weeks of Treatment in Patients with Early Rheumatoid Arthritis; C. Peterfy, et al
Abstract 1612; Oral Abstract Session; November 7, 2011; 2:45 p.m.;
Location: W 474 A
Study Related to Outcomes and Predictors in Early Rheumatoid Arthritis Patients Treated with Adalimumab Plus Methotrexate, Methotrexate Alone or Methotrexate Plus Subsequent Adalimumab; J. Smolen, et al
Abstract 1698; Oral Abstract Session; November 7, 2011; 5:15 p.m.;
Location: W 375 C
Results of a Phase 4, Double-Blind, Placebo-Controlled Trial Related to Withdrawal of Adalimumab in Early Rheumatoid Arthritis Patients Who Attained Stable Low Disease Activity with Adalimumab Plus Methotrexate; A. Kavanaugh, et al
Abstract 1699; Oral Abstract Session; November 7, 2011; 5:30 p.m.;
Location: W 375 C
Final 10-Year Results of an Open-Label Extension of a Phase 3 Trial Related to Initial Combination Therapy with Adalimumab Plus Methotrexate in Patients with Long-standing RA; E. Keystone, et al
Abstract 2228; Poster Session; November 8, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Phase 3b and Post-Marketing Observational Study Related to Safety and Effectiveness of Adalimumab in Patients with Rheumatoid Arthritis During More Than Five Years of Therapy; G. Burmester, et al
Abstract 2216; Poster Session; November 8, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Juvenile Idiopathic Arthritis
Study Related to Long-Term Efficacy and Safety of Adalimumab for up to Six Years in Patients with Juvenile Idiopathic Arthritis; D. Lovell, et al
Abstract 265; Poster Session; November 6, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Ankylosing Spondylitis/Spondyloarthritis
Five-Year Results Related to Improvement of Spinal Mobility, Physical Function and Quality of Life in Patients with Ankylosing Spondylitis; D. van der Heijde, et al
Abstract 535; Poster Session; November 6, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Results from a Phase 3 Study Related to Efficacy and Safety of Adalimumab in Patients with Non-Radiographic Axial Spondyloarthritis; J. Sieper, et al
Abstract 2486A; Oral Abstract Session; November 8, 2011; 2:30 p.m.;
Location: W 475 A
Health and Economic Outcomes
Study Related to The Impact of Disease Duration on Work Status in Patients with Rheumatoid Arthritis; L. Harrold, et al
Abstract 108; Poster Session; November 6, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Impact of Juvenile Idiopathic Arthritis on Parents' Work Absences; R. Rasu, et al
Abstract 259; Poster Session; November 6, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Work Absences and Costs Associated with Rheumatoid Arthritis: A Comparison between Employees with and without Rheumatoid Arthritis in a U.S. Population; R. Brook, et al
Abstract 913; Poster Session; November 7, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Study Related to Effect of Adalimumab on Function, Health-Related Quality of Life, Work Productivity and Daily Activities in Patients with Non-Radiographic Axial Spondyloarthritis; W. Maksymowych, et al
Abstract 1312; Poster Session; November 7, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Validation of the Patient Acceptable Work State: Establishing Thresholds for Patient-Reported Outcomes in a Longitudinal, Observational Study in Patients with Ankylosing Spondylitis; W. Maksymowych, et al
Abstract 1326; Poster Session; November 7, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Results from a 26-Week Analysis of Combination Therapy with Adalimumab+Methotrexate Related to Work Ability, Physical Function, Fatigue and Other Patient-Reported Outcomes in Early Rheumatoid Arthritis; R. van Vollenhoven, et al
Abstract 2189; Poster Session: November 8, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Souce: abbott.com
"At this year's ACR, taking place in our home town of Chicago, researchers will share a broad spectrum of compelling data for HUMIRA across approved and investigational indications," said John Leonard, M.D., senior vice president, Global Pharmaceutical Research and Development, Abbott. "These studies underscore our commitment to advancing treatment for rheumatologic diseases and meeting the needs of patients, physicians and payors around the world."
Presentation Highlights
Abbott data being presented at ACR include the first presentation of results from ABILITY-1, the first Phase 3 study to evaluate an anti-tumor necrosis factor medication (anti-TNF) in patients with non-radiographic axial spondyloarthritis. These data were selected for an oral presentation on November 8.
The company also will present clinical and patient-reported outcomes from OPTIMA, the first global prospective trial using a treat-to-target philosophy in the treatment of moderate to severe rheumatoid arthritis. 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. In OPTIMA, the treatment goal was a composite primary endpoint of low disease activity score (DAS28<3.2) and no radiographic progression (change from baseline in modified total Sharp score of less than or equal to 0.5).
Additionally, Abbott is presenting data from among the longest open-label extension studies in RA: 10-year data from the open-label extension of the DE019 trial of patients with moderate to severe long-standing RA and eight-year data from the open-label extension of the PREMIER trial of patients with early moderate to severe RA. Abbott also will present five-year results from the open-label extension of the ATLAS study. ATLAS is a Phase 3, multicenter, double-blind trial of patients with active AS randomized to HUMIRA 40 mg every other week or placebo for 24 weeks followed by an open-label extension up to five years.
Identified below are some HUMIRA abstracts of interest (all times are CST):
Rheumatoid Arthritis
Study Related to Clinical and Radiographic Implications of Time to Treatment Response in Early Rheumatoid Arthritis Patients with Baseline Levels of Disease Activity Reflective of a Clinical Practice Setting; E. Keystone, et al
Abstract 417; Poster Session; November 6, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Analysis of Genetic Influence of HLA-DRB1, IL4R and FcγRIIb on Radiographic Responses to Methotrexate Monotherapy or Adalimumab Plus Methotrexate Through 26 Weeks in Patients with Early Rheumatoid Arthritis; A. Skapenko, et al
Abstract 154; Poster Session; November 6, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Eight-Year Results of an Open-Label Extension of a Phase 3 Trial Related to Initial Combination Therapy with Adalimumab Plus Methotrexate in Patients with Early Rheumatoid Arthritis; F. Breedveld, et al
Abstract 1231; Poster Session; November 7, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Study Related to Baseline Levels of the Inflammatory Biomarker C-Reactive Protein Correlation with Magnetic Resonance Imaging Measures of Synovitis at Baseline and After 26 Weeks of Treatment in Patients with Early Rheumatoid Arthritis; C. Peterfy, et al
Abstract 1612; Oral Abstract Session; November 7, 2011; 2:45 p.m.;
Location: W 474 A
Study Related to Outcomes and Predictors in Early Rheumatoid Arthritis Patients Treated with Adalimumab Plus Methotrexate, Methotrexate Alone or Methotrexate Plus Subsequent Adalimumab; J. Smolen, et al
Abstract 1698; Oral Abstract Session; November 7, 2011; 5:15 p.m.;
Location: W 375 C
Results of a Phase 4, Double-Blind, Placebo-Controlled Trial Related to Withdrawal of Adalimumab in Early Rheumatoid Arthritis Patients Who Attained Stable Low Disease Activity with Adalimumab Plus Methotrexate; A. Kavanaugh, et al
Abstract 1699; Oral Abstract Session; November 7, 2011; 5:30 p.m.;
Location: W 375 C
Final 10-Year Results of an Open-Label Extension of a Phase 3 Trial Related to Initial Combination Therapy with Adalimumab Plus Methotrexate in Patients with Long-standing RA; E. Keystone, et al
Abstract 2228; Poster Session; November 8, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Phase 3b and Post-Marketing Observational Study Related to Safety and Effectiveness of Adalimumab in Patients with Rheumatoid Arthritis During More Than Five Years of Therapy; G. Burmester, et al
Abstract 2216; Poster Session; November 8, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Juvenile Idiopathic Arthritis
Study Related to Long-Term Efficacy and Safety of Adalimumab for up to Six Years in Patients with Juvenile Idiopathic Arthritis; D. Lovell, et al
Abstract 265; Poster Session; November 6, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Ankylosing Spondylitis/Spondyloarthritis
Five-Year Results Related to Improvement of Spinal Mobility, Physical Function and Quality of Life in Patients with Ankylosing Spondylitis; D. van der Heijde, et al
Abstract 535; Poster Session; November 6, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Results from a Phase 3 Study Related to Efficacy and Safety of Adalimumab in Patients with Non-Radiographic Axial Spondyloarthritis; J. Sieper, et al
Abstract 2486A; Oral Abstract Session; November 8, 2011; 2:30 p.m.;
Location: W 475 A
Health and Economic Outcomes
Study Related to The Impact of Disease Duration on Work Status in Patients with Rheumatoid Arthritis; L. Harrold, et al
Abstract 108; Poster Session; November 6, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Impact of Juvenile Idiopathic Arthritis on Parents' Work Absences; R. Rasu, et al
Abstract 259; Poster Session; November 6, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Work Absences and Costs Associated with Rheumatoid Arthritis: A Comparison between Employees with and without Rheumatoid Arthritis in a U.S. Population; R. Brook, et al
Abstract 913; Poster Session; November 7, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Study Related to Effect of Adalimumab on Function, Health-Related Quality of Life, Work Productivity and Daily Activities in Patients with Non-Radiographic Axial Spondyloarthritis; W. Maksymowych, et al
Abstract 1312; Poster Session; November 7, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Validation of the Patient Acceptable Work State: Establishing Thresholds for Patient-Reported Outcomes in a Longitudinal, Observational Study in Patients with Ankylosing Spondylitis; W. Maksymowych, et al
Abstract 1326; Poster Session; November 7, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Results from a 26-Week Analysis of Combination Therapy with Adalimumab+Methotrexate Related to Work Ability, Physical Function, Fatigue and Other Patient-Reported Outcomes in Early Rheumatoid Arthritis; R. van Vollenhoven, et al
Abstract 2189; Poster Session: November 8, 2011; 9 a.m. – 11 a.m.;
Location: Poster Hall
Souce: abbott.com