Healthcare Industry News: Humira
News Release - November 2, 2011
Abbott to Present Broad Spectrum of Compelling Data for HUMIRA(R) (Adalimumab) at American College of Rheumatology Annual Scientific MeetingData Highlight Efficacy, Safety and Health Outcomes
ABBOTT PARK, Ill., Nov. 2, 2011 -- (Healthcare Sales & Marketing Network) -- Abbott (NYSE:ABT ) 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."
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.
A comprehensive list of ACR abstracts is available at www.rheumatology.org.
Identified below are some Humira abstracts of interest (all times are CST):
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 Fc?RIIb 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
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
Humira (adalimumab) is a prescription medicine 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.
Humira is used alone, with methotrexate, or with certain other medicines to reduce the signs and symptoms of moderate to severe polyarticular juvenile idiopathic arthritis in children 4 years of age and older.
Humira is used to reduce the signs and symptoms of ankylosing spondylitis in adults.
Humira is used alone or with certain other medicines to reduce the signs and symptoms of psoriatic arthritis in adults. It may prevent further damage to bones and joints and may help with the ability to perform daily activities.
Humira is not approved for the treatment of spondyloarthritides other than ankylosing spondylitis and psoriatic arthritis.
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.
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