Abbott to present wide range of investigational efficacy, safety and health outcomes data on HUMIRA®

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.

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):

Rheumatoid Arthritis

• Final 10-year Results of an Open-label Extension of a Phase 3 Trial of Combination Therapy with Adalimumab Plus Methotrexate in Patients with Long-standing Rheumatoid Arthritis; E. Keystone, et al
  – Abstract SAT0127; Poster; 9 June, 2012; 10:15 a.m.; Location: Poster Area
• Results Following 10 Years of Treatment with Adalimumab in Follow-up Trial; M. Weinblatt, et al
  – Abstract AB0479; Publication only
• Study Evaluating the Long-Term Effectiveness and Safety of Adalimumab in Patients with Moderate Versus Severe Rheumatoid Arthritis; G. Burmester, et al
  – Abstract FRI0159; Poster; 8 June, 2012; 11:45 a.m.; Location: Poster Area
• Results from the OPTIMA Study Evaluating Long-term Disease Control in Early, Moderate to Severe Rheumatoid Arthritis with Adalimumab and Methotrexate; P. Emery, et al
  – Abstract FRI0171; Poster; 8 June, 2012; 11:45 a.m.; Location: Poster Area

Ankylosing Spondylitis/Spondyloarthritis

• Week-68 Results from an Open-label Extension of a Phase 3 Study Evaluating the Efficacy and Safety of Adalimumab in Patients with Non-radiographic Axial Spondyloarthritis; J. Sieper, et al
  – Abstract THU0275; Poster; 7 June, 2012; 11:45 a.m.; Location: Poster Area
• Results from a Phase 3 Study on the Efficacy and Safety of Adalimumab in Patients with Peripheral Spondyloarthritis; P. Mease, et al
  – Abstract THU0280; Poster; 7 June, 2012; 11:45 a.m.; Location: Poster Area

Juvenile Idiopathic Arthritis

• Results from a Phase 3b Study Evaluating the Efficacy and Safety of Adalimumab in Children with Active Polyarticular Juvenile Idiopathic Arthritis Aged 2 to 4 Years or > 4 Years Weighing <15 Kg; D. Kingsbury, et al
  – Abstract FRI0337; Poster; 8 June, 2012; 11:45 a.m.; Location: Poster Area

Long-Term Safety Across Diseases

• 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

Health and Economic Outcomes

• Results from the OPTIMA Study Related to Adalimumab and Patient-reported Outcomes and Work Productivity in Early Rheumatoid Arthritis Patients; A. Kavanaugh, et al
  – Abstract AB0450; Publication only
• Study Related to the Use of Anti-TNF Therapy and Cardiovascular Event Risk in Rheumatoid Arthritis; M. Nurmohamad, et al
  – Abstract OP0002; Oral Presentation; 6 June, 2012; 4:15 p.m.; Location: Hall 5.2 B
• Analysis of Randomized Trials Related to Adalimumab and the Risk of Major Adverse Cardiovascular Events in Rheumatoid Arthritis; G. Burmester, et al
  – Abstract FRI0145; Poster Tour; 8 June, 2012; 12:15 p.m.; Location: Poster Area Hall 2.2
• Results from a Study Estimating Prevalence and Gender Distribution of Axial Spondyloarthritis Among Patients in US Rheumatology Practices; S. Rao, et al
  – Abstract FRI0406; Poster Tour; 8 June, 2012; 12:15 p.m.; Location: Poster Area Hall 4.2

General Disease State

• Results from an Analysis of Registry Data Comparing the Disease Burden of Patients with Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis and the Implications on Treatment; J. Sieper, et al
  – Abstract OP0266; Oral Presentation; 6 June, 2012; 9:50 a.m.; Location: Hall 5.2 B
• Results from an Analysis Evaluating Adherence to Subcutaneous vs. Oral Disease-Modifying Antirheumatic Drugs (DMARDS) in Rheumatoid Arthritis; M. Bergman
  – Abstract AB1376; Publication only
• Results from an Analysis of Registry Data Regarding Factors Associated with Work Status and Missed Work Days in Rheumatoid Arthritis; L. Harrold, et al
  – Abstract SAT0469; Poster; 9 June, 2012; 10:15 a.m.; Location: Poster Area

Approved indications for HUMIRA vary worldwide by country or region.

About HUMIRA® (adalimumab)

Uses

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.