NORTH CHICAGO, Ill., June 2, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that data on HUMIRA® (adalimumab), investigational medicines and research, including real-world evidence, aiming to improve clinical outcomes for patients with rheumatologic diseases, will be presented at the Annual European Congress of Rheumatology (EULAR 2016), June 8 – 11, in London. These data add to the body of evidence supporting the safety and efficacy of adalimumab, an anti-TNF therapy, and AbbVie's continued commitment to innovation across immunology.
"At EULAR 2016, AbbVie is presenting scientific research on adalimumab across autoimmune diseases, including new areas like non-infectious uveitis, where there is an unmet need for patients," said Dominik Hochli, vice president, global medical affairs, AbbVie. "Building on more than a decade of experience in rheumatology, we are focused on expanding treatment options with new therapies to further improve patient care within the rheumatology community across the globe."
Data from the VISUAL Phase 3 pivotal studies evaluating the efficacy and safety of adalimumab in patients with non-infectious intermediate, posterior and panuveitis will be presented. Non-infectious uveitis is a group of diseases characterized by inflammation of the uvea, the middle layer of the eye, which can lead to reduced vision or vision loss.1 Adalimumab is not currently approved to treat any form of uveitis.
AbbVie will also present research on investigational medicines looking at multiple scientific approaches and novel solutions to help improve patient care for a variety of autoimmune diseases. New Phase 2 data on ABT-494, an investigational, once-daily, oral selective JAK1 inhibitor for the treatment of rheumatoid arthritis, will be presented. The Phase 3 clinical program is currently underway.
Abstracts of Interest
HUMIRA (AbbVie-Sponsored) Abstracts
Rheumatoid Arthritis
Uveitis
Psoriatic Arthritis
Juvenile Idiopathic Arthritis
Axial Spondyloarthritis
Ankylosing Spondylitis
Peripheral Spondyloarthritis
Cross Indications
Investigational Medicines Abstracts
Rheumatoid Arthritis
Systemic Lupus Erythematosus
About HUMIRA
Since first gaining approval 13 years ago, HUMIRA has been approved in more than 90 countries, and is currently being used to treat more than 989,000 patients worldwide2 across 13 globally approved indications.3,4
About HUMIRA in the European Union3
HUMIRA is currently indicated for the treatment of adults with moderate to severe rheumatoid arthritis, severe active progressive rheumatoid arthritis not previously treated with methotrexate, active polyarticular juvenile idiopathic arthritis in patients from the age 2 years, active enthesitis-related arthritis in patients from 6 years of age and older, severe active ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, active and progressive psoriatic arthritis, moderate to severe chronic plaque psoriasis in adults and severe chronic plaque psoriasis in children and adolescents from 4 years of age, active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adults with an inadequate response to conventional systemic HS therapy, moderately to severely active Crohn's disease in adults and paediatric patients (from 6 years of age) and moderately to severely active ulcerative colitis in adults.
For more information, read the Humira SmPC: https://www.medicines.org.uk/emc/search/?q=humira
Important EU Safety Information3
HUMIRA is contraindicated in patients with active tuberculosis or other severe infections such as sepsis, and opportunistic infections and in patients with moderate to severe heart failure (NYHA class III/IV). It is also contraindicated in patients hypersensitive to the active substance or to any of the excipients. The use of HUMIRA increases the risk of developing serious infections which may, in rare cases, be life-threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with HUMIRA. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.
(See SmPC at https://www.medicines.org.uk/emc/search/?q=humira for full details)
Globally, prescribing information varies; refer to the individual country product label for complete information.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
References:
SOURCE AbbVie
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