AbbVie's Research And Commitment To Helping People Living With Rheumatologic Diseases Highlighted At The Annual European Congress Of Rheumatology (EULAR 2016)

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

• A Randomized Crossover Comparison of Injection Site Pain with 40 MG/0.8 ML and 40 MG/0.4ML Formulations of Adalimumab in Patients with Rheumatoid Arthritis; Nash P, et al.
• Reduction of Concomitant Oral Methotrexate or Corticosteroids in Combination Treatment with Adalimumab Does Not Affect Effectiveness in Patients with Rheumatoid Arthritis;Keystone E, et al.
• Disease Activity and Biologic Use in Patients with Rheumatoid Arthritis and Psoriatic Arthritis in the Past 10 Years: Results from the CORRONA Registry; Kavanaugh A, et al.
• Delay In Initiation Of Biologics Among Bio-Eligible Patients With Rheumatoid Arthritis In US: Evidence From The CORRONA Registry; Pappas DA, et al.
• Clinical Responses and Synovial Vascularity in Obese Rheumatoid Arthritis Patients Treated with Adalimumab and Methotrexate; Kaeley GS, et al.
• The Impact of Early Treatment with Adalimumab on Rheumatoid Factor and Anti-Citrullinated Peptide Antibody Levels in Patients with Rheumatoid Arthritis in the OPTIMA Trial; Smolen JS, et al.
• Predicting DAS28-CRP <2.6 and Low Disease Activity Status at 6 Months Based on Early Clinical Response in Rheumatoid Arthritis Patients; Smolen JS, et al.
• Treatment Adherence and Attitudes Towards Systemic Medications in Patients With Rheumatoid Arthritis in Different Geographical Regions; Smolen JS, et al.
• Depression and Cardiovascular Outcomes in Patients with Rheumatoid Arthritis (RA) Using a Treat-to-Target Approach to Therapy versus Usual Care; Princic N, et al.
• Real-world impact of Taiwan Health Policy on Dose Tapering And Withdrawing Biologics in Rheumatoid Arthritis Patients: A Retrospective Chat Review study; Chang C, et al.
• Comparison of Flare Definitions in Rheumatoid Arthritis Patients Upon Biologics Dose Tapering: A Chart Review Study in Taiwan; Chang C, et al.
• Need To Advance Therapy In Rheumatoid Arthritis Patients Treated With Triple Nbdmard Vs Biologic Combination Therapy: Results From The CORRONA Registry; Pappas D, et al.

Uveitis

• Adalimumab in Patients with Active and Inactive, Non-Infectious Uveitis: VISUAL I and VISUAL II Trials;Brézin AP, et al.
• Clinical Relevance of the Treatment Failure as Assessed by the 25-Item Visual Functioning Questionnaire in Patients with Intermediate-, Posterior- and Pan-Uveitis: Results from the VISUAL-1 Trial; Brézin A, et al.
• Quiescence in Active and Inactive Non-Infectious Intermediate, Posterior, or Panuveitis in Patients Treated with Adalimumab: Visual I and Visual II Trials;Landewe R, et al.

Psoriatic Arthritis

• Characterization of Psoriatic Arthritis Patients By Skin And Joint Severity: Results From The CORRONA Spondyloarthritis Registry; Mease P, et al.
• Impact of Patient Perception of Psoriasis and Psoriatic Arthritis Severity on Patient-reported Outcomes: An Analysis from the ADELPHI Database; Boehncke WH, et al.

Juvenile Idiopathic Arthritis

• Safety and Effectiveness of Adalimumab±Methotrexate for the Treatment of Polyarticular Juvenile Idiopathic Arthritis (pJIA): STRIVE Registry;Ruperto N, et al.

Axial Spondyloarthritis

• Baseline Results from PROOF A 5-Year Observational Study of Long-Term Disease Outcome in Axial Spondyloarthritis; Inman RD, et al.

Ankylosing Spondylitis

• Relative Efficacy of Adalimumab Versus Secukinumab in Active Ankylosing Spondylitis: A Matching-Adjusted Indirect Comparison;Betts KA, et al.

Peripheral Spondyloarthritis

• Performance Of Modified Minimal Disease Activity (MDA) In Patients With Peripheral Spondyloarthritis: Post-Hoc Analysis Of Ability; Coates L, et al.

Cross Indications

• Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease;Horneff G, et al.

Investigational Medicines Abstracts
Rheumatoid Arthritis

• Safety and Efficacy of ABT-494, a Novel Selective JAK1 Inhibitor, in Patients with Active Rheumatoid Arthritis with an Inadequate Response to Methotrexate;Genovese MC, et al.
• Safety and Efficacy of ABT-494, a Novel Selective JAK1 Inhibitor, in Patients with Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Anti-TNF Biologic Therapy;Kremer JM, et al.
• Safety, Tolerability, and Pharmacodynamics of ABT-122, A Dual TNF- and IL-17Targeted Dual Variable Domain (DVD)-IG in Patients with Rheumatoid Arthritis;Fleischmann RM, et al.

Systemic Lupus Erythematosus

• Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the BCL-2 Inhibitor Venetoclax (ABT-199) in a Phase 1 Single and Multiple Ascending Dose Study in Female Patients with Systemic Lupus Erythematosus;Lu P, et al.

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:

1. Durrani OM, Tehrani NN, Marr JE, Moradi P, Stavrou P, Murray PI. Degree, duration, and causes of visual loss in uveitis. Br J of Ophthalmol. 2004;88(9):1159-1162.
2. AbbVie Data on File.
3. Humira [summary of product characteristics]. AbbVie Inc.; May 2016. https://www.medicines.org.uk/emc/search/?q=humira. Updated May 11, 2016. Accessed May 26, 2016
4. Pharmaceutical and Medical Devices Agency (PMDA) website. New Drugs Approved in FY 2013. Available at: http://www.pmda.go.jp/files/000153463.pdf#page=1. Accessed May 26, 2016.

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