NORTH CHICAGO - AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that it will present new safety and efficacy results for RINVOQ (upadacitinib) in adult patients with moderate to severe active rheumatoid arthritis, primary data of RINVOQ for investigational use in psoriatic arthritis, as well as additional data on HUMIRA (adalimumab) in psoriatic arthritis at the European E-Congress of Rheumatology (EULAR) 2020, June 3-6.

A total of 25 abstracts will be presented across multiple rheumatic conditions, including rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.

'As a leader in immunology for over two decades, AbbVie is dedicated to developing innovative therapies for patients living with debilitating, chronic immune-mediated conditions,' said Marek Honczarenko MD, PhD, vice president, global immunology development, AbbVie. 'The new research from across our portfolio presented at EULAR underscores our commitment to improving the standard of care and highlights the potential for our therapies to make a meaningful difference in patients living with rheumatic diseases.'

AbbVie will for the first time present data from the SELECT-CHOICE clinical trial. It is the sixth study in the SELECT rheumatoid arthritis clinical trial program, evaluating efficacy and safety of RINVOQ compared to abatacept in patients with moderate to severe active rheumatoid arthritis and prior inadequate response or intolerance to biologic DMARDs. In addition, new long-term efficacy and safety data of up to 72 weeks from the SELECT-COMPARE study and up to 84 weeks from the SELECT-MONOTHERAPY study, along with three additional analyses evaluating the safety profile of RINVOQ, will be presented.

In addition to sharing new data from the robust Phase 3 SELECT rheumatoid arthritis clinical trial program, AbbVie will present investigational data evaluating RINVOQ in adult patients with active psoriatic arthritis from the SELECT-PsA 1 study in a late-breaker presentation and primary data from the SELECT-PsA 2 study. In SELECT-PsA 1, RINVOQ was compared to placebo and adalimumab in patients with an inadequate response to non-biologic DMARDs. In SELECT-PsA 2, RINVOQ was compared to placebo in patients with an inadequate response to biologic DMARDs. RINVOQ is being investigated for the treatment of psoriatic arthritis and its efficacy and safety have not been established.

About RINVOQTM (upadacitinib)

Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.1-8 In August 2019, RINVOQ received US FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. In December 2019, RINVOQ was approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. The approved dose for RINVOQ in rheumatoid arthritis is 15mg. Phase 3 trials of RINVOQ in rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are ongoing.1-10 Use of RINVOQ in psoriatic arthritis is not approved and its safety and efficacy have not been established by regulatory authorities.

About HUMIRA in the European Union11

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, including methotrexate, has been inadequate.

Important EU Safety Information about HUMIRA (adalimumab)11

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; serious allergic reactions including anaphylaxis have been reported. The use of HUMIRA increases the risk of developing serious infections, including hepatitis B reactivation, 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. Rare cases of pancytopenia, aplastic anaemia, demyelinating disease, lupus, lupus-related conditions and Stevens-Johnson syndrome have been reported in patients treated with HUMIRA. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.

About AbbVie in Rheumatology

For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with rheumatic diseases reach their treatment goals.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.

Forward-Looking Statements

Some statements in this news release are, or may be considered, 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, the possibility that the proposed acquisition of Allergan will not be pursued, failure to obtain necessary regulatory approvals or required financing or to satisfy any of the other conditions to the proposed acquisition, failure to realize the expected benefits of the proposed acquisition, failure to promptly and effectively integrate Allergan's businesses, significant transaction costs and/or unknown or inestimable liabilities, potential litigation associated with the proposed acquisition, 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 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission (SEC). 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.

Contact:

Jana Umbreit

Tel: +1 (224) 214-8657

Email: jana.umbreit@abbvie.com

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