AbbVie to Present New Data for Upadacitinib and HUMIRA® (adalimumab) at the 2018 ACR/ARHP Annual Meeting

- Oral presentations include three of the five pivotal studies from AbbVie's SELECT Phase 3 program to support regulatory submission for investigational upadacitinib in patients with moderate to severe rheumatoid arthritis

- New studies of HUMIRA® (adalimumab) add to the body of research evaluating treatment across multiple rheumatic conditions, including rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis and uveitis

- Thirty-five abstracts demonstrate AbbVie's leadership in immunology through commitment to advancing scientific research for patients living with rheumatic conditions

NORTH CHICAGO, Ill. /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it will present data from multiple studies of upadacitinib, an investigational oral JAK1-selective inhibitor, and HUMIRA® (adalimumab) at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting, October 19-24, in Chicago.

Three studies have been selected for oral presentations from AbbVie's global SELECT Phase 3 clinical program evaluating the safety and efficacy of upadacitinib in patients with moderate to severe rheumatoid arthritis. SELECT includes more than 4,000 patients across six studies. 

"While additional treatments have come to market in recent decades, there continues to be a need to advance scientific research to support optimal disease management for patients living with rheumatic conditions," said Marek Honczarenko, M.D., Ph.D., vice president, global immunology development, AbbVie. "The data we're presenting at this year's ACR/ARHP meeting, featuring HUMIRA and pipeline medicines, illustrate our ongoing commitment to researching additional therapeutic options and advancing care for patients, as well as AbbVie's leadership in immunology."

A total of 35 abstracts will be presented across multiple rheumatic conditions, including rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis and uveitis.

HUMIRA data to be presented at the meeting will include an analysis of long-term disease control in patients with juvenile idiopathic arthritis receiving HUMIRA treatment for up to six years, as well as the long-term inhibition of radiographic progression and quality of life measures in patients with moderate to severe psoriatic arthritis taking HUMIRA. HUMIRA is one of the most comprehensively studied biologics available for immune-mediated inflammatory diseases, and is supported by more than 21 years of clinical trial experience in immunology.¹

Data from several Health Economics and Outcomes Research (HEOR) studies will also be presented, including an assessment of the economic burden on patients with psoriatic arthritis and ankylosing spondylitis who have inflammatory bowel disease, and the disease severity of patients with rheumatoid arthritis who are bio-naïve and receiving treatment with csDMARDs.

Rheumatic diseases affect patients' joints, tendons, ligaments, bones and muscles.² Early intervention with an effective treatment is critical for controlling rheumatic diseases and preventing permanent damage.³

For more information about AbbVie's work in rheumatology, please read "The Future of Rheumatology: How Genes, Lifestyle and Environment Factor In" on www.abbvie.com.

Key Abstracts of Interest:

Upadacitinib Abstracts

• Upadacitinib as Monotherapy: A Phase 3 Randomized Controlled Double-Blind Study in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate. Smolen et al.; Oral Presentation; Sunday, October 21, 2018, 2:30 p.m.-4:00 p.m. CEST
• A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib to Placebo and to Adalimumab, in Patients with Active Rheumatoid Arthritis with Inadequate Response to Methotrexate. Fleischmann et al.; Oral Presentation; Sunday, October 21, 2018, 2:30 p.m.-4:00 p.m. CEST
• A Phase 3, Randomized, Controlled Trial Comparing Upadacitinib Monotherapy to MTX Monotherapy in MTX-Naïve Patients with Active Rheumatoid Arthritis. Vollenhoven et al.; Oral Presentation; Sunday, October 21, 2018, 2:30 p.m.-4:00 p.m. CEST
• Rapid Response With Upadacitinib Treatment in Patients with Rheumatoid Arthritis and an Inadequate Response to csDMARDs or bDMARDs. Fitzgerald et al.; Poster Session; Tuesday, October 23, 2018, 9:00 a.m.-11:00 a.m. CEST
• The Association Between Patient Reported Outcomes and Clinical Measures Among Rheumatoid Arthritis Patients: Analyses Using Phase 3 Clinical Trials of Upadacitinib. V Strand et al.; Poster Session; Tuesday, October 23, 2018, 9:00 a.m.-11:00 a.m. CEST
• Impact of 12 Weeks of Upadacitinib Treatment on Individual and Composite Disease Measures in Patients With Rheumatoid Arthritis and Inadequate Response to Conventional Synthetic or Biologic DMARDs. Vollenhoven et al.; Poster Session; Tuesday, October 23, 2018, 9:00 a.m.-11:00 a.m. CEST
• Upadacitinib Monotherapy Improves Patient-Reported Outcomes in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate. Strand et al.; Poster Session; Tuesday, October 23, 2018, 9:00 a.m.-11:00 a.m. CEST

HUMIRA Abstracts

• Impact of Clinical Specialty Setting and Geographic Regions on Disease Management in Patients with Psoriatic Arthritis: Results from a Cross-sectional Observational Study in the United States. Mease et al.; Poster Session; Monday, October 22, 2018, 9:00 a.m.-11:00 a.m. CEST
• Long-term, real-world safety of adalimumab in rheumatoid arthritis. Harrold et al.; Poster Session; Monday, October 22, 2018, 9:00 a.m.-11:00 a.m. CEST
• Long-Term Efficacy and Safety of Adalimumab By Immunosuppressant Use in Patients with Non-Infectious Uveitis; Poster Session; Tuesday, October 23, 2018, 9:00 a.m.-11:00 a.m. CEST
• Long-Term Inhibition of Radiographic Progression with Originator Adalimumab in Patients with Moderate to Severe Psoriatic Arthritis with or without Radiographic Damage at Baseline. Coates et al. Poster Session; Tuesday, October 23, 2018, 9:00 a.m.-11:00 a.m. CEST
• Long-term Disease Control Among Patients With Juvenile Idiopathic Arthritis Receiving Adalimumab (Humira) Treatment for up to Six Years. Lovell et al.; Poster Session; Tuesday, October 23, 2018, 9:00 a.m.-11:00 a.m. CEST

HEOR Abstracts

• Disease Severity among Bio-naive RA patients on csDMARDs. Harrold et al.; Poster Session; Sunday, October 21, 2018, 9:00 a.m.-11:00 a.m. CEST
• Inflammatory Bowel Disease is Associated with a Substantial Economic Burden in Patients with Psoriatic Arthritis and in Patients with Ankylosing Spondylitis. Bergman et al.; Poster Session; Sunday, October 21, 2018, 9:00 a.m.-11:00 a.m. CEST

The 2018 ACR/AHRP Annual Meeting abstracts are available at www.acrabstracts.org.

About Upadacitinib 
Discovered and developed by AbbVie, upadacitinib is an investigational oral agent engineered to selectively inhibit JAK1, which plays an important role in the pathophysiology of rheumatoid arthritis and other immune-mediated inflammatory disorders.^4,5 Phase 3 trials of upadacitinib in psoriatic arthritis are ongoing and it is also being investigated to treat Crohn's disease, ulcerative colitis, ankylosing spondylitis and atopic dermatitis.^{6,7,8,9,10,11}

Upadacitinib is an investigational oral agent and is not approved by regulatory authorities. Safety and efficacy have not been established.

About HUMIRA in the U.S.
Uses¹²

HUMIRA is a prescription medicine used:

• To reduce the signs and symptoms of:
• Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities.
• Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
• Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities.
• Ankylosing spondylitis (AS) in adults.
• Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to certain other medications. HUMIRA is also used to reduce signs and symptoms and to achieve clinical remission in these adults who have lost response to or are unable to tolerate infliximab.
• Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in children 6 years of age and older when certain other treatments have not worked well enough.
• Moderate to severe hidradenitis suppurativa (HS) in adults.
• In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
• To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
• To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye) and panuveitis (all parts of the eye) (UV) in adults and children 2 years of age and older.

Important Safety Information¹²

HUMIRA is a TNF blocker medicine that affects the immune system and can lower the body's ability to fight infections. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy, even if their TB test was negative. 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. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, as these infections may happen or become more severe if people use HUMIRA. People should tell their doctor if they have had TB or hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.

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. If using TNF blockers, including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated.

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. Children should be brought up to date on all vaccines before starting HUMIRA.

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.

HUMIRA is given by injection under the skin.

The benefits and risks of HUMIRA should be carefully considered before starting therapy.

Please click here for the Full Prescribing Information and Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you cannot afford your medication, contact www.pparx.org for assistance.

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, 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 2017 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.

1. Burmester G.R., et al. Adalimumab safety and mortality rates from global clinical trials of six immune-mediated inflammatory diseases. Ann Rheum Dis. 2009; 68:1863–1869.
2. National Institutes of Health. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Arthritis and Rheumatic Diseases. Available at: https://www.niams.nih.gov/health-topics/arthritis-and-rheumatic-diseases. Last accessed September 13, 2018. 
3. Kwiatkowska B, Raciborski F, Klak A, et al. Early diagnosis of rheumatic diseases: an evaluation of the present situation and proposed changes. Reumatologia. 2015; 53(1): 3–8.
4. Voss, J, et al; Pharmacodynamics Of a Novel Jak1 Selective Inhibitor In Rat Arthritis and Anemia Models and In Healthy Human Subjects. [abstract]. Arthritis Rheum 2013;65 Suppl 10 :2374. DOI: 10.1002/art.2013.65.issue-s10.
5. Pipeline – Our Science | AbbVie. AbbVie. 2017. Available at: https://www.abbvie.com/our-science/pipeline.html.   Accessed on September 13, 2018.
6. A Study Comparing ABT494 to Placebo in Subjects With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone (SELECT-NEXT). ClinicalTrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT02675426. Accessed on April 5, 2018.
7. A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 1). ClinicalTrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on September 13, 2018.
8. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on September 13, 2018.
9. A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT Axis 1). 2018. Available at: https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed on September 13, 2018.
10. A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2018. Available at:  https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on September 13, 2018.
11. Phase 2b AD Dose Ranging Study (40wk) N=160. ClinicalTrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT02925117. Accessed on September 13, 2018.
12. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.