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Press release content from PR Newswire. The AP news staff was not involved in its creation.

AbbVie to Showcase Depth of Immunology Portfolio and Pipeline at the 2019 ACR/ARP Annual Meeting

November 4, 2019

NORTH CHICAGO, Ill., Nov. 4, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it will present data from multiple studies of RINVOQ™ (upadacitinib), HUMIRA® (adalimumab) and SKYRIZI™ (risankizumab) at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, November 8-13, in Atlanta. A total of 38 abstracts will be presented across multiple rheumatic conditions, including rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA).

“AbbVie looks forward to sharing the latest research across our recently expanded rheumatology portfolio at this year’s meeting, including data that further support our recent FDA approval of RINVOQ,” said Marek Honczarenko, M.D., Ph.D., vice president, global immunology development, AbbVie. “New data being presented on upadacitinib, risankizumab and adalimumab across multiple rheumatic diseases will highlight the potential for all three treatment options to help more patients achieve their treatment goals.”

For the first time, safety and efficacy data evaluating upadacitinib versus placebo for the treatment of signs and symptoms in patients with active AS who had an inadequate response to nonsteroidal anti-inflammatory drugs will be presented during a plenary session at the meeting. A number of upadacitinib RA abstracts will also be featured, including:

Investigators will also present new patient-reported outcomes in patients with moderate to severe PsA who were treated with adalimumab, as well as data evaluating the safety and efficacy of risankizumab in patients with active PsA.

KEY ABSTRACTS OF INTEREST:

UPADACITINIB ABSTRACTS

Ankylosing Spondylitis

Rheumatoid Arthritis

ADALIMUMAB ABSTRACTS

Psoriatic Arthritis

RISANKIZUMAB ABSTRACT

Psoriatic Arthritis

The 2019 ACR/ARP Annual Meeting abstracts are available at www.acrabstracts.org.

Rheumatic diseases affect patients’ joints, tendons, ligaments, bones and muscles.1 Early diagnosis and intervention with an effective treatment is critical to controlling rheumatic diseases and preventing permanent damage.2

About RINVOQ3
Discovered and developed by AbbVie, RINVOQ is an oral JAK inhibitor approved by the U.S. Food and Drug Administration (FDA) and under review with health authorities globally for the treatment of moderately to severely active rheumatoid arthritis and being studied in other immune-mediated inflammatory diseases.4-13 Earlier this year, RINVOQ received U.S. Food and Drug Administration approval for patients with moderately to severely active rheumatoid arthritis. RINVOQ also received a positive opinion from the Committee for Medicinal Products for Human Use and is currently in European Union regulatory review for patients with moderately to severely active rheumatoid arthritis. Phase 3 trials of RINVOQ in psoriatic arthritis, Crohn’s disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are ongoing and it is also being investigated to treat ankylosing spondylitis. 4,8-12

RINVOQ U.S. Use and Important Safety Information
RINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children under 18 years of age.

Important Safety Information about RINVOQ™ (upadacitinib)

What is the most important information I should know about RINVOQ?
RINVOQ is a medicine that can lower the ability of your immune system to fight infections. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay.

What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:

̶ Fever, sweating, or chills

̶ Muscle aches

̶ Cough

̶ Shortness of breath

̶ Feeling tired

̶ Weight loss

̶ Warm, red, or painful skin
or sores on your body

̶ Blood in phlegm

̶ Diarrhea or stomach pain

̶ Burning when urinating or
urinating more often than normal

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.

Especially tell your HCP if you take:

Ask your HCP or pharmacist if you are not sure if you are taking any of these medicines.

What should I tell my HCP AFTER starting RINVOQ?
Tell your HCP right away if you:

̶ Swelling

̶ Sudden unexplained chest pain

̶ Pain or tenderness in the leg

̶ Shortness of breath

What are the common side effects of RINVOQ?
These include: upper respiratory tract infections (common cold, sinus infections), nausea, cough, and fever. These are not all the possible side effects of RINVOQ.

RINVOQ is taken once a day with or without food. Do not split, break, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it.

This is the most important information to know about RINVOQ. For more information, talk to your HCP.

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 are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

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

About SKYRIZI14
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.15

SKYRIZI is approved in the U.S., European Union and Canada for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, and in Japan for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adult patients who have an inadequate response to conventional therapies.

Phase 3 trials of SKYRIZI in Crohn’s disease and psoriatic arthritis are ongoing, and it is also being investigated to treat ulcerative colitis.13,16-19

SKYRIZI (risankizumab-rzaa) U.S. Use and Important Safety Information
SKYRIZI™ is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

What is the most important information I should know about SKYRIZI?
SKYRIZI may cause serious side effects, including infections. SKYRIZI is a prescription medicine that may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI.

Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of SKYRIZI?
SKYRIZI may cause serious side effects. See “What is the most important information I should know about SKYRIZI?”

The most common side effects of SKYRIZI include upper respiratory infections, fungal skin infections, headache, feeling tired and injection site reactions.

These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects.

Use SKYRIZI exactly as your healthcare provider tells you to use it.

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

About HUMIRA in the U.S.
Uses20

HUMIRA is a prescription medicine used:

Important Safety Information
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.

About AbbVie
AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

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, competition from other products, challenges to intellectual property, 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 2018 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 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.

2 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.

3 RINVOQ™ (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.

4 A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (SELECT-PsA 2). ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03104374. Accessed on October 31, 2019.

5 Cohen S., et al. Safety profile of upadacitinib in Rheumatoid Arthritis: Integrated analysis from the SELECT Phase 3 Clinical Program. EULAR 2019; THU0167.

6 Bergman M., et al. Upadacitinib Treatment and the Routine Assessment of Patient Index Data 3 (RAPID3) Among Patients with Rheumatoid Arthritis. 2019 ACR/ARHP Annual Meeting; 551.

7 Burmester G.R., et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.

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. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on October 23, 2019.

9 Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)- Measure Up 1. ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03569293. Accessed on October 23, 2019.

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. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on October 23, 2019.

11 A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT Axis 1). ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed on October 23, 2019.

12 A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on October 23, 2019.

13 Pipeline – Our Science | AbbVie. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on March 8, 2019.

14 SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie Inc.

15 Duvallet, E., Sererano, L., Assier, E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.

16 A Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT03105128. Accessed on March 8, 2019.

17 BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT02719171. Accessed on March 8, 2019.

18 A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065. ClinicalTrials.gov. 2018. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03398135. Accessed on March 8, 2019.

19 A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy. ClinicalTrials.gov. 2018. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03398148. Accessed on March 8, 2019.

20 HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.

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SOURCE AbbVie