StemCell Therapy

- Researchers to share updates on long-term safety and efficacy of RINVOQ for the treatment of moderate to severe rheumatoid arthritis

- Presentations to highlight patient-reported outcomes of RINVOQ in people living with psoriatic arthritis, ankylosing spondylitis and rheumatoid arthritis

- New safety and efficacy data of RINVOQ through 64 weeks in treating ankylosing spondylitis, as well as an integrated safety analysis for psoriatic arthritis, will also be presented

NORTH CHICAGO, Ill., Oct. 28, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the presentation of new data on RINVOQ (upadacitinib) and HUMIRA (adalimumab) across multiple rheumatic diseases at the American College of Rheumatology's annual meeting (ACR Convergence 2020), to be held virtually November 5-9. A total of 38 abstracts, including seven oral presentations, will be presented from a broad range of studies in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

"At AbbVie, we have a focused vision of improving the care and advancing treatment options for people living with rheumatic diseases, which is illustrated by the body of research that will be presented at this year's ACR meeting," said Marek Honczarenko M.D., Ph.D., vice president, global immunology development, AbbVie. "These data underscore the potential for RINVOQ and HUMIRA to help more people living with rheumatic diseases reach their goals."

Data evaluating the long-term safety and efficacy of RINVOQ in rheumatoid arthritis will be presented, including:

84-week data on RINVOQ as a monotherapy in patients with inadequate response to methotrexate

72-week RINVOQ monotherapy data in methotrexate-nave patients

72-week data comparing RINVOQ versus HUMIRA in patients with inadequate response to methotrexate

An integrated safety update reflecting up to three years of treatment with RINVOQ

Oral presentations will also highlight the safety and efficacy of RINVOQ in the treatment of psoriatic arthritis (through 24 weeks) and ankylosing spondylitis (through 64 weeks), while a poster presentation will provide a new integrated safety analysis from two Phase 3 trials evaluating the safety profile of RINVOQ in psoriatic arthritis.

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Further, several presentations will show patient-reported outcomes for RINVOQ in the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, including its impact on pain reduction and physical function.

Key AbbVie rheumatology abstracts in the ACR Convergence 2020 program include:

Rheumatoid Arthritis

Safety Profile of Upadacitinib up to 3 Years of Exposure in Patients with Rheumatoid Arthritis. SB Cohen, et al. Abstract Number: 0237; Poster Session: Friday, November 6, 9 11 a.m. EST

Long-Term Safety and Effectiveness of Upadacitinib or Adalimumab in Patients with Rheumatoid Arthritis: Results at 72 Weeks. R Fleischmann, et al. Abstract Number: 0212; Poster Session: Friday, November 6, 9 11 a.m. EST

Upadacitinib as Monotherapy in Patients with Rheumatoid Arthritis and Prior Inadequate Response to Methotrexate: Results at 84 Weeks. JS Smolen, et al. Abstract Number: 0209; Poster Session: Friday, November 6, 9 11 a.m. EST

Incidence and Risk of Venous Thromboembolic Events Among Patients with Rheumatoid Arthritis Enrolled in the Upadacitinib Clinical Trial Program. E Choy, et al. Abstract Number: 0215; Poster Session: Friday, November 6, 9 11 a.m. EST

Upadacitinib Monotherapy in Methotrexate-nave Patients with Rheumatoid Arthritis: Results at 72 Weeks. R van Vollenhoven, et al. Abstract Number: 0207; Poster Session: Friday, November 6, 9 11 a.m. EST

Impact of Upadacitinib or Adalimumab as Initial Therapy on the Achievement of 48-week Treatment Goals in Patients with Rheumatoid Arthritis and Inadequate Response to Methotrexate: Post Hoc Analysis of a Phase 3 Study. E Mysler, et al. Abstract Number: 0228; Poster Session: Friday, November 6, 9 11 a.m. EST

Radiographic Outcomes in Patients with Rheumatoid Arthritis Receiving Upadacitinib as Monotherapy or in Combination with Methotrexate: Results at 2 Years. CG Peterfy, et al. Abstract Number: 1231; Poster Session: Sunday, November 8, 9 11 a.m. EST

Patient-Reported Outcomes of Upadacitinib versus Abatacept in Patients with Rheumatoid Arthritis and an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs: 12-Week Results of a Phase 3 Study. M Bergman, et al. Abstract Number: 1728; Poster Session: Monday, November 9, 9 11 a.m. EST

Evaluation of Response to Pneumococcal Vaccination in Patients with Rheumatoid Arthritis Receiving Upadacitinib: Results from a Phase 2 Open-Label Extension Study. K Winthrop, et al. Abstract Number: 1996; Oral Presentation: Monday, November 9, 10 10:50 a.m. EST

Incidence and Risk Factors for Herpes Zoster in Rheumatoid Arthritis Patients Receiving Upadacitinib. K Winthrop, et al. Abstract Number: 2002; Oral Presentation: Monday, November 9, 3 3:50 p.m. EST

Psoriatic Arthritis

Efficacy and Safety of Upadacitinib in Patients with Active Psoriatic Arthritis and Inadequate Response to Biologic Disease-Modifying Anti-Rheumatic Drugs: A Double-Blind, Randomized Controlled Phase 3 Trial. MC Genovese, et al. Abstract Number: 0504; Oral Presentation: Friday, November 6, 3 3:50 p.m. EST

Impact of Upadacitinib on Reducing Pain in Patients with Active Psoriatic Arthritis: Results from Two Phase 3 Trials in Patients with Inadequate Response to Non-biologic or Biologic DMARDs. IB McInnes, et al. Abstract Number: 0896; Poster Session: Saturday, November 7, 9 11 a.m. EST

Improvement in Patient-Reported Outcomes in Patients with Psoriatic Arthritis with Inadequate Response to Non-Biologic DMARDs Treated with Upadacitinib versus Placebo or Adalimumab: Results from a Phase 3 Study. V Strand, et al. Abstract Number: 1341; Poster Session: Sunday, November 8, 9 11 a.m. EST

Improvement in Patient-Reported Outcomes for Upadacitinib Versus Placebo Among Patients With Psoriatic Arthritis and an Inadequate Response to Biologic Disease-Modifying Anti-Rheumatic Drugs. V Strand, et al. Abstract Number: 1371; Poster Session: Sunday, November 8, 9 11 a.m. EST

Safety Profile of Upadacitinib in Psoriatic Arthritis: Integrated Analysis From Two Phase 3 Trials. GR Burmester, et al. Abstract Number: 1350; Poster Session: Sunday, November 8, 9 11 a.m. EST

Characterization of Remission in Patients with Psoriatic Arthritis Treated with Upadacitinib: Post-hoc Analysis from Two Phase 3 Trials. P Mease, et al. Abstract Number: 1355; Poster Session: Sunday, November 8, 9 11 a.m. EST

Efficacy and Safety of Upadacitinib versus Placebo and Adalimumab in Patients with Active Psoriatic Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Anti-Rheumatic Drugs: A Double-Blind, Randomized Controlled Phase 3 Trial. IB McInnes, et al. Abstract Number: 2026; Oral Presentation: Monday, November 9, 11 11:50 a.m. EST

Ankylosing Spondylitis

Effect of Upadacitinib on Reducing Pain in Patients with Active Ankylosing Spondylitis and Inadequate Response to Nonsteroidal Anti-inflammatory Drugs. A Deodhar, et al. Abstract Number: 0369; Poster Session: Friday, November 6, 9 11 a.m. EST

Efficacy and Safety of Upadacitinib in Patients with Active Ankylosing Spondylitis: 1-Year Results from a Randomized, Double-Blind, Placebo-Controlled Study with Open-Label Extension. A Deodhar, et al. Abstract Number: 2023; Oral Presentation: Monday, November 9, 11 11:50 a.m. EST

A full list of all 38 AbbVie abstracts accepted for presentation at ACR Convergence 2020 can be found here.

About RINVOQ (upadacitinib)Discovered and developed by AbbVie, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.1-3 In August 2019, RINVOQ received U.S. Food and Drug Administration 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 15 mg. Phase 3 trials of RINVOQ in psoriatic arthritis, rheumatoid arthritis, axial spondyloarthritis, Crohn's disease, atopic dermatitis, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.4-12 Use of RINVOQ in ankylosing spondylitis and psoriatic arthritis is not approved and its safety and efficacy have not been established by regulatory authorities.

Important Safety Information about RINVOQ (upadacitinib)13

RINVOQ U.S. Use and Important Safety InformationRINVOQ 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.

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.

Serious infections have happened in some people taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your HCP should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You may be at higher risk of developing shingles (herpes zoster).

Lymphoma and other cancers, including skin cancers, can happen in people taking RINVOQ.

Blood clots in the veins of the legs or lungs and arteries are possible in some people taking RINVOQ. This may be life-threatening and cause death.

Tears in the stomach or intestines and changes in certain laboratory tests can happen. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.

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

Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection such as:

Have TB or have been in close contact with someone with TB.

Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), or blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.

Have other medical conditions including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.

Live, have lived, or have traveled to parts of the country that increase your risk of getting certain kinds of fungal infections, such as the Ohio and Mississippi River valleys and the Southwest. If you are unsure if you've been to these areas, ask your HCP.

Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.

Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant while taking RINVOQ and for at least 4 weeks after your last dose.

Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. You should not breastfeed while taking RINVOQ and for at least 6 days after your last dose.

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:

Have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse.

Have any signs or symptoms of blood clots during treatment with RINVOQ, including:

Have a fever or stomach-area pain that does not go away, and a change in your bowel habits.

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 http://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 HUMIRA in the U.S.

UsesHUMIRA is a prescription medicine used:

To reduce the signs and symptoms of:

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) in adults and children 2 years of age and older.

Important Safety InformationHUMIRA 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 in RheumatologyFor 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. For more information on AbbVie in rheumatology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/rheumatology.html.

About AbbVieAbbVie'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. For more information about AbbVie, please visit us at http://www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

Forward-Looking StatementsSome 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, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. 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, as updated by its subsequent Quarterly Reports on Form 10-Q. 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:

AbbVie Data on File. ABVRRTI70713.

AbbVie Data on File. ABVRRTI70838.

AbbVie Data on File. ABVRRTI70869.

Pipeline Our Science | AbbVie. AbbVie. 2019. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on August 17, 2020.

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.

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. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on August 17, 2020

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. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on August 17, 2020.

A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT Axis 1). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed on August 17, 2020.

A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on August 17, 2020.

A Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03607422. Accessed on August 17, 2020.

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. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on August 17, 2020.

A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (SELECT-TAK). ClinicalTrials.gov. 2020. Available at https://clinicaltrials.gov/ct2/show/record/NCT04161898. Accessed on October 13, 2020.

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

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