PR Newswire | Nov 1, 2021 08:31AM EDT

Convergence 2021

11/01 07:31 CDT

AbbVie Highlights Innovative Research From Its Rheumatology Portfolio at ACR Convergence 2021- Thirty-eight abstracts underscore AbbVie's commitment to advancing its portfolio of medicines to help more people living with rheumatic diseases NORTH CHICAGO, Ill., Nov. 1, 2021

NORTH CHICAGO, Ill., Nov. 1, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the presentation of new data on RINVOQ(r) (upadacitinib), SKYRIZI(r) (risankizumab) and HUMIRA(r) (adalimumab) across multiple rheumatic diseases at the American College of Rheumatology's annual meeting (ACR Convergence 2021), to be held virtually Nov. 3-9. A total of 38 abstracts, including two oral presentations and one plenary session presentation, will be presented from a broad range of studies in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

"Many people continue to struggle with the daily, debilitating challenges of rheumatic diseases," said Brandee Pappalardo, Ph.D., M.P.H., vice president, U.S. immunology medical affairs, AbbVie. "The data we're presenting at this year's ACR meeting reflect our commitment to advancing our portfolio of medicines to help more people achieve meaningful disease control."

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

Rheumatoid Arthritis

* Long-term safety and efficacy data through three years of upadacitinib and adalimumab for patients with prior inadequate response to methotrexate (MTX) * Data on sustainability of response to upadacitinib among patients with prior inadequate response or intolerance to biologic disease modifying anti-rheumatic drugs (bDMARDS)

Psoriatic Arthritis

* Efficacy of upadacitinib on axial symptoms in people with active psoriatic arthritis and axial involvement

Ankylosing Spondylitis

* Long-term efficacy and safety data through two years of upadacitinib in patients who had an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) and were bDMARD-nave

Cross-Rheumatic Diseases

* Long-term safety data of upadacitinib across rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis trials from the SELECT clinical program

A plenary session will highlight data on the efficacy and safety of risankizumab for active psoriatic arthritis in patients who either previously had an inadequate response or intolerance to conventional synthetic DMARDs (csDMARDs) or who previously had an inadequate response or intolerance to biologics.

Key AbbVie rheumatology abstracts at ACR Convergence 2021 include:

PresentationAbstract Title Details All times CT

Rheumatoid Arthritis

Abstract # 0828 Long-Term Safety and Efficacy of Upadacitinib or Adalimumab in Poster Patients with Rheumatoid Arthritis: Results at 3 Years from the Session B SELECT-COMPARE Study Nov. 7, 2021 7:30-9:30 a.m.

Abstract # 0832 Consistency in Time to Response with Upadacitinib as MonotherapyPoster or Combination Therapy and Across Patient Populations with Session B Rheumatoid Arthritis Nov. 7, 2021 7:30-9:30 a.m.

Abstract # 0837 Sustainability of Response Between Upadacitinib and Adalimumab Poster in Patients with Rheumatoid Arthritis: Results Through 3 Years Session B from the SELECT-COMPARE Trial Nov. 7, 2021 7:30-9:30 a.m.

Abstract # 1230 Impact of Serologic Status on Clinical Responses to UpadacitinibPoster or Abatacept in Patients with Rheumatoid Arthritis and Prior Session C Inadequate Response to Biologic DMARDs: Sub-Group Analysis from the Phase 3 SELECT-CHOICE Study Nov. 8, 2021 7:30-9:30 a.m.

Abstract # 1234 Routine Assessment of Patient Index Data 3 (RAPID3) in Patients Poster with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Session C Therapy Nov. 8, 2021 7:30-9:30 a.m.

Abstract # 1240 Biomarker Driven Dissection of Inflammation Modulatory Effects Poster of Upadacitinib versus Abatacept in Patients with Active Session C Rheumatoid Arthritis Refractory to Biologic DMARDs Nov. 8, 2021 7:30-9:30 a.m.

Abstract # 1241 Comparison of the Effects of Upadacitinib Monotherapy with MTX Poster on Protein Biomarkers in MTX-Na?ve and MTX-Inadequate RespondersSession C in Patients with Active Rheumatoid Arthritis: Results from the SELECT-EARLY and SELECT-MONOTHERAPY Phase 3 Studies Nov. 8, 2021 7:30-9:30 a.m.

Abstract # 1687 Integrated Laboratory Abnormality Profiles of Upadacitinib with up to 4.5 Years of Exposure in Patients with Rheumatoid Poster Arthritis Treated in a Phase 3 Clinical Trial Session D Nov. 9, 2021 7:30-9:30 a.m.

Abstract # 1692 Poster Long-Term Efficacy and Safety of Upadacitinib in Patients with Session D Rheumatoid Arthritis: 3-year Results from the SELECT-EARLY Study Nov. 9, 2021 7:30-9:30 a.m.

Abstract # 1694 Sustainability of Response to Upadacitinib Among Patients with Poster Active Rheumatoid Arthritis Refractory to Biological Session D Disease-Modifying Anti-Rheumatic Drugs Nov. 9, 2021 7:30-9:30 a.m.

Psoriatic Arthritis

Abstract # 0183 Efficacy and Safety of Risankizumab for Active Psoriatic Poster Arthritis: 24-Week Results from the Phase 3, Randomized, Session A Double-blind Clinical Trial for CsDMARD-IR and Bio-IR Patients Nov. 6, 2021 7:30-9:30 a.m.

Abstract # 0205 An Observational Study from the Perspective of Rheumatology in Poster the Management of Patients with Psoriatic Arthritis in Turkey - Session A LOOP Study Nov. 6, 2021 7:30-9:30 a.m.

Abstract # 0234 Poster Impact of Early Pain Improvement on Patient-Reported Outcomes inSession A Patients with Psoriatic Arthritis: Results from a Phase 3 Trial Nov. 6, 2021 7:30-9:30 a.m.

Abstract # 0453 Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 24-Week Integrated Results From 2 Phase 3, Plenary Randomized, Double-blind Clinical Trials for CsDMARD-IR and Session Bio-IR Patients Nov. 6, 2021 9:45-10 a.m.

Abstract # 1156 Impact of Treatment Experience on Patient Preferences and Poster Disease Burden in Psoriatic Arthritis: Results from a Session C Rheumatology Patient Research Registry Nov. 8, 2021 7:30-9:30 a.m.

Abstract # 1344 Impact of Achieving Minimal Disease Activity on Patient-ReportedPoster Outcome Measures and Disease Activity Among Patients with Session C Psoriatic Arthritis Treated with Biologic and Targeted Synthetic DMARDs Nov. 8, 2021 7:30-9:30 a.m.

Abstract # 1345 Long-Term Safety and Effectiveness of Upadacitinib in Patients Poster with Psoriatic Arthritis: Results at 56 Weeks from the Session C SELECT-PsA 1 Study Nov. 8, 2021 7:30-9:30 a.m.

Abstract # 1910 Association Between Clinically Meaningful Improvements in Patient-Reported Outcomes and Stringent Measures of Disease Abstract Activity in Patients with Psoriatic Arthritis Treated with Session Upadacitinib versus Placebo or Adalimumab: Results from a Phase 3 Trial Nov. 9, 2021 1:15-1:30 p.m.

Abstract # 1945 Efficacy of Upadacitinib on Psoriatic Arthritis with Axial Abstract Involvement Defined by Investigator Assessment and PRO-Based Session Criteria: Results from Two Phase 3 Studies Nov. 9, 2021 3:30-3:45 p.m.

Ankylosing Spondylitis

Abstract # 0749 Association Between Clinically Meaningful Back Pain Improvement Poster and Patient-Reported Outcomes and Disease Activity in Patients Session B with Ankylosing Spondylitis: Results from a Phase 2/3 Trial Nov. 7, 2021 7:30-9:30 a.m.

Abstract # 0920 Influence of Baseline Demographics on Improvements in Disease Poster Activity Measures in Patients with Ankylosing Spondylitis Session B Receiving Upadacitinib: A Post Hoc Subgroup Analysis Nov. 7, 2021 7:30-9:30 a.m.

Abstract # 0924 Efficacy and Safety of Upadacitinib in Patients with Active Poster Ankylosing Spondylitis: 2-Year Results from a Randomized, Session B Double-Blind, Placebo-Controlled Study with Open-Label Extension Nov. 7, 2021 7:30-9:30 a.m.

Abstract # 0926 Predictors of 1-Year Treatment Response Among Poster Upadacitinib-Treated Patients with Ankylosing Spondylitis: A Session B Post Hoc Analysis Nov. 7, 2021 7:30-9:30 a.m.

Cross-Rheumatology

Abstract # 1691 Long-Term Safety Profile of Upadacitinib in Patients with Poster Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Session D Spondylitis Nov. 9, 2021 7:30-9:30 a.m.

Abstract # 1802 Comparison of Axial and Peripheral Manifestations in Patients Poster with Psoriatic Arthritis and Ankylosing Spondylitis in Session D Upadacitinib Clinical Trials Nov. 9, 2021 7:30-9:30 a.m.

A full list of all 38 AbbVie abstracts accepted for presentation at ACR Convergence 2021 can be found here.

Use of upadacitinib in psoriatic arthritis and ankylosing spondylitis is not approved in the U.S. and its safety and efficacy are currently under review by the U.S. Food and Drug Administration (FDA). Use of risankizumab in psoriatic arthritis is not approved and its safety and efficacy are currently under review by the U.S. FDA.

About RINVOQ(r) (upadacitinib)Discovered and developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2.1The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known. RINVOQ 15 mg is approved by the European Commission for adults with moderate to severe active rheumatoid arthritis, adults with active psoriatic arthritis and adults with active ankylosing spondylitis. RINVOQ is approved by the European Commission for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to severe atopic dermatitis. RINVOQ 15 mg is also approved by the U.S. Food and Drug Administration (FDA) for adults with moderately to severely active rheumatoid arthritis. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.2-11

Important Safety Information about RINVOQ(r)(upadacitinib)1

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: * Fever, sweating or chills * Shortness of breath * Warm, red, or painful skin or sores on your body * Muscle aches * Feeling tired * Blood in phlegm * Diarrhea or stomach pain * Cough * Weight loss * Burning when urinating or urinating more often than normal

* 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:

* Medicines for fungal or bacterial infections * Rifampicin or phenytoin * Medicines that affect your immune system

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: * Swelling * Sudden unexplained chest pain * Pain or tenderness in the leg * Shortness of breath

* 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/medwatchor 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.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About HUMIRA (adalimumab) in the U.S.

UsesHUMIRA 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 can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your 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 or with methotrexate. * Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities. * Ankylosing spondylitis (AS) in adults. * Moderate to severe hidradenitis suppurativa (HS) in people 12 years and older.

* To treat moderate to severe Crohn's disease (CD) in adults and children 6 years of age and older. * To treat moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older. 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 Information About HUMIRA(r) (adalimumab)

What is the most important information I should know about HUMIRA?You should discuss the potential benefits and risks of HUMIRA with your doctor. HUMIRA is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay.

* 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. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB. * Cancer. For children and adults taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. 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, your chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn't heal.

What should I tell my doctor BEFORE starting HUMIRA?Tell your doctor about all of your health conditions, including if you:

* Have an infection, are being treated for infection, or have symptoms of an infection * Get a lot of infections or infections that keep coming back * Have diabetes * Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB * Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis. These infections may happen or become more severe if you use HUMIRA. Ask your doctor if you are unsure if you have lived in these areas * Have or have had hepatitis B * Are scheduled for major surgery * Have or have had cancer * Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barr syndrome * Have or had heart failure * Have recently received or are scheduled to receive a vaccine. HUMIRA patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting HUMIRA * Are allergic to rubber, latex, or any HUMIRA ingredients * Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed * Have a baby and you were using HUMIRA during your pregnancy. Tell your baby's doctor before your baby receives any vaccines

Also tell your doctor about all the medicines you take. You should not take HUMIRA with ORENCIA(r) (abatacept), KINERET(r) (anakinra), REMICADE(r) (infliximab), ENBREL(r) (etanercept), CIMZIA(r) (certolizumab pegol), or SIMPONI(r) (golimumab). Tell your doctor if you have ever used RITUXAN(r) (rituximab), IMURAN(r) (azathioprine), or PURINETHOL(r) (mercaptopurine, 6-MP)b(r)

What should I watch for AFTER starting HUMIRA?HUMIRA can cause serious side effects, including:

* Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle. * Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash. * Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth. * Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness. * Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale. * Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain. * Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun. * Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death. * Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.

Call your doctor or get medical care right away if you develop any of the above symptoms.

Common side effects of HUMIRA include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away.

Remember, tell your doctor right away if you have an infection or symptoms of an infection, including:

* Fever, sweats or chills * Muscle aches * Cough * Shortness of breath * Blood in phlegm * Weight loss * Warm, red or painful skin sores on your body * Diarrhea or stomach pain * Burning when you urinate * Urinating more often than normal * Feeling very tired

HUMIRA is given by injection under the skin.

This is the most important information to know about HUMIRA. For more information, talk to your health care provider.

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 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.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About SKYRIZI(r) (risankizumab-rzaa) in the United States12SKYRIZI 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).

Important Safety Information

What is the most important information I should know about SKYRIZI(r)(risankizumab-rzaa)?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.

* Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: * fever, sweats, or chills * muscle aches * weight loss * cough * warm, red, or painful skin or sores on your body different from your psoriasis * diarrhea or stomach pain * shortness of breath * blood in your mucus (phlegm) * burning when you urinate or urinating more often than normal

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

* have any of the conditions or symptoms listed in the section "What is the most important information I should know about SKYRIZI?" * have an infection that does not go away or that keeps coming back. * have TB or have been in close contact with someone with TB. * have recently received or are scheduled to receive an immunization (vaccine). Medications that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine. * are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby. * are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk.

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, feeling tired, fungal skin infections, headache, 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. SKYRIZI is available in a 150 mg/mL prefilled syringe and pen.

This is not a complete summary of all safety information.

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

If you are having difficulty paying for your medicine, AbbVie may be able to help. VisitAbbVie.com/myAbbVieAssistto learn more.

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

Globally, prescribing information varies; refer to the individual country product label for complete information.

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 atwww.abbvie.com. Follow @AbbVie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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's2020 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.

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7. 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. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03104374. Accessed: June 2021.

8. A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03738397. Accessed: June 2021.

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