AbbVie Highlights Innovative Research From Its Rheumatology Portfolio at ACR Convergence 2021
AbbVie (NYSE: ABBV) today announced the presentation of new data on RINVOQ® (upadacitinib), SKYRIZI® (risankizumab) and HUMIRA® (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.”
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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-naïve
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:
Abstract Title
Presentation Details
All times CT
Rheumatoid Arthritis
Long-Term Safety and Efficacy of Upadacitinib or Adalimumab in Patients with Rheumatoid Arthritis: Results at 3 Years from the SELECT-COMPARE Study
Abstract #0828
Poster Session B
Nov. 7, 2021
7:30-9:30 a.m.
Consistency in Time to Response with Upadacitinib as Monotherapy or Combination Therapy and Across Patient Populations with Rheumatoid Arthritis
Abstract #0832
Poster Session B
Nov. 7, 2021
7:30-9:30 a.m.
Sustainability of Response Between Upadacitinib and Adalimumab in Patients with Rheumatoid Arthritis: Results Through 3 Years from the SELECT-COMPARE Trial
Abstract #0837
Poster Session B
Nov. 7, 2021
7:30-9:30 a.m.
Impact of Serologic Status on Clinical Responses to Upadacitinib or Abatacept in Patients with Rheumatoid Arthritis and Prior Inadequate Response to Biologic DMARDs: Sub-Group Analysis from the Phase 3 SELECT-CHOICE Study
Abstract #1230
Poster Session C
Nov. 8, 2021
7:30-9:30 a.m.
Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy
Abstract #1234
Poster Session C
Nov. 8, 2021
7:30-9:30 a.m.
Biomarker Driven Dissection of Inflammation Modulatory Effects of Upadacitinib versus Abatacept in Patients with Active Rheumatoid Arthritis Refractory to Biologic DMARDs
Abstract #1240
Poster Session C
Nov. 8, 2021
7:30-9:30 a.m.
Comparison of the Effects of Upadacitinib Monotherapy with MTX on Protein Biomarkers in MTX-Naïve and MTX-Inadequate Responders in Patients with Active Rheumatoid Arthritis: Results from the SELECT-EARLY and SELECT–MONOTHERAPY Phase 3 Studies
Abstract #1241
Poster Session C
Nov. 8, 2021
7:30-9:30 a.m.
Integrated Laboratory Abnormality Profiles of Upadacitinib with up to 4.5 Years of Exposure in Patients with Rheumatoid Arthritis Treated in a Phase 3 Clinical Trial
Abstract #1687
Poster Session D
Nov. 9, 2021
7:30-9:30 a.m.
Long-Term Efficacy and Safety of Upadacitinib in Patients with Rheumatoid Arthritis: 3-year Results from the SELECT-EARLY Study
Abstract #1692
Poster Session D
Nov. 9, 2021
7:30-9:30 a.m.
Sustainability of Response to Upadacitinib Among Patients with Active Rheumatoid Arthritis Refractory to Biological Disease-Modifying Anti-Rheumatic Drugs
Abstract #1694
Poster Session D
Nov. 9, 2021
7:30-9:30 a.m.
Psoriatic Arthritis
Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 24-Week Results from the Phase 3, Randomized, Double-blind Clinical Trial for CsDMARD-IR and Bio-IR Patients
Abstract #0183
Poster Session A
Nov. 6, 2021
7:30-9:30 a.m.
An Observational Study from the Perspective of Rheumatology in the Management of Patients with Psoriatic Arthritis in Turkey – LOOP Study
Abstract #0205
Poster Session A
Nov. 6, 2021
7:30-9:30 a.m.
Impact of Early Pain Improvement on Patient-Reported Outcomes in Patients with Psoriatic Arthritis: Results from a Phase 3 Trial
Abstract #0234
Poster Session A
Nov. 6, 2021
7:30-9:30 a.m.
Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 24-Week Integrated Results From 2 Phase 3, Randomized, Double-blind Clinical Trials for CsDMARD-IR and Bio-IR Patients
Abstract #0453
Plenary Session
Nov. 6, 2021
9:45-10 a.m.
Impact of Treatment Experience on Patient Preferences and Disease Burden in Psoriatic Arthritis: Results from a Rheumatology Patient Research Registry
Abstract #1156
Poster Session C
Nov. 8, 2021
7:30-9:30 a.m.
Impact of Achieving Minimal Disease Activity on Patient-Reported Outcome Measures and Disease Activity Among Patients with Psoriatic Arthritis Treated with Biologic and Targeted Synthetic DMARDs
Abstract #1344
Poster Session C
Nov. 8, 2021
7:30-9:30 a.m.
Long-Term Safety and Effectiveness of Upadacitinib in Patients with Psoriatic Arthritis: Results at 56 Weeks from the SELECT-PsA 1 Study
Abstract # 1345
Poster Session C
Nov. 8, 2021
7:30-9:30 a.m.
Association Between Clinically Meaningful Improvements in Patient-Reported Outcomes and Stringent Measures of Disease Activity in Patients with Psoriatic Arthritis Treated with Upadacitinib versus Placebo or Adalimumab: Results from a Phase 3 Trial
Abstract #1910
Abstract Session
Nov. 9, 2021
1:15-1:30 p.m.
Efficacy of Upadacitinib on Psoriatic Arthritis with Axial Involvement Defined by Investigator Assessment and PRO-Based Criteria: Results from Two Phase 3 Studies
Abstract #1945
Abstract Session
Nov. 9, 2021
3:30-3:45 p.m.
Ankylosing Spondylitis
Association Between Clinically Meaningful Back Pain Improvement and Patient-Reported Outcomes and Disease Activity in Patients with Ankylosing Spondylitis: Results from a Phase 2/3 Trial
Abstract #0749
Poster Session B
Nov. 7, 2021
7:30-9:30 a.m.
Influence of Baseline Demographics on Improvements in Disease Activity Measures in Patients with Ankylosing Spondylitis Receiving Upadacitinib: A Post Hoc Subgroup Analysis
Abstract #0920
Poster Session B
Nov. 7, 2021
7:30-9:30 a.m.
Efficacy and Safety of Upadacitinib in Patients with Active Ankylosing Spondylitis: 2-Year Results from a Randomized, Double-Blind, Placebo-Controlled Study with Open-Label Extension
Abstract #0924
Poster Session B
Nov. 7, 2021
7:30-9:30 a.m.
Predictors of 1-Year Treatment Response Among Upadacitinib-Treated Patients with Ankylosing Spondylitis: A Post Hoc Analysis
Abstract #0926
Poster Session B
Nov. 7, 2021
7:30-9:30 a.m.
Cross-Rheumatology
Long-Term Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis
Abstract #1691
Poster Session D
Nov. 9, 2021
7:30-9:30 a.m.
Comparison of Axial and Peripheral Manifestations in Patients with Psoriatic Arthritis and Ankylosing Spondylitis in Upadacitinib Clinical Trials
Abstract #1802
Poster Session D
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® (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-2.1 The 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® (upadacitinib)1
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.
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:
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:
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.
Globally, prescribing information varies; refer to the individual country product label for complete information.
About HUMIRA (adalimumab) in the U.S.
Uses
HUMIRA is a prescription medicine used:
To reduce the signs and symptoms of:
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® (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-Barré 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® (abatacept), KINERET® (anakinra), REMICADE® (infliximab), ENBREL® (etanercept), CIMZIA® (certolizumab pegol), or SIMPONI® (golimumab). Tell your doctor if you have ever used RITUXAN® (rituximab), IMURAN® (azathioprine), or PURINETHOL® (mercaptopurine, 6-MP)b®
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® (risankizumab-rzaa) in the United States12
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).
Important Safety Information
What is the most important information I should know about SKYRIZI® (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:
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/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 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 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. For more information on AbbVie in rheumatology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/rheumatology.html.
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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
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, 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 2020 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:
1. RINVOQ® (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
2. 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.
3. 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: June 2021.
4. 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: June 2021.
5. 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: June 2021.
6. 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: June 2021.
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.
9. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed: June 2021.
10. 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: June 2021.
11. 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: June 2021.
12. SKYRIZI® (risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
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SOURCE AbbVie
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