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NORTH CHICAGO, Ill., Nov. 8, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it would present new data across its rheumatology portfolio, including RINVOQ® (upadacitinib) for rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, and SKYRIZI® (risankizumab) for psoriasis and psoriatic arthritis at the American College of Rheumatology's annual meeting (ACR Convergence 2022) taking place November 10-14 in Philadelphia, PA, as well as virtually.
"AbbVie has a rich legacy spanning more than two decades where we have consistently worked to deliver new insights and innovation in rheumatology," said Celine Goldberger, M.D., Ph.D., vice president, head of U.S. medical affairs, AbbVie. "Data being presented at this year's ACR meeting further reflect AbbVie's commitment to advancing our portfolio of medicine to help more people living with chronic and debilitating conditions achieve meaningful disease control."
Data to be presented includes:
Select AbbVie abstracts presented at ACR 2022 are outlined below.
Abstract Title
Presentation
Details
All times ET
Rheumatoid Arthritis
Safety and Efficacy of Upadacitinib in Patients with Rheumatoid Arthritis and
Inadequate Response or Intolerance to Biologic DMARDs: Results Through 5
Years From the SELECT-BEYOND Study
Abstract #0294;
Poster Session A;
Nov. 12, 2022
1:00–3:00 p.m.
Safety and Efficacy of Upadacitinib in Patients with Rheumatoid Arthritis and
Inadequate Response to Conventional Synthetic DMARDs: Results Through 5
Years From the SELECT-NEXT Study
Abstract #0295;
Poster Session A;
Nov. 12, 2022
1:00–3:00 p.m.
Healthcare Resource Utilization and Economic Burden of Patients with Adequate
and Inadequate Responses to Advanced Therapies for Rheumatoid Arthritis in
Japan
Abstract #2006;
Poster Session D;
Nov. 14, 2022
1:00–3:00 p.m.
Psoriatic Arthritis
Risankizumab (RZB) Demonstrates Long-Term Efficacy Across Subgroups in
Patients with Active Psoriatic Arthritis (PsA): A Post Hoc, Integrated Analysis
From the Phase 3 (KEEPsAKE 1 and KEEPsAKE 2) Studies
Abstract #0308;
Poster Session A;
Nov. 12, 2022
1:00–3:00 p.m.
Efficacy of Risankizumab in the Treatment of PsA Patients with Limited and
Extensive Joint Involvement
Abstract #1504;
Poster Session C;
Nov. 13, 2022
1:00–3:00 p.m.
The Impact of Second-Line Therapeutic on Disease Control After Discontinuation
of First Line TNF Inhibitor in Patients with PsA: Analysis from the CorEvitas
Psoriatic Arthritis/Spondylarthritis Registry
Abstract #1600;
Oral Presentation;
Room 201;
Nov. 13, 2022
3:45–3:55 p.m.
Axial Spondyloarthritis
Efficacy of Upadacitinib in Patients with Non-Radiographic Axial Spondyloarthritis
Stratified by Objective Signs of Inflammation at Baseline
Abstract #0419;
Poster Session A;
Nov. 13, 2022
1:00–3:00 p.m.
The Impact of Cycling Among Tumor Necrosis Factor Inhibitors on Disease
Control in Patients with Axial Spondyloarthritis: A Study from the CorEvitas
PsA/SpA Registry
Abstract #1499;
Poster Session C;
Nov. 13, 2022
1:00–3:00 p.m.;
and Live Ignite
Talk at the Center
City Stage, from
1:20-1:25 p.m.
Cross-Rheumatology
Malignancy in the Upadacitinib Clinical Trial Programs for Rheumatoid Arthritis,
Psoriatic Arthritis, and Ankylosing Spondylitis
Abstract #0292;
Poster Session A;
Nov. 12, 2022
1:00–3:00 p.m.;
and Live Ignite
Talk at the Center
City Stage on Nov.
14, 2022 1:30-
1:35 p.m.
MACE and VTE Across Upadacitinib Clinical Trial Programs in Rheumatoid
Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis
Abstract #0510;
Oral Presentation;
Room 119;
Nov. 12, 2022
4:00-4:10 p.m.
SKYRIZI (risankizumab) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization of SKYRIZI globally.
The full list of all 36 abstracts and ACR Convergence 2022 scientific program can be found here.
About RINVOQ® (upadacitinib) in the United States
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-2.8 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.
In the U.S., RINVOQ 15 mg is approved for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers; adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers; adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers and adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy.8 RINVOQ 45 mg is approved for use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers as an induction therapy once daily for 8 weeks. The recommended dose of RINVOQ for maintenance treatment is 15 mg once daily. A dosage of 30 mg once daily may be considered for patients with refractory, severe or extensive disease. Discontinue RINVOQ if an adequate response is not achieved with the 30 mg dose. Use the lowest effective dosage needed to maintain response. RINVOQ 15 mg once daily can also be initiated in adults and children 12 years of age and older weighing at least 40 kg with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics or when use of those therapies is inadvisable. In these children and adults less than 65 years of age who do not achieve an adequate response, the dose may be increased to 30 mg once daily.
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.9-16
RINVOQ® (upadacitinib) U.S. Use and Important Safety Information8
USES
RINVOQ is a prescription medicine used to treat:
It is not known if RINVOQ is safe and effective in children with juvenile idiopathic arthritis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.
RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis.
It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about RINVOQ?
RINVOQ may cause serious side effects, including:
Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.
What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:
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:
If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist.
What should I avoid while taking RINVOQ?
Avoid food or drink containing grapefruit during treatment with RINVOQ as it may increase the risk of side effects.
What should I do or tell my HCP AFTER starting RINVOQ?
What are other possible side effects of RINVOQ?
Common side effects include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, and increased liver enzyme levels.
A separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ.
These are not all the possible side effects of RINVOQ.
How should I take RINVOQ?
RINVOQ is taken once a day with or without food. Do not split, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets.
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 SKYRIZI® (risankizumab-rzaa) in the United States17
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).
SKYRIZI U.S. Uses and Important Safety Information17
SKYRIZI is a prescription medicine used to treat adults with:
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SKYRIZI® (risankizumab-rzaa)?
SKYRIZI is a prescription medicine that may cause serious side effects, including:
Serious allergic reactions:
Infections:
SKYRIZI 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.
Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.
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?"
Liver problems in Crohn's disease: A person with Crohn's disease who received SKYRIZI through a vein in the arm developed changes in liver blood tests with a rash that led to hospitalization. Your healthcare provider will do blood tests to check your liver before, during, and up to 12 weeks of treatment and may stop treatment with SKYRIZI if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach (abdominal) pain, tiredness (fatigue), loss of appetite, yellowing of the skin and eyes (jaundice), and dark urine.
The most common side effects of SKYRIZI in people treated for Crohn's disease include: upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, and urinary tract infection.
The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, feeling tired, injection site reactions, and fungal skin infections.
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, a 600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector.
This is the most important information to know about SKYRIZI. 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 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. Anchored by a longstanding commitment to discovering and delivering transformative therapies, we pursue cutting-edge science that improves our understanding of promising new pathways and targets, ultimately helping more people living with rheumatic diseases reach their treatment goals. For more information, visit AbbVie in rheumatology.
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, and women's health, in addition to products and services across our Allergan Aesthetics portfolio. 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, 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 2021 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.
US-MULT-221303
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SOURCE AbbVie