Latest News by Industry
NORTH CHICAGO, Ill., Sept. 29, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today revealed the spectrum of new data from studies of risankizumab (SKYRIZI®) in Crohn's disease and upadacitinib (RINVOQ®) in ulcerative colitis and Crohn's disease that will be presented as live presentations and e-Posters at the United European Gastroenterology (UEG) Week 2022, October 8-11 in Vienna and online. In total, AbbVie is presenting 17 abstracts across a broad range of studies in inflammatory bowel disease (IBD).
"With two decades of world-class science and an unwavering commitment to patients, we continue to advance research within our robust gastro portfolio with the goal of positively impacting the lives of people living with inflammatory bowel disease," said Chiedzo Mpofu, MBChB, Ph.D., vice president, Global Medical Affairs, Immunology, AbbVie. "Our data at UEG Week 2022 reinforce our dedication to innovation and partnership with the gastroenterology community to help address a wide range of patient needs and investigate diverse solutions to help advance standards of care for IBD patients."
Key data to be presented include:
* The use of upadacitinib and risankizumab are investigational in Crohn's disease in the European Union.
AbbVie abstracts in the UEG Week 2022 program include:
Abstract Title | Session Details |
Risankizumab / Crohn's Disease | |
Induction and Maintenance Treatment with Risankizumab Leads to | e-Poster Presentation Sunday, Oct 9 9 a.m. |
Fatigue Improvement Correlates with Reductions in Work Productivity | e-Poster Presentation Sunday, Oct 9 9 a.m. |
Baseline and Early Predictors of Response to Risankizumab Induction and | Live Moderated Poster MP442 Monday, Oct 10 14:06 – 14:12 p.m. |
52-Weeks Risankizumab Subcutaneous Maintenance Dosing is Efficacious and | Live Oral Presentation Monday, Oct 10 14 – 14:12 p.m. |
Clinical and Endoscopic Improvements with Risankizumab Induction and | Live Oral Presentation Monday, Oct 10 14:24 – 14:36 p.m. |
Upadacitinib / Ulcerative Colitis | |
Efficacy and safety of upadacitinib in patients with moderately to severely active | e-Poster Session P0440 Sunday, Oct 9 9 a.m. |
Efficacy and safety of upadacitinib maintenance therapy in patients with | Live Oral Presentation OP001 Sunday, Oct 9 13:55 – 14:07 p.m. |
Benefit-risk assessment of upadacitinib treatment in patients with moderately to | Live Moderated Poster MP243 Monday, Oct 10 11:12 – 11:18 a.m. |
Matching-Adjusted Indirect Comparison of Upadacitinib Versus Vedolizumab | Live Moderated Poster MP244 Monday, Oct 10 11:18 – 11:24 a.m. |
Benefits of high versus low dose upadacitinib as maintenance treatment in | Live Oral Presentation OP197 Tuesday, Oct 11 11:24 – 11:36 a.m. |
Symptoms and Laboratory Values as Proxies for Endoscopic and Histologic | Live Moderated Poster MP409 Tuesday, Oct 11 11:48 – 11:54 a.m. |
Efficacy of Upadacitinib Dose Escalation in Phase 3 Long-term Extension | Live Oral Presentation OP199 Tuesday, Oct 11 11:48 – 12:00 p.m. |
Impact of Inflammatory Burden on Efficacy of Upadacitinib Maintenance | Live Moderated Poster MP441 Tuesday, Oct 11 14 – 14:06 p.m. |
Upadacitinib / Crohn's Disease | |
Efficacy and Safety of Upadacitinib Induction Therapy in Patients with | Live Oral Presentation OP219 Monday, Oct 10 14:36 – 14:48 p.m. |
Disease State Abstracts / Inflammatory Bowel Disease | |
Steroid use in a high proportion of IBD patients – first results from the German | e-Poster Presentation P0436 Sunday, Oct 9 9 a.m. |
Patient-reported burden of corticosteroid use in inflammatory bowel disease in | Live Oral Presentation OP107 Monday, Oct 10 11:12 – 11:24 a.m. |
Patterns of corticosteroid exposure and excess in inflammatory bowel disease: | Live Moderated Poster MP110 Sunday, Oct 9 15:54 – 16 p.m. |
The full scientific program for the UEG Week 2022 is available here.
Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
About Ulcerative Colitis
Ulcerative colitis is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) of the large intestine that causes continuous mucosal inflammation extending, to a variable extent, from the rectum to the more proximal colon.1,2 The hallmark signs and symptoms of ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence.1,3 The disease course of ulcerative colitis varies between patients and can range from quiescent disease to chronic refractory disease, which in some cases can lead to surgery or complications, including cancer or death.2,4 The severity of symptoms and unpredictability of disease course can lead to substantial burden and often disability among those living with the disease.5
About Crohn's Disease
Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal (or digestive) tract, causing persistent diarrhea, abdominal pain and rectal bleeding.2,6,7 It is a progressive disease, meaning it gets worse over time.2,7 Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease—not only physically, but also emotionally and economically.5
About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.8-15 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.8
In the EU, RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.8 The use of upadacitinib in Crohn's disease is not approved and its safety and efficacy have not been established by global regulatory authorities. Phase 3 trials of RINVOQ in atopic dermatitis, axial spondylarthritis, Crohn's disease, giant cell arteritis, psoriatic arthritis, rheumatoid arthritis, Takayasu arteritis and ulcerative colitis are ongoing.9-15
US Indications and Important Safety Information about RINVOQ® (upadacitinib)8
U.S. 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, or ankylosing spondylitis.
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.
U.S. 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:
What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:
̶ Fever, sweating, or ̶ Shortness of breath ̶ Warm, red, or | ̶ Muscle aches ̶ Feeling tired ̶ Blood in phlegm ̶ Diarrhea or | ̶ Cough ̶ Weight loss ̶ Burning when |
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 do or tell my HCP AFTER starting RINVOQ?
̶ Swelling ̶ Pain or tenderness in one or | ̶ Sudden unexplained chest or ̶ Shortness of breath or difficulty |
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 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 RINVOQ.
Globally, prescribing information varies; refer to the individual country product label for complete information.
About SKYRIZI® (risankizumab)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.16,17 The use of risankizumab in Crohn's disease is not approved in the EU and its safety and efficacy have not been established by regulatory authorities. Phase 3 trials of SKYRIZI in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing.9,18,19
US Indications and Important Safety Information about SKYRIZI® (risankizumab)17
What is the most important information I should know about SKYRIZI® (risankizumab-rzaa)?
SKYRIZI is a prescription medication that may cause serious side effects, including:
Serious Allergic Reactions:
Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction:
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.
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 people with Crohn's disease: A person with Crohn's disease who received SKYRIZI by intravenous infusion developed changes in liver blood tests with a rash that led to hospitalization. Your doctor 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 doctor 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, injection site reactions, fever, headache, stomach(abdominal) pain, back pain, joint pain, and low red blood cells (anemia).
The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis 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, a 600mg/10mL intravenous infusion, and a 360mg/2.4mL 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 Gastroenterology
With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.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, 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.
References:
View original content: https://www.prnewswire.com/news-releases/abbvie-highlights-robust-gastroenterology-portfolio-with-new-data-in-crohns-disease-and-ulcerative-colitis-at-the-ueg-week-2022-301636362.html
SOURCE AbbVie