Non-radiographic axial spondyloarthritis

A total of 29 abstracts, including three late-breaking presentations, demonstrate AbbVie and Allergan Aesthetics' shared commitment to advancing science across a spectrum of immune-mediated dermatologic conditions and aesthetic indications NORTH CHICAGO, Ill., March 6, 2024 /PRNewswire/ --AbbVie (NYSE: ABBV) and Allergan Aesthetics, an AbbVie company, today announced they will present 29 abstracts, including three late-breaking presentations, during the 2024 American Academy of Dermatology (AAD) Annual Meeting, March 8-12, in San Diego, California. The presented data across AbbVie and Allergan Aesthetics' extensive portfolios reinforce the companies' ongoing commitment to developing transformative medical dermatology and aesthetic treatments to advance and redefine the standard of care for patients. The oral and poster presentations from AbbVie highlight efficacy, durability and safety data across the company's dermatology portfolio. Notable presentations include: Efficacy data of RINVOQ® (upadacitinib) on nighttime itch and sleep disturbance, and minimal disease activity in patients with moderate-to-severe atopic dermatitis Data evaluating the efficacy of SKYRIZI® (risankizumab-rzaa) on difficult to treat areas including for the treatment of scalp and nail psoriasis compared to apremilast in adults with moderate psoriasis, and safety and efficacy of SKYRIZI® (risankizumab-rzaa) in adults with moderate to severe plaque psoriasis with palmoplantar (nonpustular) involvement Data evaluating changes in tissue-resident memory T cell (Trm) populations after high-induction dosing of SKYRIZI® (risankizumab-rzaa) in patients with moderate-to-severe plaque psoriasis AbbVie is also presenting data across a number of underserved dermatologic diseases across new and existing molecules. Key research includes: Phase 2 efficacy and safety data for lutikizumab (ABT-981), which has a novel mechanism of action, in the treatment of moderate to severe hidradenitis suppurativa being presented for the first time at a medical meeting Efficacy and safety results of a Phase 2, 52-week study for upadacitinib in the treatment of non-segmental vitiligo New data on disease and economic burden of alopecia areata in the United States "AbbVie's commitment to advancing standards of care in dermatology is underscored by the breadth of new research presented at AAD this year," said Andrew Anisfeld, Ph.D., vice president, global medical affairs, Immunology, AbbVie. "We are dedicated to improving patient outcomes and helping to redefine treatment expectations so that all patients may feel free in their own skin." With a growing pipeline of more than 60 programs in development, Allergan Aesthetics has one of the most robust portfolios for aesthetics innovation in the industry. At AAD the company will spotlight: Detailed results from two Phase 3 studies of onabotulinumtoxinA (BOTOX® Cosmetic) for the treatment of platysma prominence, an aesthetically unappealing disruption to the lines and contour of the lower face and neck that can occur as part of the natural aging process. Topline results shared in 2023 demonstrated all primary and secondary endpoints were met for both studies,1 and if approved, onabotulinumtoxinA will be the first and only neurotoxin for this indication. Data on the safety and effectiveness of JUVÉDERM® VOLUMA® XC for injection in the temple region to improve moderate to severe temple hollowing in adults over the age of 21.2 JUVÉDERM® VOLUMA® XC is the first and only hyaluronic acid (HA) dermal filler to receive U.S. FDA approval for the improvement of moderate to severe temple hollowing with results lasting up to thirteen months with optimal treatment.2 Data on a novel cosmetic regimen for mild to moderate facial acne. "Allergan Aesthetics is focused on creating evidence-based products and technologies that advance aesthetics medicine and address the evolving needs of patients and providers globally," said John Maltman, Ph.D., vice president, global aesthetics medical affairs, Allergan Aesthetics. "With patient safety and optimal outcomes as our main priorities, we are proud to share our learnings and engage with the larger medical community at AAD." Select AbbVie and Allergan Aesthetics abstracts at AAD 2024 are outlined below. The 2024 AAD Annual Meeting e-Posters are available here and late-breaking sessions are available here. SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization of SKYRIZI globally. About RINVOQ® (upadacitinib) Discovered and developed by AbbVie scientists, RINVOQ is a 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-2.3 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. Phase 3 trials of RINVOQ alopecia areata, ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn's disease, giant cell arteritis, hidradenitis suppurativa, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus (SLE), Takayasu arteritis, ulcerative colitis and vitiligo are ongoing.4-17 Use of upadacitinib in vitiligo is not approved and its safety and efficacy have not been evaluated by regulatory authorities. RINVOQ (upadacitinib) U.S. Uses and Important Safety Information3 RINVOQ is a prescription medicine used to treat: Adults with moderate to severe rheumatoid arthritis (RA) when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated. Adults with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with active ankylosing spondylitis (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used, and did not work well or could not be tolerated. Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with moderate to severe Crohn's disease (CD) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children with juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn's disease. Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended. 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. What is the most important information I should know about RINVOQ? RINVOQ may cause serious side effects, including: Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while 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 healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster). Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor. Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP's advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen. Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker. Blood clots: Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor. Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away. Tears in the stomach or intestines. This happens most often in people who take nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. Get medical help right away if you get stomach-area pain, fever, chills, nausea, or vomiting. Changes in certain laboratory tests. 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. 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: 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. Are a current or past smoker. Have had a heart attack, other heart problems, or stroke. Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), 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 red or white blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system. Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of 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 findings in 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 during treatment with RINVOQ and for 4 weeks after your last dose. There is a pregnancy surveillance program for RINVOQ. The purpose of the program is to collect information about the health of you and your baby. If you become pregnant while taking RINVOQ, you are encouraged to report the pregnancy by calling 1-800-633-9110. Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 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 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? 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. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including: Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw Pain or discomfort in your arms, back, neck, jaw, or stomach Shortness of breath with or without chest discomfort Breaking out in a cold sweat Nausea or vomiting Feeling lightheaded Weakness in one part or on one side of your body Slurred speech Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including: Swelling Pain or tenderness in one or both legs Sudden unexplained chest or upper back pain Shortness of breath or difficulty breathing Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits. 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, leukopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, increased liver enzyme levels, pneumonia, low number of red blood cells (anemia), and infection of the stomach and intestine (gastroenteritis). 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. Some people taking RINVOQ may see medicine residue (a whole tablet or tablet pieces) in their stool. If this happens, call your healthcare provider. 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 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 for RINVOQ. Globally, prescribing information varies; refer to the individual country product label for complete information. About SKYRIZI® (risankizumab-rzaa) SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.18 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.18 Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis are ongoing.19 - 24 SKYRIZI® (risankizumab-rzaa) U.S. Indications and Important Safety Information25 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). active psoriatic arthritis (PsA). moderate to severe Crohn's disease. 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: Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction: fainting, dizziness, feeling lightheaded (low blood pressure) swelling of your face, eyelids, lips, mouth, tongue, or throat trouble breathing or throat tightness chest tightness skin rash, hives itching 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. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: fever, sweats, or chills cough shortness of breath blood in your mucus (phlegm) muscle aches warm, red, or painful skin or sores on your body different from your psoriasis weight loss diarrhea or stomach pain burning when you urinate or urinating more often than normal 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: 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). Medicines 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. become pregnant while taking SKYRIZI. You are encouraged to enroll in the Pregnancy Registry, which is used to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry. 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. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit 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 Lutikizumab (ABT-981) Lutikizumab (ABT-981) is a dual-variable-domain interleukin (IL) 1α/1β antagonist being investigated in several immune-mediated diseases, including hidradenitis suppurativa (HS) and ulcerative colitis. Studies have shown IL 1α and 1β are elevated in HS lesions.26 Lutikizumab is an investigational agent and is not approved by regulatory authorities. Safety and efficacy have not been established. BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information BOTOX® Cosmetic (onabotulinumtoxinA) is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet, and frown lines between the eyebrows in adults. Talk to your doctor about BOTOX® Cosmetic and whether it's right for you. There are risks with this product—the effects of BOTOX® Cosmetic may spread hours to weeks after injection causing serious symptoms. Alert your doctor right away as difficulty swallowing, speaking, breathing, eye problems or muscle weakness can be a sign of a life-threatening condition. If this happens, do not drive a car, operate machinery, or do other dangerous activities. Patients with these conditions before injection are at the highest risk. Swallowing problems may last for several months. Side effects may include allergic reactions, neck and injection-site pain, fatigue and headache. Allergic reactions can include rash, welts, asthma symptoms, and dizziness. Don't receive BOTOX® Cosmetic if there's a skin infection. Tell your doctor your medical history, muscle or nerve conditions (including ALS/Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome), and medications, including botulinum toxins, as these may increase the risk of serious side effects. Please see BOTOX® Cosmetic Full Product Information including Boxed Warning and Medication Guide. Globally, prescribing information varies; refer to the individual country product label for complete information. JUVÉDERM® VOLUMA® XC Important Information INDICATIONS JUVÉDERM® VOLUMA® XC injectable gel is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face, for augmentation of the chin region to improve the chin profile, and for supraperiosteal injection to augment the temple region to improve temple hollowing in adults over the age of 21. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: Not for patients with a history of anaphylaxis, presence of multiple severe allergies, or allergies to Gram-positive bacterial proteins or lidocaine in these products. WARNINGS: Do not inject into blood vessels. Introduction of this product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Rare but serious adverse events associated with the intravascular injection of dermal fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Treatment should be deferred where there is active infection or inflammatory process at the injection site. PRECAUTIONS: This product should only be used by healthcare professionals who are knowledgeable about the anatomy and the product for use in indicated areas, and who have appropriate training in facial anatomy, vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complications. The safety for use during pregnancy, breastfeeding, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been established. Dermal filler implantation carries a risk of infection. Use in patients who are taking products that prolong bleeding may increase bruising/bleeding at the injection site. Use with caution in patients on immunosuppressive therapy. Patients may experience late-onset adverse events with injectable gel implants. ADVERSE EVENTS: The most common reported side effects were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. The majority were mild or moderate in severity. To report an adverse reaction, please call Allergan® Product Support at 1-877-345-5372. Please visit rxabbvie.com for more information. The products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner. SkinMedica® Most SkinMedica® products are intended to meet the FDA's definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA and the statements have not been evaluated by the FDA. 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, and eye care – in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. About Allergan Aesthetics At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit . 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 and uses of future or conditional verbs, 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 expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. 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 2023 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, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References AbbVie. (2023, September 18). Allergan Aesthetics Announces Positive Topline Results from Second Phase 3 Study of OnabotulinumtoxinA (BOTOX® Cosmetic) for the Treatment of Platysma Prominence [Press release]. JUVÉDERM® VOLUMA® XC Patient Labeling for Temple. 2024. RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2023. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. Available at: . Accessed March 24, 2023. A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults with Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE). ClinicalTrials.gov. Available at: . Accessed March 24, 2023. 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. Available at: . Accessed March 24, 2023. 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. Available at: . Accessed March 24, 2023. 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. Available at: . Accessed March 24, 2023. Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema) (Measure Up 1). ClinicalTrials.gov. Available at: . Accessed February 22, 2024 A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2). ClinicalTrials.gov. Available at: . Accessed February 22, 2024 A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (AD Up). ClinicalTrials.gov. Available at: . Accessed February 22, 2024. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants with Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. Available at: . Accessed March 30, 2023. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants with Takaysu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. Available at: . Accessed March 30, 2023. Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus (SELECT-SLE). ClinicalTrials.gov. Available at: . Accessed February 19, 2024. A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy (Step-Up HS). ClinicalTrials.gov. Available at: . Accessed February 19, 2024 A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo (Viti-Up). ClinicalTrials.gov. Available at: . Accessed February 19, 2024. A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata (Up-AA). ClinicalTrials.gov. Available at: . Accessed February 19, 2024. Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011. Nov 43(7):503-11. A Study on the long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis. ClinicalTrials.gov. 2021. Available at: . Accessed on February 17, 2023. A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov. 2021. Available at: . Accessed on March 8, 2022. A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis. ClinicalTrials.gov. 2021. Available at: . Accessed on March 8, 2022. A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis. Available at: . Accessed on March 8, 2022. BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. Available at: . Accessed on March 8, 2022. BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. Available at: . Accessed on March 8, 2022. SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie Inc. VanderZee et al British Journal of Dermatology (2011) 164, p1292–98; Kanni et al (2015) PLoS ONE 10(6): e0130522. Company Codes: NYSE:ABBV

Revenue in 2023 reached € 5.25 billion (-5%; -6% CER1), net sales were € 4.87 billion (-5%; -6% CER1) – in-line with financial guidance Strong performance by newly launched growth drivers (net sales growth at Act rates): EVENITY® +140%, FINTEPLA® +94%, BIMZELX® +323%. RYSTIGGO® with € 19 million since July, ZILBRYSQ® launched globally since Q1 2024 Underlying profitability (adj. EBITDA2) was € 1.35 billion (+7%; -1% CER1), 25.7% of revenue – better than the guidance due to higher EVENITY® contribution and good cost management U.S. FDA accepted the filings of BIMZELX® for psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS). The application for hidradenitis suppurativa (HS) has also been submitted to FDA. FDA action and potential approvals expected for all indications before the end of 2024 Financial guidance for 2024: Revenue expected to grow to € 5.5-5.7 billion, adjusted EBITDA2 23.0-24.5% of revenue, Core EPS3 of € 3.70-4.40 BRUSSELS, Feb. 28, 2024 /PRNewswire/ -- UCB Full-Year Report 2023 – regulated information "Our 2023 performance showcases our unwavering commitment to ensuring people with severe diseases can live the life they like, as free as possible from challenges of disease, reaching more than 3.2 million patients globally with severe immunological and neurological conditions. In the last 14 months we obtained 14 approvals, across 6 patient populations and across 3 continents, fuelling our growth for a decade plus. As an example, superior patient experience and UCB's dedication have allowed to double the number of patients using BIMZELX ® in Europe over six months," Jean-Christophe Tellier, CEO UCB commented. "For future growth, we are studying innovative, potential medicines for 10 patient populations in 12 clinical development programs with expected news flow in 2024. What guides us is our belief that everyone deserves to live the best life that they can. We are therefore pleased with the growing access to our medicines across geographies, and we continue to decrease our greenhouse gas emissions in line with our commitment to reach net zero emissions." FY 2023 revenue reached € 5.25 billion (-5%; -6% CER1). Net sales reached € 4.87 billion (-5%; -6% CER1), based on the stable performance of CIMZIA® and the strong growth of BRIVIACT®, FINTEPLA® and BIMZELX®. As expected, this was more than offset by the contracting effects from the losses of exclusivity of two products. Underlying profitability (adjusted EBITDA2) reached € 1.35 billion (7%; -1% CER1), despite lower revenue due to the losses of exclusivity, higher operating expenses – reflecting the investments into the future growth of UCB, namely into product launches - and compensated by higher operating income. Profit amounted to € 343 million (-18%; -34% CER1). Core EPS3 were € 4.20 after € 4.37 in 2022. The Board of Directors of UCB proposes a dividend of € 1.36 per share (gross), + 3 cents. Sandrine Dufour, CFO UCB says: "A year with good product growth and strong launches - we are pleased to deliver again solid financial results. As expected, we're seeing the impacts from the losses of exclusivity for two products diminishing in the second half and thanks to the strong revenue performance of our growth assets, we returned to growth in the second half with almost +3%. Continued smart resource allocation and a strong contribution from EVENITY® enabled us to invest in the product launches. In 2024, we will accelerate our investments launching three products around the globe, including a direct to consumer (DTC) campaign in the U.S. for BIMZELX®, previously slated for 2023. We are on our way to deliver growth for a decade plus. Our financial guidance for 2024 foresees a growing top line and an almost stable adjusted EBITDA margin. Our commitment for 2025 for growing the top line to at least € 6 billion and an improved margin stands." Regulatory and Clinical Pipeline Update UCB continuously innovates and strives to find new ways to deliver solutions to people living with severe immunological and neurological diseases, leading in 2023 to a clinical development pipeline with 12 clinical programs ongoing spanning 10 different medicines, set to help 10 different patient populations. Since January 2023 and in the key regions U.S., EU and Japan, UCB obtained 14 approvals across six patient populations. 8 regulatory reviews are ongoing. Below the details since the Half-Year Report 2023: Regulatory Update In June 2023, E KEPPRA® (levetiracetam) was approved in Japan for the treatment of partial-onset epileptic seizures in young patients (1m-<4years of age). In July 2023, the European Medicines Agency (EMA) has accepted for review the marketing authorization application of bimekizumab for the treatment of adults with moderate to severe hidradenitis suppurativa (HS), a chronic, recurrent, and debilitating skin condition with high unmet medical need. In July 2023, UCB submitted the marketing authorization application for the epilepsy medicine BRIVIACT® (brivaracetam) to PMDA in Japan. This application is for the treatment of partial onset seizures (POS) with or without secondary generalization in adult patients (≥16 years of age) with monotherapy and adjunctive therapy. In September 2023, UCB announced the approval of RYSTIGGO® (rozanolixizumab) and ZILBRYSQ® (zilucoplan) for the treatment of adult patients with generalized myasthenia gravis (gMG) in Japan, where RYSTIGGO® is indicated for patients inadequately responding to corticosteroids or non-corticosteroid immunosuppressants and ZILBRYSQ® is indicated for patients who inadequately respond to steroids or other immunosuppressants. In February 2023, PMDA in Japan accepted for review the filing of rozanolixizumab in a priority review. In October 2023, UCB announced U.S. FDA approval of ZILBRYSQ® (zilucoplan) for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody-positive (anti-AChRAb+). ZILBRYSQ® is the first once-daily subcutaneous, targeted C5 complement inhibitor for gMG. It is the only once-daily gMG-targeted therapy for self-administration. In October 2023, the U.S. FDA approved BIMZELX® (bimekizumab-bkzx), the first and only IL-17A and IL-17F inhibitor, for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In November 2023, UCB filed bimekizumab for the treatment of hidradenitis suppurativa (HS), a chronic, painful, and debilitating skin condition, with PMDA in Japan. In December 2023, ZILBRYSQ® (zilucoplan) was approved in the European Union for the treatment of adults with gMG who are anti-AChRAb+. In September 2023, UCB received CHMP positive opinion for zilucoplan for the treatment of adults with gMG in Europe. In December 2023, BIMZELX® was approved in Japan for the treatment of adult patients with active psoriatic arthritis (PsA), adult patients with active ankylosing spondylitis (AS) and adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA). In January 2023, PMDA in Japan had accepted for review the filing for BIMZELX® in these indications. In early January 2024, RYSTIGGO® (rozanolixizumab) was approved in the European Union for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. In November 2023, UCB received the CHMP positive opinion for rozanolixizumab for treatment of adults with generalized myasthenia gravis in Europe. In February 2024, UCB announced that the U.S. FDA accepted the supplemental biologics license applications (sBLA) seeking approval of BIMZELX® (bimekizumab-bkzx) for three new spondyloarthritides indications: psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS). The fourth sBLA for hidradenitis suppurativa (HS) has also been submitted to FDA. UCB expects FDA action and potential approvals for all indications before the end of 2024. Pipeline Update In November 2023, first patients were included in a phase 2a study with UCB0022. UCB0022 is designed to enhance the potency of endogenous dopamine 'when and where needed'. UCB0022 is an orally available, brain-penetrant, small molecule acting as a Dopamine-1 receptor positive allosteric modulator. UCB0022 could bring, as symptomatic treatment, significant positive impact on the quality of life of people who are suffering from Parkinson's symptoms despite an adequately dosed treatment without bothersome side effects that can result from Dopamine-receptor overstimulation. First results are expected in H1 in 2025. During H2 2023, UCB9741 and UCB1381 progressed successfully and moved into Phase 2a status with first headline results expected in H2 2024. Atopic Dermatitis (AtD) is a common inflammatory skin disorder with higher prevalence rates among children. Despite evolving standard of care, unmet needs for moderate to severe AtD patients persist. Multiple pathways are believed to be the driver of pathobiology in AtD, as such UCB is developing two anti-bodies targeting distinct pathways. All other clinical studies are continuing as planned, with headline results expected for 11 programs in 2024. Net sales break-down by key products Due to rounding, some financial data may not add up in the tables. CIMZIA® (certolizumab pegol) reached more than 180 000 people living with inflammatory TNF-mediated diseases. CIMZIA® is showing a stronger growth than the anti-TNF market – based on differentiation. CIMZIA® is offering treatment for women of childbearing age across 6 indications and for rheumatoid arthritis patients with high rheum factor levels. In Europe as well as in international markets growth trend continues. Volume growth in the U.S. remains robust with 5% plus. Also in Japan, volume growth was positive but over-compensated by the regular mandatory price cut. VIMPAT® (lacosamide) was accessed by over 500 000 people living with epilepsy and is experiencing generic competition since March 2022 in the U.S. and since September 2022 in Europe due to loss of exclusivity. In Japan, the net sales show continued growth. KEPPRA® (levetiracetam) reached over 1.7 million people living with epilepsy. Net sales went down due to continued generic erosion in Japan since 2022. In all other markets, KEPPRA® is off patent for more than a decade. BRIVIACT® (brivaracetam), was used by 190 000 people living with epilepsy and showed significant growth in all regions it is available to patients. BRIVIACT® is currently under regulatory review in Japan. BRIVIACT® has a different mode of action from Vimpat® and differentiates from KEPPRA®. FINTEPLA® (fenfluramine) reached more than 3 000 patients and their families living with seizures associated with rare epileptic syndromes - Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS). Partner Nippon Shinyaku in Japan books the in-market sales. FINTEPLA® was added to the UCB portfolio in March 2022. Following a settlement in a patent dispute in late 2023, UCB is now considering Q4 2033 as a later loss of exclusivity in the U.S. BIMZELX® (bimekizumab) is available to people living with psoriasis in more than 40 countries, including the U.S. since mid-November 2023. Additionally, it is available to people living with active psoriatic arthritis (PsA), with active ankylosing spondylitis (AS) and active non-radiographic axial spondyloarthritis (nr-axSpA) in Europe since May 2023 and in Japan since December 2023. More than 18 000 patients had access to the product. NAYZILAM® (midazolam) Nasal SprayCIV, a nasal rescue treatment for epilepsy seizure clusters in the U.S. reached over 70 000 patients and net sales of € 94 million, a plus by 21% (24% CER) EVENITY® (romosozumab) since launch globally reached more than 600 000 women living with postmenopausal osteoporosis at high risk of fracture. Net sales in Europe increased to € 60 million after € 25 million in 2022. EVENITY® is being launched successfully globally by Amgen, Astellas and UCB since 2019, with net sales outside Europe reported by the partners. EVENITY® showed strong growth annualizing worldwide sales of more than US$ 1 billion. The worldwide profit contribution from EVENITY® is recognized under 'Other operating income'. RYSTIGGO® (rozanolixizumab-noli), a new treatment option for people living with generalized myasthenia gravis (gMG) was launched in the U.S. in July 2023. In 2023, net sales amounted to € 19 million. At the end of 2023, RYSTIGGO® was launched in Japan and the launches throughout Europe are starting in Q1 2024. "The statutory auditor has issued an unqualified report with no emphasis of matter paragraph dated 27 February 2024 on the company's consolidated accounts as of and for the year ended 31 December 2023, and has confirmed that the accounting data reported in the accompanying press release is consistent, in all material respects, with the accounts from which it has been derived." Revenue in 2023 reached € 5 252 million (-5%; -6% CER1) and net sales were € 4 867 million (-5%; -6% CER1). This was driven by the continued growth of UCB's product portfolio – namely BRIVIACT®, NAYZILAM® and FINTEPLA® showed double digit growth. CIMZIA® is the largest drug in the portfolio, showing stable performance and an increase at constant rates. EVENITY® as well as newly launched BIMZELX® more than doubled net sales. This performance was over-compensated by the known effects of the loss of exclusivity for VIMPAT® in the U.S. and Europe and E KEPPRA® in Japan. Royalty income and fees were € 77 million (-9%; -7% CER1) and other revenue went up by 5% (6% CER1) to € 308 million due to continued partnership activities, milestones and other payments from R&D partners and include a one-time amount of € 70 million from a milestone. Adjusted Gross profit (Gross Profit before "amortization of intangible assets linked to sales") was € 4 033 million (-5%; -6% CER1) and well in-line with the net sales performance. The adjusted gross margin remained stable at 76.8% as in 2022. Gross profit after "amortization of intangible assets linked to sales" reached € 3 545 million – a gross margin of 67.5% after 69.7% in 2022 and reflecting the addition of FINTEPLA® amortization. This amortization has been revised in late 2023 following a settlement in a patent dispute in the U.S. UCB is now considering Q4 2033 as the loss of exclusivity in the U.S. Operating expenses declined to € 2 888 million (-9%; -7% CER1) reflecting higher marketing and selling expenses, lower research and development expenses, slightly higher general and administration expenses and an "other operating income" which more than doubled. Total operating expenses are consisting of: 7% higher marketing and selling expenses of € 1 594 million (+10% CER1) – focused reallocation and cost discipline allowed to invest behind the launches and pre-launch activities for UCB's growth drivers: Global FINTEPLA® launch activities in two indications, global BIMZELX® launch activities in up to four indications, global launch activities for RYSTIGGO® and ZILBRYSQ®. 2% lower research and development expenses of € 1 630 million (-1% CER1) reflect the continued investments in UCB's progressing R&D pipeline today encompassing 10 potential new treatment options in clinical studies for patients living with severe diseases in 5 phase 3 trials and 7 proof-of-concept (phase 2a) trials as well as ongoing earlier research activities. The R&D ratio reached 31% in 2023 after 30% in 2022 due to lower revenue. 2% higher general and administrative expenses of € 230 million (+3% CER) Other operating income went up to € 566 million following € 216 million in 2022 – driven by the net contribution of € 368 million (+53%) from EVENITY®. Other 'other operating income' was from the sale of a portfolio of established brands in Europe (€ 145 million), in early 2023. Underlying operational profitability – adjusted EBITDA2 – increased by 7% to € 1 349 million (-1% CER1) due to efficient performance and cost management: lower revenue due to generic erosion, high operating expenses - reflecting the investments into the future growth of UCB, namely into product launches - and compensated by high operating income. The adjusted EBITDA ratio for 2023 (in % of revenue) reached 25.7%, after 22.8% in 2022. Total impairment, restructuring and other expenses decreased to € 53 million, after € 90 million in 2022. In 2022, this was mainly driven by fees and restructuring expenses related to the acquisition of Zogenix in March 2022. Net financial expenses went up to € 163 million from € 74 million, based on higher interest rates as well as higher interest cost due to higher net debt in connection with the acquisition of Zogenix in March 2022. Also, positive currency income in 2022 did not reoccur in 2023. Income tax expenses were € 98 million compared to € 91 million in 2022. The average effective tax rate was 22% compared to 18% in 2022, reflecting the lower earnings and the earnings mix. Profit amounted to € 343 million (-18%; -34% CER1). Core earnings per share, adjusted for the after-tax impact of to be adjusted items, the financial one-offs, the after-tax contribution from discontinued operations and the net amortization of intangibles linked to sales, reached € 4.20 after € 4.37 in 2022, based on stable 190 million weighted average shares outstanding. Dividend - The Board of Directors of UCB proposes a dividend of €1.36 per share (gross), +2%. Financial Guidance 2024 - The year 2024 will be marked by intense ongoing global launches of the UCB growth drivers, BIMZELX®, RYSTIGGO®, ZILBRYSQ® and FINTEPLA® as well as EVENITY®. For 2024, UCB is aiming for an increase of revenues to the range of € 5.5 - € 5.7 billion taking into account the launches and the continued solid contributions from the existing product portfolio. UCB will accelerate investments in launches around the globe to offer potential new solutions for people living with severe diseases and remains committed to invest into research and development advancing its late-stage and early development pipeline. At the same time, UCB will continue to be cost disciplined and, as in 2023, to actively manage the tail of its portfolio. Underlying profitability, adjusted EBITDA, is expected in the range of 23.0% - 24.5% of revenue. Core earnings per share are therefore expected in the range of € 3.70 - 4.40 per share – based on an average of 190 million shares outstanding. The figures for the financial guidance 2024 as mentioned above are calculated on the same basis as the actual figures for 2023. Guidance for 2025: UCB confirms its growth ambition for 2025 based on the strong product portfolio and the strong growth drivers. Revenue in 2025 is expected to reach at least € 6 billion and the underlying profitability (adjusted EBITDA) at the low end of the range of low to mid-thirties in percent of revenue. Find the financial reports on UCB website: Today, UCB will host a conference call/video webcast at 08.00 (EST) / 13.00 (GMT) / 14.00 (CET) Register here: For further information, contact UCB: Check out our IR App on the App Store and Google Play About UCB UCB, Brussels, Belgium ( ) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9 000 people in approximately 40 countries, the company generated revenue of € 5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news Forward looking statements This press release contains forward-looking statements, including, without limitation, statements containing the words "potential", "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guaranteeing future performance and are subject to known and unknown risks, uncertainties, and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include but are not limited to: global spread and impacts of wars and pandemics, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring and retention of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB's efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems. Given these uncertainties, you are cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are made only as of the date of this press release, and do not reflect any potential impacts from the evolving conflicts, wars, pandemics, as well as any other adversity, unless indicated otherwise. The company continues to follow the development diligently to assess the financial significance of these events, as the case may be, to UCB. UCB expressly disclaims any obligation or duty to update any forward-looking statements in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. View original content to download multimedia: SOURCE UCB Company Codes: EuronextBrussels:UCB, OTC-PINK:UCBJY

– A total of 17 accepted abstracts, including nine oral presentations and eight posters, reinforce AbbVie's commitment to produce a portfolio of products that aim to improve the lives of patients living with inflammatory bowel diseases (IBD) – Oral data presentations include a new post-hoc analysis of clinical and endoscopic outcomes from the SEQUENCE trial comparing risankizumab (SKYRIZI®) versus ustekinumab, results from the COMMAND Phase 3 study of risankizumab as a maintenance therapy in adult patients with moderately to severely active ulcerative colitis (UC), and long-term safety results from the U-ENDURE trial of upadacitinib (RINVOQ®) in adult patients with moderately to severely active Crohn's disease (CD) – Research accepted for presentation reiterates AbbVie's commitment to understanding the needs of the gastroenterology community and advance standards of care in IBD NORTH CHICAGO, Ill., Feb. 19, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced that 17 AbbVie-sponsored abstracts, including new data from its inflammatory bowel disease (IBD) portfolio, have been accepted for presentation at the 19th Congress of European Crohn's and Colitis Organisation (ECCO) taking place in Stockholm, Sweden from February 21-24. Among the accepted research are nine oral presentations and eight posters. The research spans risankizumab (SKYRIZI®) and upadacitinib (RINVOQ®) in both Crohn's disease (CD) and ulcerative colitis (UC). "Despite continued advancements, many patients are still suffering from the debilitating effects of living with IBD," said Sofie Berg, Pharm.D, Ph.D., therapeutic area head, international immunology, International Medical Affairs, AbbVie. "Our collection of data at this year's congress is indicative of our relentless quest to advance the standards of care in IBD by including endoscopic outcomes, such as mucosal healing, as key trial endpoints." Key data presentations include: Several post-hoc analyses of data from the SEQUENCE trial comparing risankizumab versus ustekinumab in CD OP36: Risankizumab versus ustekinumab for the achievement of clinical outcomes and symptom improvement in patients with moderate to severe Crohn's disease: Results from the Phase 3b SEQUENCE trial (24 February 2024; 10:00-10:10 CET) DOP18: Risankizumab versus ustekinumab for the achievement of endoscopic outcomes in patients with moderate-to-severe Crohn's disease: Results from the Phase 3b SEQUENCE trial (22 February 2024; 18:33-18:39 CET) DOP64: Steroid-sparing effect of risankizumab versus ustekinumab in patients with moderately to severely active Crohn's disease: Post-hoc results from the Phase 3b SEQUENCE trial (23 February 2024; 17:40-17:46 CET) DOP10: Efficacy of risankizumab versus ustekinumab by baseline Crohn's disease location: Post-hoc analysis of the SEQUENCE head-to-head trial (22 February 2024; 17:45-17:51 CET) The primary safety and efficacy maintenance results from the COMMAND Phase 3 study of risankizumab in adult patients with UC OP06: Risankizumab maintenance therapy in patients with moderately to severely active ulcerative colitis: Efficacy and safety in the randomised Phase 3 COMMAND study (22 February 2024; 15:30-15:40 CET) Post-hoc analyses of the risankizumab Phase 2b/3 trials in patients with UC P683: Economic impact of achieving mucosal healing on ulcerative colitis-related hospitalisations and work productivity in patients with moderately to severely active ulcerative colitis: A post-hoc analysis of risankizumab Phase 2b/3 trials (23 February 2024; 12:40-13:40 CET) P593: Efficacy of risankizumab in patients with moderately to severely active ulcerative colitis by prior advanced therapy failure and mechanism of action: Post-hoc analysis of the INSPIRE and COMMAND Phase 3 studies (23 February 2024; 12:40-13:40 CET) Long-term efficacy and safety data from Phase 3 maintenance studies across the gastroenterology portfolio for CD OP10: Efficacy and safety of upadacitinib in patients with moderately to severely active Crohn's disease: Results from the U-ENDURE long-term extension (23 February 2024; 9:00-9:10 CET) DOP53: Long-term efficacy and safety of risankizumab in patients with moderate to severe Crohn's disease up to 3 years of treatment: Results from the FORTIFY open-label long-term extension (23 February 2024; 18:22-18:28 CET) Retreatment with upadacitinib in patients with UC P1008: Efficacy and safety of retreatment with upadacitinib after treatment interruption in ulcerative colitis: Data from the Phase 3 long-term extension study U-ACTIVATE (23 February 2024; 12:40-13:40 CET) The full scientific program for ECCO 2024 is available here. "Research in IBD has resulted in new efficacious treatment options over the past couple of years. However, we are still seeing patients with uncontrolled disease," said Remo Panaccione, M.D., professor of medicine and director of the IBD unit, University of Calgary. "It is critically important that as the treatment paradigm shifts, the gastroenterology community shifts with it. Emerging data from studies in CD and UC from the AbbVie portfolio provide insight on what may be possible, as we work with our patients to set more ambitious treatment goals to help reduce the burden of disease." Risankizumab is not approved for the treatment of ulcerative colitis. SKYRIZI® (risankizumab) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally. About Inflammatory Bowel Disease (IBD) Inflammatory bowel disease (IBD) is a group of diseases characterized by chronic inflammation of the gastrointestinal (GI) tract. Crohn's disease (CD) and ulcerative colitis (UC) are the most common forms of IBD. In both CD and UC, the immune system causes inflammation and damage to the mucosa – or lining – of the gut.1-3 Specifically, CD manifests as inflammation within the GI tract, most commonly in the area between the small intestine (ileum) and the colon, causing persistent diarrhea and abdominal pain.1,4 UC is a chronic, idiopathic, immune-mediated IBD of the large intestine that causes continuous mucosal inflammation extending, to a variable extent, from the rectum to the more proximal colon.3,5 The hallmark signs and symptoms of UC include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence.3,5 CD and UC are progressive diseases, meaning they get worse over time and may lead to life-threatening complications or surgery.6,7 Because the signs and symptoms of CD and UC are unpredictable, they cause a significant burden on people living with the disease—not only physically, but also emotionally and economically.7,8 About Risankizumab (SKYRIZI®) 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.9-12 SKYRIZI is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis and Crohn's disease.9,10 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 and JAK-2 relative to JAK-3, and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.13-14 Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis, Takayasu arteritis, and systemic juvenile idiopathic arthritis are ongoing.12 U.S. Indications and Important Safety Information about SKYRIZI® (risankizumab-rzaa)9 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). active psoriatic arthritis (PsA). moderate to severe Crohn's disease. 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: Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction: – fainting, dizziness, feeling lightheaded (low blood pressure) – swelling of your face, eyelids, lips, mouth, tongue, or throat – trouble breathing or throat tightness – chest tightness – skin rash, hives – itching 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. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: – fever, sweats, or chills – cough – shortness of breath – blood in your mucus (phlegm) – muscle aches – warm, red, or painful skin or sores on your body different from your psoriasis – weight loss – diarrhea or stomach pain – burning when you urinate or urinating more often than normal 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: 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). Medicines 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. become pregnant while taking SKYRIZI. You are encouraged to enroll in the Pregnancy Registry, which is used to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry. 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. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit 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. This is not a complete summary of all safety information. 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. U.S. Indications and Important Safety Information about RINVOQ (upadacitinib) 13 USES RINVOQ is a prescription medicine used to treat: Adults with moderate to severe rheumatoid arthritis (RA) when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated. Adults with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with active ankylosing spondylitis (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used, and did not work well or could not be tolerated. Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with moderate to severe Crohn's disease (CD) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children with juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn's disease. Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended. 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: Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while 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 healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster). Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor. Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP's advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen. Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker. Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor. Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away. Tears in the stomach or intestines. This happens most often in people who take nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. Get medical help right away if you get stomach-area pain, fever, chills, nausea, or vomiting. Changes in certain laboratory tests. 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. 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: 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. Are a current or past smoker. Have had a heart attack, other heart problems, or stroke. Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), 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 red or white blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system. Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of 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 findings in 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 during treatment with RINVOQ and for 4 weeks after your last dose. There is a pregnancy surveillance program for RINVOQ. The purpose of the program is to collect information about the health of you and your baby. If you become pregnant while taking RINVOQ, you are encouraged to report the pregnancy by calling 1-800-633-9110. Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 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 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? 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. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including: Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw Pain or discomfort in your arms, back, neck, jaw, or stomach Shortness of breath with or without chest discomfort Breaking out in a cold sweat Nausea or vomiting Feeling lightheaded Weakness in one part or on one side of your body Slurred speech Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including: Swelling Pain or tenderness in one or both legs Sudden unexplained chest or upper back pain Shortness of breath or difficulty breathing Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits. 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, leukopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, increased liver enzyme levels, pneumonia, low number of red blood cells (anemia), and infection of the stomach and intestine (gastroenteritis). 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. Some people taking RINVOQ may see medicine residue (a whole tablet or tablet pieces) in their stool. If this happens, call your healthcare provider. 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 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. This is not a complete summary of all safety information. 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 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 . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. 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 and uses of future or conditional verbs, 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 expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. 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 2022 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, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References: Crohn's & Colitis Foundation. The facts about inflammatory bowel diseases. Crohn's & Colitis Foundation. Published November 2014. Accessed August 13, 2021. Crohn's & Colitis Foundation. Overview of Crohn's disease. Crohn's & Colitis Foundation. Accessed June 16, 2021. National Institute of Diabetes and Digestive and Kidney Diseases. Ulcerative colitis. National Institute of Diabetes and Digestive and Kidney Diseases. Accessed August 13, 2021. Mayo Clinic. Crohn's disease - Symptoms and causes. Mayo Clinic. Accessed June 16, 2021. Monstad, I., et al. Clinical course and prognosis in ulcerative colitis: results from population-based and observational studies. Ann Gastroenterol. 2014; 27(2): 95–104. Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016 Mar;22(3 Suppl):s51-60. Kaplan, G. The global burden of IBD: from 2015 to 2025. Nat Rev Gastroenterol Hepatol. 2015 Dec;12(12):720-7. doi: 10.1038/nrgastro.2015.150. Gajendran M., et al. A comprehensive review and update on ulcerative colitis. Dis Mon. 2019 Dec;65(12):100851. doi: 10.1016/j.disamonth.2019.02.004. Epub 2019 Mar 2. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.; 2024. SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: . Accessed on January 11, 2024. Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011. Nov 43(7):503-11. Pipeline – Our Science | AbbVie. AbbVie. 2023. Available at: . Accessed on January 11, 2024. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.; 2023. RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co KG. Available at: . A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2021. Available at: . Accessed on January 11, 2024. SOURCE AbbVie