Rifampin

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) will present findings from 29 abstracts, including late-breaking presentations at the European Association for the Study of the Liver (EASL) Congress, May 27-30, 2026, Barcelona. These presentations advance understanding of primary biliary cholangitis (PBC) and viral hepatitis. New data on primary biliary cholangitis (PBC) and viral hepatitis will be presented by Gilead at the European Association for the Study of the Liver (#EASL2026) Congress In PBC, Gilead will present randomized and long-term study data for Livdelzi® (seladelpar), known as Lyvdelzi® in the European Union. Analyses from the Phase 3 RESPONSE trial ( NCT04620733 ) will evaluate efficacy and safety in participants with risk factors for disease progress, including elevated liver stiffness and metabolic syndrome. Interim data from the Phase 3 ASSURE study ( NCT03301506 ) will assess the relationship between biochemical response and liver stiffness trends over 36 months, including outcomes in individuals with alkaline phosphatase (ALP) levels between 1 to 1.67x the upper limit of normal (ULN). Together these data provide a multidimensional view of Livdelzi’s efficacy, safety and durability across a broad PBC population. Livdelzi is a first‑in‑class delpar (selective PPAR‑delta agonist) indicated for the treatment of PBC to be used in combination with ursodeoxycholic acid (UDCA) for those with an inadequate response to UDCA, or as monotherapy for patients unable to tolerate UDCA. “Primary biliary cholangitis is a chronic, progressive disease where reducing disease activity is critical to improving long‑term outcomes. Minimizing impact on quality of life is also key for people living with PBC,” said Swati Tole, MD, MS, Senior Vice President, Clinical Development, Inflammation at Gilead Sciences. “At EASL, we are sharing data that further define Livdelzi’s potential to address both disease activity and symptoms such as pruritus.” Advancements in Hepatitis Delta Virus Presentations will also focus on hepatitis delta virus (HDV), a severe co‑infection in people with chronic hepatitis B. The program will include several analyses evaluating investigational bulevirtide, a first‑in‑class entry inhibitor, in diverse HDV patient populations, reflecting continued efforts to better understand HDV disease management and treatment approaches. “People living with HDV face a severe disease with limited treatment options. These analyses highlight the breadth of ongoing research and Gilead’s continued leadership in advancing the understanding of HDV, including efforts to evaluate Hepcludex across diverse patient populations,” said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development, Virology at Gilead Sciences. “We remain committed to continuously building on emerging evidence to help improve how this disease is managed over time, and we encourage clinicians to engage with evolving data to help inform care for people living with HDV.” Analyses from Phase 2 and Phase 3 studies, including MYR301 (NCT03852719) and MYR204 (NCT03852433) will evaluate clinical, virologic, and biochemical outcomes, as well as safety and tolerability, through 96 weeks across HDV subgroups. An additional study uses a machine‑learning model to identify risk factors for progression to advanced liver disease in adults with HDV infection in the United States. Advancing Equitable Care for Hepatitis B and C Additional presentations highlight progress across viral hepatitis, including HBV cure research, long‑term disease management, and HCV elimination efforts. In hepatitis B, Gilead will present data from its cure research program, including studies of GS‑2829 and GS‑6779, evaluating HBeAg loss and immune biomarkers. In hepatitis C, presentations highlight real‑world elimination efforts and patient‑centered outcomes. Key Abstracts at EASL 2026: ID Abstract Title PBC Clinical Data LBP-037 Seladelpar leads to decreases in serum proteins associated with PBC disease severity: proteomic analysis from the pivotal RESPONSE trial SAT-316 Efficacy and safety of seladelpar in patients with primary biliary cholangitis and alkaline phosphatase levels between 1 and 1.67 × upper limit of normal: interim results from the open-label ASSURE study THU-270 Biochemical response is associated with liver stiffness stability in patients with primary biliary cholangitis treated with seladelpar for up to 36 months: interim results from the open-label ASSURE study SAT-363 Efficacy and safety of seladelpar in patients with primary biliary cholangitis and risk factors for progression including younger age at diagnosis or higher liver stiffness in the pivotal RESPONSE study SAT-362 Efficacy and safety of seladelpar vs placebo in patients with primary biliary cholangitis and metabolic syndrome in the pivotal phase 3 RESPONSE study RWE SAT-306 Demographic and clinical characteristics of United States real-world patients with primary biliary cholangitis and alkaline phosphatase between 1 and 1.67 vs >1.67 × upper limit of normal despite ursodeoxycholic acid treatment HEOR SAT-387 Meaningful within-patient change on the 5-D itch scale in patients with primary biliary cholangitis experiencing pruritus HDV Clinical Data FRI-587 Bulevirtide monotherapy is safe and well tolerated in chronic hepatitis delta: An integrated safety analysis of bulevirtide clinical trials at week 96 WED-593 Integrated efficacy analysis of bulevirtide 10 mg from studies MYR204 and MYR301 at weeks 48 and 96 across subgroups WED-576 Safety of bulevirtide 10 mg is consistent across demographic and clinical subgroups: Results from an integrated analysis RWE FRI-031 Predictors of advanced liver disease events among individuals with hepatitis delta virus infection in a large United States administrative claims dataset: a machine learning analysis HEOR FRI-605 Impact of bulevirtide treatment on patient-reported outcomes among patients with hepatitis delta in Europe HCV RWE WED-047 Progress towards hepatitis C virus elimination in English prisons - 7-year outcomes on a multi-stakeholder project HBV Clinical Data FRI-624 Factors associated with lack of alanine aminotransferase normalization in patients with chronic hepatitis B virus after 8 years of tenofovir-based treatment RWE FRI-030 Synergistic effect of diabetes and hypertension on the risk of liver disease progression in hepatitis B virus infection HBV Cure Clinical Data WED-580 Baseline and on-treatment characteristics of HBeAg-positive patients and correlates of HBeAg loss following GS-2829 and GS-6779 therapeutic vaccination in virally suppressed patients with chronic hepatitis B WED-578 Transcriptomic profiling reveals distinct immune signatures in chronic hepatitis B and identifies blood transcriptional modules associated with hepatitis B e antigen loss For more information, including a complete list of abstract titles being presented at the meeting, please visit the EASL website. Please see below for the U.S. Indications and Important Safety Information for Livdelzi. Marketing Authorizations for Bulevirtide In July 2023, the European Commission granted full Marketing Authorization (MA) for Hepcludex (bulevirtide) 2 mg for the treatment of adults with chronic hepatitis delta virus (HDV) infection and compensated liver disease (conditional approval was received in July 2020). Hepcludex 2 mg also has full marketing authorization in the United Kingdom, Switzerland, Australia, Canada, United Arab Emirates, Israel and Kuwait. Bulevirtide is not approved in the United States. In the U.S. and other regions where it is not authorized, bulevirtide 2 mg is an investigational product, and its safety and efficacy have not been established or approved by the U.S. Food and Drug Administration (FDA) or other health authorities. Bulevirtide 10 mg, GS-2328 and GS-6779 are investigational and not approved anywhere globally. The safety and efficacy of these programs have not been established. U.S. Indication for Livdelzi Livdelzi is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The FDA approved this indication under accelerated approval based on a reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Limitations of Use for Livdelzi: Use of Livdelzi is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy). U.S. Important Safety Information for LIVDELZI Warnings and Precautions Fractures: Fractures occurred in 4% of LIVDELZI-treated patients compared to no placebo-treated patients. Consider the risk of fracture in the care of patients treated with LIVDELZI and monitor bone health according to current standards of care. Liver Test Abnormalities: LIVDELZI has been associated with dose-related increases in serum transaminase (AST and ALT) levels > 3 x ULN in patients receiving 50 mg and 200 mg once daily (5x and 20x higher than the recommended dosage of 10 mg once daily). Perform baseline clinical and laboratory testing when starting LIVDELZI and monitor thereafter according to routine patient management. Interrupt treatment if the liver tests (ALT, AST, total bilirubin, and/or ALP) worsen, or if the patient develops signs and symptoms of clinical hepatitis (eg, jaundice, right upper quadrant pain, eosinophilia). Consider permanent discontinuation if liver tests worsen after restarting LIVDELZI. Biliary Obstruction: Avoid use of LIVDELZI in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt LIVDELZI and treat as clinically indicated. Adverse Reactions The most common adverse reactions (≥5%) with LIVDELZI were headache (8%), abdominal pain (7%), nausea (6%), abdominal distension (6%), and dizziness (5%). Drug Interactions OAT3 Inhibitors and Strong CYP2C9 Inhibitors: Avoid coadministration with LIVDELZI due to increased LIVDELZI exposure. Rifampin: Monitor biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during LIVDELZI treatment. Coadministration may result in delayed or suboptimal biochemical response of LIVDELZI. Dual Moderate CYP2C9 and Moderate-to-Strong CYP3A4 Inhibitors and BCRP Inhibitors (eg, cyclosporine): Monitor closely for adverse effects. Concomitant administration with LIVDELZI may increase LIVDELZI exposure. CYP2C9 Poor Metabolizers Using Moderate-to-Strong CYP3A4 Inhibitors: Monitor more frequently for adverse reactions as concomitant use of a moderate-to-strong CYP3A4 inhibitor in patients who are CYP2C9 poor metabolizers may increase LIVDELZI exposure and risk of LIVDELZI adverse reactions. Bile Acid Sequestrants: Administer LIVDELZI at least 4 hours before or 4 hours after taking a bile acid sequestrant, or at as great an interval as possible. Pregnancy and Lactation Pregnancy: There are insufficient data from human pregnancies exposed to LIVDELZI to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Report pregnancies to Gilead Sciences, Inc., at 1-800-445-3235. Lactation: There are no data on the presence of LIVDELZI in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for LIVDELZI and any potential adverse effects on the breastfed infant from LIVDELZI. About Gilead Sciences in Liver Disease For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. We have helped to transform hepatitis C from a chronic condition into one that can be cured for millions of people. For people living with hepatitis B or D, our focus on advancing our medicines drives hope that today’s research will turn into tomorrow’s cures. Beyond viral hepatitis, we’re working to deliver advanced treatments for people living with PBC. But our commitment doesn’t stop there. Through our ground-breaking science and collaborative partnerships, we strive to create healthier futures for everyone living with liver disease. We are committed to a future without liver disease. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials or studies, including those involving bulevirtide, Livdelzi, GS-2829 and GS-6779 (such as RESPONSE, ASSURE, MYR301 and MYR204); uncertainties relating to regulatory applications and related filing and approval timelines, including additional pending and potential applications for programs and/or indications currently under evaluation, and the risk that any such approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Hepcludex, Livdelzi, Lyvdelzi, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. U.S. full Prescribing Information for Livdelzi is available at www.gilead.com. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).

AbbVie presents 18 abstracts in Crohn's disease and ulcerative colitis Breadth of data from real-world evidence and clinical trials reinforce risankizumab and upadacitinib efficacy, safety profile, and durability NORTH CHICAGO, Ill. , May 5, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the presentation of new data across its gastroenterology portfolio at the 2026 Digestive Disease Week (DDW) Annual Meeting, May 2-5 in Chicago. AbbVie will present 18 abstracts, including real-world evidence and long-term findings for SKYRIZI ® (risankizumab-rzaa) and RINVOQ ® (upadacitinib) in Crohn's disease and ulcerative colitis. "As a leader in gastroenterology, AbbVie remains focused on advancing the understanding of IBD and helping raise the standard of care through scientific innovation and a broad portfolio of marketed and investigational therapies," said Andrew Anisfeld, Ph.D., vice president, global medical affairs, immunology, AbbVie . "Our research presented at DDW adds to the growing body of evidence demonstrating the sustained durability of clinical and endoscopic response, as well as the established safety profile, of risankizumab and upadacitinib for people living with IBD." Real-World Data for Patients on Risankizumab in Crohn's Disease Sustained symptom relief and reduced need for concomitant therapy: A 52-week follow-up of adults with moderately to severely active Crohn's disease treated with risankizumab from the ASPIRE-CD study showed rapid and sustained improvements in abdominal pain, bowel urgency and liquid/soft stools. Among patients with extraintestinal manifestations of arthritis and skin conditions, 25% and 46%, respectively, reported experiencing relief at Week 52. By Week 52, the use of corticosteroids decreased from 34% at baseline to 7%, and over-the-counter therapies had decreased from 72% at baseline to 49%. Improved quality of life: In an analysis of health-related quality of life (HRQL) and treatment satisfaction after initiating risankizumab in patients enrolled in the ASPIRE-CD study, 77% reported improvement in life enjoyment by Week 52. In addition, patients had improved general wellbeing, including improved sexual health and improved work productivity and daily activity levels one year after starting risankizumab. Overall satisfaction with Crohn's disease treatments improved among all patients (from 50% at baseline to nearly 87% at Week 52), particularly patients who were still being treated with risankizumab at Week 52 (92% satisfaction). Low Switch Rate for Risankizumab Among Crohn's Disease Patients Treatment persistence: A real-world study of US claims data analyzed the switch rates over a 24-month period among patients with Crohn's disease initiating a new biologic therapy. It found the switch rate was 14% for risankizumab, compared with 21% for ustekinumab, 30% for vedolizumab, 33% for infliximab, and 36% for adalimumab. This pattern was also seen among biologic-naïve patients. Lower Odds of Hospitalization Observed After Switch to Upadacitinib Biologic dose-escalation vs. switching to upadacitinib in a real-world setting: A retrospective analysis of US claims data found that among patients with Crohn's disease or ulcerative colitis treated with a biologic therapy, patients who were switched to upadacitinib had a 31% lower odds of hospitalization and 26% lower odds of emergency department visits than those who increased average weekly dose of the biologic therapy. Endoscopic Improvements in Difficult-to-Treat Crohn's Disease Treating patients with Perianal Fistulizing Crohn's disease: Among patients with Perianal Fistulizing Crohn's disease (PFCD), in two Phase 3 trials, those who responded to upadacitinib 45 mg were re-randomized to receive maintenance treatment with upadacitinib (15 mg or 30 mg) or placebo for 52 weeks. In this post-hoc analysis, upadacitinib-treated patients showed endoscopic improvements through 52 weeks, regardless of fistula response, as demonstrated by reductions in Simple Endoscopic Score for Crohn's disease (SES-CD). Majority of these patients were without an adequate response to anti-tumor necrosis factor (TNF) therapy. Select AbbVie abstracts are highlighted below, and all the 2026 DDW Annual Meeting posters are available here : Abstract Title Presentation Number Real-World Switching Rates Among Patients with Crohn's Disease Treated with Biologics in the United States Su1657 Improvements in Simple Endoscopic Scores for Crohn's Disease in Upadacitinib-Treated Patients with Perianal Fistulizing Disease: Post Hoc Analysis of the Phase 3 Trials Su1495 Risankizumab Reduces Crohn's Disease-Related Symptoms and Concomitant Therapy Use in Adults with Crohn's Disease: Year 1 Results From the ASPIRE-CD Study Sa1504 Risankizumab Improves Health-Related Quality of Life in Adults with Crohn's Disease: Year 1 Results from the ASPIRE-CD Study Mo1674 Comparative Real-World Outcomes Following Dose Escalation of Current Biologic Therapy Versus Switching to Upadacitinib Among Patients with Crohn's Disease or Ulcerative Colitis: A Propensity Score Matched Analysis Tu1655 About SKYRIZI ® (risankizumab-rzaa) SKYRIZI is an interleukin-23 (IL-23) inhibitor that blocks IL-23 by selectively 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. 1 SKYRIZI is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderately to severely active ulcerative colitis, plaque psoriasis, psoriatic arthritis and Crohn's disease. 1 On April 27, 2026, AbbVie announced submission of an application to the FDA seeking approval of SKYRIZI ® for subcutaneous induction for the treatment of adult patients with moderately to severely active CD. SKYRIZI ® (risankizumab-rzaa) U.S. Uses and Important Safety Information 1 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. moderate to severe Crohn's disease. moderate to severe ulcerative colitis. 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 may happen while being treated for Crohn's disease or ulcerative colitis: 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 at least 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 and ulcerative colitis include: upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, urinary tract infection, and rash. 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 (risankizumab-rzaa) is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector. This is the most important information to know about SKYRIZI. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more. Please click here for the Full Prescribing Information and Medication Guide . 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. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. Upadacitinib is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus and vitiligo. The use of upadacitinib for these diseases is not FDA approved, and its safety and efficacy has not been established for these diseases. RINVOQ ® (upadacitinib) U.S. Uses and Important Safety Information 2 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 giant cell arteritis (GCA) . 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, or after taking a different injection or pill (systemic therapy) when your healthcare provider does not recommend TNF blockers. 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, or after taking a different injection or pill (systemic therapy) when your healthcare provider does not recommend TNF blockers. It is not known if RINVOQ is safe and effective in children with 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. It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis. It is not known if RINVOQ LQ is safe and effective in children with atopic dermatitis. RINVOQ/RINVOQ LQ is a prescription medicine used to treat: Children 2 years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Children 2 to less than 18 years of age 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. It is not known if RINVOQ/RINVOQ LQ is safe and effective in children under 2 years of age with polyarticular juvenile idiopathic arthritis or psoriatic arthritis. IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib) 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 or 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 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 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, swelling of the feet and hands (peripheral edema), 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 HCP. These are not all the possible side effects of RINVOQ. How should I take RINVOQ/RINVOQ LQ? 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. RINVOQ LQ is taken twice a day with or without food. RINVOQ LQ is available in a 1 mg/mL oral solution. RINVOQ LQ is not the same as RINVOQ tablets. Do not switch between RINVOQ LQ and RINVOQ tablets unless the change has been made by your HCP. *Unless otherwise stated, "RINVOQ" in the IMPORTANT SAFETY INFORMATION refers to RINVOQ and RINVOQ LQ. 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/PatientAccessSupport to learn more. Please click here for the Full Prescribing Information and Medication Guide . 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 including immunology, neuroscience and oncology – 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 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, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. 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 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. 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 SKYRIZI [Package Insert]. North Chicago, IL: AbbVie Inc.; 2026. RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2025 Global Media: Giovanna Chandler giovanna.chandler@abbvie.com U.S. Media: Stephanie Tennessen stephanie.tennessen@abbvie.com Investors: Liz Shea liz.shea@abbvie.com View original content: SOURCE AbbVie