Tofacitinib Citrate

Upadacitinib demonstrated superiority versus adalimumab for primary endpoint of achieving low disease activity (DAS28-CRP≤3.2) and ranked secondary endpoint of remission (DAS28-CRP<2.6) at week 121 SELECT-SWITCH is the first Phase 3b/4 head-to-head trial comparing TNF inhibitor cycling with switching to upadacitinib in adults with moderate to severe rheumatoid arthritis and inadequate response or intolerance to a TNF inhibitor1 The safety profile for upadacitinib was consistent with previously reported studies, with no new safety risks identified in the 12-week period1,2 NORTH CHICAGO, Ill., Oct. 20, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from the Phase 3b/4 head-to-head SELECT-SWITCH study evaluating the efficacy and safety of upadacitinib (RINVOQ®) 15 mg, once daily, compared to adalimumab (HUMIRA®) 40 mg, every other week, in adult patients with moderate to severe rheumatoid arthritis (RA) on a stable background of methotrexate (MTX) who had an inadequate response or intolerance to a TNF inhibitor (TNFi) other than adalimumab.1 This study achieved the primary endpoint and the majority of ranked secondary endpoints at week 12 with no new safety risks identified.1 "SELECT-SWITCH is the first head-to-head trial comparing TNF inhibitor cycling with switching to the JAK inhibitor upadacitinib," said lead study investigator Eduardo Mysler, M.D., rheumatologist and executive medical director, Organización Medica de Investigación, Argentina. "Upadacitinib demonstrated superiority in achieving low disease activity and remission at week 12 in nearly twice as many patients compared to adalimumab, providing clinicians with evidence-based guidance for those who need an alternative approach after failure or intolerance of initial TNF inhibitor therapy." A significantly higher proportion of patients who received upadacitinib achieved low disease activity (defined as Disease Activity Score 28 C-reactive Protein [DAS28-CRP]≤3.2; primary endpoint) and remission (defined as DAS28-CRP<2.6; ranked secondary endpoint) compared to adalimumab at week 12. Upadacitinib also demonstrated superiority versus adalimumab for additional ranked secondary endpoints measured at week 12.1 43.3% of patients receiving upadacitinib achieved DAS28-CRP≤3.2 compared to 22.4% of patients on adalimumab (p<0.001) 28.4% of patients receiving upadacitinib achieved DAS28-CRP<2.6 compared to 14.5% of patients on adalimumab (p<0.001) Full results will be published in an upcoming medical journal and shared at future medical congresses. Treatment guidelines establish remission as the optimal treatment goal in RA, yet more than half of patients fail to achieve remission, even on advanced therapies.3-5 As longer disease duration is associated with a reduced likelihood of achieving remission, it is important to optimize treatment strategies as early as possible in the disease course.6 TNFis are the most common first-line targeted therapy in RA, and switching to a second TNFi is highly prevalent in clinical practice, despite limited evidence on the efficacy of TNFi cycling compared to switching to a different mode of action after the first TNFi failure.7-15 "These positive results strengthen the growing body of evidence supporting the benefits of switching to a new mechanism of action after inadequate response or intolerance to a first TNF inhibitor," said Andrew Anisfeld, Ph.D., vice president, global medical affairs, immunology, AbbVie. "The recommended goals for treatment of people with RA are to achieve remission or low disease activity, and this study demonstrated upadacitinib can deliver these outcomes for many patients." The safety profile for upadacitinib and adalimumab in this study were consistent with previously reported studies; with no new safety risks identified in the 12-week period.1,2,16 The most frequently reported treatment emergent AEs (≥ 3%) in any treatment group were urinary tract infection, nasopharyngitis and RA (worsening).1 Rates of serious adverse events were generally balanced across the treatment groups, occurring in 2.4% of patients treated with adalimumab and 2.0% of patients treated with upadacitinib. One malignancy was reported in each group. No adjudicated venous thromboembolism, major adverse cardiovascular event or deaths were observed.1 About Rheumatoid Arthritis Affecting more than 17 million people worldwide, rheumatoid arthritis is a complex, systemic autoimmune disease that occurs when the immune system mistakenly attacks joints, creating inflammation that causes the tissue inside of joints to thicken, damaging the bones and associated connective tissue.17-19 Pain, fatigue and stiffness are among the signs and symptoms of rheumatoid arthritis that can have an impact on daily living.20 If not properly treated, rheumatoid arthritis can lead to permanent, debilitating bone and cartilage damage. About SELECT-SWITCH (M23-700) SELECT-SWITCH is a Phase 3b/4 multicenter, randomized, double-blind, double-dummy, active comparator-controlled study, comparing the efficacy and safety of upadacitinib versus adalimumab in 492 adult patients with moderate to severe rheumatoid arthritis on a stable background of methotrexate (MTX) and who had an inadequate response or intolerance to a single TNF inhibitor (TNFi) other than adalimumab. The study comprises a 35-day screening period, a 12-week randomized, double-blind, double-dummy, active comparator-controlled (Period 1), followed by a 36-week blinded extension period (Period 2). Participants were randomized 1:1 to receive upadacitinib (15 mg once daily orally) + MTX versus adalimumab (40 mg subcutaneously every other week) + MTX. Eligible patients continue to receive the same study treatment in Period 2 as assigned in Period 1, up to 48 weeks. The primary endpoint of the study is the percentage of participants achieving low disease activity, defined as Disease Activity Score 28 C-reactive protein [DAS28-CRP])≤3.2 at the end of Period 1 (Week 12). More information on this trial can be found at . About the SELECT Study Program The robust SELECT Phase 3 rheumatoid arthritis program has evaluated more than 4,900 patients with moderate to severe rheumatoid arthritis in six studies. The studies include assessments of efficacy, safety and tolerability across multiple rheumatoid arthritis patient populations, including in patients with prior non-response to advanced therapies.21-23 Key measures of efficacy evaluated include ACR responses, Disease Activity Score (DAS28-CRP), patient-reported outcomes and inhibition of radiographic progression. More information on these trials can be found at (NCT02675426, NCT02706873, NCT02629159, NCT03086343, NCT02706847, NCT02706951). About RINVOQ® (upadacitinib) Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In human leukocyte cellular assays, RINVOQ inhibited cytokine-induced STAT phosphorylation mediated by JAK1 and JAK1/JAK3 more potently than JAK2/JAK2 mediated STAT phosphorylation.2 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus and vitiligo.24-28 RINVOQ (upadacitinib) U.S. Uses and Important Safety Information2 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: 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: 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. Globally, prescribing information varies; refer to the individual country product label for complete information. HUMIRA (adalimumab) U.S. Uses and Important Safety Information17 Uses: HUMIRA is a prescription medicine used: To reduce the signs and symptoms of: Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities. Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone or with methotrexate. Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities. Ankylosing spondylitis (AS) in adults. Moderate to severe hidradenitis suppurativa (HS) in people 12 years and older. To treat moderate to severe Crohn's disease (CD) in adults and children 6 years of age and older. To treat moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines. To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate. To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults and children 2 years of age and older. IMPORTANT SAFETY INFORMATION About HUMIRA ® (adalimumab) What is the most important information I should know about HUMIRA? You should discuss the potential benefits and risks of HUMIRA with your doctor. HUMIRA is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB. Cancer. For children and adults taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including HUMIRA, your chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn't heal. What should I tell my doctor BEFORE starting HUMIRA? Tell your doctor about all of your health conditions, including if you: Have an infection, are being treated for infection, or have symptoms of an infection Get a lot of infections or infections that keep coming back Have diabetes Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis. These infections may happen or become more severe if you use HUMIRA. Ask your doctor if you are unsure if you have lived in these areas Have or have had hepatitis B Are scheduled for major surgery Have or have had cancer Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome Have or had heart failure Have recently received or are scheduled to receive a vaccine. HUMIRA patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting HUMIRA Are allergic to rubber, latex, or any HUMIRA ingredients Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed Have a baby and you were using HUMIRA during your pregnancy. Tell your baby's doctor before your baby receives any vaccines Also tell your doctor about all the medicines you take. You should not take HUMIRA with ORENCIA® (abatacept), KINERET® (anakinra), REMICADE® (infliximab), ENBREL® (etanercept), CIMZIA® (certolizumab pegol), or SIMPONI® (golimumab). Tell your doctor if you have ever used RITUXAN® (rituximab), IMURAN® (azathioprine), or PURINETHOL® (mercaptopurine, 6-MP). What should I watch for AFTER starting HUMIRA? HUMIRA can cause serious side effects, including: Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle. Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash. Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth. Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness. Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale. Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain. Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun. Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death. Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus. Call your doctor or get medical care right away if you develop any of the above symptoms. Common side effects of HUMIRA include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away. Remember, tell your doctor right away if you have an infection or symptoms of an infection, including: Humira is given by injection under the skin. This is the most important information to know about HUMIRA. For more information, talk to your health care provider. Please click here for the Full Prescribing Information and Medication Guide. Globally, prescribing information varies; refer to the individual country product label for complete information. 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, 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 2024 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 AbbVie. Data on file: ABVRRTI 81918 RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2025. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2021;73(7):924-939. doi:10.1002/acr.24596 Smolen JS, Landewé RBM, Bergstra SA, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023;82(1):3-18. doi:10.1136/ard-2022-223356 Khader Y, Beran A, Ghazaleh S, Lee-Smith W, Altorok N. Predictors of remission in rheumatoid arthritis patients treated with biologics: a systematic review and meta-analysis. Clin Rheumatol. 2022 Dec;41(12):3615-3627. Furst DE, Pangan AL, Harrold LR, Chang H, Reed G, Kremer JM, Greenberg JD. Greater likelihood of remission in rheumatoid arthritis patients treated earlier in the disease course: results from the Consortium of Rheumatology Researchers of North America registry. Arthritis Care Res (Hoboken). 2011 Jun;63(6):856-64. Sullivan E, Kershaw J, Blackburn S, Mahajan P, Boklage SH. Biologic Disease-Modifying Antirheumatic Drug Prescription Patterns Among Rheumatologists in Europe and Japan. Rheumatol Ther. 2020;7(3):517-535. doi:10.1007/s40744-020-00211-w Holdsworth EA, Donaghy B, Fox KM, Desai P, Collier DH, Furst DE. Biologic and Targeted Synthetic DMARD Utilization in the United States: Adelphi Real World Disease Specific Programme for Rheumatoid Arthritis. Rheumatol Ther. 2021;8(4):1637-1649. doi:10.1007/s40744-021-00357-1 Zhao SS, Kearsley-Fleet L, Bosworth A, Watson K; BSRBR-RA Contributors Group, Hyrich KL. Effectiveness of sequential biologic and targeted disease modifying anti-rheumatic drugs for rheumatoid arthritis. Rheumatology (Oxford). 2022;61(12):4678-4686. doi:10.1093/rheumatology/keac190 Johnson KJ, Sanchez HN, Schoenbrunner N. Defining response to TNF-inhibitors in rheumatoid arthritis: the negative impact of anti-TNF cycling and the need for a personalized medicine approach to identify primary non-responders. Clin Rheumatol. 2019;38(11):2967-2976. doi:10.1007/s10067-019-04684-1 Karpes Matusevich AR, Duan Z, Zhao H, et al. Treatment Sequences After Discontinuing a Tumor Necrosis Factor Inhibitor in Patients With Rheumatoid Arthritis: A Comparison of Cycling Versus S Strategies. Arthritis Care Res (Hoboken). 2021;73(10):1461-1469. doi:10.1002/acr.24358 Edgerton C, Frick A, Helfgott S, Huston KK, Singh JA, Zueger P, Anyanwu SI, Patel P, Soloman N. Real-World Treatment and Care Patterns in Patients With Rheumatoid Arthritis Initiating First-Line Tumor Necrosis Factor Inhibitor Therapy in the United States. ACR Open Rheumatol. 2024 Apr;6(4):179-188. Wei W, Knapp K, Wang L, Chen CI, Craig GL, Ferguson K, Schwartzman S. Treatment Persistence and Clinical Outcomes of Tumor Necrosis Factor Inhibitor Cycling or Switching to a New Mechanism of Action Therapy: Real-world Observational Study of Rheumatoid Arthritis Patients in the United States with Prior Tumor Necrosis Factor Inhibitor Therapy. Adv Ther. 2017 Aug;34(8):1936-1952. doi: 10.1007/s12325-017-0578-8. Gauthier G, Levin R, Vekeman F, Reyes JM, Chiarello E, Ponce de Leon D. Treatment patterns and sequencing in patients with rheumatic diseases: a retrospective claims data analysis. Curr Med Res Opin. 2021;37(12):2185-2196. doi:10.1080/03007995.2021.1981278 Migliore A, Pompilio G, Integlia D, Zhuo J, Alemao E. Cycling of tumor necrosis factor inhibitors versus switching to different mechanism of action therapy in rheumatoid arthritis patients with inadequate response to tumor necrosis factor inhibitors: a Bayesian network meta-analysis. Ther Adv Musculoskelet Dis. 2021 Mar 29;13:1759720X211002682. HUMIRA [Package Insert]. North Chicago, IL: AbbVie Inc.; 2025. GBD 2021 Rheumatoid Arthritis Collaborators. Global, regional, and national burden of rheumatoid arthritis, 1990-2020, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023;5(10):e594-e610. Published 2023 Sep 25. doi:10.1016/S2665-9913(23)00211-4 Arthritis Foundation. Rheumatoid Arthritis: Causes, Symptoms, Treatments and More . Accessed September 22, 2025 Hunter T, et al. Rheumatology International. Prevalence of rheumatoid arthritis in the United States adult population in healthcare claims databases, 2004–2014. April 2017. American College of Rheumatology. Rheumatoid Arthritis. Available at: . Accessed September 22, 2025. Genovese MC, Fleischmann R, Combe B, Hall S, Rubbert-Roth A, Zhang Y, Zhou Y, Mohamed MF, Meerwein S, Pangan AL. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2513-2524. Rubbert-Roth A, Enejosa J, Pangan AL, Haraoui B, Rischmueller M, Khan N, Zhang Y, Martin N, Xavier RM. Trial of Upadacitinib or Abatacept in Rheumatoid Arthritis. N Engl J Med. 2020 Oct 15;383(16):1511-1521. Fleischmann RM, Blanco R, Hall S, Thomson GTD, Van den Bosch FE, Zerbini C, Bessette L, Enejosa J, Li Y, Song Y, DeMasi R, Song IH. Switching between Janus kinase inhibitor upadacitinib and adalimumab following insufficient response: efficacy and safety in patients with rheumatoid arthritis. Ann Rheum Dis. 2021 Apr;80(4):432-439. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants with Takaysu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. Available at: . Accessed September 22, 2025. 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 September 22, 2025. 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 September 22, 2025. 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 September 22, 2025. 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 September 22, 2025. SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Approximately 80% of Omvoh-treated patients in the LUCENT-3 study who achieved clinical remission at one year maintained long-term, corticosteroid-free clinical and endoscopic remission At four years, nearly all patients who achieved clinical remission at one year had improvements in bowel urgency, one of the most disruptive symptoms for patients INDIANAPOLIS, Oct. 7, 2025 /PRNewswire/ -- New data from Eli Lilly and Company (NYSE: LLY) showed Omvoh (mirikizumab-mrkz) is the first and only interleukin-23p19 (IL-23p19) to help patients with moderately to severely active ulcerative colitis (UC) achieve sustained, long-term outcomes through four years. The results were seen across multiple symptomatic, clinical, endoscopic, histologic and quality-of-life measures, including among patients who had previously failed a biologic or advanced therapy (27%). These data are the final results from the LUCENT-3 Phase 3 open-label extension study and will be presented at United European Gastroenterology (UEG) Week, taking place Oct. 4-7 in Berlin.1 "Helping people with ulcerative colitis achieve long-term comprehensive disease control is a major goal for gastroenterologists, as it has remained out of reach for many patients," said Bruce Sands, M.D., M.S., Dr. Burrill B. Crohn Professor of Medicine and Chief of the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai. "These long-term findings reinforce mirikizumab as a highly effective biologic for UC management, showing sustained clinical, endoscopic and steroid-free remission over four years, and improvement in bowel urgency, which can present a significant burden on patients' lives." In LUCENT-3, the following results were observed after four years of total treatment among those who achieved clinical remission with Omvoh at one year in the Phase 3 LUCENT-2 study: 78% achieved corticosteroid-free clinical remission 78% sustained long-term clinical remission 81% sustained endoscopic remission, defined as an endoscopic subscore of 0 or 1 (excluding friability) 90% achieved remission on the Inflammatory Bowel Disease Questionnaire (IBDQ) 66% achieved histological-endoscopic mucosal improvement, an important marker of deep inflammation resolution 93% achieved a 3 or more-point reduction on the Urgency Numeric Rating Scale (UNRS)*, and 74% achieved UNRS = 0 or 11 *UNRS is the patient-centric scale of 0-10 that evaluates bowel urgency severity, with 0 being no bowel urgency and 10 being worst possible bowel urgency. These data were also evaluated using a modified non-responder imputation (mNRI), presented in the About the LUCENT Clinical Trial Program section below. These results build upon previously disclosed first-of-their-kind long-term results for Omvoh in both UC and Crohn's disease. The long-term safety profile in patients with moderately to severely active UC was consistent with the known safety profile of Omvoh with no new safety signals observed. Of patients who completed one year of blinded Omvoh maintenance therapy in LUCENT-2 and continued on to LUCENT-3, 12% reported a serious adverse event, while 7% discontinued treatment due to an adverse event.1 "With these results, Omvoh continues to set a high standard as the first and only IL-23p19 with evidence of sustained efficacy and consistent safety in ulcerative colitis over four years," said Mark Genovese, M.D., senior vice president of Lilly Immunology development. "Lilly is shaping the future of IBD care to make life better for patients by redefining what's possible in terms of steroid-free, long-lasting, comprehensive disease control, including durable clinical and endo-histologic remission and relief of disruptive symptoms like bowel urgency." Beyond ongoing UC studies, including in pediatric patients (NCT05784246), Lilly is advancing combination studies of mirikizumab aimed at delivering breakthrough induction efficacy while maintaining long-term remission and safety. These include studies with eltrekibart (NCT06598943), a monoclonal antibody that targets neutrophil-driven inflammation, and with LY4268989 (MORF-057) (NCT07186101), an oral α4β7 integrin inhibitor. Lilly is also advancing novel science to uncover the potential of incretins in immunology and has initiated the COMMIT-UC (NCT06937086) and COMMIT-CD (NCT06937099) trials evaluating the concomitant use of mirikizumab with an incretin-based therapy. Omvoh has received regulatory approvals for the treatment of moderately to severely active UC and moderately to severely active Crohn's disease in adults and has been approved in 44 countries around the world. Disclosure: Dr. Sands is a paid consultant for Lilly. He has not been compensated for any media work. About the LUCENT Clinical Trial Program Omvoh was studied in two Phase 3 randomized, double-blind and placebo controlled clinical trials that evaluated the efficacy and safety of mirikizumab in adults with moderately to severely active ulcerative colitis (UC) and included patients who had never tried a biologic (biologic-naïve) and harder-to-treat patients who had previously taken a biologic that failed. Patients (N=1279) were randomized 3:1 to receive Omvoh 300 mg IV or placebo IV Q4W at Weeks 0, 4, and 8 in the blinded induction study (LUCENT-1). Omvoh responders from LUCENT-1 (N=581) were re-randomized 2:1 to receive Omvoh 200 mg or placebo subcutaneous (SC) Q4W for 40 weeks in the blinded maintenance study (LUCENT-2) (52 weeks of continuous therapy). LUCENT-1 and LUCENT-2 studies included those who had inadequate response, loss of response, or failed to tolerate any of the following: corticosteroids, immunomodulators (6-mercaptopurine and azathioprine), biologic therapy (TNF blocker, vedolizumab) or Janus kinase inhibitors (JAKi, tofacitinib). Additionally, 41% of patients in LUCENT-1 had failed at least one biologic, 3% had failed a JAKi and 57% were biologic and JAKi-naïve.2 LUCENT-3, the single-arm long-term Phase 3 open-label extension of LUCENT-1 and LUCENT-2, evaluated the efficacy and safety of mirikizumab in patients with UC for an additional three years of treatment (up to four years total). Using a mNRI analysis to handle discontinuation and missing data, response rates among Week 52 mirikizumab remitters for major efficacy endpoints included: corticosteroid-free remission (62%), clinical remission (62%), endoscopic remission (66%), IBDQ remission (73%), histologic-endoscopic mucosal improvement (53%), 3 or more-point reduction on UNRS (75%) and UNRS = 0 or 1 (60%).1 Indications and Usage for Omvoh (mirikizumab-mrkz) (in the United States) Omvoh is an interleukin-23 antagonist indicated for adults with: Moderately to severely active ulcerative colitis Moderately to severely active Crohn's disease Important Safety Information for Omvoh (mirikizumab-mrkz) CONTRAINDICATIONS Omvoh is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis during intravenous infusion, have been reported with Omvoh administration. Infusion-related hypersensitivity reactions, including mucocutaneous erythema and pruritus, were reported during induction. If a severe hypersensitivity reaction occurs, discontinue Omvoh immediately and initiate appropriate treatment. Infections Omvoh may increase the risk of infection. Do not initiate treatment with Omvoh in patients with a clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing Omvoh. Instruct patients to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur. If a serious infection develops or an infection is not responding to standard therapy, monitor the patient closely and do not administer Omvoh until the infection resolves. Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Omvoh. Do not administer Omvoh to patients with active TB infection. Initiate treatment of latent TB prior to administering Omvoh. Consider anti-TB therapy prior to initiation of Omvoh in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after Omvoh treatment. In clinical trials, subjects were excluded if they had evidence of active TB, a history of active TB, or were diagnosed with latent TB at screening. Hepatotoxicity Drug-induced liver injury in conjunction with pruritus was reported in a clinical trial subject following a longer than recommended induction regimen. Omvoh was discontinued. Liver test abnormalities eventually returned to baseline. Evaluate liver enzymes and bilirubin at baseline and for at least 24 weeks of treatment. Monitor thereafter according to routine patient management. Consider other treatment options in patients with evidence of liver cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction. Immunizations Avoid use of live vaccines in patients treated with Omvoh. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or non-live vaccines in patients treated with Omvoh. ADVERSE REACTIONS Most common adverse reactions associated with Omvoh (≥2% of subjects and at a higher frequency than placebo) in ulcerative colitis treatment are upper respiratory tract infections and arthralgia during the induction study (UC-1), and upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection during the maintenance study (UC-2). Most common adverse reactions associated with Omvoh in the Crohn's disease study (CD-1) (≥5% of subjects and at a higher frequency than placebo) are upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests. Omvoh injection is available as a 300 mg/15 mL solution in a single-dose vial for intravenous infusion, and as a 100 mg/mL solution or a 200 mg/2 mL solution in a single dose prefilled pen or prefilled syringe for subcutaneous injection. Refer to the Prescribing Information for dosing information. MR HCP ISI CD APP Click to access provided Prescribing Information and Medication Guide . See Instructions for Use provided with the device. About Omvoh Omvoh (mirikizumab-mkrz) is an interleukin-23p19 (IL-23p19) antagonist indicated for the treatment of moderately to severely active ulcerative colitis and Crohn's disease in adults. Omvoh selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of inflammatory bowel disease.3 Omvoh and its delivery device base are trademarks owned by Eli Lilly and Company. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Omvoh (mirikizumab-mrkz) as a treatment for people with moderate to severe ulcerative colitis and moderate to severe Crohn's disease and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that Omvoh will receive additional regulatory approvals, or that Omvoh will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. References 1 Sands, B, et al. Mirikizumab provides sustained long-term efficacy up to 4 years of treatment for ulcerative colitis: final results from the LUCENT-3 open-label extension study. 2025 United European Gastroenterology Week. October 4-7, 2025. 2 Sands, B, et al. Three-year efficacy and safety of mirikizumab following 152 weeks of continuous treatment for ulcerative colitis: results from the LUCENT-3 open-label extension study. Inflammatory Bowel Diseases, 2024;, izae253, 3 Omvoh. Prescribing Information. Lilly USA, LLC. SOURCE Eli Lilly and Company WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED