Tofacitinib Citrate

20 scientific presentations underscore the breadth of AbbVie's leadership in Inflammatory Bowel Disease (IBD) research programs Latest long-term and real-world data with SKYRIZI®(risankizumab) and RINVOQ® (upadacitinib) provide additional insight into clinical and endoscopic outcomes over approximately three years in moderately to severely active Crohn's disease and ulcerative colitis New data evaluating endoscopic remission with investigational dual-targeting therapy ABBV-466 in patients with moderate-to-severe Crohn's disease will also be presented NORTH CHICAGO, Ill., Oct. 17, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the presentation of 20 new scientific abstracts from its IBD portfolio at the 2026 United European Gastroenterology (UEG) Week, October 17-20 in Barcelona, Spain. Together, the data reflect the breadth of AbbVie's research across IBD, including established therapies studied over longer treatment periods and in real-world clinical practice. "Crohn's disease and ulcerative colitis are chronic, lifelong conditions, and understanding how patients respond to treatment over time and in everyday clinical practice is critical," said Sofie Berg, Pharm.D., Ph.D., therapeutic area head, immunology, international medical affairs, AbbVie. "The data presented at UEGW 2026 build on our growing body of evidence that can help clinicians move toward favorable long-term outcomes for people living with IBD." Key data to be presented include: Long-term data in moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD) – Open-label extension and post-hoc analyses add to the evidence base for clinical and endoscopic outcomes with risankizumab and upadacitinib Risankizumab in UC: COMMAND showed sustained clinical and endoscopic outcomes up to three years of maintenance treatment. As-observed clinical remissiona rates of 54.0%–73.1% and endoscopic remissionb rates of 38.8%–53.5% were achieved at week 96 with 180mg across advanced therapy-naïve and advanced therapy-experienced patients. Upadacitinib in CD: U-ENDURE as-observed analyses showed that clinical and endoscopic outcomes were maintained through approximately four years of treatment. At Week 144, clinical remissionc was achieved by 78.9% of patients receiving 15 mg and 86.6% receiving 30 mg. Endoscopic remissiond was achieved by 47.1% and 64.2% of patients, respectively. Upadacitinib in the Real World: New Insights from Clinical Practice Interim results from the real-world UPlift study showed that 70.2% of evaluable patients (N=497) with moderate to severe Crohn's disease achieved clinical responsee with upadacitinib within 12 weeks, with a median time to first response of 13 days. A real-world claims analysis of patients (N=514) with UC or CD showed that patients who switched from a Tumor Necrosis Factor inhibitor (TNFi) to upadacitinib had lower rates of IBD-related hospitalizations (9.5% vs 16.3%) or surgery (6.9% vs 10.6%) over 12 months compared with patients who cycled to another TNFi. Additional Findings on Risankizumab Subcutaneous Induction in CD Data presented at UEGW will further expand on findings from the Phase 3 AFFIRM study evaluating subcutaneous risankizumab induction and maintenance in CD. Following the first presentation of AFFIRM results at the 2026 American College of Gastroenterology Annual Scientific Meeting, the UEGW presentations will provide additional analyses examining outcomes by prior advanced therapy exposure and further characterizing clinical and endoscopic outcomes among patients who responded to subcutaneous risankizumab induction and continued treatment. aDefined as stool frequency (SF) score ≤ 1, and not greater than baseline, rectal bleeding score = 0, and endoscopic subscore ≤ 1 without evidence of friability. bDefined as endoscopic subscore = 0. cDefined as average daily very soft or liquid SF ≤2.8 and average daily abdominal pain (AP) score ≤1.0 and both not greater than induction baseline. dDefined as Simplified Endoscopic Score for Patients with Crohn's Disease ≤ 4 and at least a 2-point reduction from baseline and no subscore > 1 in any individual variable, as scored by a central reviewer. eDefined as the first day with ≥30% decrease in daily very soft or liquid SF and/or ≥30% decrease in daily AP score and both not worse than baseline AND a prospective 7-day average daily CR-PRO starting on the first day of daily CR-PRO; prospective 7-day average daily CR-PRO was defined as ≥30% decrease in average daily very soft or liquid SF and/or ≥30% decrease in average daily AP score and both not worse than baseline. Only patients with either baseline SF or AP >0 and both non-missing with at least one postbaseline assessment of CR-PRO2 are included. The 2026 UEGW Congress program is available here. Select abstracts and oral presentations from AbbVie include: SKYRIZI® (risankizumab) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally. About SKYRIZI ® SKYRIZI is an interleukin (IL)-23 inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.1 SKYRIZI is approved by the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of moderately to severely active plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.1,2 On August 27, 2026, AbbVie announced submission of an application to the European Medicines Agency (EMA) seeking approval of SKYRIZI® for subcutaneous induction for the treatment of adult patients with moderately to severely active CD. EU Indications and Important Safety Information about SKYRIZI ® (risankizumab) 1 Indications Skyrizi (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy. Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Skyrizi is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy. Skyrizi is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy. Important Safety Information Risankizumab is contraindicated in patients hypersensitive to the active substance or to any of the excipients, and in patients with clinically important active infections (e.g. active tuberculosis). Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Patients treated with risankizumab should be instructed to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops such an infection or is not responding to standard therapy for the infection, the patient should be closely monitored and risankizumab should not be administered until the infection resolves. Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Prior to initiating therapy with risankizumab, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment. Serious hypersensitivity reactions, including anaphylaxis, have been reported with use of risankizumab. If a serious hypersensitivity reaction occurs, administration of risankizumab should be discontinued immediately and appropriate therapy initiated. The most frequently reported adverse reactions were upper respiratory infections (13% in psoriasis, 15.6% in Crohn's disease and 26.2% in ulcerative colitis). Commonly (≥ 1/100 to < 1/10) reported adverse reactions included tinea infections, headache, pruritus, rash, eczema, fatigue, and injection site reactions. This is not a complete summary of all safety information. See Skyrizi full Summary of Product Characteristics (SmPC) at Globally, prescribing information varies; refer to the individual country product label for complete information. About RINVOQ ® (upadacitinib) Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.3,4 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.3 Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for hidradenitis suppurativa, Takayasu arteritis and systemic lupus erythematosus and in pediatric studies for systemic juvenile idiopathic arthritis, atopic dermatitis, ulcerative colitis and Crohn's disease. EU Indications and Important Safety Information about RINVOQ ® (upadacitinib) 3 Indications Rheumatoid arthritis RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate. Psoriatic arthritis RINVOQ is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate. Polyarticular juvenile idiopathic arthritis RINVOQ is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) [polyarticular rheumatoid factor positive {RF+} or negative {RF-}, extended oligoarticular], in patients 2 years of age and older who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate. Axial spondyloarthritis Non-radiographic axial spondyloarthritis (nr-axSpA) RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. Giant cell arteritis RINVOQ is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Atopic dermatitis RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy. Alopecia areata RINVOQ is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. Vitiligo RINVOQ is indicated for the treatment of non-segmental vitiligo in adults and adolescents 12 years and older who are candidates for systemic therapy. Ulcerative colitis RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. Crohn's disease RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. Important Safety Information Contraindications RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy. Special warnings and precautions for use RINVOQ should only be used if no suitable treatment alternatives are available in patients: - 65 years of age and older; - patients with history of atherosclerotic cardiovascular (CV) disease or other CV risk factors (such as current or past long-time smokers); - patients with malignancy risk factors (e.g. current malignancy or history of malignancy). Use in patients 65 years of age and older Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients ≥65 years of age, as observed in a large randomised study of tofacitinib (another Janus Kinase (JAK) inhibitor), RINVOQ should only be used in these patients if no suitable treatment alternatives are available. In patients ≥65 years of age, there is an increased risk of adverse reactions with RINVOQ 30 mg once daily. Consequently, the recommended dose for long-term use in this patient population is 15 mg once daily. Immunosuppressive medicinal products Use in combination with other potent immunosuppressants is not recommended. Serious infections Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis and sepsis have been reported with RINVOQ. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported. RINVOQ should not be initiated in patients with an active, serious infection, including localized infections. RINVOQ should be interrupted if a patient develops a serious or opportunistic infection until the infection is controlled. A higher rate of serious infections was observed with RINVOQ 30 mg compared to 15 mg. As there is a higher incidence of infections in the elderly and patients with diabetes in general, caution should be used when treating these populations. In patients ≥65 years of age, RINVOQ should only be used if no suitable treatment alternatives are available. Tuberculosis Patients should be screened for TB before starting RINVOQ. RINVOQ should not be given to patients with active TB. Anti-TB therapy may be appropriate for select patients in consultation with a physician with expertise in the treatment of TB. Patients should be monitored for the development of signs and symptoms of TB. Viral reactivation Viral reactivation, including cases of herpes zoster, was reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with RINVOQ. Consider interruption of RINVOQ if the patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should occur before and during therapy. If hepatitis B virus DNA is detected, a liver specialist should be consulted. Vaccination The use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating RINVOQ, in agreement with current immunization guidelines. Malignancy Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including RINVOQ. In a large randomised active‑controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma, and non-melanoma skin cancer (NMSC), was observed with tofacitinib compared to tumour necrosis factor (TNF) inhibitors. A higher rate of malignancies, including NMSC, was observed with RINVOQ 30 mg compared to 15 mg. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. In patients ≥65 years of age, patients who are current or past long-time smokers, or patients with other malignancy risk factors (e.g., current malignancy or history of malignancy), RINVOQ should only be used if no suitable treatment alternatives are available. Hematological abnormalities Treatment should not be initiated, or should be temporarily interrupted, in patients with hematological abnormalities observed during routine patient management. Gastrointestinal perforations Events of diverticulitis and gastrointestinal perforations have been reported in clinical trials and from post marketing sources. RINVOQ should be used with caution in patients who may be at risk for gastrointestinal perforation (e.g., patients with diverticular disease, a history of diverticulitis, or who are taking non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or opioids). Patients with active Crohn's disease are at increased risk for developing intestinal perforation. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis or gastrointestinal perforation. Major adverse cardiovascular events MACE were observed in clinical studies of RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of MACE, defined as CV death, non-fatal myocardial infarction and non-fatal stroke, was observed with tofacitinib compared to TNF inhibitors. Therefore, in patients ≥65 years of age, patients who are current or past long-time smokers, and patients with history of atherosclerotic CV disease or other CV risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. Lipids RINVOQ treatment was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Hepatic transaminase elevations Treatment with RINVOQ was associated with an increased incidence of liver enzyme elevation. Hepatic transaminases must be evaluated at baseline and thereafter according to routine patient management. If alanine transaminase (ALT) or aspartate transaminase (AST) increases are observed and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded. Venous thromboembolism Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) were observed in clinical trials for RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a dose‑dependent higher rate of VTE including DVT and PE was observed with tofacitinib compared to TNF inhibitors. In patients with CV or malignancy risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. In patients with known VTE risk factors other than CV or malignancy risk factors (e.g. previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, and inherited coagulation disorder), RINVOQ should be used with caution. Patients should be re-evaluated periodically to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue RINVOQ in patients with suspected VTE. Retinal vein occlusion Retinal vein occlusion has been reported in patients treated with JAK inhibitors, including upadacitinib. Patients should be advised to promptly seek medical care in case they experience symptoms suggestive of retinal vein occlusion. Hypersensitivity reactions Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving RINVOQ. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy. Hypoglycemia in patients treated for diabetes There have been reports of hypoglycemia following initiation of JAK inhibitors, including RINVOQ, in patients receiving medication for diabetes. Dose adjustment of anti-diabetic medication may be necessary in the event that hypoglycemia occurs. Medication residue in stool Reports of medication residue in stool or ostomy output have occurred in patients taking RINVOQ tablets. Most reports described anatomic (e.g., ileostomy, colostomy, intestinal resection) or functional gastrointestinal conditions with shortened gastrointestinal transit times. Patients should be instructed to contact their healthcare professional if medication residue is observed repeatedly. Patients should be clinically monitored, and alternative treatment should be considered if there is an inadequate therapeutic response. Giant cell arteritis RINVOQ monotherapy should not be used for the treatment of acute relapses as efficacy in this setting has not been established. Corticosteroids should be given according to medical judgement and practice guidelines. Excipients with known effect RINVOQ 1 mg/ml oral solution contains 0.3 mg sodium benzoate in each ml. Adverse reactions The most commonly reported adverse reactions in RA, PsA, and axSpA clinical trials (≥2% of patients in at least one of the indications) with RINVOQ 15 mg were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, ALT increased, bronchitis, nausea, neutropenia, cough, AST increased, and hypercholesterolemia. Overall, the safety profile observed in patients with psoriatic arthritis or active axial spondyloarthritis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with RA. The most commonly reported adverse reactions in AD trials (≥2% of patients) with RINVOQ 15 mg or 30 mg were upper respiratory tract infection, acne, herpes simplex, headache, blood CPK increased, cough, folliculitis, abdominal pain, nausea, neutropenia, pyrexia, and influenza. Dose dependent increased risks of infection and herpes zoster were observed with RINVOQ. The safety profile for RINVOQ 15 mg and 30 mg in adolescents was similar to that in adults. With long-term exposure, skin papilloma was reported in adolescents in the RINVOQ 15 mg and 30 mg groups. The most commonly reported adverse reactions in the UC and CD trials (≥3% of patients) with RINVOQ 45 mg, 30 mg or 15 mg were upper respiratory tract infection, pyrexia, blood CPK increased, anemia, headache, acne, herpes zoster, neutropenia, rash, pneumonia, hypercholesterolemia, bronchitis, AST increased, fatigue, folliculitis, ALT increased, herpes simplex, and influenza. The overall safety profile observed in patients with UC was generally consistent with that observed in patients with RA. Overall, the safety profile observed in patients with CD treated with RINVOQ was consistent with the known safety profile for RINVOQ. Overall, the safety profile observed in patients with GCA treated with RINVOQ 15 mg was generally consistent with the known safety profile for RINVOQ. Overall, the safety profile observed in paediatric patients with pJIA treated with RINVOQ was consistent with the known safety profile of RINVOQ. The safety profile of RINVOQ 15 mg and 30 mg observed in patients with alopecia areata was generally consistent with the known safety profile in patients with atopic dermatitis. The safety profile of RINVOQ 15 mg observed in patients with vitiligo was generally consistent with the known safety profile in patients with atopic dermatitis. A higher incidence of hypercholesterolemia was observed in patients with vitiligo treated with RINVOQ 15 mg compared to placebo. The most common serious adverse reactions were serious infections. The safety profile of RINVOQ with long term treatment was generally similar to the safety profile during the placebo-controlled period across indications. RINVOQ is available in 15 mg, 30 mg, and 45 mg prolonged-release tablets and 1 mg/ml oral solution. RINVOQ tablets and RINVOQ oral solution are not bioequivalent. Refer to the Summary of Product Characteristics for posology and method of administration. This is not a complete summary of all safety information. See RINVOQ full Summary of Product Characteristics (SmPC) at Globally, prescribing information varies; refer to the individual country product label for complete information. About TARGET-CD: TARGET-CD (M24-885) is a global Phase 2a, multicenter, randomized platform study designed to evaluate multiple investigational targeted therapies, including monotherapy and combination approaches, in adults with moderately to severely active Crohn's disease. The innovative platform design enables evaluation of the efficacy, safety, and mechanistic profiles of different therapeutic strategies using a common comparator, with the goal of rapidly advancing new treatment approaches for patients with Crohn's disease. More information on the TARGET-CD trial can be found at (NCT06548542). About ABBV-466: ABBV-466 is an investigational dual-targeting therapy combining risankizumab, an IL-23 inhibitor, with trosunilimab, an α4β7 inhibitor, to address complementary drivers of inflammation in Crohn's disease. The approach is designed to inhibit inflammatory signaling while limiting immune-cell trafficking to the gut, with the goal of achieving deeper disease control than either pathway alone. ABBV-466 is investigational and its safety and efficacy have not been established by regulatory authorities. About AbbVie in Immunology AbbVie is relentless in our pursuit to redefine the standard of care for patients living with immune-mediated conditions, with the goal of helping them live a life free from the limitations of their disease. For nearly 30 years, AbbVie has led and helped shape the field of immunology through groundbreaking science and trusted medicines. Building on deep expertise across gastroenterology, rheumatology and dermatology, and other areas of high unmet need, we continue to invest in a broad and differentiated pipeline – spanning innovative modalities, novel mechanisms of action and next-generation approaches designed to conquer the complex biology underlying immune-mediated disease. Today, more than 1 million patients worldwide are treated with AbbVie's immunology medicines, approved in more than 175 countries across 20+ immune-mediated diseases that impact adult and pediatric populations. As we work to strengthen our legacy and drive the next wave of innovation, we remain focused on delivering meaningful progress for patients and expanding access to our medicines. For more information, please visit . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas 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. Summary of product characteristics. AbbVie; 2026. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc. RINVOQ. Summary of product characteristics. AbbVie; 2026. Pipeline. AbbVie. 2026. Accessed September 24, 2026. SOURCE AbbVie 21% more press release views with Request a Demo

In LUCENT-2, more than one in four (27.7%) Omvoh-treated patients with ulcerative colitis achieved comprehensive disease control, a novel composite outcome defined by simultaneous symptomatic, endoscopic and histologic remission, biomarker normalization and no corticosteroid use In VIVID-1, one in five (20.4%) Omvoh-treated patients with Crohn's disease achieved corticosteroid-free deep remission, a composite outcome defined by simultaneous clinical remission, endoscopic remission and no corticosteroid use Across both types of inflammatory bowel disease, including patients with prior biologic failure, achieving comprehensive disease control or corticosteroid-free deep remission was associated with improved patient-reported outcomes INDIANAPOLIS, Oct. 15, 2026 /PRNewswire/ -- New data analyses from Eli Lilly and Company (NYSE: LLY) show patients with moderately to severely active ulcerative colitis (UC) and Crohn's disease treated with Omvoh (mirikizumab-mrkz) achieved multiple treatment goals simultaneously at one year, as measured by comprehensive disease control in UC and corticosteroid-free deep remission in Crohn's disease. These multidimensional outcomes were observed even in patients with prior biologic failure, a population often facing greater treatment challenges. More than one-third of patients in the UC analysis and nearly half of patients in the Crohn's disease analysis had previously experienced biologic treatment failure. Furthermore, patients who achieved these endpoints were more likely to also achieve remission on the Inflammatory Bowel Disease Questionnaire (IBDQ), a validated patient-reported measure of health-related quality of life. Together, these findings reflect an evolution of treatment goals in inflammatory bowel disease (IBD), looking across symptoms, inflammation and impact of disease on daily life to support a more holistic, patient-centered approach that goes beyond clinical remission. These post-hoc data from the LUCENT and VIVID programs will be presented at United European Gastroenterology (UEG) Week 2026.1,2 "Treatment in inflammatory bowel disease is often measured one endpoint at a time. These new data show that patients treated with Omvoh achieved multiple treatment goals simultaneously at one year, including those with prior biologic failure, and were more likely to report better quality of life," said Anabela Cardoso, senior vice president, Lilly Immunology Medical Affairs. "These findings reinforce the impact that Omvoh can have for people living with ulcerative colitis and Crohn's disease and show that a higher bar for disease control is achievable." A comprehensive approach to IBD management considers multiple dimensions of disease, including the symptoms patients experience, what clinicians can objectively measure and how disease affects daily life.3-4 In previously published real-world studies, improvements across multiple dimensions of disease have been associated with a lower risk of flares, steroid use, hospitalization and surgery over time.4-7 "Inflammatory bowel disease is complex, and understanding treatment impact requires a broader view than any single endpoint can provide. These endpoints reflect a meaningful shift in how we define treatment success," said Stefan Schreiber, M.D., University Hospital Schleswig-Holstein, Christian-Albrecht University of Kiel. "Across the LUCENT and VIVID programs, Omvoh-treated patients achieved multidimensional treatment outcomes, including comprehensive disease control in ulcerative colitis and corticosteroid-free deep remission in Crohn's disease. Importantly, these outcomes were also observed in patients with prior biologic failure." Comprehensive disease control with Omvoh in ulcerative colitis Comprehensive disease control is a novel composite outcome, informed by an international expert consensus3, that combines clinical remission *, no corticosteroid use for at least 12 weeks before Week 52, histologic remission† and fecal calprotectin ≤250 μg/g. Omvoh is the first IL-23p19 inhibitor evaluated for comprehensive disease control in UC, reflecting an evolving approach to treatment goals that goes beyond individual measures of disease activity for people living with UC. Comprehensive disease control was evaluated in a post hoc analysis at one year in patients with UC who responded to Omvoh at Week 12 in the LUCENT-1 induction study and were re-randomized in LUCENT-2 to continue Omvoh or receive placebo. More than one-third of patients (35.3%) had previously experienced biologic treatment failure. At one year:1 27.7% of patients treated with Omvoh achieved comprehensive disease control compared with 14% receiving placebo.‡ Among patients with prior biologic failure, 23.4% of those treated with Omvoh achieved comprehensive disease control compared with 9.4% receiving placebo.‡ Among Omvoh-treated patients, 91.1% of those who achieved comprehensive disease control also achieved IBDQ remission§, compared with 65.2% of those who did not achieve comprehensive disease control. Omvoh-treated patients who achieved comprehensive disease control were also more likely to report no to minimal bowel urgency (bowel urgency remission) and greater improvements in work productivity than those who did not achieve comprehensive disease control.∥ Corticosteroid-free deep remission with Omvoh in Crohn's disease Corticosteroid-free deep remission was evaluated in a post hoc analysis at one year in patients with Crohn's disease in VIVID-1. Nearly half of patients (48.6%) had previously experienced biologic treatment failure. Corticosteroid-free deep remission is a composite outcome that combines clinical remission (as measured by the Crohn's Disease Activity Index), endoscopic remission and no corticosteroid use for at least 12 weeks before Week 52.¶ At one year:2 20.4% of patients receiving Omvoh achieved corticosteroid-free deep remission compared with 2% receiving placebo.# Among patients with prior biologic failure, 15.7% of those treated with Omvoh achieved corticosteroid-free deep remission compared with none of those receiving placebo.# Among Omvoh-treated patients, 88.1% of those who achieved corticosteroid-free deep remission also achieved IBDQ remission§, compared with 51% of those who did not achieve corticosteroid-free deep remission. The safety findings observed in the Phase 3 LUCENT and VIVID clinical trial programs have been reported previously. The most common adverse reactions associated with Omvoh treatment in LUCENT-1 and -2 (reported in at least 2% of subjects at a higher frequency than placebo) were upper respiratory tract infections, injection site reactions, arthralgia, rash, headache and herpes viral infection. In VIVID-1, the most common adverse reactions associated with Omvoh treatment (reported in at least 5% of subjects at a higher frequency than placebo) were upper respiratory tract infections, injection site reactions, headache, arthralgia and elevated liver tests.8 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 47 countries. Omvoh is also approved as a single-injection maintenance regimen for adults with UC in several countries around the world, including the U.S., EU, Canada and Japan. Lilly continues to advance the standard of care in gastroenterology through the next wave of immunology innovation, including combination approaches, novel mechanisms and the potential of incretins. Lilly is pursuing combination studies of mirikizumab aimed at delivering breakthrough induction efficacy while maintaining long-term remission and safety. These include studies in UC with eltrekibart (NCT06598943), a monoclonal antibody that targets neutrophil-driven inflammation, and with zotemtegrast (NCT07186101), an oral α4β7 integrin inhibitor. In Crohn's disease, Lilly is studying mirikizumab in combination with an FXR agonist (NCT07483099). The COMMIT-UC (NCT06937086) and COMMIT-CD (NCT06937099) trials are investigating the concomitant use of mirikizumab and an incretin-based therapy in adults with UC or Crohn's disease and obesity or overweight with at least one additional weight-related comorbid condition. In addition, trials of mirikizumab in pediatric patients are ongoing, including a long-term extension study in UC and Crohn's disease (NCT04844606) and an ongoing Phase 3 study in pediatric Crohn's disease (NCT05509777). About the LUCENT Clinical Trial Program Omvoh was studied in two Phase 3 clinical trials which evaluated the efficacy and safety of Omvoh in adults with moderately to severely active UC, in both biologic-naïve patients and those who had previously failed a biologic or Janus kinase inhibitor (JAKi). The randomized, double-blind, placebo-controlled LUCENT-1 (induction) study included patients with an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, biologic therapy, or JAKi, and LUCENT-2 (maintenance) evaluated continued treatment versus placebo in patients who achieved a clinical response to Omvoh in LUCENT-1. About the VIVID Clinical Trial Program VIVID-1 was a Phase 3 randomized, double-blind, placebo-controlled 52-week study in adults with moderately to severely active Crohn's disease. Patients randomized to Omvoh received Omvoh 900 mg by intravenous (IV) infusion at Week 0, Week 4 and Week 8, followed by a maintenance dose of 300 mg by subcutaneous injection (SC) at Week 12 and then every four weeks (Q4W) for 40 weeks. About Omvoh Omvoh (mirikizumab-mrkz) 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.8 Omvoh and its delivery device base are trademarks owned by Eli Lilly and Company. Endnotes and References *Clinical remission (based on the modified Mayo score [mMS]): stool frequency subscore=0 or 1 with a ≥1-point decrease from baseline, and rectal bleeding subscore=0, and endoscopic subscore (ES)=0 or 1 (excluding friability). †Histologic remission: Geboes subscores of 0 for grades 2b (neutrophils in lamina propria), 3 (neutrophils in epithelium), 4 (crypt destruction) and 5 (erosion or ulceration). ‡In LUCENT-2, patients randomized to placebo had achieved clinical response with Omvoh during LUCENT-1 induction and were then re-randomized to discontinue from Omvoh and receive placebo through the maintenance period. Patients randomized to Omvoh continued treatment, for a total of 52 weeks from induction baseline. §Inflammatory Bowel Disease Questionnaire (IBDQ) remission: total score ≥170. ∥No to minimal bowel urgency (bowel urgency remission) was defined as an Urgency NRS score of 0 or 1; work productivity assessed using the Work Productivity and Activity Impairment Questionnaire for UC (WPAI). ¶Corticosteroid-free Crohn's Disease Activity Index (CDAI)-based deep remission: CDAI <150, endoscopic remission (SES-CD ≤4 and ≥2-point reduction from baseline with no subscore >1) and no corticosteroid use during the 12 weeks before Week 52. #Patients receiving placebo in VIVID-1 were randomized to placebo at baseline. Those who did not respond by Week 12 switched to Omvoh and were counted as non-responders in this analysis. 1Schreiber S, et al. Mirikizumab therapy enables comprehensive disease control with improved quality of life in patients with moderately-to-severely active ulcerative colitis: a post-hoc analysis of Phase 3 LUCENT-1 and LUCENT-2 trials. American College of Gastroenterology (ACG) Annual Scientific Meeting; October 11, 2026; Nashville, TN. P-1182. 2Schreiber S, et al. Mirikizumab effect on deep remission with improved quality of life in moderately to severely active Crohn's disease: a post hoc analysis from VIVID-1. United European Gastroenterology Week 2026;. October 18, 2026; Barcelona, Spain. MP0290. 3Schreiber, S, Danese, S, Dignass, A, et al. Defining comprehensive disease control for use as a treatment target for ulcerative colitis in clinical practice: International Delphi consensus recommendations. J Crohns Colitis. 2024;18(1):91–105. 4Fanizzi, F, D'Amico, F, Peyrin-Biroulet, L, Danese, S, & Dignass, A. Treatment targets in IBD: Is it time for new strategies? Best Pract Res Clin Gastroenterol. 2025;77:101990. 5Shehab M, et al. Histological disease activity as predictor of clinical relapse, hospitalization, and surgery in inflammatory bowel disease: systematic review and meta-analysis. Inflamm Bowel Dis. 2024;30(4):563-572. doi:10.1093/ibd/izad119 6Andronic AM, Toader E. P398 Disease clearance: a potential target for management of patients with ulcerative colitis. J Crohns Colitis. 2023;17(Suppl 1):i529. doi:10.1093/ecco-jcc/jjac190.0528 7Pai RK, D'Haens G, Kobayashi T, et al. Histologic assessments in ulcerative colitis: the evidence behind a new endpoint in clinical trials. Expert Rev Gastroenterol Hepatol. 2024;18(1-3):73-87. doi:10.1080/17474124.2024.2326838 8Omvoh. Prescribing Information. Lilly USA, LLC. 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 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 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 referenced 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 moderately to severely active ulcerative colitis and moderately to severely active 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 future study results will be consistent with the results to date, or that Lilly will execute its strategies as planned. 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. SOURCE Eli Lilly and Company 21% more press release views with Request a Demo