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New post-hoc analysis demonstrated efficacy of RINVOQ® (upadacitinib) in moderate-to-severe atopic dermatitis patients with varying degrees of severity in head and neck involvement, with results in skin clearance, itch resolution and impact on quality of life at 16 weeks1 Atopic dermatitis in the head and neck regions can have a significant impact on the quality of life for patients and is highly prevalent based on real-world observational studies2-4 New data showcasing depth and strength across AbbVie's dermatology portfolio will be presented at the 33rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam NORTH CHICAGO, Ill., Sept. 25, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive results from a new post-hoc analysis from the Measure Up 1 and Measure Up 2 Phase 3 studies. The analysis evaluated the efficacy of upadacitinib (15 mg or 30 mg) in patients with moderate-to-severe atopic dermatitis (AD) stratified by the severity of disease in the head and neck region at baseline compared to placebo across 16 weeks.1 In this analysis, several optimal and stringent treatment targets – including the achievement of near complete skin clearance in the head and neck region (EASI Head & Neck score <1), near complete skin clearance (EASI 90), no to little itch (WP-NRS 0/1) and minimal or no impact on quality of life (DLQI 0/1) – were assessed with the treatment of upadacitinib across patient subgroups. Patients were stratified by no-to-mild, moderate, or severe head and neck involvement.1 Living with uncontrolled AD can have a substantial physical, emotional and social impact on patients' lives and is often associated with significant long-term disease burden from debilitating symptoms.5 Research shows that AD in specific sites such as the head, neck, face and hands can have a significant impact on symptom frequency and quality of life for patients.2,6 In the real-world observational setting, 70% of AD patients in the UP-TAINED study and at least 74.5% of AD patients in the AD-VISE study had head and neck region involvement at baseline.3,4 The high prevalence reinforces the need for effective therapies in this high impact, challenging to treat area. "These data stratify the severity of atopic dermatitis in the head and neck region, which is a part of the body that has significant impact on patients and is challenging to treat," said Kilian Eyerich, MD, PhD, chair and professor at the Department of Dermatology and Venerology of the University of Freiburg, Germany. "At 16 weeks, RINVOQ showed efficacy in patients with moderate-to-severe atopic dermatitis with various degrees of head and neck involvement, achieving optimal treatment targets with combined measures of EASI 90 and WP-NRS 0/1, along with improvement on the patients' quality of life measured by DLQI 0/1 in a substantial number of patients." New post-hoc analysis of the Measure Up 1 and Measure Up 2 studies showed that a higher proportion of patients with moderate-to-severe AD with varying degrees of head and neck involvement treated with upadacitinib (15 mg or 30 mg) achieved the following optimal treatment targets compared to placebo at week 16: near complete skin clearance in the head and neck region (EASI Head & Neck Score <1), minimal or no impact on quality of life (DLQI 0/1), and minimal disease activity, which is the simultaneous achievement of near complete skin clearance (EASI 90) and no to little itch (WP-NRS 0/1)1: Primary efficacy and safety results from these ongoing pivotal studies have been previously reported: . "Despite taking steps to manage their condition, many patients with atopic dermatitis continue to live with debilitating symptoms, especially in highly visible areas such as head and neck that can intensify one's physical and emotional burden," said Andrew Anisfeld, PhD, vice president, global medical affairs, immunology, AbbVie. "These data contribute to our ongoing commitment to elevate the standard of care in atopic dermatitis so patients can strive for the best possible outcomes." Additional abstracts to be presented at EADV 2024 supporting the efficacy and safety profile of RINVOQ (upadacitinib) for moderate-to-severe AD include: Efficacy and safety of upadacitinib vs dupilumab in adults and adolescents with moderate-to-severe atopic dermatitis: results of an open-label, efficacy assessor-blinded head-to-head phase 3b/4 study (LEVEL UP): This study evaluated the efficacy and safety of RINVOQ (15 mg once daily starting dose and dose-adjusted based on clinical response) versus dupilumab (per its labeled dose) in adults and adolescents (≥12 years of age) with moderate-to-severe atopic dermatitis (AD) who had an inadequate response to systemic therapy or when use of those therapies was inadvisable. The primary endpoint was achievement of both EASI 90 and WP-NRS 0/1 at Week 16.7 FC08.04 Oral Presentation on Friday, 27 September 2024, 16:30-16:40 Effectiveness of upadacitinib in adults and adolescents with atopic dermatitis: 6-month interim analysis of the real-world multicountry AD-VISE study: An interim analysis of the AD-VISE study evaluating the effectiveness and durability of response to upadacitinib for skin clearance (EASI) and itch resolution (WP-NRS) in real-world settings. Results include 578 adult and adolescent patients with moderate-to-severe AD treated with upadacitinib (15 mg or 30 mg).3 P0683 E-Poster Baseline criteria from a real world non-interventional study with Upadacitinib for the treatment of systemic atopic dermatitis: an analysis based on guideline criteria (UP-TAINED): An interim analysis of the UP-TAINED study including baseline visit data from 351 patients with moderate-to-severe AD treated with upadacitinib in real-world settings in Germany. Results show that patients treated with upadacitinib met German checklist criteria for systemic therapy.4 P0535 E-Poster About Atopic Dermatitis Atopic dermatitis is a chronic, relapsing inflammatory condition characterized by a cycle of intense itching and scratching leading to cracked, scaly, oozing skin.8,9 It affects up to an estimated 10% of adults and 24.6% of adolescents.9-11 Between 20% and 46% of adults with atopic dermatitis have moderate-to-severe disease.12 The range of symptoms poses significant physical, psychological and economic burden on individuals impacted by the disease.9,13 About Measure Up 1 and Measure Up 2 Measure Up 1 and Measure Up 2 are Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled studies designed to evaluate the safety and efficacy of RINVOQ in adult and adolescent (12 years or older) patients with moderate to severe atopic dermatitis who are candidates for systemic treatment. Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg or placebo. The co-primary endpoints were the percentage of patients achieving EASI 75 and a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 after 16 weeks of treatment. Patients receiving placebo were switched to either RINVOQ 15 mg or RINVOQ 30 mg at week 16.14,15 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. In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.16 Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, giant cell arteritis, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo.17-22 EU Indications and Important Safety Information about RINVOQ® (upadacitinib)23 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. 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. 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. 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 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 nonsteroidal antiinflammatory 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. 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. 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 in adolescents was similar to that in adults. The safety and efficacy of the 30 mg dose in adolescents are still being investigated. 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. 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. 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 AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References: Eyerich K, Mendes-Bastos P, Holzer G, et al. Efficacy of upadacitinib in treating atopic dermatitis in the head and neck regions. Poster presented at: European Academy of Dermatology and Venereology Congress; September 25-28, 2024; Amsterdam, the Netherlands. ePoster P0734. Silverberg JI, et al. Patient burden and quality of life in atopic dermatitis in US adults: a population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340-C347. doi:10.1016/j.anai.2018.07.006 Gooderham MJ, Pereyra-Rodriguez JJ, Sinclair R, et al. Effectiveness of upadacitinib in adults and adolescents with atopic dermatitis: 6-month interim analysis of the real-world multicountry AD-VISE study. Poster presented at: European Academy of Dermatology and Venereology Congress; September 25-28, 2024; Amsterdam, the Netherlands. ePoster P0683. Weidinger S, Pinter A, Weyergraf T, et al. Baseline criteria from a real world non-interventional study with upadacitinib for the treatment of systemic atopic dermatitis: an analysis based on guideline criteria. Poster presented at: European Academy of Dermatology and Venereology Congress; September 25-28, 2024; Amsterdam, the Netherlands. ePoster P0535. Wollenberg A, Gooderham M, Katoh N, et al. Patient-reported burden in adults with atopic dermatitis: an international qualitative study. Arch Dermatol Res. 2024;316(7):380. doi:10.1007/s00403-024-03130-w Hang L, Aroman MS, Taieb C, et al. The impact of eczema involving visible areas of the skin on patients' quality of life. JEADV Clin Pract. 2022;1:105-110. doi:10.1002/jvc2.20 Silverberg JI, Bunick C, Hong HC, et al. Efficacy and safety of upadacitinib vs dupilumab in adults and adolescents with moderate-to-severe atopic dermatitis: results of an open-label, efficacy assessor-blinded head-to-head phase 3b/4 study (Level Up). Paper presented at: European Academy of Dermatology and Venereology Congress; September 25-28, 2024; Amsterdam, the Netherlands. FC08.04. Nutten S. Atopic dermatitis: global epidemiology and risk factors. Ann Nutr Metab. 2015;66(suppl 1):8-16. doi:10.1159/000370220 Weidinger S, Beck LA, Bieber T, Kabashima K, Irvine A. Atopic dermatitis. Nat Rev Dis Primers. 2018;4(1):1. doi:10.1038/s41572-018-0001-z Simpson EL, Paller AS, Siegfried EC, et al. Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis: a phase 3 randomized clinical trial. JAMA Dermatol. 2020;156(1):44-56. doi:10.1001/jamadermatol.2019.3336 Blauvelt A, Guttman-Yassky E, Paller AS, et al. Long-term efficacy and safety of dupilumab in adolescents with moderate-to-severe atopic dermatitis: results through week 52 from a phase III open-label extension trial (LIBERTY AD PED-OLE). Am J Clin Dermatol. 2022;23(3):365-383. doi:10.1007/s40257-022-00683-2 Shrestha S, Miao R, Wang L, Chao J, Yuce H, Wei W. Burden of atopic dermatitis in the United States: analysis of healthcare claims data in the commercial, Medicare, and Medi-Cal databases. Adv Ther. 2017;34(8):1989-2006. doi:10.1007/s12325-017-0582-z European Federation of Allergy and Airways Diseases Patients' Associations. Atopic eczema: itching for life report—quality of life and costs for people with severe atopic eczema in Europe. Published July 2018. Accessed August 28, 2023. Evaluation of upadacitinib in adolescent and adult patients with moderate to severe atopic dermatitis (eczema) (Measure Up 1). ClinicalTrials.gov identifier: NCT03569293. Updated March 5, 2024. Accessed April 9, 2024. A study to evaluate upadacitinib in adolescents and adults with moderate to severe atopic dermatitis (Measure Up 2). ClinicalTrials.gov identifier: NCT03607422. Updated March 5, 2024. Accessed April 9, 2024. RINVOQ. Summary of product characteristics. AbbVie. Accessed September 19, 2024. A study to evaluate the safety and effectiveness of upadacitinib tablets in adult and adolescent participants with severe alopecia areata (Up-AA). ClinicalTrials.gov identifier: NCT06012240. Updated September 19, 2024. Accessed September 19, 2024. A study to evaluate the safety and efficacy of upadacitinib in participants with giant cell arteritis (SELECT-GCA). ClinicalTrials.gov identifier: NCT03725202. Updated February 23, 2024. Accessed September 19, 2024. A study to assess change in disease activity and adverse events of oral upadacitinib in adult and adolescent participants with moderate to severe hidradenitis suppurativa who have failed anti-TNF therapy (Step-Up HS). ClinicalTrials.gov identifier: NCT05889182. Updated August 29, 2024. Accessed April 9, 2024. A study to evaluate the efficacy and safety of upadacitinib in participants with Takayasu arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov identifier: NCT04161898. Updated March 22, 2024. Accessed April 9, 2024. 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 identifier: NCT05843643. Updated September 19, 2024. Accessed April 9, 2024. A study to assess adverse events and effectiveness of upadacitinib oral tablets in adult and adolescent participants with vitiligo (Viti-Up). ClinicalTrials.gov identifier: NCT06118411. Updated March 28, 2024. Accessed April 9, 2024. RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2024. SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

At week 24, upadacitinib met the primary endpoint of percent change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) with 11 mg and 22 mg doses versus placebo in adults with non-segmental vitiligo (NSV)1 At week 52, the percent reduction from baseline in F-VASI was numerically greater than results at week 24 for all upadacitinib doses1,2 The safety pro consistent with the known safety pro upadacitinib1,2 NORTH CHICAGO, Ill., Oct. 11, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that its Phase 2b study evaluating upadacitinib (RINVOQ®) in adults with non-segmental vitiligo (NSV) met the primary endpoint of percent change from baseline in the Facial Vitiligo Area Scoring Index (F-VASI) at week 24 with the 11 mg and 22 mg doses versus placebo.1 The percent reduction from baseline in F-VASI at week 52 was numerically greater than results at week 24 for all upadacitinib doses.2 No new safety signals were identified beyond the known safety pro upadacitinib. Based on these data, AbbVie is advancing its clinical program of upadacitinib in vitiligo to Phase 3. "There is a high unmet need in vitiligo, with no systemic treatment options approved, leaving patients frustrated in seeking options for re-pigmentation of the skin," said Roopal Thakkar, M.D., senior vice president, development and regulatory affairs and chief medical officer, AbbVie. "We will continue to apply our significant experience in advancing research and driving innovation in treatments for immune-mediated diseases, including underserved diseases with high burden on patients, such as vitiligo." At week 24, upadacitinib achieved the primary endpoint of percent change from baseline (%CFB) in F-VASI with 11 mg and 22 mg doses versus placebo. F-VASI is a tool that measures re-pigmentation of the face and is used to assess the extent of re-pigmentation and treatment response in clinical trials.3 Higher response rates were also observed with upadacitinib versus placebo in secondary endpoints, including F-VASI 75 (≥75% reduction from baseline in F-VASI) at week 24 with the 11 mg and 22 mg doses and Total Vitiligo Area Scoring Index (T-VASI) 50 (≥50% reduction from baseline in T-VASI) at Week 24 with the 22 mg dose. The mean percent reduction from baseline in F-VASI was numerically greater at week 52 than results at week 24 for all upadacitinib dose groups.2 In addition, response rates observed for F-VASI 75 and T-VASI 50 at week 52 were numerically greater than those at week 24 for all upadacitinib dose groups.2 Among patients who continued upadacitinib treatment through week 52, %CFB in F-VASI and response rates for F-VASI 75 and T-VASI 50 were as follows: "Vitiligo impacts millions of people globally, and there is no cure. The disease can have a great impact on patients' physical and mental health, as depigmentation of the skin can be severe," said Thierry Passeron, M.D., Ph.D., professor and chair, Department of Dermatology, Université Côte d'Azur. "In vitiligo, it can take time to see optimal skin re-pigmentation during treatment, which makes long-term studies critical to providing valuable insights on a treatment's meaningful impact for patients." No new safety signals were observed beyond the known safety pro upadacitinib.1,2 Treatment-emergent adverse event (TEAE) rates were generally similar with upadacitinib and placebo in period 1 (most common TEAEs: COVID-19, acne, headache, and nasopharyngitis). Numerically higher rates of serious TEAEs and TEAEs leading to study drug discontinuation were observed in the upadacitinib 22 mg group versus the other groups. One death adjudicated as undetermined/unknown cause and deemed by the investigator to have no reasonable possibility of being related to study drug occurred in the upadacitinib 22 mg group (period 1). One adjudicated event of nonfatal ischemic stroke occurred with upadacitinib 11 mg (period 2) in a patient with known cardiovascular risk factors. One event of malignancy (breast cancer) occurred with upadacitinib 11 mg (period 2) in a patient with positive family history of breast cancer. Throughout the study, a single event of serious infection (COVID-19 pneumonia) was reported in the upadacitinib 22 mg group. There were no adjudicated events of venous thromboembolism, gastrointestinal perforation, or active tuberculosis.2 The use of upadacitinib in vitiligo is not approved and its safety and efficacy have not been evaluated by regulatory authorities. Vitiligo is a chronic, immune condition that affects up to 2% of the global population.4 The disease is unique to each patient, where white patches of depigmentation develop on the skin, most often around the mouth and eyes, fingers and wrists, armpits and groin.5 The most bothersome patches appear on the face, which makes F-VASI a key measure of clinical improvement in vitiligo for patients and dermatologists.3 NSV is the most common form of vitiligo – affecting approximately eight in 10 people with vitiligo6 – in which patches appear on both sides of the body symmetrically, and may spread over time.5 People with vitiligo can also experience an emotional and psychological burden that can impact their quality of life.4 The 24-week data in this release and partial 52-week data are being presented as an oral presentation during the European Academy of Dermatology and Venerology (EADV) Congress in Berlin, Germany, on October 12, 2023. The partial 52-week data is based on the data cutoff date of January 13, 2023. Approximately 58% of patients had an opportunity to reach 52-week at that time. The full 52-week data in this release will be presented at an upcoming medical meeting. About the Phase 2 Study in Vitiligo1,2 The 52-week, Phase 2b multicenter, randomized, double-blind, placebo-controlled study (NCT04927975) comprises two periods. Enrolled patients were aged 18–66 years with NSV, a Facial Vitiligo Area Scoring Index (F-VASI) of 1.1 and a Total Vitiligo Area Scoring Index (T-VASI) of 22, both mean scores at baseline. In period one, 185 patients (18 to 65 years old) were randomly assigned to once-daily upadacitinib 22 mg (N=43), upadacitinib 11 mg (N=47), upadacitinib 6 mg (N=49), or placebo (N=46) for 24 weeks of treatment. 166 patients (89.7%) continued to a 28-week blinded extension (period two). In period two, patients receiving upadacitinib during period one continued their respective regimens (upadacitinib 22 mg, N=33; upadacitinib 11 mg, N=45; upadacitinib 6 mg, N=45); patients who received placebo in period one were pre-assigned to receive either upadacitinib 11 mg (N=21) or upadacitinib 22 mg (N=22) in period 2. About RINVOQ® (upadacitinib)8 Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor with seven approved indications and is currently being studied in several immune-mediated diseases.7,8 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.8 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. Use of upadacitinib in vitiligo is not approved and its safety and efficacy have not been evaluated by regulatory authorities. EU Indications and Important Safety Information about RINVOQ® (upadacitinib)8 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. 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. 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. 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 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 nonsteroidal antiinflammatory 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. 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. 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. 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 pro in patients with psoriatic arthritis or active axial spondyloarthritis treated with RINVOQ 15 mg was consistent with the safety pro 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 pro RINVOQ 15 mg in adolescents was similar to that in adults. The safety and efficacy of the 30 mg dose in adolescents are still being investigated. 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, neutropaenia, rash, pneumonia, hypercholesterolemia, bronchitis, aspartate transaminase increased, fatigue, folliculitis, alanine transaminase increased, herpes simplex, and influenza. The overall safety pro in patients with UC was generally consistent with that observed in patients with RA. Overall, the safety pro in patients with CD treated with RINVOQ was consistent with the known safety pro RINVOQ. The most common serious adverse reactions were serious infections. The safety pro upadacitinib with long–term treatment was generally similar to the safety pro the placebo–controlled period across indications. 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 AbbVie in Dermatology For more than a decade, AbbVie has worked to uncover new solutions and improve care for people with serious skin diseases, including psoriasis, psoriatic arthritis, hidradenitis suppurativa and atopic dermatitis. With a broad clinical trial program, we continue to actively research and adapt to the evolving needs of the dermatology community and advance our pipeline to help people achieve their treatment goals and live beyond their skin disease. For more information, visit AbbVie in dermatology. About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2022 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References Hamzavi, I., et al. Efficacy and Safety of Upadacitinib in a Phase 2, Double-Blind, Dose-Ranging Study of Adults With Extensive Non-Segmental Vitiligo. 2023 European Academy of Dermatology and Venereology (EADV) Congress. October 2023. AbbVie. Data on file: ABVRRTI77148 Kitchen H, et al. Meaningful Changes in What Matters to Individuals with Vitiligo: Content Validity and Meaningful Change Thresholds of the Vitiligo Area Scoring Index (VASI). Dermatol Ther (Heidelb). 2022 Jul;12(7):1623-1637. doi: 10.1007/s13555-022-00752-8. Epub 2022 Jun 30. PMID: 35773559; PMCID: PMC9245872. Krüger C, Schallreuter KU. Int J Dermatol. 2012;51(10):1206–12 National Health Service. Vitiligo. Available at: (also,openings%2C%20such%20as%20the%20eyes. Accessed September 2023. Gandhi K, Ezzedine K, Anastassopoulos KP, Patel R, Sikirica V, Daniel SR, Napatalung L, Yamaguchi Y, Baik R, Pandya AG. Prevalence of Vitiligo Among Adults in the United States. JAMA Dermatol. 2022 Jan 1;158(1):43-50. doi: 10.1001/jamadermatol.2021.4724. PMID: 34787670; PMCID: PMC8600454. Pipeline – Our Science | AbbVie. 2023. Available at: . Accessed September 2023. RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co KG. Available at: View original content: SOURCE AbbVie Company Codes: NYSE:ABBV

Three ongoing, randomized, double-blind, multicenter Phase 3 studies demonstrated the long-term efficacy and safety pro RINVOQ® (upadacitinib) in treating moderate to severe atopic dermatitis based on results across 140 weeks1 Response rates for EASI 75 and vIGA-AD 0/1 (co-primary endpoints) and for EASI 90 and WP-NRS 0/1 at week 16 were sustained through week 140 among patients treated with RINVOQ1 Safety results were consistent with the known safety pro upadacitinib, with no new safety signals observed1 Data will be presented as an oral presentation at the 32nd European Academy of Dermatology and Venereology (EADV) Congress NORTH CHICAGO, Ill., Oct. 11, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new data analyses from the Measure Up 1, Measure Up 2 and AD Up Phase 3 studies that further demonstrated the long-term efficacy and safety pro RINVOQ® (upadacitinib) among adults and adolescents 12 years and older with moderate to severe atopic dermatitis through 140 weeks. Study results will be orally presented on Wednesday, October 11, at the 32nd European Academy of Dermatology and Venereology (EADV) Congress in Berlin. "Patients with moderate to severe atopic dermatitis often face relentless itch and inflammatory skin symptoms that can impact their everyday lives," said Mudra Kapoor, M.D., vice president, global medical affairs, immunology, AbbVie. "These results reinforce our commitment to providing an effective, long-term treatment option for those living with this debilitating disease and other chronic, immune-mediated conditions." In the Measure Up 1, Measure Up 2 and AD Up Phase 3 studies, a significantly higher proportion of patients treated with upadacitinib (15 mg or 30 mg) achieved the co-primary endpoints of improvement in skin clearance, measured by an EASI score of 75 (EASI 75) and vIGA-AD 0/1 at week 16, compared to those who received placebo.1 Additionally, more upadacitinib-treated patients achieved the secondary endpoint of improvement in skin clearance, measured by an EASI score of 90 (EASI 90), and an additional endpoint of itch reduction (WP-NRS 0/1) at week 16, compared to placebo-treated patients.1 The efficacy of both upadacitinib doses was consistently maintained for these important measures across all three studies through week 140.1 Upadacitinib (15 mg and 30 mg) was generally well tolerated, and the safety data in the long-term extension of the three studies were consistent with the known safety pro upadacitinib, with no new safety signals observed.1 These results demonstrated that when taken continuously for a long-term period, upadacitinib has an acceptable benefit and risk pro the treatment of moderate to severe atopic dermatitis. Additionally, the most common adverse events across all three studies were COVID-19, upper respiratory tract infection, acne and nasopharyngitis.1 The full safety data for these studies will be presented at EADV. "We are encouraged by these results as they solidify upadacitinib's potential to improve care for people living with atopic dermatitis," said Jonathan Silverberg, M.D., Ph.D., MPH, professor of dermatology and director of clinical research at the George Washington University School of Medicine and Health Sciences. "While upadacitinib has been shown to be an effective treatment option for patients with atopic dermatitis in the short term, these data demonstrate a consistent safety pro efficacy with long-term treatment." About Measure Up2 Measure Up 1 and Measure Up 2 are Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled studies designed to evaluate the safety and efficacy of RINVOQ in adult and adolescent (12 years or older) patients with moderate to severe atopic dermatitis who are candidates for systemic treatment. Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg or placebo. The co-primary endpoints were the percentage of patients achieving EASI 75 and a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 after 16 weeks of treatment. Patients receiving placebo were switched to either RINVOQ 15 mg or RINVOQ 30 mg at week 16. About AD Up3 AD Up is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ in adult and adolescent (12 years or older) patients with moderate to severe atopic dermatitis who are candidates for systemic treatment. Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg or placebo, all in combination with topical corticosteroids (TCS). The co-primary endpoints were the percentage of patients achieving EASI 75 and a vIGA-AD of 0/1 after 16 weeks of treatment. Patients receiving placebo plus TCS were switched to either RINVOQ 15 mg or RINVOQ 30 mg plus TCS at week 16. About Atopic Dermatitis Atopic dermatitis is a chronic, relapsing inflammatory condition characterized by a cycle of intense itching and scratching leading to cracked, scaly, oozing skin.4,5 It affects up to an estimated 10 percent of adults and 24.6 percent of adolescents.5-7 Between 20 and 46 percent of adults with atopic dermatitis have moderate to severe disease.8 The range of symptoms poses significant physical, psychological and economic burden on individuals impacted by the disease.5,9 About RINVOQ® (upadacitinib)10 Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor with seven approved indications and is currently being studied in several further immune-mediated diseases.10 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.10 EU Indications and Important Safety Information about RINVOQ® (upadacitinib)10 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. 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. 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. 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, randomized study of tofacitinib (another 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 nonsteroidal 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. 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. 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. 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 pro in patients with psoriatic arthritis or active axial spondyloarthritis treated with RINVOQ 15 mg was consistent with the safety pro 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 pro RINVOQ 15 mg in adolescents was similar to that in adults. The safety and efficacy of the 30 mg dose in adolescents are still being investigated. 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, neutropaenia, rash, pneumonia, hypercholesterolemia, bronchitis, aspartate transaminase increased, fatigue, folliculitis, alanine transaminase increased, herpes simplex, and influenza. The overall safety pro in patients with UC was generally consistent with that observed in patients with RA. Overall, the safety pro in patients with CD treated with RINVOQ was consistent with the known safety pro RINVOQ. The most common serious adverse reactions were serious infections. The safety pro upadacitinib with long–term treatment was generally similar to the safety pro the placebo–controlled period across indications. 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 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. AbbVie Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2022 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References: Silverberg, J, et al. Efficacy and Safety of Upadacitinib Through 140 Weeks in Adolescents and Adults with Moderate-to-Severe Atopic Dermatitis: Phase 3 Randomized Clinical Trial Results. 2023 European Academy of Dermatology and Venereology (EADV) Congress. October 2023. Guttman-Yassky E., et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021; 397(10290): 2151-2168. doi:10.1016/S0140-6736(21)00588-2. Reich K, Teixeira HD, Bruin-Weller, et al. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021; 397(10290): 2169-2181. Nutten S. Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr Metab 2015;66(suppl 1):8–16. doi: 10.1159/000370220. Weidinger, S., et al. Atopic dermatitis. Nat Rev Dis Primers 4, 1(2018). doi: 10.1038/s41572-018-0001-z. Simpson EL, Paller AS, Siegfried EC, et al. Efficacy and Safety of Dupilumab in Adolescents With Uncontrolled Moderate to Severe Atopic Dermatitis: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2020;156(1):44-56. doi:10.1001/jamadermatol.2019.3336 Blauvelt A, Guttman-Yassky E, Paller AS, et al. Long-Term Efficacy and Safety of Dupilumab in Adolescents with Moderate-to-Severe Atopic Dermatitis: Results Through Week 52 from a Phase III Open-Label Extension Trial (LIBERTY AD PED-OLE). Am J Clin Dermatol. 2022;23(3):365-383. doi:10.1007/s40257-022-00683-2 Shrestha S., et al. Burden of Atopic Dermatitis in the United States: Analysis of Healthcare Claims Data in the Commercial, Medicare, and Medi-Cal Databases. Adv Ther. 2017;34(8):1989–2006. EFA. Atopic Eczema: Itching for Life Report. 2018. Available at: . Accessed on August 28, 2023. Abbvie, Ltd. RINVOQ (upadacitinib) [summary of product characteristics]. Accessed August 28, 2023. Company Codes: NYSE:ABBV