Papilloma

RINVOQ is the first and only oral Janus kinase (JAK) inhibitor approved in the European Union (EU) to treat adult patients with giant cell arteritis (GCA) The approval is supported by data from the pivotal Phase 3 SELECT-GCA trial which demonstrated that RINVOQ achieved the primary endpoint of sustained remission* and key secondary endpoints, including reduction in disease flares, lower cumulative steroid exposure and complete remission †1 This marks the eighth approved indication for RINVOQ in the EU2 NORTH CHICAGO, Ill., April 8, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Commission (EC) granted marketing authorization to RINVOQ® (upadacitinib; 15 mg, once daily) for the treatment of giant cell arteritis (GCA) in adult patients. RINVOQ is the first and only oral JAK inhibitor approved in the EU, as well as Iceland, Liechtenstein and Norway, for the treatment of adult patients with GCA. "GCA is a challenging and often debilitating condition. Patients may endure headaches, jaw pain and muscle aches, with many fearing sudden and permanent vision loss,"3 said Prof. Dr. med. Wolfgang Schmidt, M.D., MACR, Waldfriede Hospital, Department of Rheumatology, Berlin, Germany, and SELECT-GCA trial investigator. "Results from the SELECT-GCA trial show that patients can achieve sustained remission and reduce their cumulative steroid exposure with RINVOQ, addressing important patient goals in the treatment of GCA." GCA is an autoimmune disease that causes inflammation of the temporal and other cranial arteries, the aorta, and other large and medium arteries. GCA generally impacts patients older than 50 years, most commonly between the ages of 70 and 80 years.3 "The EC approval of RINVOQ in GCA provides patients and physicians with a new treatment option and the first oral advanced therapy for adults living with GCA – a particularly vulnerable population due to older age and frequent comorbidities,"3,4 said Roopal Thakkar, M.D., executive vice president, research & development, chief scientific officer, AbbVie. "This exciting milestone demonstrates our commitment to ongoing research and expanding indications in areas of high unmet need to help patients achieve better outcomes, including sustained disease remission." The EC approval is supported by data from the Phase 3 SELECT-GCA trial, which was recently published in the New England Journal of Medicine.1 In this trial, primary and key secondary endpoints were achieved with RINVOQ 15 mg and a 26-week steroid taper regimen compared to placebo in combination with a 52-week steroid taper regimen.1 Primary endpoint results from the Phase 3 SELECT-GCA trial demonstrated: Sustained remission*: 46.4% of patients receiving RINVOQ 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission at week 52, compared with 29.0% of patients receiving placebo in combination with a 52-week steroid taper regimen (p=0.002).1 Key secondary endpoints included: Reduction in disease flares: 34.3% of patients receiving RINVOQ 15 mg in combination with a 26-week steroid taper regimen experienced at least one disease flare through week 52 versus 55.6% of patients receiving placebo in combination with a 52-week steroid taper regimen (p=0.001).1 Lower cumulative steroid exposure: Through 52 weeks, cumulative steroid exposure was significantly lower for patients receiving RINVOQ 15 mg in combination with a 26-week steroid taper regimen than for patients receiving placebo in combination with a 52-week steroid taper regimen (median exposure of 1615 mg versus 2882 mg, respectively; p<0.001).1 Sustained complete remission†: 37.1% of patients receiving RINVOQ 15 mg in combination with a 26-week steroid taper regimen achieved sustained complete remission through week 52, compared with 16.1% of patients receiving placebo in combination with a 52-week steroid taper regimen (p<0.001).1 During the 52-week, placebo-controlled period, the safety profile of RINVOQ was generally consistent with that observed in other approved indications.2 Similar rates of serious adverse events were observed in patients receiving RINVOQ 15 mg and in those receiving placebo.1 Serious infections occurred in 5.7% of the RINVOQ 15 mg group and 10.7% of the placebo group.1 The proportions of patients with events of interest were balanced across treatment groups for incidence of malignancy (excluding nonmelanoma skin cancer; 1.9% in the RINVOQ 15 mg group vs 1.8% in the placebo group) and venous thromboembolism (3.3% in the RINVOQ 15 mg group vs 3.6% in the placebo group).1 There were no adjudicated major adverse cardiac events (MACEs) in the RINVOQ 15 mg group, compared with two events in the placebo group.1 Four treatment-emergent deaths were reported, two in the placebo group and two in the RINVOQ 15 mg group. Of the two treatment-emergent deaths in the RINVOQ 15 mg group, one was attributed to COVID-19 and the other was adjudicated as an unexplained cause.1 RINVOQ is approved in the EU for the treatment of adults with radiographic axial spondylarthritis, nonradiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, adults and adolescents with atopic dermatitis, and now adults with GCA.2 *Sustained remission is defined as having an absence of GCA signs and symptoms from week 12 through week 52 and adherence to the protocol-defined steroid taper over the course of the study term.1 †Sustained complete remission is defined as having an absence of GCA signs and symptoms from week 12 through week 52, adherence to the protocol-defined steroid taper, and normalization of both erythrocyte sedimentation rate and high-sensitivity C-reactive protein from week 12 through week 52.1 About Giant Cell Arteritis Giant cell arteritis (GCA), also known as temporal arteritis, is an autoimmune disease of medium and large arteries, characterized by granulomatous inflammation of the three-layered vessel wall, which affects temporal and other cranial arteries as well as the aorta and other large arteries.3,5 GCA can cause headache, jaw pain, and changes in or loss of vision, including sudden and permanent loss of vision.3 It is the most common vasculitis affecting adults in western countries.3 White women over the age of 50 – most commonly between the ages of 70 and 80 years – have the highest risk of developing GCA. Although women are more likely than men to develop GCA, research suggests that men are more likely to have ocular manifestations with their disease.6 About SELECT-GCA SELECT-GCA (M16-852) is a Phase 3, multicenter, randomized, double-blind placebo-controlled study designed to evaluate the safety and efficacy of upadacitinib in 428 patients with GCA. The study consists of two parts. The first part, which is reported in this release, evaluated the efficacy of upadacitinib in combination with a 26-week corticosteroid taper regimen compared with placebo in combination with a 52-week corticosteroid taper regimen. In addition, the study assessed the safety and tolerability of upadacitinib in these patients. The efficacy and safety of withdrawing versus continuing upadacitinib in maintaining remission in participants who achieved sustained remission in the first part will be evaluated in the second part of the study.7 Top-line results of part one of the study were shared in April 2024. For more information regarding this study, please visit ClinicalTrials.gov (identifier: NCT03725202). About Upadacitinib (RINVOQ®) Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.2,8 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK 1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.2 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.9-14 EU Indications and Important Safety Information about RINVOQ® (upadacitinib)2 Indications Giant cell arteritis RINVOQ is indicated for the treatment of giant cell arteritis (GCA) in adult patients. 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. Medication Residue in Stool Reports of medication residue in stool or ostomy output have occurred in patients taking RINVOQ. 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. Glucocorticoids should be given according to medical judgement and practice guidelines. 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. 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. 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. Overall, the safety profile observed in patients with GCA treated with RINVOQ 15 mg was generally consistent with the known safety profile for RINVOQ. 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 Rheumatology For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Anchored by a longstanding commitment to discovering and delivering transformative therapies, we pursue cutting-edge science that improves our understanding of promising new pathways and targets, ultimately helping more people living with rheumatic diseases reach their treatment goals. For more information, visit AbbVie in rheumatology. 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, 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 2024 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 Blockmans D, Penn SK, Setty AR, et al. A phase 3 trial of upadacitinib for giant-cell arteritis. N Engl J Med. Published online April 2, 2025; doi:10.1056/NEJMoa2413449. RINVOQ. Summary of Product Characteristics. AbbVie; 2025. Ameer MA, Peterfy RJ, Khazaeni B. Giant cell arteritis (temporal arteritis). Updated August 8, 2023. Mohammad AJ, Englund M, Turesson C, et al. Rate of Comorbidities in Giant Cell Arteritis: A Population-based Study. J Rheumatol. 2017;44(1):84-90. doi:10.3899/jrheum.160249 Weyand CM, Goronzy JJ. Immunology of giant cell arteritis. Circ Res. 2023;132(2):238-250. doi:10.1161/CIRCRESAHA.122.322128 Giant cell arteritis. Arthritis Foundation. Accessed January 9, 2025. AbbVie. Data on file: ABVRRTI78418. Pipeline. AbbVie. 2023. Accessed January 9, 2025. A study to evaluate the safety and efficacy of upadacitinib in participants with giant cell arteritis (SELECT-GCA). ClinicalTrials.gov identifier: NCT03725202. Accessed January 9, 2025. A study to evaluate the efficacy and safety of upadacitinib in participants with Takaysu arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov identifier: NCT04161898. Accessed January 9, 2025. Program to assess adverse events and change in disease activity of oral upadacitinib in adult participants with moderate to severe systemic lupus erythematosus (SELECT-SLE). ClinicalTrials.gov identifier: NCT05843643. Accessed January 9, 2025. A study to assess change in disease activity and adverse events of oral upadacitinib in adult and adolescent participants with moderate to severe hidradenitis suppurativa who have failed anti-TNF therapy (Step-Up HS). ClinicalTrials.gov identifier: NCT05889182. Accessed January 9, 2025. 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. Accessed January 9, 2025. A study to evaluate the safety and effectiveness of upadacitinib tablets in adult and adolescent participants with severe alopecia areata (UP-AA). ClinicalTrials.gov identifier: NCT06012240. Accessed January 9, 2025. SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Significant progress toward submitting a biologics license application (BLA) for INO-3107 as a potential treatment for recurrent respiratory papillomatosis (RRP) Resolved previously announced manufacturing issue concerning the single-use array component of the CELLECTRA device and completed drafting of all non-device BLA modules On track to begin rolling submission of BLA in mid-2025 and to request priority review with goal of completing the submission in the second half of 2025 and receiving acceptance of the submission by end of the year Announced durability data from retrospective study showing that 50% of patients achieved a Complete Response in the second 12-month period (year 2) with 86% of patients showing a reduction in surgery of 50% or greater in year 2; data to be included in BLA submission Announced promising interim results from ongoing proof-of-concept Phase 1 trial showing DNA-encoded monoclonal antibodies (DMAb) targeting COVID-19 were well tolerated and exhibited long-lasting in vivo production DMAb technology has the potential to overcome traditional monoclonal antibody production challenges, such as short half-life and anti-drug immune responses, making it a potentially promising platform for a broad range of diseases DNA Medicine technology has the potential to provide long term production of therapeutic antibodies and deliver a broad spectrum of therapeutic proteins that could be used to treat diseases with missing or defective proteins Resolved previously announced manufacturing issue concerning the single-use array component of the CELLECTRA device and completed drafting of all non-device BLA modules On track to begin rolling submission of BLA in mid-2025 and to request priority review with goal of completing the submission in the second half of 2025 and receiving acceptance of the submission by end of the year Announced durability data from retrospective study showing that 50% of patients achieved a Complete Response in the second 12-month period (year 2) with 86% of patients showing a reduction in surgery of 50% or greater in year 2; data to be included in BLA submission DMAb technology has the potential to overcome traditional monoclonal antibody production challenges, such as short half-life and anti-drug immune responses, making it a potentially promising platform for a broad range of diseases DNA Medicine technology has the potential to provide long term production of therapeutic antibodies and deliver a broad spectrum of therapeutic proteins that could be used to treat diseases with missing or defective proteins PLYMOUTH MEETING, Pa., March 18, 2025 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced its financial results and operational highlights for the fourth quarter and full year ended December 31, 2024 and provided a business update and description of operational highlights during the year. "INOVIO's recent progress puts us on the cusp of achieving several long-term goals for our DNA medicines, most importantly the submission of our first BLA and potential transition to a commercial-stage company," said Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer. "By resolving the previously announced device array component issue, we are back on track to submitting our first BLA for INO-3107 to the FDA. We anticipate starting our submission in mid-2025 with non-device related modules under the agency's rolling submission program, assuming it is granted, with the goal of having the complete submission accepted for priority review before the end of the year. We continue to believe that INO-3107 has the potential to be the preferred product candidate offering durable clinical benefit, tolerability and a patient-centric dosing regimen and are moving forward with urgency." Dr. Michael Sumner, INOVIO's Chief Medical Officer, said, "While delivering INO-3107 to patients remains our primary focus, we are extremely pleased with recently announced data from a proof-of-concept trial with our DMAb technology that showed durable in vivo antibody production. DMAbs represent a potential breakthrough as they have the ability to overcome traditional monoclonal antibody production challenges, such as short half-life and anti-drug immune responses. They have the potential to transform treatments for infectious diseases, as well as cancer and metabolic disorders by enabling long-term production of therapeutic antibodies and other proteins. Unlike other delivery platforms, our DNA-based approach has demonstrated sustained antibody production without generating anti-drug antibodies, making it a potentially promising long-term solution for conditions requiring continuous therapeutic protein delivery. We look forward to continuing to advance this technology and other promising pipeline candidates through collaborations and other potential strategic opportunities." Operational Highlights INO-3107 – Recurrent Respiratory Papillomatosis (RRP) Made significant progress toward submitting the BLA by completing the drafting of all non-device modules and resolving the previously announced manufacturing issue involving the single-use array component of the CELLECTRA device and enabling the final step of FDA-required device verification (DV) testing. Reported data from a retrospective trial (RRP-002) showing that patients continued to improve into years two and three following their initial dosing regimen when compared to their response at Week 52. In the trial, one-half of RRP patients treated with INO-3107 achieved a complete response (CR) and required no surgery in the second 12-month period when evaluated at the end of year two. Published and presented the full safety and efficacy data for the Phase 1/2 trial, as well as new immunology data demonstrating the ability of INO-3107 to induce antigen-specific T cell responses against HPV-6 and HPV-11 and drive recruitment of those T cells into airway tissues and papilloma of RRP patients, which could potentially slow or eliminate papilloma regrowth. This data was published in Nature Communications in February 2025. The European Medicines Agency's Committee for Advanced Therapies (CAT) certified the quality and non-clinical data for INO-3107, confirming that CMC data and nonclinical results available to date comply with the scientific and technical standards to be used in evaluating a potential European Marketing Authorization Application. INO-3107 was designated an innovative medicine as part of the U.K.'s Innovative Licensing and Access Pathway (ILAP). Progressed commercial readiness plans, including refining go-to-market strategy focused on patient and physician needs; driving key strategic decisions on pricing and access, product distribution, targeting and segmentation, and product positioning; and developing plans for the build out of the commercial organization. Next Steps: Complete FDA-required design-verification testing - anticipated to be complete in first half of 2025. Update IND and initiate confirmatory trial. Submit BLA to the FDA – anticipate beginning rolling submission process mid-2025 and requesting priority review with goal of completing submission in second half of 2025 and receiving FDA acceptance of submission by year end. Submit a long-term study protocol to the FDA following BLA submission. Present and publish clinical, immunology and durability data at targeted scientific and medical conferences in 2025. INO-3112 - Oropharyngeal Squamous Cell Carcinoma (OPSCC) Advanced development plans for a Phase 3 trial for INO-3112 in combination with LOQTORZI® (toripalimab-tpzi), a recently approved PD-1 inhibitor in the U.S. and Europe. Gained alignment with FDA on the planned Phase 3 trial design and received initial feedback from European regulatory authorities on proposed trial design. Entered into a clinical collaboration and supply agreement with Coherus BioSciences, Inc. for the use of LOQTORZI in the trial. Next Steps: Finalize protocol of the Phase 3 trial in consultation with the FDA. INOVIO anticipates it will conduct the trial in North America and Europe in patients with locoregionally advanced, high-risk, HPV16/18-positive OPSCC. Complete ongoing manufacture of drug supply for trial. Other Pipeline Updates Top-line interim results were announced from an ongoing Phase 1 proof-of-concept trial evaluating DMAbs targeting COVID-19. In the trial, 100% (24/24) of participants who reached week 72 maintained biologically relevant levels of DMAbs, confirming the durability of in vivo antibody production. Notably, no participant developed anti-drug antibodies, a common challenge observed in other gene-based delivery platforms, such as adeno-associated virus mediated antibody expression. Additionally, the DMAbs were well tolerated in the trial, with the most common side effects being mild, temporary injection site reactions, such as pain and redness. The trial is being led by The Wistar Institute in collaboration with INOVIO, AstraZeneca, and the University of Pennsylvania and funded by the Defense Advanced Research Projects Agency (DARPA) and the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND). INOVIO and its partners anticipate additional data to be presented at upcoming scientific conferences and published in a peer-reviewed journal. Advanced development plans for a Phase 2 trial for INO-4201 as a potential booster to ERVEBO® (rVSV-ZEBOV), including gaining alignment with FDA on the trial's protocol and path to potential approval. In 2025, the company anticipates finalizing the trial protocols and seeking funding to support trial activities. INOVIO also plans to submit the data from its completed Phase 1b trial to a peer-reviewed publication for publication, including FANG assay data indicating that boosting with INO-4201 can elicit neutralizing antibody response comparable to that achieved by ERVEBO, an approved primary series vaccination against Ebola. Continued efforts to move INO-5401 into its next stage of development for glioblastoma (GBM), which the company believes will be a controlled Phase 2 trial. INOVIO plans on completing manufacture of drug supply for the next trial during 2025. The Basser Center at the University of Pennsylvania continues evaluating the tolerability and immunogenicity of INO-5401 in a fully enrolled Phase 1 study exploring the potential to prevent cancer in people with BRCA1 or BRCA2 mutations. INOVIO's collaborator, ApolloBio, continues recruitment into its Phase 3 trial evaluating INO-3100 as a potential treatment for HPV 16/18 positive cervical dysplasia in China. Operational and Financial Updates Announced appointment of Steven Egge as Chief Commercial Officer in July 2024. Mr. Egge has broad commercial and therapeutic area experience, including in HPV-related diseases and cancers, vaccines and rare diseases, and has overseen or contributed to more than a dozen commercial product launches throughout his career. Raised over $72 million in gross proceeds from ATM and two offerings of equity securities in April and December 2024. 2024 Financial Results Cash, Cash Equivalents and Short-term Investments: As of December 31, 2024, cash, cash equivalents and short-term investments were $94.1 million compared to $145.3 million as of December 31, 2023. Revenues: Total revenues were $117,000 and $218,000 for the quarter and year ended December 31, 2024, respectively, compared to $103,000 and $832,000 for the same periods in 2023. Research and Development (R&D) Expenses: R&D expenses for the quarter and year ended December 31, 2024 were $12.9 million and $75.6 million, respectively, compared to $17.3 million and $86.7 million for the same periods in 2023. The decrease in R&D expenses was primarily the result of lower employee and consultant compensation, including stock-based compensation, lower drug manufacturing and clinical trial expenses related to INO-4800, partially offset by an increase in drug manufacturing costs related to INO-3107 and higher engineering professional and outside services related to device development, among other variances. General and Administrative (G&A) Expenses: G&A expenses were $7.6 million and $37.0 million, respectively, for the quarter and year ended December 31, 2024, versus $10.2 million and $47.6 million, respectively, for the same periods in 2023. The decrease in G&A expenses was primarily related to a decrease in employee compensation, including stock-based compensation, and a decrease in legal expenses, among other variances. Total Operating Expenses: Total operating expenses were $20.5 million and $112.6 million for the quarter and year ended December 31, 2024, respectively, compared to $27.5 million and $144.8 million for the same period in 2023. Net Loss: INOVIO's net loss for the quarter and year ended December 31, 2024 was $19.4 million, or $0.65 per basic and diluted share, and $107.3 million, or $3.95 per basic and diluted share, respectively, compared to net loss of $25.0 million, or $1.10 per basic and diluted share, and $135.1 million, or $6.09 per basic and diluted share, for the quarter and year ended December 31, 2023, respectively. Shares Outstanding: As of December 31, 2024, INOVIO had 36.1 million common shares outstanding and 50.0 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting, and conversion, as applicable, of its outstanding common stock warrants, pre-funded warrants, stock options, restricted stock units and convertible preferred stock. INOVIO's balance sheet and statement of operations are provided below. Additional information is included in INOVIO's annual report on Form 10-K for the year ended December 31, 2024, which can be accessed at: http://ir.inovio.com/financials/default.aspx. Cash Guidance INOVIO estimates its current cash, cash equivalents and short-term investments balances to support the company's operations into the first quarter of 2026. This projection includes an operational net cash burn estimate of approximately $27 million for the first quarter of 2025. These cash runway projections do not include any further capital-raising activities that INOVIO may undertake. Conference Call / Webcast Information INOVIO's management will host a live conference call and webcast with slides at 4:30 p.m. ET today to discuss INOVIO's financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO's website at http://ir.inovio.com/events-and-presentations/default.aspx. About INOVIO's DNA Medicines Platform INOVIO's DNA medicines platform has two innovative components: precisely designed DNA plasmids, delivered by INOVIO's proprietary investigational medical device, CELLECTRA®. INOVIO uses proprietary technology to design its DNA plasmids, which are small circular DNA molecules that work like software the body's cells can download to produce specific proteins to target and fight disease. INOVIO's proprietary CELLECTRA® delivery devices are designed to optimally deliver its DNA medicines to the body's cells without requiring chemical adjuvants or lipid nanoparticles and without the risk of the anti-vector response historically seen with viral vector platforms. About INOVIO INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit www.inovio.com. Forward-Looking Statements This press release contains certain forward-looking statements relating to our business, including the planned initiation and conduct of pre-clinical studies and clinical trials and the availability and timing of data from those studies and trials, the completion of the FDA-required device verification testing, the planned submission of a BLA in mid-2025 and request for priority review and goal of FDA's acceptance of the submission by the end of 2025, the potential commercial launch of INO-3107 if regulatory approval is obtained, the potential benefits of our product candidates and the expected sufficiency of our cash resources into the first quarter of 2026. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024 and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured, or commercialized, that the results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law. Contacts Media: Jennie Willson, (267) 429-8567, communications@inovio.com Investors: Peter Vozzo, ICR Healthcare, 443-213-0505, investor.relations@inovio.com Inovio Pharmaceuticals, Inc. CONSOLIDATED BALANCE SHEETS December 31, 2024 2023 ASSETS Current assets: Cash and cash equivalents $65,813,297 $14,310,862 Short-term investments 28,300,232 130,982,913 Accounts receivable from affiliated entities 1,199,056 2,405,228 Prepaid expenses and other current assets, including with affiliated entity 2,517,465 5,414,097 Total current assets 97,830,050 153,113,100 Fixed assets, net 3,659,818 4,960,986 Investments in affiliated entity 1,613,844 2,780,287 Operating lease right-of-use assets 8,113,840 9,491,735 Other assets 1,979,654 605,315 Total assets $113,197,206 $170,951,423 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and accrued expenses $16,200,013 $19,847,744 Accounts payable and accrued expenses due to affiliated entities 1,351,163 1,070,519 Accrued clinical trial expenses 2,021,860 2,365,382 Common stock warrant liability 13,255,188 — Operating lease liability 2,497,360 2,406,522 Grant funding liability, including from affiliated entity — 109,407 Convertible senior notes — 16,770,654 Total current liabilities 35,325,584 42,570,228 Operating lease liability, net of current portion 9,367,827 11,032,066 Total liabilities 44,693,411 53,602,294 Commitments and contingencies Inovio Pharmaceuticals, Inc. stockholders' equity: Preferred stock—par value $0.001; Authorized shares: 10,000,000, issued and outstanding shares: 9 at December 31, 2024 and 2023 — — Common stock—par value $0.001; Authorized shares: 600,000,000 at December 31, 2024 and 2023, issued and outstanding: 36,099,991 at December 31, 2024 and 22,793,075 at December 31, 2023 36,099 22,792 Additional paid-in capital 1,799,362,625 1,740,954,074 Accumulated deficit (1,730,219,262) (1,622,965,136) Accumulated other comprehensive loss (675,667) (662,601) Total Inovio Pharmaceuticals, Inc. stockholders' equity 68,503,795 117,349,129 Total liabilities and stockholders' equity $113,197,206 $170,951,423 Inovio Pharmaceuticals, Inc. CONSOLIDATED STATEMENTS OF OPERATIONS For the Year ended December 31, 2024 2023 Revenue from collaborative arrangements and other contracts, including affiliated entity $217,756 $832,010 Operating expenses: Research and development 75,620,340 86,676,563 General and administrative 36,996,338 47,582,104 Impairment of goodwill — 10,513,371 Total operating expenses 112,616,678 144,772,038 Loss from operations (112,398,922) (143,940,028) Other income (expense): Interest income 4,766,993 8,133,290 Interest expense (177,833) (1,222,789) Change in fair value of common stock warrant liability 2,808,608 — (Loss) gain on investment in affiliated entity (1,166,443) 773,145 Net unrealized gain on available-for-sale equity securities 2,077,182 5,850,626 Other expense, net (3,163,711) (4,711,596) Net loss $(107,254,126) $(135,117,352) Net loss per share Basic and diluted $(3.95) $(6.09) Weighted average number of common shares outstanding Basic and diluted 27,160,863 22,173,662 View original content to download multimedia:https://www.prnewswire.com/news-releases/inovio-reports-fourth-quarter-and-full-year-2024-financial-results-and-operational-highlights-302405001.html SOURCE INOVIO Pharmaceuticals, Inc.

The positive opinion is based on results from the pivotal Phase 3 SELECT-GCA trial that evaluated the efficacy and safety of upadacitinib in adults with giant cell arteritis (GCA)1 The primary endpoint of sustained remission* and key secondary endpoints, including reduction in disease flares, lower cumulative steroid exposure, and complete remission,† were met1 GCA is an autoimmune disease that causes inflammation of the large and medium cranial arteries, resulting in potentially debilitating symptoms2 NORTH CHICAGO, Ill., Feb. 28, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of upadacitinib (RINVOQ®; 15 mg, once daily) for the treatment of adult patients with GCA. The final European Commission decision is expected in the first half of 2025. If approved, upadacitinib would be the first and only oral advanced therapy for adults living with GCA. "Giant cell arteritis is an inflammatory disease that, if left untreated, can lead to severe outcomes like blindness, stroke or aortic aneurysm,"2 said Prof. Dr. med. Wolfgang Schmidt, M.D., MACR, Waldfriede Hospital, Department of Rheumatology, Berlin, Germany, and SELECT-GCA trial investigator. "This positive opinion recognizes the unmet need for adults living with giant cell arteritis, and I look forward to the European Commission's final decision." The CHMP positive opinion is supported by data from the pivotal Phase 3 SELECT-GCA clinical trial evaluating the efficacy and safety of upadacitinib in adults 50 years and older with GCA.1 In the first study period, patients were randomized to receive upadacitinib 7.5 mg or 15 mg in combination with a 26-week corticosteroid taper regimen or placebo in combination with a 52-week corticosteroid taper regimen.1 During the 52-week, placebo-controlled period, the safety profile of upadacitinib was generally consistent with that observed in other approved indications.1 "The CHMP's positive opinion for upadacitinib for adults living with giant cell arteritis is an important step toward our goal of improving outcomes for patients suffering with this disease," said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. "We are committed to advancing the standards of care for immune-mediated diseases and addressing unmet patient needs, today and in the future." RINVOQ is approved in the European Union (EU) for the treatment of adults with radiographic axial spondylarthritis, nonradiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and adults and adolescents with atopic dermatitis.3 Use of upadacitinib in GCA is not currently approved in the EU. *Sustained remission is defined as having an absence of GCA signs and symptoms from week 12 through week 52 and adherence to the protocol-defined steroid taper over the course of the study term.1 †Sustained complete remission is defined as having an absence of GCA signs and symptoms from week 12 through week 52, adherence to the protocol-defined steroid taper, and normalization of both erythrocyte sedimentation rate and high-sensitivity C-reactive protein from week 12 through week 52.1 About Giant Cell Arteritis Giant cell arteritis (GCA), also known as temporal arteritis, is an autoimmune disease of medium and large arteries, characterized by granulomatous inflammation of the three-layered vessel wall, which affects temporal and other cranial arteries as well as the aorta and other large arteries.2,4 GCA can cause headache, jaw pain, and changes in or loss of vision, including sudden and permanent loss of vision.2 It is the most common vasculitis affecting adults in western countries.2 White women over the age of 50 – most commonly between the ages of 70 and 80 years – have the highest risk of developing giant cell arteritis. Although women are more likely than men to develop GCA, research suggests that men are more likely to have ocular manifestations with their disease.5 About SELECT-GCA SELECT-GCA (M16-852) is a Phase 3, multicenter, randomized, double-blind placebo-controlled study designed to evaluate the safety and efficacy of upadacitinib in 428 patients with GCA. The study consists of two periods. The first period, which is reported in this release, evaluated the efficacy of upadacitinib in combination with a 26-week corticosteroid taper regimen compared to placebo in combination with a 52-week corticosteroid taper regimen. In addition, the study assessed the safety and tolerability of upadacitinib in these patients. The second period will evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in the first period.6 Top-line results of the study were shared in April 2024. For more information regarding this study, please visit ClinicalTrials.gov (Identifier NCT03725202). About Upadacitinib (RINVOQ®) Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.3,7 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK 1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.3 Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, giant cell arteritis, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus and vitiligo.8-13 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. 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. Medication Residue in Stool Reports of medication residue in stool or ostomy output have occurred in patients taking upadacitinib. 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. 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. 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. 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 in Rheumatology For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Anchored by a longstanding commitment to discovering and delivering transformative therapies, we pursue cutting-edge science that improves our understanding of promising new pathways and targets, ultimately helping more people living with rheumatic diseases reach their treatment goals. For more information, visit AbbVie in rheumatology. 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 2024 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 Blockmans D, Penn SK, Setty A, et al. LBA0001 Efficacy and safety of upadacitinib in patients with giant cell arteritis (SELECT-GCA): a double-blind, randomized controlled phase 3 trial. Ann Rheum Dis. 2024;83(suppl 1):232-233. doi:10.1136/annrheumdis-2024-eular.LBA25 Ameer MA, Peterfy RJ, Khazaeni B. Giant cell arteritis (temporal arteritis). Updated August 8, 2023. RINVOQ. Summary of Product Characteristics. Accessed January 24, 2025. Weyand CM, Goronzy JJ. Immunology of giant cell arteritis. Circ Res. 2023;132(2):238-250. doi:10.1161/CIRCRESAHA.122.322128 Giant cell arteritis. Arthritis Foundation. Accessed January 9, 2025. AbbVie. Data on file: ABVRRTI78418. Pipeline. AbbVie. 2023. Accessed January 9, 2025. A study to evaluate the safety and efficacy of upadacitinib in participants with giant cell arteritis (SELECT-GCA). ClinicalTrials.gov identifier: NCT03725202. Accessed January 9, 2025. A study to evaluate the efficacy and safety of upadacitinib in participants with Takaysu arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov identifier: NCT04161898. Accessed January 9, 2025. Program to assess adverse events and change in disease activity of oral upadacitinib in adult participants with moderate to severe systemic lupus erythematosus (SELECT-SLE). ClinicalTrials.gov identifier: NCT05843643. Accessed January 9, 2025. A study to assess change in disease activity and adverse events of oral upadacitinib in adult and adolescent participants with moderate to severe hidradenitis suppurativa who have failed anti-TNF therapy (Step-Up HS). ClinicalTrials.gov identifier: NCT05889182. Accessed January 9, 2025. 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. Accessed January 9, 2025. A study to evaluate the safety and effectiveness of upadacitinib tablets in adult and adolescent participants with severe alopecia areata (UP-AA). ClinicalTrials.gov identifier: NCT06012240. Accessed January 9, 2025. ALL-RNQR-250052 SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED