Upadacitinib hemihydrate

Companies like Biogen and Royalty Pharma (Litifilimab), Biogen and UCB (Dapirolizumab pegol), Idorsia Pharmaceuticals and Viatris (Cenerimod), Novartis (Ianalumab, YTB3231), Kyowa Kirin (KK-4277), and others are advancing late, mid, and early-stage drugs, showing promise in the systemic lupus erythematosus treatment market. LAS VEGAS, July 9, 2026 /PRNewswire/ -- Systemic lupus erythematosus (SLE) is a chronic, complex autoimmune disease that can affect multiple organ systems, with disease severity and clinical manifestations varying considerably among patients. Despite significant advances in understanding its pathophysiology, SLE remains incurable, and current treatment strategies primarily focus on controlling disease activity, achieving remission or low disease activity, preventing irreversible organ damage, minimizing flares, and improving patients' long-term quality of life. The therapeutic landscape for SLE remains limited, with only two therapies currently approved by the US FDA specifically for the disease: BENLYSTA (belimumab) from GlaxoSmithKline and SAPHNELO (anifrolumab) from AstraZeneca. Conventional treatment continues to rely on nonsteroidal anti-inflammatory drugs (NSAIDs), antimalarial agents, glucocorticoids, immunosuppressants, and other supportive therapies. While glucocorticoids remain a cornerstone of disease management, their well-documented long-term toxicities have intensified efforts to reduce steroid exposure through treat-to-target strategies. The persistent need for multiple lines of therapy and the limitations associated with existing treatments highlight the substantial unmet need for safer and more effective disease-modifying options. Discover what is the future of the systemic lupus erythematosus (SLE) drugs market @ The SLE pipeline is robust and increasingly diverse, with several late-stage and emerging therapies targeting novel immune pathways. Prominent investigational candidates include obinutuzumab (Roche), ianalumab (Novartis), dapirolizumab pegol (Biogen/UCB), upadacitinib (AbbVie), deucravacitinib (Bristol Myers Squibb), litifilimab (Biogen and Royalty Pharma), and other innovative agents that have the potential to improve disease control while reducing treatment-related toxicity. Aparna Thakur, Project Manager of Forecasting at DelveInsight, said that Oral small molecules such as cenerimod (S1P1 modulator), deucravacitinib (TYK2 inhibitor), and upadacitinib (JAK1 inhibitor) target multiple immune pathways in SLE, reflecting a shift toward oral multi-pathway immune modulation in treatment. In parallel, CAR T-cell therapies are emerging as a potentially transformative approach for patients with refractory SLE by enabling targeted B-cell depletion and immune system reprogramming that could deliver durable, treatment-free remission. Leading programs in this space include rapcabtagene autoleucel (YTB-323), zolacabtagene autoleucel, resecabtagene autoleucel (CABA-201), and obecabtagene autoleucel (obe-cel, AUCATZYL), signaling a potential shift from lifelong immunosuppression toward one-time disease-modifying interventions. As per Thakur, CD19-directed CAR-T therapies, including rapcabtagene autoleucel, zolacabtagene autoleucel, and resecabtagene autoleucel, show strong potential in SLE by inducing deep B-cell depletion and durable remission, though safety risks such as CRS and ICANS require intensive monitoring. Reflecting the growing innovation and expanding therapeutic opportunities in this space, DelveInsight estimates that the SLE market across the leading markets, including the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, was valued at approximately USD 3 billion in 2025 and is projected to grow at a CAGR of 10.4% through 2036. Below, we highlight 6 emerging late-stage therapies poised to reshape the future of the systemic lupus erythematosus treatment market. Biogen and Royalty Pharma's Litifilimab CLEC4C protein inhibitors Litifilimab (BIIB059) is a humanized IgG1 monoclonal antibody designed to target BDCA2 (Blood Dendritic Cell Antigen 2) and is being developed as a potential therapy for systemic lupus erythematosus (SLE). BDCA2 is a receptor primarily found on plasmacytoid dendritic cells (pDCs), a specialized immune cell population involved in the production of inflammatory mediators. By binding to BDCA2, litifilimab suppresses pDC activation, thereby reducing the release of type I interferons (IFN-I) along with other proinflammatory cytokines and chemokines implicated in SLE pathogenesis. Biogen is currently evaluating litifilimab in two global Phase III clinical studies, TOPAZ-1 (NCT04895241) and TOPAZ-2 (NCT04961567), for patients with SLE, with topline results anticipated by the end of 2026. In October 2025, the company announced that patient enrollment had been completed for both Phase III trials and that the expected data readout timeline had been accelerated to the second half of 2026. Earlier, in February 2025, Biogen entered into a funding agreement with Royalty Pharma, under which it is eligible to receive up to USD 200 million in 2025 and an additional USD 50 million in 2026 to help support the ongoing development of the litifilimab program. Roche's Obinutuzumab (GAZYVA/GAZYVARO) TSLP inhibitor Obinutuzumab is a glycoengineered monoclonal antibody designed to target the CD20 protein expressed on the surface of lymphoma and leukemia cells. As a type II anti-CD20 antibody, it exhibits greater antibody-dependent cellular cytotoxicity and stronger direct cell-killing activity compared with conventional CD20 antibodies. After binding to CD20, obinutuzumab promotes B-cell destruction by engaging immune effector cells, directly triggering intracellular death-signaling pathways, and activating the complement cascade. In Europe, the therapy is marketed under the name GAZYVARO. In February 2026, Roche submitted regulatory applications in the United States and Europe seeking approval of obinutuzumab for the treatment of Systemic Lupus Erythematosus. Subsequently, in April 2026, Roche announced that the FDA had accepted its supplemental Biologics License Application (sBLA) for obinutuzumab in SLE. The filing is based on positive results from the Phase III ALLEGORY study, which showed a statistically significant and clinically meaningful improvement in the primary endpoint. The FDA is expected to issue a decision on the application by December 2026. Discover more about which pipeline drugs could transform systemic lupus erythematosus treatment @ Systemic Lupus Erythematosus Market Size Novartis' Ianalumab BAFF-R inhibitor, ADCC-mediated B-cell depletor Ianalumab, a novel monoclonal antibody developed by Novartis, targets the B-cell Activating Factor Receptor (BAFF-R). It is designed to inhibit BAFF-R signaling while simultaneously promoting B-cell depletion through antibody-dependent cellular cytotoxicity (ADCC). The therapy is currently being evaluated in two Phase III clinical studies for systemic lupus erythematosus (SLE): NCT05639114 (SIRIUS-SLE 1) and NCT05624749 (SIRIUS-SLE 2). According to Novartis' 2026 interim financial report, topline results from the Phase III SIRIUS-SLE 1 and SIRIUS-SLE 2 trials are expected in 2027. Pending positive outcomes, the company plans to submit Ianalumab for regulatory approval in SLE in 2028. Johnson & Johnson's Nipocalimab (IMAAVY) FcRn blockade Nipocalimab is an investigational immunoselective therapy engineered to selectively bind with high affinity to the neonatal Fc receptor (FcRn), blocking its activity and lowering circulating pathogenic IgG antibodies while maintaining essential immune functions. The therapy is being evaluated across three major autoantibody-driven disease areas: rheumatologic disorders, rare autoantibody-mediated conditions, and maternal-fetal diseases, where inhibiting IgG interaction with FcRn in the placenta is expected to reduce the transfer of harmful maternal alloantibodies to the fetus. In March 2026, Johnson & Johnson announced that the U.S. Food and Drug Administration granted Fast Track Designation (FTD) to nipocalimab for the treatment of Systemic Lupus Erythematosus. Explore systemic lupus erythematosus competitors Johnson & Johnson marketed products @ Systemic Lupus Erythematosus Marketed Drugs Idorsia Pharmaceuticals and Viatris' Cenerimod Sphingosine 1-phosphate receptor modulators Cenerimod is a highly selective Sphingosine-1-Phosphate Receptor 1 (S1P1) modulator administered as a once-daily oral tablet. Although the exact cause of systemic lupus erythematosus remains unclear, dysregulated T and B lymphocytes are recognized as central drivers of disease pathogenesis. By selectively targeting the S1P1 receptor, cenerimod is designed to modulate lymphocyte trafficking and reduce immune-mediated inflammation. The therapy is currently being evaluated in two Phase III clinical trials, OPUS-1 (NCT05648500) and OPUS-2 (NCT05672576), for the treatment of SLE. The US FDA has also granted Fast Track Designation (FTD) to cenerimod, underscoring its potential to address an unmet medical need in SLE. In February 2025, Idorsia Pharmaceuticals amended its collaboration agreement with Viatris for the development of cenerimod. Under the revised terms, Idorsia's contribution toward the drug's 2025 development costs was reduced by USD 100 million. In exchange, the company agreed to a USD 250 million reduction in future regulatory and commercial milestone payments while granting Viatris expanded territorial commercialization rights for cenerimod. AbbVie's RINVOQ (upadacitinib) JAK 1 inhibitor Upadacitinib (ABT-494) is a selective inhibitor of Janus kinase 1 (JAK1) that is approved for the treatment of several immune-mediated inflammatory diseases, including ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn's disease, giant cell arteritis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. In addition to its approved indications, the therapy is currently under clinical investigation for potential use in alopecia areata, hidradenitis suppurativa (HS), systemic lupus erythematosus (SLE), Takayasu arteritis, and vitiligo. AbbVie's RINVOQ (upadacitinib) continues to be an interesting lupus asset after its Phase 2 SLEek study showed meaningful activity in moderate to severe systemic lupus erythematosus, with the 30 mg monotherapy arm meeting the primary endpoint and achieving steroid-sparing benefit versus placebo. Updated data presented in 2023 also showed durability through 48 weeks, with fewer flares, longer time to first flare, and sustained improvements in disease-activity measures such as SRI-4, BICLA, and LLDAS, while no new safety signals were reported. The key development story is that AbbVie advanced RINVOQ into Phase 3 lupus testing after the positive Phase 2 readout, but it did not move forward with the ABBV-599 combination because elsubrutinib did not add enough efficacy to justify development. Find out more about top SLE CAR-T pipeline assets @ Systemic Lupus Erythematosus Clinical Trials Source: Systemic Lupus Erythematosus Market Report Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SLE companies, including GlaxoSmithKline, AstraZeneca, Genentech (Roche), AbbVie, Bristol Myers Squibb, Novartis, MorphoSys, UCB Pharma, Biogen, Juno Therapeutics, Johnson & Johnson Innovative Medicine, Idorsia Pharmaceuticals, Viatris, Merck, and others. Related Reports Systemic Lupus Erythematosus Clinical Trial Analysis Complement 3 Glomerulopathy Pipeline Insight – 2026 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key SLE companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Therapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, and others. JAK Inhibitors Market JAK Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key JAK inhibitors companies, including Incyte Corporation, Aclaris Therapeutics, Sareum, Takeda, AstraZeneca, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Arcutis Biotherapeutics, Reistone Biopharma, and others. FcRn Inhibitors Market FcRn Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key FcRn inhibitors companies, including Immunovant, Viridian Therapeutics, argenx, and others. TSLP Inhibitors Market TSLP Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key TSLP inhibitors companies, including Sanofi, Uniquity Bio, Upstream Bio, Keymed Biosciences, Belenos Bioscience, Biosion, Pfizer, and others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 SOURCE DelveInsight Business Research, LLP 21% more press release views with Request a Demo

If approved, upadacitinib is expected to be the first systemic medication for patients with non-segmental vitiligo, addressing important treatment needs for those living with the chronic, unpredictable autoimmune disease Positive CHMP opinion is supported by data from the Phase 3 Viti-Up clinical studies, in which upadacitinib achieved both co-primary endpoints demonstrating at least a 50% improvement in total body repigmentation (T-VASI 50) and at least a 75% improvement in facial repigmentation (F-VASI 75) from baseline at week 481 NORTH CHICAGO, Ill., June 29, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of upadacitinib (RINVOQ®; 15 mg, once daily) for the treatment of adult and adolescent patients with non-segmental vitiligo (NSV). The final European Commission decision is expected in the coming months. If approved, upadacitinib is expected to be the first systemic medication for patients with non-segmental vitiligo. "Vitiligo is an autoimmune skin disease with high stigma and significant burden to patients with limited treatment options available," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "A positive opinion for upadacitinib in non-segmental vitiligo is an important step forward in providing patients with a systemic treatment option." The CHMP positive opinion is supported by data from the ongoing Phase 3 Viti-Up clinical program, including two replicate, randomized, placebo-controlled, double-blind studies evaluating the efficacy and safety of upadacitinib in adult and adolescent patients with NSV. Upadacitinib 15 mg met both co-primary endpoints and key secondary endpoints, with significant improvements in total body and facial repigmentation.1 The safety profile of upadacitinib 15 mg was consistent with that observed in approved indications, with no new safety signals.1 Upadacitinib is approved in the European Union (EU) for the treatment of adults and adolescents with atopic dermatitis, and adults with radiographic axial spondylarthritis, non-radiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and giant cell arteritis. Use of upadacitinib in NSV is not currently approved in the EU. About Vitiligo Vitiligo is a chronic, autoimmune disease characterized by the loss of pigment-producing cells (melanocytes), resulting in white patches of skin that can appear anywhere on the body and at any time.2 It imposes a significant psychosocial burden, profoundly affecting an individual's confidence, identity and daily life.3 Non-segmental vitiligo (NSV), the most common form of vitiligo afflicting approximately 84% of patients, is marked by symmetrical and bilateral depigmented white patches and is prone to unpredictable progression even after long periods of stability.2,4-6 While location varies, many patients report patches on critical areas such as the face, feet, hands and groin. Despite its immune-mediated nature, vitiligo is often considered primarily a cosmetic problem, which can lead to stigma and psychological impact on patients' lives.7-9 Vitiligo management is anchored in three primary treatment goals: disease stabilization, repigmentation, and maintaining repigmentation.10,11 There are currently no approved systemic medicines specifically indicated for these treatment goals in vitiligo. About Viti-Up Clinical Trials Upadacitinib M19-044 was conducted under a single protocol encompassing two replicate Phase 3 studies (Study 1 and Study 2) with independent randomization, investigative sites, data collection, analysis and reporting for each study. The trials were designed to evaluate the efficacy, safety and tolerability of upadacitinib in adult and adolescent patients (ages 12 and older) living with non-segmental vitiligo (NSV) who were eligible for systemic therapy. In Period A of both studies, participants were randomized in a 2:1 ratio to receive either upadacitinib 15 mg once daily or placebo for 48 weeks. Participants who completed Period A were eligible to enter Period B, a 112-week open-label extension in which all patients received upadacitinib 15 mg once daily. In total, Study 1 and Study 2 Periods A and B span 160 weeks. The two trials randomized 614 participants with NSV across 90 sites worldwide. More information on these trials can be found at (NCT06118411). The co-primary endpoints were based on the achievement of Total Vitiligo Area Scoring Index (T-VASI) 50, defined as at least 50% reduction in T-VASI from baseline, at week 48, and the achievement of Facial Vitiligo Area Scoring Index (F-VASI) 75, defined as at least 75% reduction in F-VASI from baseline, at week 48 with the treatment of upadacitinib 15 mg compared with placebo in adults and adolescents with NSV. The secondary endpoints include the achievement of F-VASI 50, defined as at least a 50% reduction in F-VASI from baseline, at week 48, and the achievement of F-VASI 75, defined as at least a 75% reduction in facial vitiligo area from baseline, at week 24. These endpoints were designed to assess the degree and timing of re-pigmentation on the face, an area among the most visible and psychosocially impactful for people living with NSV. About RINVOQ ® (upadacitinib) Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo. The use of upadacitinib in non-segmental vitiligo is not approved; its safety and efficacy are under regulatory review by the U.S. FDA and the European Medicines Agency. EU Indications and Important Safety Information about RINVOQ ® (upadacitinib) 12 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. Giant cell arteritis RINVOQ is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Atopic dermatitis RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy. Ulcerative colitis RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. Crohn's disease RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. Important Safety Information Contraindications RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy. Special warnings and precautions for use RINVOQ should only be used if no suitable treatment alternatives are available in patients: - 65 years of age and older; - patients with history of atherosclerotic cardiovascular (CV) disease or other CV risk factors (such as current or past long-time smokers); - patients with malignancy risk factors (e.g. current malignancy or history of malignancy) Use in patients 65 years of age and older Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients ≥65 years of age, as observed in a large randomised study of tofacitinib (another Janus Kinase (JAK) inhibitor), RINVOQ should only be used in these patients if no suitable treatment alternatives are available. In patients ≥65 years of age, there is an increased risk of adverse reactions with RINVOQ 30 mg once daily. Consequently, the recommended dose for long-term use in this patient population is 15 mg once daily. Immunosuppressive medicinal products Use in combination with other potent immunosuppressants is not recommended. Serious infections Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis and sepsis have been reported with RINVOQ. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported. RINVOQ should not be initiated in patients with an active, serious infection, including localized infections. RINVOQ should be interrupted if a patient develops a serious or opportunistic infection until the infection is controlled. A higher rate of serious infections was observed with RINVOQ 30 mg compared to 15 mg. As there is a higher incidence of infections in the elderly and patients with diabetes in general, caution should be used when treating these populations. In patients ≥65 years of age, RINVOQ should only be used if no suitable treatment alternatives are available. Tuberculosis Patients should be screened for TB before starting RINVOQ. RINVOQ should not be given to patients with active TB. Anti-TB therapy may be appropriate for select patients in consultation with a physician with expertise in the treatment of TB. Patients should be monitored for the development of signs and symptoms of TB. Viral reactivation Viral reactivation, including cases of herpes zoster, was reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with RINVOQ. Consider interruption of RINVOQ if the patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should occur before and during therapy. If hepatitis B virus DNA is detected, a liver specialist should be consulted. Vaccination The use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating RINVOQ, in agreement with current immunization guidelines. Malignancy Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma, and non-melanoma skin cancer (NMSC), was observed with tofacitinib compared to tumour necrosis factor (TNF) inhibitors. A higher rate of malignancies, including NMSC, was observed with RINVOQ 30 mg compared to 15 mg. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. In patients ≥65 years of age, patients who are current or past long-time smokers, or patients with other malignancy risk factors (e.g., current malignancy or history of malignancy), RINVOQ should only be used if no suitable treatment alternatives are available. Hematological abnormalities Treatment should not be initiated, or should be temporarily interrupted, in patients with hematological abnormalities observed during routine patient management. Gastrointestinal perforations Events of diverticulitis and gastrointestinal perforations have been reported in clinical trials and from post-marketing sources. RINVOQ should be used with caution in patients who may be at risk for gastrointestinal perforation (e.g., patients with diverticular disease, a history of diverticulitis, or who are taking non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or opioids. Patients with active Crohn's disease are at increased risk for developing intestinal perforation. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis or gastrointestinal perforation. Major adverse cardiovascular events MACE were observed in clinical studies of RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of MACE, defined as CV death, non-fatal myocardial infarction and non-fatal stroke, was observed with tofacitinib compared to TNF inhibitors. Therefore, in patients ≥65 years of age, patients who are current or past long-time smokers, and patients with history of atherosclerotic CV disease or other CV risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. Lipids RINVOQ treatment was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Hepatic transaminase elevations Treatment with RINVOQ was associated with an increased incidence of liver enzyme elevation. Hepatic transaminases must be evaluated at baseline and thereafter according to routine patient management. If alanine transaminase (ALT) or aspartate transaminase (AST) increases are observed and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded. Venous thromboembolism Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) were observed in clinical trials for RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a dose‑dependent higher rate of VTE including DVT and PE was observed with tofacitinib compared to TNF inhibitors. In patients with CV or malignancy risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. In patients with known VTE risk factors other than CV or malignancy risk factors (e.g. previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, and inherited coagulation disorder), RINVOQ should be used with caution. Patients should be re-evaluated periodically to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue RINVOQ in patients with suspected VTE. Retinal vein occlusion Retinal vein occlusion has been reported in patients treated with JAK inhibitors, including upadacitinib. Patients should be advised to promptly seek medical care in case they experience symptoms suggestive of retinal vein occlusion. Hypersensitivity reactions Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving RINVOQ. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy. Hypoglycemia in patients treated for diabetes There have been reports of hypoglycemia following initiation of JAK inhibitors, including RINVOQ, in patients receiving medication for diabetes. Dose adjustment of anti-diabetic medication may be necessary in the event that hypoglycemia occurs. Medication Residue in Stool Reports of medication residue in stool or ostomy output have occurred in patients taking RINVOQ. Most reports described anatomic (e.g., ileostomy, colostomy, intestinal resection) or functional gastrointestinal conditions with shortened gastrointestinal transit times. Patients should be instructed to contact their healthcare professional if medication residue is observed repeatedly. Patients should be clinically monitored, and alternative treatment should be considered if there is an inadequate therapeutic response. Giant Cell Arteritis RINVOQ monotherapy should not be used for the treatment of acute relapses as efficacy in this setting has not been established. Corticosteroids should be given according to medical judgement and practice guidelines. Adverse reactions The most commonly reported adverse reactions in RA, PsA, and axSpA clinical trials (≥2% of patients in at least one of the indications) with RINVOQ 15 mg were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, ALT increased, bronchitis, nausea, neutropenia, cough, AST increased, and hypercholesterolemia. Overall, the safety profile observed in patients with psoriatic arthritis or active axial spondyloarthritis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with RA. The most commonly reported adverse reactions in AD trials (≥2% of patients) with RINVOQ 15 mg or 30 mg were upper respiratory tract infection, acne, herpes simplex, headache, blood CPK increased, cough, folliculitis, abdominal pain, nausea, neutropenia, pyrexia, and influenza. Dose dependent increased risks of infection and herpes zoster were observed with RINVOQ. The safety profile for RINVOQ 15 mg and 30 mg in adolescents was similar to that in adults. With long-term exposure, skin papilloma was reported in adolescents in the RINVOQ 15 mg and 30 mg groups. The most commonly reported adverse reactions in the UC and CD trials (≥3% of patients) with RINVOQ 45 mg, 30 mg or 15 mg were upper respiratory tract infection, pyrexia, blood CPK increased, anemia, headache, acne, herpes zoster, neutropenia, rash, pneumonia, hypercholesterolemia, bronchitis, AST increased, fatigue, folliculitis, ALT increased, herpes simplex, and influenza. The overall safety profile observed in patients with UC was generally consistent with that observed in patients with RA. Overall, the safety profile observed in patients with CD treated with RINVOQ was consistent with the known safety profile for RINVOQ. Overall, the safety profile observed in patients with GCA treated with RINVOQ 15 mg was generally consistent with the known safety profile for RINVOQ. 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. S ee 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 Immunology AbbVie is relentless in our pursuit to redefine the standard of care for patients living with immune-mediated conditions, with the goal of helping them live a life free from the limitations of their disease. For more than 20 years, AbbVie has led and helped shape the field of immunology through groundbreaking science and trusted medicines. Building on deep expertise across gastroenterology, rheumatology and dermatology, and other areas of high unmet need, we continue to invest in a broad and differentiated pipeline – spanning innovative modalities, novel mechanisms of actions and next-generation approaches designed to conquer the complex biology underlying immune-mediated disease. Today, more than 1 million patients worldwide are treated with AbbVie's immunology medicines, approved in more than 175 countries across 19 immune-mediated diseases that impact adult and pediatric populations. As we work to strengthen our legacy and drive the next wave of innovation, we remain focused on delivering meaningful progress for patients and expanding access to our medicines. For more information, please visit . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References AbbVie. Data on file ABVRRTI82545 Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015;386(9988):74-84. doi:10.1016/S0140-6736(14)60763-7 Krüger C, Schallreuter KU. A review of the worldwide prevalence of vitiligo in children/adolescents and adults. Int J Dermatol. 2012;51(10):1206-1212. doi:10.1111/j.1365-4632.2011.05377.x Mazzei Weiss ME. Vitiligo: to biopsy or not to biopsy?. Cutis. 2020;105(4):189-190. Ezzedine K, Lim HW, Suzuki T, et al. Revised classification/nomenclature of vitiligo and related issues: the Vitiligo Global Issues Consensus Conference. Pigment Cell Melanoma Res. 2012;25(3):E1-13 Taneja N, Sreenivas V, Sahni K, Gupta V, Ramam M. Disease Stability in Segmental and Non-Segmental Vitiligo. Indian Dermatol Online J. 2021 Aug 2;13(1):60-63. doi: 10.4103/idoj.IDOJ_154_21. PMID: 35198469; PMCID: PMC8809159 Hlača N, Žagar T, Kaštelan M, Brajac l, Prpić-Massari L. Current concepts of vitiligo immunopathogenesis. Biomedicines. 2022;10(7):1639. doi:10.3390/biomedicines10071639 Abdel-Malek ZA, Jordan C, Ho T, Upadhyay PR, Fleischer A, Hamzavi l. The enigma and challenges of vitiligo pathophysiology and treatment. Pigment Cell Melanoma Res. 2020;33(6):778-787. doi:10.1111/pcmr.12878 Birlea SA, Goldstein NB, Norris DA. Repigmentation through melanocyte regeneration in vitiligo. Dermatol Clin. 2017;35(2):205-218. doi:10.1016/j.det.2016.11.015 van Geel N, Speeckaert R, Taïeb A, et al. Worldwide expert recommendations for the diagnosis and management of vitiligo: position statement from the International Vitiligo Task Force part 1: towards a new management algorithm. J Eur Acad Dermatol Venereol. 2023;37(11):2173-2184. doi:10.1111/jdv.19451 Seneschal J, Boniface K. Vitiligo: Current therapies and future treatments. Dermatol Pract Concept. 2023;13(4S2):e2023313S. doi:10.5826/dpc.1304S2a313 RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2026 21% more press release views with Request a Demo