Tofacitinib Citrate

RINVOQ is the first and only systemic medication approved in the European Union to treat adult and adolescent patients with non-segmental vitiligo (NSV) The approval is supported by data from the Phase 3 Viti-Up clinical program, which showed that RINVOQ achieved statistically significant total body (T-VASI 50) and facial repigmentation (F-VASI 75) from baseline at week 48, versus placebo1 NORTH CHICAGO, Ill., July 29, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has approved RINVOQ® (upadacitinib; 15 mg, once daily) for the treatment of adult and adolescent patients 12 years and older with non-segmental vitiligo (NSV) who are candidates for systemic therapy.1 With this approval, RINVOQ is now the first and only systemic medication approved in the European Union for NSV, the most common form of vitiligo.2 "The European Commission's approval of RINVOQ as the first and only systemic treatment for non-segmental vitiligo is an advancement for patients living with this chronic autoimmune disease," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "People with vitiligo have limited treatment options, and RINVOQ's approval addresses a significant need for patients across Europe." Vitiligo is a chronic autoimmune disease characterized by irregular white patches on the skin, resulting from the selective destruction of melanocytes – the cells responsible for skin pigmentation. Non-segmental vitiligo (NSV) is the most common type, accounting for 84% of all vitiligo cases.2-4 Vitiligo should not be dismissed as a cosmetic disease, as its effects can be psychologically devastating, often posing a considerable burden on patients' quality of life and resulting in high rates of depression and anxiety.5,6 The unpredictable course of vitiligo, which might progress at any time, and the associated fear of having new and/or expanding vitiligo lesions even after long periods of stability, contribute to the burden of patients living with the disease.2,7 Data Supporting the EC Approval The EC approval of RINVOQ is supported by data from the Phase 3 Viti-Up clinical program (M19-044), including two replicate, randomized, placebo-controlled, double-blind studies evaluating the efficacy and safety of RINVOQ in adult and adolescent patients with NSV.1 As previously reported in both studies, RINVOQ 15 mg met both co-primary endpoints with statistically significant and clinically meaningful improvements in total body (T-VASI 50) and facial repigmentation (F-VASI 75) at week 48 versus placebo.1 RINVOQ met key ranked secondary endpoints, including stabilization of disease extent as assessed by T-VASI in patients with actively progressing disease at baseline.1 The safety profile of RINVOQ in both studies was generally consistent with that observed in approved indications, with no new safety signals.1 "Given the immune-mediated and unpredictable nature of non-segmental vitiligo, holistic therapeutic management including early diagnosis, appropriate treatment and precise assessment of disease extent and activity is crucial," said Diamant Thaçi, M.D., Ph.D., professor, Comprehensive Center for Inflammatory Medicine, University of Lübeck, and Viti-Up trial investigator. "The approval of RINVOQ provides an advanced systemic treatment option that targets the immune dysregulation that causes vitiligo and has the potential to stabilize disease while allowing for repigmentation." RINVOQ is also approved in the European Union 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, and adults and adolescents with severe alopecia areata.1 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 ranked secondary endpoints include the achievement of F-VASI 50, defined as at least a 50% reduction in F-VASI from baseline, at week 48, the achievement of F-VASI 75, defined as at least a 75% reduction in facial vitiligo area from baseline, at week 24, and, in actively progressing patients, no increase in disease extent based on the achievement of no increase from baseline in T-VASI at week 8 and 12. 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, as well as the potential to stabilize disease extent in actively progressing patients. About RINVOQ ® (upadacitinib) Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.1,8 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 JAK2.1 Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for hidradenitis suppurativa, Takayasu arteritis and systemic lupus erythematosus. The use of upadacitinib in non-segmental vitiligo is under regulatory review by the U.S. FDA. EU Indications and Important Safety Information about RINVOQ ® (upadacitinib) 1 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. Alopecia areata RINVOQ is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. Vitiligo RINVOQ is indicated for the treatment of non-segmental vitiligo in adults and adolescents 12 years and older who are candidates for systemic therapy. Ulcerative colitis RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. Crohn's disease RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. Important Safety Information Contraindications RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy. Special warnings and precautions for use RINVOQ should only be used if no suitable treatment alternatives are available in patients: 65 years of age and older; patients with history of atherosclerotic cardiovascular (CV) disease or other CV risk factors (such as current or past long-time smokers); patients with malignancy risk factors (e.g. current malignancy or history of malignancy) Use in patients 65 years of age and older Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients ≥65 years of age, as observed in a large randomised study of tofacitinib (another Janus Kinase (JAK) inhibitor), RINVOQ should only be used in these patients if no suitable treatment alternatives are available. In patients ≥65 years of age, there is an increased risk of adverse reactions with RINVOQ 30 mg once daily. Consequently, the recommended dose for long-term use in this patient population is 15 mg once daily. Immunosuppressive medicinal products Use in combination with other potent immunosuppressants is not recommended. Serious infections Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis and sepsis have been reported with RINVOQ. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported. RINVOQ should not be initiated in patients with an active, serious infection, including localized infections. RINVOQ should be interrupted if a patient develops a serious or opportunistic infection until the infection is controlled. A higher rate of serious infections was observed with RINVOQ 30 mg compared to 15 mg. As there is a higher incidence of infections in the elderly and patients with diabetes in general, caution should be used when treating these populations. In patients ≥65 years of age, RINVOQ should only be used if no suitable treatment alternatives are available. Tuberculosis Patients should be screened for TB before starting RINVOQ. RINVOQ should not be given to patients with active TB. Anti-TB therapy may be appropriate for select patients in consultation with a physician with expertise in the treatment of TB. Patients should be monitored for the development of signs and symptoms of TB. Viral reactivation Viral reactivation, including cases of herpes zoster, was reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with RINVOQ. Consider interruption of RINVOQ if the patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should occur before and during therapy. If hepatitis B virus DNA is detected, a liver specialist should be consulted. Vaccination The use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating RINVOQ, in agreement with current immunization guidelines. Malignancy Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma, and non-melanoma skin cancer (NMSC), was observed with tofacitinib compared to tumour necrosis factor (TNF) inhibitors. A higher rate of malignancies, including NMSC, was observed with RINVOQ 30 mg compared to 15 mg. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. In patients ≥65 years of age, patients who are current or past long-time smokers, or patients with other malignancy risk factors (e.g., current malignancy or history of malignancy), RINVOQ should only be used if no suitable treatment alternatives are available. Hematological abnormalities Treatment should not be initiated, or should be temporarily interrupted, in patients with hematological abnormalities observed during routine patient management. Gastrointestinal perforations Events of diverticulitis and gastrointestinal perforations have been reported in clinical trials and from post-marketing sources. RINVOQ should be used with caution in patients who may be at risk for gastrointestinal perforation (e.g., patients with diverticular disease, a history of diverticulitis, or who are taking non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or opioids). Patients with active Crohn's disease are at increased risk for developing intestinal perforation. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis or gastrointestinal perforation. Major adverse cardiovascular events MACE were observed in clinical studies of RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of MACE, defined as CV death, non-fatal myocardial infarction and non-fatal stroke, was observed with tofacitinib compared to TNF inhibitors. Therefore, in patients ≥65 years of age, patients who are current or past long-time smokers, and patients with history of atherosclerotic CV disease or other CV risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. Lipids RINVOQ treatment was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Hepatic transaminase elevations Treatment with RINVOQ was associated with an increased incidence of liver enzyme elevation. Hepatic transaminases must be evaluated at baseline and thereafter according to routine patient management. If alanine transaminase (ALT) or aspartate transaminase (AST) increases are observed and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded. Venous thromboembolism Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) were observed in clinical trials for RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a dose‑dependent higher rate of VTE including DVT and PE was observed with tofacitinib compared to TNF inhibitors. In patients with CV or malignancy risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. In patients with known VTE risk factors other than CV or malignancy risk factors (e.g. previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, and inherited coagulation disorder), RINVOQ should be used with caution. Patients should be re-evaluated periodically to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue RINVOQ in patients with suspected VTE. Retinal vein occlusion Retinal vein occlusion has been reported in patients treated with JAK inhibitors, including upadacitinib. Patients should be advised to promptly seek medical care in case they experience symptoms suggestive of retinal vein occlusion. Hypersensitivity reactions Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving RINVOQ. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy. Hypoglycemia in patients treated for diabetes There have been reports of hypoglycemia following initiation of JAK inhibitors, including RINVOQ, in patients receiving medication for diabetes. Dose adjustment of anti-diabetic medication may be necessary in the event that hypoglycemia occurs. Medication Residue in Stool Reports of medication residue in stool or ostomy output have occurred in patients taking RINVOQ. 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 RINVOQ. Package insert. North Chicago, IL: AbbVie Inc.; 2026. Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015;386(9988):74-84. doi:10.1016/S0140-6736(14)60763-7 Speeckaert R, van Geel N. Distribution patterns in generalized vitiligo. J Eur Acad Dermatol Venereol. 2014;28(6):755-762. doi:10.1111/jdv.12171 Taneja N, Sreenivas V, Sahni K, Gupta V, Ramam M. Disease stability in segmental and non-segmental vitiligo. Indian Dermatol Online J. 2022;13(1):60-63. doi:10.4103/idoj.IDOJ_154_21 Bibeau K, Ezzedine K, Harris JE, et al. Mental health and psychosocial quality-of-life burden among patients with vitiligo: findings from the global VALIANT study. JAMA Dermatol. 2023;159(10):1124-1128. doi:10.1001/jamadermatol.2023.2787 Salama AH, Alnemr L, Khan AR, Alfakeer H, Aleem Z, Ali-Alkhateeb M. Unveiling the unseen struggles: a comprehensive review of vitiligo's psychological, social, and quality of life impacts. Cureus. 2023;15(9):e45030. doi:10.7759/cureus.45030 Albelowi LM, Alhazmi RM, Ibrahim S. The pathogenesis and management of vitiligo. Cureus. 2024;16(12):e75859. doi:10.7759/cureus.75859 Pipeline. AbbVie. 2026. Accessed July 27, 2026. SOURCE AbbVie 21% more press release views with Request a Demo

Despite the size of the ever-growing inflammatory bowel disease (IBD) drug market and its diversity of modalities from JAK inhibitors to IL-23s, unmet needs and treatment gaps remain. That’s according to a new paper from Nimbus Therapeutics and Back Bay Life Science Advisors, which surveyed 36 U.S. gastroenterologists to gauge physician perspectives on the current treatment landscape, what’s to come and what they want to see next. When it comes to unmet needs, the doctors’ perceived gaps largely concern clinical remission. For patients with moderate-to-severe ulcerative colitis, which is one of the two diseases within the IBD umbrella, 81% of physicians surveyed marked achieving clinical remission as one of their top three “most urgent” unmet needs. Over half (56%) also ranked increased durability of clinical remission as one of their most urgent unmet needs, while 44% put achieving faster healing in the top three. Beyond that, the survey also reflects a thriving interest in oral therapies. The IBD treatment market is largely dominated by biologic medicines, which are often administered through infusions or autoinjector pens. According to the survey, however, patients are seeking oral options. Seventy-five percent of respondents agreed that more than half of their patients would have chosen an oral product with “equivalent efficacy and safety.” Fifty-three percent said more than 75% of their patients would have preferred an oral option, while 31% said more than 90% would have done so. The leading oral therapies for IBD are currently JAK inhibitors, such as AbbVie’s Rinvoq and Pfizer’s Xeljanz. However, the drugs’ safety profiles remain a concern. Among physicians surveyed, 56% cited the JAK inhibitors’ boxed warning related to major adverse cardiovascular events as one of the “greatest limitations” of currently available JAK drugs for ulcerative colitis. Meanwhile, 42% pointed to the boxed warning regarding an increased risk of all-cause mortality. Clinical remission was also cited as a concern, with 36% of physicians identifying the durability of remission as one of the drugs’ greatest limitations. “The primary barrier to broader JAK inhibitor adoption is not the efficacy that these drugs can achieve, but the risk profile that comes with them,” Nimbus and Back Bay Life Science advisors explained in the paper. As one GI key opinion leader that the paper cites put it, “If we had Rinvoq without the safety concerns and inability to use in pregnancy, that would be huge—we could use it in earlier lines of therapy.” The survey suggests that a different approach might be needed for future IBD pills. Among respondents, 67% ranked biologic-comparable efficacy as a top priority for future oral agents, while 50% prioritized improved patient-reported outcomes, such as quality of life. The findings suggest physicians are seeking both “deeper disease control and improvements in how patients feel and function,” the paper’s authors wrote. More specifically, Nimbus and Back Bay said the most “valuable future oral therapies in IBD will be those that combine clinically meaningful efficacy, durable disease control, favorable safety, minimal monitoring burden, and a practical dosing profile.” More options could be on the horizon. The paper points to a “rapidly expanding” oral IBD pipeline that includes TYK2 inhibitors, microRNA-modulating therapies and other agents. However, the available efficacy data suggest these prospects have not yet met the high bar set by JAK inhibitors. Despite physicians’ “enthusiasm” for oral therapies, emerging IBD drugs will need to demonstrate strong efficacy, durable disease control and favorable safety profiles.