- RINVOQ is the first and only systemic medication approved in the European Union to treat adult and adolescent patients with non-segmental vitiligo (NSV) who are candidates for systemic therapy
- Phase 3 Viti-Up-1 and Viti-Up-2 studies show that among patients continuing RINVOQ, the proportions who achieved facial (F-VASI 75) and total body (T-VASI 50) repigmentation continued to increase through week 76
- Findings from a phototherapy substudy show numerically higher responses with RINVOQ in combination with narrowband ultraviolet B (NB-UVB) phototherapy than with RINVOQ alone
- Data are being shared in a late-breaking oral presentation at the 2026 European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria
NORTH CHICAGO, Ill., Oct. 1, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced late-breaking results from the ongoing Phase 3 Viti-Up-1 and Viti-Up-2 studies of RINVOQ® (upadacitinib; 15 mg once daily) in non-segmental vitiligo (NSV), showing continued facial and total body repigmentation through week 76.
Presented at the 2026 European Academy of Dermatology and Venereology (EADV) Congress, data also include week-28 findings from a phototherapy substudy, in which treatment groups receiving RINVOQ plus whole-body narrowband ultraviolet B (NB-UVB) phototherapy showed numerically higher repigmentation responses than groups receiving RINVOQ alone.
"Vitiligo is a chronic, unpredictable disease that can affect skin across the body, underscoring the need for systemic treatment options that go beyond addressing individual areas," said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. "These late-breaking data support that RINVOQ can provide meaningful long-term repigmentation for patients with vitiligo and provide an early foundation for further research into its combination with NB-UVB phototherapy."
Continued Repigmentation with RINVOQ Through 76 Weeks
Following the 48-week placebo-controlled period (Period A) in the ongoing Phase 3 Viti-Up-1 and Viti-Up-2 studies, patients either entered an open-label extension (OLE) and received RINVOQ 15 mg once daily or entered a phototherapy substudy.
In patients who continued on RINVOQ 15 mg once daily in the OLE, proportions of patients achieving F-VASI 75 and T-VASI 50 continued to increase from week 48 through week 76. Results for F-VASI 75 and T-VASI 50 in both studies are shown in the tables below.
Viti-Up-1 & Viti-Up-2 Observed-Case Analyses
Viti-Up-1
Viti-Up-2
RINVOQ 15 mg
Continued RINVOQ 15 mg
Continued
once daily at Week RINVOQ 15 mg once daily at Week
48 48 RINVOQ 15 mg
once daily at Week once daily at Week
76 76
(N=130)
(N=145)
(N=127)
(N=137)
F-
VASI
75* 33.1 % 55.1 % 27.6 % 47.4 %
T-
VASI
50* 29.2 % 42.5 % 26.2 % 40.1 %
*F-VASI 75 = >=75% reduction from baseline in Facial Vitiligo Area Scoring Index; T-VASI 50 = >=50% reduction from baseline in Total Vitiligo Area Scoring Index
Findings With RINVOQ and NB-UVB Phototherapy
Following completion of Period A in Viti-Up-1 or Viti-Up-2, 84 adults who failed to achieve T-VASI 90 at week 48 and met additional eligibility criteria were re-randomized to receive RINVOQ 15 mg once daily alone or in combination with whole-body NB-UVB phototherapy twice weekly for 28 weeks.
All groups showed improvement in facial and total body repigmentation from baseline, with numerically higher response rates observed in the RINVOQ + NB-UVB phototherapy combination groups than in the RINVOQ monotherapy groups. Detailed F-VASI 75 and T-VASI 50 results are shown in the table below.
Efficacy at Week 28 (NRI*)
Viti-Up-1/2 Period A Treatment (Tx): Placebo
Phototherapy Substudy Tx: RINVOQ RINVOQ + NB-UVB
(N=15) (N=15)
F-VASI 75 40.0 % 46.7 %
T-VASI 50 20.0 % 33.3 %
Viti-Up-1/2 Period A Tx: RINVOQ
Phototherapy Substudy Tx: RINVOQ RINVOQ + NB-UVB
(N=27) (N=27)
F-VASI 75 37.0 % 59.3 %
T-VASI 50 33.3 % 63.0 %
*NRI = Non-responder Imputation
"These findings are important for physicians treating people with vitiligo because they extend our understanding of repigmentation with continued RINVOQ treatment and provide the first data on combining NB-UVB with an approved systemic JAK inhibitor," said Julien Seneschal, M.D., Ph.D., professor of dermatology at the National Reference Center for Rare Skin Diseases, University of Bordeaux, France. "This research opens an important path for further investigation into how combination approaches could evolve to support patient care in non-segmental vitiligo."
Safety results for week 76 in Viti-Up-1 and Viti-Up-2 and for week 28 in the phototherapy substudy were consistent with the known safety profile of upadacitinib and with the profile observed during the 48-week Period A; no new safety signals were reported.
RINVOQ is the first and only systemic medication approved in the European Union for the treatment of adult and adolescent patients 12 years and older with NSV who are candidates for systemic therapy. The approval was based on results from the Phase 3 Viti-Up clinical program at week 48 versus placebo. The use of RINVOQ in non-segmental vitiligo is under regulatory review by the U.S. FDA.
About Viti-Up Clinical Trials
Viti-Up (upadacitinib M19-044) consists of two ongoing replicate Phase 3 studies (Viti-Up-1 and Viti-Up-2) conducted under a single protocol, with independent randomization, investigative sites, data collection, analysis and reporting for each study. The trials evaluate the efficacy, safety and tolerability of upadacitinib in adult and adolescent patients (ages 12 and older) with non-segmental vitiligo (NSV) who are candidates 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, an 112-week open-label extension in which all patients, including those initially randomized to placebo, received upadacitinib 15-mg once daily; together, Periods A and B span 160 weeks. The two studies randomized 614 participants with NSV across 90 sites worldwide. Following completion of Period A in Viti-Up-1 or Viti-Up-2, 84 adults who failed to achieve T-VASI 90 at week 48 and met additional eligibility criteria were re-randomized to receive RINVOQ 15 mg once daily alone or in combination with whole-body NB-UVB phototherapy twice weekly for 28 weeks.
More information on these trials can be found at www.clinicaltrials.gov (NCT06118411).
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.1,2 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 and in pediatric studies for systemic juvenile idiopathic arthritis, atopic dermatitis, ulcerative colitis and Crohn's disease.
EUIndicationsandImportantSafetyInformationaboutRINVOQ®(upadacitinib)1
Indications
Rheumatoidarthritis
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.
Psoriatic arthritis
RINVOQ is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.
Polyarticular juvenile idiopathic arthritis
RINVOQ is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) [polyarticular rheumatoid factor positive {RF+} or negative {RF-}, extended oligoarticular], in patients 2 years of age and older who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.
Axial spondyloarthritis
Non-radiographic axial spondyloarthritis (nr-axSpA)
RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.
Giant cell arteritis
RINVOQ is indicated for the treatment of giant cell arteritis (GCA) in adult patients.
Atopic dermatitis
RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.
Alopecia areata
RINVOQ is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.
Vitiligo
RINVOQ is indicated for the treatment of non-segmental vitiligo in adults and adolescents 12 years and older who are candidates for systemic therapy.
Ulcerative colitis
RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
Crohn's disease
RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
Important Safety Information
Contraindications
RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.
Special warnings and precautions for use
RINVOQ should only be used if no suitable treatment alternatives are available in patients:
- 65 years of age and older;
- patients with history of atherosclerotic cardiovascular (CV) disease or other CV risk factors (such as current or past long-time smokers);
- patients with malignancy risk factors (e.g. current malignancy or history of malignancy)
Use in patients 65 years of age and older
Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients ≥65 years of age, as observed in a large randomised study of tofacitinib (another Janus Kinase (JAK) inhibitor), RINVOQ should only be used in these patients if no suitable treatment alternatives are available. In patients ≥65 years of age, there is an increased risk of adverse reactions with RINVOQ 30 mg once daily. Consequently, the recommended dose for long-term use in this patient population is 15 mg once daily.
Immunosuppressive medicinal products
Use in combination with other potent immunosuppressants is not recommended.
Serious infections
Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis and sepsis have been reported with RINVOQ. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported. RINVOQ should not be initiated in patients with an active, serious infection, including localized infections. RINVOQ should be interrupted if a patient develops a serious or opportunistic infection until the infection is controlled. A higher rate of serious infections was observed with RINVOQ 30 mg compared to 15 mg. As there is a higher incidence of infections in the elderly and patients with diabetes in general, caution should be used when treating these populations. In patients ≥65 years of age, RINVOQ should only be used if no suitable treatment alternatives are available.
Tuberculosis
Patients should be screened for TB before starting RINVOQ. RINVOQ should not be given to patients with active TB. Anti-TB therapy may be appropriate for select patients in consultation with a physician with expertise in the treatment of TB. Patients should be monitored for the development of signs and symptoms of TB.
Viral reactivation
Viral reactivation, including cases of herpes zoster, was reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with RINVOQ. Consider interruption of RINVOQ if the patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should occur before and during therapy. If hepatitis B virus DNA is detected, a liver specialist should be consulted.
Vaccination
The use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating RINVOQ, in agreement with current immunization guidelines.
Malignancy
Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including RINVOQ. In a large randomised active?controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma, and non-melanoma skin cancer (NMSC), was observed with tofacitinib compared to tumour necrosis factor (TNF) inhibitors. A higher rate of malignancies, including NMSC, was observed with RINVOQ 30 mg compared to 15 mg. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. In patients ≥65 years of age, patients who are current or past long-time smokers, or patients with other malignancy risk factors (e.g., current malignancy or history of malignancy), RINVOQ should only be used if no suitable treatment alternatives are available.
Hematological abnormalities
Treatment should not be initiated, or should be temporarily interrupted, in patients with hematological abnormalities observed during routine patient management.
Gastrointestinal perforations
Events of diverticulitis and gastrointestinal perforations have been reported in clinical trials and from post marketing sources. RINVOQ should be used with caution in patients who may be at risk for gastrointestinal perforation (e.g., patients with diverticular disease, a history of diverticulitis, or who are taking non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or opioids. Patients with active Crohn's disease are at increased risk for developing intestinal perforation. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis or gastrointestinal perforation.
Major adverse cardiovascular events
MACE were observed in clinical studies of RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of MACE, defined as CV death, non-fatal myocardial infarction and non-fatal stroke, was observed with tofacitinib compared to TNF inhibitors. Therefore, in patients ≥65 years of age, patients who are current or past long-time smokers, and patients with history of atherosclerotic CV disease or other CV risk factors, RINVOQ should only be used if no suitable treatment alternatives are available.
Lipids
RINVOQ treatment was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.
Hepatic transaminase elevations
Treatment with RINVOQ was associated with an increased incidence of liver enzyme elevation. Hepatic transaminases must be evaluated at baseline and thereafter according to routine patient management. If alanine transaminase (ALT) or aspartate transaminase (AST) increases are observed and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.
Venous thromboembolism
Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) were observed in clinical trials for RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a dose?dependent higher rate of VTE including DVT and PE was observed with tofacitinib compared to TNF inhibitors. In patients with CV or malignancy risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. In patients with known VTE risk factors other than CV or malignancy risk factors (e.g. previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, and inherited coagulation disorder), RINVOQ should be used with caution. Patients should be re-evaluated periodically to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue RINVOQ in patients with suspected VTE.
Retinal vein occlusion
Retinal vein occlusion has been reported in patients treated with JAK inhibitors, including upadacitinib. Patients should be advised to promptly seek medical care in case they experience symptoms suggestive of retinal vein occlusion.
Hypersensitivity reactions
Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving RINVOQ. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy.
Hypoglycemia in patients treated for diabetes
There have been reports of hypoglycemia following initiation of JAK inhibitors, including RINVOQ, in patients receiving medication for diabetes. Dose adjustment of anti-diabetic medication may be necessary in the event that hypoglycemia occurs.
Medication residue in stool
Reports of medication residue in stool or ostomy output have occurred in patients taking RINVOQ tablets. Most reports described anatomic (e.g., ileostomy, colostomy, intestinal resection) or functional gastrointestinal conditions with shortened gastrointestinal transit times. Patients should be instructed to contact their healthcare professional if medication residue is observed repeatedly. Patients should be clinically monitored, and alternative treatment should be considered if there is an inadequate therapeutic response.
Giant cell arteritis
RINVOQ monotherapy should not be used for the treatment of acute relapses as efficacy in this setting has not been established. Corticosteroids should be given according to medical judgement and practice guidelines.
Excipients with known effect
RINVOQ 1 mg/ml oral solution contains 0.3 mg sodium benzoate in each ml.
Adverse reactions
The most commonly reported adverse reactions in RA, PsA, and axSpA clinical trials (≥2% of patients in at least one of the indications) with RINVOQ 15 mg were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, ALT increased, bronchitis, nausea, neutropenia, cough, AST increased, and hypercholesterolemia. Overall, the safety profile observed in patients with psoriatic arthritis or active axial spondyloarthritis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with RA.
The most commonly reported adverse reactions in AD trials (≥2% of patients) with RINVOQ 15 mg or 30 mg were upper respiratory tract infection, acne, herpes simplex, headache, blood CPK increased, cough, folliculitis, abdominal pain, nausea, neutropenia, pyrexia, and influenza. Dose dependent increased risks of infection and herpes zoster were observed with RINVOQ. The safety profile for RINVOQ 15 mg and 30 mg in adolescents was similar to that in adults. With long-term exposure, skin papilloma was reported in adolescents in the RINVOQ 15 mg and 30 mg groups.
The most commonly reported adverse reactions in the UC and CD trials (≥3% of patients) with RINVOQ 45 mg, 30 mg or 15 mg were upper respiratory tract infection, pyrexia, blood CPK increased, anemia, headache, acne, herpes zoster, neutropenia, rash, pneumonia, hypercholesterolemia, bronchitis, AST increased, fatigue, folliculitis, ALT increased, herpes simplex, and influenza. The overall safety profile observed in patients with UC was generally consistent with that observed in patients with RA. Overall, the safety profile observed in patients with CD treated with RINVOQ was consistent with the known safety profile for RINVOQ.
Overall, the safety profile observed in patients with GCA treated with RINVOQ 15 mg was generally consistent with the known safety profile for RINVOQ.
Overall, the safety profile observed in paediatric patients with pJIA treated with RINVOQ was consistent with the known safety profile of RINVOQ.
The safety profile of RINVOQ 15 mg and 30 mg observed in patients with alopecia areata was generally consistent with the known safety profile in patients with atopic dermatitis.
The safety profile of RINVOQ 15 mg observed in patients with vitiligo was generally consistent with the known safety profile in patients with atopic dermatitis. A higher incidence of hypercholesterolemia was observed in patients with vitiligo treated with RINVOQ 15 mg compared to placebo.
The most common serious adverse reactions were serious infections.
The safety profile of RINVOQ with long term treatment was generally similar to the safety profile during the placebo-controlled period across indications.
RINVOQ is available in 15 mg, 30 mg, and 45 mg prolonged-release tablets and 1 mg/ml oral solution. RINVOQ tablets and RINVOQ oral solution are not bioequivalent. Refer to the Summary of Product Characteristics for posology and method of administration.
This is not a complete summary of all safety information.
See RINVOQ full Summary of Product Characteristics (SmPC) at http://www.ema.europa.eu
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 action and next-generation approaches designed to conquer the complex biology underlying immune-mediated disease.
Today, more than 1 million patients worldwide are treated with AbbVie's immunology medicines, approved in more than 175 countries across 20+ immune-mediated diseases that impact adult and pediatric populations. As we work to strengthen our legacy and drive the next wave of innovation, we remain focused on delivering meaningful progress for patients and expanding access to our medicines. For more information, please visit www.abbvie.com/immunology.
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 www.abbvie.com. 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. Summary of product characteristics. AbbVie; 2026.
- Pipeline. AbbVie. 2026. Accessed September 8, 2026. https://www.abbvie.com/our-science/pipeline.html
Global Media: Investors:
Mary Byun Liz Shea
mary.byun@abbvie.com liz.shea@abbvie.com
U.S. Media:
Sarah Kittel
sarah.kittel@abbvie.com
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