AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Children with Active Polyarticular Juvenile Idiopathic Arthritis

• RINVOQ is now approved in the European Union for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients two years of age and older who have responded inadequately to, or who are intolerant to, one or more DMARDs¹
• Approval was based on the open-label Phase 1 SELECT-YOUTH study and data from adults with rheumatoid arthritis^1,2
• A new oral solution of RINVOQ was approved for use in patients with pJIA¹
• RINVOQ is currently approved in the European Union for 11 indications across various immune-mediated, inflammatory diseases¹

NORTH CHICAGO, Ill., Sept. 22, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has approved RINVOQ^® (upadacitinib; 15 mg tablet and weight-based 1 mg/mL oral solution) for the treatment of active polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular), in patients two years of age and older 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.¹

"The European Commission's approval of RINVOQ for pJIA expands the treatment options available to pediatric patients and their families, offering the potential for remission, improvements in pain and physical function," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "RINVOQ's new indication continues to build on our differentiated immunology portfolio with breadth and depth across therapeutic areas and patient populations."

Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease of childhood and is estimated to impact approximately 126,000 children in Europe.³ pJIA is a subtype of JIA and is characterized by inflammation in five or more joints – including the small joints of the hands and feet and large joints like the knees, hips and ankles – that persists for at least six weeks in children and adolescents.^4,5 This disease can be painful and debilitating and, if left untreated, may lead to joint damage.^3,6 Ongoing disease activity in pJIA is common, with persistent symptoms or flares affecting many patients into adulthood.^6-8

Data Supporting the EC Approval
The EC approval of RINVOQ for pJIA is supported by the SELECT-YOUTH study and data from adult patients with rheumatoid arthritis. The SELECT-YOUTH study is a single-arm, open-label, global, Phase 1 study evaluating the pharmacokinetics, efficacy, safety and tolerability of RINVOQ in patients ages 2 to <18 years.^1,2

RINVOQ demonstrated efficacy as early as week 12, with response rates improving through week 48, as shown below.^1,2 The efficacy observed in children with pJIA was generally consistent with responses in adult patients with rheumatoid arthritis.¹

Functional ability, as measured by C-HAQ, improved, with a mean change from baseline of −0.46 (n=115) at week 12 and −0.64 (n=108) at week 48. Pain scores also improved, with a mean change from baseline of −26.2 (n=116) at week 12 and −30.8 (n=109) at week 48. C-HAQ and pain data are reported as observed.²

In the study, no new safety risks were identified.⁹ The rate of treatment-emergent adverse events (TEAEs) was 499.6 events per 100 patient-years (E/100 PY). The rate of serious adverse events was 10.2 E/100 PY. The rate of TEAEs that led to discontinuation of the study drug was 2.7 E/100 PY. No cases of major cardiovascular or thrombotic events, malignancies or deaths were reported during the study period.² No negative impact on growth or development was observed.⁹

"The SELECT-YOUTH results underscore that clinical remission for children with pJIA is not a rare hope but a critical and achievable outcome that helps reduce the risk of permanent joint damage in some of our youngest, most vulnerable patients," said Prof. Dr. Gerd Horneff, head of the Department of General Pediatrics, Asklepios Clinic, Sankt Augustin, Germany. "The approval of RINVOQ in active pJIA provides a new oral systemic treatment option for patients suffering from this often-debilitating condition."

RINVOQ is also approved in the European Union for the treatment of adults and adolescents with atopic dermatitis, non-segmental vitiligo and alopecia areata and for adults with radiographic axial spondyloarthritis, non-radiographic axial spondyloarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease and giant cell arteritis.¹

About the SELECT-YOUTH Study
The SELECT-YOUTH (M15-340) study is a single-arm, open-label, global, Phase 1 study to evaluate the pharmacokinetics, efficacy, safety and tolerability of upadacitinib in patients with polyarticular course juvenile idiopathic arthritis (pcJIA), ages 2 to <18 years. This study consists of three parts: Part 1 consisted of a seven-day multiple-dose pharmacokinetic evaluation, after which patients in Parts 2 and 3 of the trial received a low dose of upadacitinib (equivalent to 15 mg) by using either a twice-daily oral solution or once-daily extended-release tablet based on their body weight and ability to swallow tablets. For more detailed information on this study, please visit clinicaltrials.gov (NCT03725007).

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.^1,10 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.

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.

Polyarticular juvenile idiopathic arthritis

RINVOQ is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (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 pediatric 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 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 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

1. RINVOQ. Summary of product characteristics. AbbVie; 2026.
2. AbbVie. Data on file: ABVRRTI83601.
3. Garner AJ, Saatchi R, Ward O, Hawley DP. Juvenile idiopathic arthritis: a review of novel diagnostic and monitoring technologies. Healthcare (Basel). 2021;9(12):1683. doi:10.3390/healthcare9121683
4. Macaubas C, Nguyen K, Milojevic D, Park JL, Mellins ED. Oligoarticular and polyarticular JIA: epidemiology and pathogenesis. Nat Rev Rheumatol. 2009;5(11):616-626. doi:10.1038/nrrheum.2009.209
5. Petty RE, Southwood TR, Manners P, et al. International League of Associations for Rheumatology classification of juvenile idiopathic arthritis: second revision, Edmonton, 2001. J Rheumatol. 2004;31(2):390-392.
6. Hashkes PJ, Laxer RM. Medical treatment of juvenile idiopathic arthritis. JAMA. 2005;294(13):1671-1684. doi:10.1001/jama.294.13.1671
7. Glerup M, Rypdal V, Arnstad ED, et al. Long-term outcomes in juvenile idiopathic arthritis: eighteen years of follow-up in the population-based Nordic juvenile idiopathic arthritis cohort. Arthritis Care Res (Hoboken). 2020;72(4):507-516. doi:10.1002/acr.23853
8. Balay-Dustrude E, Weiss NS, Sutton A, Shenoi S. Predictors of disease activity in patients with juvenile idiopathic arthritis at 12 and 24 months after diagnosis. ACR Open Rheumatol. 2024;6(8):489-496. doi:10.1002/acr2.11701
9. AbbVie. Data on file: ABVRRTI83825.
10. Pipeline. AbbVie. 2026. Accessed July 8, 2026. https://www.abbvie.com/our-science/pipeline.html

SOURCE AbbVie

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