Upadacitinib SELECT-YOUTH trial design and efficacy in polyarticular JIA
The European Commission has approved upadacitinib (RINVOQ) for active polyarticular juvenile idiopathic arthritis (pJIA) in children 2 years of age and older who have responded inadequately to or are intolerant of one or more disease-modifying antirheumatic drugs (DMARDs), AbbVie announced September 22, 2026.¹ The approval covers polyarticular rheumatoid factor-positive and rheumatoid factor-negative JIA and the extended oligoarticular subtype, and includes a 15 mg tablet and a weight-based 1 mg/mL oral solution.¹ Upadacitinib may be used as monotherapy or in combination with methotrexate.¹
Upadacitinib, an oral Janus kinase (JAK) inhibitor, is approved in the European Union for 11 indications, including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, giant cell arteritis, atopic dermatitis, alopecia areata, non-segmental vitiligo, ulcerative colitis, and Crohn disease.¹ The pJIA authorization is upadacitinib's first pediatric rheumatology indication in the EU, extending the JAK inhibitor's rheumatology use, previously limited to adult disease, to children.¹ Juvenile idiopathic arthritis affects approximately 126,000 children across Europe, making it the most common rheumatic disease of childhood.¹
The approval is supported by data from SELECT-YOUTH (M15-340), a phase 1, single-arm, open-label, global study evaluating upadacitinib in patients 2 to less than 18 years of age with polyarticular course JIA.² The study enrolled 122 patients treated with open-label upadacitinib, evaluating pharmacokinetics, efficacy, and safety rather than comparing against placebo.² Dosing was weight-based, using the 15 mg tablet or the 1 mg/mL oral solution.²
At week 48, 79.5% of patients achieved an American College of Rheumatology Pediatric 70 (ACR Pedi 70) response, and 43.4% achieved remission, defined as a Juvenile Arthritis Disease Activity Score-27 using C-reactive protein (JADAS27-CRP) of one or less, using non-responder imputation (NRI) for missing data.¹ Early response was observed by week 12, with an ACR Pedi 70 response of 66.4% and remission in 23.0% of patients.¹ Functional ability, measured by the Childhood Health Assessment Questionnaire (C-HAQ), improved with a mean change of -0.64 at week 48 among 108 evaluable patients, and pain scores improved by a mean of -30.8 at week 48 among 109 evaluable patients.¹
Key Facts
What is upadacitinib approved for in the EU?
The European Commission approved upadacitinib (RINVOQ) for active polyarticular juvenile idiopathic arthritis in children 2 years of age and older who have responded inadequately to or are intolerant of one or more DMARDs.¹
What did the SELECT-YOUTH trial show?
In the phase 1 SELECT-YOUTH trial, 79.5% of pediatric patients achieved an ACR Pedi 70 response and 43.4% achieved remission at week 48 with open-label upadacitinib.²
Was upadacitinib's safety profile different in children?
No new safety risks were identified in SELECT-YOUTH, with no cardiovascular or thrombotic events, malignancies, deaths, or negative impact on growth or development reported, according to AbbVie.¹
What is Upadacitinib’s safety profile and regulatory context in polyarticular JIA?
Safety findings in SELECT-YOUTH were consistent with upadacitinib's known profile in adult indications, according to AbbVie.¹ Exposure-adjusted serious adverse events (AEs) occurred at a rate of 10.2 per 100 patient-years, and treatment-emergent AEs occurred at a rate of 499.6 per 100 patient-years.¹ Discontinuations due to AEs occurred at a rate of 2.7 per 100 patient-years.¹
No new safety risks were identified in the pediatric population, and no cardiovascular or thrombotic events, malignancies, or deaths were reported during the study.¹ AbbVie said no negative impact on growth or development was observed among patients receiving upadacitinib.¹ The approval gives children with polyarticular JIA who have had an inadequate response to, or are intolerant of, one or more DMARDs a JAK inhibitor treatment option.¹
Roopal Thakkar, MD, executive vice president, research and development, and chief scientific officer, AbbVie, said, “The European Commission's approval of RINVOQ for pJIA expands the treatment options available to pediatric patients and their families.”¹
The pJIA authorization extends upadacitinib's use into a new rheumatology population in the EU, following prior approvals for rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and giant cell arteritis in adults.¹ AbbVie's EU label expansion also follows the company's continued build-out of upadacitinib across immune-mediated inflammatory diseases outside rheumatology, including ulcerative colitis and Crohn disease.¹
Upadacitinib has been available in the US for pediatric polyarticular JIA since June 4, 2024, when the FDA approved RINVOQ tablets and the weight-based RINVOQ LQ oral solution for children 2 years of age and older with active pJIA who had an inadequate response to or intolerance of one or more TNF blockers.³ That eligibility criterion is narrower than the EU's, which allows inadequate response to or intolerance of any DMARD rather than TNF blockers specifically. The 2024 FDA decision, which covered both pJIA and juvenile psoriatic arthritis, marked upadacitinib's first pediatric approvals in the US and brought its total authorized indications to 8 at the time.
References
ClinicalTrials.gov. A study to evaluate the pharmacokinetics, safety, and tolerability of upadacitinib in pediatric subjects with polyarticular course juvenile idiopathic arthritis (SELECT-YOUTH). Identifier: NCT03725007. Accessed September 22, 2026. https://clinicaltrials.gov/study/NCT03725007
