The European Commission has approved AbbVie’s RINVOQ (upadacitinib) for polyarticular juvenile idiopathic arthritis in patients aged 2 and older.
Written By: Rishabh Sonawane, BPharm
Reviewed By: Pharmacally Editorial Team
AbbVie’s RINVOQ (upadacitinib) has received European Commission approval for active polyarticular juvenile idiopathic arthritis (pJIA) in patients aged 2 years and older who have responded inadequately to, or are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs). The approval expands RINVOQ’s use into pediatric rheumatology and includes a new weight-based oral solution for children with pJIA.
EU Approval Expands Pediatric Treatment Options
The approval covers polyarticular rheumatoid factor-positive and rheumatoid factor-negative disease, as well as extended oligoarticular JIA. RINVOQ can be used as monotherapy or in combination with methotrexate.
Juvenile idiopathic arthritis is the most common rheumatic disease of childhood and affects an estimated 126,000 children in Europe. Polyarticular JIA involves inflammation in five or more joints, including the hands, feet, knees, hips and ankles. Persistent inflammation can cause pain, impaired physical function and joint damage, with disease activity sometimes continuing into adulthood.
Upadacitinib is a selective and reversible Janus kinase (JAK) inhibitor that preferentially inhibits JAK1-mediated signaling. By modulating cytokine signaling involved in immune and inflammatory responses, the drug reduces pathways that contribute to chronic inflammation.
SELECT-YOUTH Study Supported the Approval
The EC decision was supported by the single-arm, open-label Phase 1 SELECT-YOUTH study (M15-340; NCT03725007), together with data from adults with rheumatoid arthritis. The global study evaluated the pharmacokinetics, efficacy, safety and tolerability of upadacitinib in patients aged 2 to younger than 18 years with polyarticular-course JIA.
Among 122 patients evaluated for efficacy, clinical responses emerged by week 12 and increased through week 48. At week 12, 66.4% of patients achieved an American College of Rheumatology pediatric 70% response (ACR70), increasing to 79.5% at week 48.
Remission, defined as a Juvenile Arthritis Disease Activity Score based on C-reactive protein (JADAS27-CRP) of 1 or lower, was achieved by 23.0% of patients at week 12 and 43.4% at week 48.
Functional ability also improved. The mean Childhood Health Assessment Questionnaire (C-HAQ) score changed by −0.46 points at week 12 and −0.64 points at week 48 from baseline. Because lower C-HAQ scores indicate less disability, these negative changes represent an improvement in functional ability. Pain scores also improved, with mean changes from baseline of −26.2 points at week 12 and −30.8 points at week 48.
No New Safety Risks Identified
The SELECT-YOUTH study identified no new safety risks. Treatment-emergent adverse events occurred at a rate of 499.6 events per 100 patient-years, while serious adverse events occurred at 10.2 events per 100 patient-years. Events leading to treatment discontinuation occurred at 2.7 events per 100 patient-years.
No major cardiovascular events, thrombotic events, malignancies or deaths were reported during the study period. The study also reported no negative impact on growth or development.
New Oral Solution Adds Pediatric Administration Option
The European approval includes RINVOQ 15 mg extended-release tablets and a weight-based 1 mg/mL oral solution for patients with pJIA. In SELECT-YOUTH, patients received an equivalent 15 mg dose using either the oral solution or once-daily extended-release tablet according to body weight and their ability to swallow tablets.
The oral formulation provides an additional administration option for younger children who may not be able to take tablets.
pJIA Becomes RINVOQ’s 11th EU Indication
With the pJIA approval, RINVOQ now has 11 approved indications in the European Union. These cover rheumatoid arthritis, psoriatic arthritis, polyarticular JIA, non-radiographic axial spondyloarthritis, ankylosing spondylitis, giant cell arteritis, atopic dermatitis, alopecia areata, non-segmental vitiligo, ulcerative colitis and Crohn’s disease.
The broader development program continues to evaluate upadacitinib in hidradenitis suppurativa, Takayasu arteritis and systemic lupus erythematosus, alongside pediatric studies in systemic JIA, atopic dermatitis, ulcerative colitis and Crohn’s disease.
The pJIA decision therefore extends the clinical use of upadacitinib into a younger patient population while adding a pediatric oral formulation to RINVOQ’s European product offering.
Reference
AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Children with Active Polyarticular Juvenile Idiopathic Arthritis, AbbVie, 22 September 2026
About the Writer
Rishabha Sonawane, B.Pharm (LinkedIn) is healthcare writer with a strong interest in medical writing, regulatory affairs, clinical research, and AI-driven drug discovery. He has completed specialized training from the NIH and ICMR in clinical pharmacology, clinical research, and scientific writing. Passionate about evidence-based healthcare communication, he focuses on translating complex scientific research into clear, accurate, and engaging medical content.