North Chicago, Illinois, U.S., September 22, 2026

AbbVie has announced that the European Commission has approved RINVOQ® (upadacitinib) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older who have responded inadequately to, or are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs). The approval covers polyarticular rheumatoid factor-positive and rheumatoid factor-negative disease as well as extended oligoarticular disease. RINVOQ may be administered as monotherapy or in combination with methotrexate, and the European authorization includes both the existing 15 mg tablet and a newly approved weight-based 1 mg/mL oral solution for pediatric patients. The regulatory decision expands the European use of AbbVie’s selective and reversible JAK inhibitor into another pediatric immune-mediated inflammatory disease.

RINVOQ Expands Pediatric Treatment Options

Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease of childhood, and polyarticular JIA affects multiple joints, including the hands, feet, knees, hips and ankles. The condition can cause persistent inflammation, pain and impaired physical function, while uncontrolled disease activity may contribute to permanent joint damage. AbbVie said the European Commission decision expands treatment options for children and families living with active pJIA after inadequate response or intolerance to DMARD therapy. The authorization represents an important expansion of the RINVOQ label, which already includes multiple indications for immune-mediated inflammatory diseases in the European Union. The approval was supported by data from the SELECT-YOUTH Phase 1 study, together with data from adult patients with rheumatoid arthritis. SELECT-YOUTH was a global, single-arm, open-label study evaluating the pharmacokinetics, efficacy, safety and tolerability of upadacitinib in patients aged 2 to less than 18 years with polyarticular-course JIA. According to AbbVie, clinical responses were observed as early as Week 12, with response rates improving through Week 48.

SELECT-YOUTH Shows Clinical Response Through Week 48

In the SELECT-YOUTH study, 66.4% of patients achieved an ACR Pediatric 70 response at Week 12, increasing to 79.5% at Week 48 using nonresponder imputation. The proportion of patients meeting the study’s defined remission measure, JADAS27-CRP ≤1, increased from 23.0% at Week 12 to 43.4% at Week 48. Functional ability also improved, with the mean change from baseline in the Childhood Health Assessment Questionnaire reaching −0.46 at Week 12 and −0.64 at Week 48. Pain scores similarly improved during the study period.

Advertisement

cGxPJobs Banner

AbbVie reported that no new safety risks were identified in the pediatric study and that the safety profile observed in children with pJIA was consistent with the known safety profile of RINVOQ. During the study, no cases of major cardiovascular or thrombotic events, malignancies or deaths were reported, and the company reported no negative impact on growth or development. The reported safety findings will remain important as RINVOQ is used in a pediatric population, particularly because JAK inhibitors carry established warnings and precautions that require appropriate medical assessment and monitoring.

AbbVie Broadens RINVOQ Immunology Portfolio

RINVOQ is a selective and reversible Janus kinase (JAK) inhibitor discovered and developed by AbbVie scientists. With the latest European approval, the medicine is authorized for 11 indications across immune-mediated inflammatory diseases, according to AbbVie. These include rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, giant cell arteritis, atopic dermatitis, alopecia areata, vitiligo, ulcerative colitis, Crohn’s disease and now active pJIA. The pediatric approval also highlights the importance of developing age-appropriate formulations for children with chronic inflammatory diseases. The newly approved oral solution provides a weight-based administration option for younger patients who may have difficulty swallowing tablets. For AbbVie, the decision further expands the clinical reach of RINVOQ while adding a pediatric indication to its broader immunology portfolio. Continued clinical use and post-authorization experience will provide additional information on the medicine’s role in managing active pJIA across eligible pediatric patients in Europe.

Source: AbbVie press release