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 DMARDs. Approval was based on the open-label Phase 1 SELECT-YOUTH study and data from adults with rheumatoid arthritis. A new oral solution of RINVOQ was approved for use in patients with pJIA. RINVOQ is currently approved in the European Union for 11 indications across various immune-mediated, inflammatory diseases.

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.

Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease of childhood and is estimated to impact approximately 126,000 children in Europe. 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. This disease can be painful and debilitating and, if left untreated, may lead to joint damage. Ongoing disease activity in pJIA is common, with persistent symptoms or flares affecting many patients into adulthood.

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

Efficacy Measure Week 12 RINVOQ* (N=122) Week 48 RINVOQ* (N=122)

70% improvement of disease activity (ACR pediatric 70 response), NRI 1 66.4% 79.5%

Remission (JADAS27-CRP ≤1), NRI 1 23.0% 43.4%

*All patients received RINVOQ 15 mg tablet or oral solution weight-based equivalent. ACR=American College of Rheumatology; CRP=C-reactive protein; JADAS=Juvenile Arthritis Disease Activity Score; NRI=nonresponder imputation.

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.

In the study, no new safety risks were identified. 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 t...