AbbVie has received European Commission approval for Rinvoq to treat active polyarticular juvenile idiopathic arthritis in patients aged two years and older who have responded inadequately to, or are intolerant to, one or more DMARDs. The decision covers both the 15 mg tablet and a new weight‑based oral solution.
“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, 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 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 for at least six weeks and can lead to long‑term joint damage if untreated.
The approval is supported by the open‑label phase 1 SELECT‑YOUTH study and data from adults with rheumatoid arthritis. SELECT‑YOUTH evaluated pharmacokinetics, efficacy, safety and tolerability in patients aged two to under 18 years.
Rinvoq showed efficacy as early as week 12, with response rates improving through week 48. Functional ability and pain scores also improved over the same period.
In the study, no new safety risks were identified. No cases of major cardiovascular or thrombotic events, malignancies or deaths were reported, and no negative impact on growth or development was observed.
“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 now approved in the EU for 11 immune‑mediated, inflammatory indications.
