HQ Team
September 22, 2026: The European Commission has approved AbbVie Inc.’s drug for the treatment of active polyarticular juvenile idiopathic arthritis 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.
Polyarticular juvenile idiopathic arthritis (pJIA) is a subtype of juvenile idiopathic arthritis (JIA), and JIA is the most common rheumatic disease of childhood, estimated to impact approximately 126,000 children in Europe.
AbbVie’s tablet and oral solution Rinvoq was approved following early-stage clinical trials and data from adult patients evaluating the pharmacokinetics, efficacy, safety and tolerability of the medicine, and in patients aged two to less than 18 years, according to a company statement.
Rinvoq (upadacitinib) may be used as monotherapy or in combination with methotrexate.
Differentiated immunology portfolio
“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, M.D., 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.”
pJIA is characterised 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.
New oral option
Rinvoq showed efficacy as early as week 12, with response rates improving through week 48. The efficacy observed in children with pJIA was generally consistent with responses in adult patients with rheumatoid arthritis, according to the company statement.
The trial 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 Paediatrics, 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 currently approved in the European Union for 11 indications across immune-related, inflammatory diseases in adults and adolescents, such as atopic dermatitis, non-segmental vitiligo and alopecia areata and for adults with radiographic axial spondyloarthritis, non-radiographic axial spondyloarthritis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis.
Rinvoq is being studied in end-stage clinical trials for hidradenitis suppurativa, Takayasu arteritis and systemic lupus erythematosus and in pediatric studies for systemic juvenile idiopathic arthritis, atopic dermatitis, ulcerative colitis and Crohn’s disease.
