On June 4, AbbVie announced that the U.S. FDA approved the use of RINVOQ® (upadacitinib) for the treatment of pediatric patients two years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA) who have had an insufficient response to, or are intolerant of, one or more tumor necrosis factor (TNF) inhibitors. In addition, a new dosage form of RINVOQ® LQ (upadacitinib) oral solution, based on weight-based dosing, is now available in the U.S. for the pediatric population.

Dr. Roopal Thakkar, Senior Vice President, Global Therapeutic Areas and Chief Medical Officer of AbbVie, said: "RINVOQ has always been an important addition to the treatment of a wide range of rheumatic diseases, helping adult patients achieve meaningful disease control. Now, AbbVie is proud to offer RINVOQ in tablets and oral solution for our younger patients.

Nearly 300,000 children and adolescents in the U.S. have some form of juvenile idiopathic arthritis, including pJIA and PsA. polyarticular juvenile idiopathic arthritis is characterized by inflammation of five or more joints that lasts for at least six weeks in children and adolescents up to age 16. Psoriatic juvenile idiopathic arthritis is characterized by arthritis and skin lesions associated with psoriasis. These chronic conditions can be painful and debilitating and, if left untreated, can lead to joint damage. Despite advances in treatment, achieving long-term remission remains elusive for many patients with juvenile idiopathic arthritis, with about half of patients requiring ongoing treatment into adulthood.

Aarat Patel, M.D., Adult and Pediatric Rheumatology, St. Mary's Hospital Rheumatology Center, said

Pediatric patients with pJIA and PsA may be severely limited in their ability to perform daily physical tasks and participate in daily activities. Understanding their immediate needs and the similar challenges of the disease in adulthood underscores the need for more treatment options. Providing treatment options for patients who are poor responders to TNFi meets the needs of the medical community, patients and their families.

Data supporting the approval of
The approval of RINVOQ and RINVOQ LQ Oral Solution was based on data from well-controlled studies of RINVOQ in adult rheumatoid arthritis (RA) and PsA patients, pharmacokinetic data from adult patients with RA and PsA and 51 pediatric patients with active polyarticular juvenile idiopathic arthritis, as well as pharmacokinetic data from 83 pediatric patients in the age group of 2 to under 18 years with active polyarticular safety data results from pediatric patients with juvenile idiopathic arthritis. Based on population pharmacokinetic modeling and simulations, upadacitinib plasma exposures in pediatric patients with pJIA and PsA are expected to be comparable to those observed in adult patients with RA and PsA at the recommended doses.

About the Safety of RINVOQ/RINVOQ LQ
Overall, the safety profile observed in pediatric patients with active polyarticular juvenile idiopathic arthritis treated with RINVOQ/RINVOQ LQ remains consistent with the known safety profile of RINVOQ.

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