RINVOQ® Approved for Pediatric Polyarticular JIA and Psoriatic Arthritis

AbbVie has announced the approval of RINVOQ® (upadacitinib) in the United States for treating pediatric patients aged two years and older who suffer from active polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA). This new indication follows an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. Alongside this, a weight-based oral solution, RINVOQ® LQ, has also been introduced for these young patients.

The approval marks a significant extension of RINVOQ's utility, now covering eight indications across various immune-mediated inflammatory diseases. Dr. Roopal Thakkar, AbbVie’s Senior Vice President and Chief Medical Officer, highlighted RINVOQ's role in providing meaningful disease control for adults and expressed pride in making the therapy available to younger patients in both tablet and oral solution forms.

Approximately 300,000 children and adolescents in the U.S. are diagnosed with some form of juvenile idiopathic arthritis, which includes pJIA and PsA. The polyarticular form involves inflammation in five or more joints, lasting for at least six weeks in individuals under 16. Psoriatic arthritis combines joint inflammation with skin lesions associated with psoriasis. Both conditions are chronic and can be painful and debilitating, potentially leading to joint damage if untreated. Despite advancements, long-term remission can be elusive, with around half of the patients requiring continued treatment into adulthood.

Dr. Aarat Patel, a specialist in adult and pediatric rheumatology, emphasized the debilitating impact these conditions can have on daily activities and the importance of having additional treatment options for those who do not respond well to TNF blockers. He noted the significance of addressing the needs of pediatric patients and their potential long-term challenges.

The approvals for RINVOQ and RINVOQ LQ are supported by data from well-controlled studies in adult patients with rheumatoid arthritis (RA) and PsA, as well as pharmacokinetic data from both adult patients and 51 pediatric patients with juvenile idiopathic arthritis with active polyarthritis. Safety data from 83 pediatric patients, aged two to under 18 years, were also considered. The plasma exposures of upadacitinib in pediatric patients with pJIA and PsA, at the recommended dosage, are predicted to be similar to those observed in adults with RA and PsA, based on pharmacokinetic modeling and simulation.

In terms of safety, the profile of RINVOQ/RINVOQ LQ in pediatric patients with juvenile idiopathic arthritis was consistent with the known safety profile of RINVOQ. However, patients are warned about potential serious side effects, including serious infections, increased risk of death in older patients with cardiovascular risk factors, cancer and immune system issues, major cardiovascular events, blood clots, serious allergic reactions, and gastrointestinal tears. It is recommended that patients have their healthcare providers test for infections such as tuberculosis before starting treatment and monitor for signs and symptoms during treatment.

AbbVie is committed to helping patients access RINVOQ and other medications through several support programs, including a co-pay card that may reduce out-of-pocket costs for eligible patients and the myAbbVie Assist program, which provides the medication at no cost to those who qualify.

RINVOQ, developed by AbbVie scientists, is a JAK inhibitor being studied for various immune-mediated inflammatory diseases. Clinical trials are ongoing for conditions such as alopecia areata, ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn's disease, giant cell arteritis, hidradenitis suppurativa, PsA, RA, systemic lupus erythematosus, Takayasu arteritis, ulcerative colitis, and vitiligo.

In summary, RINVOQ's approval for pediatric use in treating pJIA and PsA is a significant milestone, offering new hope and treatment options for young patients suffering from these debilitating conditions.