AbbVie announced that RINVOQ® (upadacitinib) is now approved in the U.S. for treating pediatric patients aged two years and older with active polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA), who have not responded adequately or are intolerant to one or more tumor necrosis factor (TNF) blockers. Additionally, a new weight-based oral solution, RINVOQ® LQ, is available for these patients.
Dr. Roopal Thakkar, senior vice president, chief medical officer, global therapeutics at AbbVie, highlighted the significance of RINVOQ in achieving disease control in adults and expressed pride in extending this treatment to younger patients.
Juvenile idiopathic arthritis affects nearly 300,000 children and adolescents in the U.S. The polyarticular form involves inflammation in five or more joints for at least six weeks before the age of 16, while psoriatic arthritis includes joint inflammation and psoriasis-related skin lesions. These chronic diseases can be debilitating and may cause joint damage if untreated.
Dr. Aarat Patel, a pediatric rheumatologist, emphasized the need for additional treatment options for children with pJIA and PsA, noting the limitations these conditions impose on daily activities and the likelihood of persistence into adulthood.
The approvals are based on studies demonstrating comparable upadacitinib plasma exposures in pediatric patients to those in adults with RA and PsA, supported by safety data from pediatric patients with juvenile idiopathic arthritis with active polyarthritis.
The safety profile of RINVOQ in pediatric patients mirrors that in adults, with serious side effects including infections, increased risk of death, cancer, cardiovascular events, blood clots, allergic reactions, and gastrointestinal issues.
For more information about RINVOQ, visit RINVOQ.com.
AbbVie offers patient support programs, including a co-pay card and myAbbVie Assist for those with limited or no insurance. Details are available at AbbVie.com/myAbbVieAssist.
RINVOQ, a JAK inhibitor, is being studied for multiple inflammatory diseases, with ongoing Phase 3 trials for various conditions. RINVOQ’s approval and safety information cover its use in adults and children for several conditions, with specific safety precautions and potential side effects detailed in the medication guide.
For more details and prescribing information, visit the provided links. AbbVie remains committed to advancing care for people with rheumatic diseases through innovative therapies.