Upadacitinib Available for Pediatric Patients with pJIA, PsA

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Upadacitinib (Rinvoq; AbbVie) is now available in the US for treating pediatric patients 2 years old or older with active polyarticular juvenile idiopathic arthritis (pJIA) as well as psoriatic arthritis (PsA), according to a press release from AbbVie. In addition, the company shared that a new weight-based oral solution is now available as an option for these pediatric patients.¹

"Rinvoq has been an important addition to the treatment landscape for various rheumatic diseases, helping adult patients achieve meaningful disease control," Roopal Thakkar, MD, senior vice president and chief medical officer of global therapeutics at AbbVie said in the release. "AbbVie is proud to now offer Rinvoq as a tablet and oral solution to some of our youngest patients."

According to AbbVie, nearly 300,000 children and adolescents in the US have a form of juvenile idiopathic arthritis, which includes pJIA and PsA. “These chronic diseases can be painful and debilitating and, if left untreated, may lead to joint damage,” the company said in the release. AbbVie noted reaching long-term remission is difficult for many patients living with a form of juvenile idiopathic arthritis, with roughly half requiring ongoing treatment into adulthood.

A 2020 study found that even 18 years after disease onset, a substantial portion of the 434-person cohort still had active disease despite advancements in treatment.Over 45% of the cohort still had active disease nearly 2 decades after diagnosis, with roughly 23% developing JIA-related damage.²

"Pediatric patients with pJIA and PsA can be severely limited in their ability to complete daily physical tasks and participate in everyday activities. Understanding their needs today and knowing the likelihood of disease in adulthood underscores the need for additional treatment options," said Aarat Patel, MD, adult and pediatric rheumatologist at Bon Secours Rheumatology Center of St. Mary's Hospital in Richmond, Virginia, in the release. "Having a treatment option available for patients who do not respond well to a tumor necrosis factor inhibitor addresses a need for the healthcare community, patients, and their families."

Several studies led to the approval of upadacitinib, with data showing positive results for adult patients with rheumatoid arthritis (RA) and PsA as well as for 51 pediatric patients with pJIA. AbbVie said in the release that pharmacokinetic data from adult patients with RA and PsA and safety data from 83 pediatric patients two to less than 18 years of age with pJIA also supported the approval of the therapy. Based on pharmacokinetic modeling, the company predicts that upadacitinib plasma exposures in pediatric patients with pJIA and PsA at the recommended dosage should be comparable to those observed in adults with RA and PsA.

They found the safety of upadacitinib for these pediatric patients was constant with the known safety profile of the drug, with adverse events including:

• Serious infections 
• Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor
• Cancer and immune system problems (Increased risk of some cancers, including lymphoma and skin. Current or past smokers have higher risk for lymphoma and lung cancer.)
• Increased risk of major cardiovascular (CV) events(heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially in current or past smokers)
• Blood clots (some fatal, in veins of the legs or lungs and arteries. This occurred more often in people 50 years and older who have at least 1 heart disease (CV) risk factor)
• Serious allergic reactions. Do not take if allergic to RINVOQ or its ingredients.
• Tears in the stomach or intestines; changes in certain laboratory test results.

Upadacitinib is a JAK inhibitor discovered and developed by AbbVie. It is being studied in several immune-mediated inflammatory diseases, with phase 3 trials of alopecia areata, ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn's disease, giant cell arteritis, hidradenitis suppurativa, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus, Takayasu arteritis, ulcerative colitis and vitiligo all ongoing.

References

1. RINVOQ® (upadacitinib) now available for pediatric patients two years and older with polyarticular juvenile idiopathic arthritis and psoriatic arthritis. News release. AbbVie. June 4, 2024. Accessed June 4, 2024. https://news.abbvie.com/2024-06-04-RINVOQ-R-upadacitinib-Now-Available-for-Pediatric-Patients-Two-Years-and-Older-with-Polyarticular-Juvenile-Idiopathic-Arthritis-and-Psoriatic-Arthritis
2. Glerup M, Rypdal V, Arnstad ED, et al. Long-term outcomes in juvenile idiopathic arthritis: eighteen years of follow-up in the population-based nordic juvenile idiopathic arthritis cohort. Arthritis Care Res (Hoboken). 2020;72(4):507-516. doi:10.1002/acr.23853