Upadacitinib Expands Indication to Pediatric Patients with pJIA, PsA

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The approvals were based on data from well-controlled studies of the drug in adult patients with PsA and RA.

Upadicitinib Expands Indication to Pediatric Patients with pJIA, PsA

Credit: US Food and Drug Administration

Upadacitinib (Rinvoq) is now indicated in the United States for the treatment of pediatric patients aged ≥ 2 years with active polyarticular juvenile idiopathic arthritis (pJIA) and patients aged 2 to < 18 years with psoriatic arthritis (PsA) who have had inadequate response or intolerance to ≥ 1 tumor necrosis factor (TNF) blockers. A weight-based oral solution (Rinvoq LQ) is also offered as a treatment option for younger patients.1

pJIA and PsA are painful chronic conditions characterized by joint inflammation that can severely reduce quality of life and, in some cases, lead to joint damage. The current expansion is particularly important because, despite continued advancements in treatment, remission rates remain lackluster among these patient populations, with approximately half of pediatric patients needing treatment into adulthood.2

"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, chief medical officer, global therapeutics, AbbVie, stated.1 “AbbVie is proud to now offer RINVOQ as a tablet and oral solution to some of our youngest patients.”

The approvals of both the tablet form of upadacitinib and the new oral solution version were based on data from well-controlled studies of the drug in adult patients with PsA and rheumatoid arthritis (RA), incorporating pharmacokinetic data. The studies also included 51 pediatric patients with JIA and active polyarthritis, and safety data from 83 pediatric patients with JIA and active polyarthritis. AbbVie noted the plasma exposures among the pediatric patient population are expected to be comparable to adult patients based on population pharmacokinetic modeling and simulation.1

"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," Aarat Patel, MD, adult and pediatric rheumatology, Bon Secours Rheumatology Center of St. Mary’s Hospital, said in a statement.1 "Having a treatment option available for patients who do not respond well to a TNFi addresses a need for the healthcare community, patients, and their families.”

References

  1. RINVOQ® (UPADACITINIB) now available for pediatric patients two years and older with polyarticular juvenile idiopathic arthritis and psoriatic arthritis. AbbVie News Center. 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. Hashkes PJ, Laxer RM. Medical Treatment of Juvenile Idiopathic Arthritis. JAMA. 2005;294(13):1671–1684. doi:10.1001/jama.294.13.1671.
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