AbbVie announced that its blockbuster drug Rinvoq (upadacitinib) is now indicated in the US for the treatment of pediatric patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA). The medication is indicated for those who had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

Additionally, a new weight-based oral solution, Rinvoq LQ (upadacitinib), is now available as an option for these pediatric populations.¹

Nearly 300,000 children and adolescents in the U.S. have a form of juvenile idiopathic arthritis, which includes pJIA and PsA.^2-3 The polyarticular form of juvenile idiopathic arthritis is characterized by inflammation in five or more joints that persists for at least six weeks in children and adolescents before 16 years of age.² The psoriatic arthritis form of juvenile idiopathic arthritis is characterized by both joint inflammation and skin lesions associated with psoriasis.⁴

"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 company news release. "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."

Data Supporting the Approvals

The approvals of RINVOQ and RINVOQ LQ oral solution are supported by evidence from well-controlled studies of Rinvoq in adult patients with rheumatoid arthritis (RA) and PsA, pharmacokinetic data from adult patients with RA and PsA, as well as 51 pediatric patients with juvenile idiopathic arthritis with active polyarthritis, in addition to safety data from 83 pediatric patients 2 to less than 18 years of age with juvenile idiopathic arthritis with active polyarthritis. Upadacitinib plasma exposures in pediatric patients with pJIA and PsA at the recommended dosage are predicted to be comparable to those observed in adults with RA and PsA based on population pharmacokinetic modeling and simulation.

Overall, the safety profile observed in pediatric patients with juvenile idiopathic arthritis with active polyarthritis treated with Rinvoq/Rinvoq LQ was consistent with the known safety profile of RINVOQ.

Rinvoq is available in 15 mg, 30 mg, and 45 mg extended-release tablets.

Rinvoq is a JAK inhibitor FDA approved to treat serveral immune-mediated inflammatory diseases, including adults and children with psoriatic arthritis. It is also being studied to treat alopecia areata, ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn's disease, giant cell arteritis, hidradenitis suppurativa, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus (SLE), Takayasu arteritis, ulcerative colitis and vitiligo. 

References

¹ RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2024.
² Petty RE, Southwood TR, Manners P, et al. International League of Associations for Rheumatology classification of juvenile idiopathic arthritis: second revision, Edmonton, 2001. J Rheumatol. 2004;31(2):390-392.
³ Helmick CG, Felson DT, Lawrence RC, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Arthritis Rheum. 2008;58(1):15-25. doi:10.1002/art.23177.
⁴ Brunello F, Tirelli F, Pegoraro L, et al. New Insights on Juvenile Psoriatic Arthritis. Front Pediatr. 2022;10:884727. Published 2022 May 26. doi:10.3389/fped.2022.884727.