RINVOQ LQ's Impact on Pediatric Arthritis Care, with Casey Schlacher

Casey Schlacher

Credit: LinkedIn

Upadacitinib (Rinvoq) has recently expanded its indication in the United States for the treatment of pediatric patients with the introduction of a new weight-based oral solution, RINVOQ LQ. The drug is approved for 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.¹

In an interview with HCPLive, Casey Schlacher, Medical Affairs Therapeutic Area Head, Rheumatology, at AbbVie, discusses the importance of the US Food and Drug Administration (FDA)-approved expansion for treating these painful chronic conditions that can severely reduce quality of life and, in some cases, lead to joint damage.

What inspired the team to evaluate upadacitinib in this specific patient population?

Casey Schlacher: At AbbVie, our goal is to help as many patients as possible with our medicines. We look at multiple factors such as the unique needs of the patient population, currently available treatments and remaining unmet needs. While there has been advancement in treatment options for patients with forms of JIA, many still do not achieve remission or low disease activity (LDA), may be intolerant to certain treatments or may lose response over time.

We are proud that RINVOQ (upadacitinib; 15 mg tablet) and RINVOQ LQ (upadacitinib; 1 mg/mL oral solution) are approved and available to support pediatric patients 2 years and older with pJIA and PsA, provided they have had an inadequate response or intolerance to one or more TNF blockers.

What is the basis for the FDA approval?

CS: In partnership with the FDA, this approval is based on extrapolation from extensive data of upadacitinib in rheumatoid arthritis (RA). Notably for the pediatric population, we included findings from the Phase 1 SELECT-YOUTH study evaluating pharmacokinetics, safety, and efficacy in subjects 2 to < 18 years of age with active pJIA. Improvements in pJIA signs and symptoms, disease activity, and function were observed at week 12 across all age groups. These improvements were maintained through 48 weeks. Safety was consistent with the known safety profile of upadacitinib, and no new safety signals were identified in SELECT-YOUTH.

What is the clinical significance of these results?

CS: The significance of the SELECT-YOUTH results along with the larger extrapolation data set that supported this approval is now having a new treatment option available. We’re supporting a need for healthcare professionals in having additional treatments to consider following use of tumor necrosis factor inhibitors (TNFi), in addition to supporting the needs of the caregiver and patient community by offering 2 administration options of a tablet and oral solution (dosed based on patient weight), which are the preferred route of administration in the pediatric population. New approvals within JIA can offer more options for effective disease management.

What are the next steps for the team?

CS: For the SELECT-YOUTH study, our team is continuing to evaluate safety and tolerability of upadacitinib with Part 2 and 3 long-term extensions currently ongoing. Patients will be followed for up to 3 years which allows our team to better understand the longer-term outcomes of upadacitinib when used to treat pJIA over time.

Is there anything else you would like our audience to know?

CS: Based on the American College of Rheumatology (ACR) Guidelines for JIA with polyarthritis, prompt initiation of effective therapy is critical in preventing permanent joint damage and improving outcomes. JIA has risk of long-term disability, so the need for treatments with rapid response that get patients to LDA quickly is critical. We’re proud that RINVOQ and RINVOQ LQ oral solution are available as another tool in healthcare professionals’ toolboxes when treating these pediatric populations after leveraging a TNFi.

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.}