FDA Approves 2 Upadacitinib Formulations for Children with pJIA & PsA

The study’s efficacy findings were largely consistent with responses in patients with RA. No serious adverse events or adverse events leading to drug discontinuation were reported during the study.⁸ Most adverse events were mild to moderate, consisting of COVID-19 infection, upper respiratory tract infection, nasopharyngitis, gastroenteritis, fever, abdominal pain and nausea. A high proportion of patients (84% and greater) in two age groups—2 to <6 years old and 6–10 years old—achieved a JIA ACR30, 50 and 70 response (i.e., a 30, 50 or 70% reduction in the signs and symptoms of JIA) at week 12.

Clinical Considerations

The upadacitinib oral solution is not substitutable with the upadacitinib extended-release tablets. Any changes between these formulations should be made by a qualified clinician.

Prior to treatment, clinicians should update the patient’s immunizations. Also consider evaluating the patient for active and latent tuberculosis, viral hepatitis, hepatic function and pregnancy status. If the patient has an absolute lymphocyte count of <500 cells/mm³, an absolute neutrophil count <1,000 cells/mm³ or a hemoglobin level of <8 g/d, interrupt or avoid initiating therapy with upadacitinib.

Upadacitinib has a boxed warning regarding serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis. A risk evaluation and mitigation strategy is included with its dosing.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Supplemental approval letter: Rinvoq (upadacitinib) extended-release tablets for pJIA and psoriatic arthritis in patients at least 2 years old. U.S. Food & Drug Administration. 2024 April 26.
2. New drug application approval letter: Rinvoq LQ (upadacitinib) oral solution. U.S. Food & Drug Administration. 2023 Apr 26.
3. Rinvoq (upadacitinib) now available for pediatric patients two years and older with polyarticular juvenile idiopathic arthritis and psoriatic arthritis [news release]. AbbVie.  2023 Jun 4.
4. New drug application approval letter: Rinvoq (upadacitinib) extended-release tablets. U.S. Food & Drug Administration. 2019 Aug 16.
5. Supplemental approval letter: TNF blocker intolerance indication for Rinvoq (upadacitinib) injection. U.S. Food & Drug Administration. 2021 Dec 14.
6. Highlights of prescribing information: Rinvoq (upadacitinib). U.S. Food & Drug Administration. 2023 May 18.
7. Highlights of prescribing information: Rinvoq LQ (upadacitinib). U.S. Food & Drug Administration. 2024 Apr 26.
8. Brenner H, Horneff G, Foeldvari I, et al. Safety and efficacy of upadacitinib for pediatric patients with polyarticular course juvenile idiopathic arthritis: An interim analysis of an open-label, phase 1 trial [OP 0164]. Ann Rheum Dis. 2023;82:108–109.