{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T21:21:43Z","timestamp":1792012903912,"version":"4.4.0"},"reference-count":20,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,9,27]],"date-time":"2025-09-27T00:00:00Z","timestamp":1758931200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,9,27]],"date-time":"2025-09-27T00:00:00Z","timestamp":1758931200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>On April 26, 2024, FDA approved Rinvoq (upadacitinib, extended\u2010release [ER] tablets) and Rinvoq LQ (1 mg\/mL oral solution), a new pediatric immediate\u2010release (IR) formulation, for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) and active psoriatic arthritis (PsA) in patients 2 years of age and older. The approved dosing regimens include a weight\u2010tiered twice daily (BID) regimen with IR oral solution and a once\u2010daily (QD) regimen with ER tablets. The objective of this article is to summarize the FDA's major review findings and considerations supporting these approvals from a regulatory perspective. This clinical development program included a single study (Study 1) conducted in pediatric subjects aged 2 to less than 18 years with JIA with active polyarthritis to evaluate the pharmacokinetics (PK), safety, and tolerability of multiple doses of upadacitinib. No clinical trials or dedicated PK studies were conducted in pediatric patients with PsA. Efficacy was extrapolated from adults with rheumatoid arthritis (RA) or PsA to pediatric patients with pJIA or PsA, respectively, based on a PK\u2010matching approach considering disease similarity, similar response to treatment, and comparable PK exposure. PK data analysis and simulations showed that the approved upadacitinib pediatric dosing regimen, including a BID regimen with IR oral solution and QD regimen with ER tablet, provide comparable PK exposure (Cmax and AUC) in pediatric subjects with pJIA or PsA as compared to the approved 15 mg ER tablet QD regimen in adults with RA or PsA, respectively, supporting the efficacy extrapolation from adults to pediatric subjects.<\/jats:p>","DOI":"10.1002\/jcph.70104","type":"journal-article","created":{"date-parts":[[2025,9,27]],"date-time":"2025-09-27T16:19:22Z","timestamp":1758989962000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Approval of Upadacitinib in Pediatric Patients with Active Polyarticular Juvenile Idiopathic Arthritis or Active Psoriatic Arthritis: A Regulatory Perspective"],"prefix":"10.1002","volume":"66","author":[{"given":"Lei","family":"He","sequence":"first","affiliation":[{"name":"Division of Inflammation and Immune Pharmacology Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Da","family":"Zhang","sequence":"additional","affiliation":[{"name":"Division of Pharmacometrics Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric J.","family":"Gapud","sequence":"additional","affiliation":[{"name":"Division of Rheumatology and Transplant Medicine Office of New Drugs Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzette","family":"Peng","sequence":"additional","affiliation":[{"name":"Division of Rheumatology and Transplant Medicine Office of New Drugs Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ozlem","family":"Belen","sequence":"additional","affiliation":[{"name":"Division of Rheumatology and Transplant Medicine Office of New Drugs Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chandrahas","family":"Sahajwalla","sequence":"additional","affiliation":[{"name":"Division of Inflammation and Immune Pharmacology Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suresh","family":"Doddapaneni","sequence":"additional","affiliation":[{"name":"Division of Inflammation and Immune Pharmacology Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Youwei","family":"Bi","sequence":"additional","affiliation":[{"name":"Division of Pharmacometrics Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianmeng","family":"Chen","sequence":"additional","affiliation":[{"name":"Division of Inflammation and Immune Pharmacology Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,9,27]]},"reference":[{"key":"e_1_2_11_2_1","first-page":"390","article-title":"International League of Associations for Rheumatology classification of juvenile idiopathic arthritis: second revision, Edmonton, 2001","volume":"31","author":"Petty RE","year":"2004","journal-title":"J Rheumatol"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1542\/pir.33.7.303"},{"key":"e_1_2_11_4_1","first-page":"379","article-title":"Polyarticular juvenile idiopathic arthritis \u2013 epidemiology and management approaches","volume":"6","author":"Oberle EJ","year":"2014","journal-title":"Clin Epidemiol"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/RHU.0000000000000819"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.3389\/fped.2022.884727"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clim.2020.108396"},{"key":"e_1_2_11_8_1","unstructured":"NigrovicP.Psoriatic juvenile idiopathic arthritis: pathogenesis clinical manifestations and diagnosis. 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