Pharmacokinetic and safety profile of tofacitinib in children with polyarticular course juvenile idiopathic arthritis: results of a phase 1, open-label, multicenter study

Juvenile idiopathic arthritis (JIA) is the most common pediatric rheumatic disease and a leading cause of childhood disability. The objective of this study was to characterize the PK, safety, and taste acceptability of tofacitinib in patients with JIA. This Phase 1, open-label, multiple-dose (twice...

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Veröffentlicht in:	Pediatric rheumatology online journal 2017-12, Vol.15 (1), p.86-86, Article 86
Hauptverfasser:	Ruperto, Nicolino, Brunner, Hermine I, Zuber, Zbigniew, Tzaribachev, Nikolay, Kingsbury, Daniel J, Foeldvari, Ivan, Horneff, Gerd, Smolewska, Elzbieta, Vehe, Richard K, Hazra, Anasuya, Wang, Rong, Mebus, Charles A, Alvey, Christine, Lamba, Manisha, Krishnaswami, Sriram, Stock, Thomas C, Wang, Min, Suehiro, Ricardo, Martini, Alberto, Lovell, Daniel J
Format:	Artikel
Sprache:	eng
Schlagworte:	Analysis Dosage and administration Drug therapy Janus kinase inhibitor Juvenile idiopathic arthritis Juvenile rheumatoid arthritis Patient outcomes Pediatric Pediatric research Pharmacokinetics Safety Safety and security measures Tofacitinib Treatment outcome
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Zusammenfassung:	Juvenile idiopathic arthritis (JIA) is the most common pediatric rheumatic disease and a leading cause of childhood disability. The objective of this study was to characterize the PK, safety, and taste acceptability of tofacitinib in patients with JIA. This Phase 1, open-label, multiple-dose (twice daily [BID] for 5 days) study of tofacitinib in patients with active (≥ 5 joints) polyarticular course JIA was conducted from March 2013-December 2015. Patients were allocated to one of three age-based cohorts: Cohort 1, 12 to
ISSN:	1546-0096 1546-0096
DOI:	10.1186/s12969-017-0212-y