Pharmacokinetics, Efficacy, and Safety of Upadacitinib in Pediatric Patients With Polyarticular‐Course Juvenile Idiopathic Arthritis: An Interim Analysis of an Open‐Label, Phase 1 Trial
Authors' conclusion
This interim analysis demonstrates that the bodyweight-based dosing regimen of upadacitinib was well tolerated and efficacious in pediatric patients with pcJIA.
Study context
- Population
- Pediatric patients aged 2 to <18 years with pcJIA
- Participants
- 57 patients
- Outcome
- Pharmacokinetics, efficacy and safety of upadacitinib
Methodological detailssingle-arm, interim analysis, 7-day pharmacokinetic assessment, then long-term efficacy and safety evaluation for up to 156 weeks, including an additional long-term safety cohort, Interim analysis: available pharmacokinetic and safety data and efficacy data through week 48
- Single-arm
- Interim analysis
- 7-day pharmacokinetic assessment, then long-term efficacy and safety evaluation for up to 156 weeks, including an additional long-term safety cohort
- Interim analysis: available pharmacokinetic and safety data and efficacy data through week 48
Main finding
As reported in the abstract
Pharmacokinetics
- Median time to maximum concentration, tablet
- approximately three hours
- Median time to maximum concentration, oral solution
- approximately one hour
- Harmonic mean functional half-life, tablet
- approximately five hours
- Harmonic mean functional half-life, oral solution
- approximately two hours
Further findings
| Outcome | Values |
|---|---|
| JIA ACR 30/50/70/90/100 responses · week 12Interim analysis | Upadacitinib JIA ACR30 91.8% · JIA ACR50 89.8% · JIA ACR70 69.4% · JIA ACR90 49.0% · JIA ACR100 32.7% |
Efficacy maintenance · week 48
- Efficacy generally maintained through week 48; improvement in additional efficacy end points also observed
Safety
Adverse events · median exposure duration of 412 days
- Patients reporting adverse events
- 52 of 57
- Interim analysis
- Predominately mild to moderate in severity and consistent with the known safety profile of upadacitinib
Serious adverse events · median exposure duration of 412 days
- Patients with serious adverse events
- 6
- Interim analysis
Original publication
Pharmacokinetics, Efficacy, and Safety of Upadacitinib in Pediatric Patients With Polyarticular‐Course Juvenile Idiopathic Arthritis: An Interim Analysis of an Open‐Label, Phase 1 Trial. Arthritis Care Res (Hoboken). Published 22 December 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →