Sarilumab in Polyarticular‐Course Juvenile Idiopathic Arthritis: Dose‐Finding and 1‐Year Analysis of a Phase 2b, Open‐Label, Multicenter Study
Authors' conclusion
In patients with pcJIA receiving the selected dose from baseline, pharmacokinetic exposure was comparable to a dose of 200 mg q2w for adults with rheumatoid arthritis.
Study context
- Population
- Patients with polyarticular-course JIA (pcJIA)73 on selected dose from baseline
- Participants
- 101 patients
- Outcome
- Pharmacokinetic exposure (AUC0-Շ over 2-week dose interval, Cmax, Ctrough)
Methodological detailsmulticentre, three sequential parts, each with core-treatment and extension phase, dose-finding
- Multicentre
- Three sequential parts, each with core-treatment and extension phase
- Dose-finding
Main finding
As reported in the abstract
Pharmacokinetic exposure at steady state, selected dose from baseline (n = 73)
| Group | Cmax | AUC0-14 days | Ctrough |
|---|---|---|---|
| Group A | 27.1 mg/L | 276 day*mg/L | 9.57 mg/L |
| Group B | 40.4 mg/L | 395 day*mg/L | 14.4 mg/L |
Cmax
Group A27.1 mg/L
Group B40.4 mg/L
AUC0-14 days
Group A276 day*mg/L
Group B395 day*mg/L
Ctrough
Group A9.57 mg/L
Group B14.4 mg/L
Further findings
JIA-ACR 30/50/70/90 response rates, selected dose from baseline · week 48
- JIA-ACR30
- 100%
- JIA-ACR50
- 100%
- JIA-ACR70
- 93.8%
- JIA-ACR90
- 76.6%
Deaths
- No deaths occurred
Safety
Adverse events
- Patients with AEs, of 73
- 70 (95.9%)
Grade 3/4 neutropenia
- Patients with grade 3/4 neutropenia
- 27 (37%)
- No associated infections
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Sarilumab in Polyarticular‐Course Juvenile Idiopathic Arthritis: Dose‐Finding and 1‐Year Analysis of a Phase 2b, Open‐Label, Multicenter Study. Arthritis Care Res (Hoboken). Published 24 March 2026. doi:10.
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