Trial reportJournal of pharmacokinetics and pharmacodynamics2026
Modeling, Simulation, and Extrapolation to Optimize Pediatric Development Plan: Sarilumab Polyarticular-Course juvenile arthritis Application.
Trial report in Journal of pharmacokinetics and pharmacodynamics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Sarilumab in Polyarticular-Course Juvenile Idiopathic Arthritis: Dose-Finding and 1-Year Analysis of a Phase 2b, Open-Label, Multicenter Study.Arthritis care & research · 2026Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Polyarticular-course juvenile idiopathic arthritis (pcJIA) is a chronic condition that manifests before the age of 16 years, with pathology similar to that of adult rheumatoid arthritis (RA). Sarilumab is an interleukin-6 receptor inhibitor approved for RA and pcJIA. To obtain the approval for pcJIA, a single-arm, multiple-dose phase 2 study was conducted to determine the sarilumab dose for pcJIA. The population pharmacokinetics analysis of the phase 2 dose-finding portion data showed comparable pharmacokinetics; exposure–response analyses demonstrated similar or greater efficacy (JIA-ACR30/50/70), and consistent safety (reduction in absolute neutrophil count) in patients with pcJIA compared with adult patients with RA at similar sarilumab exposure. Based on the adult-to-pediatric extrapolation concept and justifications using modeling and simulation, the phase 2 sample size was increased to generate sufficient efficacy and safety data and evidence at selected doses and the requirement for a randomized controlled study in patients with pcJIA was waived. This novel approach enabled the pcJIA dose proposal by aligning with adult RA exposures, streamlined clinical development by removing the control arm requirement and minimized children participation while ensuring robustness of sarilumab efficacy and safety evidence for approval.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.