06. Identification of optimal subcutaneous doses of tocilizumab in children with polyarticular-course juvenile idiopathic arthritis
Bibliographic record
Abstract
Background: Efficacy and safety of intravenous (IV) tocilizumab (TCZ) have been shown in patients (pts) with polyarticular-course juvenile idiopathic arthritis (pcJIA).1 Aims: Determine appropriate dosing regimens of subcutaneous (SC) TCZ in pcJIA. Methods: Pts enrolled were aged 1-17 years with pcJIA, inadequate response/intolerance to methotrexate, and TCZ-naive or receiving TCZ IV with adequate disease control. TCZ was administered open label by body weight (BW)–based dosing modeled on IV dosing in pcJIA and SC dosing in adult rheumatoid arthritis: pcJIA pts <30 kg received TCZ 162 mg every 3 weeks (Q3W) and pts ≥30 kg received TCZ 162 mg Q2W for 52 weeks. Safety, efficacy (exploratory), and model-computed pharmacokinetic (PK) and pharmacodynamic (PD) parameters were assessed. Results: Fifty-two pts enrolled; 27 <30 kg and 25 ≥30 kg BW; 85% and 56%, respectively were TCZ naive. Since no notable difference in steady state PK occurred in naive vs non-naive pts, pooled data are shown. Median Cmin was similar between BW groups and higher than with TCZ IV (TCZ IV median Cmin: 3.2 μg/mL for 10 mg/kg <30 kg BW and 7.3 μg/mL for 8 mg/kg ≥30 kg BW) ensuring adequate exposure from SC doses. Median Cmax from SC dosing was lower than from IV dosing. Changes in PD parameters for TCZ-naive pts were consistent with those observed for TCZ IV. JADAS-71 scores generally improved, with trends consistent with those observed for TCZ IV. Infections were the most frequent adverse event (AE), reported in 36 pts; 2 serious infections occurred in 1 pt. No serious anaphylaxis, AE leading to withdrawal of study treatment, opportunistic infection, serious hepatic AE, gastrointestinal perforation, or death occurred. Overall there were 4 serious AEs in 3 pts (7.9/100 pt-year, consistent with TCZ IV).
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".