Efficacy and safety of ruxolitinib cream in children aged 2 to 11 years with atopic dermatitis: Results from TRuE-AD3, a phase 3, randomized double-blind study
Bibliographic record
Abstract
BACKGROUND: Ruxolitinib (Janus kinase 1 and Janus kinase 2 inhibitor) cream demonstrated efficacy and safety in adolescents and adults with mild-to-moderate atopic dermatitis (AD). OBJECTIVE: To evaluate 8-week efficacy and safety of ruxolitinib cream in children with mild-to-moderate AD. METHODS: This phase 3 study (TRuE-AD3; NCT04921969) enrolled children aged 2-11 years with an Investigator's Global Assessment (IGA) score of 2 or 3 and 3% to 20% affected body surface area. Patients were randomized 2:2:1 to twice-daily ruxolitinib cream (0.75% or 1.5%) or vehicle for 8 weeks. The primary endpoint was the proportion of patients achieving IGA treatment success (IGA-TS; score of 0/1 with ≥2-grade improvement from baseline) at Week 8. RESULTS: Children (N = 330) were randomized to vehicle (n = 65), 0.75% ruxolitinib cream (n = 134), or 1.5% ruxolitinib cream (n = 131). At Week 8, significantly more patients achieved IGA-TS with 0.75%/1.5% ruxolitinib cream (36.6%/56.5%) versus vehicle (10.8%; P = .0001/P < .0001). Improvements in itch and quality of life were also observed. The safety profile was consistent with that observed in adults and adolescents. LIMITATIONS: Enrollment was limited to patients in North America. CONCLUSION: Ruxolitinib cream provided superior improvements versus vehicle in AD signs and symptoms in children with mild-to-moderate AD and was well tolerated.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 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 source (direct Gemma or distilled Codex), 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".