Efficacy and Safety of Ruxolitinib Cream for the Treatment of Atopic Dermatitis: Results From Two Phase 3, Randomized, Double-Blind Studies
Bibliographic record
Abstract
Background• Atopic dermatitis (AD) is a chronic, inflammatory skin disease that greatly impacts patients' quality of life 1,2 • Janus kinases (JAKs) modulate inflammatory cytokines involved in the pathogenesis of AD 3 and may also directly modulate itch 4 • Ruxolitinib (RUX) is a potent, selective inhibitor of JAK1 and JAK2 5 • In a phase 2 study (NCT03011892), RUX cream provided strength-dependent efficacy in patients with AD and a safety profile similar to vehicle 6 Objectives • To report efficacy and safety of RUX cream in patients with AD in two phase 3 studies (TRuE-AD1 [NCT03745638] and TRuE-AD2 [NCT03745651]) Methods Patients and Study Design• Eligible patients were aged ≥12 years with AD for ≥2 years, an Investigator's Global Assessment (IGA) score of 2 or 3, and 3% to 20% affected body surface area • Key exclusion criteria were unstable course of AD, other types of eczema, immunocompromised status, use of AD systemic therapies during the washout period and during the study, use of AD topical therapies (except bland emollients) during the washout period and during the study, and any serious illness/medical condition that could interfere with study conduct, interpretation of data, or patients' well-being • TRuE-AD1 and TRuE-AD2 had identical study designs (Figure 1) -In both studies, patients were randomized (2:2:1) to either of 2 RUX cream strength regimens (0.75% twice daily [BID], 1.5% BID) or vehicle cream for 8 weeks of double-blind treatment -Patients on RUX cream could subsequently continue treatment for 44 weeks; patients initially randomized to vehicle were re-randomized 1:1 to either RUX cream regimen
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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 | 0.005 | 0.004 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
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".