Crisaborole Topical Ointment, 2%, a novel nonsteroidal, anti-inflammatory, topical, phosphodiesterase 4 inhibitor, reduced pruritus and signs of atopic dermatitis in 2 phase 3 studies in children and adults with mild-to-moderate atopic dermatitis
Bibliographic record
Abstract
Abstract Atopic dermatitis (AD) is an inflammatory skin disease with intense pruritus and eczematous lesions. Crisaborole Topical Ointment, 2% (Anacor Pharmaceuticals, Palo Alto, CA), is an investigational, nonsteroidal, anti-inflammatory, topical, phosphodiesterase 4 inhibitor for the treatment of AD. Here, we present the impact of crisaborole on pruritus and signs of AD evaluated as supportive efficacy endpoints for 2 Phase 3 studies (301, 302). Patients ≥2 years old with mild-to-moderate AD were enrolled in 2 double-blind, vehicle-controlled, multicenter Phase 3 studies of identical design. Patients were randomized 2:1 to receive crisaborole or vehicle twice daily for 28 days. Supportive efficacy endpoints examined severity of pruritus (measured twice daily) and signs of AD (measured weekly) on a 4-point scale (None [0] to Severe [3]). Success was defined for pruritus or each sign or symptom of AD as achievement of None (0) or Mild (1) with ≥1-grade improvement from baseline. Improvement in pruritus was achieved sooner in crisaborole-treated patients than vehicle-treated patients (pooled data: median, 1.37 vs 1.70 days; P = 0.001). A greater proportion of crisaborole-treated patients achieved success for all clinical signs of AD by Day 29 (301, 302; erythema: 62.8% vs 46.1%; 54.9% vs 33.9%; induration/papulation: 57.7% vs 54.8%; −51.9% vs 40.2%; exudation: 41.0% vs 33.3%; 38.1% vs 27.2%; excoriation: 63.0% vs 51.8%; 57.2% vs 44.2%; lichenification: 51.7% vs 46.5%; 51.4% vs 35.3%). In 2 large Phase 3 studies, crisaborole demonstrated early relief of pruritus and showed improvement in all measured signs of AD. Crisaborole Topical Ointment, 2%, may represent a safe and efficacious treatment for patients ≥2 years with mild-to-moderate AD.
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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 | 0.000 |
| 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".