288 Once-daily crisaborole as a long-term maintenance treatment in patients with mild-to-moderate atopic dermatitis: A 52-week clinical trial
Bibliographic record
Abstract
Abstract Treatments for atopic dermatitis (AD) often fail to achieve lasting disease control despite patient adherence, with safety concerns limiting the long-term use of many therapies. Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate AD. Crisaborole has the potential as a long-term maintenance therapy. To assess the long-term efficacy and safety of crisaborole once daily as a maintenance treatment to reduce the incidence of flares in patients who had achieved response with treatment with crisaborole twice daily. CrisADe CONTROL (NCT04040192) was a randomized, double-blind, vehicle-controlled, 52-week, phase 3 study of patients aged ≥ 3 months with mild-to-moderate AD involving ≥ 5% treatable body surface area. In an open-label run-in period, patients received crisaborole twice daily for up to 8 weeks. Patients who achieved success per Investigator’s Static Global Assessment (ISGA; ISGA score of 0 [clear] or 1 [almost clear] with a ≥ 2-grade improvement from baseline) and ≥ 50% reduction from baseline on the Eczema Area and Severity Index during the run-in were randomly assigned to receive blinded crisaborole or vehicle once daily during the 52-week maintenance period. Patients who experienced a flare (ISGA score ≥2) during the maintenance period switched to crisaborole twice daily for up to 12 weeks (assessed every 4 weeks); if the flare resolved (ISGA score ≤ 1), patients resumed their blinded once-daily treatment. Endpoints included flare-free maintenance until the onset of the first flare (primary), the number of days without flare and the number of flares. The incidence of treatment-emergent adverse events was also evaluated. Of 270 randomly assigned patients, 135 were assigned to crisaborole and 135 to a vehicle once daily. The median time of flare-free maintenance was longer for patients treated with crisaborole vs. vehicle (111 vs. 30 days, respectively; P = 0.0034). The mean number of flare-free days was higher for patients treated with crisaborole vs. vehicle (234.0 vs. 199.4, respectively; P = 0.0346). The mean number of flares was lower for patients treated with crisaborole vs. vehicle (0.95 vs. 1.36, respectively; P = 0.0042). Crisaborole was well tolerated, with no unexpected safety findings or new safety signals when used as a maintenance treatment for 52 weeks. Once-daily treatment with crisaborole was effective and well tolerated for long-term maintenance treatment and flare reduction in adult and paediatric patients 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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| 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) | 0.006 | 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".