Skin clearance, duration of treatment-free interval, and safety of tapinarof cream 1% once daily: Results from ADORING 3, a 48-week phase 3 open-label extension trial in adults and children down to 2 years of age with atopic dermatitis
Bibliographic record
Abstract
BACKGROUND: In 2 pivotal phase 3 trials, tapinarof demonstrated significant efficacy and was well tolerated in patients down to age 2 years with atopic dermatitis. OBJECTIVE: Assess skin clearance rates, duration of treatment-free intervals, and safety of tapinarof in a phase 3 open-label extension trial. METHODS: Patients from the ADORING 1 and 2 pivotal phase 3 trials, a 4-week maximal usage pharmacokinetics trial, and tapinarof-naive patients received tapinarof for up to 48 weeks. Treatment was based on Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score. Patients with vIGA-AD≥1 received tapinarof until vIGA-AD=0. Patients achieving vIGA-AD=0 discontinued tapinarof and were monitored for treatment-free interval. Patients with vIGA-AD≥2 were re-treated until vIGA-AD=0. RESULTS: Seven hundred twenty-eight patients enrolled. Overall, 51.9% achieved vIGA-AD=0, and 81.6% achieved vIGA-AD=0 or 1 at least once. After first achieving complete clearance and discontinuing treatment, the mean first treatment-free interval was 79.8 consecutive days. Tapinarof was well tolerated, with no new safety signals. Most-frequent adverse events were folliculitis (12.1%), nasopharyngitis (6.9%), and upper respiratory tract infection (6.9%). LIMITATIONS: Open-label; treatment-free interval potentially underestimated. CONCLUSION: Tapinarof was well tolerated and resulted in high skin clearance rates that were maintained off-therapy and consistent safety in patients down to age 2 years.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 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".