Apremilast in Japanese patients with palmoplantar pustulosis: A randomized, Phase 3 trial
Bibliographic record
Abstract
BACKGROUND: Palmoplantar pustulosis (PPP) is a difficult-to-treat chronic dermatitis with limited treatment options. OBJECTIVES: To report results from a Phase 3 study of apremilast in patients with moderate to severe PPP (NCT05174065). METHODS: In this randomized, placebo-controlled, double-blind, confirmatory study, Japanese adults with PPP Area and Severity Index (PPPASI) total score ≥12, PPPASI pustules/vesicles severity score ≥2 and inadequate response to topicals were randomly assigned (1:1) to apremilast or placebo for 16 weeks, followed by an active treatment phase where all patients received apremilast through Week 52. The primary endpoint was a ≥50% reduction in PPPASI total score (PPPASI-50) at Week 16, evaluated in all randomized patients. Safety outcomes were assessed in all patients who received ≥1 dose of the study drug. RESULTS: Between March 8, 2022 to April 28, 2023, 176 patients (141 [80%] women, 35 [20%] men) were randomly assigned to apremilast (n = 88 [50%]) or placebo (n = 88 [50%]). Mean (SD) PPPASI total score at baseline was 22.1 (8.1) in the apremilast group and 22.0 (8.4) in the placebo group. A significantly greater proportion of patients achieved PPPASI-50 at Week 16 with apremilast versus placebo (60 of 88 [68%] vs. 31 of 88 [35%]; treatment difference: 32.6% [95% CI: 18.7, 46.5], p < 0.0001). Improvements were maintained through Week 52. The most common adverse events (≥10% of patients) during the double-blind phase in patients receiving apremilast were diarrhea (placebo: n = 3 [3%]; apremilast: n = 17 [19%]), feces soft (placebo: n = 1 [1%]; apremilast: n = 15 [17%]), headache (placebo: n = 2 [2%]; apremilast: n = 10 [11%]) and nausea (placebo: n = 1 [1%]; apremilast: n = 10 [11%]). There were no events of depression or fatal adverse events. CONCLUSIONS: In this Phase 3 trial, apremilast was effective in Japanese patients with moderate to severe PPP. Adverse events were consistent with the known safety profile of apremilast. CLINICALTRIALS: gov: NCT05174065.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 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) | 0.005 | 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".