O03 Apremilast, an Oral Phosphodiesterase-4 Inhibitor, is Associated with Long-Term (104-Week) Improvements in Enthesitis and Dactylitis in Patients with Psoriatic Arthritis: Pooled Results from Three Phase III Randomized Controlled Trials
Bibliographic record
Abstract
Background: PALACE 1 (NCT01172938), 2 (NCT01212757) and 3 (NCT01212770) evaluated apremilast (APR) efficacy and safety in patients with active PsA. We report the impact of APR treatment on enthesitis and dactylitis, hallmark features of PsA, over 104 weeks in a pooled analysis of PALACE 1–3. Methods: Patients were randomized (1:1:1) to receive placebo, APR 30 mg twice a day (APR30) or APR 20 mg twice a day (APR20). From weeks 24 to 52, patients received double-blind APR30 or APR20 treatment; a 4-year open-label extension phase is ongoing. Pre-planned analyses examined data pooled across PALACE 1–3 at week 24 from patients with pre-existing enthesitis and/or dactylitis using the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) (range 0-13) and dactylitis count (range 0-20), respectively. Analyses at week 24 used last observation carried forward for missing values; in patients qualifying for early escape at week 16, that value was carried forward. For all others, the last post-baseline value was carried forward for missing values at week 24. Weeks 52 and 104 were based on data as observed.
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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 | 0.004 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.005 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 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".