166 Long-term (156-week) improvements in dactylitis and enthesitis with apremilast inpsoriatic arthritis subjects: analysis of a large, pooled PALACE 1-3 database
Bibliographic record
Abstract
Background: PALACE 1, 2, and 3 assessed apremilast (APR) efficacy/safety in subjects with active psoriatic arthritis (PsA) despite prior conventional disease-modifying anti-rheumatic drugs (DMARDs) and/or biologics. We report the impact of long-term APR 30 mg BID (APR30) on pre-existing dactylitis and enthesitis in the studies. Methods: Subjects were randomised (1:1:1) to placebo, APR30, or APR 20 mg BID stratified by baseline DMARD use (yes/no). After the 24-week placebo-controlled phase, all subjects received APR and could enroll in long-term follow-up. Data for subjects with pre-existing dactylitis or enthesitis were pooled across PALACE 1-3. Dactylitis count (range: 0-20) was used to assess dactylitis improvement. Evaluation of enthesitis used the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES; range: 0-13). Analyses utilised the last-observation-carried-forward methodology at week 24 and data as observed for weeks 52 and 156. Results: Among subjects with dactylitis (n = 610) or enthesitis (n = 915) at baseline and ≥1 post-baseline value, baseline mean dactylitis counts and MASES ranged from 3.2 to 3.4 and 4.4 to 4.8, respectively. At week 24, mean change in dactylitis count was −1.8 (APR30) vs. −1.3 (placebo) (P=0.0097); more APR30 vs. placebo subjects achieved dactylitis counts=0. Mean change in MASES was −1.3 (APR30) vs. −0.9 (placebo) (P=0.0194); more APR30 vs. placebo subjects achieved MASES=0. The effect on enthesitis was confirmed in the ACTIVE study of APR subjects with ≤1 prior DMARD using the Gladman Enthesitis Index, focusing on more peripheral sites of activity; significant effect for APR vs. placebo was seen as early as week 2; at week 24, mean change was −1.5 vs. −0.5 (P=0.0032, mixed-model repeated-measure). Sustained improvements in dactylitis and enthesitis severity were seen with continued APR treatment at week 156 in PALACE 1-3: 79.6% achieved dactylitis count=0 and mean percent change was −83.6%; 55.0% of APR subjects achieved MASES=0 and mean percent change was −65.2% (Table 1).
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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 | 0.011 | 0.011 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.007 |
| Bibliometrics | 0.002 | 0.004 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".