217. Long-Term (104-Week) Efficacy and Safety Profile of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis: Results from a Phase III, Randomized, Controlled Trial and Open-Label Extension (PALACE 1)
Bibliographic record
Abstract
Background: Apremilast (APR), an oral phosphodiesterase 4 inhibitor, helps regulate immune responses in PsA. PALACE 1 compared the efficacy/safety of APR with placebo in patients with active PsA despite prior conventional DMARDs and/or biologics. We report the efficacy/safety of APR treatment over 104 weeks. Methods: Patients were randomized (1:1:1) to placebo, APR 20 mg b.i.d. (APR20), or APR 30 mg b.i.d. (APR30) stratified by baseline DMARD use (yes/no). Patients whose swollen/tender joint counts (SJC/TJC) had not improved ≥20% at week 16 were considered non-responders and were required to be re-randomized (1:1) to APR20 or APR30 if initially randomized to placebo, or continued on their initial APR dose. At week 24, all remaining placebo patients were re-randomized (1:1) to APR20 or APR30. Double-blind APR treatment continued to week 52; patients could continue APR up to 4 additional years. Results: 504 randomized patients received ≥1 dose of study medication (placebo n = 168; APR20 n = 168; APR30 n = 168). At week 52, modified ACR20 response was achieved by 63.0% and 54.6% of patients continually treated with APR20 or APR30 from baseline, respectively. Approximately 80% (285/344) of randomized patients completing Week 52 were still receiving APR at the data cutoff during their second year of APR exposure. Patients receiving APR from baseline demonstrated sustained improvements at Week 104 in modified ACR20/ACR50/ACR70 response [61.3%/29.8%/16.0% (APR20) and 66.3%/35.6%/19.8% (APR30)]; median percentage change in SJC/TJC [−88.9%/−80.5% (APR20) and −87.5%/−76.7% (APR30)]; mean change in HAQ-DI [−0.33 (APR20) and −0.43 (APR30)]; mean change in DAS28 [CRP; −1.61 mg/l (APR20) and −1.83 mg/l (APR30)]; achievement of DAS28 (CRP) <2.6 mg/l [35.1% (APR20) and 38.6% (APR30)]; and PASI-50/PASI-75 response [53.7%/36.6% (APR20) and 54.7%/30.2% (APR30)]. No new safety concerns were observed with treatment through week 104. During weeks >52 to ≤104, adverse events (AEs) occurring in ≥5% of APR-exposed patients were nasopharyngitis and upper respiratory tract infection; most AEs were mild/moderate in severity with no long-term increase in AE incidence and severity. Diarrhoea and nausea occurred at lower rates in weeks >52 to ≤104 (1.7% and 1.2%, respectively) than in weeks 0 to ≤52 (15.3% and 12.4%, respectively). Serious AEs occurred in 6.4% (APR20) and 4.7% (APR30) over weeks >52 to ≤104. Fewer discontinuations due to AEs occurred during weeks >52 to ≤104 (1.5%) than weeks 0 to ≤52 (8.2%).
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 distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".