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)
Notice bibliographique
Résumé
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%).
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».