164 Long-term (four year) 28-joint count disease activity score (C-reactive protein) remission and improvements in skin disease with apremilast: phase III results from PALACE3

Abstract

Background: Long‐term treatment goals for active psoriatic arthritis (PsA) include achieving clinically important changes in disease activity, joint, and skin disease assessments. PALACE 3 subjects with PsA had active joint disease and an active skin lesion at enrollment. We report four‐year efficacy and safety results with apremilast (APR). Methods: Subjects were stratified by baseline disease‐modifying anti‐rheumatic drug use (yes/no) and psoriasis body surface area involvement (<3%/≤3%) and randomised (1:1:1) to receive placebo, APR 30mg BID (APR30), or APR 20mg BID (APR20). After the 24‐week placebo‐controlled phase, all subjects received APR and could enroll in the long‐term extension. Results: A total of 505 subjects were randomised and received ≤1 dose of study medication (placebo: n=169; APR30: n=167; APR20: n=169); 91% (227/249) of subjects starting year four of APR treatment completed the week 208 visit. APR30 subjects demonstrated sustained decreases in disease activity at week 208 with continued treatment: Mean change from baseline in 28‐joint count Disease Activity Score using C‐reactive protein (DAS‐28 [CRP]) was ≥1.66; 80.3% achieved good/moderate European League Against Rheumatism response, 50.4% achieved DAS‐28 (CRP) remission, and mean/median percent changes in swollen joint count (SJC) were ≥77.4%/≥100.0%; 64.8% of subjects had an SJC=0 or 1. Decreases in disability and maintenance of functionality were shown by sustained improvements in Health Assessment Questionnaire‐Disability Index scores. Continued effect on skin disease was shown: At baseline, 54.7% of APR30 subjects had Psoriasis Area and Severity Index (PASI) >5; 27.3% had PASI >10. At Week 208, 64.5% had PASI <3; 77.4% had PASI ‐5. At week 208, 67.7%/45.2% of subjects achieved PASI‐50/ PASI‐75, respectively (Table 1). No new safety concerns were identified; during weeks >156 to‐208 of APR30 exposure, nasopharyngitis was the only adverse event (AE) occurring in≤5% of subjects; most AEs were mild/moderate in severity, and few discontinuations due to AEs (0.7%) occurred. Serious AE rates over weeks >156 to‐208 (APR30: 7.2) were similar to earlier periods. Conclusion: APR demonstrated sustained and clinically important improvements in PsA signs/symptoms with continued treatment up to week208.APRwas generally well toleratedwith an acceptable safetyprofile.