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). Method(s): Subjects were stratified by baseline disease-modifying anti-rheumatic drug use (yes/no) and psoriasis body surface area involvement (<3%/ =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 156 to-208 (APR30: 7.2) were similar to earlier periods. Conclusion(s): APR demonstrated sustained and clinically important improvements in PsA signs/symptoms with continued treatment up to week208.APRwas generally well toleratedwith an acceptable safetyprofile.