AB0758 REAL-WORLD EFFICACY AND SAFETY OF APREMILAST IN BELGIAN PATIENTS WITH PSORIATIC ARTHRITIS: FINAL ANALYSIS OF THE MULTICENTRE, PROSPECTIVE APOLO STUDY

Background: Real-world evidence on the efficacy and safety for patients (pts) with psoriatic arthritis (PsA) treated with apremilast (APR) is lacking but required to understand the uptake and potential of the drug. Objectives: To assess the efficacy and safety of APR in pts with active PsA from routine clinical practice in Belgium. Methods: In this multicentre, prospective study, the primary endpoint was the PsA Response Criteria (PsARC) response 6 months after APR initiation, defined as improvement in ≥2 (at least 1 must be joint swelling or tenderness) and no worsening in any of 4 criteria: swollen joint count (SJC [0-66]), tender joint count (TJC [0-68]), Physician’s Global Assessment of Disease Activity and Pt’s Global Assessment of Disease Activity. Other endpoints included the 12-item PsA Impact of the Disease (PsAID12) questionnaire, Health Assessment Questionnaire-Disability Index (HAQ-DI), Physician’s and Pt’s Numerical Rating Scale assessing disease activity for the most affected joint, psoriasis-involved body surface area, enthesitis, dactylitis and pain. Results: In total, 107 pts were enrolled and included in the baseline (BL) demographics/disease characteristics and safety analyses. The efficacy population comprised 69 pts (pts who started APR ≤30 days before inclusion in the study and completed ≥150 days of treatment). Mean age was 53 years, mean body mass index was 29 kg/m2 and 56% were female. Mean duration of PsA was ≈8 years (87.1 months). One-third of pts presented with short disease duration (time since diagnosis of PsA: ≤2 years); 84% were biologic naive. The most frequently reported comorbidities were cardiovascular disease (30%) and hypercholesterolemia (24%). At BL, mean (SD) SJC was 8.0 (6.5); mean (SD) TJC was 14.2 (12.5). Pts from the efficacy population were representative of the overall population. Fifty-four pts (60%) continued APR treatment for 6 months; 38 (36%) had discontinued APR (insufficient efficacy: n=15; adverse events [AEs]: n=16; intolerance: n=6; other reason: n=1). AEs were mostly mild or moderate in nature and consistent with APR’s known safety and tolerability profile.1 At Month 6, data were available for 49 pts, 65% of whom were PsARC responders. Mean change from BL in SJC was −5.23, with improvements (defined as ≥30% decrease per PsARC) observed in 80% of pts; 42% had no swollen joints at 6 months. Comparable results were seen for TJC, with mean changes from BL of −5.34 and improvements observed in 71% of pts; 27% had no tender joints at 6 months. Among pts with enthesitis at BL (n=21), 43% achieved a score of 0 by Month 6. Among pts with dactylitis at BL (n=18), 83% achieved a count of 0 by Month 6. Impact of PsA on quality of life (QoL) from the pt’s perspective was assessed using the PsAID12 questionnaire and characterized by physical and psychological domains. After 3 and 6 months of treatment, 33% and 50% of pts with PsAID >4 at BL (n=60) achieved PsAID12 ≤4, respectively (cutoff value for Pt Acceptable Symptom State2). Improvements were observed in all 12 domains at Months 3 and 6 compared with BL (Figure). In all, 66% of pts showed a decrease ≥0.35 in HAQ-DI; the proportion of pts reaching a global HAQ-DI