Ab0743 real-World Effectiveness and Safety of Apremilast in Belgian Patients With Psoriatic Arthritis: Analysis From the Multicentre, Prospective, Non-Interventional Apolo Study

Abstract

BackgroundReal-world evidence on effectiveness and safety data for patients (pts) with psoriatic arthritis (PsA) in the Belgium clinical practice setting is lacking.ObjectivesTo assess the effectiveness and safety of apremilast (APR) in pts with active PsA from routine clinical practice in Belgium.MethodsIn this multicentre, prospective, non-interventional study (APOLO), the PsA Response Criteria (PsARC) response 6 months after aPR initiation was the primary endpoint. PsARC response was defined as improvement in ≥2 and no worsening of any of the following 4 measures: tender joint count (TJC; 0-68), swollen joint count (SJC; 0-66), Physician’s Global assessment of Disease activity (PhGA) and Patient’s Global assessment of Disease activity (PtGA). Other endpoints included PsAID12, HAQ-DI, Physician’s and Patient’s Numerical Rating Scale (NRS) assessing disease activity for the most affected joint, psoriasis-affected body surface area (BSA), enthesitis, dactylitis, pain and pruritus. The current analysis is based on observed data.ResultsThe first 55 of a planned 150 Belgian pts receiving aPR for up to 6 months were evaluated. Mean age was 52.5 yrs, mean BMI was 27.1 kg/m2 and 47.3% were female. Mean durations of psoriasis and PsA were 15.8 yrs and 8.1 yrs, respectively; ≈80% of pts were biologic-naive. At baseline (BL), mean (SD) SJC was 8.0 (5.4), mean (SD) TJC was 12.7 (9.5) and mean (SD) body surface affected was 12.3% (20.8%); 31.0% of pts had dactylitis and 47.8% had enthesitis. In total, 35 pts (63.6%) continued aPR treatment for 6 months; 20 (36.4%) had discontinued aPR (insufficient effectiveness: 21.8%; adverse events: 10.9%, intolerance: 3.6%). After 6 months of aPR initiation, 69.6% of pts had a PsARC response. Mean changes from BL in SJC were −4.4 (Month 3) and −5.7 (Month 6), with improvements in SJC (defined as ≥30% decrease per PsARC) observed in most pts (Month 3: 78.3%; Month 6: 83.3%). Comparable results were seen for TJC: Mean changes from BL were −7.2 (Month 3) and −6.7 (Month 6), with improvements observed in most pts (Month 3: 78.3%; Month 6: 80%). Decreases in PhGA score of ≥1 from BL were observed in most pts at Months 3 (73.7%) and 6 (66.7%). Mean (SD) Physician’s NRS scores decreased from 5.6 (2.6) at BL to 2.5 (2.0) at Month 6. Among pts with enthesitis at BL who had data available at Month 6, 54.5% achieved a score of 0. Among pts with dactylitis at BL who had data available at Month 6, 44.4% achieved a score of 0. BL mean (SD) PsAID12 score of 5.9 (1.6) decreased to 3.7 (1.8) at Month 6. Mean (SD) BSA improved from 12.3% (20.8%) at BL to 7.5% (14.7%) at Month 6. An improvement of ≥20% in HAQ-DI at Month 6 was achieved by 73.1% of pts. Improvements were also seen in PtGA score, overall pain and pruritus. No new safety and tolerability concerns from known overall safety profile of aPR.ConclusionResults from this real-world PsA study confirmed an improvement in disease activity with aPR in both physician-assessed and pt-reported outcomes for most pts. Overall, improvements were observed afte...