AB0758 REAL-WORLD EFFICACY AND SAFETY OF APREMILAST IN BELGIAN PATIENTS WITH PSORIATIC ARTHRITIS: FINAL ANALYSIS OF THE MULTICENTRE, PROSPECTIVE APOLO STUDY
Authors: K. De Vlam, A. Nzeusseu Toukap, M. J. Kaiser, J. Vanhoof, P. Remans, S. DI Romana, F. Van den Bosch, V. Vanhoof, R. Lories
Journal: Annals of the Rheumatic Diseases (2020)

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/m 2 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 &gt;4 at BL (n=60) achieved PsAID12 ≤4, respectively (cutoff value for Pt Acceptable Symptom State 2 ). 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 &lt;0.5 increased over time (14% at 3 months; 20% at 6 months). Conclusion: Results from APOLO, a study assessing the impact of APR in routine settings, indicated that APR is associated with rapid and sustained improvements in PsA signs and symptoms and QoL in an important proportion of pts. Safety and tolerability were consistent with the known profile of APR. References: [1]Kavanaugh A, et al. Arthritis Res Ther. 2019;21:118. 2. Gossec L, et al. Ann Rheum Dis. 2014;73:1012-1019. Disclosure of Interests: Kurt de Vlam Consultant of: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – consultant, Speakers bureau: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – speakers bureau and honoraria, Adrien Nzeusseu Toukap Grant/research support from: AbbVie, Celgene Corporation, Janssen, Pfizer, UCB – grant/research support, Consultant of: AbbVie, Eli Lilly, Janssen, Novartis, UCB – consultant, Speakers bureau: AbbVie, Eli Lilly, Janssen, Novartis, UCB – advisory board member, Marie-Joëlle Kaiser Consultant of: Celgene Corporation – consultant, Johan Vanhoof: None declared, Philip Remans: None declared, Silvana Di Romana: None declared, Filip van den Bosch Consultant of: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Speakers bureau: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Virginie Vanhoof Employee of: Amgen Inc. – employment; Celgene BeLux – employment at the time of study conduct, Rik Lories Grant/research support from: AbbVie, Boehringer Ingelheim, Celgene Corporation, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Samumed and UCB – grant/research support (on behalf of Leuven Research and Development), Consultant of: AbbVie, Boehringer Ingelheim, Celgene Corporation, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Samumed and UCB – consultant (on behalf of Leuven Research and Development), Speakers bureau: AbbVie, Boehringer Ingelheim, Celgene Corporation, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Samumed and UCB – speaker (on behalf of Leuven Research and Development)