AB1116 APREMILAST IN PSORIATIC ARTHRITIS. ULTRASOUND ANALYSIS (JOINT-ENTHESES-UNGUEAL INDEX) OF THE EFFICACY AND VARIABLES CORRELATION STUDY

BackgroundWe conducted a study using ultrasonography (US) to evidence inflammatory changes (joint-enthesis-ungueal) in active PsA (aPsA) patients who started Apremilast (A) in clinical practice.ObjectivesObtain a 20, 50, 70 % reduction in the US index (UIC) at 12 months, and study correlation between variables.MethodsPhase IV, multicenter, prospective and open-label clinical trial conducted in 9 centres from 2018 to 2021. All patients signed the informed consent. Approval by the ethical committee was obtained, code PSA-PI-006421. PsA patients (≥ 2 swollen joints), ≥ 2 joint US synovitis and ≥ 1 US enthesitis at screening were recruited. 52 weeks follow up (baseline, 1, 6, 9 & 12 months). US & clinic variables, and ESR & CRP were registered at each visit. US scans were scored according to Ficjan et al [1]. Ungueal nail plate (NP) and subungueal thickness (ST) US evaluation of 2nd, 3rd and 5th finger was done.Results48 patients screened and 46 included (2 screening failure) in follow up. 26 completed the study. A 20 % (main objective) reduction in UIC was obtained, until 40%, but not 50/70%. Clinical and US variables were reduced, ESR and CRP did not change during follow-up (Table 1). Strong correlation was observed between UIC and SJC, moderate between UIC and TJC, PGA, PtGA, CRP. A reduction in clinical onychopathy, NP lesion, and slight relation between lesion, and high ST and ST with onychopathy was seen but didn’t achieve statistical significance (reduced sample size). 75 adverse events in 33 patients were registered, only 1 severe. Reasons for withdrawal were: 6 patients AE, 8 no efficacy, and 6 other reasons (loss of follow-up, withdrawal of consent).ConclusionApremilast is a safe, well tolerated, and useful treatment in different patterns of PsA (joint, enthesis) demonstrated by an ultrasonography score. Ultrasound can identify nail disease in PsA patients.Reference[1]Ficjan A, Husic R, Gretler J, Lackner A, Graninger WB, Gutierrez M, et al. Ultrasound composite scores for the assessment of inflammatory and structural pathologies in Psoriatic Arthritis (PsASon-Score). Arthritis Res Ther. 2014;16(1):1–13.Acknowledgements:NIL.Disclosure of InterestsNone Declared.