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

J. J. De Agustin, G. Añez, D. Reina-Sanz, S. Heredia, J. Ramirez, A. Cuervo, J. Rodríguez, C. Moragues Pastor, P. Moya, A. Laiz, M. Moreno, M. Arévalo, M. Pujol Busquets, G. Salvador Alarcon, N. Busquets-Pérez, A. Ponce Fernandez, M. Pascual-PastorHospital Universitari Vall d’Hebron, Rheumatology, Barcelona, Spain Hospital Universitari Vall d’Hebron: Reumatologia, Rheumatology, Barcelona, Spain Hospital de Sant Joan Despí Moisès Broggi, Rheumatology, Sant Joan Despí, Spain Hospital Clínic de Barcelona, Rheumatology, Barcelona, Spain Bellvitge University Hospital, Rheumatology, L’Hospitalet de Llobregat, Spain Hospital de la Santa Creu i Sant Pau, Rheumatology, Barcelona, Spain Hospital Parc Taulí de Sabadell, Rheumatology, Sabadell, Spain Hospital Universitari MútuaTerrassa, Rheumatology, Terrassa, Spain Hospital General de Granollers, Rheumatology, Granollers, Spain  Background We 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. Objectives Obtain a 20, 50, 70 % reduction in the US index (UIC) at 12 months, and study correlation between variables. Methods Phase 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 2, 3rd and 5 finger was done. Results 48 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). Conclusion Apremilast 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. Table 1. Variables changes in aPsA patients treated with Apremilast variable 0 1 m 6 m 9 m 12 m p PGA 455.6 (1.2)CI[5.2; 6] 454.1 (2)[3.5; 4.7] 312.4 (1.9)[1.8; 3.1] 272.4 (1.9)[1.7; 3.2] 262.6 (1.9)[1.8; 3.4] <0.001 PtGA 456.2 (1.9)[5.6; 6.8] 455.1 (2.5)[4.4; 5.9] 313.4 (1.9)[2.7; 4.1] 263.1 (2.4)[2.1; 4] 263.8 (2.1)[3; 4.7] <0.001 LEI 451.4 (1.6)[0.9; 1.9]] 451 (1.3)[0.7; 1.4]] 310.9 (1.2)[0.5; 1.4] 270.5 (1.1)[0.1; 0.9] 260.8 (1.2)[0.3; 1.3] 0.01 NAD 455.8 (5.8)[4.1; 7.6] 454.4 (4.8)[3; 5.8] 312.9 (4)[1.4; 4.4] 272.4 (3.6)[1; 3.8] 263 (4)[1.4; 4.6] 0.009 NAT 453.2 (2.4)[2.5; 3.9] 452.1 (2.2)[1.4; 2.7] 310.9 (1.8)[0.3; 1.6] 271.1 (1.9)[0.4; 1.9] 261 (1.4)[0.5; 1.6] 0.001 CRP 431.7 (3.7)[0.6; 2.9] 420.9 (1.9)[0.3; 1.5] 290.9 (1.4)[0.4; 1.5] 270.9 (1.3)[0.3; 1.4] 261 (1.7)[0.3; 1.7] n.s US joint 4517.6 (11)[14.3; 20.9] 4512.4 (8.5)[9.8; 15] 319.2 (7.2)[6.5; 11.8] 277.9 (8.1)[4.7; 11.1] 267.5 (6.7)[4.9; 10.2] 0.006 US entheses 456 (3.9)[4.9; 7.2] 453.9 (3.1)[3; 4.9] 313.7 (2.8)[2.7; 4.7] 273.3 (3)[2.1; 4.5] 263.2 (2.5)[2.2; 4.2] <0.001 US total (UIC) 4523.6 (12.6)[19.9; 27.4] 4516.3 (9.8)[13.4; 19.3] 3112.8 (8)[9.9; 15.8] 2711.1 (9.5)[7.4; 14.9] 2610.7 (7.6)[7.7; 13.8] <0.001 ESR 4118.3 (16.8)[13; 23.6] 4216.7 (12.4)[12.8; 20.6] 3017.6 (15.8)[11.7; 23.5] 2712.7 (10.3)[8.6; 16.7] 2515.7 (12)[10.7; 20.6] n.s PGA, physician global assessment; PtGA, patient global assessment; LEI, Leeds enthesitis index; SJC, swollen joint count; TJC, tender joint count, CRP, c reactive protein; ESR; erythrosedimentation rate Acknowledgements: NIL. Disclosure of Interests None Declared. Keywords: Psoriatic arthritis, Biomarkers, Ultrasound DOI: 10.1136/annrheumdis-2023-eular.1397Citation: , volume 82, supplement 1, year 2023, page 1787Session: Psoriatic arthritis - treatment (Publication only)