2116: Assessment of the Ultrasound and Clinical Response to Apremilast Using a Joint-periarticular-nail Ultrasound Index and Clinical Evaluation in Patients with Active Psoriatic Arthritis

Juan Josè de Agustin¹, Gustavo Añez¹, delia reina², Sergi Heredia³, Felipe Julio Ramirez Garcia⁴, Andrea Cuervo⁵, Jesus Rodriguez⁶, Carmen Moragues⁶, Patricia Moya⁷, Mireia Moreno⁸, Marta Arévalo⁸, Manel Pujol⁹, Georgina Salvador⁹, Noemi Busquets¹⁰, andres Ponce¹⁰, Ana Maria Laiz Alonso⁷ and MAria Pascual Pastor¹¹, ¹Vall D'hebron University Hospital, Barcelona, Spain, ²Complex Hospitalari Moisès Broggi, Sant Joan Despí, Catalonia, Spain, ³Complex Hospitalari Moisès Broggi, Sant Joan Despi, Catalonia, Spain, ⁴Hospital Clínic, Barcelona, Spain, ⁵Hospital Clínico y Provincial de Barcelona, Barcelona, Spain, ⁶Hospital Bellvitge, Hospitalet de Llobregat, Spain, ⁷Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, ⁸Parc Tauli Hospital Universitari, Sabadell, Catalonia, Spain, ⁹Hospital Universitario MútuaTerrassa, Terrassa, Spain, ¹⁰Hospital General de Granollers, Granollers, Spain, ¹¹Hospital Universitari Vall d'Hebron, Barcelona, Spain

Background/Purpose: Psoriatic arthritis (PsA) is a chronic inflammatory disease involving joint and enthesis disease. Ultrasound (US) has demonstrated its useful tool for the diagnosis of PsA and monitoring of inflammatory lesions in PsA. Our purpose is to conduct a study using US to evidence inflammatory changes in the joint and in the entheses in patients with active PsA (aPsA) who started Apremilast in clinical practice. Main objective was to obtain a 20% reduction in the US index (UIC) at 12 months.

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), and ≥ 2 joint US synovitis and ≥ 1 US enthesitis at screening were recruited. 52 weeks follow up (baseline, and 1, 6, 9, 12 months). US (joint, tendon & enthesis), clinic (SJC, TJC, LEI, PGA, PtGA), and biological parameters (ESR & CRP) were registered at each visit. US scans were scored according to Ficjan et al (1). Also, an ungueal (nail plate (NP) and subungueal thickness (ST)) US evaluation of 2^nd, 3rd and 5^th finger was done. We performed a descriptive analysis. Qualitative variables as number and percentage, and quantitative variables as median and interquartile range (IQR) were described. Confidence intervals were considered at 95%. The one-sample t-test was performed to determine whether the reduction between [UIC] before and after the intervention was greater than the reference value of 20%.

A generalized linear mixed effect model was fitted with clinical parameters as the outcome and duration of follow-up as the main covariate. Changes in clinical parameters over time were evaluated by means of the time slope. To consider the individual variability in clinical parameters, the model was adjusted for a random intercept effect.

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.

Results: 48 patients (3 excludes screening failure) screened and 46 included in follow up. 26 completed the 52 weeks study and were used for analysis. Baseline characteristics are in table 1. Main objective was achieved, and reduction was high until 40%. All, clinical and US variables (joint, tendon & enthesis), were significantly reduced after 12 months of follow-up (table 2). ESR and CRP did not change at follow up. Secondary objective, 50% of reduction was not achieved. A reduction in 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 (AE) in 33 patients were register during study, only 1 was consider severe (SAE). 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 image ultrasonography score. Ultrasound can identify nail disease in PsA patients.
Table 1. Demographic characteristics of patients and comorbidities by organ system
CI, coefficient interval

Table 2. Evolution of clinic, biological and ultrasound variables in 52 weeks follow up in aPsA patients treated with Apremilast.
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
Disclosures: J. de Agustin, None; G. Añez, Amgen; d. reina, Amgen; S. Heredia, Amgen; F. Ramirez Garcia, Amgen; A. Cuervo, Amgen; J. Rodriguez, Amgen; C. Moragues, Amgen; P. Moya, Amgen; M. Moreno, Amgen; M. Arévalo, Amgen; M. Pujol, Amgen; G. Salvador, Amgen; N. Busquets, Amgen; a. Ponce, Amgen; A. Laiz Alonso, Amgen; M. Pascual Pastor, Amgen.