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There are few real-world setting studies focused on apremilast effectiveness (i.e., retention rate) in psoriatic arthritis (PsA). The main aim of this retrospective observational study is the assessment of apremilast 3-year retention rate in real-world PsA patients. Moreover, the secondary objective is to report the reasons of apremilast discontinuation and the factors related to treatment persistence.In fifteen Italian rheumatological referral centers, all PsA consecutive patients who received apremilast were enrolled. Anamnestic data, treatment history, and PsA disease activity (DAPSA) at baseline were recorded. The Kaplan-Meier curve and the Cox analysis computed the apremilast retention rate and treatment persistence-related risk factors. A p-value 0.05 was considered statistically significant.The 356 enrolled patients (median age 60 [interquartile range IQR 52-67] yrs; male prevalence 42.7%) median observation period was 17 [IQR 7-34] months (7218 patients-months). The apremilast retention rate at 12, 24, and 36 months was, respectively, 85.6%, 73.6%, and 61.8%. The main discontinuation reasons were secondary inefficacy (34% of interruptions), gastro-intestinal intolerance (24%), and primary inefficacy (19%). Age and oligo-articular phenotype were related to treatment persistence (respectively hazard ratio 0.98 IQR 0.96-0.99; p = 0.048 and 0.54 IQR 0.31-0.95; p = 0.03).Almost three-fifths of PsA patients receiving apremilast were still in treatment after 3 years. This study confirmed its effectiveness and safety profile. Apremilast appears as a good treatment choice in all oligo-articular PsA patients and in those ones burdened by relevant comorbidities. Key Points • Apremilast retention rates in this real-life cohort and trials are comparable. • The oligo-articular phenotype is associated with long-lasting treatment (i.e., 3 years). • No different or more prevalent adverse events were observed.

Introduction: Enthesitis and dactylitis are difficult-to-treat features of psoriatic arthritis (PsA), leading to disability and affecting quality of life. Objective: The aim of this study is to evaluate enthesitis (using the Leed enthesitis index (LEI)) and dactylitis at 6 and 12 months in patients treated with apremilast. Methods: Patients affected by PsA from fifteen Italian rheumatological referral centers were screened. The inclusion criteria were: (a) enthesitis or dactylitisphenotype; (b) treatment with apremilast 30 mg bid. Clinical and treatment history, including PsA disease activity, were recorded. Mann–Whitney and chi-squared tests were used to assess the differences between independent groups, and Wilcoxon matched pairs signed-rank test assessed the differences between dependent samples. A p-value of

Objectives To investigate the reliability of the OMERACT US Task Force definition of US enthesitis in SpA. Methods In this web exercise, based on the evaluation of 101 images and 39 clips of the main entheses of the lower limbs, the elementary components included in the OMERACT definition of US enthesitis in SpA (hypoechoic areas, entheseal thickening, power Doppler signal at the enthesis, enthesophytes/calcifications, bone erosions) were assessed by 47 rheumatologists from 37 rheumatology centres in 15 countries. Inter- and intra-observer reliability of the US components of enthesitis was calculated using Light’s kappa, Cohen’s kappa, Prevalence And Bias Adjusted Kappa (PABAK) and their 95% CIs. Results Bone erosions and power Doppler signal at the enthesis showed the highest overall inter-reliability [Light’s kappa: 0.77 (0.76–0.78), 0.72 (0.71–0.73), respectively; PABAK: 0.86 (0.86–0.87), 0.73 (0.73–0.74), respectively], followed by enthesophytes/calcifications [Light’s kappa: 0.65 (0.64–0.65), PABAK: 0.67 (0.67–0.68)]. This was moderate for entheseal thickening [Light’s kappa: 0.41 (0.41–0.42), PABAK: 0.41 (0.40–0.42)], and fair for hypoechoic areas [Light’s kappa: 0.37 (0.36–0.38); PABAK: 0.37 (0.37–0.38)]. A similar trend was observed in the intra-reliability exercise, although this was characterized by an overall higher degree of reliability for all US elementary components compared with the inter-observer evaluation. Conclusions The results of this multicentre, international, web-based study show a good reliability of the OMERACT US definition of bone erosions, power Doppler signal at the enthesis and enthesophytes/calcifications. The low reliability of entheseal thickening and hypoechoic areas raises questions about the opportunity to revise the definition of these two major components for the US diagnosis of enthesitis.

We evaluated the 3-year drug survival and efficacy of the biosimilar SB4/Benepali in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) patients, previously treated with etanercept (ETA). Drug survival rate was calculated using the Kaplan–Meier method and Cox proportional hazard models were developed to examine predictors of SB4 discontinuation. 236 patients (120 RA, 80 PsA and 36 AS), aged 60.7 ± 13.8 years and with an ETA duration of 4.1 ± 3.4 years were included. The 3-year retention rate for SB4 was 94.4%, 88% and 86% in AS, RA and PsA patients, respectively, with no difference between groups. Patients without comorbid disease had higher retention rates vs. patients with comorbid disease (90% vs. 60%, p < 0.0001). Disease activity, as measured by DAS28, DAPSA and BASDAI remained stable over the 3 years. Comorbid disease (hazard ratio; HR: 4.06, p < 0.0001) and HAQ at baseline (HR: 2.42, p = 0.0024) significantly increased the risk of SB4 discontinuation, while previous ETA duration was negatively associated with SB4 discontinuation (HR: 0.97, p = 0.0064). Forty-one (17.4%) patients left the study due to the interruption of the SB4 treatment, 31 (75.6%) discontinued due to inefficacy and 10 (24.4%) due to adverse events. This real-life study confirms the similar efficacy profile of ETA with long-term retention and a good safety profile in inflammatory arthritis patients.

The recent introduction of ABP 501, an adalimumab biosimilar, in the treatment of rheumatic diseases was supported by a comprehensive comparability exercise with its originator. On the other hand, observational studies comparing adalimumab and ABP 501 in inflammatory arthritis are still lacking. The main aim of this study is to compare the clinical outcomes of the treatment with adalimumab, both the originator and ABP 501, in a large cohort of patients affected by autoimmune arthritis in a real life setting. We retrospectively analysed the baseline characteristics and the retention rate in a cohort of patients who received at least a course of adalimumab (originator or ABP 501) from January 2003 to December 2020. We stratified the study population according to adalimumab use: naive to original (oADA), naive to ABP 501 (bADA) and switched from original to ABP 501 (sADA). The oADA, bADA and sADA groups included, respectively, 724, 129 and 193 patients. In each group, the majority of patients had a diagnosis of rheumatoid arthritis. The total observation period was 9805.6 patient-months. The 18-month retentions rate in oADA, bADA and sADA was, respectively, 81.5%, 84.0% and 88.0% (p > 0.05). The factors influencing the adalimumab retention rate were an axial spondylarthritis diagnosis (Hazard Ratio (HR) 0.70; p = 0.04), switch from oADA to ABP 501 (HR 0.53; p = 0.02) and year of prescription (HR 1.04; p = 0.04). In this retrospective study, patients naive to the adalimumab originator and its biosimilar ABP 501 showed the same retention rate. Patients switching from the originator to biosimilar had a higher retention rate, even though not statistically significant, when compared to naive.

Resume Objectifs Rechercher la prevalence echographique des depots de cristaux d’urate de sodium au niveau des hanches de patients goutteux et explorer l’association entre les images echographiques et les observations cliniques et serologiques. Methodes Une echographie bilaterale de la hanche a ete realisee chez 40 patients consecutifs ayant recu le diagnostic de goutte selon les derniers criteres de classification de l’ACR/EULAR (American College of Rhumatology/European League Against Rheumatism) et 25 sujets temoins. La presence a l’echographie de depots de cristaux a ete objectivee a l’aide des criteres de l’OMERACT (International Outcome Measures in Rheumatology Clinical Trials) : agregats et/ou tophus intra-articulaires localises a la hanche et signe du « double contour » sur le cartilage hyalin de la tete femorale. Resultats L’examen echographique a revele des depots de cristaux dans au moins une hanche chez 17 des 40 patients (42,5 %) goutteux et chez 2 des 25 sujets temoins (8,0 %) (p = 0,0029). Les agregats, le tophus et le signe du double contour ont ete retrouves dans au moins une hanche chez respectivement 13 (32,5 %), 6 (15,0 %) et 6 (15,0 %) des 40 patients goutteux. Une association moderee a ete observee entre la duree de la maladie (p = 0,004, Rpb = 0,442), le nombre de crises de goutte au cours de l’annee precedente (p = 0,029, Rpb = 0,346), la presence de tophus sous-cutanes (p = 0,037, V = 0,330) et les depots de cristaux a l’echographie. Conclusion D’apres nos resultats, la detection a l’echographie des cristaux d’urate de sodium au niveau de la hanche est courante chez les patients goutteux.

Objectives To investigate the prevalence of the ultrasound findings indicative of monosodium urate crystal deposits at the hip joint in patients with gout and to explore the association between the ultrasound findings and the clinical and serological features. Methods Bilateral ultrasound assessment of the hip joint was carried out in 40 consecutive patients with gout, diagnosed according to the latest Gout American College of Rheumatology/European League Against Rheumatism classification criteria, and 25 disease controls. Ultrasound evidence of crystal deposits was obtained using the Outcome Measures in Rheumatology definitions: hip intra-articular aggregates and/or tophi, and “double contour” sign over the hyaline cartilage of the femoral head. Results The ultrasound examination revealed crystal deposits in at least one hip in 17 out of 40 patients (42.5%) with gout, and in 2 out of 25 disease controls (8.0%) (P = 0.0029). Aggregates, tophi, and “double contour” sign were found in at least one hip in 13 (32.5%), 6 (15.0%) and 6 (15.0%) out of 40 patients with gout, respectively. A moderate association between disease duration (P = 0.004, Rpb = 0.442), number of gouty “attacks” in the previous year (P = 0.029, Rpb = 0.346), presence of subcutaneous tophi (P = 0.037, V = 0.330) and ultrasound crystal deposits was found. Conclusion Our results indicate that detecting monosodium urate crystals by ultrasound is common at hip joint in patients with gout.

Objectives: To determine the prevalence and distribution of US-detected qualitative cartilage damage at metacarpal heads of patients with RA and hand OA. Methods: Fifty-two RA patients and 34 patients with hand OA were enrolled. US examination of the metacarpal head cartilage from the II to V finger of both hands was performed. A total of 414 MCP joints in RA and 266 MCP joints in OA patients were scanned with a linear probe up to 22 MHz. Qualitative assessments using a previously described scoring system for cartilage damage were performed. The prevalence and distribution of cartilage damage were analysed. Multivariate regression analysis was used to determine the predictive value of age, gender, BMI, disease duration and the presence of RF and anti-CCP antibodies for US-detected cartilage damage. Results: The metacarpal head cartilage was positive for cartilage damage in 35.7% (148/414) of MCP joints in RA and in 43.6% (116/266) of MCP joints in OA patients. In RA, the hyaline cartilage of the II and III metacarpal heads (bilaterally) was the most frequently affected. In OA, cartilage damage was more homogeneously distributed in all MCP joints. Multivariate regression analysis showed that age and disease duration, but not gender, BMI or autoantibody status, were independent predictors of US-detected cartilage damage in RA. Conclusion: Cartilage damage was found in more than one-third of the MCP joints in both RA and OA patients, and in RA patients, the II and III MCP joints were the most damaged.

Background/objective The aims of this study were to describe in detail the ultrasound (US)-guided procedures in our daily rheumatology practice, to evaluate the feasibility and accuracy of US-guided procedures, and to test the efficacy of our disinfection protocol in preventing infectious complications. Methods This was a cross-sectional and monocentric study. Information regarding patients' age, sex, body mass index, rheumatic disease, US pathological findings, aspirated and/or injected anatomical site, US equipment (ie, probe type and frequency), and needle type was consecutively collected for each US-guided procedure in a third-level rheumatology center. Results A total of 643 US-guided procedures were performed, with a mean of 5.2 procedures per working-day. In 94.2% of the patients, only one procedure was carried out, whereas in 5.8%, more than one. The mean time was 7 ± 2.5 minutes. Ultrasound-guided procedures were highly accurate (accuracy rate higher than 95%) and safe (adverse events were reported in 0.8%). Our disinfection protocol was effective in preventing infectious complications. Probes with frequency values between 8 to 13 MHz and 20-, 21-, and 22-gauge needles were the most frequently used at shoulder, knee, wrist, elbow, and ankle level. High-frequency linear probes (ranging between 18 and 22 MHz) and 23- and 25-gauge needles were used for injecting small joints of the hands and feet. Convex low-frequency probe (2-7 MHz) and 18- and 20-gauge needles were the most used for performing hip joint aspirations and/or injections. Conclusions This study reports useful information for setting up a service providing US-guided procedures in rheumatology and supports the feasibility, accuracy, and safety of US-guided procedures.

Background: The concept of frailty is a recent issue in the rheumatologic field, by now, the prevalence of frailty among individuals with rheumatoid arthritis (RA) has not been extensively examined and few studies on frailty in RA adults have been conducted. Moreover, the relationship between frailty and sociodemographic or disease characteristics in RA are unknown. Objectives: The aims of the present research were to assess the prevalence of frailty and its potential associated factors in adult patients with RA. Methods: Consecutive RA patients and healthy controls were assessed according the Survey of Health, Ageing and Retirement in Europe Frailty Instrument (SHARE-FI) (1), and classified as frail, pre-frail or non-frail. Patients underwent to a clinimetric assessment in order to establish disease activity (Simple Disease Activity Index [SDAI]), function (Health Assessment Questionnaires Disability Index [HAQ-DI]), comorbidities (modified Rheumatic Disease Comorbidity Index [mRDCI])(2), and radiographic damage (Simple Erosion Narrowing Score [SENS]). Chi-square, analysis of variance (ANOVA), and multinomial logistic regression analyses were used to test the prognostic value of frailty for the outcomes of interest. Results: 210 consecutive RA patients were included (72 male, 138 female) and the mean age was 60.4 years. The study group was composed by 100 healthy controls (63 females and 47 males). The mean age was 59.1. According to SHARE-FI criteria, 35 RA patients (16.6%) were categorized as frail, 68 (32.4%) as pre-frail, and 107 (51%) as non-frail, while 8 control subjects were categorized as frail, (8%), 17 as pre-frail (17%), and 75 as non-frail (75%) (chi-squared 12.8; p=0.0016). The results from logistic regression analysis revealed that age (odd ratio [OR] = 1.12, 95% confidence interval [CI] = 1.07-1.17; P Conclusion: Frailty or pre-frailty are common in RA. The SHARE-FI may be a specific tool for the screening of frailty in RA and may summarize the results of a comprehensive RA assessment providing a marker of deficits accumulation. Future studies will need to examine longitudinal relationships between frailty and health outcomes in RA. References [1] Romero-Ortuno R, Walsh CD, Lawlor BA, et al. A frailty instrument for primary care: findings from the Survey of Health, Ageing and Retirement in Europe (SHARE). BMC Geriatr2010;10:57 [2] Iannone F, Salaffi F, Fornaro M, Di Carlo M, Gentileschi S, Cantarini L, Lopalco G. Influence of baseline modified Rheumatic Disease Comorbidity Index (mRDCI) on drug survival and effectiveness of biological treatment in patients affected with Rheumatoid arthritis, Spondyloarthritis and Psoriatic arthritis in real-world settings. Eur J Clin Invest. 2018;48(11):e13013. Disclosure of Interests: Marco Di Carlo: None declared, sonia farah: None declared, eleonora Di Donato: None declared, marina carotti Speakers bureau: abbvie pfizer novartis roche bms sanofi, Fausto Salaffi Grant/research support from: Abbvie, Roche, Novartis, BMS, Pfizer, Sanofi, Speakers bureau: Abbvie, Roche, Novartis, Pfizer, Sanofi, BMS

The aims of the present research were to assess the prevalence of frailty and its potential associated factors in a cohort of adult patients with rheumatoid arthritis (RA). Consecutive RA patients and healthy controls were assessed according to the Survey of Health, Ageing and Retirement in Europe Frailty Instrument (SHARE-FI), and classified as frail, pre-frail, or non-frail. Chi-square, analysis of variance (ANOVA), and multinomial logistic regression analyses were used to test the prognostic value of frailty for the outcomes of interest. Two hundred and ten consecutive RA patients (65.7% female, mean age 60.4 years) and 100 healthy controls (63% female, mean age 59.1 years) were included. According to SHARE-FI criteria, 35 RA patients (16.6%) were categorized as frail, 68 (32.4%) as pre-frail, and 107 (51%) as non-frail, while 8 control subjects were categorized as frail, (8%), 17 as pre-frail (17%), and 75 as non-frail (75%) (chi-squared 12.8; P = 0.0016). The results from logistic regression analysis revealed that age (odds ratio [OR] = 1.12, 95% confidence interval [CI] = 1.07–1.17; P

To develop and validate in a preliminary way a novel radiographic scoring system for psoriatic arthritis (PsA), called Simplified Psoriatic Arthritis Radiographic Score (SPARS). Radiographs of hands and feet were obtained from consecutive PsA patients and assessed by two readers. For each joint (30 joints in the hands, ten joints in the feet), the combination of the erosions, joint narrowing space (JNS) and bony proliferation (BP) has been assessed, giving a value of 1 for erosions presence, 1 for JNS presence, and 1 for BP presence (SPARS score range, 0–120). Reliability was assessed by calculating the intraclass correlation coefficient (ICC) and smallest detectable difference (SDD) of the readings. To determine the convergent validity, SPARS was compared to the modified Sharp/van der Heijde Score (mSvdHS) and to the Ratingen scoring system (PARS). One-hundred and five hands and feet radiographs have been assessed. The inter- and intra-rater reliability were excellent (inter-rater reliability 0.934, and intra-rater reliability for both readers 0.845 and 0.876). The SDD for the average SPARS scores of the two readers was 8.0. SPARS correlated strongly with mSvdHS (r = 0.926; p

To develop and to test in a preliminary way a new self-administered screening tool, called DETection of Arthritis in Inflammatory boweL diseases (DETAIL) questionnaire, in patients suffering from inflammatory bowel disease (IBD) not previously diagnosed as having a spondyloarthritis (SpA). DETAIL questionnaire was realized through the interrogation of 95 experts. They were asked to rate the importance of a list of items, derived from a review of the referral models of SpA, to detect the SpA manifestations in IBD patients. The six top-rated items composed the questionnaire, tested in IBD patients not already diagnosed having a SpA. One-hundred and twenty-eight patients were tested with the DETAIL questionnaire in the gastroenterology setting. After the rheumatologic assessment, in 21 (16.4%) subjects was diagnosed a SpA according to the Assessment of SpondyloArthritis international Society (ASAS) classification criteria. Of the six items of the DETAIL questionnaire, the best positive likelihood ratio (LR+) was found in item 2 (LR+ 3.82), exploring dactylitis, and in item 6 (LR+ 3.82) and item 5 (LR+ 3.40), two questions exploring inflammatory low back pain. Enthesitis (item 3—LR+ 2.87) and peripheral synovitis (item 1 – LR+ 2.81) gave similar results, while item 4, exploring the duration of low back pain, resulted in the worst performance (LR+ 1.99). Three of the six items answered in affirmative way gave a post-test probability ≥ 75%. The presence of a fibromyalgia represents a major confounder. The DETAIL questionnaire showed good screening properties that need to be confirmed in broader cohorts.

To validate in a multicentric cohort of patients a self-administered PsA screening tool, called Simple Psoriatic Arthritis Screening (SiPAS) questionnaire, to screen psoriasis patients for signs and symptoms of PsA.The SiPAS questionnaire was validated in a multicentric Italian cohort of psoriasis patients referred to two rheumatological centres.A total of 202 psoriasis patients were screened with SiPAS in the validation study. Sixty-two psoriasis patients (30.7%) were diagnosed with PsA. The five screening questions (1. Have you ever had a finger or a toe and/or another joint swollen and painful without any apparent reason?; 2. Occasionally, has an entire finger or toe become swollen, making it look like a 'sausage'?; 3. Do you wake up at night because of low back pain?; 4. Have you had pain in your heels?; 5. Has a doctor ever diagnosed you with psoriatic arthritis?) with a dichotomous response, demonstrated high sensitivity and specificity for predicting PsA. Likelihood ratios for individual parameters varied between 2.06 and 4.75. Using the Bayesian Analysis, the presence of three of five items answered as "yes" showed respectively a sensibility and a specificity of 79% and 87%, with a positive likelihood ratio of 6.14.The SiPAS questionnaire is able to quickly screen psoriasis patients for PsA. A SiPAS score ≥3 is an indication for referral to a rheumatologist. The SiPAS needs further validation.

Objectives This study was designed (a) to evaluate an improved quantitative lung fibrosis score based on a computer-aided diagnosis (CaM) system in patients with systemic sclerosis (SSc),—related interstitial lung disease (SSc-ILD), (b) to investigate the relationship between physiologic parameters (forced vital capacity [FVC] and single-breath diffusing capacity for carbon monoxide [DLCO]), patient-centred measures of dyspnea and functional disability and CaM and visual reader-based (CoVR) methods, and (c) to identify potential surrogate measures from quantitative and visual HRCT measurement. Methods 126 patients with SSc underwent chest radiography, HRCT and PFTs. The following patient-centred measures were obtained: modified Borg Dyspnea Index (Borg score), VAS for breathing, and Health Assessment Questionnaire-Disability Index (HAQ-DI). HRCT abnormalities were scored according to the conventional visual reader-based score (CoVR) and by a CaM. The relationships among the HRCT scores, physiologic parameters (FVC and DLCO, % predicted) results and patient-centred measures, were calculated using linear regression analysis and Pearson’s correlation. Multivariate regression models were performed to identify the predictor variables on severity of pulmonary fibrosis. Results Subjects with limited cutaneous SSc had lower HAQ-DI scores than subjects with diffuse cutaneous SSc (p