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BackgroundPatients suffering from FM are challenged by symptoms such as chronic pain, fatigue, sleep disturbance and emotional distress. These symptoms lead to a physical capacity impairment, and FM patients report consequences on their activities of daily life and difficulties in fulfilling their work roles, resulting in reduced work capacity, presenteeism (coming to work despite health or personal issues, often resulting in a loss of productivity), absenteeism, and inability to work. Changes in ability to work are crucial to comprehend since they provide a more objective sign of function than other self-reported measures.ObjectivesTo assess (a) the impacts of fibromyalgia (FM) symptoms on patients’ ability to work and (b) the relationship between FM severity level and lost productivity from the perspective of patients.MethodsFM female patients were retrospectively evaluated for this cross-sectional study. FM severity was determined using the revised Fibromyalgia Impact Questionnaire (FIQR). Work Productivity and Activity Impairment-Fibromyalgia (WPAI-FM) was used to evaluate patients’ employment status. Differences across FM severity states were evaluated using the one-way analysis of variance (ANOVA) and chi-square or Fisher’s exact test. The Pearson’s r test was performed for the correlation analysis.ResultsThe study included 209 subjects, 64 (30.6%) had mild, 64 (30.6%) had moderate, and 81 (38.8%) had severe FM; 57.9% were working full-time, and 42.1% were working part-time. According to WPAI-FM the work productivity and activity impairment resulted: absenteeism 7.03%; presenteeism 44.35%; activity impairment 47.24%; overall work productivity loss 58.23%. Disease severity was associated with decreased work productivity. Presenteeism, overall work productivity loss, and activity impairment demonstrated significant correlations with FIQR and PainDETECT Questionnaire.ConclusionFM severity is associated to a reduced job productivity. Early identification and treatment of FM may provide a window of opportunity for job preservation.References[1]Salaffi F, Mozzani F, Draghessi A et al (2016) Identifying the symptom and functional domains in patients with fibromyalgia: results of a cross-sectional Internet-based survey in Italy. J Pain Res 9:279-86.[2]Al-Allaf AW (2007) Work disability and health system utilization in patients with fibromyalgia syndrome. J Clin Rheumatol 13:199-201.[3]Mukhida K, Carroll W, Arseneault R (2020) Does work have to be so painful? A review of the literature examining the effects of fibromyalgia on the working experience from the patient perspective. Can J Pain 4:268-86.Figure 1.WPAI-FM scores (A, absenteeism; B, presenteeism; C, activity impairment; D, work productivity loss) across FM severity states.Disclosure of InterestsNone declared

BackgroundFibromyalgia (FM) is a chronic musculoskeletal pain syndrome of unknown etiopathogenesis. Its development and maintenance are related to a complex interplay of biological, psychological, and contextual factors. Among the contextual factors, sociodemographic aspects are poorly elucidated.ObjectivesThis study aimed to evaluate the relationships between sociodemographic/clinical factors and symptom severity measures using a web-based registry of patients with FM.MethodsThe study included adult patients recruited between November 2018 and April 2019 at 19 Italian rheumatology centers. All the patients underwent a complete physical examination and those laboratory tests specified in the revised European League Against Rheumatism (EULAR) recommendations for the management of FM. The inclusion criteria were (a) age from 18 to 80 years and (b) diagnosis of FM based on the 2010/2011 criteria of the American College of Rheumatology (ACR), made by a rheumatologist with at least 10 years of experience. All patients were asked to complete a package of questionnaires about their sociodemographic data (age, sex, marital status, education and BMI), disease-related variables, their quality of life, and the type(s) of pharmacological and non-pharmacological treatments currently received. The data and measures were electronically entered into the web-based Italian Fibromyalgia Registry (IFR) by physicians working at those 19 Italian rheumatology centers. Two disease-specific questionnaires were used for the clinical evaluation in this study: the Revised Fibromyalgia Impact Questionnaire (FIQR) and the Polysymptomatic Distress Scale (PDS).ResultsData relating to 3,221 patients (3001 women and 220 men) was collected. The ANOVA showed significant difference in mean FIQR scores when the five marital conditions (cohabiter, married, separated/divorced, single, widowed) were compared (F 3.321, p ConclusionOur results indicated that being male and separated/divorced is associated to higher severity of FM symptoms, as rated with FIQR. Furthermore, a relationship between educational level and FIQR scores has been detected. This study supports the importance of collecting simple SES measures to identify environmental risk factors for FM severity.References[1]Sarzi-Puttini P, Giorgi V, Marotto D, et al. Fibromyalgia: an update on clinical characteristics, aetiopathogenesis and treatment. Nat. Rev. Rheumatol. 2020;16(11) 645-60.[2]Salaffi F, Farah S, Di Carlo M, et al. The Italian Fibromyalgia Registry: a new way of using routine real-world data concerning patient-reported disease status in healthcare research and clinical practice. Clin Exp Rheumatol. 2020;38 Suppl 123(1):65-71.AcknowledgementsAcknowledgements to all the colleagues involved in SIR Fibromyalgia groupDisclosure of InterestsNone declared

BackgroundCatastrophizing has been demonstrated to be linked with central sensitization (CS), although few studies have investigated the potential of interactions between catastrophizing and CS in patients receiving JAK inhibitors.ObjectivesTo explore the link between changes in Simplified Disease Activity Index (SDAI) and changes in pain catastrophizing, pain intensity, neuropathic pain component (NPC) and CS symptoms that occur with the introduction of a novel treatment targeting the JAK/STAT signalling pathway.Methods115 patients in an ongoing prospective observational analysis filled out questionnaires at the start and conclusion of the research, using the Pain Catastrophizing Scale (PCS) and Central Sensitization Inventory (CSI). The study included 22 patients on tofacitinib monotherapy (5 mg BD), 19 on tofacitinib and MTX, 19 on baricitinib monotherapy (4 mg OD), 14 on baricitinib and MTX, 17 on upadacitinib monotherapy (15 mg OD), 16 on upadacitinib and MTX, and 8 on filgotinib (200mg OD) and MTX. The disease activity index was evaluated by the simplified disease activity index (SDAI). The US scoring system validated in the US-CLARA was used. The Semantic Questionnaire for Rheumatology (SQR) and PainDETECT questionnaire (PDQ), were used to assess pain severity and NPC. Using multivariable linear regression models, we investigated the connection between changes in SDAI and in CSI, PCS, PDQ, SQR and US score.ResultsAt baseline, the percentage of RA patients who exceeded the thresholds for the presence of NPC (PDQ > 19 points) of the CSI (> 40 points) and PCS (> 30 points) were 43.5%, 36.5%, and 62.6%, respectively. After 4 weeks of treatment, the patient-reported scores and the disease composite index decreased significantly, SRQ (pConclusionAfter starting a Jak inhibitor, pain catastrophizing, but not articular inflammation on US, diminishes along with disease activity. These findings provide credence to the concept of catastrophizing as a dynamic construct that may be adjusted by therapy aimed at reducing inflammatory disease activity and pain levels in the RA patient.References[1]Hammer HB, et al. Pain catastrophizing, subjective outcomes, and inflammatory assessments including ultrasound: results from a longitudinal study of rheumatoid arthritis patients. Arthritis Care Res 2018;70:703–12[2]Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011;152(3 Suppl):S2–S15Table 1.Multivariate regression analysis, using SDAI (Simplified Disease Activity Index) changes as dependent variable.Independent variablesCoefficientStd. ErrorTP(Constant)-0.7239ACPA, titre-0.00024100.002528-0.09530.9242Age, yrs-0.090630.1028-0.8810.3803BMI-0.16000.2787-0.5740.5671Disease duration, yrs-0.10030.1611-0.6230.5347Educational level, yrs-0.10720.3703-0.2890.7728Diff. CSI0.31940.19841.6100.1105Diff. SRQ0.070180.37260.1880.8509Diff US score1.22480.70241.7440.0842Diff PCS0.50090.21602.3180.0224Diff PDQ0.18600.22710.8190.4146Abbreviations: ACPA= Anti-Citrullinated Protein/peptide Antibody; BMI= Body Mass Index; CSI= Central Sensitization Inventory; SRQ= Semantic Questionnaire for Rheumatology; US= Ultrasonography; PCS= Pain Catastrophizing Scale; PDQ= PainDETECT Questionnaire.Disclosure of InterestsNone declared

BackgroundPatients with fibromyalgia (FM) complain many symptoms besides musculoskeletal pain: e.g. fatigue, sleep difficulties, a swollen feeling in tissues, paresthesia, cognitive dysfunction, dizziness, and symptoms of overlapping conditions such as irritable bowel syndrome, headaches and restless legs syndrome. These conditions can be grouped under the umbrella term of central sensitization (CS) syndromes.ObjectivesThe goal of the present study was to explore additional evidence of convergent and discriminant validity of the Central Sensitization Inventory (CSI) in a large sample of subjects with fibromyalgia (FM).MethodsPatients were consecutively enrolled for a cross-sectional assessment comprehensive of three FM-specific measures (the revised Fibromyalgia Impact Questionnaire [FIQR], the modified Fibromyalgia Assessment Status [modFAS], and the Polysymptomatic Distress Scale [PDS]) and of CSI. To test the convergent validity, the Spearman’s rho was used to measure the degree of correlation between the variables CSI and the FM-specific measures. To assess discriminant validity, CSI scores were grouped according to FIQR disease severity states, and differences between these groups studied with the Kruskal-Wallis test. Interpretative cut-offs were established with the interquartile reconciliation approach.ResultsThe study included 562 FM patients, 199 (35.4%) were classified as having central sensitization syndrome (CSI ≥40). CSI was largely correlated with modFAS (rho = 0.580; p ConclusionThe current study successfully showed additional evidence of the convergent and discriminant validity of the CSI in FM patients.References[1]Salaffi F, Mozzani F, Draghessi A, et al. Identifying the symptom and functional domains in patients with fibromyalgia: results of a cross-sectional Internet-based survey in Italy. J Pain Res. 2016;9:279-86.[2]Yunus MB. Role of central sensitization (CS) in symptoms beyond muscle pain, and the evaluation of a patient with widespread pain. Best Pract Res Clin Rheumatol. 2007;21:481-497.[3]Salaffi F, Franchignoni F, Giordano A, et al. Psychometric characteristics of the Italian version of the revised Fibromyalgia Impact Questionnaire using classical test theory and Rasch analysis. Clin Exp Rheumatol. 2013; 31(Suppl 79):41–49.Figure 1.Distribution of the CSI score according to the different CSI score ranks of the overall cohort. Bars show median and interquartile range. CSI, central sensitization inventoryFigure 2.Spydergrams of the individual CSI scores in FM patients (n° 562)Disclosure of InterestsNone declared

BackgroundThere are a variety of composite disease activity monitoring methods and patient-centered metrics available for psoriatic arthritis (PsA). The Psoriatic Arthritis 5-Thermometer scales (PsA-5Ts) is a new tool, proposed, with the aim of improving its diagnostic accuracy.ObjectivesThe goal of this research was to evaluate data on the measurement qualities of the PsA-5Ts, a composite measure of disease activity in PsA patients, in a real-world scenario (Figure 1).Figure 1.The Psoriatic Arthritis 5 Thermometer scales (PsA-5Ts) scoring and calculation ruleMethodsA total of 155 PsA patients were enrolled between May 2018 and December 2021. Adult-onset PsA CASPAR criteria were used to classify patients affected by PsA, while ASAS criteria were used to classify patients affected by axial-PsA (axPsA). All patients completed the PsA-5Ts, a simple instrument with five “thermometers” that incorporate pain, fatigue, physical function, skin disorders, and depression into a single assessment of disease activity. Additional continuous measures of disease activity (e.g., DAPSA, PASDAS, CPDAI) and patient-reported outcomes (PROs) measures of disease health status (e.g., PSAID and SF-36) were analyzed as comparisons. Spearman’s correlations and cross-tabulations were used to examine concurrent validity. Receiver operating characteristic (ROC) curve method was used to assess discriminant validity. As an external criterion, the Minimal Disease Activity (MDA) levels were used.ResultsThe 96 female and 59 male patients ranged in age from 20 to 79 years old and had been living with PsA for an average of 8.35.2 years (6 months to 22 years). The PsA-5Ts’ area under the ROC curve (AUC-ROC) was 0.944. (95 percent CI 0.895 to 0.974) (Figure 2). The PsA-5Ts had same discriminant validity as the DAPSA, CPDAI, PASDAS, and PSAID, but it was better than the SF-36 (p=0.0011). PsA-5Ts subscales were highly significantly different between the MDA status (all at pFigure 2.ROC curve analysis (AUC-ROC curves values, standard error and 95% confidence intervals) for the discriminatory power of disease activity, according to the different composite disease activity indices (DAPSA; CPDAI and PASDAS) and patient-reported outcomes (PROs) measures (PsA-5Ts, PSAID and SF-36). Receiver operating characteristic curves illustrating the relationship between sensitivity and complement of specificity (100-specificity) in PsA for activity measures using MDA as an external indicator. A line that runs diagonally across the figure from lower left to upper right will have an area of 0.5; this represents an instrument that does not discriminate.ConclusionFor the evaluation of disease activity in PsA, PsA-5Ts is a useful alternative to continuous composite indices and other patient-centered assessments. The PsA-5Ts make data collection simpler, and they should be used in both clinical studies and everyday clinical treatment. In order to establish the tool’s clinical relevance, longitudinal construct validity, which concerns the measure’s capacity to identify a real change in health status as well as its accuracy in detecting changes of various magnitudes, must be addressed.References[1]Salaffi F, Di Carlo M, Carotti M, Farah S. The Patient-Reported Outcomes Thermometer-5-Item Scale (5T-PROs): Validation of a New Tool for the Quick Assessment of Overall Health Status in Painful Rheumatic Diseases. Pain Res Manag.[2]Di Carlo M, Becciolini A, Lato V, Crotti C, Favalli EG, Salaffi F. The 12-item Psoriatic Arthritis Impact of Disease Questionnaire: Construct Validity, Reliability, and Interpretability in a Clinical Setting. J Rheumatol. 2017;44(3):279-285.[3]Salaffi F, Sarzi-Puttini P, Atzeni F. How to measure chronic pain: new concepts. Best Pract Res Clin Rheumatol. 2015;29(1):164-186.Disclosure of InterestsNone declared

BackgroundInterstitial lung disease (ILD) is common in systemic sclerosis (SSc) patients and despite recent advances in the treatment represents still the major cause of death. It may be established within the first 4 years of SSc and frequently is subclinical [1].To evaluate the presence of ILD, there are different available tools in addition to the clinical evaluation including respiratory functional tests (RFT) and imaging methods, especially HRCT which remain the mainstay for the diagnosis of SSc-ILD.It has been recently proposed that pulmonary ultrasound (US) may have a potential role for the assessment of ILD in patients with SSc [2, 3]. Despite the growing body of evidence, there are no established data regarding its potential role in both detecting ILD in subclinical stages and on the follow-up of SSc patients.ObjectivesTo investigate the validity of US in detecting subclinical ILD in SSc and to determine its potential in the follow-up of these patients.Methods133 patients without respiratory symptoms and 133 healthy controls were included. Borg scale dyspnea index, Rodnan skin score (RSS) and pulmonary auscultation were performed. X-ray and respiratory function tests (RFT) were performed the same day. An expert rheumatologist blinded to clinical assessment performed the US. To determine the concurrent validity high-resolution CT (HRCT) scans was performed. HRCT findings were scored according to Warrick score whereas US findings were classified according the previously proposed scale. An inter-observer reliability was performed. A follow-up including US, RFT and Borg scale was done every 3 months for 12 months.ResultsA total of 54 of 133 SSc patients (40.6%) showed US signs of ILD in contrast to healthy controls (4.8%) (p=0.0001). The clinical and laboratory variables associated with ILD were anti-centromere antibodies (p=0.005) and RSS (p=0.004). A positive correlation was demonstrated between the US and HRCT findings (p=0.001). Sensitivity and specificity of US in detecting ILD was 91.2% and 88.6% respectively. A good inter-observer reliability was also observed (k = 0.72).In the follow-up, a total of 30 patients (22.6%) that demonstrated US signs of ILD at baseline showed US worsening. Nine patients (30%) developed symptoms of ILD.ConclusionUS is valid to detect subclinical ILD-SSc. Our results showed a high prevalence of this complication. Despite encouraging data, it seems still controversial its role in monitoring the ILD progression in SSc.References[1]Salaffi F, Carotti M, Baldelli S, et al. Subclinical interstitial lung involvement in rheumatic diseases. Correlation of high resolution computerized tomography and functional and cytologic findings. Radiol Med 1999;97:33-41.[2]Tardella M, Gutierrez M, Salaffi F, et al. Ultrasound in the assessment of pulmonary fibrosis in connective tissue disorders: correlation with high-resolution computed tomography. J Rheumatol 2012; 39:1641-47.[3]Gargani L, Doveri M, D’Errico L, et al. Ultrasound lung comets in systemic sclerosis: a chest sonography hallmark of pulmonary interstitial fibrosis. Rheumatology 2009;48:1382-87.Disclosure of InterestsNone declared