Central Sensitization in Psoriatic Arthritis: Relationship With Composite Measures of Disease Activity, Functional Disability, and Health-Related Quality of Life.

OBJECTIVE: To investigate the prevalence of central sensitization (CS) in patients with psoriatic arthritis (PsA) and its association with disease activity and patient-reported outcome measures. METHODS: This cross-sectional study included adults with PsA without coexisting fibromyalgia (FM). Patients underwent a clinimetric assessment to collect variables regarding disease activity, quality of life (QOL), functional ability, impact of disease, and CS. Spearman ρ was used to examine the relationship between CS Inventory (CSI) scores and other variables. A multivariate analysis was performed to determine the independent contribution of each variable to the 12-item Psoriatic Arthritis Impact of Disease (PsAID-12) score. RESULTS: One hundred fifty-seven patients were enrolled. Of them, 45.2% scored a CSI ≥ 40, indicating a high probability of CS. Significant correlations were found between CSI and disease activity, as evaluated by Disease Activity in Psoriatic Arthritis score and Psoriatic Arthritis Disease Activity Score (ρ 0.587 and ρ 0.573, respectively), between CSI and the Health Assessment Questionnaire (ρ 0.607), and between CSI and the 36-item Short Form Health Survey physical component summary and mental component summary scores (ρ -0.405 and ρ -0.483, respectively). In multivariate analysis, CSI score was the principal independent variable (P < 0.001) contributing to PsAID-12 score. CONCLUSION: Patients with PsA with symptoms of CS had higher disease activity, worse functional ability, and worse QOL. The presence of CS is the major contributor in the impact of disease.

Delay in fibromyalgia diagnosis and its impact on the severity and outcome: a large cohort study.

OBJECTIVES: To evaluate the impact of the diagnostic delay on fibromyalgia (FM) severity. METHODS: Data were retrospectively extracted from a large database of patients with FM belonging to the Italian Fibromyalgia Registry (IFR) residents on the Marche Region. The diagnosis of FM was formulated according to the 2016 American College of Rheumatology (ACR) criteria. The following information was obtained: time to diagnosis [categorised in early diagnosis (ED) if FM diagnosed within one year, late diagnosis (LD) if FM diagnosed more than 1 year but less than 5 years, and very late diagnosis (VLD) if FM diagnosed over 5 years from symptoms onset], revised Fibromyalgia Impact Questionnaire (FIQR), modified Fibromyalgia Assessment Status (FASmod), and Polysymptomatic Distress Scale (PDS) [consisting of the sum of Widespread Pain Index (WPI) and Symptom Severity Scale (SSS)]. RESULTS: The study included 616 FM patients (92.2% female), with a mean disease duration of 6.46 (SD 4.14) years and a mean (SD) time to diagnosis of 3.45 (2.39) years. The ED group included 169 patients, the LD 320 patients, and the VLD 127 patients. Comparing the differences among groups, a significant difference in disease severity was observed in all the clinimetric indices in increasing the time to reach the diagnosis (p=0.000001): the median PDS scores were 13.36 (interquartile range [IQR] 7.00-20.00), 16.09 (IQR 9.00-22.00), and 23.00 (IQR 18.25-26.00) for ED, LD, and VLD, respectively. CONCLUSIONS: Delayed diagnosis is associated with poorer patient outcomes, including worsening severity.

Kihon Checklist validation in patients with rheumatoid arthritis: Italian translation, cross-cultural adaptation, and evaluation of the validity in comparison to two frailty screening tools based on the Fried phenotype and deficit accumulation model.

OBJECTIVES: To compare the diagnostic test accuracy in terms of discriminant validity of the Kihon Checklist (KCL), Italian version, with respect to the Comprehensive Rheumatologic Assessment of Frailty (CRAF), and the Survey of Health, Ageing and Retirement in Europe Frailty Instrument (SHARE-FI) in identifying the presence of frailty in rheumatoid arthritis (RA) patients. METHODS: An Italian version of the KCL was obtained by a consensus of experts. Then, adult RA patients underwent a cross-sectional evaluation inclusive of KCL, CRAF, and SHARE-FI. The performance of the tools was determined in terms of differences in areas under the receiver operating characteristic curves (AUC-ROCs) considering the Cardiovascular Health Study (CHS) criteria has external gold standard. For KCL, the optimal cut-point was determined at the Youden index. RESULTS: The study included 219 RA patients. The three tools provided varying frailty prevalence percentages, from 16.0% (SHARE-FI) to 35.6% (CRAF). No scale performed better than others, according to AUC-ROCs comparisons, and when compared to the CHS criteria, all scales have an accuracy rate >80%. A KCL cut-off point of 7 resulted the optimum trade-off for sensitivity (93.3%), specificity (90.8%), with a positive likelihood ratio of 10.15. CONCLUSIONS: All the tools examined were useful and reflected the definition of frailty, however, the KCL was the most suitable since it is self-administered and might enable interventions in RA patients.

Palmitoylethanolamide and acetyl-L-carnitine act synergistically with duloxetine and pregabalin in fibromyalgia: results of a randomised controlled study.

OBJECTIVES: Fibromyalgia (FM) is characterised by a form of debilitating pain that is unresponsive to standard analgesics. The aim of this study was to evaluate the efficacy of supplementing ongoing pregabalin (PGB) and duloxetine (DLX) treatment with palmitoylethanolamide (PEA) and acetyl-L-carnitine (ALC) for 24 weeks in FM patients. METHODS: After undergoing three months of stable treatment with DLX+PGB, FM patients were randomised to continue the same treatment (Group 1) or to add PEA 600 mg b.i.d + ALC 500 mg b.i.d. (Group 2) for a further 12 weeks. Every two weeks throughout the study, cumulative disease severity was estimated using the Widespread Pain Index (WPI) as the primary outcome measure; the secondary outcomes were the fortnightly scores of the patient-completed revised Fibromyalgia Impact Questionnaire (FIQR) and the modified Fibromyalgia Assessment Status (FASmod) questionnaire. All three measures were expressed as time-integrated area under the curve (AUC) values. RESULTS: One hundred and thirty (91.5%) of the initial 142 FM patients completed the study: 68 patients in Group 1 and 62 in Group 2. Twenty-four weeks after randomisation, the Group 2 patients showed additional significant improvements in all three outcome measures. Although there was some fluctuation in both groups during the study period, the AUC values of the WPI scores steadily decreased in Group 2 (p=0.048), which also showed better outcomes in terms of the AUC values of the FIQR (p=0.033) and FASmod scores (p=0.017). CONCLUSIONS: This is the first randomised controlled study demonstrating the effectiveness of the adding on therapy of PEA+ALC to DLX+PGB in FM patients.

The measurement of fibromyalgia severity: converting scores between the FIQR, the PSD and the FASmod.

OBJECTIVES: The revised Fibromyalgia Impact Questionnaire (FIQR) is a widely used fibromyalgia severity assessment tool that was introduced in 2009 prior to the publication of the American College of Rheumatology (ACR) preliminary fibromyalgia criteria in 2010 and its revision in 2016. In 2020, the modified Fibromyalgia Assessment Scale (FASmod) was published. The Polysymptomatic Distress scale (PSD) of the fibromyalgia criteria and FASmod include assessments of pain location severity and can be used for diagnosis as well as in non-fibromyalgia patients. The aim of this study is to provide equations for the conversion of the FIQR scores to PSD and FASmod as an aid to understanding and sharing fibromyalgia severity information. METHODS: 3089 patients with fibromyalgia, diagnosed according to the ACR 2010/2011 criteria and belonging to the Italian Fibromyalgia Registry completed FIQR, FASmod and PSD questionnaires. Pearson's correlation coefficient was used to test the correlations between indices. The least square regression approach was used to produce predictive equations for each scale based on the remaining scales. RESULTS: FIQR was correlated with PSD (r=0.714) and FASmod (r=0.801); PSD and FASmod showed the highest correlation (r=0.897), expected since they assess the same constructs. Predictive equations showing a linear model were effective in producing mean cohort values, but individual predictions deviated substantially, precluding prediction in the individual patient. CONCLUSIONS: Conversion equations that allow for interconversion of multiple scales fibromyalgia severity assessment scales are produced. These can be useful in obtaining mean values for cohorts but are not accurate enough for use in individual patients.

Determining the PASS cut-off points for the FIQR, FASmod and PSD in patients with fibromyalgia: a registry-based study.

OBJECTIVES: To determine the cut-off values of Patient Acceptable Symptom State (PASS) for the revised Fibromyalgia Impact Questionnaire (FIQR), the modified Fibromyalgia Assessment Scale (FASmod), and the Polysymptomatic Distress scale (PSD) and to determine the predictors of PASS in patients with fibromyalgia (FM). METHODS: FM patients belonging to the Italian Fibromyalgia Registry (IFR) completed the FIQR, the FASmod and the PSD. The PASS was assessed using a dichotomous answer. The cut-off values were obtained through the receiver operating characteristic curve (ROC) analyses. A multivariate logistic regression analysis was performed to determine predictors of achieving the PASS. RESULTS: 5545 women (93.7%) and 369 males (6.3%) were included in the study. The 27.8% of patients reported an acceptable symptom state. Patients in PASS differed in all patient-reported outcome measures (p <0.001). The FIQR PASS threshold was ≤58 (area under the ROC curve [AUC] = 0.819). The FASmod PASS threshold was ≤23 (AUC = 0.805) and the PSD PASS threshold was ≤16 (AUC = 0.773). In the pairwise AUC comparison, the discriminatory power of the FIQR PASS outperforms both FASmod PASS (p = 0.0124) and PSD PASS (p <0.0001). Multivariate logistic analysis showed that FIQR items related to memory and pain were the only predictors of PASS. CONCLUSIONS: The FIQR, FASmod, and PSD PASS cut-off points for FM patients have never been determined before. This study provides additional information to facilitate interpretation of the severity assessment scales in daily practice and clinical research related to FM patients.

Quantification of sarcopenia in patients with rheumatoid arthritis by measuring the cross-sectional area of the thigh muscles with magnetic resonance imaging.

PURPOSE: To determine the utility of cross-sectional area (CSA) measurements on magnetic resonance imaging (MRI), at the level of the thigh muscles, to estimate muscle mass in discriminating rheumatoid arthritis (RA) patients with sarcopenia from those without. MATERIALS AND METHODS: Consecutive female RA patients were enrolled for this cross-sectional study. Patients were assessed for disease activity, radiological damage, handgrip strength, physical performance and for the presence of sarcopenia, identified in accordance with the EWGSOP2 criteria. A 1.5 T MRI machine was used to scan the thigh muscles. A dimensional region growth algorithm (Horos™) was used to segment the muscles CSAs (in cm2) on MR images located 25 cm above the knee joint (MRI-CSA-25). The MRI-CSA-25 was obtained by summing the CSAs of the individual muscles. MRI-CSA-25 was correlated (Pearson's r) with the other variables, and its optimal cut-off point (Youden index) for sarcopenia diagnosis was identified in relation to the EWGSOP2 criteria. RESULTS: 32 RA female patients were studied, 34.4% diagnosed as sarcopenic. The mean MRI-CSA-25 was 151.00 cm2 for patient with sarcopenia, 275.57 cm2 for patient without sarcopenia (p < 0.001). MRI-CSA-25 correlated significantly with measures of physical performance, and disease activity, but not with radiological damage or age. The MRI-CSA-25 optimal cut-off point in discriminating sarcopenic patients was identified at 182.00 cm2 (AUC-ROC = 0.894). CONCLUSION: MRI-CSA-25 can differentiate sarcopenic versus non-sarcopenic RA patients, representing an imaging biomarker of this condition.

Muscle involvement in systemic lupus erythematosus: multimodal ultrasound assessment and relationship with physical performance.

OBJECTIVES: The objectives of this study were (1) to explore US findings for muscle mass, muscle quality and muscle stiffness in SLE patients and healthy subjects; (2) to investigate the relationship between the US muscle findings and physical performance in SLE patients and healthy subjects. METHODS: Quadriceps muscle thickness was used for assessment of muscle mass, muscle echogenicity (using a visual semi-quantitative scale and grayscale analysis with histograms) for assessment of muscle quality, and point shear-wave elastography (SWE) for assessment of muscle stiffness in 30 SLE patients (without previous/current myositis or neuromuscular disorders) and 15 age-, sex- and BMI-matched healthy subjects. Hand grip strength tests and short physical performance battery (SPPB) tests were carried out in the same populations. RESULTS: No difference was observed between SLE patients and healthy subjects for quadriceps muscle thickness (35.2 mm ±s.d. 6.8 vs 34.8 mm ± s.d. 6.0, respectively, P = 0.79). Conversely, muscle echogenicity was significantly increased in SLE patients (visual semi-quantitative scale: 1.7 ± s.d. 1.0 vs 0.3 ± s.d. 0.5, respectively, P < 0.01; grayscale analysis with histograms: 87.4 mean pixels ± s.d. 18.8 vs 70.1 mean pixels ± s.d. 14.0, respectively, P < 0.01). Similarly, SWE was significantly lower in SLE patients compared with healthy subjects {1.5 m/s [interquartile range (IQR) 0.3] vs 1.6 m/s (IQR 0.2), respectively, P = 0.01}. Muscle echogenicity was inversely correlated with grip strength (visual semi-quantitative scale, Rho: -0.47, P = 0.01; grayscale analysis with histograms, Rho: -0.41, p < 0.01) and SPPB (visual semi-quantitative scale, Rho: -0.50, P < 0.01; grayscale analysis with histograms Rho: -0,46, P < 0.01). CONCLUSIONS: US assessment of muscle echogenicity and stiffness is useful for the early detection of muscle involvement in SLE patients.

Quantification of bone marrow oedema and fat metaplasia in sacroiliac joints in spondyloarthritis patients using histographic magnetic resonance imaging analysis.

OBJECTIVES: To demonstrate a possible basis for a quantitative magnetic resonance imaging (MRI) approach that uses histographic analysis to determine bone marrow oedema (BME) and fat metaplasia at sacroiliac joints (SIJs) level in patients with axial spondyloarthritis (axSpA). METHODS: In this prospective, cross-sectional study, consecutive axSpA patients with inflammatory low back pain underwent 1.5-T MRI. MRI images were scored on a 4-point (0-3) scoring system both for BME and fat metaplasia by two radiologists. A region-of-interest based histographic quantitative analysis was used to assess MRI images. Using the area under the receiver operating characteristic curve (AUC-ROC) approach was tested the diagnostic accuracy of histographic analysis for detecting BME vs. BME and fat metaplasia on MRI images. RESULTS: 17 of the 43 patients (39.5%) included only had a BME lesion, while the remaining 26 patients (60.5%) had both BME and fat metaplasia at the SIJ level. Inter-rater agreement between readers was good (weighted kappa 0.643). On MRI images, BME and BME+fat metaplasia showed significant difference in histographic analysis (p<0.001), with an AUC-ROC of 0.898, and an optimal cut-off point of 311 at histographic analysis in the distinction of BME vs. fat metaplasia. CONCLUSIONS: Histographic analysis could represent a method for quantifying BME on MRI images of SIJs in patients with axSpA. This type analysis can provide important prognostic information and guide the choice of treatment in patients with sacroiliitis.

A cross-sectional research on female workers examining the loss of productivity caused by mild, moderate and severe fibromyalgia.

OBJECTIVES: To assess (a) the impacts of fibromyalgia (FM) symptoms on patients' ability to work and (b) the relationship between FM severity states and lost productivity from the perspective of patients. METHODS: FM 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. RESULTS: The 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. CONCLUSIONS: FM severity is associated to a reduced job productivity. Early identification and treatment of FM may provide a window of opportunity for job preservation.

Overactive bladder syndrome and sexual dysfunction in women with fibromyalgia and their relationship with disease severity.

OBJECTIVES: The aim of this study was to evaluate the prevalence and severity of overactive bladder syndrome (OAB) and sexual dysfunction in fibromyalgia (FM) patients, as well as their relationship with disease severity. METHODS: Consecutive adult female patients with FM were enrolled. Patients filled in a comprehensive questionnaire package including demographic variables, disease severity assessment (revised Fibromyalgia Impact Questionnaire [FIQR]), neuropathic pain features (PainDetect Questionnaire [PDQ]), severity of OAB symptoms (Overactive Bladder Symptom Score [OABSS]), and determining sexual functioning (Female Sexual Function Index [FSFI]). RESULTS: The study included 481 patients, 116 (24.11%) had mild OAB, 82 patients (17.04%) had moderate OAB, and 34 patients had serious OAB (7.06%). In 14.17% of patients the bladder condition was causing them major issues in terms of discomfort. In 7.87% of patients the bladder condition was causing them significant problems. Sexual dysfunctions were found in 91 patients (18.91%). Using the FSFI as dependent variable, multivariate analysis revealed a positive relationship between sexual dysfunction and variables of disease burden (FIQR, p<0.0001; PDQ, p<0.0001, widespread pain index [WPI], p=0.0037). Using OABSS as the dependent variable, multivariate regression revealed a substantial contribution from FIQR (p<0.0001), PDQ (p=0.0037), and WPI (p=0.0030). CONCLUSIONS: FM has the potential to affect both psychological and physiological processes in women with OAB and sexual dysfunction. These results emphasize the importance of a multidisciplinary approach to treat patients with overactive bladder syndrome and sexual dysfunction in FM.

Sociodemographic factors in fibromyalgia: results from the Italian Fibromyalgia Registry.

OBJECTIVES: Fibromyalgia (FM) is a chronic musculoskeletal pain syndrome of unknown aetiopathogenesis. Its development and maintenance are related to the interplay of biological, psychological, and contextual factors. Among the contextual factors, sociodemographic aspects are poorly elucidated. This study aimed to evaluate the relationships between sociodemographic/clinical factors and symptom severity measures using a web-based registry of patients with FM. METHODS: Adult patients with an ACR 2010/2011 diagnosis of FM underwent a clinical evaluation and were asked to complete questionnaires covering their sociodemographic data (gender, age, marital status, educational level), and disease-specific measures (the revised Fibromyalgia Impact Questionnaire (FIQR), and the Polysymptomatic Distress Scale (PDS)). RESULTS: Data 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<0.01). While males and females were found to have comparable FIQR scores, the interaction between gender and marital status indicated that separated/divorced males have higher FIQR scores (F 5.684, p=0.001). The multiple regression analysis demonstrated that patients who reported lower educational level experienced more severe FM symptoms, as scored with FIQR (p<0.0001). CONCLUSIONS: Our 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.

Fibromyalgia severity according to age categories: results of a cross-sectional study from a large national database.

OBJECTIVES: The role of age in influencing the severity of fibromyalgia (FM) is still controversial. The aim of this study is to define the contribution of age in the severity of FM from data from a large national database. METHODS: This cross-sectional study included adult patients with FM diagnosed according to the 2010/2011 American College of Rheumatology criteria. Disease severity was assessed with the revised Fibromyalgia Impact Questionnaire (FIQR) and the modified Fibromyalgia Assessment Status (FAS 2019mod). Patients were grouped into five age categories (between 18-40 years, between 41-50 years, between 51-60 years, between 61-70 years, and ≥71 years). Differences in disease severity between groups were assessed by one-way analysis of variance (ANOVA). RESULTS: The study included 2889 patients (199 males and 2690 females), mean age of 52.58 (±11.82) years, with a mean FIQR score of 59.22 (±22.98) and a mean FAS 2019mod of 25.50 (±8.66). Comparing the mean values of the various indices between age categories, there were no statistically significant differences between the groups for FIQR total score and FAS 2019mod. However, the 60-70 years category showed the lowest scores for both scales. The main difference emerged for the FIQR physical function subscale, where the ≥71 years category showed significantly higher scores (p<0.05) compared the 18-40 years category. CONCLUSIONS: The severity of FM has a significant level of stationarity according to age categories. Patients between 60-70 years have a lower disease burden. Physical function is the health domain with the most significant difference between the groups.

The value of ultrasound and magnetic resonance imaging scoring systems in explaining handgrip strength and functional impairment in rheumatoid arthritis patients: a pilot study.

PURPOSE: The goal of this study is to investigate the relationship between joint inflammation and damage of the wrists and hands, measured by semiquantitative ultrasound and magnetic resonance imaging scoring systems, with functional disability and handgrip strength (HGs). MATERIALS AND METHODS: Consecutive adult RA patients with active disease, as defined by a Disease Activity Score 28 joints C-reactive protein (DAS28-CRP) > 3.2, underwent a cross-sectional evaluation comprehensive of a clinimetric assessment, an HGs evaluation, an ultrasound assessment aimed at calculating the UltraSound-CLinical ARthritis Activity (US-CLARA), and a magnetic resonance imaging scored according to the modified Simplified Rheumatoid Arthritis Magnetic Resonance Imaging Score (mod SAMIS). The Spearman's rho correlation coefficient was used to test the correlations. RESULTS: Sixty-six patients with RA were investigated (age 55.6 ± 12.2 years). The mod SAMIS total score and the US-CLARA had a weak but significant correlation (rho = 0.377, p = 0.0018). Among the mod SAMIS sub-scores, there was a significant relationship between mod SAMIS bone edema (SAMIS-BME) and US-CLARA (rho = 0.799, p < 0.001) and mod SAMIS synovitis (SAMIS synovitis) and US-CLARA (rho = 0.539, p < 0.001). There were also significant negative relationships between the HGs score and the mod SAMIS total score and US-CLARA (rho = - 0.309, p = 0.011 and rho = - 0.775, p < 0.0001, respectively). CONCLUSIONS: BME and synovitis have an influence on the function of the upper extremities. The US-CLARA and the mod SAMIS total score are intriguing options for semiquantitative assessment of joint inflammation and damage in RA.

Ultrasound and magnetic resonance imaging as diagnostic tools for sarcopenia in immune-mediated rheumatic diseases (IMRDs).

Sarcopenia is characterized by loss of muscle mass, altered muscle composition, fat and fibrous tissue infiltration, and abnormal innervation, especially in older individuals with immune-mediated rheumatic diseases (IMRDs). Several techniques for measuring muscle mass, strength, and performance have emerged in recent decades. The portable dynamometer and gait speed represent the most frequently used tools for the evaluation of muscle strength and physical efficiency, respectively. Aside from dual-energy, X-ray, absorptiometry, and bioelectrical impedance analysis, ultrasound (US) and magnetic resonance imaging (MRI) techniques appear to have a potential role in evaluating muscle mass and composition. US and MRI have been shown to accurately identify sarcopenic biomarkers such as inflammation (edema), fatty infiltration (myosteatosis), alterations in muscle fibers, and muscular atrophy in patients with IMRDs. US is a low-cost, easy-to-use, and safe imaging method for assessing muscle mass, quality, architecture, and biomechanical function. This review summarizes the evidence for using US and MRI to assess sarcopenia.

Early response to JAK inhibitors on central sensitization and pain catastrophizing in patients with active rheumatoid arthritis.

OBJECTIVES: To evaluate the effect of 4 weeks of treatment with Janus kinase inhibitors (JAKis) on central sensitization (CS) and pain catastrophizing, and to determine the pain-related variables predictive of disease activity improvement, in patients with active rheumatoid arthritis (RA). METHODS: Consecutive RA patients with active disease starting a JAKi have been enrolled in this prospective observational study. Patients have been assessed at baseline and after 4 weeks of treatment. The evaluation was comprehensive of disease activity [Simplified Disease Activity Index (SDAI) and ultrasonographic (US) score] and of questionnaires aimed at investigating primarily CS [Central Sensitization Inventory (CSI)] and pain catastrophizing [Pain Catastrophizing Scale (PCS)]. Differences (Δ values) between the final and baseline were studied with the t test, Δ values of the variables were correlated with each other using Pearson's test, and predictor variables for improvement in SDAI were also investigated using multivariate regression analysis. RESULTS: A total of 115 patients were evaluated. Overall, all variables demonstrated significant improvement between baseline and final except the US score. In particular, CSI decreased from 36.73 to 32.57 (p < 0.0001), PCS decreased from 32.46 to 28.72 (p = 0.0001). ΔSDAI showed a significant correlation with both ΔPCS and ΔCSI (r = 0.466 and 0.386, respectively, p < 0.0001). ΔPCS was the only variable predictive of an improvement in SDAI (coefficient = 0.500, p = 0.0224). CONCLUSION: JAKis would appear to have a positive effect on pain-related variables, particularly CS and pain catastrophizing, for the genesis of which extra-synovial mechanisms are responsible.

Validity of the Central Sensitization Inventory compared with traditional measures of disease severity in fibromyalgia.

OBJECTIVE: The goal of this 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). METHODS: Patients 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 cutoffs were established with the interquartile reconciliation approach. RESULTS: The study included 562 FM patients, 199 (35.4%) were classified as having central sensitization syndrome (CSI ≥40). CSI was largely correlated with modFAS (ρ = 0.580; p < 0.0001), FIQR (ρ = 0.542; p < 0.0001), and PDS (ρ = 0.518; p < 0.0001). The differences between the CSI scores in accordance with the FIQR were significant (p < 0.000001). CSI cutoffs proposed for FM: 21 between remission and mild severity, 30 between mild and moderate severity, 37 between moderate and severe disease, and 51 between severe and very severe disease. CONCLUSION: The current study successfully showed additional evidence of the convergent and discriminant validity of the CSI in FM patients.

Prevalence of COVID infections in a population of rheumatic patients from Lombardy and Marche treated with biological drugs or small molecules: A multicentre retrospective study.

OBJECTIVE: The COVID-19 pandemic has raised questions about the management of systemic immunosuppressive treatments for rheumatic conditions. It is well known that rheumatic patients are at risk of developing infections because of their immunocompromised state. Moreover, drugs such as hydroxychloroquine or tocilizumab that are widely used to treat rheumatic diseases are now being used to treat COVID-19. The aim of this multicentre retrospective study of rheumatic patients in the Italian regions of Lombardy and Marche was to determine whether patients receiving biological or small molecules treatment are more susceptible to the development of COVID-19 than the general population. METHODS: The local registry data of 10,260 rheumatic patients being treated with bDMARDs or small molecules were evaluated from 15 March to 23 April 2020. The final analysis was based on the registry data relating to 7.204, telephone contacts and/or outpatient visits. RESULTS: Forty-seven of the 7.204 patients were diagnosed with COVID-19, seven of whom died; the patients who had symptoms resembling those of COVID-19 but had negative swabs were considered negative for the disease. The overall infection rate was 0.65, and the crude case fatality risk (CFR) in the patients with COVID-19 was 14.9%. There was no difference in the mortality rate among the patients receiving the different individual biological drugs or small molecules. CONCLUSIONS: Our findings suggest that the susceptibility of rheumatic patients to COVID-19 is the same as that of the general population, but confirm that age, disease duration, and the number of co-morbidities are associated with an increased risk of a severe form of the disease. It seems that immunosuppressants drugs do not effectively represent a risk factor for COVID- 19.

Definition of fibromyalgia severity: findings from a cross-sectional survey of 2339 Italian patients.

OBJECTIVE: To establish optimal cut-off values for the scores of the revised Fibromyalgia Impact Questionnaire (FIQR), the modified Fibromialgia Assessment Scale (FAS 2019mod), and the Polysymptomatic Distress Scale (PDS) in order to distinguish five levels of FM disease severity. METHODS: Consecutive FM patients were evaluated with the three clinimetric indices, and each patient was required to answer the anchor question: 'In general, would you say your health is 1 = very good, 2 = good, 3 = fair, 4 = poor, or 5 = very poor?'-which represented the external criterion. Cut-off points were established through the interquartile reconciliation approach. RESULTS: The study sample consisted of 2181 women (93.2%) and 158 men (6.8%), with a mean age of 51.9 (11.5) years, and mean disease duration was 7.3 (6.9) years. The overall median FIQR, FAS 2019 mod and PDS scores (25th-75th percentiles) were respectively 61.16 (41.16-77.00), 27.00 (19.00-32.00) and 19.0 (13.00-24.00). Reconciliation of the mean 75th and 25th percentiles of adjacent categories defined the severity states for FIQR: 0-23 for remission, 24-40 for mild disease, 41-63 for moderate disease, 64-82 for severe disease and >83 for very severe disease; FAS 2019 mod: 0-12 for remission, 13-20 for mild disease, 21-28 for moderate disease, 29-33 for severe disease and >33 for very severe disease; PDS: 0-5 for remission, 6-15 for mild disease, 16-20 for moderate disease, 21-25 for severe disease and >25 for very severe disease. CONCLUSIONS: Disease severity cut-offs can represent an important improvement in interpreting FM.

The effect of novel coronavirus disease-2019 (COVID-19) on fibromyalgia syndrome.

OBJECTIVES: Fibromyalgia syndrome (FM) is a complex disease that is mainly characterised by chronic widespread pain, fatigue and sleep disturbances and may be precipitated or worsened by many stressors. The aim of this study was to observe the behaviour of FM symptoms during the course of coronavirus disease 2019 (COVID-19). METHODS: Patients who had been diagnosed as having FM for ≥3 months were recruited between February and May 2020. The collected data were age, sex, educational level and marital status; height and weight; and the scores of the revised Fibromyalgia Impact Questionnaire (FIQR), the modified Fibromyalgia Assessment Status 2019 (FASmod), and the Polysymptomatic Distress Scale (PDS). The patients were divided into those with or without concomitant COVID-19 infection. RESULTS: Eight hundred and ninety-seven (93%) of the 965 patients (881 women [91.3%] and 84 men [8.7%]) were followed up on an outpatient basis because of FM and 68 (7.0%) were either followed up as out-patients or hospitalised because of COVID-19. There was no difference in the sociodemographic data of the two groups, but there were statistically significant between-group differences in the results of the clinimetric tests. The major differences between the score of the items (those with the greatest disease impact) were the following related symptoms: sleep quality (FIQR15), fatigue/energy (FIQR13), pain (FIQR12), stiffness (FIQR14). CONCLUSIONS: The mean total and subdomain scores of all the tests were significantly higher in the patients with COVID-19, which suggests that global FM symptoms are more severe in patients with infection. Further studies of the post-COVID19 patients are being carried out in order to discover whether the worsened symptomatology continues because of their hypersensitised state.