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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.

Fibromyalgia (FM) remains a condition with a pathogenesis that is not completely understood, affecting a significant portion of the global population. This article summarises the main advances in FM during the last year. Even in 2023, research on FM was notably active. From a clinimetric perspective, studies have been conducted to evaluate the possibilities of interchanging the primary indices of disease severity, primarily for studies with substantial case numbers. Regarding FM pathogenesis, ongoing research focuses on small fiber neuropathy: some studies have documented its association with central sensitisation, while others have revealed distinct sensory profiles in patients with FM and small fiber neuropathy compared to those solely with small fiber neuropathy. Dorsal root ganglia seem to play a crucial role in the pathogenesis of FM as they host satellite glial cells, which are targeted by pain-driving immunoglobulin G. These antibodies have been identified in a subset of patients exhibiting high symptom severity. An important study conducted on animal models confirmed the role of neuroinflammation at the level of dorsal root ganglia, in this case mediated by polymorphonuclear neutrophils. Mounting evidence underscores the link between COVID-19 and the persistence of FM symptoms after recovery. In identifying potential biomarkers aiding FM diagnosis, research has also concentrated on studying the expression of specific circulating microRNAs. Recent discoveries have unveiled novel therapeutic strategies for FM, especially focused in non-pharmacological interventions. This includes a focus on non-invasive brain stimulation and exercise programs, all directed towards relieving symptoms and improving functionality in individuals affected by the condition.

Objectives: We aimed to 1) evaluate by power Doppler (PD) ultrasound (US) the response to therapy of the most inflamed joint and enthesis (target sites) in psoriatic arthritis (PsA) patients starting a biologic disease-modifying anti-rheumatic drug (bDMARD); and 2) to investigate the correlation between the US response and clinical data., Methods: Consecutive PsA patients with US synovitis and US 'active' enthesitis, starting a bDMARD, were included. The joint with the highest OMERACT-EULAR-US composite score and the enthesis with the highest PD grade (targets) were identified at baseline. The US examination and clinical assessment were performed at 0, 3 and 6 months. The response of OMERACT-EULAR-US synovitis composite score was defined as reaching a grade = 0 at follow-up examination; synovial and entheseal PD responses were defined as a PD=0 and/or a reduction of ≥2 PD grades at follow-up examination., Results: Thirty patients were included. Synovitis composite score, synovial PD and entheseal PD showed significant responses at 3 and 6 months compared to baseline (p<0.01). Synovial PD responses were higher than entheseal PD responses at 3 months (71.4% vs 40.0%, p=0.01) and 6 months (77.8% vs. 46.7%, p=0.02). US synovitis responses were correlated with DAPSA (p<0.01) and MDA responses (p=0.01 for composite score, p=0.02 for PD)., Conclusions: US was found sensitive for monitoring treatment response in PsA patients starting a biologic drug. Entheseal PD was less responsive than synovial PD, suggesting that enthesitis may represent a 'difficult-to-treat' domain in PsA.

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.

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.

Objectives: To identify the predictive factors of treatment response to acupuncture in patients with fibromyalgia (FM)., Methods: Patients with FM refractory to standard drug therapy underwent eight weekly acupuncture sessions. Significant improvement, defined as a reduction of at least 30% of the revised Fibromyalgia Impact Questionnaire (FIQR), was assessed at the end of the eight weeks (T1) of treatment and three months after the end of treatment (T2). Univariate analysis was conducted to identify predictors of significant improvement at T1 and T2. Variables that resulted to be significantly associated with clinical improvement at univariate analysis were included in multivariate models., Results: Analyses were conducted on 77 patients (9 males, 11.7%). At T1, significant improvement in FIQR was recorded in 44.2% of patients. At T2, persistent significant improvement was recorded in 20.8% of patients. In the multivariate analysis, predictive variables of treatment failure were tender point count (TPC) (odds ratio [OR] =0.49, 95% confidence interval [95% CI]: 0.28-0.86, p=0.01) and pain magnification (OR=0.68, 95% CI: 0.47-0.99, p=0.04) assessed with the Pain Catastrophising Scale, at T1. At T2, the only predictive variable of treatment failure was concomitant duloxetine use (OR=0.21, 95% CI: 0.05-0.95, p=0.04)., Conclusions: High TPC and a tendency for pain magnification predict immediate treatment failure, while duloxetine therapy predicts it three months after completion of the acupuncture course. The identification of clinical characteristics of unfavourable response to acupuncture could help to implement a cost-effective prevention of treatment failure in FM.

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.

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.

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.

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.

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.

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.

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.

Objectives: The aim of this study was to determine the cut-off number of lung ultrasound (LUS) B-lines that identifies a significant rheumatoid arthritis-interstitial lung disease (RA-ILD)., Methods: RA patients with suspected RA-ILD were consecutively enrolled. Patients underwent LUS (carried out in 14 defined intercostal spaces), chest HRCT, pulmonary function tests, and clinical evaluation. The diagnosis of RA-ILD was based on a semi-quantitative evaluation of chest HRCT using a computer-aided method (CaM). The discriminative validity of the LUS versus HRCT has been studied by using the receiver operating characteristic (ROC) curve analysis., Results: 72 consecutive RA patients (21 male, 51 female) were evaluated, with a mean age of 63.0 (SD 11.5 years). The mean estimate of pulmonary fibrosis using the CaM was 11.20% (SD 7.48) at chest HRCT, while at LUS the mean number of B-lines was 10.65 (SD 15.11). A significant RA-ILD, as measured by the CaM at HRCT, was detected in 25 patients (34.7%). The presence of 9 B-lines was found to be the optimal cut-off at ROC curve analysis. This LUS cut-off defines the presence of significant RA-ILD with a sensitivity of 70.0%, a specificity of 97.62%, and a positive likelihood ratio of 29.4., Conclusions: The present study provided data to determine the number of B-lines to identify a significant RA-ILD. LUS may represent a useful technique to select RA patients to be assessed by chest HRCT.

Objectives: To determine the prevalence and distribution of the ultrasound (US) findings indicating cartilage and bone damage at the metacarpal head (MH) in a group of healthy subjects (HS), and their association with the clinical and US data. We also aimed to provide standard reference values of cartilage thickness., Methods: US scans of the dorsal aspect of the metacarpophalangeal joints (MCPj) from 2nd to 5th finger of both hands were performed in 179 HS. The presence of cartilage damage, osteophytes and bone erosions was recorded., Results: Cartilage damage, osteophytes and bone erosions were found in at least one MCPj in 30 (16.8%), 17 (9.5%) and 4 (2.2%) out of 179 HS, respectively. Signs of cartilage damage were found in 91 out of 1432 MHs (6.4%). Blurring of the chondrosynovial margin, minimal and severe thinning were detected in 73.7%, 26.3% and 0% of the 91 MHs, respectively. Osteophytes and bone erosions were found in 31 (2.2%) and in 4 (0.3%) MCPjs. The thickness of the MH cartilage ranged between 0.41 and 1.10 mm in males and between 0.36 and 1.03 mm in females. A significant association was found between cartilage thickness and age (r=-0.33, p<0.001), sex (rpb=0.42, p<0.001), height (r=0.39, p<0.001) and osteophytes in the same joint (v=-0.54, p<0.001) and between working condition and osteophytes (v=0.31, p=0.021)., Conclusions: This cross-sectional study reports the prevalence of US findings of joint damage in a large cohort of HS. Moreover, standard reference values of the MH cartilage thickness in HS are provided.

Objectives: To investigate the diagnostic performance of dual-energy computed tomography (DECT) in detection bone marrow oedema (BME) in patients with sacroiliitis associated with axial spondyloarthritis (axial SpA)., Methods: Patients with axial SpA according to the ASAS criteria underwent DECT and 1.5-T magnetic resonance imaging (MRI). DECT was post-processed for generating virtual non-calcium (VNCa) images. The presence of abnormal bone marrow attenuation was scored on DECT VNCa images and MRI using a four-point classification system: 0-1 = absent or non-significant oedema, 2 = oedema present in a third of the articular surface, 3 = oedema present in 2/3 of the articular surface, 4 = diffuse oedema throughout the articular surface. Diagnostic accuracy values for BME were calculated for DECT images (quantitative assessment) by using receiver operating characteristic (ROC) curves analysis, applying MRI as gold standard., Results: Eighty sacroiliac joints from 40 axial SpA patients were included for study analysis, and 36 sacroiliac joints (45%) were classified as having BME at MRI and compared to DECT. Sensitivity, specificity, and positive likelihood ratio (LR+) in the identification of BME at DECT were 90.0%, 92.8%, and 12.6 respectively. Negative LR was 0.11, positive predictive value 93.1%, and negative predictive value 89.7%. The area under the curve (AUC) was 0.953 in the differentiation of the presence of BME. A cut-off value of -1.6 HU (Youden's index = 0.828) yielded a sensitivity of 90.0% and specificity of 92.8%, with an LR+ of 12.6, in the detection of BME in the sacroiliac joints., Conclusions: DECT VNCa images had good diagnostic performance in the evaluation of the extent of BME in patients with sacroiliitis associated with axial SpA.

Objectives: To evaluate the clinical efficacy of ultrasound (US)-guided soft tissue adapted biocompatible hyaluronic acid (STABHA) injections in the subacromial-subdeltoid bursa of patients with supraspinatus tendon tear., Methods: In this prospective study, patients with a symptomatic partial-thickness or small full-thickness supraspinatus tendon tear, diagnosed by US, were consecutively enrolled. Patients received one injection at baseline visit and one after 2 weeks and performed rehabilitation therapy. Clinical assessment was performed with visual analogue scale (VAS) for pain, Constant-Murley Scale (CMS), and patient reported efficacy on a 0-4 Likert scale. Patients were examined at baseline, at week 2 and at week 12., Results: Thirty patients were enrolled. Sixteen (53.3%) and 19 (63.3%) patients reported significant improvement at week 12 in pain and function, respectively. Reduction in VAS pain was statistically significant both at week 2 and at week 12 in comparison with baseline visit (mean-difference -27.2 and -36.8, respectively, p<0.01). The same trend was observed with CMS (mean-difference 17.7 and 19.8, respectively, p<0.01). At week 12, 18 patients (60.0%) reported a subjective improvement. At week 12, in non-responders (n=14) US detected inflammatory changes and/or progression of tendon tear in 7 (50.0%) patients and no relevant changes in 7 (50.0%)., Conclusions: US-guided STABHA injections followed by rehabilitation therapy were found effective in improving both pain and shoulder function at the 12-week follow-up. In half of the non-responders, US allowed the detection of US findings responsible for treatment failure.

Objectives: To evaluate the performance of two screening tools, respectively Pain Detect Questionnaire (PDQ) and Douleur Neuropathique 4 questions (DN4), and the optimal cut-off point of the sural nerve cross-sectional area (CSA), in identifying the neuropathic pain features suggestive of a small fiber neuropathy (SFN), in patients with fibromyalgia syndrome (FM)., Methods: Consecutive adult female FM patients fulfilling the American College of Rheumatology (ACR) 2016 criteria have been enrolled. Patients underwent a clinical assessment and ultrasound examination of the sural nerve CSA. In each patient was established the presence of neuropathic pain features suggestive of the presence of SFN. The performance of PDQ versus DN4 was compared to the clinical judgment of SFN as external criterion analysing the area under the receiver operating characteristic curve (AUCROC). The optimal sural nerve CSA cut-off was established with the ROC curve analysis versus the clinical judgment of SFN., Results: The study involved 80 patients (mean age 49.5±10.5 years, mean disease duration 5.2±4.9 years, mean revised FIQR score 60.9±19.6). Comparing the AUC-ROCs of the screening tools with clinical judgment of SFN, a better AUC was documented, although not significantly (p=0.715), for DN4 (0.875) compared to PDQ (0.857). A sural nerve CSA of 3 mm2 identifies neuropathic pain features with a sensitivity of 70% and a specificity of 90%., Conclusions: Screening tools have a good concordance in identifying neuropathic pain features suggestive of SFN in FM patients, although a better performance is provided by DN4. Determining the CSA sural nerve with an ultrasound examination may provide some information about the possible presence of SFN.

Fibromyalgia syndrome is one of the most common causes of chronic widespread pain, but pain accompanies a wide range of ancillary symptoms. To date, its aetiopathogenesis remains elusive, and diagnosis is exquisitely clinical, due to the lack of biomarkers or specific laboratory alterations in fibromyalgia patients. This position paper has the purpose to summarise the current scientific knowledge and expert opinions about the main controversies regarding fibromyalgia syndrome, namely: (i) fibromyalgia definition and why it is still not recognised in many countries as a distinct clinical entity; (ii) fibromyalgia severity and how to evaluate treatment outcome; (iii) how to treat fibromyalgia and which is a correct approach to fibromyalgia patients.

Early diagnosis and timely and appropriate treatments positively influence the history of fibromyalgia syndrome (FM), with favourable repercussions at clinical, psychological, social and economic levels. Notwithstanding, there are still significant problems with timeliness of diagnosis, access to pharmacological therapies - particularly to innovative ones - and appropriate and effective taking in charge of patients. All the aforementioned factors have a great impact on FM patients' quality of life. Indeed, even though the World Health Organisation recognised FM as a chronic condition in the International Classification of Diseases 10th edition (ICD-10), many countries still fail to recognise the syndrome, and this negatively influences the capability to appropriately protect and care for patients. This is the case in several European Countries. In Italy, a few Regions have started to put in place precise indications for people suffering from FM, aiming at the implementation of diagnostic-therapeutic pathways. The Diagnostic-Therapeutic Care Pathway (DTCP) provides an important tool to meet the needs of patients suffering from chronic diseases. They present the organisation of an integrated assistance network. This includes a seamless path for disease prevention, diagnosis and treatment, by means of cooperation among physicians and other healthcare professionals.

Objectives: Frailty is a topic that is gaining more and more interest in rheumatology. The aims of this study were to develop and preliminarily validate a frailty index dedicated to rheumatoid arthritis (RA) called the Comprehensive Rheumatologic Assessment of Frailty (CRAF)., Methods: Ten major frailty domains of CRAF were identified: nutritional status, weakness, falls, comorbidity, polypharmacy, social activity, pain, fatigue, physical function, and depression. Convergent validity was evaluated correlating the scores of the CRAF with the Frailty Instrument for Primary Care of the Survey of Health, Ageing and Retirement in Europe (SHARE-FI). Discriminant validity was assessed using receiver operating characteristic (ROC) curve analysis. Multivariate logistic regression model procedure was used to assess the relative contribution of the individual determinants on the CRAF., Results: Among the 219 RA patients, 79 (36.1%) were defined as non-frail (CRAF ≤0.12), 63 (28.8%) mild frail (0.12 0.36). In testing for convergent validity, a significant correlation was found between CRAF and SHARE-FI (p <0.0001). The discriminatory power of CRAF was higher than those of the SHARE-FI (difference between areas under the ROC curves=0.0853± 0.0282. Variables associated with frailty at the multivariate analysis were advanced age and high disease activity (both at p<0.0001)., Conclusions: The CRAF demonstrated a robust validity and good discriminant accuracy. Implementation of the frailty assessment into the routine rheumatological practice could represent a major advance in RA care.

Objectives: To develop and test in a preliminary way a new self-administered and user-friendly screening tool, called SImple FIbromyalgia Screening (SIFIS) questionnaire, to screen Italian speaking patients for the presence of fibromyalgia (FM)., Methods: The development of the SIFIS questionnaire followed five steps: identification of a specific patient population, item pool development, item reduction, test of the provisional questionnaire, and validation study. The item generation was carried out by a review of the literature on the existing questionnaires. Thirty-three items were identified, and a survey was performed among 139 specialists. The frequency importance product allowed us to select the six most significant items. The validation study allowed the determination of sensitivities, specificities and likelihood ratios (LRs) aiming to calculate the post-test probability of the presence of FM, by applying the Bayesian Analysis Model method., Results: The preliminary testing was performed in 284 subjects with multi-site pain. In 230 (80.9%) of them, FM was diagnosed according to the modified 2010 American College of Rheumatology (ACR) criteria. For each of the six items, LRs varied between 3.37 and 5.00. The best positive LR was found in item 1, exploring persistent pain. The presence of four out of six items gave a post-test probability ≥80% (range: 81.8-87.1%)., Conclusions: The SIFIS questionnaire is a useful tool that can be used for potential screening.

Objectives: To establish the weight of the subjective components of the Disease Activity index for Psoriatic Arthritis (DAPSA) in psoriatic arthritis (PsA) patients and comorbid fibromyalgia syndrome (FM)., Methods: In PsA patients not fulfilling the DAPSA remission, it has been calculated the DAPSA-patient (DAPSA-P), an index represented by the ratio between the sum of the subjective components (tender joint count+patient global assessment of disease activity+visual analogue scale pain) and DAPSA in its entirety (swollen joint count+tender joint count+patient global assessment of disease activity+visual analogue scale pain+C-reactive protein [in mg/ dl]). The DAPSA-P ranges from 0 to 1, and values closer to 1 suggest a major weight of the subjective components, while values closer to 0 indicate a greater contribution of the swollen joint count and C-reactive protein, the two factors more closely related to inflammation. It was also defined as the presence of a comorbid FM, and it was established the DAPSA-P cut-off point distinguishing for the presence of a comorbid FM through the receiver operating characteristic (ROC) curve analysis., Results: DAPSA-P was higher in all PsA+FM patients. Analysing the receiver operating characteristic curve, the DAPSA-P cut-off distinguishing a comorbid FM was 0.775., Conclusions: DAPSA-P can help to measure how comorbid FM inflates DAPSA.

Objectives: Fibromyalgia (FM), the most frequently encountered cause of widespread musculoskeletal pain, affects an estimated 2% of the general Italian population. However, it is not a homogeneous clinical entity, and a number of interacting factors can influence patient prognosis and the outcomes of standardised treatment programmes. Registries are a source of high-quality data for clinical research, but relating this information to individual patients is technically challenging. The aim of this article is to describe the structure and objectives of the first Italian Fibromyalgia Registry (IFR), a new web-based registry of patients with FM., Methods: The IFR was developed to collect, store, and share information electronically entered by physicians throughout Italy who are members of the Italian Society of Rheumatology and have a particular interest in FM. It has a web-based architecture that uses two separate servers and an encryption algorithm to ensure the confidentiality and integrity of the exchanged data. The questionnaires included on the platform are the Revised Fibromyalgia Impact Questionnaire (FIQR), the modified Fibromyalgia Assessment Status (ModFAS), and the Polysymptomatic Distress Scale (PDS)., Results: The registry includes data relating to 2,339 patients (93.2% female) who satisfied the 1990 or 2010/2011 American College of Rheumatology Classification Criteria for Fibromyalgia at the time of diagnosis. At the time of this analysis, the patients had a mean age of 51.9 years (SD 11.5) and a mean disease duration of 7.3 years (SD 6.9). The majority were married (71.3%), and generally well educated. The overall median FIQR, ModFAS and PDS scores and 25th-75th percentiles were respetively 61.16 (41.16-77.00), 8.91 (41.16-77.00), and 19.0 (13.00-24.00). The six highest scoring items indicating the greatest impact of the disease on the patients related to fatigue/energy (7.18), sleep quality (6.87), tenderness (6.69), pain (6.68), stiffness (6.66), and environmental sensitivity (6.35). A high proportion of the responding patients reported experiencing pain in the neck (80.46%), upper back (68.36%), and lower back (75.05%)., Conclusions: The IFR is the most comprehensive FM registry in Italy, and provides healthcare professionals with a secure, reliable, and easy-to-use means of monitoring the patients' clinical progression, treatment history and treatment responses. This can help clinicians to plan patient management, facilitates research study patient recruitment, and provides the participating pain clinics with statistics based on real-world data. It also helps address the Italian Ministry of Health long-term goal of using precision medicine for chronic pain prevention and treatment. It is hoped that the IFR will enhance both scientific research and clinical practice.

Objectives: The aim of this study was to investigate the effectiveness of a web-based exercise intervention in improving the severity of symptoms in different health domains in patients with fibromyalgia (FM)., Methods: Consecutive FM patients insufficiently responding to drug treatment (defined as a score of >4 on a numerical rating scale of pain) were enrolled in a web-based intervention group (Fibro-Web) and underwent a 24-week daily home exercise programme. They were evaluated through the revised Fibromyalgia Impact Questionnaire (FIQR) and the Modified Fibromyalgia Assessment Status questionnaire (Mod FAS) at baseline, and then every two weeks until the end of the programme. The outcomes were compared with those of patients receiving usual care., Results: The final analysis was based on 140 patients: 68 in the Fibro-Web group and 72 in the usual care group. At the end of the 24-week study period, the patients in the Fibro-Web group showed a significant improvement in overall and sub-scale scores of the FIQR (p=0.0279) and Mod FAS (p=0.0057), expressed as time-integrated values. This improvement started in the 16th week., Conclusions: The use of a web-based daily exercise programme in FM patients significantly improves disease severity indices.

Objectives: Good drug survival of tumour necrosis factor inhibitors (TNFi) has been shown in axial spondyloarthritis (axSpA) patients treated in real-life setting. However, few studies have compared drug survival of the first TNF inhibitor between radiographic axSpA (r-axSpA) and non-radiographic axSpA (nr-axSpA) patients in real-world clinical practice. The aim of this work was to evaluate the effectiveness by assessing the retention rate of first-line TNFi in r-axSpA and nr-axSpA patients. Baseline predictive factors for TNFi discontinuation were also evaluated., Methods: We retrospectively assessed axSpA patients, who underwent first line therapy with TNFi. Demographic and clinical data was obtained through structured interview, review of medical records and physical examination. Disease activity indices such as the Bath Ankylosing Spondylitis Metrology Index (BASMI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Ankylosing Spondylitis Disease Activity Score evaluating C Reactive Protein (ASDAS-CRP), Leeds Enthesitis Index (LEI) were assessed at baseline. Moreover Health Assessment QuestionnaireDisability Index (HAQ), erythrocyte sedimentation rate (ESR, mm/h), CRP (mg/dl) and HLA-B27 were recorded as well. Data on x-ray and magnetic resonance imaging of the sacroiliac joints were also collected. Drug retention rates were analysed using Kaplan-Meier curves; log-rank test was performed to demonstrate differences in the survival functions. Cox regression models were used to estimate the inference of several disease and clinical characteristics on drug discontinuation., Results: Drug survival of first-line TNFi was significantly lower in patients who had nr-axSpA than in those with r-axSpA (p=0.005). HLA-B27 frequency was higher in patients with x-ray sacroiliitis than in those with nr-axSpA (p=0.01) as well as mean CRP serum level (p=0.0001), whereas both mean BASDAI and LEI score were higher in patients with nr-axSpA than in those with r-axSpA (p=0.018 and p=0.007, respectively). Global retention rate in our cohort was 60.34% with mean survival time (MST) of 58.68 months (95% CI 47.93-69.42). MST for patients diagnosed with r-axSpA was 66.79 months (95% CI 53.54-80.04) and 39.05 months (95% CI 24.12-53.99) for those with nr-axSpA. Moreover, nr-axSpA (HR 1.620), higher BMI (HR 1.093) and BASFI, (HR 1.192) had an impact on drug discontinuation, whereas HLA-B27 presence (HR. 0.523) had protective effect., Conclusions: Effectiveness of TNFi, seems to be lower in nr-axSpA patients than in those with r-axSpA. In addition obesity and functional disability negatively impact the persistence on first line TNFi in axSpA patients in real life setting.

Objectives: To establish the cut-off points for disease severity states of two self-administered questionnaires (the revised version of the Fibromyalgia-Impact Questionnaire [FIQR] and the Fibromyalgia Assessment Status [FAS]) designed for the evaluation of multidimensional aspects of fibromyalgia (FM)., Methods: In this cross-sectional study, consecutive FM patients completed both FIQR and FAS. The external criterion for grading disease severity was the item one of the Short Form-36 Health Survey (SF-36). The reconciliation approach of the 75th-25th percentiles of adjacent ranks was applied to establish cut-off points distinguishing between disease activity states., Results: 521 FM patients (80.0% women, mean age 49 years) completed the assessment. The overall mean (standard deviation [SD]) FIQR and FAS were 47.87 (SD 20.69) and 5.57 (SD 2.09), respectively. The highest FIQR scored items were those related to sleep quality, fatigue/energy, pain, stiffness, tenderness, and environmental sensitivity. With the reconciliation of 75th-25th percentiles of adjacent ranks, the FIQR cut-off points obtained were: remission ≤30, mild severity >30 and ≤45, moderate severity >46 and ≤65, high severity >65. The same approach for FAS leaded to: remission ≤4, mild severity >4 and ≤5.5, moderate severity >5.6 and ≤7.0, high severity >7.0. The majority of the subjects was classified as suffering from a moderate (FIQR 28.4%; FAS 23.2%) or severe (FIQR 24.4%; FAS 30.7%) FM., Conclusions: The FIQR and FAS cut-off points for remission, mild, moderate and high disease severity are valid measures which can be easily applied in daily clinical practice.

Objectives: 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., Methods: The SiPAS questionnaire was validated in a multicentric Italian cohort of psoriasis patients referred to two rheumatological centres., Results: 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., Conclusions: 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: Targeted drugs against key pathogenetic molecules such as TNF-alpha have significantly improved outcomes in rheumatoid arthritis (RA). They are widely used in clinical practice and drug registries give us information to support their use. Adalimumab (ADA) is able to induce a comprehensive disease control in RA by achieving clinical, functional and radiographic control., Methods: By interrogating 2 Italian registries, LORHEN and GISEA, we analysed the efficacy of ADA in first- or second-line in a total of 2262 RA patients., Results: Patients in 1st line were significantly older, with lower disease activity and HAQ scores compared to 2nd line. In 1st line, rates of DAS28-remission (DAS28rem) at 2 years were 34.4% while 26.5% in 2nd line (p=0.038). A normal HAQ score (HAQ≤0.5) was achieved in 53.5% after 2 years in 1st line versus 30.1% in 2nd (p<0.0001). DAS28rem+HAQ≤0.5, a combined parameter that we defined global clinical disease control, was reached in 20.7% in 1st line versus 13.3% in 2nd (p<0.01). Five-year-survival on therapy was higher for patients in 1st line (45.6% vs. 33.2%, p<0.0001). Discontinuation due to lack of efficacy was lower in 1st line (37.4 vs. 54.4%, p<0.0001). Rates of adverse events were similar., Conclusions: Responses in 1st line are generally significantly better than after a first anti-TNF-alpha failure but patients in 2nd line have a worse clinical and functional profile. A global disease control with clinical and functional remission is an achievable target in both lines.

Objectives: To investigate the 6-month impact of the catastrophic earthquakes that struck central Italy in August and October 2016 on the health-related quality of life (HRQoL) of patients with fibromyalgia (FM)., Methods: We compared a cohort of 55 consecutive FM patients who had been exposed to an earthquake with a control group of 49 FM patients who had not been exposed to it. At each time-point (baseline, and after one, two, four and six months), the patients completed self-reported electronic versions of the revised Fibromyalgia Impact Questionnaire (FIQR) and the Fibromyalgia Activity Score (FAS) on a web platform., Results: At baseline, there were no significant between-group differences in the total FIQR score or the scores of its three domains of function, overall impact and symptoms, and no significant differences in the total FAS score or the FAS fatigue, quality of sleep, and Self-Assessment Pain Scale (SAPS) scores. However, after six months of observation, the median total FIQR score was higher in the earthquake-exposed patients (241.00, 95% confidence interval [CI] 230.55-255.35) than in the unexposed patients (177.50, 95% CI 157.30-185.48; p<0.0001), and the same was true of the median total FAS score (26.86, 95% CI 25.78-28.18 vs. 22.76, 95% CI 20.92-24.34; p<0.0001). Moreover, there were also significant differences in all of the FIQR and FAS domain scores., Conclusions: A natural catastrophe such as an earthquake can have a significant impact on the major domains of pain, fatigue, sleep, and the overall quality of life of FM patients.