Farah Sonia
Verified @gmail.com
dipartimento Scienze cliniche e molecolari
Università Politecnica delle Marche
RESEARCH INTERESTS
Rheumatology, Biomedical Engineering
59
Scopus Publications
Scopus Publications
- Geographical disparities in fibromyalgia severity: An Italian study
Marco Di Carlo, Sonia Farah, Fabiola Atzeni, Alessandra Alciati, Manuela Di Franco, Cristina Iannuccelli, Laura Bazzichi, Gerolamo Bianchi, Massimo Giovale, Rosella Tirri,et al.
Wiley
AbstractBackgroundGeographic origin may represent a variable capable of influencing health status. This study aims to investigate the presence of differences of disease severity in Italian patients with fibromyalgia from different macro‐regions.MethodsThis retrospective, cross‐sectional study involved patients included in the Italian Fibromyalgia Registry. Three geographical macro‐regions were identified, comprising patients from Northern Italy, Central Italy and Southern Italy. Clinical differences (evaluated through PolySymptomatic Distress Scale [PSD], revised Fibromyalgia Impact Questionnaire [FIQR] and modified Fibromyalgia Assessment Status [FASmod]) among the geographical macro‐regions were studied using one‐way analysis of variance (ANOVA) and the Scheffé's test.ResultsA total of 6095 patients (5719 females and 376 males) were included, with 1957 from Northern Italy, 2979 from Central Italy and 1159 from Southern Italy. All studied clinical indices showed a trend indicative of greater disease severity in Southern Italy, followed by Northern Italy and then Central Italy (mean values for PSD: 19.97 ± 6.20 in Northern Italy, 18.61 ± 7.12 in Central Italy, 23.01 ± 5.66 in Souther Italy). These differences were statistically significant for the overall scores of all studied indices, evaluated with ANOVA (all p < 0.001) and in the head to head comparisons, evaluted with Scheffé's test.ConclusionsGeographic background is significantly associated with variations in the severity of fibromyalgia in Italian patients.Significance StatementThis is the first study to demonstrate geographical origin‐dependent intra‐national differences in the severity of fibromyalgia. The results confirm the necessity of considering fibromyalgia within the context of the biopsychosocial model and of implementing healthcare policies targeted towards the most underserved regions. - Remote-Customized Telecontrol for Patients with Rheumatoid Arthritis: The iARPlus (Innovative Approach in Rheumatology) Initiative
Fausto Salaffi, Sonia Farah, Eleonora Di Donato, Massimo Sonnati, Emilio Filippucci, Rossella De Angelis, Francesco Gabbrielli, and Marco Di Carlo
MDPI AG
Objective. Telecontrol approaches for rheumatoid arthritis (RA) management aim to enhance patient outcomes. This pilot study assessed whether the Rheumatoid Arthritis Impact of Disease (RAID) approach could be used during teleconsultations to monitor RA disease activity through a web-based platform called iARPlus (Innovative Approach in Rheumatology). Methods. Forty RA patients participated in two in-person visits (baseline and 12 months) and seven teleconsultations over 12 months, collected via the iARPlus portal and accessible through an internet browser. Disease activity, at baseline and follow-up, was measured using the Clinical Disease Activity Index (CDAI) and self-reported RAID scores throughout the study. The RAID approach, developed by the European Alliance of Associations for Rheumatology (EULAR), combines key patient-reported outcomes (PROs). Results. Nineteen patients (mean age: 49.3 years) were treated with Janus kinase inhibitors (JAKis), and 21 patients (mean age: 48.1 years) received adalimumab. All patients had active disease (mean CDAI 27.9 ± 4.8). Strong correlations were found between CDAI and RAID scores at baseline (ρ = 0.809, p < 0.0001) and at follow-up (ρ = 0.789, p < 0.0001). JAKi-treated patients showed greater reductions in RAID scores, pain relief, and higher rates of disease remission compared to adalimumab-treated patients. Conclusions. RAID scores were effective in teleconsultations for assessing RA disease activity. JAKi treatment resulted in better pain control and disease activity improvement compared to adalimumab. Further studies are needed to confirm the clinical and economic benefits of telecontrol for RA management. - A Mediation Appraisal of Neuropathic-like Symptoms, Pain Catastrophizing, and Central Sensitization-Related Signs in Adults with Knee Osteoarthritis—A Cross-Sectional Study
Fausto Salaffi, Marina Carotti, Sonia Farah, Carlo Ciccullo, Antonio Pompilio Gigante, Francesca Bandinelli, and Marco Di Carlo
MDPI AG
Objective. To investigate the relationships among neuropathic pain (NP), pain catastrophizing (PC), and central sensitization (CS) in relation to functional status and radiological damage in patients with knee osteoarthritis (OA). Methods. This cross-sectional study included knee OA patients derived from an observational cohort. The Spearman correlation test was used to analyze the relationship between the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the PainDetect Questionnaire (PDQ), Central Sensitization Inventory (CSI), and Pain Catastrophizing Scale (PCS). The Kruskal–Wallis test was employed to compare WOMAC scores according to CSI categories. A multivariate analysis was conducted to identify predictors of functional ability, with the WOMAC score as the dependent variable and the independent variables including pain-related indices such as PCS, PDQ, and CSI, along with Kellgren–Lawrence (K-L) grading and demographic characteristics. Results. This study included 149 patients (76.5% female; mean age 71.5 years; mean duration of pain 8.1 years). In total, 23.5% exhibited NP, 30.9% showed PC, and 33.6% had CS. Higher mean values of WOMAC were correlated with CSI categories (p < 0.0001). WOMAC showed a significant relationship with CSI (rho = 0.791; p < 0.0001), PDQ (rho = 0.766; p < 0.0001), and PCS (rho = 0.536; p < 0.0001). In the multiple regression analysis, WOMAC was independently associated with CSI (p < 0.0001), PDQ (p < 0.0001), and PC (p = 0.0001). No association was observed between the K-L grading and the other variables. Conclusions. A reduced functional capacity in patients with knee OA is correlated with the presence of NP, PC and CS, without being significantly associated with radiological damage. - Imaging of Sacroiliac Pain: The Current State-of-the-Art
Marina Carotti, Luca Ceccarelli, Anna Claudia Poliseno, Francesca Ribichini, Francesca Bandinelli, Enrico Scarano, Sonia Farah, Marco Di Carlo, Andrea Giovagnoni, and Fausto Salaffi
MDPI AG
Pain in the sacroiliac (SI) region is a common clinical manifestation, often caused by diseases involving the SI joints. This is typically due to inflammation or degenerative changes, while infections or cancer are less frequent causes. The SI joint is challenging to image accurately because of its distinct anatomical characteristics. For an accurate diagnosis, conventional radiography often needs to be supplemented with more precise methods such as magnetic resonance imaging (MRI) or computed tomography (CT). Sacroiliitis, a common presenting feature of axial spondyloarthritis (axial SpA), manifests as bone marrow edema, erosions, sclerosis, and joint space narrowing. Septic sacroiliitis and repetitive stress injuries in sports can also cause changes resembling inflammatory sacroiliitis. Other conditions, such as osteitis condensans ilii (OCI), can mimic the radiologic characteristics of sacroiliitis. Inflammatory lesions are diagnosed by concurrent erosions, hyperostosis, and ankylosis. Ligament ossifications or mechanical stress can also result in arthritic disorders. Determining the exact diagnosis can be aided by the distribution of the lesions. Inflammatory lesions can affect any part of the articulation, including the inferior and posterior portions. Mechanical lesions, such as those seen in OCI, often occur in the anterior middle region of the joint. In cases of idiopathic skeletal hyperostosis, ligament ossification is found at the joint borders. This pictorial essay describes common SI joint problems, illustrated with multimodal imaging data. We, also, discuss strategies for selecting the best imaging modalities, along with imaging pitfalls, key points, and approaches for treating patients with suspected inflammatory back pain. - Magnetic Resonance Imaging (MRI)-Based Semi-Quantitative Methods for Rheumatoid Arthritis: From Scoring to Measurement
Fausto Salaffi, Marina Carotti, Marco Di Carlo, Luca Ceccarelli, Sonia Farah, Anna Claudia Poliseno, Andrea Di Matteo, Francesca Bandinelli, and Andrea Giovagnoni
MDPI AG
Rheumatoid arthritis (RA) is a chronic autoimmune disease that primarily affects the small joints of the hands and feet, characterized by pain, inflammation, and joint damage. In this context, magnetic resonance imaging (MRI) is useful to identify and monitor joint/tendon inflammation and the evolution of joint damage, playing a key role in treatment response evaluation, in addition to clinical measurements. Various methods to quantify joint inflammation and damage with MRI in RA have been developed, such as RA-MRI Score (RAMRIS), Early RA-MRI Score (ERAMRS), and Simplified RA-MRI Score (SAMIS). RAMRIS, introduced in 2002, offers an objective means to assess inflammation and damage via MRI in RA trials, encompassing findings such as synovitis, bone erosion, and edema/osteitis. Recently, an updated RAMRIS version was developed, which also includes the evaluation of joint space narrowing and tenosynovitis. The RAMRIS-5, which is a condensed RAMSIS version focusing on five hand joints only, has been proven to be a valuable resource for the semi-quantitative evaluation of RA joint damage, both in early and established disease. This narrative literature review will provide an overview of the MRI scoring systems that have been developed for the assessment of joint inflammation and structural damage in RA patients. - Trajectory of Change in the Severity of Symptoms in Patients with Fibromyalgia over 24 Months: Exploratory Analyses of a Combination Pharmacological Intervention
Fausto Salaffi, Maria Giovanna Lommano, Benedetta Bianchi, Sonia Farah, Francesca Bandinelli, Piercarlo Sarzi-Puttini, and Marco Di Carlo
MDPI AG
Symptoms of fibromyalgia (FM) fluctuate and vary in severity. The current study aimed to evaluate the efficacy of palmitoylethanolamide (PEA) and acetyl-L-carnitine (ALC) in FM patients over a 24-month period and to investigate the mediating function of pain catastrophizing subdomains in unfavorable relationships with disease severity levels in patients with FM. Patients were evaluated at baseline, after 12 months, and after 24 months, using different patient-reported measures (FIQR, FASmod, PSD, and PCS) to distinguish different levels of FM disease severity. A reduction of 30% or more from baseline was considered clinically important (“markedly improved”). A multivariate analysis was performed to identify the variables predictive of an FIQR reduction. Twenty-two patients (28.6%) were classified as “markedly improved”, 16 patients (20.8%) as “slightly/moderately improved”, and 39 patients (50.6%) as “not improved.” The FIQR, FASmod, and PSD scores were significantly reduced at 24 months. The pain magnification domain score of the PCS was the only variable predictive of worse FIQR scores (Wald coefficient: −2.94; p = 0.047). These results suggest a potential long-term therapeutic role for the PEA + ALC combination, with pain magnification being the primary predictor of poor efficacy. - Delay in fibromyalgia diagnosis and its impact on the severity and outcome: a large cohort study
Fausto Salaffi, Sonia Farah, Benedetta Bianchi, Maria Giovanna Lommano, and Marco Di Carlo
Clinical and Experimental Rheumatology
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. - Low-Carbon Monoxide Diffusing Capacity, Patient-Reported Measures and Reduced Nailfold Capillary Density Are Associated with Interstitial Lung Disease in Systemic Sclerosis
Rossella De Angelis, Edoardo Cipolletta, Francesca Francioso, Marina Carotti, Sonia Farah, Andrea Giovagnoni, and Fausto Salaffi
MDPI AG
The aim of this paper is to identify factors associated with interstitial lung disease (ILD) in patients with systemic sclerosis (SSc) and build an algorithm to better define this association for a personalised application in clinical practice. Methods. A total of 78 SSc patients underwent HRCT to assess ILD. Demographic, clinical and laboratory variables were collected, focusing on those associated either directly or indirectly with lung involvement. The discriminant value of each variable was determined using the operating characteristic curves (ROC) and included in a model to estimate the strength of ILD association in SSc. Results. Thirty-three (42.31%) patients showed ILD on HRCT. DLco, M-Borg, GERD-Q and capillary density were significantly associated with the presence of ILD-SSc. A model including these variables had a coefficient of determination (R2) of 0.697. DLco had an AUC of 0.861 (p < 0.001) with a cut-off of ≤72.3% (sensitivity 78.8%, specificity 91.1%, +LR 8.86). The m-Borg Scale showed an AUC of 0.883 (p < 0.001) with a cut-off >2 (sensitivity 84.8%, specificity 82.2%, +LR 4.77), GERD-Q had an AUC of 0.815 (p < 0.001) with a cut-off >7 (sensitivity 72.7%, specificity 86.7%, +LR 5.45). The capillary density showed an AUC of 0.815 (p < 0.001) with a cut-off of ≤4.78 (sensitivity 87.9%, specificity 68.9%, +LR 2.82). Based on the pre-test probability values, these four variables were applied to Fagan’s nomogram to calculate the post-test probability of this association. Conclusions. Our study identified four associated clinical factors of ILD in SSc patients. Moreover, their inclusion in an algorithm for the post-test probability, tailored to the specific patients’ characteristics, significantly increases the ability to find out the presence of SSc-ILD. - Central Sensitization in Psoriatic Arthritis: Relationship With Composite Measures of Disease Activity, Functional Disability, and Health-Related Quality of Life
Fausto Salaffi, Sonia Farah, Benedetta Bianchi, and Marco Di Carlo
The Journal of Rheumatology
ObjectiveTo investigate the prevalence of central sensitization (CS) in patients with psoriatic arthritis (PsA) and its association with disease activity and patient-reported outcome measures.MethodsThis 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.ResultsOne 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.ConclusionPatients 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. - Feldenkrais awareness though movement intervention for fibromyalgia syndrome: A proof-of-concept study
Valeria Giorgi, Sonia Farah, Fausto Salaffi, Gabriella Butera, and Piercarlo Sarzi-Puttini
Elsevier BV - The Psoriatic Arthritis 5-Thermometer Scales (PsA-5Ts): Measurement Properties of a New Multidimensional Composite Tool for the Quick Assessment of the Overall Health Status in Psoriatic Arthritis
Fausto Salaffi, Marina Carotti, Sonia Farah, and Marco Di Carlo
MDPI AG
Background: Psoriatic arthritis (PsA) is a heterogeneous condition that is difficult to assess. The goal of this research was to evaluate the clinimetric properties of the Psoriatic Arthritis 5-Thermometer Scales (PsA-5Ts), a new patient-reported outcome (PRO) to measure the overall health status in PsA patients. Methods: The PsA-5Ts were compared to composite measures of disease activity (DAPSA, PASDAS, CPDAI) and PROs (PsAID-12 and SF-36). The convergent validity was assessed through the Spearman’s correlation coefficient and the discriminant validity through the receiver operating characteristic (ROC) curve analysis, applying the Minimal Disease Activity (MDA) as an external criterion. Results: The cross-sectional assessment included 155 patients. Significant high correlations were observed when comparing PsA-5Ts to composite indices of disease activity and PROs (all at significance levels of p < 0.0001). The PsA-5Ts subscales were highly significantly different in terms of MDA status (all at p < 0.0001). The PsA-5Ts had good discriminant validity like that of the DAPSA, CPDAI, PASDAS, and PsAID-12, and better than that of the SF-36, with an area under the ROC curve of 0.944 (65% CI 0.895–0.974). Conclusions: The PsA-5Ts are an easy-to-use PRO that can be integrated with disease activity indices in the assessment of PsA in daily clinical practice. - 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
Fausto Salaffi, Sonia Farah, and Marco Di Carlo
Clinical and Experimental Rheumatology
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. - Imaging of the peripheral nervous system in nociplastic pain: An ultrasound study in patients with fibromyalgia
Marco Di Carlo, Benedetta Bianchi, Edoardo Cipolletta, Sonia Farah, Emilio Filippucci, and Fausto Salaffi
Wiley
BACKGROUND AND PURPOSE Although fibromyalgia (FM) is considered a central sensitization syndrome, studies investigating peripheral nerves in this condition are not available. The primary objective of this study is to investigate the sonographic changes (ie, increased cross-sectional area [CSA]), of peripheral nerves in patients with FM compared to healthy controls. The secondary objective is to identify potential clinical correlations associated with increased CSA in patients with FM. METHODS In this cross-sectional observational study, consecutive female patients with FM underwent sonographic assessment using a standardized scanning protocol. The CSA of seven nerves was measured bilaterally at 11 anatomic sites by an experienced sonographer. Differences in CSA of nerves were compared with those of healthy subjects by one-way analysis of variance. Patients underwent clinimetric evaluation aimed at investigating disease severity, neuropathic pain features, depression, anxiety, fatigue, and autonomic symptoms to explore the possible correlation between CSA and clinical features. RESULTS Forty-seven patients and 20 healthy controls were enrolled. Differences in terms of increased CSA between patients and healthy controls were identified at multiple levels, mainly at the level of the sural nerve, vagus nerve, and sixth cervical nerve root (for all, p < .001). Sonographic findings, however, did not correlate with the clinical features explored. CONCLUSIONS Patients with FM show higher CSA of nerves than healthy subjects. The increased CSA is most evident at the sural nerve, vagus nerve, and sixth cervical nerve root. Ultrasound, a relatively easy-to-use technique, could identify morphological changes, in peripheral nervous structures in patients with FM. - The measurement of fibromyalgia severity: converting scores between the FIQR, the PSD and the FASmod
Fausto Salaffi, Marco Di Carlo, Sonia Farah, Manuela Di Franco, Laura Bazzichi, Gerolamo Bianchi, Rosella Tirri, Fabiola Atzeni, Serena Guiducci, Giuliana Guggino,et al.
Clinical and Experimental Rheumatology
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
Fausto Salaffi, Marco Di Carlo, Manuela Di Franco, Gerolamo Bianchi, Laura Bazzichi, Rosella Tirri, Serena Guiducci, Roberto Gorla, Fabiola Atzeni, Roberto Giacomelli,et al.
Clinical and Experimental Rheumatology
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. - Palmitoylethanolamide and acetyl-L-carnitine act synergistically with duloxetine and pregabalin in fibromyalgia: results of a randomised controlled study
Fausto Salaffi, Sonia Farah, Piercarlo Sarzi-Puttini, and Marco Di Carlo
Clinical and Experimental Rheumatology
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. - Quantification of sarcopenia in patients with rheumatoid arthritis by measuring the cross-sectional area of the thigh muscles with magnetic resonance imaging
Fausto Salaffi, Marina Carotti, Anna Claudia Poliseno, Luca Ceccarelli, Sonia Farah, Marco Di Carlo, and Andrea Giovagnoni
Springer Science and Business Media LLC
Abstract 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. - Inflammaging and Frailty in Immune-Mediated Rheumatic Diseases: How to Address and Score the Issue
Fausto Salaffi, Andrea Di Matteo, Sonia Farah, and Marco Di Carlo
Springer Science and Business Media LLC
AbstractFrailty is a new concept in rheumatology that can help identify people more likely to have less favorable outcomes. Sarcopenia and inflammaging can be regarded as the biological foundations of physical frailty. Frailty is becoming more widely accepted as an indicator of ageing and is linked to an increased risk of negative outcomes such as falls, injuries, and mortality. Frailty identifies a group of older adults that seem poorer and more fragile than their age-matched counterparts, despite sharing similar comorbidities, demography, sex, and age. Several studies suggest that inflammation affects immune-mediated pathways, multimorbidity, and frailty by inhibiting growth factors, increasing catabolism, and by disrupting homeostatic signaling. Frailty is more common in the community-dwelling population as people get older, ranging from 7 to 10% in those over 65 years up to 40% in those who are octogenarians. Different parameters have been validated to identify frailty. These primarily relate to two conceptual models: Fried’s physical frailty phenotype and Rockwood’s cumulative deficit method. Immune-mediated rheumatic diseases (IMRDs), such as rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, systemic sclerosis, and vasculitis, are leading causes of frailty in developing countries. The aim of this review was to quantitatively synthesize published literature on the prevalence of frailty in IMRDs and to summarize current evidence on the relevance and applicability of the most widely used frailty screening tools. - Reliability assessment of ultrasound muscle echogenicity in patients with rheumatic diseases: Results of a multicenter international web-based study
Andrea Di Matteo, Erica Moscioni, Maria Giovanna Lommano, Edoardo Cipolletta, Gianluca Smerilli, Sonia Farah, Carla Airoldi, Sibel Zehra Aydin, Andrea Becciolini, Karina Bonfiglioli,et al.
Frontiers Media SA
ObjectivesTo investigate the inter/intra-reliability of ultrasound (US) muscle echogenicity in patients with rheumatic diseases.MethodsForty-two rheumatologists and 2 radiologists from 13 countries were asked to assess US muscle echogenicity of quadriceps muscle in 80 static images and 20 clips from 64 patients with different rheumatic diseases and 8 healthy subjects. Two visual scales were evaluated, a visual semi-quantitative scale (0–3) and a continuous quantitative measurement (“VAS echogenicity,” 0–100). The same assessment was repeated to calculate intra-observer reliability. US muscle echogenicity was also calculated by an independent research assistant using a software for the analysis of scientific images (ImageJ). Inter and intra reliabilities were assessed by means of prevalence-adjusted bias-adjusted Kappa (PABAK), intraclass correlation coefficient (ICC) and correlations through Kendall’s Tau and Pearson’s Rho coefficients.ResultsThe semi-quantitative scale showed a moderate inter-reliability [PABAK = 0.58 (0.57–0.59)] and a substantial intra-reliability [PABAK = 0.71 (0.68–0.73)]. The lowest inter and intra-reliability results were obtained for the intermediate grades (i.e., grade 1 and 2) of the semi-quantitative scale. “VAS echogenicity” showed a high reliability both in the inter-observer [ICC = 0.80 (0.75–0.85)] and intra-observer [ICC = 0.88 (0.88–0.89)] evaluations. A substantial association was found between the participants assessment of the semi-quantitative scale and “VAS echogenicity” [ICC = 0.52 (0.50–0.54)]. The correlation between these two visual scales and ImageJ analysis was high (tau = 0.76 and rho = 0.89, respectively).ConclusionThe results of this large, multicenter study highlighted the overall good inter and intra-reliability of the US assessment of muscle echogenicity in patients with different rheumatic diseases. - Multimodal ultrasound muscle assessment in patients with rheumatic diseases: A patient-based reliability study
Gianluca Smerilli, Erica Moscioni, Roberta Sclocco, Maria Giovanna Lommano, Edoardo Cipolletta, Vincenzo Maccarrone, Sonia Farah, Rossella De Angelis, Fausto Salaffi, Walter Grassi,et al.
Oxford University Press (OUP)
Abstract Objectives The aim was to explore the inter-reliability of a newly developed US scanning protocol (multimodal US) for the assessment of different aspects of sarcopenia-related muscle involvement, including muscle mass, muscle quality and muscle stiffness [using point shear-wave elastography (SWE)], in patients with rheumatic and musculoskeletal diseases (RMDs). Methods Quadriceps muscle mass (i.e. muscle thickness), muscle quality (i.e. muscle echogenicity evaluated with both a visual semi-quantitative scale and a dedicated software package for image analysis, ImageJ) and point SWE measurements were obtained by two rheumatologists (blinded to each other’s evaluation) in consecutive RMD patients without previous/current myositis or neuromuscular disorders. Inter-reliability was assessed using the intraclass correlation coefficient (ICC) for continuous variables and Cohen’s kappa (κ) for categorical variables. Results A total of 45 RMD patients were enrolled [mean age 54.5 (16.0) years, male-to-female ratio 1:1.5, mean BMI 24.6 (4.6) kg/m2], 10 with PsA, 7 RA, 5 AS, 5 PMR, 4 SLE, 4 gout, 4 OA, 3 FM and 3 SSc. The grade of inter-rater reliability was excellent for muscle mass [ICC = 0.969 (0.953 &lt; ICC &lt; 0.979)]. Regarding muscle echogenicity, the agreement was substantial/almost perfect using the visual semi-quantitative scale (weighted linear = 0.793, weighted squared = 0.878) and excellent using ImageJ analysis [ICC = 0.916 (0.876 &lt; ICC &lt; 0.944)]. Finally, a good agreement was obtained for point SWE measurements [ICC = 0.76 (0.712 &lt; ICC &lt; 0.8)]. Conclusion Multimodal US is a novel and reliable tool for the evaluation of different aspects of muscle involvement (muscle mass, muscle quality and muscle stiffness) in RMD patients. - Muscle involvement in systemic lupus erythematosus: multimodal ultrasound assessment and relationship with physical performance
Andrea Di Matteo, Gianluca Smerilli, Edoardo Cipolletta, Richard J Wakefield, Rossella De Angelis, Anna Maria Risa, Fausto Salaffi, Sonia Farah, Catalina Villota-Eraso, Vincenzo Maccarrone,et al.
Oxford University Press (OUP)
Abstract 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 &lt; 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 &lt; 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 &lt; 0.01) and SPPB (visual semi-quantitative scale, Rho: –0.50, P &lt; 0.01; grayscale analysis with histograms Rho: –0,46, P &lt; 0.01). Conclusions US assessment of muscle echogenicity and stiffness is useful for the early detection of muscle involvement in SLE patients. - Validity of the Central Sensitization Inventory compared with traditional measures of disease severity in fibromyalgia
Fausto Salaffi, Sonia Farah, Claudia Mariani, Piercarlo Sarzi‐Puttini, and Marco Di Carlo
Wiley
OBJECTIVE The 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). 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 cut-offs 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 (rho = 0.580; p <0.0001), FIQR (rho = 0.542; p <0.0001), and PDS (rho = 0.518; p <0.0001). The differences between the CSI scores in accordance with the FIQR were significant (p <0.000001). CSI cut-offs 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. - Ultrasound and magnetic resonance imaging as diagnostic tools for sarcopenia in immune-mediated rheumatic diseases (IMRDs)
Fausto Salaffi, Marina Carotti, Andrea Di Matteo, Luca Ceccarelli, Sonia Farah, Catalina Villota-Eraso, Marco Di Carlo, and Andrea Giovagnoni
Springer Science and Business Media LLC
AbstractSarcopenia 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. - Quantification of bone marrow oedema and fat metaplasia in sacroiliac joints in spondyloarthritis patients using histographic magnetic resonance imaging analysis
Fausto Salaffi, Luca Ceccarelli, Marina Carotti, Marco Di Carlo, Sonia Farah, and Andrea Giovagnoni
Clinical and Experimental Rheumatology
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. - Overactive bladder syndrome and sexual dysfunction in women with fibromyalgia and their relationship with disease severity
Fausto Salaffi, Marco Di Carlo, Sonia Farah, Valeria Giorgi, Nadia Mosca, and Piercarlo Sarzi-Puttini
Clinical and Experimental Rheumatology
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.