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ObjectiveFibromyalgia (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.MethodsAdult 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)).ResultsData relating to 3,221 patients (3001 women and 220 men) was collected. The ANOVA showed significant difference in mean FIQR scores when the five marital conditions (cohabiter, married, separated/divorced, single, widowed) were compared ( F 3.321, p< 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

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.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.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.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.

Fibromyalgia is a severe and disabling chronic pain syndrome affecting millions of people worldwide. Various patients' subgroups were identified using different atheoretical measures, hardly effective to tailor treatments. Previous literature findings showed the relevance of fibromyalgia patients' illness perceptions in adjusting to the disease. The present study aims to identify clusters of fibromyalgia patients based on their illness perceptions and investigate whether they can differ across pain, mood, physical functioning, catastrophising, and pain acceptance measures.Fifty-three newly referred fibromyalgia patients completed clinical and psychological questionnaires. Patients' subgroups were created by applying hierarchical cluster analysis to their answers to Illness Perception Questionnaire-Revised subscales. Potential differences across subgroups in outcome variables were tested.Cluster analysis identified two patient groups. Group A (32 patients) had a higher representation of fibromyalgia as a chronic disease with severe consequences, lower beliefs in personal and treatment control, and a higher fibromyalgia-related emotional distress than group B (21 patients). Clusters did not differ on pain intensity and duration. Group A, compared to group B, showed worse physical functioning and overall impairment due to fibromyalgia, a poorer psychological condition, a higher tendency to catastrophise, and less pain acceptance.Study findings reveal two fibromyalgia subgroups differing in emotional suffering and impairment despite similar pain intensity and duration. Patients' illness perceptions and attitudes towards pain, like catastrophising and acceptance, might be critical in adjusting to the disease. A detailed assessment of such risk and protective factors is critical to differentiate patients' subgroups with different needs and thus offering tailored treatments.

The use of biosimilars is constantly growing, prompting healthcare payers to encourage the switch to these drugs which are less expensive than the reference bio-originator. While switching from a bio-originator to a biosimilar is supported by increasing evidence, data on the switch between different biosimilars of the same reference product are scant. Our study aimed to evaluate the effectiveness of the non-medical switch both between adalimumab (ADA) bio-originator and SB5 biosimilar and between two different ADA biosimilars in patients with inflammatory chronic arthritis.We observed adult patients with a diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) treated with ADA bio-originator or ABP501 ADA biosimilar (Amgevita) who switched to SB5 ADA biosimilar (Imraldi) for administrative/economic reasons. Patients were followed up for 4 months.One hundred and ten patients [33 RA, 40 PsA, 37 axSpA; F:M= 49:61; median age 56 years (25th-75th percentile 48-66)] switched from ADA bio-originator to SB5. After 4 months (T4), we observed a significant reduction of patients in remission/low disease activity (baseline 92.7% vs. T4 80.9%; p=0.009), with a risk of moderate-high disease activity significantly higher after the switch [RR 2.6 (95% IC 1.2 to 5.7), p=0.01]. However, no differences were found in DAS28-CRP, DAPSA, ASDAS-CRP, and BASDAI, while patients with RA and PsA experienced a worsening in the patient global assessment-VAS (p=0.04 and p=0.02, respectively), and in patients with PsA a worsening in HAQ was also observed (p=0.03). Forty patients switched from ABP501 biosimilar to SB5 [12 with RA, 25 with PsA, and 3 with axSpA; F:M=24:16; median age 56 years (25th-75th percentile 44-66)]. After 4 months, no differences in DAS28-CRP and DAPSA nor in the percentage of patients in remission/low disease activity were found compared to baseline. Likewise, no differences were found in patient-reported outcomes (PROs).Our results provide a reassuring profile of effectiveness when switching from ADA originator to one of its biosimilars and between two different biosimilars. However, the worse outcome in PROs in patients initially treated with the bio-originator addresses the attention to a possible nocebo response, which should encourage comprehensive communication with patients.

ObjectiveThe 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.MethodsThis 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).ResultsThe 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

In rheumatoid arthritis (RA), females usually have a worse prognosis. To date, the influence of physician gender in the evaluation of RA activity is still largely unknown.To investigate the discrepancy in RA disease activity assessment between male and female physicians and to compare patient and evaluator perception of disease activity and global health (GH) status.One female and one male rheumatologist evaluated 154 RA patients recording tender and swollen joint count, GH, evaluator global assessment (EGA), and patient global assessment (PGA) disease activity. A third rheumatologist calculated DAS28, CDAI, and SDAI. Difference was evaluated by Wilcoxon test. Physician-patient agreement was assessed by intraclass correlation coefficient.GH, PGA, and DAS28 were higher when recorded by the female examiner. Male EGA was higher than female. Among male patients, PGA was higher when collected by the female examiner. The probability of being judged as having an active disease did not rely on physician gender. The agreement with the physician's evaluation of disease activity was high. PGA values were higher than EGA in both examiners. The physician-patient agreement was moderate for the male examiner and good for the female. The female physician had a higher agreement with both genders.Subjective measure of disease activity differs between female and male rheumatologists, contributing to a different evaluation of disease activity. Patients have a higher perception of disease activity compared to physicians. The stronger agreement between female physicians and patients may be related to a more emphatic setting established by the female physician.

Objective The aim of this study was to assess the real-life adherence of Italian rheumatologist to the 2013 EULAR recommendations and treatment outcome in rheumatoid arthritis (RA) patients who started a conventional synthetic disease-modifying anti-rheumatic drug (csDMARD). Methods The MITRA study is an Italian multicentre observational cohort focused on treatment naïve RA patients with early diagnosis recruited in an 18-month period starting from 2015. The data related to treatment with csDMARDs during the following 12 months follow-up were presented in this paper. Results Two-hundred and fifty-nine RA patients from MITRA cohort who had a follow-up visit and started a csDMARD were included in the prospective analysis. Methotrexate was started as first conventional DMARD in 224 (86.4%) patients. During the first year after starting conventional DMARDs, 175 (67.6%) RA patients reached the pre-specified target, which was DAS28 remission (

Fibromyalgia (FM) diagnosis follows the American College of Rheumatology (ACR) criteria, based on clinical evaluation and written questionnaires without any objective diagnostic tool. The lack of specific biomarkers is a tragic aspect for FM and chronic pain diseases in general. Interestingly, the endogenous opioid system is close to the immune one because of the expression of opioid receptors on lymphocytes membrane. Here we analyzed the role of the Mu opioid receptor on B lymphocytes as a specific biomarker for FM and osteoarthritis (OA) patients. We enrolled three groups of females: FM patients, OA patients (chronic pain control group) and healthy subjects (pain-free negative control group). We collected blood samples to apply immunophenotyping analysis. Written tests were administrated for psychological analysis. Data were statistically analyzed. Final results showed that the percentage of Mu-positive B cells were statistically lower in FM and OA patients than in pain-free subjects. A low expression of Mu-positive B cell was not associated with the psychological characteristics investigated. In conclusion, here we propose the percentage of Mu-positive B cells as a biological marker for an objective diagnosis of chronic pain suffering patients, also contributing to the legitimacy of FM as a truly painful disease.

In this longitudinal study, we assessed the role of musculoskeletal ultrasound (US) in predicting the efficacy of JAK inhibitors (JAKi) in rheumatoid arthritis (RA) patients.We enrolled RA patients starting baricitinib or tofacitinib. All patients were evaluated at baseline and after 4, 12, 24, 48 weeks. Disease activity was calculated by Disease Activity Score 28 (DAS28CRP); US examination in 22 joints (I-V MCPs and PIPs, wrists) aimed at evaluating inflammatory features (synovial effusion and hypertrophy, power Doppler-PD), scored through a semi-quantitative scale (0-3). The total US (0-198) and PD (0-66) scores were calculated. We scanned bilateral flexor (I-V fingers of hands) and extensor compartments (1-6) tendons: tenosynovitis was scored as absent/present (0/1), resulting in a total score ranging from 0 to 22.We studied 102 patients (M/F 15/87; median age 59.2 years, IQR 17.75; median disease duration 144 months, IQR 126), 61 treated with baricitinib and 41 with tofacitinib. At baseline, the median total US score was 18 (IQR 19) and the median PD score 2 (4). We observed a significant reduction in both total and PD US scores at all time-points (p0.0001). At baseline, 75.4% of patients showed tenosynovitis involving at least one tendon, with a median score of 2 (IQR 3.5) significantly decreasing after 24 weeks (p=0.02). At multivariate analysis, PD and tenosynovitis score significantly correlated with changes in DAS28CRP.The present study confirmed the early efficacy of JAKi in RA patients by using US evaluation. Furthermore, we found that power Doppler and tenosynovitis scores could play a predictive role in response to treatment.

Objective Various studies have shown that overweight and obesity are central features of FM, but the real impact of a high BMI on clinical severity in patients with FM is still controversial. The aim of this study was to analyse the relationships between BMI categories and measures of symptom severity and functional impairment using data from a Web-based registry of patients with FM. Methods Adult patients with an ACR 2010/2011 diagnosis of FM underwent a complete physical examination and laboratory tests and were asked to complete a package of questionnaires covering their sociodemographic and treatment details, in addition to the following disease-specific questionnaires: the revised Fibromyalgia Impact Questionnaire (FIQR), the modified Fibromyalgia Assessment Status questionnaire (ModFAS) and the Polysymptomatic Distress Scale (PDS). Results A total of 2339 patients were recruited and divided into two weight categories, underweight/normal (U/N, n = 1127, 48.2%) and overweight/obese (O/O, n = 1212, 51.8%). The total and subscales of FIQR, ModFAS and PSD scores were significantly higher in the O/O patients, as were all the mean scores of the individual FIQR items (P Conclusion Our findings demonstrate that O/O patients with FM are significantly more impaired than U/N patients in all the symptomatological and functional domains as measured using the FIQR, ModFAS and PDS, thus suggesting that being O/O has an additional effect on symptoms and function.

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

SARS-CoV-2 vaccines appear to be the most promising strategy for fighting the virus and protecting also those who might be at higher risk of severe COVID-19, such as patients with rheumatic and musculoskeletal diseases (RMDs). However, vaccine hesitancy might greatly impair the possibility to reach herd immunity and curtail the virus.1 2 As underlined by some studies performed before vaccine availability, a non-negligible proportion of subjects among the general population would have refused vaccination against COVID-19.3 4 During the first weeks of the ongoing vaccination campaign, we proposed an online survey to adult patients with RMDs residing in the Lazio region followed up at our tertiary referral centre in Rome, Italy. Healthy controls (HCs) were recruited using the ‘best friend’ system. Participants had to report on eight different domains with two possible answers: ‘yes’ or ‘no’ (table 1). View this table: Table 1 Multivariable models predicting willingness to receive COVID-19 vaccination and other SARS-CoV-2 and/or vaccine-related outcomes in patients with RMDs and healthy controls Only for the item ‘Willingness to receive COVID-19 vaccination’, answers were ‘yes’ or ‘no/don’t know’, with the possibility to give an explanation in case …

The aim of the study was to investigate the presence of subclinical vascular damage in polymyalgia rheumatica (PMR). We enrolled PMR patients having major cardiovascular risk factors (MCVRF) and, as controls, patients with MCVRF. All underwent: color Doppler ultrasound to evaluate the common carotid intima-media thickness (IMT), the anterior–posterior abdominal aortic diameter (APAD), and the prevalence of carotid artery stenosis; the cardio-ankle vascular index (CAVI) to measure arterial stiffness together with the ankle-brachial index (ABI) to investigate the presence of lower-extremity peripheral arterial disease. Finally, we measured the serum levels of adipocytokines implicated in vascular dysfunction. As a result, 48 PMR and 56 MCVRF patients were included. An increase of IMT (1.07/0.8–1.2 vs 0.8/0.8–1.05; p = 0.0001), CAVI (8.7/7.8–9.3 vs 7.6/6.9–7.8; p 2 = 0.845 and r2 = 0.556, respectively; p

We thank Konstantinos Parperis for his correspondence to our letter ‘To consider or not antimalarials as a prophylactic intervention in the SARS-CoV-2 (Covid-19) pandemic’ speculating on prophylactic use of antimalarials for subjects at high risk of getting infected by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).1 2 As the author highlights, at this time, it is preferable to be cautious when addressing this topic. These days, the scientific information is moving faster than usual, and new data are available every day; however, the scientific evidence collected to …

We thank Sergei Moiseev and colleagues for their comment in response to our letter ‘To consider or not antimalarials as a prophylactic intervention in the SARS-CoV-2 (Covid-19) pandemic’.1 2 Antimalarial drugs hydroxychloroquine (HCQ) and chloroquine have been largely used for treating patients with systemic lupus erythematosus and other autoimmune rheumatic diseases (ARDs) for decades, and they are safe and well tolerated in such patients.3 Conversely, there is still little evidence on their effectiveness in patients with Covid-19. As Moiseev and colleagues have pointed out, more data have been published after the submission of our letter; therefore, we welcome the opportunity to give an update. The results of five studies are now available: three open-label and two randomised controlled trials4–8 (table 1). All studies have small sample sizes and enrolled non-critically ill patients. Gautret et al extended their previous results confirming the fast reduction of viral load in 80 hospitalised Covid-19 patients treated …

Rheumatoid arthritis (RA) is a systemic, autoimmune disease characterized by joint involvement, with progressive cartilage and bone destruction. Genetic and environmental factors determine RA susceptibility. In recent years, an increasing number of studies suggested that diet has a central role in disease risk and progression. Several nutrients, such as polyunsaturated fatty acids, present anti-inflammatory and antioxidant properties, featuring a protective role for RA development, while others such as red meat and salt have a harmful effect. Gut microbiota alteration and body composition modifications are indirect mechanisms of how diet influences RA onset and progression. Possible protective effects of some dietary patterns and supplements, such as the Mediterranean Diet (MD), vitamin D and probiotics, could be a possible future adjunctive therapy to standard RA treatment. Therefore, a healthy lifestyle and nutrition have to be encouraged in patients with RA.

Rheumatoid arthritis (RA) is a chronic inflammatory disease with increased risk of cardiovascular events and mortality that can be attributed to accelerated atherosclerosis. This pilot study aimed to investigate if changes in blood parameters were compatible with atherosclerotic events in RA patients. To this aim, 45 RA women (aged more than 18 years), and 25 age and gender-matched healthy donors (HD) were included. Biomarkers of oxidative stress, platelet activation and platelet aggregation were analysed in RA patients at baseline and after six months of treatment with disease modifying anti-rheumatic drugs (DMARDs). Flow cytometry analysis revealed that ca. 4% of platelets was in activated state (evaluated in term of Annexin V and PAC-1 positivity) in RA patients at baseline, and that the 76% of platelets displayed mitochondrial hyperpolarization. Moreover, platelets from RA patients at baseline aggregated more than those from HD after whole blood treatment with adenosine diphosphate. Interestingly, platelet aggregation in patients at baseline positively correlated with disease activity measured by DAS28 score. After six months of treatment with DMARDs, platelet activation and platelet aggregation reached values comparable to those of HD. Our preliminary data suggest that platelets might play an active role in the atherosclerosis occurring in RA patients.

In the last decades of the Fascist regime, women’s illustrated magazines (rotocalchi) incorporated and spread models of femininity coming from abroad, which coexisted with the Fascist ideal of the ...

In a previous report of two married cohabiting couples affected by polymyalgia rheumatica (PMR), we noticed that the wife of one couple and both members of the other couple suffered from symptomatic diverticular disease (DD), whose diagnosis was made before the onset of PMR. We investigated whether DD might be a risk factor for the development of PMR. We conducted a case-control study informed on a database containing the prospectively collected medical records of consecutive PMR patients. Among comorbidities, attention was focused on symptomatic DD, provided that the diagnosis had been made by colonoscopy and/or computed tomography scan. As controls, we identified one control per case at random among those matched by age and sex attending the ophthalmic and orthopedic outpatient clinics, as long as a PMR diagnosis had been excluded. A logistic regression model was used, following a multiplicative model, and results were presented as odds ratio (OR) and 95% confidence intervals (95% CI). The most frequent comorbidities in the two groups of patients (121 cases and 121 controls) were chronic coronary artery disease, atrial fibrillation, diabetes mellitus, hypertension, DD, hypercholesterolemia, osteoporosis, chronic obstructive pulmonary disease, gastroesophageal reflux disease, and cholelithiasis. The association between PMR and DD (OR = 4.06; 95% CI: 1.76-9.35) was by far stronger than that found comparing PMR with the other comorbidities. The chronic bowel inflammation induced by dysbiosis in patients with symptomatic DD could be a critical immunopathological mechanism supporting the development or exacerbation of PMR in susceptible individuals.

These days, the entire scientific community is facing the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) emergency, characterised last 11 March by WHO as a pandemic. Social behaviour modification measures may somehow limit the spreading of the infection. However, in the case of an extremely contagious pathogen, the huge number of infected people may be a challenge for the health system. What if there was a prophylactic drug? In the light of their in vitro effect and early clinical results, antimalarial drugs chloroquine (CQ) and hydroxychloroquine (HCQ) have been proposed for patients with SARS-CoV2-related pneumonia (Covid-19) and are now included in the Chinese guidelines for the management of Covid-19 (version 7, 3 March 2020). Antiviral activity of antimalarials has been known for more than 10 years (see online supplementary text).### Supplementary data [annrheumdis-2020-217367supp001.pdf] Recently, Wang et al demonstrated that at low micromolar concentration CQ was …

Lung involvement is related to the natural history of anti-citrullinated proteins antibodies (ACPA)-positive rheumatoid arthritis (RA), both during the pathogenesis of the disease and as a site of disease-related injury. Increasing evidence suggests that there is a subclinical, early lung involvement during the course of the disease, even before the onset of articular manifestations, which can potentially progress to a symptomatic interstitial lung disease. To date, reliable, non-invasive markers of subclinical lung involvement are still lacking in clinical practice. The aim of this study is to evaluate the diagnostic potential of functional assessment and serum biomarkers in the identification of subclinical lung involvement in ACPA-positive subjects. Fifty ACPA-positive subjects with or without confirmed diagnosis of RA (2010 ARC-EULAR criteria) were consecutively enrolled. Each subject underwent clinical evaluation, pulmonary function testing (PFT) with assessment of diffusion lung capacity for carbon monoxide (DLCO), cardiopulmonary exercise testing (CPET), surfactant protein D (SPD) serum levels dosage and high-resolution computed tomography (HRCT) of the chest. The cohort was composed of 21 ACPA-positive subjects without arthritis (ND), 10 early (disease duration &lt, 6 months, treatment-na&iuml, ve) RA (ERA) and 17 long-standing (disease duration &lt, 36 months, on treatment) RA (LSRA). LSRA patients had a significantly higher frequency of overall HRCT abnormalities compared to the other groups (p = 0.001). SPD serum levels were significantly higher in ACPA-positive subjects compared with healthy controls (158.5 &plusmn, 132.3 ng/mL vs 61.27 &plusmn, 34.11 ng/mL, p &lt, 0.0001) and showed an increasing trend from ND subjects to LSRD patients (p = 0.004). Patients with HRCT abnormalities showed significantly lower values of DLCO (74.19 &plusmn, 13.2% pred. vs 131.7 &plusmn, 93% pred., p = 0.009), evidence of ventilatory inefficiency at CPET and significantly higher SPD serum levels compared with subjects with no HRCT abnormalities (213.5 &plusmn, 157.2 ng/mL vs 117.7 &plusmn, 157.3 ng/mL, p = 0.018). Abnormal CPET responses and higher SPD levels were also associated with specific radiological findings. Impaired DLCO and increased SPD serum levels were independently associated with the presence of HRCT abnormalities. Subclinical lung abnormalities occur early in RA-associated autoimmunity. The presence of subclinical HRCT abnormalities is associated with several functional abnormalities and increased SPD serum levels of SPD. Functional evaluation through PFT and CPET, together with SPD assessment, may have a diagnostic potential in ACPA-positive subjects, contributing to the identification of those patients to be referred to HRCT scan.

We aimed to investigate whether small-fibre pathology, a common skin biopsy finding in patients with fibromyalgia, implies clinically important abnormalities of somatosensory system function and verify whether it is associated with voltage-gated sodium channel variants. In 57 consecutively enrolled patients with fibromyalgia, we used skin biopsy to distinguish patients with and without small-fibre pathology. In all patients, we assessed somatosensory system function using quantitative sensory testing (QST) and laser-evoked potentials and investigated voltage-gated sodium channel genotyping. We then compared these variables in patients with and without small-fibre pathology. We found that clinical measures, QST, and laser-evoked potential variables did not differ between patients with and without small-fibre pathology. In most patients with small-fibre pathology, QST and laser-evoked potential variables fell within normative ranges commonly used in clinical practice. Of the 57 patients, one patient without small-fibre pathology and 2 patients with small-fibre pathology had rare variants of voltage-gated sodium channels, namely SCN11A, SCN9A, and SCN1A variants. The SCN9A variant, found in a patient with small-fibre pathology, was an already profiled gain-of-function mutation, previously reported in small-fibre neuropathy. Our findings suggest that small-fibre pathology has a negligible impact on somatosensory system function in fibromyalgia. The genetic analysis suggests that patients with rare small-fibre neuropathy due to voltage-gated sodium channel variants may be misdiagnosed as patients with fibromyalgia.

Background The introduction of TNF inhibitors have revolutionized the outcome of patients affected by Rheumatoid Arthritis (RA). In the last years, pharmaco-economic implications determined the introduction of biosimilar as alternative to originator biological drugs. Phase I and head-to-head phase III clinical studies demonstrated pharmacokinetic equivalence and comparability in terms of efficacy, safety, immunogenicity and tolerability. However, biosimilar drugs demonstrated some differences related to charge and glycosylation, not influencing the function and the ability to bind the soluble TNF. To date, very few data are available concerning the use of biosimilar drugs in a real-life setting. Results from DANBIO registry suggested a lower retention rate in RA patients switchers from Etanercept originator (ETA) to biosimilar (SB4) versus the historic ETA cohort and higher in comparison with historic SB4 patients (1). Objectives To compare the efficacy of ETA versus SB4 in a cohort of RA patients in a real life setting. Methods In this monocentric case-control prospective study, we consecutively enrolled RA patients starting ETA or SB4 treatment from 2015. RA diagnosis was made according with ACR/EULAR 2010 criteria (2). Data were collected and entered into a standardized, computerized, electronically filled-in form. We included patient demographics, date of diagnosis, comorbidities and previous and concomitant medications. The clinical evaluation included the count of swollen and tender joints and the patient‘s and physician’s global disease assessment based on a visual analogue scale (VAS; range, 0 to 100 mm). Disease activity was measured according to the disease activity score in 28 joints (DAS28ESR) (3). The patients were asked to fill in the Health Assessment Questionnaire (HAQ). All the patients were evaluated at the beginning of treatment (T0) and after 4 (T1) and 12 months (T2). Clinical response to treatment was evaluated by using EULAR criteria (4). Results We evaluated 35 RA patients treated with SB4 (M/F 2/33; median age 63 years, IQR 21; median disease duration 108 months, IQR 138) and 40 with ETA (M/F 5/35; median age 60.5 years, IQR 20; median disease duration 102 months, IQR 141). Biologic drug was prescribed as first-line biological treatment in 71.4% of SB4 cohort and in 80.0% of ETA. At T0 no significant differences were observed among the two groups in terms of DAS28ESR [SB4 median 4.6 (IQR 1.8), ETA 4.3 (IQR 1.9), p=ns] and HAQ [SB4: median 1 (IQR 1.05), ETA median 1 (IQR 0.85), p=ns]. In both groups we observed a significant reduction of DAS28 values at T1 (BS4 p=0.01; ETA p Conclusion The results of our study confirmed in a real-life setting the efficacy of SB4 in RA patients, as demonstrated by the significant reduction of DAS28ESR values after 4 and 12 months of treatment, similarly to ETA. Nonetheless, ETA seems to be able to induce a remission status earlier than SB4. References [1] Glintborg B, et al. Ann Rheum Dis. 2018 [2] Aletaha D, et al. Arthritis Rheum. 2010 [3] Anderson JK, et al. Arthritis Care Res. 2011 [4] van Gestel AM, et al. Arthritis Rheum. 1996 Disclosure of Interests Ramona Lucchetti: None declared, Fulvia Ceccarelli: None declared, Carlo Perricone Speakers bureau: BMS; Lilly, Celgene, Sanofi, Simona Truglia: None declared, Francesca Miranda: None declared, Manuela Di Franco: None declared, Valeria Riccieri: None declared, Rossana Scrivo: None declared, Antonio Sili Scavalli: None declared, francesca spinelli: None declared, cristiano alessandri: None declared, Guido Valesini: None declared, Roberta Priori: None declared, fabrizio conti: None declared

Background Rheumatoid arthritis (RA) is more prevalent in women than men (F:M=4:1), due to hormonal, genetic and environment factors. Women present higher disease activity markers as Disease Activity Score-28 (DAS28) and Health Assessment Questionnaire (HAQ), at the onset and after c-DMARDs therapy, without correlation with radiographic damage. Objectives The purpose of this study was to assess gender differences in RA patients after anti- tumor necrosis factor (TNF) α treatment. Methods Ninety-six patients were enrolled at the beginning of anti-TNF α therapy (etanercept and adalimumab). All patients satisfied 1987 and 2010 ACR criteria for RA. They underwent to clinical and clinimetric evaluation at baseline (T0) and after three (T3) and six (T6) months of therapy with: tender and swollen joints, Visual Analogic Scale (VAS) pain, VAS patient and physician, DAS28, Clinical/Simplified clinical disease activity index (CDAI/SDAI) and HAQ. The evaluation of erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Rheumatoid Factor (RF) and anti-citrullinated protein antibody (ACPA) was performed in all patients. Results Among these patients, 70 were women and 26 men; 81 patients (58 female, 23 male) started etanercept and 15 adalimumab (12 female, 3 male). They presented a mean age of 56.4 ± 14.5 years (women 55.2 ± 15.4, men 60 ± 11.2) and mean disease duration of 11 ± 6.8 years (woman 11.51 ± 6.3, men 9.6 ± 8.1). Both women and men had a DAS28 reduction after 3 and 6 months therapy (p Conclusion In this study, both women and men had a good response to anti-TNF treatment but women presented worse clinical response. Female gender resulted the only variable associated with DAS28 reduction differences. We could hypothesize that beyond to biological factors, also social contest, daily life and work activity could explain a worse impact of disease on women. References [1] Neovius M, Ann Rheum Dis 2011; [2] O.L. Quintero, et al., Journal of Autoimmunity 2012. [3] M Ahlm aen, Ann Rheum Dis 2010. [4] Jawaheer, et al, The Journal of Rheumatology 2010. [5] Jawaheer, et al, The Journal of Rheumatology 2012. [6] Arnett FC, Arthritis Rheum 1988. [7] Aletaha D, Arthritis Rheum 2010. Disclosure of Interests None declared

Introduction: Pregabalin is indicated for the treatment of fibromyalgia and pregabalin-treated subjects have shown improved pain, sleep and functional measures in placebo-controlled and open-label studies. This article reviews pregabalin’s safety profile.Areas covered: The safety findings in pregabalin clinical trials were accessed by a PubMed search using the key words ‘pregabalin’ or ‘anti-epilectics drug’ or ‘gabapentinoids’ or ‘anticonvulsants’ and ‘fibromyalgia’. Although frequent, the side effects of pregabalin therapy are usually mild to moderate, well tolerated in the long term, and can be monitored in a primary care setting.Expert opinion: Pregabalin therapy may be associated with somnolence, dizziness, weight gain and periphereal edema. Potential drug interactions are not common, and pregabalin seems to be well tolerated in combination with antidepressants. The demonstrated efficacy of pregabalin suggests that the risk/benefit ratio favours its use.

Objectives Autophagy may represent a functional processing event that creates a substrate for autoreactivity. In particular, autophagy may play a role in the pathogenesis of RA, since autophagy is a key cellular event involved in the generation of citrullinated peptides, with consequent breakage of tolerance. Thus, in RA, autophagy may be the common feature in several situations (including smoking, joint injury and infection) that may drive the adaptive responses to citrullinated self-proteins. The aim of this study was the analysis, in vitro, of the role of autophagy in the generation of citrullinated peptides and, in vivo, of the relationship between autophagy and the production of anti-CCP antibodies (Abs). Methods For autophagy induction, fibroblast-like synoviocytes, primary fibroblasts and monocytes were stimulated with tunicamycin or rapamycin. Peptidyl arginine deiminase activity was tested by enzyme-linked immunosorbent assay, and protein citrullination was evaluated by western blotting. The main citrullinated RA candidate antigens, vimentin, α-enolase and filaggrin, were demonstrated by immunoprecipitation. The relationship between autophagy and anti-CCP Abs was analysed in 30 early-active RA patients. Results Our results demonstrated in vitro a role for autophagy in the citrullination process. Cells treated with tunicamycin or rapamycin showed peptidyl arginine deiminase 4 activation, with consequent protein citrullination. Immunoblotting and immunoprecipitation experiments, using specific Abs, identified the main citrullinated proteins: vimentin, α-enolase and filaggrin. In vivo, a significant association between levels of autophagy and anti-CCP Abs was observed in treatment-naive early-active RA patients. Conclusion These findings support the view that the processing of proteins in autophagy generates citrullinated peptides recognized by the immune system in RA.

Fibromyalgia is a chronic disorder whose symptoms have a devastating effect on patients' lives as they limit their ability to engage in everyday working and social activities, and make it difficult to maintain normal relationships with family, friends and employers. None of the currently available drugs are fully effective against the whole spectrum of symptoms of pain, fatigue, sleep disturbances and depression, but increasing efforts by the pharmaceutical industry have led to the introduction of new investigational drugs and new formulations of older drugs, as well as studies of the possibility of applying drugs currently used for other diseases. The aim of this review is to summarise the data relating to the new therapeutic options that have become available over the last few years.