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Objective To describe people with gout who were diagnosed with coronavirus disease 2019 (COVID-19) and hospitalized and to characterize their outcomes. Methods Data on patients with gout hospitalized for COVID-19 between March 12, 2020, and October 25, 2021, were extracted from the COVID-19 Global Rheumatology Alliance registry. Descriptive statistics were used to describe the demographics, comorbidities, medication exposures, and COVID-19 outcomes including oxygenation or ventilation support and death. Results One hundred sixty-three patients with gout who developed COVID-19 and were hospitalized were included. The mean age was 63 years, and 85% were male. The majority of the group lived in the Western Pacific Region (35%) and North America (18%). Nearly half (46%) had two or more comorbidities, with hypertension (56%), cardiovascular disease (28%), diabetes mellitus (26%), chronic kidney disease (25%), and obesity (23%) being the most common. Glucocorticoids and colchicine were used pre-COVID-19 in 11% and 12% of the cohort, respectively. Over two thirds (68%) of the cohort required supplemental oxygen or ventilatory support during hospitalization. COVID-19-related death was reported in 16% of the overall cohort, with 73% of deaths documented in people with two or more comorbidities. Conclusion This cohort of people with gout and COVID-19 who were hospitalized had high frequencies of ventilatory support and death. This suggests that patients with gout who were hospitalized for COVID-19 may be at risk of poor outcomes, perhaps related to known risk factors for poor outcomes, such as age and presence of comorbidity.

L’artirite reumatoide (AR) è la più diffusa patologia autoimmune in Italia con elevati costi terapeutici e previdenziali associati. Questa patologia colpisce circa lo 0.5-1% della popolazione adulta, prevalentemente di genere femminile. Essendo una patologia degenerativa, i cui danni sono frequentemente irreversibili, una diagnosi precoce così come un adeguato trattamento ed un elevato livello di compliance del paziente allo stesso, potrebbero rallentare il peggioramento della malattia. Inoltre sono poco noti i possibili effetti della malattia e del suo trattamento sulle gravidanze e i successivi outcome gravidici. I principali obiettivi della tesi quindi sono: i) valutare l’aderenza alle linee guida per il trattamento dell’ AR da parte dei clinici, ii) valutare l’aderenza al trattamento per AR da parte del paziente, iii) stimare costo ed efficacia delle cure erogate nelle cliniche specializzate per il trattamento di pazienti con AR, iv) analizzare gli esiti gravidici e il raggiungimento della gravidanza in donne con AR trattate con metotrexate (MTX). La prima tematica ha riguardato la valutazione di come sono state implementate le linee guida della European Alliance of Associations for Rheumatology (EULAR) per il trattamento dell’AR e l’impatto dell’aderenza a queste linee guida sulla probabilità di ospedalizzazione. I principali risultati di questo studio hanno mostrato come i pazienti con un’ottima aderenza alle linee guida, se confrontati con quelli con bassa aderenza, abbiano un rischio del 24% inferiore di incorrere in ospedalizzazione. La seconda tematica ha riguardato la valutazione dell’impatto dell’aderenza al trattamento con Disease-Modifying Anti-Rheumatic Drugs (DMARDs), terapia suggerita dall’EULAR, sul raggiungimento della remissione clinica di malattia. I dati provengono dal database ELECTRA (con informazioni cliniche e provenienti da database amministrativi) di pazienti con AR trattati presso l’IRCCS Policlinico San Matteo (Pavia). Si è osserva, Rheumatoid arthritis (RA) is, in Italy, the most widespread autoimmune disease with high associated costs for the National Health Service. This disease affects about 0.5-1% of the adult population, mainly of the female gender. Being a degenerative disease, whose damages are frequently irreversible, an early diagnosis as well as an adequate treatment and a high level treatment compliance of the patient, could slow down the worsening of the disease. Furthermore, the possible effects of RA and its treatment on pregnancies and subsequent pregnancy outcomes are not well known. The main objectives of the thesis are therefore: i) to evaluate the adherence to guidelines for the treatment of RA, ii) to evaluate the patient's adherence to RA treatment, iii) to estimate the cost and effectiveness of care provided in specialized clinics for the treatment of RA patients, iv) to analyze pregnancy outcomes and the likelihood of achieving pregnancy in women with RA treated with methotrexate (MTX). The first issue concerned the assessment of how the guidelines of the European Alliance of Associations for Rheumatology (EULAR) for the treatment of RA have been implemented, and the impact of adherence to these guidelines on the probability of hospitalization. The main results of this study showed that patients with excellent adherence to guidelines, when compared with those with low adherence, have a 24% lower risk of hospitalization. The second topic concerned the evaluation of the impact of adherence to treatment with Disease-Modifying Anti-Rheumatic Drugs (DMARDs), the therapy suggested by EULAR, on the achievement of disease clinical remission (defined as a substantial decrease or absence of symptoms). The ELECTRA database, which contains clinical information and information from administrative databases of RA patients treated at the IRCCS Policlinico San Matteo (Pavia), was considered for the analysis. The main finding showed that a 10-unit percentage increase in proportion of day

Objective As part of European League against Rheumatism (EULAR)/European Musculoskeletal Conditions Surveillance and Information Network, 20 user-focused standards of care (SoCs) for rheumatoid arthritis (RA) addressing 16 domains of care were developed. This study aimed to explore gaps in implementation of these SoCs across Europe.Methods Two cross-sectional surveys on the importance, level of and barriers (patients only) to implementation of each SoC (0-10, 10 highest) were designed to be conducted among patients and rheumatologists in 50 European countries. Care gaps were calculated as the difference between the actual and maximum possible score for implementation (ie, 10) multiplied by the care importance score, resulting in care gaps (0-100, maximal gap). Factors associated with the problematic care gaps (ie, gap >= 30 and importance >= 6 and implementation= 6) were further analysed in multilevel logistic regression models.Results Overall, 26 and 31 countries provided data from 1873 patients and 1131 rheumatologists, respectively. 19 out of 20 SoCs were problematic from the perspectives of more than 20% of patients, while this was true for only 10 SoCs for rheumatologists. Rheumatologists in countries with lower gross domestic product and non-European Union countries were more likely to report problematic gaps in 15 of 20 SoCs, while virtually no differences were observed among patients. Lack of relevance of some SoCs (71%) and limited time of professionals (66%) were the most frequent implementation barriers identified by patients.Conclusions Many problematic gaps were reported across several essential aspects of RA care. More efforts need to be devoted to implementation of EULAR SoCs.

Background: Multimorbidity is a growing concern for healthcare systems, with many countries experiencing demographic transition to older population profiles. A simple multisource comorbidity score (MCS) has been recently developed and validated. A very large real-world investigation was conducted with the aim of measuring inequalities in the MCS distribution across Italy. Methods: Beneficiaries of the Italian National Health Service aged 50-85 years who in 2018 were resident in one of the 10 participant regions formed the study population (15.7 million of the 24.9 million overall resident in Italy). MCS was assigned to each beneficiary by categorizing the individual sum of the comorbid values (i.e. the weights corresponding to the comorbid conditions of which the individual suffered) into one of the six categories denoting a progressive worsening comorbidity status. MCS distributions in women and men across geographic partitions were compared. Results: Compared with beneficiaries from northern Italy, those from centre and south showed worse comorbidity profile for both women and men. MCS median age (i.e. the age above which half of the beneficiaries suffered at least one comorbidity) ranged from 60 (centre and south) to 68 years (north) in women and from 63 (centre and south) to 68 years (north) in men. The percentage of comorbid population was lower than 50% for northern population, whereas it was around 60% for central and southern ones. Conclusion: MCS allowed of capturing geographic variability of multimorbidity prevalence, thus showing up its value for addressing health policy in order to guide national health planning.

Idiopathic inflammatory myopathies (IIMs) encompass a heterogeneous group of rare autoimmune diseases characterised by muscle weakness and inflammation, but in antisynthetase syndrome arthritis and interstitial lung disease are more frequent and often inaugurate the disease. Clinical practice guidelines (CPGs) have been proposed for IIMs, but they are sparse and heterogeneous. This work aimed at identifying: i) current available CPGs for IIMs, ii) patients' and clinicians' unmet needs not covered by CPGs. It has been performed in the framework of the European Reference Network on rare and complex connective tissue and musculoskeletal diseases (ReCONNET), a network of centre of expertise and patients funded by the European Union's Health Programme. Fourteen original CPGs were identified, notably recommending that: i) extra-muscular involvements should be assessed; ii) corticosteroids and methotrexate or azathioprine are first-line therapies of IIMs. iii) IVIG is a treatment of resistant-DM that may be also used in other resistant-IIMs; iv) physical therapy and sun protection (in DM patients) are part of the treatment; v) tumour screening for patients with DM include imaging of chest, abdomen, pelvis and breast (in woman) along with colonoscopy (in patients over 50 years); vi) disease activity and damages should be monitor using standardised and validated tools. Yet, only half of these CPGs were evidence-based. Crucial unmet needs were identified both by patients and clinicians. In particular, there was a lack of large multidisciplinary working group and of patients' preferences. The following fields were not or inappropriately targeted: diagnosis; management of extra-muscular involvements other than skin; co-morbidities and severe manifestations.

The prevalence of ANA and anti-ENA in the general population is not well established, especially their clinical significance in healthy subjects. We herein determined the prevalence and predictive value of serum ANA and anti-ENA for connective tissue diseases (CTD), cancer, and mortality. We took advantage of a randomly selected sample of the 1998 general population (Isola I) consisting of 2828 subjects (53% women, age 43 ± 13 years) from a well-defined Northern Italian area. Serum ANA and anti-ENA were tested on the 2690 samples available in 2012 (Isola II, 50% women, age 58 ± 13 years). Administrative databases were searched for CTD, cancer diagnosis, and death cases occurring between enrollment and December 31, 2013. The hazard ratio (HR) was calculated for incident cases. Serum ANA is positive in 18.1% for any titer and 6.1% for titers ≥ 1:160, 23% in subjects over 50 years and 13.1% and 6.1% for any titer and titers ≥ 1:160, respectively, in women. The HR for CTD development was significantly high for all ANA titers, with the highest for ANA ≥ 1:160 (HR 14.19, 95% CI 3.07-65.68). ANA positivity was not associated with cancer (HR 1.03; 95% CI 0.75-1.43), or with mortality (HR adjusted for age and sex 1.40; 95% CI 0.94-2.09). Serum anti-ENA is positive in a minority of subjects with highest figures for anti-nucleosome (1.9%), -histone (1.6%) and -PM/Scl (1.5%). In conclusion, serum ANA prevalence in the general population is highest in senior subjects and in women, while the female predominance is significantly lower compared to overt CTD. Serum ANA is associated with an increased probability of CTD development over time, but does not influence survival or cancer risk.

At present, growing scientific evidence from the medical literature and expert opinion provides strong consideration for a mandatory role of glucocorticoids (GCs) in the management of rheumatoid arthritis (RA). Earlier application strategies were based on initial high doses, with subsequent tapering schedules, resulting in dose-related side effects. Recent low-dose GC schemes are more feasible in routine care, while providing evidence of clinical, functional and structural efficacy. Thus, initial low-dose GC 'bridging' treatment on a disease- modifying antirheumatic drug background should be included in any existing recommendations for RA management, as very recently advocated by the EULAR Task Force 2013 updated guidelines. Long-term low-dose therapy appears to provide acceptable safety, leading to long-standing slowing of structural damage, seen even after GC therapy withdrawal. Gaps in knowledge about the optimal method to taper and possibly discontinue GC treatment remain, and this topic should be addressed in clinical trials and observational studies. Recent efforts in GC medication have also included the introduction of a modified-release drug formulation capable of drug delivery consistent with chronobiological pathogenetic rhythms of disease, which has been quite efficacious in controlling the signs and symptoms related to pathways of circadian cytokines. Long-term data will further clarify the add-on benefits of such modified-release formulations.

Objectives: This study aimed to evaluate whether the early achievement of clinical remission influences overall survival in an inception cohort of patients with inflammatory polyarthritis (IP). Methods: Consecutive early IP patients, recruited to a primary care based inception cohort from 1990 to 1994 and from 2000 to 2004 were eligible for this study. Remission was defined as absence of clinically detectable joint inflammation on a 51-joint count. In sensitivity analyses, less stringent de finitions of remission were used, based on 28-joint counts. Remission was assessed at 1, 2 and 3 years after baseline. All patients were flagged with the national death register. Censoring was set at 1 May 2011. The effect of remission on mortality was analysed using the Cox proportional hazard regression model, and presented as HRs and 95% CIs. Results: A total of 1251 patients were included in the analyses. Having been in remission at least once within the first 3 years of follow-up was associated with a significantly lower risk of death: HR 0.72 (95% CI 0.55 to 0.94). Patients who were in remission 1 year after the baseline assessments and had persistent remission over time had the greatest reduction in mortality risk compared with patients who never achieved remission within the first 3 years of follow-up: HR 0.58 (95% CI 0.37 to 0.91). Remission according to less stringent definitions was associated with progressively lower protective effect. Conclusions: Early and sustained remission is associated with decreased all-cause mortality in patients with IP. This result supports clinical remission as the target in the management of IP.

As our understanding of the pathogenesis of autoimmune diseases is growing, new therapies are being developed to target disease-specific pathways. Since the introduction of etanercept in 1998, several biotechnological agents have been developed, most of them indicated in the treatment of rheumatoid arthritis, but also psoriatic arthritis. Most currently available molecules target TNF-alfa with different strategies (i.e., etanercept, infliximab, adalimumab, golimumab, and certolizumab pegol), IL-6 (tocilizumab), CTLA-4 (abatacept), and B cells (rituximab, belimumab) as they are key mediators in the cascade of inflammation. Further, small molecules have been recently developed to target intracellular signaling, such as Janus Kinases for tofacitinib, the first FDA-approved small molecule for rheumatoid arthritis. Most novel treatments are being developed for arthritis with specific differences between rheumatoid and psoriatic arthritis, as well as for systemic lupus erythematosus, following the approval of belimumab. Finally, biologic therapies are effective also in gout, mainly targeting interleukin-1 to block the inflammasome. This review article describes the new and upcoming treatment options for rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, and gout to dissect what we should be aware of when discussing these new and promising molecules.

Background: Eumusc.net (http://www.eumusc.net) is a European project supported by the EU and European League Against Rheumatism to improve musculoskeletal care in Europe. Objective: To develop patient-centred healthcare quality indicators (HCQIs) for healthcare provision for rheumatoid arthritis (RA) patients. Methods: Based on a systematic literature search, existing HCQIs for RA were identified and their contents analysed and categorised referring to a list of 16 standards of care developed within the eumusc.net. An international expert panel comprising 14 healthcare providers and two patient representatives added topics and during repeated Delphi processes by email ranked the topics and rephrased suggested HCQIs with the preliminary set being established during a second expert group meeting. After an audit process by rheumatology units (including academic centres) in six countries (The Netherlands, Norway, Romania, Italy, Austria and Sweden), a final version of the HCQIs was established. Results: 56 possible topics for HCQIs were processed resulting in a final set of HCQIs for RA (n=14) including two for structure (patient information and calculation of composite scores), 11 for process (eg, access to care, assessments, and pharmacological and nonpharmacological treatments) and one for outcome (effect of treatment on disease activity). They included definitions to be used in clinical practice and also by patients. Further, the numerators and the denominators for each HCQI were defined. Conclusions: A set of 14 patient-centred HCQIs for RA was developed to be used in quality improvement and bench marking in countries across Europe.

Objective: To compare drug survival of different anti-TNF drugs (inliximab, INF, etanercept, ETA, and adalimumab, ADA) in rheumatoid arthritis (RA) and spondyloarthritis (SpA) by analysing data collected from an Italian multicentre observational cohort study.Methods: All patients with RA or SpA registered in the MonitorNet database who started their irst course of anti-TNF therapy were included.Overall drug survival was measured, along with speciic reasons of discontinuation (ineficacy or adverse events).A first set of analyses using RA as reference category assessed the relationship between diagnosis and drug survival.A second set of analyses stratiied by diagnosis (RA and SpA) used INF as reference drug.Adjustment for confounders was performed.The results are presented as adjusted hazard ratios (adjHR) and 95% conidence intervals (95%CI).Results: 2640 RA patients and 1220 SpA patients with a median follow-up of 17 months (IQR 7.2-33.4) were included in the analyses.Patients with a diagnosis of SpA showed a lower risk of drug discontinuation with an adjHR (95%CI) of 0.81 (0.73, 0.90).In SpA, the subset of patients with ankylosing spondylitis (AS) showed the best survival on treatment.In RA, both ETA and ADA showed a signiicantly lower probability of withdrawal when compared to INF [adjHR (95%CI) 0.46 (0.38, 0.56) and 0.68 (0.57, 0.81), respectively].Similar results were found in SpA.Conclusion: Drug survival for SpA is longer than that in RA mainly due to the AS subgroup.In both RA and SpA, ETA and ADA showed a better retention on treatment when compared to INF.

Objective: Gout is the most common arthritis in adults. Despite the availability of valid therapeutic options, the management of patients with gout is still suboptimal. The Italian Society of Rheumatology (SIR) aimed to update, adapt to national contest and disseminate the 2006 EULAR recommendations for the management of gout. Methods: The multidisciplinary group of experts included rheumatologists, general practitioners, internists, geriatricians, nephrologists, cardiologists and evidence-based medicine experts. To maintain consistency with EULAR recommendations, a similar methodology was utilized by the Italian group. The original propositions were translated in Italian and priority research queries were identified through a Delphi consensus approach. A systematic search was conducted for selected queries. Efficacy and safety data on drugs reported in RCTs were combined in a meta-analysis where feasible. The strength of recommendation was measured by utilising the EULAR ordinal and visual analogue scales. Results: The original 12 propositions were translated and adapted to Italian context. Further evidences were collected about the role of diet in the non-pharmacological treatment of gout and the efficacy of oral corticosteroids and low-dose colchicine in the management of acute attacks. Statements concerning uricosuric treatments were withdrawn and replaced with a proposition focused on a new urate lowering agent, febuxostat. A research agenda was developed to identify topics still not adequately investigated concerning the management of gout. Conclusions: The SIR has developed updated recommendations for the management of gout adapted to the Italian healthcare system. Their implementation in clinical practice is expected to improve the management of patients with gout.

Hand osteoarthritis (OA) is a common and potentially disabling disease, with different features from hip and knee OA so that a specific therapeutic approach is required. Evidence based recommendations for the management of hand OA were developed by the European League Against Rheumatism (EULAR) in 2006. The Italian Society for Rheumatology (SIR) aimed to update, adapt to national contest and disseminate the EULAR recommendations for the management of hand OA. The multidisciplinary group of experts included specialists involved in the management of patients with hand OA. In order to maintain consistency with EULAR recommendations, a similar methodology was utilized by the Italian group. The original propositions were reformulated in terms of a search query and for every recommendation a systematic search was conducted updating EULAR recommendations' review. The propositions were translated in Italian and reformulated basing on collected evidences and expert opinion. The strength of recommendation was measured for each proposition with the EULAR ordinal and visual analogue scales. The original 11 propositions of EULAR recommendations were translated and adapted to Italian context. Further evidences were collected about non-pharmacological therapies, local treatments, intra-articular injection with SYSADOA and corticosteroids, and surgery. The SIR has developed updated recommendations for the management of hand OA adapted to the Italian healthcare system. Their implementation in clinical practice is expected to improve the management of patients with hand OA.

Introduction: Gout is the most prevalent arthritis and significantly impacts on function and quality of life. Given that gout associates with disabling comorbid conditions, it is not clear whether such a complex of diseases accounts for the increased disability or if gout may play a role by itself. This study aims to evaluate the specific influence of gout and disease-related features on functional disability and health-related quality of life (HRQoL) in patients with gout followed in rheumatology clinics.Methods: A random sample of patients was drawn from clinical registries of 30 rheumatology clinics across Italy. Sociodemographic, general health and gout-specific variables were collected. Functional disability and HRQoL were assessed by the health assessment questionnaire (HAQ) and the Physical and Mental Component Summary scores (PCS and MCS) of the Short Form-36 (SF-36). Crude and adjusted ordinal logistic and linear regression models were applied to investigate the specific contribution of different variables on HAQ and SF-36 scores. Results are presented as odds ratio (OR) or mean difference (MD) and 95% confidence intervals.Results: Out of 446 patients with gout, 90% were males with a mean age of 63.9 years and median disease duration of 3.8 years; the majority of patients were overweight or obese, and with several comorbidities; 21.1% showed at least moderate disability; the PCS score was significantly lower than expected age- and gender-matched samples in the general population, while MCS score was not. After adjusting for potential sociodemographic and general-health confounders, gout-specific variables significantly impacted on HAQ, including polyarticular involvement OR 3.82 (1.63, 8.95), presence of tophi OR 1.92 (1.07, 3.43) and recent attacks OR 2.20 (1.27, 3.81). Consistent results were found for PCS. The impairment of PCS compared to the general population was limited to patients with features of chronic gout. MCS was only affected by recent attack

In rheumatoid arthritis (RA), low-dose glucocorticoid (GC) therapy has a well-established effect on disease activity. Particularly in early RA, robust evidence demonstrates that GC treatment in association with standard disease-modifying anti-rheumatic drugs (DMARDs) is effective in inducing high remission rates, earlier and more persistently. Despite international recommendations that discourage long-term concomitant GC use, the majority of the clinical trials and observational registries on biologic agents include a high proportion (up to 80%) of patients in treatment with GC. From an analysis of the literature, a substantial lack of reliable information about the efficacy of GC in association with biologic agents emerges; in particular, the role of GC co-therapy in sustaining remission after biological therapy discontinuation remains to be clarified. Given the increasing prevalence of patients in sustained remission, a rational discontinuation strategy should include low-dose GCs in the experimental design to elucidate their role in inducing and maintaining biologic-free remission, for efficacy, safety and pharmacoeconomic considerations.

Objectives. To perform a systematic review aimed to identify studies addressing the effect of the establishment of a structured organisation programme, named early arthritis clinic (EAC), finalised to manage patients with early arthritis (EA) or suspected early rheumatoid arthritis (ERA). Methods. A literature search was performed until May 2012 using electronic databases. Additional information was obtained through a hand and grey literature search. Primary and secondary outcomes and eligibility criteria have been defined. Results. The search provided a total of 3367 citations and, after the selection process, 11 non randomised controlled trials were selected, including a total of 8240 participants. The efficacy of EAC did clearly emerge with regard to reduction of the referral lag time and of the time to treatment (secondary outcomes). Only two studies met the primary outcomes: one study demonstrated that the EAC contributed to reducing disease activity and radiographic progression but not functional disability, while another reported a reduction of pain after a 6-12-month period of follow-up. Conclusion. Whether the establishment of EAC would improve the prognosis of EA in terms of primary outcomes such as clinical, functional and radiologic progression compared to patients managed outside from EAC does appear a still poorly addressed issue in the literature, which should be recognised as an urgent unmet need by the rheumatology community to gain more evidencebased information on this topic.