Publications by authors named "Alessia Alunno"

150 Publications

The facts and fictions of precision medicine in autoimmune diseases: is machine learning approach the response?

Rheumatology (Oxford) 2021 Sep 17. Epub 2021 Sep 17.

Rheumatology Unit. Department of Medicine and Surgery. University of Perugia, Perugia, Italy.

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http://dx.doi.org/10.1093/rheumatology/keab715DOI Listing
September 2021

EULAR portfolio for Rheumatology training: a EULAR School of Rheumatology initiative.

RMD Open 2021 06;7(2)

Department of Rheumatology, Hospital General Universitario de Elda, Elda, Spain.

Objective: About half of the rheumatology trainees do not use a portfolio. This project was established to reach consensus about the content of a EULAR portfolio for Rheumatology training and subsequently develop portfolio assessment forms.

Methods: After establishing a portfolio working group (WG), including nine rheumatologists and one educationalist, a systematic literature review (SLR) on the content and structure of portfolios for postgraduate learning was conducted (November 2018). This was followed by a survey among WG members and members of the EMerging EUlar NETwork, inquiring about the content and structure of existing national portfolios. The portfolio WG selected the key components of the portfolio, taking previous experience and feasibility into account. Assessment forms (eg, case-based discussion) were developed and pilot-tested.

Results: 13/2034 articles were included in the SLR (12 high/1 moderate risk of bias). Information on procedural skills, personal reflections, learning goals and multisource feedback was most often included a portfolio. Twenty-five respondents completed the survey (response≈50%). Feedback from assessors, reflective writing and formulation of learning goals were considered important dimensions to be covered in a portfolio. Six key components of the portfolio were established: curriculum vitae, personal development plan, clinical work, professional behaviours, education and research activities. Suggested minimal content for each component was formulated. Four assessment forms were successfully pilot-tested by 11 rheumatologists and their trainees.

Conclusion: A EULAR portfolio for Rheumatology training and assessment forms were developed. Portfolio implementation, particularly in countries without an existing portfolio, may promote a higher standard of rheumatology training across Europe.
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http://dx.doi.org/10.1136/rmdopen-2021-001684DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8211044PMC
June 2021

Short-Term Outcomes and Predictors of Effectiveness of Tocilizumab in Systemic Juvenile Idiopathic Arthritis: A Prospective Cohort Study.

Front Med (Lausanne) 2021 10;8:665028. Epub 2021 May 10.

Physical Medicine, Rheumatology and Rehabilitation Department, Faculty of medicine, Kafr El Sheikh University, Kafr el-Sheikh, Egypt.

Systemic Juvenile Idiopathic Arthritis (sJIA) is a unique category of juvenile arthritis in which interleukin 6 plays a major pathogenic role. This study aimed to describe the therapeutic short-term outcomes among patients with sJIA starting tocilizumab (TCZ) therapy and to identify possible predictors of treatment response. We conducted a prospective observational study including 65 patients with sJIA meeting ILAR classification criteria with active disease despite conventional therapy that were treated by TCZ between August 2019 and October 2020 as the first-line biological therapy. Clinical and serological parameters were recorded at baseline and after 1 year of TCZ therapy. After 1 year, 25% of the patients achieved minimal disease activity and 35% achieved clinically inactive disease. A significant reduction of the 10-joint juvenile arthritis disease activity score and acute phase reactants was also observed. Patients with younger age (≤7 years), shorter disease duration (≤3 years), lower disease activity, and higher serum ferritin and systemic manifestations showed more favorable results. Patients with sJIA showed favorable disease outcomes with TCZ treatment for 1 year, especially if the drugs were administered earlier in the disease course and in younger patients with a more pronounced inflammatory status. Our results may help to define the profile of patients with sJIA who are more likely to benefit from IL-6 blockade.
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http://dx.doi.org/10.3389/fmed.2021.665028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8141590PMC
May 2021

One year in review 2021: pathogenesis of rheumatoid arthritis.

Clin Exp Rheumatol 2021 May-Jun;39(3):445-452. Epub 2021 May 21.

Immuno-Allergology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy.

Rheumatoid arthritis (RA) is a chronic autoimmune disease characterised by local and systemic inflammation where the close interaction between immune cells and soluble mediators leads to amplification and perpetuation of inflammatory and remodelling processes. The research carried out in the last year in the field of RA has made it possible to identify new mechanisms involved in the pathogenesis of the disease, enabling the discovery of new potential therapeutic targets. Thus, in this review we summarise new insights in RA pathogenesis, resulting from a literature research date published in the last year.
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May 2021

Efficacy of intra-articular corticosteroid injections in knee osteoarthritis: A systematic review and meta-analysis of randomized controlled trials.

Joint Bone Spine 2021 Jul 24;88(4):105198. Epub 2021 Apr 24.

Sorbonne Université, INSERM CRSA Saint-Antoine, Department of Rheumatology, AP-HP, Saint Antoine Hospital, Paris, France.

Objective: Knee osteoarthritis (OA) is a frequent degenerative disease representing an important health and economic burden. Symptomatic medical treatments available include intra-articular (IA) injections of corticosteroids (GC) but their efficacy and safety profile are debated.

Methods: We performed a systematic literature review (SLR) and a meta-analysis (MA) of randomized controlled trials (RCTs) assessing the effect of IA GC injections for knee OA. The effect of the interventions on pain and function was extracted from the single studies and pooled. Standardized mean differences (SMD) are reported.

Results: Of 520 studies screened, 23 were included in the SLR and 15 subsequently included in the MA. IA GC showed a trend towards a superior effect compared to control on both pain (SMD -0.61 (95% CI: -1.25, 0.03)) and function (SMD -1.02 (95% CI: -2.14, 0.10)) in short term follow-up (≤6 weeks), while long term follow-up (≥24 weeks) analysis showed a trend towards superiority of controls (IA HA, IA NSAID, physiotherapy) for pain (SMD 0.68 (95% CI: -0.11, 1.47)) and function (SMD 0.88 (95% CI: -0.36, 2.12). There were no differences between interventions in medium term (>6 weeks &<24 weeks).

Conclusion: In this work, IA GC injections reduced pain and improved function early after administration (≤6 weeks) compared to placebo; while this result was no longer statistically significant with other comparators (IA hyaluronic acid or physiotherapy). Other interventions seem to be more efficient in the long term (≥24 weeks) but this effect was largely driven by single studies with large effect sizes.
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http://dx.doi.org/10.1016/j.jbspin.2021.105198DOI Listing
July 2021

EULAR Points to Consider (PtC) for designing, analysing and reporting of studies with work participation as an outcome domain in patients with inflammatory arthritis.

Ann Rheum Dis 2021 09 8;80(9):1116-1123. Epub 2021 Apr 8.

Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.

Background: Clinical studies with work participation (WP) as an outcome domain pose particular methodological challenges that hamper interpretation, comparison between studies and meta-analyses.

Objectives: To develop Points to Consider (PtC) for design, analysis and reporting of studies of patients with inflammatory arthritis that include WP as a primary or secondary outcome domain.

Methods: The EULAR Standardised Operating Procedures were followed. A multidisciplinary taskforce with 22 experts including patients with rheumatic diseases, from 10 EULAR countries and Canada, identified methodologic areas of concern. Two systematic literature reviews (SLR) appraised the methodology across these areas. In parallel, two surveys among professional societies and experts outside the taskforce sought for additional methodological areas or existing conducting/reporting recommendations. The taskforce formulated the PtC after presentation of the SLRs and survey results, and discussion. Consensus was obtained through informal voting, with levels of agreement obtained anonymously.

Results: Two overarching principles and nine PtC were formulated. The taskforce recommends to align the work-related study objective to the design, duration, and outcome domains/measurement instruments of the study (PtC: 1-3); to identify contextual factors upfront and account for them in analyses (PtC: 4); to account for interdependence of different work outcome domains and for changes in work status over time (PtC: 5-7); to present results as means as well as proportions of patients reaching predefined meaningful categories (PtC: 8) and to explicitly report volumes of productivity loss when costs are an outcome (PtC:9).

Conclusion: Adherence to these EULAR PtC will improve the methodological quality of studies evaluating WP.
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http://dx.doi.org/10.1136/annrheumdis-2020-219523DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8372378PMC
September 2021

Duplex ultrasound as a reliable alternative to CT angiography for treatment planning of peripheral artery disease.

Int Angiol 2021 Aug 9;40(4):306-314. Epub 2021 Apr 9.

Department of Vascular Surgery, Umberto I Polyclinic Hospital, Sapienza University, Rome, Italy.

Background: The aim of this work was to compare the diagnostic accuracy of Duplex ultrasound (DUS) and CT angiography (CTA) in the study of arterial vessels, in patients with chronic peripheral arterial disease (PAD) of the lower limbs to undergo endovascular revascularization with the use of intraprocedural digital angiography (DSA).

Methods: Ninety-four patients with obstructive pathology of the arterial axes of the lower limbs were enrolled in the study. In all patients, endovascular revascularization treatment was considered the most suitable therapeutic choice. For this reason, ultrasound and CTA was performed preoperatively in all and based on the data obtained it was decided to classify the arterial tree into five segments: iliac, common femoral, superficial femoral, popliteal and infra-geniculate. According to the degree of stenosis or occlusion, the arteries were scored in no stenotic, stenotic and occluded. The comparison of the data provided by the DUS and the CTA was carried out with reference to the parameters obtained by the DSA.

Results: The results of our experience have shown that in the iliac arterial district DUS proved to be less accurate than CT angiography when compared to DSA (Cohen's κ agreement of 0.91 and 1.0, respectively). Good diagnostic concordance was found in the femoro-popliteal district (Cohen's κ agreement 33 between 0.96 and 0.93). On the contrary, when the data of the infra-geniculate area were compared, CT angiography showed a net deficiency compared to DSA and DUS (Cohen's κ: 0.75).

Conclusions: Due to its accuracy, high-quality DUS performed by well-trained operators may therefore represent a good alternative to CTA in patients undergoing endovascular revascularization, in order to reduce the use of contrast-enhanced radiological imaging especially when a condition of intolerance to the contrast medium and/or renal insufficiency coexists.
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http://dx.doi.org/10.23736/S0392-9590.21.04524-7DOI Listing
August 2021

Respiratory Manifestations in Systemic Lupus Erythematosus.

Pharmaceuticals (Basel) 2021 Mar 18;14(3). Epub 2021 Mar 18.

Internal Medicine and Nephrology Unit, Department of Life, Health & Environmental Sciences, University of L'Aquila and Department of Medicine, ASL 1 Avezzano-Sulmona-L'Aquila, 67100 L'Aquila, Italy.

Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease characterized by a wide spectrum of clinical manifestations. The respiratory system can be involved in up to 50-70% of patients and be the presenting manifestation of the disease in 4-5% of cases. Every part of the respiratory part can be involved, and the severity can vary from mild self-limiting to life threatening forms. Respiratory involvement can be primary (caused by SLE itself) or secondary (e.g., infections or drug toxicity), acute or chronic. The course, treatment and prognosis vary greatly depending on the specific pattern of the disease. This review article aims at providing an overview of respiratory manifestations in SLE along with an update about therapeutic approaches including novel biologic therapies.
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http://dx.doi.org/10.3390/ph14030276DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8003168PMC
March 2021

Diet in Rheumatoid Arthritis versus Systemic Lupus Erythematosus: Any Differences?

Nutrients 2021 Feb 27;13(3). Epub 2021 Feb 27.

Rheumatology Unit, Department of Medicine, University of Perugia, Piazzale Menghini 1, 06100 Perugia, Italy.

In recent years, an increasing interest in the influence of diet in rheumatic and musculoskeletal diseases (RMDs) led to the publication of several articles exploring the role of food/nutrients in both the risk of developing these conditions in normal subjects and the natural history of the disease in patients with established RMDs. Diet may be a possible facilitator of RMDs due to both the direct pro-inflammatory properties of some nutrients and the indirect action on insulin resistance, obesity and associated co-morbidities. A consistent body of research has been conducted in rheumatoid arthritis (RA), while studies in systemic lupus erythematosus (SLE) are scarce and have been conducted mainly on experimental models of the disease. This review article aims to outline similarities and differences between RA and SLE based on the existing literature.
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http://dx.doi.org/10.3390/nu13030772DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7997440PMC
February 2021

Ferritin is associated with the severity of lung involvement but not with worse prognosis in patients with COVID-19: data from two Italian COVID-19 units.

Sci Rep 2021 03 1;11(1):4863. Epub 2021 Mar 1.

Internal Medicine and Nephrology Unit, Department of Life, Health and Environmental Sciences, University of L'Aquila, San Salvatore Hospital, L'Aquila, Italy.

The coronavirus 2019 disease (COVID-19) is characterised by a heterogeneous clinical presentation, a complex pathophysiology and a wide range of imaging findings, depending on disease severity and time course. We conducted a retrospective evaluation of hospitalized patients with proven SARS-CoV-2 infection, clinical signs of COVID-19 and computed tomography (CT) scan-proven pulmonary involvement, in order to identify relationships between clinical, serological, imaging data and disease outcomes in patients with COVID-19. Clinical and serological records of patients admitted to two COVID-19 Units of the Abruzzo region in Italy with proven SARS-CoV-2 pulmonary involvement investigated with CT scan, assessed at the time of admission to the hospital, were retrospectively evaluated. Sixty-one patients (22 females and 39 males) of median age 65 years were enrolled. Fifty-six patients were discharged while death occurred in 5 patients. None of the lung abnormalities detected by CT was different between discharged and deceased patients. No differences were observed in the features and extent of pulmonary involvement according to age and gender. Logistic regression analysis with age and gender as covariates demonstrated that ferritin levels over the 25th percentile were associated with the involvement of all 5 pulmonary lobes (OR = 14.5, 95% CI 2.3-90.9, p = 0.004), the presence of septal thickening (OR = 8.2, 95% CI 1.6-40.9, p = 0.011) and the presence of mediastinal lymph node enlargement (OR = 12.0, 95% CI 1.1-127.5, p = 0.039) independently of age and gender. We demonstrated that ferritin levels over the 25th percentile are associated with a more severe pulmonary involvement, independently of age and gender and not associated with disease outcomes. The identification of reliable biomarkers in patients with COVID-19 may help guiding clinical decision, tailoring therapeutic approaches and ultimately improving the care and prognosis of patients with this disease.
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http://dx.doi.org/10.1038/s41598-021-83831-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7921386PMC
March 2021

The past, present and future of e-health in Rheumatology.

Joint Bone Spine 2021 07 19;88(4):105163. Epub 2021 Feb 19.

Rheumatology Unit, University of Perugia, Perugia, Italy. Electronic address:

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http://dx.doi.org/10.1016/j.jbspin.2021.105163DOI Listing
July 2021

Immunomodulatory therapies for SARS-CoV-2 infection: a systematic literature review to inform EULAR points to consider.

Ann Rheum Dis 2021 Feb 15. Epub 2021 Feb 15.

Department of Rheumatology, Northwick Park Hospital, London North West University Healthcare NHS Trust, London, UK.

Objective: To summarise the available information on efficacy and safety of immunomodulatory agents in SARS-CoV-2 infection.

Methods: As part of a European League Against Rheumatism (EULAR) taskforce, a systematic literature search was conducted from January 2019 to 11 December 2020. Two reviewers independently identified eligible studies according to the Population, Intervention, Comparator and Outcome framework and extracted data on efficacy and safety of immunomodulatory agents used therapeutically in SARS-CoV-2 infection at any stage. The risk of bias was assessed with validated tools.

Results: Of the 60 372 records, 401 articles were eligible for inclusion. Studies were at variable risk of bias. Randomised controlled trials (RCTs) were available for the following drugs: hydroxychloroquine (n=12), glucocorticoids (n=6), tocilizumab (n=4), convalescent plasma (n=4), interferon beta (n=2), intravenous immunoglobulins (IVIg) (n=2) and n=1 each for anakinra, baricitinib, colchicine, leflunomide, ruxolitinib, interferon kappa and vilobelimab. Glucocorticoids were able to reduce mortality in specific subsets of patients, while conflicting data were available about tocilizumab. Hydroxychloroquine was not beneficial at any disease stage, one RCT with anakinra was negative, one RCT with baricitinib+remdesivir was positive, and individual trials on some other compounds provided interesting, although preliminary, results.

Conclusion: Although there is emerging evidence about immunomodulatory therapies for the management of COVID-19, conclusive data are scarce with some conflicting data. Since glucocorticoids seem to improve survival in some subsets of patients, RCTs comparing glucocorticoids alone versus glucocorticoids plus anticytokine/immunomodulatory treatment are warranted. This systematic literature review informed the initiative to formulate EULAR 'points to consider' on COVID-19 pathophysiology and immunomodulatory treatment from the rheumatology perspective.
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http://dx.doi.org/10.1136/annrheumdis-2020-219725DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8142448PMC
February 2021

Pathophysiology of acute respiratory syndrome coronavirus 2 infection: a systematic literature review to inform EULAR points to consider.

RMD Open 2021 02;7(1)

Centre for Rheumatology, National Institute for Health Research (NIHR) University College London Hospitals (UCLH) Biomedical Research Centre (BRC), University College London Hospitals (UCLH) NHS Foundation Trus, London, UK.

Background: The SARS-CoV-2 pandemic is a global health problem. Beside the specific pathogenic effect of SARS-CoV-2, incompletely understood deleterious and aberrant host immune responses play critical roles in severe disease. Our objective was to summarise the available information on the pathophysiology of COVID-19.

Methods: Two reviewers independently identified eligible studies according to the following PICO framework: P (population): patients with SARS-CoV-2 infection; I (intervention): any intervention/no intervention; C (comparator): any comparator; O (outcome) any clinical or serological outcome including but not limited to immune cell phenotype and function and serum cytokine concentration.

Results: Of the 55 496 records yielded, 84 articles were eligible for inclusion according to question-specific research criteria. Proinflammatory cytokine expression, including interleukin-6 (IL-6), was increased, especially in severe COVID-19, although not as high as other states with severe systemic inflammation. The myeloid and lymphoid compartments were differentially affected by SARS-CoV-2 infection depending on disease phenotype. Failure to maintain high interferon (IFN) levels was characteristic of severe forms of COVID-19 and could be related to loss-of-function mutations in the IFN pathway and/or the presence of anti-IFN antibodies. Antibody response to SARS-CoV-2 infection showed a high variability across individuals and disease spectrum. Multiparametric algorithms showed variable diagnostic performances in predicting survival, hospitalisation, disease progression or severity, and mortality.

Conclusions: SARS-CoV-2 infection affects both humoral and cellular immunity depending on both disease severity and individual parameters. This systematic literature review informed the EULAR 'points to consider' on COVID-19 pathophysiology and immunomodulatory therapies.
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http://dx.doi.org/10.1136/rmdopen-2020-001549DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7880117PMC
February 2021

EULAR points to consider on pathophysiology and use of immunomodulatory therapies in COVID-19.

Ann Rheum Dis 2021 Feb 5. Epub 2021 Feb 5.

Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, INSERM UMR1184, Department of Rheumatology, Université Paris-Saclay, Le Kremlin Bicêtre, France

Objectives: Severe systemic inflammation associated with some stages of COVID-19 and in fatal cases led therapeutic agents developed or used frequently in Rheumatology being at the vanguard of experimental therapeutics strategies. The aim of this project was to elaborate EULAR Points to consider (PtCs) on COVID-19 pathophysiology and immunomodulatory therapies.

Methods: PtCs were developed in accordance with EULAR standard operating procedures for endorsed recommendations, led by an international multidisciplinary Task Force, including rheumatologists, translational immunologists, haematologists, paediatricians, patients and health professionals, based on a systemic literature review up to 15 December 2020. Overarching principles (OPs) and PtCs were formulated and consolidated by formal voting.

Results: Two OPs and fourteen PtCs were developed. OPs highlight the heterogeneous clinical spectrum of SARS-CoV-2 infection and the need of a multifaceted approach to target the different pathophysiological mechanisms. PtCs 1-6 encompass the pathophysiology of SARS-CoV-2 including immune response, endothelial dysfunction and biomarkers. PtCs 7-14 focus on the management of SARS-CoV-2 infection with immunomodulators. There was evidence supporting the use of glucocorticoids, especially dexamethasone, in COVID-19 cases requiring oxygen therapy. No other immunomodulator demonstrated efficacy on mortality to date, with however inconsistent results for tocilizumab. Immunomodulatory therapy was not associated with higher infection rates.

Conclusions: Multifactorial pathophysiological mechanisms, including immune abnormalities, play a key role in COVID-19. The efficacy of glucocorticoids in cases requiring oxygen therapy suggests that immunomodulatory treatment might be effective in COVID-19 subsets. Involvement of rheumatologists, as systemic inflammatory diseases experts, should continue in ongoing clinical trials delineating optimal immunomodulatory therapy utilisation in COVID-19.
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http://dx.doi.org/10.1136/annrheumdis-2020-219724DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7871226PMC
February 2021

Methodological aspects of design, analysis and reporting of studies with work participation as an outcome domain in patients with inflammatory arthritis: results of two systematic literature reviews informing EULAR points to consider.

RMD Open 2021 02;7(1)

Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, Limburg, The Netherlands.

Objective: To summarise the methodological aspects in studies with work participation (WP) as outcome domain in inflammatory arthritis (IA) and other chronic diseases.

Methods: Two systematic literature reviews (SLRs) were conducted in key electronic databases (2014-2019): search 1 focused on longitudinal prospective studies in IA and search 2 on SLRs in other chronic diseases. Two reviewers independently identified eligible studies and extracted data covering pre-defined methodological areas.

Results: In total, 58 studies in IA (22 randomised controlled trials, 36 longitudinal observational studies) and 24 SLRs in other chronic diseases were included. WP was the primary outcome in 26/58 (45%) studies. The methodological aspects least accounted for in IA studies were as follows (proportions of studies positively adhering to the topic are shown): aligning the studied population (16/58 (28%)) and sample size calculation (8/58 (14%)) with the work-related study objective; attribution of WP to overall health (28/58 (48%)); accounting for skewness of presenteeism/sick leave (10/52 (19%)); accounting for work-related contextual factors (25/58 (43%)); reporting attrition and its reasons (1/58 (2%)); reporting both aggregated results and proportions of individuals reaching predefined meaningful change or state (11/58 (16%)). SLRs in other chronic diseases confirmed heterogeneity and methodological flaws identified in IA studies without identifying new issues.

Conclusion: High methodological heterogeneity was observed in studies with WP as outcome domain. Consensus around various methodological aspects specific to WP studies is needed to improve quality of future studies. This review informs the EULAR Points to Consider for conducting and reporting studies with WP as an outcome in IA.
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http://dx.doi.org/10.1136/rmdopen-2020-001522DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7868290PMC
February 2021

Young people's perspectives on patient-reported outcome measures in inflammatory arthritis: results of a multicentre European qualitative study from a EULAR task force.

RMD Open 2021 01;7(1)

Section for Outcomes Research, Centre for Medical Statistics, Informatics and Intelligent Systems, Medical University Vienna, Wien, Austria

Introduction: Although patient-reported outcome measures (PROMs) are increasingly used in clinical practice and research, it is unclear whether these instruments cover the perspective of young people with inflammatory arthritis (IA). The aims of this study were to explore whether PROMs commonly used in IA adequately cover the perspective of young people from different European countries.

Methods: A multinational qualitative study was conducted in Austria, Croatia, Italy and the Netherlands. Young people with either rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Still's disease, psoriatic arthritis (PsA) or spondyloarthritis (SpA), aged 18-35 years, participated in semistructured focus group interviews. Thematic analysis was used and data saturation was defined as no new emergent concepts in at least three subsequent focus groups.

Results: Fifty-three patients (21 with RA/JIA/Still's, 17 with PsA, 15 with SpA; 72% women) participated in 12 focus groups. Participants expressed a general positive attitude towards PROMs and emphasised their importance in clinical practice. In addition, 48 lower level concepts were extracted and summarised into 6 higher level concepts describing potential issues for improvement. These included: need for lay-term information regarding the purpose of using PROMs; updates of certain outdated items and using digital technology for data acquisition. Some participants admitted their tendency to rate pain, fatigue or disease activity differently from what they actually felt for various reasons.

Conclusions: Despite their general positive attitude, young people with IA suggested areas for PROM development to ensure that important concepts are included, making PROMs relevant over the entire course of a chronic disease.
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http://dx.doi.org/10.1136/rmdopen-2020-001517DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7849893PMC
January 2021

The Impact of SARS-CoV-2 Outbreak on Primary Sjögren's Syndrome: An Italian Experience.

Front Med (Lausanne) 2020 7;7:608728. Epub 2020 Dec 7.

Rheumatology Unit, Department of Medicine, University of Perugia, Perugia, Italy.

Since no data is available about the personal experience of people with primary Sjögren's syndrome (pSS) with regard to disease burden and management during the novel Severe Acute Respiratory Syndrome coronavirus (SARS-CoV)-2 outbreak, we aimed to explore these aspects with the ultimate goal to identify unmet needs and priorities. A telephone consultation was scheduled with patients with pSS and information regarding the disease status, ongoing treatment and symptoms/diagnosis of coronavirus disease 2019 (COVID-19) were collected. Clinical records were retrospectively evaluated to gather pre-COVID-19 information. One hundred and two patients with pSS were contacted. Most rheumatology consultations and other pSS-related tests were canceled during the SARS-CoV-2 outbreak. Less than 30% of patients contacted the rheumatologist via telemedicine despite experiencing disease flares or therapy shortage. Disease activity and patient reported symptoms significantly worsened during the closure period. All patients practiced social distancing, most of those employed switched to smart working and different work settings impacted on the type of symptom worsening. This is the first study addressing the personal experience of pSS patients resulting from the impact of the SARS-CoV2 outbreak and it identifies unmet needs and priorities requiring to be addressed. Our findings may help designing individualized strategies.
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http://dx.doi.org/10.3389/fmed.2020.608728DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7793887PMC
December 2020

Novel insights on lymphoma and lymphomagenesis in primary Sjögren's Syndrome.

Panminerva Med 2020 Dec 4. Epub 2020 Dec 4.

COVID-19 Medicine Unit, Medicine Department, ASL1 Avezzano-Sulmona-L'Aquila, L'Aquila, Italy -

Introduction: Primary Sjögren's syndrome (pSS) is a systemic autoimmune disease characterized by a chronic inflammatory process mainly affecting the exocrine glands but also burdened by a wide range of extraglandular manifestations. Non-Hodgkin lymphoma (NHL) is the most severe pSS complication worsening disease prognosis.

Evidence Acquisition: We summarized original articles published between April 2018 and May 2020 on this topic aiming to highlight novelties on lymphoma and lymphomagenesis.

Evidence Synthesis: Results have been grouped by epidemiology, etiopathogenesis and predictors of lymphoma.

Conclusions: NHL is the most severe complication of pSS and occurs in around 5-10% of patients. Over the last two years, several clinical, serological, and histopathological features have been proposed as predictive for lymphoma in pSS patients, allowing early diagnosis and consequently, better management and prognosis. Individual monitoring for disease activity and possible lymphoma development is a central clue in the evaluation of pSS patients.
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http://dx.doi.org/10.23736/S0031-0808.20.04079-3DOI Listing
December 2020

Nellix endovascular aneurysm-sealing system: a single-center experience and review of current evidence.

Future Cardiol 2020 Dec 3. Epub 2020 Dec 3.

Department of Vascular Surgery- "Sapienza" University of Rome - Policlinico "Umberto I", Viale del Policlinico, 155, 0016, Rome, Italy.

We report the 6-year results of our use of the Nellix endovascular aneurysm sealing system. This is a retrospective review of patients we treated from 2013 to 2019. The outcomes described include technical success rate, mortality, all procedure-related complications, reinterventions, open surgical conversion and secondary sac rupture. A total of 68 patients were treated. Mortality was 2.9%. Secondary interventions were carried out for distal embolization (3), stent occlusion (1), pseudoaneurysm (1) and endoleak (5). Open surgical conversion was required in 6.4% of cases. Medium- and long-term complications of EVAS occurred more frequently than expected. Because the durability of endovascular aneurysm sealing is questionable, strict postoperative surveillance of Nellix is crucial to identify features of failure.
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http://dx.doi.org/10.2217/fca-2020-0134DOI Listing
December 2020

Comment on: Equal rights in autoimmunity: is Sjögren's syndrome ever 'secondary'?

Rheumatology (Oxford) 2021 01;60(1):e32-e33

Department of Medicine, Rheumatology Unit, University of Perugia, Perugia, Italy.

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http://dx.doi.org/10.1093/rheumatology/keaa633DOI Listing
January 2021

Duplex ultrasound versus CT angiography for the treatment planning of lower-limb arterial disease.

J Ultrasound 2020 Nov 9. Epub 2020 Nov 9.

Vascular Surgery Department, Policlinico Umberto I, "Sapienza" University of Rome, Viale del Policlinico, 155, 00161, Rome, Italy.

Purpose: This study aimed to assess the diagnostic accuracy of duplex sonography (DUS) compared with that of computed tomography angiography (CTA) in detecting occlusion and stenosis in peripheral arterial disease (PAD) in candidate patients for endovascular revascularization with intraprocedural digital subtraction angiography (DSA).

Methods: The study involved 94 patients suffering from PAD who were candidates for endovascular procedures requiring DSA. They were all submitted preoperatively to DUS and CTA. Based on image analysis, five segments of the arterial tree were assessed: iliac, common femoral, superficial femoral, popliteal, and infrageniculate. According to the stenosis or occlusion degree, the arteries were rated as nonstenotic, stenotic, and occluded.

Results: The agreement between DUS and CTA findings using DSA as a reference modality was expressed as a Cohen's kappa (κ) statistic agreement. Our results show that DUS has been less accurate than CTA in evaluating iliac arterial diseases (Cohen's κ agreement of 0.91 and 1.0, respectively) when measured against DSA. We found good diagnostic concordance between DUS and DSA in detecting hemodynamic stenosis and occlusion of the femoro-popliteal axis (Cohen's κ agreement between 0.96 and 0.93). Below the knee, CTA showed even less concordance with DSA (Cohen's κ 0.75).

Conclusions: Because of its accuracy, high-quality DUS performed by well-trained operators may therefore represent a good alternative to CTA in patients undergoing endovascular revascularization to minimize the use of contrast-enhanced radiological imaging. Nevertheless, preoperative CTA imaging is required in cases of nondiagnostic DUS or when a more complete overview of the vascular tree is needed for complex invasive interventions.
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http://dx.doi.org/10.1007/s40477-020-00534-yDOI Listing
November 2020

Influence of COVID-19 pandemic on decisions for the management of people with inflammatory rheumatic and musculoskeletal diseases: a survey among EULAR countries.

Ann Rheum Dis 2020 Nov 6. Epub 2020 Nov 6.

Rheumatology and Immunology, Charite Medical Faculty Berlin, Berlin, Germany.

Objectives: To investigate how the first wave of COVID-19 pandemic influenced decisions of rheumatologists and health professionals in rheumatology regarding the management of patients with inflammatory rheumatic and musculoskeletal diseases (RMDs).

Methods: An English-language questionnaire was developed by a EULAR working group and distributed via national rheumatology societies of EULAR countries, EMEUNET and individual working group members. Responses were collected using an online survey tool. Descriptive statistics were calculated.

Results: We analysed 1286 responses from 35/45 EULAR countries. Due to containment measures, 82% of respondents indicated cancellation/postponement of face-to-face visits of new patients (84% of them offering remote consultation) and 91% of follow-up visits (96% with remote consultation). The majority of respondents (58%) perceived that the interval between symptom onset and first rheumatological consultations was longer during containment restrictions than before. Treatment decisions were frequently postponed (34%), and the majority (74%) of respondents stated that it was less likely to start a biological disease modifying anti-rheumatic drug (DMARD)/targeted synthetic DMARD during the pandemic, mainly because of patients' fear, limited availability of screening procedures and decreased availability of rheumatological services. Use of (hydroxy)chloroquine (HCQ) and tocilizumab (TCZ) for the COVID-19 indication was reported by 47% and 42% of respondents, respectively, leading to a shortage of these drugs for RMDs indications according to 49% and 14% of respondents, respectively.

Conclusion: Measures related to containment of COVID-19 pandemic led to a perceived delay between symptom onset and a first rheumatological visit, postponement of treatment decisions, and shortage of HCQ and TCZ, thereby negatively impacting early treatment and treat-to-target strategies.
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http://dx.doi.org/10.1136/annrheumdis-2020-218697DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7650208PMC
November 2020

Validation of thymic stromal lymphopoietin as a biomarker of primary Sjögren's syndrome and related lymphoproliferation: results in independent cohorts.

Clin Exp Rheumatol 2020 Jul-Aug;38 Suppl 126(4):189-194. Epub 2020 Oct 23.

Rheumatology Clinic, Udine University Hospital, Department of Medical Area, University of Udine, Italy.

Objectives: Thymic stromal lymphopoietin (TSLP) has been implicated in primary Sjögren's syndrome (pSS) and related B-cell lymphoproliferation and lymphoma (NHL) by studies on salivary pathologic tissues and serum. The purpose of this work was to validate serum TSLP as biomarker of pSS and related lymphoproliferation by the study of two additional independent cohorts.

Methods: Serum TSLP was measured by ELISA in the original published Cohort-1 from Udine, Italy, including 91 patients. Two additional cohorts were then studied for validation: Cohort-2, including 4 sub-cohorts comprising 125 patients from the Universities of Roma, L'Aquila, Pisa and Perugia, belonging to the Italian SS Study Group (GRISS), and Cohort-3, including 59 patients from the University of Athens, Greece. Overall, 159 control subjects were enrolled. Active pSS-NHL, as well as pre-lymphomatous conditions, i.e. persistent salivary gland swelling and mixed cryoglobulinaemia, were investigated in detail. In addition, serum samples from pSS-NHL in complete remission were analysed (n=27).

Results: TSLP serum levels were confirmed to be significantly higher in pSS compared to controls in both Cohort-2 and Cohort-3, in particular in patients with lymphoproliferation. Serum TSLP was much higher in pSS pre-lymphomatous conditions. Finally, active NHL showed the highest TSLP serum levels, while in NHL in remission TSLP resulted undetectable or significantly lower than in benign pSS.

Conclusions: By the study of independent cohorts, it was again demonstrated that serum TSLP levels are increased in pSS, above all in more advanced B-cell lymphoproliferation and NHL. Serum TSLP can therefore represent a novel biomarker for pSS-related lymphoproliferation.
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October 2020

Characterisation of articular manifestations in primary Sjögren's syndrome: clinical and imaging features.

Clin Exp Rheumatol 2020 Jul-Aug;38 Suppl 126(4):166-173. Epub 2020 Sep 22.

Rheumatology Unit, Department of Medicine, University of Perugia, Italy.

Objectives: Articular manifestations (AMs) are observed in a large proportion of patients with primary Sjögren's syndrome (pSS) and can occur at the time of pSS diagnosis or during the disease course. Although in the majority of cases AMs are mild and self-limiting, some patients may experience chronic polyarthritis requiring treatment with DMARDs. Ultrasonography (US) and magnetic resonance imaging (MRI) can help assessing the extent of articular involvement and guide the treatment. The aim of this study was to describe clinical, serological, and histological picture of a cohort of pSS patients with AMs.

Methods: Clinical and serological records were retrospectively evaluated and either US or MRI were performed to evaluate AMs and their features were described according to the OMERACT scoring systems.

Results: One hundred and thirty-three pSS patients were enrolled, of whom 115 (86%) with articular involvement. In particular, 91 patients (68%) displayed AMs at the time of pSS diagnosis while 24 patients (32%) during the course of the disease. Patients with AMs during the disease course were diagnosed with pSS at a younger age and reported a higher VAS dryness compared to patients displaying AMs at pSS onset. Hands and wrists were the most frequently involved sites followed by knees, shoulders and ankles. Overall, a consistent number of abnormalities were detected, more by MRI than US. Hands and wrists were the most frequently evaluated sites and the prevalence of all MRI abnormalities was similar between the different sites and comparable between the groups.

Conclusions: pSS AMs encompass a wide disease spectrum ranging from arthralgia to erosive arthritis resembling RA and therefore represent an important determinant of patients' quality of life. Imaging techniques such as US and MRI may be useful in the follow-up of pSS patients for prompt identification of AMs, for the quantification of their extent and ultimately for providing guidance on treatment and improving patient care.
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October 2020

Comparison of Rituximab Originator With CT-P10 Biosimilar in Patients With Primary Sjögren's Syndrome: A Retrospective Analysis in a Real-Life Setting.

Front Med (Lausanne) 2020 8;7:534. Epub 2020 Sep 8.

COVID-19 Medical Unit, Department of Medicine, ASL1 Avezzano-Sulmona-L'Aquila, San Salvatore Hospital, L'Aquila, Italy.

Over the last two decades, rituximab (RTX) has been widely used, albeit off-label, in primary Sjögren's syndrome (pSS). Several studies reported that B lymphocyte depletion with RTX is effective to treat some aspects within the disease spectrum, by reducing disease activity and affecting the inflammation and lymphoid organization that occur in target tissues. Notwithstanding, randomized controlled trials failed to confirm such evidence. With the recent release of several RTX biosimilars on the market, their efficacy and safety compared to the originator must be ascertained across different indications. This study aimed at comparing efficacy and safety of RTX originator and CT-P10 RTX biosimilar in pSS patients in a real-life setting. Clinical and laboratory records of pSS patients referring to a tertiary rheumatology clinic were retrospectively evaluated. Patients having received at least two courses of either RTX originator or CT-P10 with complete data at baseline and after 12, 24, 36, and 48 weeks of treatment were enrolled. Disease activity was assessed with the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) and its clinical version without the biological domain (clinESSDAI). Patient-reported symptoms were assessed with the EULAR Sjögren's Syndrome Patient-Reported Index (ESSPRI). Adverse events (AEs) occurring during the study period were also recorded. Nine patients who received RTX originator and eight patients who received CT-P10 were enrolled. Baseline clinical and serological features, including ESSDAI and ESSPRI, were similar in the two treatment groups. An efficient depletion of circulating CD19 B lymphocytes was achieved in both treatment arms. Both RTX originator and CT-P10 significantly reduced ESSDAI and clinESSDAI by week 24, and no difference between the groups was observed at any timepoint. Conversely, changes of ESSPRI overtime did not differ between the two treatment arms and were not statistically significant compared to corresponding baseline values. With regard to safety, at 48 weeks of follow-up, only four mild AEs (two in the RTX originator and two in the CT-P10 group) were observed. Our study provides the first evidence that, at 48 weeks of follow-up, RTX originator and CT-P10 display similar efficacy and safety profiles in pSS.
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http://dx.doi.org/10.3389/fmed.2020.00534DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7506066PMC
September 2020

Psychosocial burden in young patients with primary anti-phospholipid syndrome: an Italian nationwide survey (The AQUEOUS study).

Clin Exp Rheumatol 2021 Sep-Oct;39(5):938-946. Epub 2020 Sep 16.

Rheumatology and Clinical Immunology Unit, ASST Spedali Civili, Department of Clinical and Experimental Sciences, University of Brescia, Italy.

Objectives: The AQUEOUS (Anti-phospholipid syndrome: a QUEstionnaire for yOUng patientS) study aimed to assess how the diagnosis of primary anti-phospholipid syndrome (PAPS) affects the psychosocial status of young patients.

Methods: Subjects with PAPS aged 18-45 years were invited to compile an ad hoc designed questionnaire and the Short Form-12 to assess quality of life (QoL).

Results: Ninety-two patients (83.7% females) were recruited in 10 Italian centres. Vascular and obstetric manifestations were equally represented. Nearly half of the patients perceived the need for psychological support, 89.2% when considering women after pregnancy complications. Social activities and working efficiency were reduced in APS patients, also intimacy was threatened. In all cases, fatigue appeared to be the main determinant. PAPS affected family planning, due to fears of treatment side-effects, disease hereditariness, inability to care for the newborn child. Fertility appeared to be conserved: the median time to pregnancy was 2 months; assisted reproduction techniques were pursued by 5 women. Our survey documented significantly lower rates of hospitalisation and learning disabilities in 51 children born after APS diagnosis as compared to 48 children born before. PAPS patients displayed lower QoL in physical and, to a greater extent, mental scores compared to the general Italian population. Both components were significantly lower in women and in patients with fatigue.

Conclusions: The AQUEOUS study assessed for the first time the unmet needs of young PAPS patients, enabling the development of a future "youth-focused" strategy to reduce disease burden.
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September 2021

The Serological Status Affects the Prognostic Role of Salivary Gland Histology in Primary Sjögren Syndrome.

J Rheumatol 2020 12 15;47(12):1838. Epub 2020 Sep 15.

Rheumatology Unit, Department of Medicine, University of Perugia, Perugia, Italy.

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http://dx.doi.org/10.3899/jrheum.200350DOI Listing
December 2020

Multidisciplinary collaboration among young specialists: results of an international survey by the emerging EULAR network and other young organisations.

RMD Open 2020 09;6(2)

Rheumatology, Zuyderland Medical Centre Heerlen, Heerlen, Netherlands.

Background: Multidisciplinary collaboration is defined as a collective work involving multiple disciplines and is common in clinical care and research. Our aim was to describe current clinical and research collaboration among young specialists and to identify unmet needs in this area.

Methods: An online survey was disseminated by email and social media to members of the EMerging EUlar NETwork, the Young Nephrologists' Platform, the Paediatric Rheumatology European Society Emerging Rheumatologists and Researchers and the European Academy of Allergy and Clinical Immunology Junior Members.

Results: Of 303 respondents from 36 countries, 61% were female, 21% were aged below 30 years and 67% were aged 31-40 years. Young rheumatologists were the most represented (39%), followed by young nephrologists (24%), young paediatricians (20%), young allergologists (11%) then young internists (3%) and 3% other specialities. Collaborations were reported frequently by phone and email, also by various combined clinics while common local multidisciplinary meetings were uncommon. 96% would like to develop clinical research collaborations and 69% basic research collaborations. The majority of young specialists would be interested in online (84%) and/or 1-2 days (85%) common courses including case discussion (81%) and training workshops (85%), as well as webinars recorded with several specialists on a specific disease (96%).

Conclusions: This collaborative initiative highlighted wishes from young specialists for developing (1) regular local multidisciplinary meetings to discuss complex patients, (2) clinical research collaboration with combined grants and (3) multidisciplinary online projects such as common courses, webinars and apps.
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http://dx.doi.org/10.1136/rmdopen-2020-001398DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7525255PMC
September 2020

Assessment of competences in rheumatology training: results of a systematic literature review to inform EULAR points to consider.

RMD Open 2020 09;6(2)

Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands.

Objective: To summarise the literature on the assessment of competences in postgraduate medical training.

Methods: A systematic literature review was performed within a EULAR taskforce on the assessment of competences in rheumatology training and other related specialities (July 2019). Two searches were performed: one search for rheumatology and one for related medical specialities. Two reviewers independently identified eligible studies and extracted data on assessment methods. Risk of bias was assessed using the medical education research study quality instrument.

Results: Of 7335 articles in rheumatology and 2324 reviews in other specialities, 5 and 31 original studies were included, respectively. Studies in rheumatology were at variable risk of bias and explored only direct observation of practical skills (DOPS) and objective structured clinical examinations (OSCEs). OSCEs, including clinical, laboratory and imaging stations, performed best, with a good to very good internal consistency (Cronbach's α=0.83-0.92), and intrarater reliability (r=0.80-0.95). OSCEs moderately correlated with other assessment tools: r=0.48 vs rating by programme directors; r=0.2-0.44 vs multiple-choice questionnaires; r=0.48 vs DOPS. In other specialities, OSCEs on clinical skills had a good to very good inter-rater reliability and OSCEs on communication skills demonstrated a good to very good internal consistency. Multisource feedback and the mini-clinical evaluation exercise showed good feasibility and internal consistency (reliability), but other data on validity and reliability were conflicting.

Conclusion: Despite consistent data on competence assessment in other specialities, evidence in rheumatology is scarce and conflicting. Overall, OSCEs seem an appropriate tool to assess the competence of clinical skills and correlate well with other assessment strategies. DOPS, multisource feedback and the mini-clinical evaluation exercise are feasible alternatives.
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http://dx.doi.org/10.1136/rmdopen-2020-001330DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7508213PMC
September 2020
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