Publications by authors named "Linda Carli"

44 Publications

Impact of first wave of SARS-CoV-2 infection in patients with Systemic Lupus Erythematosus: Weighting the risk of infection and flare.

PLoS One 2021 13;16(1):e0245274. Epub 2021 Jan 13.

Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Introduction: The aim of this study was to investigate the incidence and clinical presentation of SARS-CoV-2 infections in a Systemic Lupus Erythematosus (SLE) cohort; to assess correlations with disease characteristics and rheumatic therapy; and to evaluate the occurrence of treatment discontinuation and its impact on disease activity.

Materials And Methods: SLE patients monitored by a single Italian centre were interviewed between February and July 2020. Patients were considered to be positive for SARS-CoV-2 infections in case of 1) positive nasopharyngeal swab; 2) positive serology associated with COVID19 suggesting symptoms. The following data were also recorded: clinical symptoms, adoption of social distancing measures, disease activity and treatment discontinuation.

Results: 332 patients were enrolled in the study. Six patients (1.8%) tested positive for SARS-CoV-2 infection, with the incidence being significantly higher in the subgroup of patients treated with biological Disease-Modifying Anti-Rheumatic Drugs (p = 0.005), while no difference was observed for other therapies, age at enrollment, disease duration, type of cumulative organ involvement or adoption of social isolation. The course of the disease was mild. Thirty-six patients (11.1%) discontinued at least part of their therapy during this time period, and 27 (8.1%) cases of disease flare were recorded. Correlation between flare and discontinuation of therapy was statistically significant (p<0.001). No significant increase of rate of flare in a subgroup of the same patients during 2020 was observed.

Conclusion: Treatment discontinuation seems to be an important cause of disease flare. Our findings suggest that abrupt drug withdrawal should be avoided or evaluated with caution on the basis of individual infection risk and comorbidities.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0245274PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7806138PMC
January 2021

How do systemic lupus erythematosus patients with very-long disease duration present? Analysis of a monocentric cohort.

Lupus 2021 Mar 7;30(3):439-447. Epub 2021 Jan 7.

Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Objective: to describe the disease path and the very long-term outcome in a monocentric cohort of patients with Systemic Lupus Erythematosus (SLE).

Methods: SLE patients with a disease duration of at least 15 years from diagnosis were enrolled. The number of hospitalizations, the disease flares occurred over the disease course and the organ damage accumulation were evaluated at 1, 2, 3, 4, 5, 10 years from diagnosis and at last observation in 2019 as well. Disease state, ongoing therapies and quality of life measures were also assessed at last visit.

Results: 126 Caucasian SLE patients were included in the analysis (95% female, median age 47.5 IQR 41-53, median disease duration 21 IQR19-26). At last visit, the majority of the patients (78.6%) was on LLDAS (remission included), 53.4% were on GC treatment and 35.7% on immunosuppressant. Furthermore, 53.2% had at least one organ damage. The majority of patients (66.7%) presented a relapsing-remitting course, for a total of 158 flares during the disease course (incidence rate: 0.79/patient-year); moreover, 84.9% of the cohort experienced at least one hospital admission, amounting to a total of 328 hospitalizations (incidence rate: 0.85/patient-year). The main reason for admission was disease activity, while the percentage of hospitalizations due to other causes has been growing over the 10 years of follow-up.

Conclusion: after a very long period of disease, most of the patients with SLE are in remission and are not taking GC therapy; however, the risk of incurring in disease flare remains a real problem.
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http://dx.doi.org/10.1177/0961203320984230DOI Listing
March 2021

One year in review 2019: psoriatic arthritis.

Clin Exp Rheumatol 2020 Nov-Dec;38(6):1046-1055. Epub 2020 Nov 17.

Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy.

Psoriatic arthritis (PsA) is an inflammatory arthritis belonging to spondyloarthritides (SpA), a group of rheumatologic diseases characterised bya wide spectrum of different clinical manifestations that tend to associate with various comorbidities and that may significantly compromise the quality of life of patients. Nowadays, it is well known how PsA may manifest in different clinical domains, in particular peripheral articular and periarticular involvement, axial involvement, skin and nail psoriasis. Moreover, the majority of patients with PsA develop comorbidities such as inflammatory bowel diseases, uveitis, but also cardiovascular diseases, psychiatric or pulmonary pathologies. The therapeutical armamentarium of PsA has been enriched during the last years, in relation to an advance in the knowledge of the immunological mechanisms at the basis of the disease; in particular, the future frontier of "personalised medicine" could lead to a further improvement in the quality of care of this group of patients. In this paper we review the literature on PsA of 2019 (Medline search of articles published from 1st January 2019 to 31st December 2019).
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December 2020

Articular involvement, steroid treatment and fibromyalgia are the main determinants of patient-physician discordance in systemic lupus erythematosus.

Arthritis Res Ther 2020 10 14;22(1):241. Epub 2020 Oct 14.

Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Via Roma 67, Pisa, Italy.

Background: Remission or the lowest possible disease activity is the main target in the management of systemic lupus erythematosus (SLE). Anyway, conflicting data are present in the literature regarding the correlation between physician-driven definitions and patient perception of the disease. The objective of this study is to evaluate the relationship between the definition of lupus low disease activity state (LLDAS) and patient's health-related quality of life (HRQoL).

Methods: This is a cross-sectional, monocentric study. Adult SLE patients were included. For each patient, demographics, disease duration, medications, comorbidities, organ damage, active disease manifestations and SELENA-SLEDAI were assessed. Patients have been categorised as follows: LLDAS, remission and active disease. Each patient completed the following patient-reported outcomes (PROs): SF-36, LIT, FACIT-Fatigue and SLAQ. A SLAQ score < 6 (25° percentile of our cohort) was used as the cut-off value to define a low disease activity state according to patient self-evaluation.

Results: We enrolled 259 consecutive SLE patients (mainly female and Caucasian, mean age 45.33 ± 13.14 years, median disease duration 14 years). 80.3% were in LLDAS, of whom 82.2% were in remission; 19.7% were active. No differences emerged for any of the PROs used between the LLDAS and the active group. Considering the LLDAS subgroup, we identified 56 patients with a subjective low disease activity (SLAQ < 6) and we defined them as "concordant"; the remaining 152 patients in LLDAS presented a subjective active disease (SLAQ ≥ 6) and were defined "discordant". Discordant patients presented more frequently ongoing and past joint involvement (p < 0.05) and a diagnosis of fibromyalgia (p < 0.01); furthermore, they were more likely to be on glucocorticoid therapy (p < 0.01). Discordant patients showed a significantly poorer HRQoL, assessed by all PROs (p < 0.0001).

Conclusions: Joint involvement, glucocorticoid therapy and comorbid fibromyalgia resulted to be the most important variables determining the poor concordance between patient and physician perspective on the disease.
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http://dx.doi.org/10.1186/s13075-020-02334-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7559765PMC
October 2020

Symmetric peripheral polyarthritis developed during SARS-CoV-2 infection.

Lancet Rheumatol 2020 Sep 13;2(9):e518-e519. Epub 2020 Jul 13.

Rheumatology Unit, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy.

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http://dx.doi.org/10.1016/S2665-9913(20)30216-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7357970PMC
September 2020

Translation, cultural adaptation and validation of the Italian version of the Brief Index of Lupus Damage: the BILDit.

Lupus 2020 Sep 13;29(10):1198-1205. Epub 2020 Jul 13.

Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Objectives: The Brief Index of Lupus Damage (BILD) is an instrument of self-evaluation of organ damage for systemic lupus erythematosus (SLE) patients. The objectives of this study were the translation, cultural adaptation and validation of the Italian version of the BILD (BILDit).

Methods: The process of translation and cultural adaptation followed published guidelines. The BILDit was pretested in a pilot study with 30 SLE patients in order to evaluate acceptability, reliability, comprehension and feasibility, and then validated in consecutive SLE patients attending our clinic.

Results: A total of 167 SLE patients were enrolled. In the pilot study, the BILDit demonstrated good acceptability, feasibility and comprehensibility and a very high degree of reliability (Cronbach's α = 1). In the validation cohort, the BILDit showed a significant positive correlation with the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI; ρ = 0.69;  < 0.001). Analysing the item-by-item correlation between the BILDit and the SDI, a good correlation ( < 0.001) was found for 73.1% of the items. In the multivariate analysis, the BILDit showed a significant positive correlation with age and disease duration ( < 0.01).

Conclusions: The BILDit seems to be an acceptable and reliable instrument for patient self-evaluation of disease damage, with a good correlation with the SDI. It can be considered as a screening tool for the evaluation of organ damage starting from the patient's perceptive.
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http://dx.doi.org/10.1177/0961203320940012DOI Listing
September 2020

Multicentric study comparing cyclosporine, mycophenolate mofetil and azathioprine in the maintenance therapy of lupus nephritis: 8 years follow up.

J Nephrol 2021 04 27;34(2):389-398. Epub 2020 May 27.

Divisione di Nefrologia e Dialisi-Padiglione Croff, Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico Milano, Via della Commenda 15, 20122, Milano, Italy.

Background: The ideal long-term maintenance therapy of Lupus Nephritis (LN) is still a matter of debate. The present study was aimed at comparing the efficacy/safety profile of cyclosporine (CsA), mycophenolate mofetil (MMF) and azathioprine (AZA) in long-term maintenance therapy of LN.

Methods: We performed a retrospective study of patients with biopsy-proven active LN. After induction therapy, all patients received maintenance therapy with CsA, MMF or AZA based on medical decision. Primary endpoint was complete renal remission (CRR) after 8 years (defined as proteinuria < 0.5 g/24 h, eGFR > 60 ml/min/1.73 mq); secondary endpoints were: CRR after 1 year, renal and extrarenal flares, progression of chronic kidney disease (CKD stage 3 or above) and side-effects.

Results: Out of 106 patients, 34 received CsA, 36 MMF and 36 AZA. Clinical and histological characteristics at start of induction therapy were comparable among groups. At start of maintenance therapy, CsA patients had significantly higher proteinuria (P = 0.004) or nephrotic syndrome (P = 0.024) and significantly lower CRR (23.5% vs 55.5% on MMF and 41.7% on AZA, P = 0.024). At one year, CRR was similar in the three groups (79.4% on CsA, 63.8% on MMF, 58.3% on AZA, P = 0.2). At 8 years, the primary endpoint was achieved by 79.4% of CsA vs 83.3% of MMF and 77.8% of AZA patients (P = 0.83); 24 h proteinuria, serum creatinine, eGFR were similar. CKD stage 3 or above developed in 8.8% of CsA, in 8.3% of MMF and in 8.3% of AZA patients (P = 0.92). Flares-free survival curves and incidence of side-effects were not different.

Conclusions: This is the first study comparing CsA, MMF and AZA on long-term LN maintenance therapy. All treatments had similar efficacy in achieving and maintaining CRR, despite more severe baseline clinical features in patients treated with CsA.
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http://dx.doi.org/10.1007/s40620-020-00753-wDOI Listing
April 2021

Impact of fatigue on health-related quality of life and illness perception in a monocentric cohort of patients with systemic lupus erythematosus.

RMD Open 2020 02;6(1)

Department of Clinical and Experimental Medicine, Rheumatology Unit, University of Pisa, Pisa, Italy

Background: Fatigue is a very common and debilitating symptom in patients with systemic lupus erythematosus (SLE), even among those with a mild or inactive disease. The objective of this study is to define fatigue determinants and describe the impact of fatigue on health-related quality of life (HRQoL) and illness perception in a monocentric cohort of patients with SLE.

Methods: This is a cross-sectional study. Adult patients with SLE were included. For each patient, demographics, medications, comorbidities, organ damage (Systemic Lupus International Collaborating Clinics Damage Index), active disease manifestations and Systemic Lupus Disease Activity Index scores were collected. It was evaluated if each patient met the definitions of remission and low disease activity. At enrolment, each patient completed the Short Form-36 (SF-36), Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F), Lupus Impact Tracker (LIT), Systemic Lupus Activity Questionnaire (SLAQ) and Brief Index of Lupus Damage (BILD). The FACIT-F questionnaire was also administered to a group of healthy controls.

Results: 223 patients were included (mean age 44.9±13.2 years, median disease duration 13 years). 18.2% had an active disease, 43.5% met the definition of remission on treatment, and 11.8% had a concomitant fibromyalgia. The median FACIT-F score of our cohort was significantly lower compared with that of healthy controls (40 vs 47; p<0.001). FACIT-F scores were irrespective of age, disease duration, disease activity and damage. FACIT-F score was significantly lower in patients with fibromyalgia (p<0.01). FACIT-F scores demonstrated a significant correlation with all other patient-reported outcomes: SF-36 (r=0.53-0.77), LIT (r=-0.78), SLAQ (r=-0.72) and BILD (r=-0.28).

Conclusions: Fatigue in patients with SLE has a strong negative impact on HRQoL and patient perception of the disease burden. Fatigue seems irrespective of disease activity but significantly influenced by the presence of fibromyalgia.
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http://dx.doi.org/10.1136/rmdopen-2019-001133DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7046978PMC
February 2020

Effectiveness of Adalimumab for the Treatment of Psoriatic Arthritis: An Italian Real-Life Retrospective Study.

Front Pharmacol 2019 13;10:1497. Epub 2019 Dec 13.

Department of Rheumatology, Hospital of Prato, Prato, Italy.

Few studies have evaluated the effectiveness of adalimumab in the real-life setting in psoriatic arthritis (PsA). To evaluate the 2-year retention rate of adalimumab in PsA patients. Potential baseline parameters influencing persistence on treatment were also evaluated. PsA patients from 16 Italian Rheumatology Units treated with adalimumab as first- or second-line biological therapy were retrospectively evaluated. Adalimumab retention rate was evaluated at 12 and 24 months. Logistic regression was used to evaluate the association between predictor variables and adalimumab retention rate. From 424 patients (53.5% male, aged 48.3 ± 12.8 years) who started treatment with adalimumab, 367 (86.6%) maintained treatment for 12 months and 313 (73.8%) for 2 years. At 24-months, Disease Activity in PsA (DAPSA) remission (defined as ≤4) and Low Disease Activity (LDA) (≤14) were achieved in 22.8% and 44.4% of patients, respectively. Adalimumab treatment significantly decreased the number of tender (7.0 ± 5.7 at baseline vs. 2.3 ± 3.5 at 24 months, p < 0.001) and swollen joints (2.7 ± 2.8 at baseline vs. 0.4 ± 0.9 at 24 months, p < 0.001), DAPSA (25.5 ± 10.9 at baseline vs. 11.0 ± 8.4 at 24 months, p < 0.001), PASI (5.3 ± 5.7 at baseline vs. 2.7 ± 2.8 at 24 months, p < 0.001) and CRP (3.8 ± 6.3 at baseline vs. 1.2 ± 1.7 at 24 months, p < 0.001). Among a range of laboratory and clinical variables, only female gender was associated with improved adalimumab persistence at 24 months (OR: 1.98, 95% CI: 1.2-3.2, p = 0.005). Independent of a range of predictor variables, adalimumab was shown to be effective, while maintaining a high retention rate after 2 years in PsA patients.
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http://dx.doi.org/10.3389/fphar.2019.01497DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6923751PMC
December 2019

One year in review 2018: axial spondyloarthritis.

Clin Exp Rheumatol 2019 Nov-Dec;37(6):889-898. Epub 2019 Nov 28.

Rheumazentrum Ruhrgebiet, Herne, Germany.

Spondyloarthritis (SpA) is the umbrella term for a broad spectrum of inflammatory rheumatic diseases with typical but also rather different clinical manifestations, limited laboratory abnormalities and characteristic imaging features. For classification purposes, a so-called non-radiographic form (nr-axSpA) is differentiated from a radiographic one (r-axSpA) which is almost identical to the classical ankylosing spondylitis (AS) that is genetically strongly associated with the major histocompatibility complex class 1 antigen HLA-B27. In axSpA, the axial skeleton is affected by both inflammation and new bone formation, and joints might be affected. Rather typical musculoskeletal manifestations of SpA are enthesitis and dactylitis, the latter mainly in psoriatic arthritis (PsA). Extra-articular manifestations such as acute anterior uveitis (AAU), psoriasis (PsO) and inflammatory bowel disease (IBD) are also typical of SpA. In this paper we review the literature on axial SpA (ax-SpA) of 2018 (Medline search of articles published from 1st January 2018 to 31st January 2019).
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December 2019

Framingham, ACC/AHA or QRISK3: which is the best in systemic lupus erythematosus cardiovascular risk estimation?

Clin Exp Rheumatol 2020 Jul-Aug;38(4):602-608. Epub 2019 Oct 28.

Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy.

Objectives: Our objective was to compare three algorithms for cardiovascular (CV) risk estimation, namely Framingham, ACC/AHA and QRISK3, in a cohort of patients with systemic lupus erythematosus (SLE).

Methods: Consecutive patients with SLE according to the ACR criteria were enrolled. Traditional risk factors, ongoing therapies, comorbidities and SLE-specific evaluations were assessed. In those without previous myocardial infarction or stroke, Framingham, ACC/AHA and QRISK3 algorithms were then used to estimate the individual risk of developing a CV disease over the next 10 years.

Results: Patients eligible for CV risk estimation were 123 out of 135 enrolled. Framingham index reported a median risk score of 4.7% (IQR 9.5-2.2), considering 29 patients (23.6%) at high CV risk. ACC/AHA index showed a median risk score of 1.4% (IQR 4.5-0.7), with 17 patients (13.8%) at high-risk. QRISK3 revealed a median risk score of 6.2% (IQR 12.5-2.8), making it possible to classify 44 patients (35.8%) at high CV risk. The subgroup analysis of subjects older than 40 years confirmed the same number of high-risk patients for both Framingham and ACC/AHA, whereas QRISK3 classified 38 subjects at high CV risk.

Conclusions: QRISK3 classifies a greater number of SLE patients at high-risk of developing CV diseases over the next 10 years in comparison with classic algorithms as Framingham and ACC/AHA. If its predictive accuracy were confirmed by longitudinal data, QRISK3 could become an important tool in the early detection of a considerable part of CV high-risk SLE patients that would be underestimated when applying classic algorithms.
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September 2020

Pregnancy and undifferentiated connective tissue disease: outcome and risk of flare in 100 pregnancies.

Rheumatology (Oxford) 2020 06;59(6):1335-1339

Rheumatology Unit, Department of Clinical and Experimental Medicine, Pisa.

Objective: UCTD is a systemic autoimmune condition that fails to fulfil the criteria for a definite CTD. Given that there are a lack of studies on links between pregnancy and UCTD, the purpose of this study was to evaluate the risk of disease flares or development of CTD in addition to the risk of adverse pregnancy outcomes in patients with UCTD.

Methods: This is a retrospective study using prospectively collected data for 100 pregnancies in 81 incidences of UCTD treated in a single referral centre.

Results: A total of 11 pregnancies (11%) ended in miscarriage in the first trimester and the remaining 89 (89%) ended with a live birth. Thirteen patients (13%) flared during pregnancy or puerperium and three (3%) suffered major flares that led to the development of SLE with renal involvement. Obstetric complications occurred in 26 of the 89 successful pregnancies (29%), including 1 case (1%) of pre-eclampsia; in some cases, a single pregnancy was affected by more than one complication. There was a significant link between disease flare and both anti-dsDNA-positive antibodies at baseline (P < 0.01) and disease activity at the beginning of pregnancy (P < 0.01).

Conclusion: The impact on pregnancy in the study's cohort appears to be less serious in UCTD than in other CTDs. Nevertheless, disease flares and obstetric complications can represent a clinical challenge and clinical and serological disease activity would appear to represent important determinants of pregnancy outcomes. Pre-pregnancy counselling and planning as well as close monitoring during pregnancy is therefore essential.
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http://dx.doi.org/10.1093/rheumatology/kez440DOI Listing
June 2020

Glucocorticoid withdrawal in systemic lupus erythematosus: are remission and low disease activity reliable starting points for stopping treatment? A real-life experience.

RMD Open 2019 11;5(2):e000916. Epub 2019 Jun 11.

Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Objectives: To evaluate the proportion of patients who have successfully withdrawn glucocorticoids (GCs) in a longitudinal cohort of patients with systemic lupus erythematosus (SLE) over a period of 6 years; to evaluate patient characteristics during GC withdrawal in relation to existing definitions of remission and Lupus Low Disease Activity State (LLDAS); and to evaluate the occurrence of flares after GC withdrawal.

Methods: Patients who attempted GC withdrawal were identified for the cohort, and the following information was assessed during withdrawal attempts: date of last disease flare, disease activity and damage and ongoing treatment. Information regarding the occurrence of disease flares after GC withdrawal was also recorded for patients who successfully stopped treatment.Definitions of remission were applied to GC withdrawal in line with European consensus criteria (Definitions of remission in SLE [DORIS]) and LLDAS in line with the Asian Pacific Lupus Consortium definition.

Results: 148 patients were involved in the study; GC withdrawal was attempted in 91 patients (61.5%) with 77 patients (84.6%) successfully stopping GCs. At the beginning of the GC reduction, the majority of patients were in complete or clinical remission (48.9% and 39.6%, respectively). Disease activity was significantly lower in patients who successfully stopped GCs, and the proportion of patients in complete remission was higher (54.2%) with respect to patients who failed in their attempt. Among patients who stopped GCs, 18 flares were recorded after a median of 1 year. The time period since the last flare was shorter in patients who experienced flares with respect to patients who did not flare (mean 0.93 years vs 6.0, p<0.001).

Conclusions: GC withdrawal is an achievable goal in SLE and may be attempted after a long-term remission or LLDAS to protect the patient from disease flares.
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http://dx.doi.org/10.1136/rmdopen-2019-000916DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6579574PMC
April 2020

One year in review 2018: psoriatic arthritis.

Clin Exp Rheumatol 2019 Mar-Apr;37(2):167-178. Epub 2019 Mar 19.

Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy.

Spondyloarthritis (SpA) is an inflammatory condition characterised by a broad spectrum of clinical manifestations, laboratory abnormalities and imaging features that genetically tend to be associated with the major histocompatibility complex class 1 antigen, HLA-B27, and in which both peripheral and axial joints might be affected. In addition to arthritis, the typical musculoskeletal manifestations are enthesitis and dactylitis. Extraarticular manifestations such as acute anterior uveitis (AAU), psoriasis (PsO) and inflammatory bowel disease (IBD) are also typical of SpA. In this article we have reviewed the literature of the past year on one of the most important variants of SpA, i.e. psoriatic arthritis (PsA) (Medline search of articles published from 1st January 2018 to 31st January 2019).
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May 2019

Antiphospholipid syndrome: state of the art on clinical practice guidelines.

RMD Open 2018 18;4(Suppl 1):e000785. Epub 2018 Oct 18.

Liga Portuguesa Contra as Doenças Reumáticas, Núcleo Síndrome de Sjögren, Lisbon, Portugal.

Antiphospholipid syndrome (APS) is a rare disease characterised by venous and/or arterial thrombosis, pregnancy complications and the presence of specific autoantibodies called antiphospholipid antibodies. This review aims to identify existing clinical practice guidelines (CPG) as part of the ERN ReCONNET project, aimed at evaluating existing CPGs or recommendations in rare and complex diseases. Seventeen papers providing important data were identified; however, the literature search highlighted the scarceness of reliable clinical data to develop CPGs. With no formal clinical guidelines in place, diagnosis and treatment of APS is largely based on consensus and expert opinion. Patients' unmet need refers to the understanding of the disease and its clinical picture and implications, the need of education for patients, family members and healthcare providers, as well as to the development of monitoring pathways involving multiple healthcare providers.
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http://dx.doi.org/10.1136/rmdopen-2018-000785DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6203101PMC
October 2018

Imaging of joints in systemic lupus erythematosus.

Clin Exp Rheumatol 2018 Sep-Oct;36 Suppl 114(5):68-73. Epub 2018 Oct 1.

Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy.

Musculoskeletal symptoms are among the most common manifestations in patients with systemic lupus erythematosus (SLE), being reported in up to 95% of patients; joint and tendon involvement can range from arthralgia to severe deforming arthropathy; while myositis a rare manifestation, comorbid fibromyalgia is reported in up to 40% of SLE patients. All these manifestations have a significant impact on the patients' quality of life, possibly leading to disability and functional impairment in daily living activities. In recent years, thanks to the availability of new imaging techniques for the assessment of tendon and joint pathologies, the approach to the definition and characterisation of these manifestations in SLE is constantly evolving. In this review we will therefore illustrate the state of the art of imaging techniques in the assessment of joint involvement in SLE, focusing on ultrasounds (US) and magnetic resonance (MRI), discussing their advantages, drawbacks and possible future developments. The main findings that emerge from the recent literature is that imaging studies may allow a more accurate definition of disease subtypes revealing an unexpected higher prevalence of joint and tendon involvement with respect to what known by clinical evaluation and standard radiography. Indeed, US and MRI also made possible the identification of joints and tendons pathologies in patients with no or very mild clinical symptoms. On the other hand, the interpretation of some findings remains uncertain, as well as the validity and feasibility of this analysis in clinical practice. Thus, further studies should clarify the clinical meaning of subclinical abnormalities detected in US and MRI scans and their impact on the long-term outcomes.
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January 2019

Remission and low disease activity in systemic lupus erythematosus: an achievable goal even with fewer steroids? Real-life data from a monocentric cohort.

Lupus Sci Med 2018 27;5(1):e000234. Epub 2018 Feb 27.

Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Objectives: To evaluate what proportion of patients fulfil the DORIS definition of remission, the definition of lupus low disease activity state (LLDAS) and LLDAS with a glucocorticoid (GC) dosage ≤5 (LLDAS5) in a longitudinal monocentric cohort of patients with SLE; to identify predictors of sustained remission and LLDAS attainment; to evaluate the effect of sustained remission and LLDAS on damage accrual over a period of 5 years and compare the two conditions in terms of clinical outcomes.

Methods: Retrospective analysis of data prospectively collected from patients with SLE followed from 2012 to 2016.

Results: 115 patients were included in this analysis. At baseline, 72% of patients were on LLDAS and almost all patients also fulfilled the LLDAS5 definition; 45% of patients were in remission on treatment, 12% were in remission off treatment, 26% were in complete remission on treatment, 2% were in complete remission off treatment. Disease activity at baseline was the strongest predictor of subsequent LLDAS and remission; the presence of joint and cutaneous manifestations was associated with a minor likelihood to achieve LLDAS or remission during follow-up.Patients in remission and LLDAS for the whole follow-up period accrued significantly less organ damage; on the contrary, patients who maintained all kinds of remissions or LLDAS for less than 50% of the time did not show any differences in damage accrual with respect to the rest of the cohort.

Conclusion: Remission and LLDAS, even with reduced GC use, are an achievable goal in clinical practice; sustained LLDAS and remission are both associated with reduced damage accrual.
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http://dx.doi.org/10.1136/lupus-2017-000234DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5844382PMC
February 2018

One year in review 2017: spondyloarthritis.

Clin Exp Rheumatol 2018 Jan-Feb;36(1):1-14. Epub 2018 Feb 5.

GenOMeC PhD, University of Siena; and Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy.

The term spondyloarthritis (SpA) represents a condition characterised by a broad spectrum of clinical manifestations, laboratory abnormalities and imaging features; in particular, SpA is an inflammatory condition in which both peripheral and axial joints might be affected. The majority of people with this disease have either psoriatic arthritis or axial spondyloarthritis, which includes ankylosing spondylitis. Less common subgroups are enteropathic SpA, which is associated with inflammatory bowel diseases (Crohn's disease and ulcerative colitis), reactive arthritis, which can occur in people following gastrointestinal or genitourinary infections and undifferentiated SpA, that does not meet the diagnostic criteria of the other subgroups at onset, but that may evolve to do so later. Very interestingly, much of the emerging data show how SpA, during its course, tends to associate with the development of some comorbidities; in particular, with cardiovascular diseases, diabetes mellitus, osteoporosis and depressive disorders. Healthcare professionals in non-specialist settings do not always recognise the signs and symptoms of SpA, particularly spinal symptoms, which may be mistakenly attributed to other causes of low back pain, thus leading to significant delays in diagnosis and treatment of the disease itself and of its related comorbidities, with consequent disease progression and disability, compromising the health-related quality of life of patients. In this paper we reviewed the literature of the past year (Medline search of articles published from 1st March 2016 to 28th February 2017) with the aim of approaching the spectrum of SpA from some different points of view, to try to give the reader an insight into this clinically challenging group of rheumatic pathologies.
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April 2018

Treatment with Allogenic Mesenchymal Stromal Cells in a Murine Model of Systemic Lupus Erythematosus.

Int J Stem Cells 2017 Nov;10(2):160-168

Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Objective: Pre-clinical and uncontrolled studies in patients with systemic lupus erythematosus (SLE) showed that mesenchymal stromal cells (MSCs) have a potential therapeutic role in refractory cases. The optimal therapeutic strategy in these patients remain to be elucidated. Our aim was to test the hypothesis that repeated administrations of 1×10/kg body weight of allogenic MSCs, that is a significantly lower dosage with respect to the fixed 1×10 MSC used in animal models, can be effective in improving the clinical course of a murine SLE model.

Methods: Bone marrow derived MSCs were obtained from 12-week-old C57BL/6J mice. Seventy-five 8 weeks old female NZ mice were randomly assigned to receive via caudal vein the following alternative treatments: 1) single infusion of 10 MSCs/kg body weight at 18 weeks of age (NZ) or at at 22 weeks of age (NZ); 2) multiple monthly infusions of 10 MSCs/kg body weight starting at 18 weeks of age (NZ) or at 22 weeks of age (NZ); 3) saline infusions (NZ) Fifteen 8 weeks old C57BL/6J mice (Envigo, Huntingdon, UK) were used as untreated controls (C). Weekly, body weight was recorded and twenty-four hour urines were collected by metabolic cages for each animal; proteinuria was detected by dipstick analysis. At sacrifice, peripheral blood samples were collected from mice and anti-dsDNA antibodies were detected by enzyme immunoassorbent assay (ELISA) method using commercial kits. At sacrifice, kidneys were analyzed for histopathology and immunohistochemical analysis for B220, CD4, MPO, CD4Foxp3, F40/80 infiltration was performed.

Results: Proteinuria occurrence was delayed NZ and NZ mice, no differences were observed in anti-dsDNA autoantibody titer among the groups at the different time-points; at 36 weeks, no significant differences were observed in term of nephritis scores. Inflammatory cells deposition (MPO and F4/80 positive cells) in NZ was significantly higher than in NZ and NZ. An overexpression of B lymphocytes (B220) was found in NZ while T regulatory cells (CD4 Foxp3 cells) were reduced in both NZ and NZ with respect to NZ.

Conclusions: Overall, our study failed to show a positive effect of a treatment with murine MSCs in this model and, for some aspects, even deleterious results seem to be observed.
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http://dx.doi.org/10.15283/ijsc17014DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5741197PMC
November 2017

Impact of Joint Involvement on Patients Reported Outcomes in Systemic Lupus Erythematosus.

Curr Rheumatol Rev 2018 ;14(2):188-192

Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy.

Objective: Joint involvement is common among patients with systemic lupus erythematosus (SLE). Aim of this work was to evaluate the correlation between the presence of joint involvement and patient-reported pain, perception of disease activity, general health and quality of life.

Methods: Fifty consecutive SLE patients were enrolled in the study. All patients underwent a complete clinical evaluation including a 44-joint count; in addition, an ultrasound evaluation of joint involvement of hands and wrists was performed. The following patients reported outcomes (PROs) were completed: Visual Analog Scales 0-100 mm (VAS) evaluating patients reported pain, patient's perception of global disease activity and general health (GH) and a validated Italian version of the Health Assessment Questionnaire (HAQ).

Results: Fourteen patients (28%) reported a significant morning stiffness lasting for more than 30 minutes; hand or wrist arthritis was clinically detectable in 10 (20%) patients, while the US evaluation exhibited at least one joint or tendon pathology in 18 patients (36%). The mean VAS score for pain and disease activity perception was 27 (±27.7) mm and 25.3 (±25.2) mm, respectively, the mean of GH score was 33.2 (±24.3) mm, and the mean HAQ score was 0.34 (±0.5). A significant correlation was observed between VAS score for pain, patient's perception of disease activity and GH and the presence of arthritis.

Conclusion: PROs may play an important role in guiding therapeutic decisions and suggest the utility of ultrasound evaluation in patients reporting articular symptoms.
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http://dx.doi.org/10.2174/1573397113666170314110022DOI Listing
October 2018

Adult-onset Still's disease: an Italian multicentre retrospective observational study of manifestations and treatments in 245 patients.

Clin Rheumatol 2016 Jul 20;35(7):1683-9. Epub 2016 May 20.

Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena, Italy.

Adult-onset Still's disease (AOSD) is a systemic inflammatory condition of unknown aetiology characterized by typical episodes of spiking fever, evanescent rash, arthralgia, leukocytosis and hyperferritinemia. Given the lack of data in Italian series, we promote a multicentric data collection to characterize the clinical phenotype of Italian patients with AOSD. Data from 245 subjects diagnosed with AOSD were collected by 15 centres between March and May 2013. The diagnosis was made following Yamaguchi's criteria. Data regarding clinical manifestations, laboratory features, disease course and treatments were reported and compared with those presented in other published series of different ethnicity. The most frequent features were the following: arthritis (93 %), pyrexia (92.6 %), leukocytosis (89 %), negative ANA (90.4 %) and neutrophilia (82 %). As compared to other North American, North European, Middle Eastern and Far Eastern cohorts, Italian data show differences in clinical and laboratory findings. Regarding the treatments, in 21.9 % of cases, corticosteroids and traditional DMARDs have not been able to control the disease while biologics have been shown to be effective in 48 to 58 patients. This retrospective work summarizes the largest Italian multicentre series of AOSD patients and presents clinical and laboratory features that appear to be influenced by the ethnicity of the affected subjects.
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http://dx.doi.org/10.1007/s10067-016-3308-8DOI Listing
July 2016

Early treatment with hydroxychloroquine prevents the development of endothelial dysfunction in a murine model of systemic lupus erythematosus.

Arthritis Res Ther 2015 Oct 6;17:277. Epub 2015 Oct 6.

Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Via Roma, 67, 56100, Pisa, Italy.

Introduction: Accelerated atherosclerosis is one of the major causes of morbidity in patients with systemic lupus erythematosus (SLE). Endothelial dysfunction (ED) is considered an early marker of atherosclerosis. It is a reversible alteration, thus representing an attractive target for prevention strategies against cardiovascular disease. Studies have shown that ED occurs in patients with SLE even in the absence of severe, active disease. Hydroxychloroquine (HCQ) is widely used in SLE to control disease activity, but its use is also associated with an improvement in long-term prognosis. Beyond the beneficial effect in well-established disease, our hypothesis is that treatment with HCQ might have a beneficial impact on ED prevention in SLE. The aim of this study was to assess the impact of early treatment with HCQ on ED in a murine model of SLE.

Methods: Twelve-week-old NZB/W F1 (NZ) and C57BL/6 J mice (controls) were allocated to receive HCQ or vehicle for 6, 12, or 18 weeks. Proteinuria and anti-double-stranded DNA autoantibodies were determined. ED was assessed in mesenteric arteries (pressurized myography). Nitric oxide (NO) availability and reactive oxygen species (ROS) production were evaluated. Vascular ROS production was measured with dihydroethidium (DHE) fluorescent dye.

Results: Starting from 18 weeks of age, NZ mice showed a progressive reduction in NO availability, which was normalized by ascorbic acid and apocynin in the up to 24-week-old group, and partly ameliorated in older animals. HCQ administration normalized the NO availability in the up to 24-week-old group, with a partial amelioration in the 30-week-old group. DHE analysis revealed a progressive increment of vascular ROS generation among NZ groups, which was prevented by apocynin. Similarly, in the NZ HCQ-treated group, vascular ROS production was abrogated.

Conclusions: The ED that characterizes this mouse model of SLE is caused by the nicotinamide adenine dinucleotide phosphate oxidase-driven ROS excess. Very early treatment with HCQ is able to exert vascular protection via an antioxidant effect.
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http://dx.doi.org/10.1186/s13075-015-0790-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4594997PMC
October 2015

Leukopenia, lymphopenia, and neutropenia in systemic lupus erythematosus: Prevalence and clinical impact--A systematic literature review.

Semin Arthritis Rheum 2015 Oct 21;45(2):190-4. Epub 2015 May 21.

Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Via Roma 67, Pisa 56100, Italy. Electronic address:

Objective: To systematically review the available evidence to evaluate (1) the prevalence and degree of leukopenia, lymphopenia, and neutropenia in patients with systemic lupus erythematosus (SLE), (2) whether these conditions carry a major infection risk for patients, and (3) whether a treatment with colony stimulating factors (CSF) can be an effective and safe option in SLE patients with leukopenia.

Material And Methods: MedLine and Embase were searched by including MeSH terms, text words, and subheadings "systemic lupus erythematosus," "leukopenia" (first search), and "colony stimulating factor" (second search). Inclusion and exclusion criteria were a priori defined and two reviewers screened the retrieved articles for selection criteria; data from the included studies were recorded in ad hoc standard forms; the results were synthesized and transported to evidence tables.

Results: A total of 17 articles were included in the systematic literature review: nine articles were retrieved for the first research question and 11 for the second while no articles satisfied the inclusion criteria for the third research question. The prevalence of leukopenia is reported in 22-41.8% of cases and lymphopenia is reported cumulatively from 15% to 82% of the patients while neutropenia is described in 20-40% of the patients. There is no evidence of a significant association between overall reduction of white blood cells and infection occurrence while some studies found a strong association between low lymphocytes/neutrophils count and the risk of major infections. Only case reports and case series have been found to investigate the safety of CSF in SLE patients.

Conclusions: The results of this systematic literature review are inconclusive for many aspects related to the original research questions and highlight the need for further studies. Indeed, the strength of the evidence is not sufficiently robust to draw specific recommendations on how to balance between the need to treat the patient with SLE with immunosuppressive drugs and the risk of severe infections.
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http://dx.doi.org/10.1016/j.semarthrit.2015.05.009DOI Listing
October 2015

One year in review 2015: systemic lupus erythematosus.

Clin Exp Rheumatol 2015 May-Jun;33(3):414-25. Epub 2015 Jun 22.

Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, and Genetic, Oncology and Clinical Medicine (GenOMeC) PhD, University of Siena, Italy.

Systemic lupus erythematosus is a multiorgan autoimmune disease with a highly variable clinical course, typically involving women in childbearing age. At present, many aspects of its pathogenesis still remain unclear. Moreover, although a significant increase of patient survival has been observed in the last decades, morbidity and mortality remain high. Finally, SLE impacts negatively on the health-related quality-of-life of patients. Therefore, multiple aspects of SLE still remain challenging and it continues to be the object of both clinical and translational clinical research. Herewith, we provide a critical digest of the recent literature on this topic.
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August 2015

Efficacy and safety of off-label use of rituximab in refractory lupus: data from the Italian Multicentre Registry.

Clin Exp Rheumatol 2015 Jul-Aug;33(4):449-56. Epub 2015 Jun 8.

Department of Medicine-DIMED, Division of Rheumatology, University of Padova, Italy.

Objectives: To evaluate the efficacy and safety of rituximab (RTX) in patients with systemic lupus erythematosus (SLE) refractory to standard therapy in the clinical practice setting.

Methods: 145 SLE patients (ACR criteria) were treated with RTX in 11 Italian Centres: 118 with two infusions (1 g), two weeks apart; 27 with 4 infusions (375 mg/m2), one week apart, followed in 10 cases by two further doses, after 1 and 2 months. Systemic complete response (CR) was defined as European Consensus Lupus Activity Measurement (ECLAM) score ≤1 and partial response (PR) as 1< ECLAM ≤3. Renal CR (RCR) and renal PR (RPR) were defined according to EULAR recommendations for management of lupus nephritis.

Results: Data from 134 (92.4%) patients were available. The mean±SD follow-up was 27.3±18.5 months. After the first course of RTX, CR or PR were observed in 85.8% and CR in 45.5% of cases; RCR or RPR in 94.1% and RCR in 30.9% of patients after 12-month follow-up. Disease flares occurred in 35.1% and renal flares in 31.2% of patients during observational period. Among patients retreated, CR or PR were observed in 84.4% and CR in 57.8% of cases. Adverse events, infections, and infusion reactions occurred after first RTX course in 23.8%, 16.4%, and 3.8% of patients and after retreatment in 33.3%, 22.2% and 11.1%, respectively. No severe infusion reactions or deaths occurred.

Conclusions: Data from Italian multicentre RTX Registry confirmed the efficacy and safety of RTX in SLE patients refractory to standard treatment in clinical practice setting.
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October 2015

The role of imaging in the evaluation of joint involvement in 102 consecutive patients with systemic lupus erythematosus.

Autoimmun Rev 2015 Jan 23;14(1):10-5. Epub 2014 Aug 23.

Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy.

Objective: To assess the prevalence of joint involvement in consecutive patients with systemic lupus erythematosus (SLE) by means of clinical assessment, joint US and MRI and to evaluate the sensitivity and specificity of physician evaluation of joint involvement.

Methods: At enrollment, patients underwent a complete physical examination including a 44-joint count, and hand deformities were scored. On the day of enrollment, each patient underwent a non-dominant hand-wrist ultrasound (US) examination and a non-dominant hand-wrist MRI study without contrast injection.

Results: One hundred and two patients (F 95, M 7) were enrolled. By physician examination hand or wrist involvement was diagnosed in 23.5%. At least one pathological finding was revealed by US examination at wrist and/or hand joints in 55%. We found a low sensitivity (46.5%) with high specificity (93.2%) of the physician assessment for the evaluation of joint involvement. The MRI imaging showed at least one erosion in 47.3% patients at the hand and in 98.9% at the wrist; in healthy subjects erosions were found in 19.6% and 97.8% at the hand and wrist, respectively.

Conclusions: In conclusion, (i) physicians tend to underestimate the severity of joint involvement in SLE; (ii) US assessment shows a high prevalence of joint and tendon involvement; and (iii) the MRI evaluation shows a high prevalence of damage, suggesting that joint involvement in SLE could be more severe than expected.
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http://dx.doi.org/10.1016/j.autrev.2014.08.007DOI Listing
January 2015

Prognostic value of flow-mediated dilation in patients with systemic lupus erythematosus: a pilot prospective cohort study.

Atherosclerosis 2014 Oct 4;236(2):381-4. Epub 2014 Aug 4.

Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

This pilot study evaluated the predictive value of flow-mediated dilation (FMD) for damage accrual in a cohort of SLE patients. Thirty-eight female SLE patients without cardiovascular involvement were enrolled. Clinical history, traditional cardiovascular risk factors, laboratory parameters, disease activity and damage and brachial artery FMD were collected at study entry and after a mean follow-up of 4.5 years. At enrollment, 18 patients (47%) presented active disease; mean FMD was 7.9 ± 3.1%, with no statistically significant differences between women with active and inactive disease. During the follow-up, 3 patients died and 14 accrued organ damage. Baseline FMD did not predict death and damage accrual. FMD showed significant decline over time, which was greater in patients with poor outcome (-3.9% vs -1.9%, p = 0.03). In conclusion, in a cohort of SLE patients, baseline FMD was not predictive of damage accrual. However, the latter was associated with progressive loss of FMD.
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http://dx.doi.org/10.1016/j.atherosclerosis.2014.07.023DOI Listing
October 2014

Ultrasound imaging in psoriatic arthritis and ankylosing spondylitis.

Clin Exp Rheumatol 2014 Jan-Feb;32(1 Suppl 80):S26-33. Epub 2014 Feb 17.

Dipartimento di Medicina Clinica e Sperimentale Università di Pisa, Pisa, Italy.

Musculoskeletal ultrasound (US) is a reliable imaging technique which has a key role in the assessment of patients with psoriatic arthritis (PsA) and ankylosing spondylitis (AS). US can help in the diagnosis of the disorder, in the evaluation of the extent of the joint and enthesis involvement and in therapy monitoring because it can reflect both morphostructural changes and inflammatory activity. Several studies have reported that US revealed pathological findings at joints and enthesis in a large number of PsA patients who do not complain of active pain and/or swelling at the time of the clinical examination and in psoriasis patients with no signs of musculoskeletal disease. The application of US in the evaluation of nail and skin involvement in patients affected by psoriasis, with or without arthritis, and the imaging of sacroiliac joints is an interesting approach. US has already become commonplace in both clinical and research fields, and improvements in US technology will offer further possibilities for future research.
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April 2014

The diagnosis and classification of undifferentiated connective tissue diseases.

J Autoimmun 2014 Feb-Mar;48-49:50-2. Epub 2014 Feb 8.

Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy.

The term undifferentiated connective tissue disease (UCTD) refers to unclassifiable systemic autoimmune diseases which share clinical and serological manifestations with definite connective tissue diseases (CTDs) but not fulfilling any of the existing classification criteria. In this review we will go through the more recent evidence on UCTD and we will discuss in what extent the availability of new criteria for the CTDs could interfere with the "UCTD concept". The development of criteria able to identify early phases of defined CTD, may help in the differentiation of stable UCTD form their early stages and may offer a valuable guide to the treating physician to set up appropriate follow up schedules as well as therapeutic protocols. This simplified subset of CTD could offer a model to study clinic pathological correlations as well as the role of possible environmental factors in the development of autoimmunity.
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http://dx.doi.org/10.1016/j.jaut.2014.01.019DOI Listing
October 2014