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OBJECTIVE To assess the variables associated with the status of low myocardial mechano-energetic efficiency (MEE) [the ratio between myocardial left ventricular (LV) work and magnitude of myocardial oxygen consumption] and whether low-MEE is a prognosticator of adverse cardiovascular outcome in patients with chronic inflammatory arthritis. METHODS A total of 432 outpatients with established chronic inflammatory arthritis without overt cardiac disease were recruited from March 2014-March 2016; 216 participants were used as comparison group. Low-MEE status was a priori identified by standard echocardiography at rest as less than 0.32 ml/s per g (5th percentile of MEE calculated in 145 healthy individuals). The pre-specified primary end-point of the study was a composite of cardiovascular death/hospitalization. Follow-up ended September 2019. RESULTS MEE was significantly lower in chronic inflammatory arthritis patients than controls (0.35 ± 0.11 vs. 0.45 ± 0.10 ml/s per g; P

We read with great interest the 2019 update of the European League Against Rheumatism (EULAR) recommendations for the management of systemic lupus erythematosus (SLE) published by Fanourakis et al .1 We would like to compliment the authors with their efforts to formulate updated recommendations which will help to improve the management of patients with SLE. They focus on different domains and introduce new concepts on disease treatment and management. The recommendations also deal with comorbidities, a huge problem in SLE patients, providing recommendations for the management of the antiphospholipid syndrome, infections and cardiovascular disease risk assessment and management. As the authors underline, the management of comorbidities in SLE is a key target to reduce damage accrual, disability and mortality. However, we believe that also osteoporosis and fractures should be considered as a …

In this retrospective study, we intended to investigate the baseline fracture risk profile in patients who started treatment with different anti-osteoporotic medications. We analyzed retrospectively the fracture risk calculated with DeFRA, a validated FRAX derived tool, in women who started an anti-osteoporotic treatment from 2010 to 2017. We analyzed baseline data of 12,024 post-menopausal women aged over 50 years. Teriparatide initiators had a baseline 10-year risk of major osteoporotic fracture of 82.1% with a Standard Deviation (SD) of 66.5%. Denosumab initiators and zoledronic acid initiators had a greater 10-year baseline risk of fracture (54.3%, SD 46.5% and 47.0%, SD 42.0 respectively) than patients initiated on alendronate (24.9%, SD 34.6%) and patients initiated on risedronate (23.9%, SD 24.1%). Using DeFRA, a FRAX™ derived tool, we showed significantly different fracture risk profiles in women who were started on various therapeutic agents for the treatment of osteoporosis in routine clinical practice.

Objectives: Subclinical left ventricular (LV) abnormalities have been reported in echocardiographic studies of patients with psoriatic arthritis (PsA). Left ventricular systolic dysfunction (LVSD) ...

Systemic chronic inflammation may favor the onset of metabolic syndrome (MetS) which represents a risk factor for CV events. Rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) are disorders with high prevalence of MetS. We assessed the factors associated with MetS and its prognostic role in non-selected RA/AS/PsA patients. Between March 2014 and April 2016, 458 patients (228 RA, 134 PsA, 96 AS) selected for a primary prevention program for cardiovascular diseases were analyzed. Primary and co-primary end points were a composite of all-cause death/all-cause hospitalization and CV death/CV hospitalization, respectively. MetS was diagnosed according to the IDF Task Force on Epidemiology and Prevention. Patients were divided into MetS + (73 = 16%) and MetS − (385 = 84%). At multivariate logistic analysis, cancer, moderate/high disease activity, higher LV mass (LVM) and degree of LV diastolic dysfunction were independently associated with MetS. At 36-month follow-up, the event rate for primary/co-primary end point was 52/15% in MetS + vs 23/7% in MetS − (both p p = 0.04) together with higher LVM, disease duration and higher prevalence of biologic DMARDs refractoriness, and to co-primary end point (HR 2.05 [CI 1.16–3.60], p = 0.01) together with older age and higher LVM. The RA/AS/PsA phenotype MetS + is a subject with moderate/high disease activity, LV structural and functional abnormalities at increased risk for cancer. MetS + identifies RA/AS/PsA patients at higher risk for CV and non-CV events, independently of traditional CV risk factors analyzed individually and traditional indexes of inflammation.

OBJECTIVES: Italy was one of the first countries significantly affected by the coronavirus disease 2019 (COVID-19) epidemic. The Italian Society for Rheumatology promptly launched a retrospective and anonymised data collection to monitor COVID-19 in patients with rheumatic and musculoskeletal diseases (RMDs), the CONTROL-19 surveillance database, which is part of the COVID-19 Global Rheumatology Alliance. METHODS: CONTROL-19 includes patients with RMDs and proven severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) updated until May 3rd 2020. In this analysis, only molecular diagnoses were included. The data collection covered demographic data, medical history (general and RMD-related), treatments and COVID-19 related features, treatments, and outcome. In this paper, we report the first descriptive data from the CONTROL-19 registry. RESULTS: The population of the first 232 patients (36% males) consisted mainly of elderly patients (mean age 62.2 years), who used corticosteroids (51.7%), and suffered from multi-morbidity (median comorbidities 2). Rheumatoid arthritis was the most frequent disease (34.1%), followed by spondyloarthritis (26.3%), connective tissue disease (21.1%) and vasculitis (11.2%). Most cases had an active disease (69.4%). Clinical presentation of COVID-19 was typical, with systemic symptoms (fever and asthenia) and respiratory symptoms. The overall outcome was severe, with high frequencies of hospitalisation (69.8%), respiratory support oxygen (55.7%), non-invasive ventilation (20.9%) or mechanical ventilation (7.5%), and 19% of deaths. Male patients typically manifested a worse prognosis. Immunomodulatory treatments were not significantly associated with an increased risk of intensive care unit admission/mechanical ventilation/death. CONCLUSIONS: Although the report mainly includes the most severe cases, its temporal and spatial trend supports the validity of the national surveillance system. More complete data are being acquired in order to both test the hypothesis that RMD patients may have a different outcome from that of the general population and determine the safety of immunomodulatory treatments.

Osteoporosis is a skeletal disorder characterized by impaired bone strength and increased risk of fragility fracture and is among the most relevant comorbidities of rheumatic diseases. The purpose of the present review is to discuss the pathogenesis of local and systemic bone involvement in inflammatory arthritides, especially Rheumatoid Arthritis, Psoriatic Arthritis, and Spondyloarthritides, as well as the effect of anti-rheumatic treatments and anti-osteoporotic medication on bone health and fracture incidence, including recent data on novel therapeutic perspective.

Inflammatory arthritis, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS), are associated with both cancer and cardiovascular (CV) adverse events. Cancer and CV abnormalities have coincident etiologic and pathophysiologic pathways in RA/PsA/AS patients. However, a comprehensive evaluation of CV system has never been performed in these patients in relation to the presence of cancer. This study was designed to assess the possible relationships between CV abnormalities and cancer among RA/PsA/AS patients. Between March 2014 and March 2015, 414 patients (214 RA, 125 PsA, and 75 SA) in sinus rhythm without known cardiac disease underwent clinical and color Doppler echocardiographic evaluation and were prospectively followed up. Patients had a mean age of 58 ± 12 years, 64% women. Forty-two patients (10.1%) had a diagnosis of cancer (made before enrollment in 24 cases and in 18 cases during the 36 months of follow-up). Skin cancer was the most frequent malignancy found, followed by thyroid, colon, pancreas, and breast cancer. Patients who had cancer were older with higher systolic blood pressure, more frequent hypertension and moderate/high disease activity, left ventricular (LV) hypertrophy, diastolic dysfunction, and higher ascending aortic stiffness index (AOSI) than those who had not. At multivariate logistic regression analysis, LV diastolic dysfunction and abnormally high AOSI emerged as conditions associated with cancer together with older age and hypertension. Cancer in RA/PsA/AS adults without history of CV disease is closely associated with specific asymptomatic CV abnormalities, such as LV diastolic dysfunction and reduced vascular elasticity, which are independent of age and hypertension.

Objective To investigate predictors of response, remission, low disease activity, damage, and drug discontinuation in patients with systemic lupus erythematosus (SLE) who were treated with belimumab. Methods In this retrospective study of a multicenter cohort of SLE patients who received intravenous belimumab, the proportion of patients who achieved remission, low disease activity, and treatment response according to the SLE Responder Index 4 (SRI-4) was determined, and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) was used to score disease damage yearly over the follow-up. Predictors of outcomes were analyzed by multivariate logistic regression with the results expressed as odds ratios (ORs) and 95% confidence intervals (95% CIs). Results The study included 466 patients with active SLE from 24 Italian centers, with a median follow-up period of 18 months (range 1-60 months). An SRI-4 response was achieved by 49.2%, 61.3%, 69.7%, 69.6%, and 66.7% of patients at 6, 12, 24, 36, and 48 months, respectively. Baseline predictors of response at 6 months included a score of ≥10 on the SLE Disease Activity Index 2000 (SLEDAI-2K) (OR 3.14 [95% CI 2.033-4.860]) and a disease duration of ≤2 years (OR 1.94 [95% CI 1.078-3.473). Baseline predictors of response at 12 months included a score of ≥10 on the SLEDAI-2K (OR 3.48 [95% CI 2.004-6.025]) and an SDI score of 0 (OR 1.74 [95% CI 1.036-2.923]). Baseline predictors of response at 24 months included a score of ≥10 on the SLEDAI-2K (OR 4.25 [95% CI 2.018-8.940]) and a disease duration of ≤2 years (OR 3.79 [95% CI 1.039-13.52]). Baseline predictors of response at 36 months included a score of ≥10 on the SLEDAI-2K (OR 14.59 [95% CI 3.54-59.79) and baseline status of current smoker (OR 0.19 [95% CI 0.039-0.69]). Patients who were in remission for ≥25% of the follow-up period (44.3%) or who had low disease activity for ≥50% of the follow-up period (66.1%) accrued significantly less damage (P = 0.046 and P = 0.007). A baseline SDI score of 0 was an independent predictor of achieving low disease activity in ≥50% of the follow-up period and remission in ≥25% of the follow-up period. Our findings suggest that the lower the baseline damage, the greater the probability of achieving remission over the course of ≥25% of the follow-up. Further, there was a negative association between the number of flares reported prior to belimumab initiation and the frequency of belimumab discontinuation due to inefficacy (P = 0.009). Conclusion In patients with active SLE and low damage at baseline, treatment with belimumab early in the disease may lead to favorable outcomes in a real-life setting.

BACKGROUND Inflammatory arthritis including rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) are disorders at increased risk of morbidity and mortality for which a validated prognostic tool for facilitating clinical management is needed. CHA2 DS2 -VASc (congestive heart failure/hypertension/age diabetes/stroke/vascular disease/age/sex category) score was initially conceived and used to estimate thromboembolic risk in non-valvular atrial fibrillation, and then successfully applied in community populations with sinus rhythm. We tested CHA2 DS2 -VASc-score as a prognosticator of adverse outcomes in patients in sinus rhythm with RA/AS/PsA. METHODS Between March 2014 and March 2015, 414 patients (214 RA, 75 AS, 125 PsA) in sinus rhythm without cardiac disease were consecutively analyzed and prospectively followed-up. Primary and co-primary end-points were a composite of all-cause death/all-cause hospitalization and CV death/CV hospitalization, respectively. RESULTS Patients were divided into LOWscore and HIGHscore groups if CHA2 DS2 -VASc was = 0/1 point or greater than 1 point, respectively. The HIGHscore group comprised 190 patients who were older with higher prevalence of CV risk factors and arthritis disease activity than 224 LOWscore patients. During a follow up of 36 months, the event rate for primary and co-primary end-point was 37% and 12% in the HIGHscore vs 22% and 4% in LOWscore group (P = .001 and .002 respectively). At multivariate Cox regression analysis CHA2 DS2 -VASc-score was related to primary end-point (hazards ratio [HR] 1.30 [1.07-1.59], P = .009) and co-primary end-point (HR 1.35 [1.01-1.79], P = .04) independently of traditional CV risk factors analyzed individually and indexes of inflammation or disease duration. CONCLUSION CHA2 DS2 -VASc-score accurately identifies in the mid-term patients in sinus rhythm with RA/AS/PsA at different risks for CV and non-CV mortality and hospitalization.

Systemic mastocytosis can give very different bone pictures: from osteosclerosis to osteoporosis. Osteoporosis is one of the most frequent manifestations particularly in adults and the most clinical relevant. It is often complicated by a high recurrence of mainly vertebral fragility fractures. The main factor of bone loss is the osteoclast with a relative or absolute predominance of bone resorption. The RANK-RANKL pathway seems of key importance, but histamine and other cytokines also play a significant role in the process. The predominance of resorption made bisphosphonates, as anti-resorptive drugs, the most rational treatment of bone involvement in systemic mastocytosis.

Available studies reported contradictory results about serum levels Dickkopf-1 (DKK1), an inhibitor of Wnt signaling in patients with ankylosing spondylitis (AS). In previous studies, we observed in other conditions that parathyroid hormone (PTH) serum levels were an important determinant of DKK1 serum levels. The aim of the present study was to investigate it in patients with AS. We recruited 71 patients diagnosed with AS. Levels of C-reactive protein (CRP), DKK1, PTH, 25OH-vitamin D, and bone turnover markers (intact N-propeptide of type I collagen, P1NP, and C-terminal telopeptide of type I collagen, CTX) were measured and compared to healthy controls (HC). Dual X-ray absorptiometry at lumbar spine and proximal femoral site was used for bone mineral density (BMD) assessment and spine X-rays were also performed. PTH serum levels were found to be significantly higher in AS patients than in HC (33.8 ± 14.11 vs 24.8 ± 13 pg/ml, p = 0.002), while mean DKK1 serum levels were lower than in HC (23.3 ± 13.1 vs 29.8 ± 15.9 pmol/l, p = 0.009). A positive correlation between DKK1 and PTH (correlation coefficient + 0.25, p = 0.03) was observed; it remained significant in a multivariate analysis. In patients with longer disease duration, DKK1 was also positively correlated with CTX (coefficient 0.42, p = 0.01), and PTH was higher in those patients with low BMD (Z-score ≤ - 1) at any site (p = 0.04). Also in AS, PTH is an important determinant of DKK1 serum levels and should be evaluated in studies on DKK1. PTH might have a role in bone involvement in AS, also through the Wnt pathway.

Background Due to chronic inflammatory status, rheumatoid arthritis (RA) patients are exposed to changes in left ventricular (LV) geometry and function. We assessed prevalence, factors associated with, and prognostic role of concentric LV geometry and systolic dysfunction (LVSD) detected by echocardiography in a large cohort of patients with RA and normal blood pressure. Hypothesis Changes in LV geometry and function are widely detectable in normotensive patients with RA analyzed in primary prevention. Methods We prospectively analyzed 194 normotensive RA patients without overt cardiac disease recruited between March 2014 and May 2016, compared with 194 non-RA matched controls. Relative wall thickness >0.43 defined concentric LV geometry. LVSD was defined as impaired global longitudinal strain (GLS). The prespecified study endpoints were all-cause hospitalization and hospitalization for cardiovascular cause. Results The 194 normotensive subjects (mean age, 54 years; 63% female; RA duration 13 years) had a prevalence of LV concentric geometry 5-fold higher and LVSD 5-fold higher than non-RA matched controls. Body mass index, LVSD, and diastolic dysfunction were associated with concentric LV geometry, while worsening renal function and older age were associated with LVSD. LVSD was independently related to the study endpoints (HR 2.37 [1.24-4.53], p = 0.009, for all-causes hospitalization and HR 6.60 [1.47-29.72], p = 0.01 for cardiovascular hospitalization). Conclusions Despite normotensive status, a consistent proportion of RA patients analyzed in primary prevention have cardiac abnormalities detectable by echocardiography. LVSD is a strong prognosticator of adverse outcome at midterm period in these patients.

Dicckopf-1 (Dkk-1) is a potent inhibitor of the Wnt canonical pathway. In rheumatoid arthritis (RA), Dkk-1 is upregulated by tumor necrosis factor-α (TNF). Certolizumab pegol (CMZ) is a biologic TNF-inhibitor (TNFi) effective in RA and slows radiographic progression. Data on the immediate effects (≤1-8 weeks) of TNFi on Wnt modulators are lacking. This study investigated the acute influence of TNFi treatment on Wnt modulators (Dkk-1 and sclerostin) and bone turnover markers (BTM), including intact N-terminal propeptide of collagen type I (PINP) and C-terminal telopeptide of type I collagen (CTX-I).This longitudinal, uncontrolled study involved female RA patients with inadequate response to conventional methotrexate who underwent treatment with CMZ. ESR, Dkk-1, sclerostin, BTM, parathyroid hormone (PTH), and 25OH-vitamin D levels were evaluated at baseline, week 1, week 4, and week 8. Radiographs of the hands and feet were obtained at baseline and the total and erosion scores were assessed using the Simple Erosion Narrowing Score method (SENS).Seventeen patients were enrolled. Dkk-1 and CTX-I significantly decreased after one week of treatment with CMZ (-49.1 ± 17.1% and -25.0 ± 20.6%, respectively, p 0.01), whereas PINP increased (+43.2 ± 31.5%, p 0.01). These changes persisted at week 4 and 8.Our study showed that TNF-alpha inhibition with CMZ promptly results in a rapid decline of serum Dkk-1 levels, alongside decreased bone resorption and increased bone formation.

Background:LN is still a severe manifestation of Systemic lupus erythematosus (SLE) and multitarget therapy is needed to control the disease especially in refractory cases.Objectives:To evaluate renal response in SLE patients with glomerulonephritis (GN) treated with Belimumab in real-life setting.Methods:Patients with proteinuria >0.5 g/24 h and/or active sediment at baseline enrolled in a multicentre Italian cohort of SLE patients (BeRLiSS study), treated with monthly iv Belimumab 10 mg/kg plus standard of care were considered in this study. Complete renal response (CRR) was defined as proteinuria 2 and no rescue therapy. Primary efficacy renal response (PERR) was defined as proteinuria ≤0.7 g/24 h, eGFR ≥60ml/min/1.73m2 and no rescue therapy. Prevalence and predictive factors of CRR and PERR at 12 and 24 months after Belimumab initiation were analyzed by multivariate logistic regression analysis.Results:A total of 91 patients were considered in this study, 79 female, mean age 40.51±9.03 years, mean disease duration 12.18±8.15 years, median follow-up time after Belimumab initiation 22 months. Twenty patients had baseline proteinuria ≥0.5 2 at baseline. Immunosuppresants were taken by 70 (76.9%) patients: 47 micofenolate, 15 azathioprine and 5 ciclosporine. Sixty patients (65.9%) were on antimalarials. During follow-up 34 (37.4%) patients achieved CRR. Among them 5 (14.7%) patients relapsed and 29 (85.3%) patients maintained remission. Mean time to achieved CRR was 9.71±5.91 months.High levels of baseline proteinuria were a negative independent predictor of CRR and PERR at 6 months (OR 0.044 CI95% 0.006-0.320 p=0.002 and OR 0.232 CI95% 0.091-0.596 p=0.002) and 12 months (OR 0.029 CI95% 0.002-0.556 p=0.019 and OR 0.056 CI95% 0.009-0.327 p=0.001). High levels of baseline creatinine were a negative independent predictor of renal response. Renal response at 6 months was a strong predictive factor of renal response at 12 and 24 months.Conclusion:Belimumab is an effective add-on therapy in the treatment of GN in real-life practice setting.Disclosure of Interests:None declared

Systemic mastocytosis (SM) is a heterogeneous group of diseases that affect almost exclusively adults and are defined by the proliferation and accumulation of clonal mast cells (MC) in various tissues. Disease subtypes range from indolent to rare but aggressive forms. Although SM is classified as a rare disease, it is believed to be likely underdiagnosed. Major signs and symptoms mainly depend on MC activation and less frequently to organ infiltration, typical of more aggressive variants. Diagnosis may be challenging, and symptoms can be aspecific and involve several organs. It is advisable to refer patients to specialized centers, having sufficient knowledge of the disease, sensitive diagnostic procedures, offering a personalized and multidisciplinary diagnostic approach, including at least hematological, allergological, dermatological and rheumatological evaluations. A precise and timely diagnosis is required for: a) adequate counseling of patients and their physicians; b) beginning of symptomatic treatment (anti-mediator therapy); c) prevention of severe manifestations of the disease (i.e., recurrent anaphylaxis, osteoporosis and bone fractures); d) cytoreductive treatment of advanced SM variants. This review aims to summarize the main manifestations of the disease and describe the ideal diagnostic approach for adult patients with suspected SM, giving physicians the main notions for correct patient diagnosis and management. This review also highlights the importance of a multidisciplinary approach in this very complex disease.

Patients with chronic inflammatory arthritis experience an increased incidence of cardiovascular (CV) events. In addition to visualizing atherosclerotic plaques, ultrasound examinations (USs) of the carotid arteries permit the measurement of subclinical markers of atherosclerosis, such as intima-media thickness (cIMT) and carotid segmental distensibility (cDC). The aims of the study were to identify the determinants of atherosclerosis acceleration (plaques, cIMT and cDC) in a sample of patients suffering from chronic arthritis and to compare these patients with a control group of people with ≤1 traditional risk factor (TRF) for CV disease.We recruited 137 patients with rheumatoid arthritis (RA), 43 patients with psoriatic arthritis (PsA), 28 patients with ankylosing spondylitis (AS) and 48 healthy volunteers without histories of previous CV events. These patients underwent carotid artery US examinations using dedicated hardware.Regression and multivariate analyses demonstrated that only age (p0.001) was consistently associated with cDC, cIMT and atherosclerotic plaques, both in the entire sample of patients with arthritis and in the subgroup of patients with RA. Among modifiable TRFs for cardiovascular disease, only hypertension, diabetes mellitus and smoking exhibited associations with some carotid phenotypes, with borderline significance. When patients with RA carrying ≤1 TRF were compared with control subjects carrying ≤1 TRF, only cDC was slightly lower in the RA group than in the control group.Age is the major determinant of subclinical atherosclerosis in patients with different types of arthritis, as the contributions of other TRFs and disease activity and duration indices to the disease seem to be limited.

Bone loss in rheumatoid arthritis (RA) is a key feature both local and systemic. Anti-citrullinated protein antibodies (ACPA) have recently been found to directly induce differentiation and activation of osteoclasts and therefore contribute to periarticular bone loss. The aim of this study was to analyze the effect of ACPA on systemic bone mineral density (BMD) in patients with established RA. This is a cross-sectional study with a single-center RA population. BMD was measured with Dual X-ray absorptiometry at lumbar and femoral sites. ACPA were measured by EIA. Multivariate analysis was performed adjusting for the main confounding variables. One hundred twenty-seven RA patients were enrolled. In univariate analysis, ACPA-positive patients showed lower BMD Z-score (SD below the age- and gender-matched mean reference value) at femoral sites (p

Chronic inflammation, such as that present in rheumatoid arthritis (RA) and psoriatic arthritis (PsA), leads to aberrations in bone remodeling, which is mediated by several signaling pathways, including the Janus kinase-signal transducer and activator of transcription (JAK-STAT) pathway. In this light, pro-inflammatory cytokines are now clearly implicated in these processes as they can perturb normal bone remodeling through their action on osteoclasts and osteoblasts at both intra- and extra-articular skeletal sites. As a selective inhibitor of JAK1 and JAK3, tofacitinib has the potential to play a role in the management of rheumatic diseases such as RA and PsA. Preclinical studies have demonstrated that tofacitinib can inhibit disturbed osteoclastogenesis in RA, which suggests that targeting the JAK-STAT pathway may help limit bone erosion. Evidence from clinical trials with tofacitinib in RA and PsA is encouraging, as tofacitinib treatment has been shown to decrease articular bone erosion. In this review, the authors summarize current knowledge on the relationship between the immune system and the skeleton before examining the involvement of JAK-STAT signaling in bone homeostasis as well as the available preclinical and clinical evidence on the benefits of tofacitinib on prevention of bone involvement in RA and PsA.Key Points• Chronic inflammation in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) leads to disturbances in bone remodeling• Bone remodeling is mediated by several signaling pathways, including the JAK-STAT pathway• Tofacitinib, a selective inhibitor of JAK1 and JAK3, is active in RA and PsA and may help limit systemic bone loss through inhibiting disturbed osteoclastogenesis• Clinical trials show that tofacitinib reduces articular bone erosion

Rheumatoid arthritis (RA) is associated with higher risk of heart failure. Several studies report that left ventricular (LV) diastolic dysfunction (LVDD), a silent precursor of heart failure, is widely present in RA patients. Very little is known about the factors related to the development of LVDD in this disease. In this study we assessed the incidence and the predictors of new-onset LVDD in RA patients. Two-hundred-ninety-five adults with RA without overt cardiac disease were prospectively analyzed from March 2014 to March 2015 by Doppler echocardiography. Among the 295 subjects evaluated, 217 (73.6%) had normal LV diastolic function and represented the final study population. At 1-year follow-up, 53 of 217 patients (24%) developed LVDD, which was of degree I (mild dysfunction) in all of them. By multivariate logistic regression analysis, lower E/A ratio of transmitral flow (ratio between the peak velocity of early diastolic “E” wave and late diastolic “A” wave of transmitral flow) was independently associated with new-onset LVDD [OR 0.17 (CI 0.09-0.57)], together with older age and higher systolic blood pressure. In a clinical predictive model derived from multivariate analysis, the new-onset LVDD rate event ranged from 0% (patients without any factor) to 75% (patients in whom the three predictors coexisted). A significant portion of patients with RA without overt cardiac disease develop LVDD at 1-year follow-up. This condition can be predicted by a simple clinical model which could improve the clinical management and the prognostic stratification of patients with RA.

Inflammatory arthritis including rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) are disorders at increased risk of morbidity and mortality for which a validated prognostic tool for facilitating clinical management is needed. CHABetween March 2014 and March 2015, 414 patients (214 RA, 75 AS, 125 PsA) in sinus rhythm without cardiac disease were consecutively analyzed and prospectively followed-up. Primary and co-primary end-points were a composite of all-cause death/all-cause hospitalization and CV death/CV hospitalization, respectively.Patients were divided into LOWscore and HIGHscore groups if CHACHA

Background: Vitamin D is known to influence the immune system in many different diseases although longitudinal studies on systemic sclerosis (SSc) are still missing. Objectives: this study wants to investigate if variations in vitamin D serum levels (25OHD) over time affect digital ulcers (DU) in SSc. Methods: this is a retrospective study on 65 patients. Data on disease characteristics and 25OHD were collected in 2011 and 2016. Results: The mean age of our cohort was 58 (12) years with a mean disease duration of 9.5 (5.3) years. Most of our patients had a limited subset (69.2%). At baseline 50.8% and 41.5% after 5 years had 25OHD Conclusion: In this study we have shown that a decrease in 25OHD increases the risk of developing DUs and that vitamin D supplementation with the doses currently recommended may be insufficient in SSc. Further studies in wider cohorts are needed to confirm these results and to evaluate the effectiveness of a more aggressive or different vitamin D supplementation. Disclosure of interests: Cristian Caimmi: None declared, Eugenia Bertoldo: None declared, alice Pozza: None declared, Paola Caramaschi: None declared, Giovanni Orsolini Speakers bureau: Grunenthal, Davide Gatti Speakers bureau: abiogen, amgen, Janssen-Cilag, Mundipharma, Pfeizer, Maurizio Rossini: None declared, Ombretta Viapiana Speakers bureau: Novartis, abbvie, Eli-Lilly, Sanofi Genzyme

Background Occult left ventricular (LV) systolic dysfunction (LVSD) is associated with worse cardiovascular outcomes in asymptomatic patients with arterial hypertension and/or diabetes mellitus. In these patients, LV systolic function may worsen or improve overtime. However, little is known about the changes in LV function during follow up of patients with rheumatoid arthritis (RA). Objectives This prospective study analyzed incidence and factors associated with changes in LV systolic function in patients with RA without known cardiovascular disease. Methods One-hundred-forty outpatients with RA without overt cardiac disease were recruited between March and December 2014. Patients underwent clinical and echocardiographic evaluation at baseline and after a median period [min-max] of 35 [23-47] months of follow up. Stress-corrected midwall fractional shortening (sc-MFS) was used as measure of LVSD and considered impaired if Results Impaired sc-MFS at follow up (sc-MFS-FU) was detected in 60/140 (43%) patients who were compared with 80 patients with normal sc-MFS-FU. Baseline sc-MFS did not differ significantly between the two groups, which appeared to diverge significantly soon after 1-year of follow up (figure). Baseline anti-citrullinated protein antibodies (ACPA) positivity, high disease activity (CDAI>10) and duration of RA were independently associated with impaired sc-MFS-FU at multiple logistic regression analysis. Among these parameters, ACPA had the highest sensitivity (80%) whereas high disease activity had the highest specificity (89%) for sc-MFS-FU. A predictive score including all three predictors (ACPA status, CDAI>10 and duration of RA) detected impaired sc-MFS-FU with a sensitivity of 78% and specificity of 82% (AUC 0.80 [IC 0.72-0.88], p Conclusion This study supports the hypothesis that changes overtime in LVSF in patients with RA are associated with ACPA, high disease activity and duration of disease. Disclosure of Interests: Alessandro Giollo: None declared, Giovanni Cioffi: None declared, Giovanni Orsolini Speakers bureau: Grunenthal, Luca Idolazzi: None declared, Antonio Carletto Speakers bureau: Roche, Novartis, MSD, Abbvie, Bristol, Jannsen, Celgene, Pfizer, Andrea Dalbeni: None declared, Federica Ognibeni: None declared, Elena Fracassi Speakers bureau: Novartis, Davide Gatti Speakers bureau: Abiogen, Amgen, Janssen-Cilag, Mundipharma, Pfeizer, Maurizio Rossini: None declared, Ombretta Viapiana Speakers bureau: Novartis, Abbvie, Eli-Lilly, Sanofi Genzyme

Background Belimumab is the unique biologic therapy available for patients with SLE. Objectives To investigate effectiveness and safety of belimumab in SLE patients in clinical practice. Methods 458 active SLE patients (ACR criteria) from 24 Italian Centers, mean±SD age 43.5±11.3 years; mean±SD disease duration 12.3±8.7 years, were treated with belimumab (10 mg/kg day 0, 14, 28 and then every 28 days), as add-on therapy. SLEDAI-2K, anti-dsDNA, C3, C4, prednisone daily dose, DAS-28, 24H proteinuria, CLASI, PGA, Fatigue (VAS 0-10) were recorded at baseline and every 6 months. Flares were defined according to SFI. Response was evaluated according to SRI-4. Statistics were performed by pairs T-test, chi-square test and multiple logistic regression (SPSS, version 22.0). Results Mean±SD follow-up was 21.2±15.3 months (range 3-60). Most common features treated with belimumab were articular in 67%, mucocutaneous in 55%, and renal in 17% of cases. Improvement of clinical and serological variables, including daily prednisone dosage, was observed (Table). SRI-4 is summarized in the Figure. At the end of follow-up 293 patients (66%) were still on belimumab. Most common cause of discontinuation were inadequate response (36%), AEs (31%), and pregnancy (8%). Mean number of flare during belimumab treatment compared with the corresponding period before belimumab initiation decreased (p 9,998 infusions were analyzed. 784 AEs were observed in 330 patients, SAEs were 43 in 36 patients. No severe infusion reactions were observed; 16 patients had infective SAEs, and 22 non infective SAEs. Conclusion We confirmed the effectiveness, the steroid sparing effect and good safety profile of belimumab in our cohort. Disclosure of Interests Luca Iaccarino: None declared, Francesca Saccon: None declared, Alessandro Mathieu: None declared, Matteo Piga: None declared, Angela Ceribelli: None declared, Carlo Selmi Grant/research support from: Abbvie, Janssen, MSD, Novartis, Pfizer, Consultant for: Abbvie, Alfa-Sigma, Biogen, BMS, Celgene, Eli-Lilly, GSK, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Roche, Sanofi-Genzyme, YCB, Speakers bureau: Abbvie, Alfa-Sigma, Biogen, BMS, Celgene, Eli-Lilly, GSK, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Roche, Sanofi-Genzyme, YCB, Paolo Cardinaletti: None declared, Armando Gabrielli: None declared, Andrea Di Matteo: None declared, Rossella De Angelis: None declared, Paola Faggioli: None declared, Antonella Laria: None declared, Micaela Fredi: None declared, Francesca Regola: None declared, Laura Andreoli: None declared, Giulia Pazzola: None declared, Carlo Salvarani: None declared, Francesco Puppo: None declared, Simone Negrini: None declared, Marcella Prete: None declared, Vito Racanelli: None declared, Elisa Gremese Consultant for: AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Sanofi, UCB, Roche, and Pfizer, Speakers bureau: BMS, Speakers bureau: Roche, Speakers bureau: AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Sanofi, UCB, Roche, and Pfizer, Maria Gerosa: None declared, Tania Ubiali: None declared, Enrica Bozzolo: None declared, Valentina Canti: None declared, Fabrizio Conti: None declared, Fulvia Ceccarelli: None declared, Elena Bartoloni Bocci: None declared, Roberto Gerli: None declared, Antonio Lobasso: None declared, Amato De Paulis: None declared, Ginevra De Marchi: None declared, Salvatore De Vita Grant/research support from: Roche, Pfizer, Abbvie, Novartis, BMS, MSD, Celgene, Janssen, Consultant for: Roche, Alessandra Bortoluzzi: None declared, Marcello Govoni Paid instructor for: Pfizer, Roche, Speakers bureau: Pfizer, Abbvie, MSD, Roche, Eli-Lilly, Celgene, Sanofi, Janssen, Francesco Benvenuti: None declared, Margherita Zen: None declared, Marta Mosca Paid instructor for: GlaxoSmithKline, Lilly, UCB, Chiara Tani: None declared, Maurizio Rossini: None declared, Giovanni Orsolini Speakers bureau: Grunenthal, Mariele Gatto: None declared, Salvatore Scarpato: None declared, Enrico Brunetta: None declared, Aurora Zumbo: None declared, Gabriele Valentini: None declared, SERENA FASANO: None declared, Giacomo Emmi: None declared, Maria Letizia Urban: None declared, Giacomo Tanti: None declared, Angela Tincani Consultant for: UCB, Pfizer, Abbvie, BMS, Sanofi, Roche, GSK, AlphaSigma, Lillly, Jannsen, Cellgene, Novartis, Andrea Doria: None declared

Background The positive effects of denosumab (DMAb) on bone mineral density (BMD) are quickly reversible after its discontinuation and concerns about the possible increase in vertebral fracture after stopping denosumab have been recently raised. Indeed, a rebound in bone turnover markers have been described after DMAb discontinuation. Dickkopf-1 (Dkk-1), and sclerostin, Wnt inhibitors, are considered master regulators of bone remodeling and directly influence the Receptor Activator of Nuclear factor Kappa B Ligand (RANKL) serum levels. Objectives We sought to determine whether the rebound of bone turnover following DMAb discontinuation is associated with dysregulation of the Wnt canonical pathway and/or with the increase in the receptor-activator of nuclear factor-kappa B ligand (RANKL) serum levels in long-term DMAb postmenopausal users. Methods The present study included patients (n = 15) with postmenopausal osteoporosis to whom DMAb was administered for 78 months and then discontinued. We collected BMD data at DMAb administration month 60 (M60), M84 (6 months after last DMAb administration, coinciding when the next DMAb dose would typically be due), and after discontinuation, 3 and 12 months of follow-up (FU-M3 and FU-M12, respectively). Serum C-terminal telopeptide of type 1 collagen (CTX-I), Dkk-1, and sclerostin were measured at M60, M84, FU-M3, and FU-M12. Serum N-terminal propeptide of type 1 procollagen (PINP) and RANKL were dosed at M60, M84, FU-M3, and FU-12. Results We found a significant decrease in the T- score at all sites at FU-M12, when compared to M84 (-0.51 ± 0.91 at the lumbar spine; -0.72 ± 0.33 at the total hip; and -0.42 ± 0.27 at the femoral neck, p Conclusion RANKL serum levels progressively increased after discontinuation of long-term DMAb while Dkk-1 and sclerostin serum levels decreased. The increase in RANKL serum levels supports the hypothesis of a sudden loss of inhibition of the resting osteoclast line after DMAb clearance, with a hyperactivation of these cells. Our results suggest that the decrease in serum Wnt inhibitors after DMAb suspension might represent a mere feedback response to the increased bone turnover. Disclosure of Interests Giovanni Adami: None declared, Angelo Fassio Speakers bureau: Abiogen Pharma, Camilla Benini: None declared, Elisabetta Vantaggiato: None declared, Kenneth Saag Grant/research support from: Amgen, Ironwood/AstraZeneca, Horizon, SOBI, Takeda, Consultant for: Abbvie, Amgen, Ironwood/AstraZeneca, Bayer, Gilead, Horizon, Kowa, Radius, Roche/Genentech, SOBI, Takeda, Teijin, Alessandro Giollo: None declared, Irma Lippolis: None declared, Luca Idolazzi: None declared, Giovanni Orsolini Speakers bureau: Grunenthal, Maurizio Rossini: None declared, Davide Gatti Speakers bureau: Abiogen, Amgen, Janssen-Cilag, Mundipharma, Pfeizer

Background Tumor Necrosis Factor-α inhibitors (TNFi) are immunosuppressive therapies that are known to increase infectious risk. Indeed, patients affected by TNFi requiring conditions are at higher risk of influenza compared with healthy controls. Furthermore, mildly reduced seroconversion rate after influenza vaccination had been reported in TNFi-treated patients. Nonetheless the immune response is considered large enough to recommend influenza vaccination in all patients affected by rheumatoid arthritis, regardless of treatment. However, there are data showing that patients are not being vaccinated as recommended. In addition, given that subjects with autoimmune conditions treated with TNFi are at higher risk for influenza, the exact number needed to vaccinate (NNV) for this condition is still unknown. Objectives We sought to determine the NNV for influenza in TNFi treated patients and the cost for preventing one case of influenza compared with general population. Methods The present analysis included data from cohorts of healthy subjects [1] and TNFi treated patients [2]. We calculated NNV for preventing one case of influenza in each cohort. NNV is the required number of patients receiving vaccination to prevent one case of a given infectious disease. NNV is the inverse of the absolute risk reduction (ARR), which is calculated as following: Control Event Rate (CER) – Experimental Event Rate (EER). In addition, the NNV gives us the opportunity to calculate the cost for preventing one case of influenza, assuming a cost per vaccine from 20 to 40 $. Results In 71,221 healthy individuals influenza vaccination reduced influenza rate from 2.3% in individuals without vaccination (CER = 0.023) to 0.9% in vaccinated individuals (EER = 0.009). The calculated NNV is 71 (NNV = 1/ARR, ARR = 0.023 – 0.009), namely 71 healthy adults need to be vaccinated to prevent one of them experiencing influenza. The costs to prevent a case of clinical influenza in healthy controls would range from 1,420 to 2,840 $. On 15,132 patients exposed to adalimumab, influenza-related adverse events have been reported in 55 of 382 not-vaccinated patients (CER = 0.14) and in 8 of 179 vaccinated patients (EER = 0.04). In this population (mean age 53.5 years, predominantly white women) the NNV of influenza vaccines is 10 (NNV = 1/ARR, ARR = 0.144 – 0.045) and preventing a case of influenza would cost approximately from 200 to 400 $, which is largely lower when compared to healthy controls’ costs. The relative risk of influenza vaccination in healthy individuals (2.3% to 0.9%, RR 0.41, 95% confidence interval (CI) 0.36 to 0.47) and rheumatoid arthritis patients treated with TNFi (14.4% to 4.5%, RR 0.31, 95% CI 0.15 to 0.64) are similar, while there is a large difference between NNVs (71 vs 10) (Figure 1). Conclusion When estimating the effectiveness of vaccinations, clinicians should always include the calculation of the NNV and not only the calculation of relative risk, which might be misleading. The difference in NNV for influenza between healthy individuals and TNFi treated patients is due to a greater absolute risk for influenza in the latter group. The present analysis provides further evidences on the effectiveness of influenza vaccination in patients affected by rheumatoid arthritis receiving treatment with TNFi and should represent a call-to-action for all rheumatologists to consider vaccination in such patients. References [1] Burmester GR, et al. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis 2017;76:414–7 [2] Demicheli V, et al. Vaccines for preventing influenza in healthy adults. Cochrane Database Syst Rev 2018;2:CD001269 Disclosure of Interests Giovanni Adami: None declared, Angelo Fassio Speakers bureau: Abiogen Pharma, Giovanni Orsolini Speakers bureau: Grunenthal, Alessandro Giollo: None declared, Davide Gatti Speakers bureau: Abiogen, Amgen, Janssen-Cilag, Mundipharma, Pfeizer, Maurizio Rossini: None declared

Background Adalimumab has been used in patients with moderately to severely active rheumatoid arthritis (RA) for over 10 years and has a well-established safety profile across multiple indications. Objective To update adverse events (AEs) of special interest from global adalimumab clinical trials in patients with RA. Methods This analysis includes 15 132 patients exposed to adalimumab in global RA clinical trials. AEs of interest included overall infections, laboratory abnormalities and AEs associated with influenza vaccination. Pregnancy outcome data were collected from the Adalimumab Pregnancy Registry. Results Serious infections and tuberculosis occurred at a rate of 4.7 and 0.3 events/100 patient-years, respectively. Two patients experienced hepatitis B reactivation. No significant laboratory abnormalities were reported with adalimumab-plus-methotrexate compared with placebo-plus-methotrexate. Influenza-related AEs occurred in 5% of vaccinated patients compared with 14% of patients not vaccinated during the study. Relative risk of major birth defects and spontaneous abortions in adalimumab-exposed women were similar between that of unexposed women with RA and healthy women. Conclusions This analysis confirms and expands the known safety profile of adalimumab and reports no additional safety risk of laboratory abnormalities, hepatitis B reactivation and pregnancy outcomes, including spontaneous abortions and birth defects. The benefits of influenza vaccination are reinforced. Trial registration numbers NCT00195663, NCT00195702, NCT00448383, NCT00049751, NCT00234845, NCT00650390, NCT00235859, NCT00647920, NCT00649545, NCT00647491, NCT00649922, NCT00538902, NCT00420927, NCT00870467, NCT00650156, NCT00647270, NCT01185288, NCT01185301.

The positive effects of denosumab (DMAb) on bone mineral density (BMD) are quickly reversible after its discontinuation. We investigated whether this rebound was associated with dysregulation of the Wnt canonical pathway and/or by the increase in the receptor-activator of nuclear factor-kappa B ligand (RANKL) serum levels.The study included patients (n = 15) with postmenopausal osteoporosis to whom DMAb was administered for 78 months and then discontinued. We collected BMD data at baseline/month 0 (M0), M60, M84 (6 months after last DMAb administration, coinciding when the next DMAb dose would typically be due), and after 3 and 12 months of follow-up (FU-M3 and FU-M12, respectively). Serum C-terminal telopeptide of type 1 collagen (CTX-I), Dickkopf-1 (Dkk-1), and sclerostin were measured at M0, M60, M84, FU-M3, and FU-M12. Serum N-terminal propeptide of type 1 procollagen (PINP) and RANKL were dosed at M60, M84, FU-M3, and FU-12.We found a significant decrease in the T-score at all sites at FU-M12, when compared to M84 (-0.51 ± 0.91 at the lumbar spine; -0.72 ± 0.33 at the total hip; and -0.42 ± 0.27 at the femoral neck, p 0.05). After DMAb discontinuation (M84 vs FU M12) CTX-I, PINP increased already at FU-M3 (+0.921 ± 0.482 ng/mL, +126.60 ± 30.36 ng/mL, respectively, p 0.01), RANKL increased at FU-M12 (+0.041 ± 0.062 ng/mL, p 0.05), while Dkk-1 and sclerostin decreased at FU-M12 (-10.90 ± 11.80 and - 13.00 ± 10.52 pmol/L, respectively, p 0.01). No changes in BMD or any of the markers were found between M60 and M84.RANKL serum levels progressively increased after discontinuation of long-term DMAb while Dkk-1 and sclerostin serum levels decreased. The increase in RANKL serum levels supports the hypothesis of a sudden loss of inhibition of the resting osteoclast line after DMAb clearance, with a hyperactivation of these cells. Our results suggest that the changes in serum Wnt inhibitors after DMAb suspension might represent a mere feedback response to the increased bone turnover.

AIM Low levels of vitamin D (25OHD) have been found to associated with digital ulcers (DUs) in systemic sclerosis (SSc), although only cross-sectional studies have been performed. We aimed to investigate if variations in vitamin D serum levels over time affect DU in SSc. METHODS This is a retrospective study on 65 patients. 25OHD was measured in 2011 and 2016 and its variations correlated with DU. RESULTS The mean age of our cohort was 58 (SD 12) years with a mean disease duration of 9.5 (5.3) years. Most of our patients had a limited SSc (69.2%). At baseline 50.8% and 41.5% after 5 years had 25OHD

Adverse cardiovascular effects, including hypertension, were described in patients with different cancers treated with tyrosine kinase inhibitors (TKI). The mechanism of TKI-related hypertension is still debated. The aim of this work was to study the effects of TKI on blood pressure (BP), searching for a relationship with possible causative factors in patients with metastatic renal cell carcinoma. We included 29 patients in a prospective, observational study, 22 were treated with a first-line drug (sunitinib), while seven participated in the second-line treatment (axitinib or cabozantinib). Patients were investigated at the beginning of antiangiogenic therapy (T0) and at one (T1), three (T2), and six months (T3) after treatment. Patients were evaluated by office blood pressure (BP) and ultrasonography to measure flow-mediated dilatation (FMD), and carotid artery distensibility (cDC) by echocardiography and nailfold capillaroscopy. Plasma endothelin-1 (p-ET-1), urine nitrates, and proteins were also measured. At T1, systolic BP, along with U proteins and p-ET-1, increased significantly. In patients with a clinically significant increase in BP (defined as either the need for an antihypertensive drug or systolic blood pressure (SBP) T1–T0 ≥10 and/or SBP ≥140 mmHg and/or diastolic blood pressure (DBP) T1–T0 ≥5 and/or DBP ≥90 mmHg), the urine nitrate concentration was lower at T0, whereas there were no differences in the p-ET-1 and U proteins. Seventeen participants showed changes in the capillaroscopic pattern at T1 with no association with BP increases. There were no differences in the FMD, cDC, and echocardiographic parameters. Our findings are consistent with those of previous studies about BP increases by TKI, and suggest a role of nitric oxide in BP maintenance in this population.

Background:Major cardiovascular disease (CVD) benefits of disease-modifying anti-rheumatic drugs (DMARDs) therapy occur in early RA patients with treat-to-target strategy. However, it is unknown whether long-term DMARDs treatment in established RA could be useful to improve CVD risk profile.Objectives:The aim of this study was to comparatively describe aortic stiffness progression in patients with longstanding and established RA treated with tumor necrosis factor inhibitors (TNFi) or conventional synthetic DMARDs (csDMARDs).Methods:Ultrasound aortic stiffness index (AoSI) has to be considered a proxy outcome measure in established RA patients. We measured AoSI in a group of RA patients on long-term treatment with TNFi or csDMARDs. Eligible participants were assessed at baseline and after 12 months; changes in serum lipids, glucose and arterial blood pressure were assessed. All patients were on stable medications during the entire follow-up.Results:We included 107 (64 TNFi and 43 csDMARDs) RA patients. Most patients (74%) were in remission or low disease activity and had some CVD risk factors (45.8% hypertension, 59.8% dyslipidemia, 45.3% smoking; table 1). The two groups did not differ significantly for baseline AoSI (5.95±3.73% vs 6.08±4.20%, p=0.867). Follow-up AoSI was significantly increased from baseline in the csDMARDs group (+1.00%; p2 CVD risk factors than in those without (figure 1).Conclusion:Long-term treatment with TNFi was associated with reduced aortic stiffness in patients with established RA and several CVD risk factors.Baseline characteristics of the study population.csDMARDs(n=43)TNFi(n=64)P valueAge, median years (IQR)58.6 (53.0, 66.0)58.1 (49.3, 67.0)0.839Female sex33 (76.7)54 (84.4)0.321Obesity5 (11.6)7 (10.9)0.999Hypertension19 (44.2)30 (46.9)0.784Anti-hypertensive drug17 (39.5)28 (43.8)0.784Smoking status, ever18 (42.9)30 (46.9)0.684Dyslipidemia30 (40.2)34 (59.8)0.085Current statin use13 (34.2)10 (15.9)0.033Diabetes mellitus3 (7.0)3 (4.7)0.676Anti-diabetic medication1 (2.3)1 (1.5)0.999CVD risk factors, median (IQR)2 (1, 3)2 (1, 3)0.199RF and/or ACPA positive28 (65.1)33 (51.6)0.165Disease duration, median years (IQR)14.1 (11.5)15.4 (10.5)0.538Methotrexate38 (88.4)52 (81.3)0.192Leflunomide5 (17.9)12 (19.0)0.999Hydroxychloroquine9 (31.0)5 (7.8)0.009Prednisone > 5 mg daily7 (7.7)5 (5.5)0.823NSAIDs6 (20.7)22 (34.4)0.227ACPA, anti-citrullinated peptides antibodies; csDMARDs, conventional synthetic disease-modifying anti-rheumatic drugs; IQR, interquartile range; NSAIDs, non-steroidal anti-inflammatory drugs; RF, rheumatoid factor; TNFi, tumor necrosis factor inhibitors. All data reported as absolute numbers (percentage) otherwise specified. P-value refers to Chi-squared or Fisher test for categorical variables or ANOVA for continuous variables.Disclosure of Interests:None declared

TNFα inhibitors (TNFαI) exert positive effects on disease activity in rheumatoid arthritis (RA). Bone involvement is a major determinant of functional impairment in this disease. Here we investigated the short-term effects of TNFαI therapy on bone metabolism and density. We studied 54 patients with RA starting a TNFαI biologic drug, in whom any factor known to interfere with bone metabolism was excluded or rigorously accounted for. We measured at baseline and after 6-month therapy bone turnover markers: N-propeptide of type I collagen (P1NP), and bone alkaline phosphates for bone formation and serum C-terminal telopeptide of type I collagen (CTX) for bone resorption. We also evaluated bone mineral density (BMD) at hip and lumbar by dual-energy X-ray absorptiometry. All bone markers rose significantly and these changes were not dependent on steroid dosage. A significant decrease in femoral neck BMD was also observed. These results indicate that TNFαI therapy in RA over 6 months is associated with an early increase in bone turnover and a decline in hip BMD.

Background:Currently, most experts agree that levels of serum 25OH-Vitamin D (25OHD) lower than 20 ng/mL represent an acceptable threshold for deficiency (1). However, recommendations for vitamin D supplementation vary between scientific societies, and the best regimen to treat deficient patients is still not clear (1).Objectives:The aim of our study was to compare the pharmacokinetic profile of three different regimes of cholecalciferol supplementation in terms of 25OHD exposure and their safety profiles.Methods:We evaluated, in healthy subjects affected by vitamin D deficiency (defined as 25OHDResults:A total of 75 subjects were randomized to receive one supplementation regimen. The descriptive of the sample at baseline and relative 25OHD levels at the various observation points are reported in table 1. 25OHD increased significantly already at week 2 in all three groups (p=0.000). At week 2, 100% of the subject of the daily regimen group presented 25OHD levels >20ng/mL, 96% in the weekly and 88% in the biweekly ones.Table 1.mean values ± SD at the different observation points.ParameterDaily 10.000 Ui(N = 25)Weekly 50.000 Ui(n = 25)Biweekly 100.000 Ui(N = 25)p-valueM:F12:137:1812:13Age (years)30.2 ± 9.936.7 ± 8.735.4 ± 11.0*0.059Body Weight (kg)65.8 ± 13.267.8 ± 10.866.6 ± 13.7*NSHeight (m)1.7 ± 0.11.68 ± 0.11.7 ± 0.1*NSBMI22.55 ± 2.723.8 ± 2.222.8 ± 2.7*NSBaseline 25OHD (ng/mL)14.6 ± 3.912.8 ± 313.5 ± 4.1*NS25OHD week 232.3 ± 526.5 ± 3.425.6 ± 5a0.007b0.00025OHD week 455 ± 10.139.9 ± 4.236.9 ± 7.2a0.000b0.00025OHD week 879.1 ± 16.253.5 ± 7.246.4 ± 8.2a0.000b0.000c0.00125OHD week 12NA58.5 ± 7.850.6 ± 9.6b0.000c0.001*ANOVA test.aDaily 10.000 Ui vs weekly 50.000 Ui.bDaily 10.000 Ui vs Biweekly 100.000 Ui.cWeekly 50.000 Ui vs biweekly 100.000 Ui.In addition, the 25OH levels of the daily regimen group at week 8 were higher than both the ones of the weekly and the biweekly regimen groups both at week 8 and week 12 (pNo serious adverse event occurred.Conclusion:All the three different regimens proved to be effective in correcting vitamin D deficiency already after 1 months (2 weeks for the daily regimen). A more refracted approach seems to more effective than the bolus-based regimens. The safety profile was excellent in all groups.References:[1]R. Bouillon, Comparative analysis of nutritional guidelines for vitamin D, Nat. Rev. Endocrinol. 13 (2017) 466–479.https://doi.org/10.1038/nrendo.2017.31.Disclosure of Interests:Angelo Fassio Speakers bureau: Angelo Fassio reports personal fees from: Abiogen and Novartis, outside the submitted work., Giovanni Adami: None declared, Ombretta Viapiana: None declared, Giovanni Orsolini: None declared, Alessandro Giollo: None declared, Maurizio Rossini Speakers bureau: AbbVie, Abiogen, Amgen, BMS, Eli-Lilly, Novartis, Pfizer, Sanofi, Sandoz and UCB, Davide Gatti Speakers bureau: Davide Gatti reports personal fees from Abiogen, Amgen, Janssen-Cilag, Mundipharma, outside the submitted work.

Background:Myocardial fibrosis is a severe complication of immune-mediated diseases, occurring in up to 30% of systemic lupus erythematosus (SLE) patients. Cardiovascular magnetic resonance imaging allows myocardial scar detection in SLE patients, but it is costly, time consuming, and unfit for patients with renal disease. Scar imaging echocardiography with ultrasound multi-pulse scheme (eSCAR) is a novel and promising technique that proved to be effective in detecting ischemic myocardial scars in patients with coronary artery disease (CAD).Objectives:To evaluate if the eSCAR technique is feasible and to better characterize SLE patients with cardiac involvement by eSCAR.Methods:We recruited consecutive patients with SLE classified according to the 2019 EULAR/ACR recommendations. Patients with diabetes mellitus, obesity, prior cardiovascular (CV) disease or anti-phospholipid (aPL) syndrome were excluded. Eligible participants underwent a thorough clinical assessment and a full echocardiography examination, including the eSCAR technique. Data on clinical variables were collected; disease activity was estimated by the SLE Disease Activity Index (SLEDAI) score. Lupus flare was defined as new/worse clinical signs and symptoms and/or lab measurements and a change/increase in treatment. Patients were compared according to the presence or absence of eSCAR. In this preliminary report, only descriptive analyses are provided. Continuous data are reported as median [25th; 75thpercentile].Results:We enrolled fifteen patients diagnosed with SLE (age 45 years [36; 47], disease duration 14 years [12; 20]), 13 (87%) were females. Median SLEDAI was 5 [2; 8]. The most frequent disease involvement included arthritis (73%), skin and mucous membranes (60%), lupus nephritis (47%) and cytopenias (47%). Patients had received treatment for lupus with 5 drugs [5; 8]. Cumulative prednisone dosage was 25 g [20; 44], whilst the current daily dosage of prednisone was 4 mg [0.0; 5.0]. Hypertension was present in 4 (27%) and hypercholesterolemia in 2 (13%) subjects; 4 patients (27%) were current or past smokers. The eSCAR technique was feasible in all participants with no adverse effects. Myocardial scars were detected in 2 patients (eSCAR-positive 13%; figure and table); eSCAR positive patients were females and had no history of cardiovascular involvement (including pericarditis); they had at least one relapse within the prior 12 months before enrollment; at least one cardiovascular risk factor was found in both patients (one was a smoker and the other one had hypertension); none received prior treatment with cyclophosphamide or rituximab; they had no renal involvement; arthritis and cytopenia were the prominent features of disease; anti-dsDNA titer was higher than eSCAR-negative patients.Conclusion:Echocardiography allowed detection of myocardial scars in patients with SLE. Our preliminary data show that eSCAR is feasible and well tolerated in a SLE population. Further data from this ongoing study will help investigate whether eSCAR might improve risk stratification, by identifying myocardial involvement in SLE patients with a more active disease.eSCAR positivePatient 1eSCAR positivePatient 2eSCAR negativeSLE patients (n=13)Age, years324545SexFemaleFemale11 F / 2 MESR mm/h29715CRP mg/L30.62Anti-dsDNA (IF)PositivePositivePositive 7 (47)Anti-dsDNA (CLIA)10514934 [7; 66]C3 (mg/L)618085 [70; 94]C4 (mg/L)41310 [9; 16]P-Cr (mg/dL)0.60.80.7 [0.6; 0.7]aPLPositiveNegative7 (47)Disease duration, years152814 [12; 15]SLEDAI1205 [2; 8]Lupus flare in the past 12 monthsyesyes5 (33)Cumulative prednisone dosage (g)606124 [19, 32]Previous use of cyclophosphamideNoNo3 (20)Previous use of rituximabNoNo1 (1)Acknowledgments:This study was granted by Gruppo LES Italia OnlusDisclosure of Interests:Alessandro Giollo: None declared, Giulia Vinco: None declared, Giovanni Orsolini: None declared, Giovanni Cioffi: None declared, Giovanni Adami: None declared, Angelo Fassio Speakers bureau: Angelo Fassio reports personal fees from: Abiogen and Novartis, outside the submitted work., Luca Idolazzi: None declared, Davide Gatti Speakers bureau: Davide Gatti reports personal fees from Abiogen, Amgen, Janssen-Cilag, Mundipharma, outside the submitted work., Flavio Luciano Ribichini: None declared, Maurizio Rossini Speakers bureau: AbbVie, Abiogen, Amgen, BMS, Eli-Lilly, Novartis, Pfizer, Sanofi, Sandoz and UCB, Ombretta Viapiana: None declared

Background:Glucocorticoid-induced osteoporosis and osteoporosis induced by adjuvant hormone therapy for breast cancer are the most common forms of secondary osteoporosis.Objectives:The exact real-life prevalence of treatment with anti-osteoporotic drugs in women with drug-induced osteoporosis is not known. In the present study, using a new mathematical and computerized algorithm, we investigate the profile of risk of fracture of women with drug-induced osteoporosis and the prevalence of treatment with anti-osteoporotic drugs.Methods:We have retrospectively analyzed the 10-year risk of major osteoporotic fracture calculated with the DeFRAcalc79 tool in postmenopausal women aged over 50 years that were initiating an anti-osteoporotic treatment (fully reimbursed according to the Nota 79). DeFRAcalc79 is a new web-based fracture risk-assessment tool (https://defra-osteoporosi.it) that arithmetically adjusts the risk based on multiple risk factors contemplated by the Nota 79, which regulates the reimbursability for osteoporosis medications in Italy (Italian Agency for Drugs, AIFA), including demographic and anthropometric data, femoral and/or lumbar spine BMD T-score, family history of femoral or vertebral fractures, number and site of previous osteoporotic fracture (including vertebral, femoral, and non-vertebral non-femoral fractures), glucocorticoid treatment (> 3 or > 12 months, ≥5 mg prednisone or equivalent), adjuvant hormone therapy for breast cancer, and comorbidities that induce an increased risk of fracture (rheumatoid arthritis and other connective tissue diseases, chronic obstructive pulmonary disease, inflammatory bowel diseases, Parkinson’s disease, multiple sclerosis, human immunodeficiency virus infection, diabetes, or severe physical handicap). This is a sub-analysis of the cross-sectional observational study to validate and further develop the DeFRA algorithm for the estimation of the risk of osteoporotic fractures, promoted by Verona hospital with the unconditional support of Amgen Srl.Results:Among 208 women, 116 (55.8%) were treated with adjuvant hormone therapy for breast cancer and 92 (44.2%) were on glucocorticoid ≥5 mg/day. Women on glucocorticoids had a greater mean 10-year risk of fracture compared to women on adjuvant hormone therapy for breast cancer (67.0% vs 39.1% pConclusion:In our cohort of patients, treatment with adjuvant hormone therapy for breast cancer was slightly more common than glucocorticoids. Women with glucocorticoid-induced osteoporosis had a greater risk of fracture compared to patients treated with adjuvant hormone therapy for breast cancer. Half of the patients on adjuvant hormone therapy for breast cancer were prescribed with denosumab. One-fifth of the patients with glucocorticoid-induced osteoporosis was treated with teriparatide. DeFRAcalc79 is a useful and practical tool for the integrated evaluation of fracture risk in drug-induced osteoporosis.Disclosure of Interests:Giovanni Adami: None declared, Angelo Fassio Speakers bureau: Angelo Fassio reports personal fees from: Abiogen and Novartis, outside the submitted work., Alessandro Giollo: None declared, Giovanni Orsolini: None declared, Ombretta Viapiana: None declared, Davide Gatti Speakers bureau: Davide Gatti reports personal fees from Abiogen, Amgen, Janssen-Cilag, Mundipharma, outside the submitted work., Maurizio Rossini Speakers bureau: AbbVie, Abiogen, Amgen, BMS, Eli-Lilly, Novartis, Pfizer, Sanofi, Sandoz and UCB

Background:A new algorithm for management of patients at low, high and very high risk of osteoporotic fractures has been recently proposed, has been also recommended treating those patients at very high risk of fracture with bone anabolics (1). A similar treatment algorithm has been applied in Italy since 2015, when the “Nota 79”, that regulates the reimbursability for osteoporosis medications, has been developed by the Italian Agency for Drugs (AIFA) (2).Objectives:In the present study, using a new mathematical and computerized algorithm, we seek to investigate the profile of risk of fracture of patients starting treatment with different anti-osteoporotic medications in Italy.Methods:We retrospectively analyzed the 10-year risk of major osteoporotic fracture calculated with the DeFRAcalc79 tool in postmenopausal women aged over 50 years that were initiating an anti-osteoporotic treatment (fully reimbursed according to the Nota 79). DeFRAcalc79 is a new web-based fracture risk-assessment tool (https://defra-osteoporosi.it) that arithmetically adjusts the risk based on the integration of multiple risk factors contemplated by the AIFA’s Nota 79, including: demographic and anthropometric data, femoral and/or lumbar spine BMD T-score, family history of femoral or vertebral fractures, number and site of previous osteoporotic fracture (including vertebral, femoral, and nonvertebral nonfemoral fractures), glucocorticoid treatment (> 3 or > 12 months, ≥5 mg prednisone or equivalent), adjuvant hormone therapy for breast or prostate cancer, and comorbidities that increase the risk (rheumatoid arthritis and other connective tissue diseases, chronic obstructive pulmonary disease, inflammatory bowel diseases, Parkinson’s disease, multiple sclerosis, HIV infection, diabetes, or severe physical handicap).Results:We retrieved data for 10,235 women prescribed with an anti-osteoporotic treatment.Figure 1shows the mean 10-year fracture risk estimated with DeFRAcalc79 tool at the time of the treatment initiation. Teriparatide users had the highest 10-year risk of fracture (67.4% Standard Deviation [SD] 21.5%). We found that in 2,231 patients starting denosumab, the 10-year baseline risk of fracture was 38.5%, SD 22.8%. In 5,759 patients initiating alendronate was 25.7%, SD 15.3% and in patients initiating risedronate was 27.9%, SD 26.9%. Patients prescribed with zoledronic acid had a mean 10-year risk of fracture of 35.6%, SD 21.6. P values between means were all Figure 1.Mean 10-year risk of fracture estimated with DeFRAcalc79 tool at the time of treatment initiation, p< 0.01 between all means.Conclusion:The risk of fracture of Italian post-menopausal women initiating different anti-osteoporotic medications varies significantly. Teriparatide is prescribed to patients with greater risk of fracture. The Nota 79 correctly individuates patients at very high risk of fracture that merit treatment with a bone anabolic. Denosumab and zoledronic acid are prescribed to patients with a greater risk of fracture compared to oral bisphosphonates.DeFRAcalc79 is a useful and practical tool for the integrated evaluation of the profile of risk of fracture.References:[1]Kanis JA et al. Algorithm for the management of patients at low, high and very high risk of osteoporotic fractures. Osteoporos Int 2019 31:1–12.https://doi.org/10.1007/s00198-019-05176-3[2]Adami G et al. Comments on Kanis et al.: Algorithm for the management of patients at low, high, and very high risk of osteoporotic fractures. Osteoporos Int. 2020. doi: 10.1007/s00198-020-05302-6. [Epub ahead of print]Disclosure of Interests:Giovanni Adami: None declared, Angelo Fassio Speakers bureau: Angelo Fassio reports personal fees from: Abiogen and Novartis, outside the submitted work., Alessandro Giollo: None declared, Giovanni Orsolini: None declared, Ombretta Viapiana: None declared, Davide Gatti Speakers bureau: Davide Gatti reports personal fees from Abiogen, Amgen, Janssen-Cilag, Mundipharma, outside the submitted work., Maurizio Rossini Speakers bureau: AbbVie, Abiogen, Amgen, BMS, Eli-Lilly, Novartis, Pfizer, Sanofi, Sandoz and UCB

Following publication of the original article [1], the authors reported a typesetting error.

Background Anti-cardiolipin (aCL) and anti-β2 glycoprotein-1 (β2GP1) antibody ELISA testing may be performed on serum, plasma, or both in accordance to the manufacturers’ suggested protocols. There exists some variability in manufacturers’ preference for serum or plasma. Various societal guidelines have published a preference for serum over plasma; however, there is scarcity of data assessing reproducibility between serum and plasma in aCL or β2GP1 testing. Objectives To determine reproducibility of aCL and β2GP1 testing between serum and plasma samples obtained in a routine clinical setting. Methods Patients with clinical serum draws for IgG/IgM aCL and β2GP1 antibodies were identified, and same-day, citrated plasma samples were obtained for repeat ELISA testing (QUANTA Lite, INOVA Diagnostics, San Diego, CA). Quantitative levels were determined for each isotype and further stratified into Negative ( Results Fifty patients were identified for study with 50 and 40 samples eligible for repeat aCL and β2GP1 plasma testing, respectively. Mean age was 49±18 years. 70% were female, 86% were Caucasian, 22% with systemic lupus erythematosus and 22% with antiphospholipid syndrome. As shown in Table 1, quantitative levels tended to be slightly higher in serum than plasma. Although a statistically significant difference was found for most of the antibodies tested, the difference between serum and plasma values were generally small. There was good agreement in reference category between serum and plasma. Kappa coefficients ranged from 0.70 to 1.00. Conclusions There appears good reproducibility of IgG/IgM aCL and β2GP1 antibody ELISA results between serum and plasma. References [1] Lakos G, Favaloro EJ, Pierangeli SS, et al. Arthritis & Rheumatology. 2012 Jan 1;64(1):1–0. [2] Lewis DA, Pound ML, Ortel TL. Journal of Thrombosis and Haemostasis. 2006Jan 1;4(1):265–7. [3] Wong RC, Favaloro EJ, Mallon D, et al. Pathology. 2008Jan 1;40(1):58–63. [4] Wong RC, Gillis D, Sturgess A, et al. Pathology. 2004Feb 1;36(1):63–8. Acknowledgements Special thanks to Susan Hartzler, Cory Blixt, Serena Navitskas, and Diane Meier. Disclosure of Interest None declared

Background Anti-phosphatidylserine prothrombin antibodies (PSPT) have been reported to be strongly associated with the lupus anticoagulant (LAC) in established antiphospholipid syndrome (APS) and autoimmune cohorts. However, there is a paucity of similar studies assessing clinical utility on an all-comer patient population undergoing evaluation for suspicions of APS. Objectives To determine the sensitivity and specificity of IgG and IgM PSPT to the LAC in patients undergoing evaluation for APS. Methods Patients from June 2017 to December 2017 undergoing evaluation for APS had blood draws for the LAC, anti-cardiolipin (aCL), anti-β2 glycoprotein-1 (β2GP1), and PSPT. Both IgG and IgM isotypes were tested for each antibody. Presence of the LAC was determined by trained haematologists interpreting a number of mixing and neutralisation studies. Demographic details were abstracted from the medical record and cases meeting the SLICC criteria for systemic lupus erythematosus (SLE) and the revised Sapporo criteria for APS were enumerated. Results Fifty six eligible patients were identified. Mean age was 50±18 years. 68% were female, 20% with SLE, and 20% with APS. At time of testing, 18% were on warfarin, 7% on direct factor Xa inhibitors and 2% on low-molecular weight heparin. The LAC was negative in 45% (25/56) of those tested. In LAC negative cases, the IgG and IgM PSPT were negative in 100% and 92% of cases, respectively. In LAC positive cases, IgG PSPT was positive in 35% and IgM PSPT was positive in 61%. Compared to the LAC, IgG PSPT was 100% (95% CI: 72%, 100%) sensitive but was only 56% (40%, 70%) specific. Similarly, the IgM isotype of PSPT showed 90% (70%, 99%) sensitivity but only 66% (48%, 81%) specificity. Overall, 38% (21/56) of the cases possessed an isolated, singly positive LAC with concurrent negative IgG/M aCL and β2GP1 antibodies. In this isolated LAC positive-only group, further testing with IgG and IgM PSPT was positive in 38% and 57% of the cases, respectively. Conclusions In this study, IgG and IgM PSPT were found to be highly sensitive to the LAC and may be a useful tool in the screening of and the interpretation of the LAC. References [1] Akhter E, Shums Z, Norman GL, Binder W, Fang H, Petri M. The Journal of Rheumatology2013;40(3):282–6. [2] Atsumi T, Ieko M, Bertolaccini ML, et al. Arthritis & Rheumatism2000;43:1982–93. [3] Bertolaccini ML, Sciascia S, Murru V, Garcia-Fernandez C, Sanna G, Khamashta MA. Thrombosis and Haemostasis2013;110:207–13. [4] Pregnolato F, Chighizola CB, Encabo S, et al. Immunologic Research2013;56:432–8. [5] Vlagea A, Gil A, Cuesta MV, et al. Clinical and Applied Thrombosis/Hemostasis2013;19:289–96. Acknowledgements Special thanks to Susan Hartzler, Cory Blixt, Serena Navitskas, and Diane Meier. Disclosure of Interest None declared

Background Early cardiovascular (CV) involvement has been found in patients with psoriatic arthritis (PsA). These patients may have a high prevalence of subclinical left ventricular (LV) dysfunction, even without established CV disease and in the absence of traditional CV risk factors. However, currently, the factors associated with LV dysfunction in PsA are unknown. Patients with inflammatory disorders are exposed to the development of excessive left ventricular mass disproportionate to the need to compensate left ventricular load, a condition named ‘inappropriately high left ventricular mass’ (iLVM). Previously, we have shown that iLVM is associated with unfavourable prognosis in patients with rheumatoid arthritis independent of traditional CV risk factors. Objectives In this cross-sectional study, we assessed the prevalence and factors associated with iLVM in a cohort of patients with PsA and tested the hypothesis that PsA is per se related to iLVM. Methods We evaluated 101 non-institutionalised patients>18 years of age diagnosed with PsA according to CASPAR criteria and consecutively recruited between March 2014 and December 2016. All PsA patients were free of symptoms or signs of cardiovascular disease. Patients with PsA were compared with 101 controls matched for age, sex, BMI, prevalence of hypertension and diabetes. Left ventricular chamber dimensions and wall thicknesses were measured according to the American Society of Echocardiography guidelines and predicted LVM was calculated using a validated equation considering height, sex and left ventricular work. iLVM was defined as measured/predicted LVM ratio above the 95% percentile of a reference population of healthy controls.1 Results iLVM was detected in 58% of patients with PsA and 18% of controls (p Conclusions More than 50% of patients with PsA have a disproportionate increase in their LVM. An inappropriately high LVM in PsA is associated with LV systolic dysfunction and LV concentric geometry. Reference [1] Cioffi G, Viapiana O, Ognibeni F, Dalbeni A, Giollo A, Adami S, Gatti D, Russo G, Barbati G, Cherubini A, Di Lenarda A, Rossini M. Prevalence and factors related to inappropriately high left ventricular mass in patients with rheumatoid arthritis without overt cardiac disease. J Hypertens2015;33:2141–2149. Disclosure of Interest None declared

Background Lower serum vitamin D levels have been associated with various autoimmune disorders. Especially in patients affected by Rheumatoid Arthritis (RA), has been observed an inverse correlation between serum levels of 25-hydroxyvitamin D (25OHD), pain and disease activity, but the cause-effect relationship is not clear. Objectives The aim of this exploratory study is to investigate the effects of supplementation with cholecalciferol (vitD3) in improving pain and disease activity in RA patients with or without vitamin D deficiency (25OHD Methods In this prospective open-label intervention study, patients fulfilling the EULAR/ACR 2010 criteria for diagnosis of RA, in non-remission (DAS28-CRP>2,6), on stable disease-modifying antirheumatic drugs, and whose treatment was not expected to be changed over a 3 month period following inclusion, were recruited. DAS28-CRP, VAS pain and serum levels of 25OHD, were evaluated at the baseline and after 3 months of supplementation with oral 100,000 IU/monthly of vitD3. Results A sample composed by 61 patients (47 females), with an average age (SD) of 5812 years within 26–86 years range were included. At baseline the mean (SD) 25OHD levels were 2210 ng/mL. 57% of the patients were found to have vitamin D deficiency ( Conclusions VitD3 supplementation appears to be associated with significant and different effects on pain and disease activity in RA patients dependent on 25OHD serum levels. Vitamin D deficiency ( Disclosure of Interest None declared

Background The ultrasonography (US) is a feasible technique when you refer to the peripheral small joints and also to the nail.1 DIP joints are not only affected by inflammatory disease and a more frequent condition is osteoarthritis (OA). The bone and synovial changes due to this condition are very similar to the ones of PSA especially regarding osteoproliferative lesions. Objectives The aim of our study was exploring through imaging the changes of nail and enthesis of extensor tendon of the finger in inflammatory and degenerative conditions in order to find structural differences of nail and DIP. Methods This is an observational study on PSO, PSA, RA or OA patients. A control group of 50 healthy volunteers was used for comparison. Diagnosis was based on clinical or scientific criteria, such as CASPAR or EULAR/ACR were applicable. The study sample included 203 individual. The ultrasonographers were blind to clinical data and diagnosis of the patient. The ultrasound examination was done with a GE Logiq S8. The structural alterations of the plate were evaluated using a semiquantitative score for the magnitude of the alteration. The score provides values from 0 (no alteration) to 3 (severly altered). A semiquantitative approach was also used for evaluation of the power Doppler signal. Results The study sample was composed by 51 patients affected by PsA, 31 affected by PSO group, 37 subjects with RA, 34 with OA and 50 HC. The analysis of nail bed PDUS revealed an unusual trend for patients affected by OA who showed a prevalence of lesions of every grade but a lower rate of normal cases. The evaluation of the PDUS of the enthesis revealed that patients affected by PsA have an increased rate of PDUS signal at the enthesis of the extensor tendon. Considering nail plate HC showed a strong difference (p value Conclusions The data support the concept that nail enthesis unit is in some way involved in different pathological conditions. No exclusive feature belongs only to one or another disease, but the data provided suggested that peculiar lesions might be found only in certain disease and in certain structures, like the entheses. The US of the nail should be considered as one of the possible and promising approach in the study of these structures. Reference [1] Arbault A, Devilliers H, Laroche D, et al. Reliability, validity and feasibility of nail ultrasonography in psoriatic arthritis. Jt Bone Spine Rev Rhum2016;83:539–44. doi:10.1016/j.jbspin.2015.11.004 Disclosure of Interest None declared

Golimumab is an anti-TNF monoclonal antibody administred subcutaneously once a month and produced with an innovative technology that minimizes immunogenicity. This paper reviews and updates the main studies on the efficacy, safety and pharmacoeconomic aspects of treatment with golimumab of psoriatic arthritis, ankylosing spondylitis and rheumatoid arthritis.

In glucocorticoid-induced osteoporosis (GIO), both bone formation and resorption are altered, however, with a relative prevalence of resorption, consistent with the positive results that have been reported with bisphosphonate treatment. Many studies have investigated the effect of bisphosphonates (BPs), a widely used class of anti-resorptive drugs, showing a positive effect on bone mineral density and fracture risk. Also in case of postmenopausal osteoporosis, the safety and cost-effectiveness profile of BPs in GIO appears good. Currently, the use of BPs is recommended at the earliest by all major scientific societies in postmenopausal women and men ≥50 years at high risk of fracture receiving glucocorticoid therapy. BPs are the most commonly used anti-osteoporotic agents and they remain the current standard of care for GIO.

The diagnosis of osteoporosis in men remains controversial. Aims of this study were to evaluate the major anthropometric determinants of BMD in a large cohort of male Italian subjects and asses the prevalence of subjects with T-score ≤−2.5 by making use of young male or female BMD reference data. 1,442 Caucasian men aged over 49 years performing a contemporary spine and hip DXA from January 2012 to June 2013 in an out-patient clinics of northern Italy were analyzed. Single and multiple regression analysis was used for correlating BMD to weight and age. The WHO cut-off value (T-score ≤−2.5) was used for the definition of osteoporosis. To compare the prevalence of osteoporosis by adopting male or female BMD reference values the Fisher’s exact test was applied. Age was significantly correlated with spine and neck BMD. The age-BMD correlation was negative for femoral neck while it was positive for the spine. When BMD values were adjusted for body weight the correlation with femoral neck BMD decreased while the positive regression coefficient between spine BMD and age increased. Spine and femoral BMD (both total hip and neck) were positively correlated with body weight. Using BMD male reference values, only 31.2 % of subjects were identified as osteoporotic at least at one site and this proportion was further reduced using female reference data. Spine was able to identify the greatest number of patients with T-score ≤−2.5 (88.7 %) while at femoral sites the proportion was considerably lower (33.6 and 13.8 % for femoral neck and total hip respectively). In our population, the proportion of male subjects with spine T-score ≤−2.5 is about 25 % of those who were referred for DXA evaluation and this proportion decreases if the female reference data for T-score calculation are chosen. Both spine and femoral neck BMD are strongly and positively related with weight but spine BMD increases with advancing age possibly as a consequence of mechanical and hormonal factors. The capability of spine DXA in identifying men with T-score ≤−2.5 is at its maximum around the fifth decade of life and it decreases later.