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The concern about the offspring’s health is one of the reasons for a reduced family size of women with rheumatic diseases (RD). Increased risk of autoimmune diseases (AD) and neurodevelopmental disorders (ND) has been reported in children born to patients with RD. Within a nationwide survey about reproductive issues of women with RD, we aimed at exploring the long-term outcome of their children. By surveying 398 patients who received their diagnosis of RD during childbearing age (before the age of 45), information about the offspring were obtained from 230 women who declared to have had children. A total of 148 (64.3%) patients were affected by connective tissue diseases (CTD) and 82 (35.7%) by chronic arthritis. Data on 299 children (156 males, 52.1%; mean age at the time of interview 17.1 ± 9.7 years) were collected. Twelve children (4.0%), who were born to patients with CTD in 75% of the cases, were affected by AD (8 cases of celiac disease). Eleven children had a certified diagnosis of ND (3.6%; 6 cases of learning disabilities); 9 of them were born to mothers with CTD (5 after maternal diagnosis). No association was found between ND and prenatal exposure to either maternal autoantibodies or anti-rheumatic drugs. Absolute numbers of offspring affected by AD and ND were low in a multicentre cohort of Italian women with RD. This information can be helpful for the counselling about reproductive issues, as the health outcomes of the offspring might not be an issue which discourage women with RD from having children.

Fibromyalgia or fibromyalgia syndrome (FMS) is defined as a central sensitization syndrome characterized by the dysfunction of neurocircuits detecting, transmitting and processing nociceptive stimuli; the prevalent manifestation is musculoskeletal pain. In addition to pain, there are multiple accompanying symptoms, in common with other algo-dysfunctional syndromes, which are reflected in a broad spectrum of somatic, neurocognitive and neuro-vegetative manifestations. An evidence-based approach is essential in FMS management, in order to improve patient health and to reduce its social burden. Since in the last ten years new international guidelines for clinical practice (Clinical Practice Guidelines or CPGs) concerning FMS diagnosis and pharmacological/ non-pharmacological management have been published, the Italian Society of Rheumatology (SIR) has decided to adapt them to the Italian national setting. The framework of the Guidelines International Network Adaptation Working Group was adopted to identify, appraise (AGREE II), synthesize, and customize the most recent CPGs on FMS to the needs of the Italian healthcare context. A working group of rheumatologists from SIR epidemiology unit and FMS experts identified relevant clinical questions to guide the systematic review of the literature. The target audience of these CPGs included physicians and healthcare professionals who manage FMS. The adapted recommendations were finally assessed by an external multidisciplinary panel. From the systematic search in databases (Pubmed/Medline, Embase) and grey literature, 6 CPGs were selected and appraised by two independent raters. The combination of the scientific evidence underlying the original CPGs with expert opinion lead to the development of 17 recommendations. The quality of evidence for each recommendation was reported and their potential impact on clinical practice was assessed. These SIR recommendations are expected to be a valuable aid in the diagnosis and treatment of FMS, as they will contribute to disseminate the best practice on the basis of the current scientific evidence.

Objective To report baseline data of SLE patients enrolled in the Lupus Italian Registry (LIRE). Methods Patients affected by SLE aged ≥ 16 years were consecutively recruited in a multicenter prospective study comparing two cohorts: patients starting biologic immunosuppressants (BC) and patients starting non-biologic immunosuppresants (NBC). Results 308 patients were enrolled, 179 in NBC and 129 in BC. Mean age at disease onset and at diagnosis was significantly higher in NBC (p = 0.023, p = 0.045, respectively). Disease duration was longer in BC (p = 0.022). Patients in BC presented arthritis more frequently (p = 0.024), those in NBC nephropathy (p = 0.03). Quality of life was worse in BC (p = 0.031). Anti-dsDNA, low C3, were significantly more frequent in BC (p Conclusion The predominant organ involvement was different in the two cohorts: kidney involvement predominated in NBC, joint involvement in BC. Despite the younger age at disease onset, patients of the BC had a longer disease duration and more frequently had taken a cumulative prednisone dosage greater than 10 g. Even the pattern of clinical manifestations inducing to prescribe biological rather than conventional immunosuppressants was quite different. Keywords: Autoantibody(ies), autoimmune disease, belimumab, cohort studies, glucocorticoids, immunosuppressants, rituximab, systemic lupus erythematosus

Over the last few years, the landscape of treatments for axial spondyloarthritis (SpA) has been rapidly evolving, urging international scientific societies to draft or update existing clinical practice guidelines (CPGs) on the management of axial SpA. The Italian Society for Rheumatology (SIR) committed to provide revised and adapted evidence- and expert-based recommendations for the management of patients with axial SpA in Italy. A systematic approach to the adaptation of existing CPGs - the ADAPTE methodology - was adopted to obtain updated recommendations suitable for the Italian context. A systematic literature search was performed in Medline and Embase databases to find international CPGs and consensus statements with recommendations for the management of axial SpA published in the previous five years. A working group composed of rheumatologists with proven experience in the management of axial SpA and methodologists identified the key research questions which guided study selection and data extraction. Guideline quality was assessed using the Appraisal of Guidelines Research and Evaluation (AGREE) II tool. The Italian recommendations were developed by endorsing or adapting and rewording some existing recommendations. The draft of the recommendations was sent to a multidisciplinary group of external reviewers for comment and rating. Six original CPGs were selected and used to create this SIR CPG, which includes a final set of 14 recommendations covering the management of patients with axial SpA across the following domains: assessment, pharmacological and non-pharmacological treatment, and follow-up. The dissemination and implementation of these SIR recommendations are expected to support an evidencebased clinical approach to the management of patients with axial SpA in Italy.

Not available

Objective The reproductive choices of women affected by rheumatic diseases (RD) can be influenced by several factors, including the quality of physician-patient communication. We conducted a survey on reproductive issues aiming at exploring the unmet needs of women with RD during childbearing age. Methods We administered 65 multiple-choice and 12 open-answer questions about pregnancy counselling, contraception, use of drugs during pregnancy and other women reproductive issues to 477 consecutive women with RD aged 18–55 years followed-up in 24 rheumatology centres in Italy. Analysis was restricted to 398 patients who received their diagnosis of RD before the age of 45. According to the RD diagnosis, patients were subdivided into 2 groups: connective tissue diseases (n = 249) and chronic arthritis (n = 149). Results At the time of interview, women in both groups had a mean age of 40 years. Nearly one third of patients in each group declared not to have received any counselling about either pregnancy desire nor contraception. A smaller family size than desired was reported by nearly 37% of patients, because of concerns related to maternal disease in one fourth of the cases. A “Disease Knowledge Index” (DKI) was created to investigate the degree of patients’ information about the implications of their RD on reproductive issues. Having received counselling was associated with higher DKI values and with a positive impact on family planning. Conclusion Italian women of childbearing age affected by RD reported several unmet needs in their knowledge about reproductive issues. Strategies are needed to implement and facilitate physician-patient communication.

Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disorder characterised by chronic joint inflammation, leading to functional disability and increased risk of premature death. Clinical practice guidelines (CPGs) are expected to play a key role in improving management of RA, across the different phases of the disease course. Since new evidence has become available, the Italian Society for Rheumatology (SIR) has been prompted to update the 2011 recommendations on management of RA. The framework of the Guidelines International Network Adaptation Working Group was adopted to identify, appraise (AGREE II), synthesize, and customize the existing RA CPGs to the Italian healthcare context. The task force consisting of rheumatologists from the SIR Epidemiology Research Unit and a committee with experience in RA identified key health questions to guide a systematic literature review. The target audience includes physicians and health professionals who manage RA in practice, and the target population includes adult patients diagnosed as having RA. An external multi-disciplinary committee rated the final version of the CPGs. From the systematic search in databases (Medline, Embase) and grey literature, 6 CPGs were selected and appraised by two independent raters. Combining evidence and statements from these CPGs and clinical expertise, 8 (Management) +6 (Safety) recommendations were developed and graded according to the level of evidence. The statements and potential impact on clinical practice were discussed and assessed. These revised recommendations are intended to provide guidance for the management of RA and to disseminate the best evidence-based clinical practices for this disease.

Osteoarthritis (OA) is the most common musculoskeletal disease leading to functional decline and loss in quality of life. Knees, hands and hips are frequently affected joints with a relevant clinical and socio-economic burden. An evidence-based approach to OA management is essential in order to improve patients’ health and to decrease social burdens. Since new international clinical practice guidelines (CPGs) focused on diagnosis or pharmacological/non-pharmacological treatment have become available in the last ten years, the Italian Society for Rheumatology (SIR) was prompted to revise and customize them for a multidisciplinary audience of specialists involved in the management of OA. The framework of the Guidelines International Network Adaptation Working Group was adopted to identify, appraise (AGREE II), synthesize, and customize the existing CPGs on OA to the needs of the Italian healthcare context. The task force, consisting of rheumatologists from the SIR epidemiology research unit and a committee with experience of OA, identified key health questions to guide a systematic review of published guidelines. The target audience included physicians and health professionals who manage OA. An external panel of stakeholders rated the guidelines. From a systematic search in databases (Pubmed/Medline, Embase) and grey literature, 11 CPGs were selected and appraised by two independent raters. Combining evidence and statements from these CPGs and clinical expertise, 16 guidelines were developed and graded according to the level of evidence. Agreement and potential impact on clinical practice were assessed. These revised guidelines are intended to provide guidance for diagnosis and treatment of OA and to disseminate best evidence-based strategies management of the disease.

Gout is a chronic disease with an increased risk of premature death related to comorbidities. Treatment of gout has proved suboptimal and clinical practice guidelines (CPGs) are expected to have a key role in achieving improvement. Since new evidence has become available, the Italian Society for Rheumatology (SIR) has been prompted to update the 2013 recommendations on the diagnosis and management of gout. The framework of the Guidelines International Network Adaptation Working Group was adopted to identify, appraise (AGREE II), synthesize, and customize the existing gout CPGs to the needs of the Italian healthcare context. The task force consisting of rheumatologists from the SIR Epidemiology Unit and a committee with experience on gout identified key health questions to guide a systematic literature review. The target audience includes physicians and health professionals who manage gout in practice, and the target population includes adult patients suspected or diagnosed as having gout. These recommendations were finally rated by an external multi-disciplinary commission. From a systematic search in databases (Medline, Embase) and grey literature, 8 CPGs were selected and appraised by two independent raters. Combining evidence and statements from these CPGs and clinical expertise, 14 recommendations were developed and graded according to the level of evidence. The statements and potential impact on clinical practice were discussed and assessed. These revised recommendations are intended to provide guidance for the diagnosis and the treatment of gout and to disseminate the best evidence-based healthcare for this disease.

Background Rheumatic Diseases (RD) frequently affect women during reproductive age, therefore counselling on family planning is crucial for their quality of life. Children’s outcome is a major topic, but no large studies are available. Objectives To assess the long-term health conditions of children born to women with RD in a large multicentre cohort. Methods 24 Rheumatology Centres distributed the questionnaire (65 multiple-choice and 12 open-answer questions) to consecutive patients (18–55 years) in September 2015. Data were analysed dividing children upon maternal diagnosis: Chronic Arthritides (CA) and Connective Tissue Diseases (CTD). Results Data were collected for 320 children (166 males, 52%) born to 184 mothers (63 CA and 121 CTD). At the time of interview, children had a mean age of 17.1±9.6 years. Preterm delivery ( Conclusions In this long-term follow-up of children born to mothers with RD in this large, multicenter study of randomly interviewed women each AIID did not display a significantly increased frequency as compared to the literature; only coeliac showed a mild increased frequency. Children with LD had a tendency to cluster in the group of mothers with CTD, especially after maternal diagnosis (4/63, 6.3%), with a higher frequency as compared to general paediatric population. No significant relationships between ND/LD and prematurity, intrauterine drug exposure or maternal autoantibodies were identified. Acknowledgements Statistical analysis supported by an unrestricted grant by UCB Pharma. The authors wish to thank Patients Associations and Participants to the survey. Disclosure of Interest None declared

Background Preventing organ damage is a major challenge in Systemic Lupus Erythematosus (SLE). Objectives To evaluate factors associated with development of damage in a prospectively followed cohort of early diagnosed SLE patients. Methods The Early Lupus Project1 encompasses 9 Italian centres recruiting, from the 1 st January 2012, an inception cohort of consecutive patients diagnosed with SLE within 12 months from appearance of four or more 1997 ACR classification criteria. At study entry and then every 6 months a large panel of data was recorded. Here, we report on factors associated with the development of damage assessed by the SLICC/ACR Damage Index (SDI). Using univariate analysis, we assessed the contribution of covariates collected at baseline (demographic, comorbidities, serological, clinical by BILAG2004 domains, disease activity by ECLAM, HRQoL by visual analogic scale) in the development of damage (SDI from 0 to ≥1). Forward-Backward Cox-regression models were fitted with covariates with p Results Overall, 279 patients were enrolled in the Early Lupus Project inception cohort up to the 31th of December 2017; 230 patients (89.6% Caucasians, 13.4% males) were eligible for this study having SDI=0 at enrolment and at least 6 months of follow-up. Mean (±SD) age at recognition of 4 ACR criteria was 36.5 (±14.4) years, median disease duration at recruitment was 1.1 months (interquartile range 0.0–4.8) and median follow-up duration was 27.4 months (interquartile range 7.2–48.0). At last follow-up visit 84 patients (36.5%) had an SDI score ≥1 (median=0; interquartile range 0–1); see figure 1A for overall SDI domains involved. Baseline dyslipidemia (p 35 year) at baseline (p=0.001; HR 2.3 95% CI 1.4–4.0) together with total dose of corticosteroids (p=0.015; HR 1.06 per gram of prednisone equivalent; 95% CI 1.01–1.11) during follow-up were the factors independently associated with increased risk of developing damage in this cohort (figure 1B). Their effect was confirmed after stratification for antimalarials (yes/no) and immunosuppressants (yes/no) use. Conclusions The early development of organ damage in this SLE patients cohort was associated with modifiable risk factors as baseline dyslipidemia and higher corticosteroid dose. Addressing them since the very early stages of the disease, and treating disease activity to target remission or minimal disease activity, may reduce damage and improve patients outcome. Reference [1] Sebastiani GD, et al. Early Lupus Project – A multicentre Italian study on systemic lupus erythematosus of recent onset. Lupus2015Oct;24(12):1276–82. Disclosure of Interest None declared

Objective To describe the clinical and serological features of a prospectively followed cohort of early diagnosed systemic lupus erythematosus (SLE) patients during a one-year follow-up period. Methods SLE patients with disease duration less than 12 months were consecutively enrolled in a multicentre, prospective study. At study entry and then every 6 months, a large panel of data was recorded. Results Of 260 patients enrolled, 185 had at least 12 months of follow-up; of these, 84.3% were female, 92.4% were Caucasians. Mean diagnostic delay was about 20 months; higher values of European Consensus Lupus Activity Measurement (ECLAM) and of organs/systems involved were both associated with shorter diagnostic delay. Clinical and serological parameters improved after study entry. However, patients' quality of life deteriorated and cardiovascular risk factors significantly increased. About one-third of patients with active disease at study entry went into remission (ECLAM = 0). Negative predictors for remission were: oral ulcers, arthritis, low C4, anti-SSB (Ro) antibodies and therapy with mycophenolate. There was a widespread use of glucocorticoids both at baseline and during follow-up. Conclusion Clinical symptoms and serological parameters improve during the first period after diagnosis. However, patients’ quality of life deteriorates. The widespread use of glucocorticoids is probably the reason for the early significant increase of some cardiovascular risk factors.

Background Rheumatic Diseases (RD) frequently affect women during reproductive age, therefore counselling on family planning is crucial for their quality of life. Children’s outcome is a major topic, but no large studies are available. This study aimed at assessing the long-term health conditions of children born to women with RD. Methods 24 Italian Rheumatology Centres distributed the questionnaire (65 multiple-choice and 12 open-answer questions) to consecutive patients (aged 18–55) during September 2015. Data were analysed dividing children upon maternal diagnosis: Chronic Arthritides (CA) and Connective Tissue Diseases (CTD). Results Data were collected for 320 children born to 184 mothers (63 CA and 121 CTD). At the time of interview, children had a mean age of 17.1±9.6 years. Pre-term delivery ( The occurrence of an autoimmune/inflammatory disease (AIID) and/or neurodevelopmental disorders (ND)/learning disabilities (LD) is reported in table 1. Twelve children (3.7%) were diagnosed with an AIID, mostly coeliac disease (8/12, 67%). Eleven children (3.4%) were diagnosed as having a ND and/or LD by a Paediatric Neuropsychiatrist. Data of in utero exposure to maternal autoantibodies and/or anti-rheumatic drugs were retrieved for 280 children (87.5%) and a comparison was performed between affected (n=11) and not-affected children (n=258). No association was found with ND/LD and in utero exposure to autoantibodies (ANA, anti-Ro, anti-dsDNA, aPL) or drugs (HCQ,AZA or steroids), neither with sex, preterm birth, birth weight or maternal diagnosis. Conclusions The long-term follow-up of children born to mothers with RD did not raise particular concerns in terms of relevant health problems. In particular, each AIID did not display a significantly increased frequency as compared to the literature. Children with ND/LD had a tendency to cluster in the group of mothers with CTD, especially after maternal diagnosis, with a higher frequency as compared to GPP (7.9% vs 3%). Our data suggest that the development of ND/LD in children of patients with RD cannot be linked exclusively to maternal disease. The results of this study can be reassuring for patients with RD about problems in the offspring possibly related to their disease.

Background Rheumatic diseases (RD) predominantly affect young women during reproductive age. Pregnancy, contraception and family planning (FP) are crucial for the quality of life of these patients. Objectives We aimed to investigate 9women9s health9 through a self-reported questionnaire. Answers from patients with connective tissue diseases (CTD) vs chronic arthritis (CA) were compared. Methods 24 centres distributed the questionnaire (65 multiple-choice and 12 open-answer questions) to women with RD (18–45years) regularly attending their outpatient clinics. Results Answers were collected from 249 CTD vs 149 CA patients. Their desire to have children was influenced by RD in 40% of cases: half of them reduced the number of children they wanted (Table 1). 39% CA vs 29% CTD were afraid of being mother because of disability. 24% CTD vs. 18% CA had at least one miscarriage; 21% CTD vs. 2% CA had more than one. 31% CTD and 34% CA were never asked about their desire to have children. 61% CTD vs 70% CA received counselling about contraception, given by a gynaecologist (G) (58% vs 64%), rheumatologist (R) (22% vs 14%) or both (7% vs 9%). 60% in both groups received a counselling before pregnancy: 34% vs 39% from R and G, 14% vs 22% by R. This positively changed family planning in 64% vs 59%. We created a Knowledge Index (based on the average of the normalized performed scores on 6 key questions for different sections): 55% CTD patients vs 44% CA had a medium-high score. A higher score directly correlated with the desire to became pregnant and with a multidisciplinary counselling. Conclusions This survey suggested that CTD have a major impact on FP and family size, possibly mediated by the increased rate of miscarriages as compared to CA. Concerns about reproductive issues could be positively overcome by adequate counselling. Rheumatologists should implement the discussion about FP and the compatibility of drugs with pregnancy in the management of young women with RD, especially those with CTD for whom contraception and pregnancy have particular implications. Acknowledgements Statistical analysis supported by an unrestricted grant by UCB Pharma Thanks to Patients9 Associations and Participants Disclosure of Interest None declared

Background Rheumatic diseases (RD) affect women during reproductive age. Children9s outcome is a major topic for counselling on family planning, but no large studies are available. Objectives We aimed at assessing the long-term health conditions of children born to mothers with RD through a self-reported questionnaire. Methods 24 Rheumatology Centers distributed the questionnaire (65 multiple choice and 12 open-answer questions) to consecutive women with RD attending their outpatient clinic during September 2015. Data were compared according to maternal diagnosis (MD) -chronic arthritis (CA) or connective tissue disease (CTD)- and to the timing of pregnancy (before or after MD of RD). Results The survey yielded data about 269 children born to 184 mothers (63 CA, 121 CTD). According to MD, children had a mean age of 17.1 (±9.6 SD) and 14.4 (±9.0 SD) years at the time of interview, and male children were 52/93 (56%) and 91/176 (52%), respectively. Twenty-nine children in the CA group (31.2%) and 64 in the CTDs group (36.4%) were born after MD of RD. Pre-term delivery (before 37 weeks) was observed in 48 cases (17.8%), mostly children born to mothers with CTD (37/48, 77%). Regarding school performance, 12 children (4.5%) repeated one year of school, in 7 cases for indolence, in 3 for learning disabilities (LD)/health problems (HP), in 2 for family problems. Eleven of these children were born before MD. Overall, 9 children (3.3%) were diagnosed with a LD and 53 children were affected by HP requiring either hospitalization or evaluation by a Specialist (Table). Three children (1%) were affected by autoimmune disease. Conclusions The long-term follow-up of children born to women with RD is reassuring of an outcome similar to that of the general pediatric population (GPP). Autoimmune diseases are not frequent. Problems seem to cluster in children born to CTD, especially after MD, with a higher frequency of LD (6.3% vs 2.5–3.5% of GPP), but no particular pattern of exposure to maternal autoantibodies nor drugs was observed. Acknowledgements Statistical analysis supported by an unrestricted grant by UCB Pharma Thanks to Patients Associations and Participants to the survey Disclosure of Interest None declared

Opportunistic infections (OIs) are not frequently seen in systemic lupus erythematosus (SLE). However, when present they are very dangerous, being potentially fatal in the majority of cases. Immunosuppressive therapy is the strongest risk factor for OI and correlates with death during infective episodes, but there are other factors predisposing to infection in SLE patients, such as several defects of the immune system that are intrinsic to the disease. The diagnosis of OI in SLE may be overlooked, owing to the fact that SLE flares may mimic infection with fever and inflammatory syndrome, and needs special attention in patients at risk. Finally, we have to consider that OIs could be a trigger of SLE too.

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

Background Preventing organ damage is a major challenge in management of Systemic Lupus Erythematosus (SLE). Few data are available on factors related to development of damage in early stages of the disease. Objectives To evaluate the early damage accrual and factors determining development and progression of damage in a prospectively followed cohort of SLE patients. Methods The Early Lupus Project comprises 8 Italian centers recruiting, from the 1st January 2012, an inception cohort of consecutive patients diagnosed with SLE. Patients were enrolled within 12 months of recognition of four or more 1997 ACR classification criteria for SLE. At study entry and then every 6 months a large panel of data was recorded. Here, we report on the development and progression of damage assessed by the SLICC/ACR Damage Index (SDI) at 6-month and 12-month of disease. Using univariate analysis, we assessed the contribution of covariates collected at baseline (demographic, serological, clinical by BILAG2004 domains, disease activity by ECLAM index and health related quality of life by visual analogic scale) in the development of damage (SDI from 0 to ≥1) and increase in pre-existing damage within 12 months from diagnosis. Stepwise regression models were fitted with covariates with p Results A total of 161 patients were enrolled in the Early Lupus Project inception cohort up to December 2014; 108 patients (93% Caucasians, 17 males) were eligible for this study having at least 12 months of disease. Mean age at recognition of 4 ACR criteria was 36.3±14.1 years, mean disease duration at recruitment was 2.8±4.3 months (median =1 month; interquartile range 0-3.8). At 6 months of disease, 22 (20.3%) patients had an SDI score of 1 or more (20 patients scored SDI=1; 4 patients scored SDI=2; 3 patients scored SDI≥3). At 12 months of disease, 27 (25.0%) patients had an SDI score of 1 or more and only one patient had increase in pre-existing damage. Age (p=0.01), dyslipidemia (p Conclusions Development of organ damage begins early in patients with SLE as effect of modifiable and non-modifiable risk factors. Addressing these since the very early stages of the disease may improve short-term outcome. Disclosure of Interest None declared

Background Systemic Lupus Erythematosus (SLE) is an autoimmune disease mostly affecting women during their thirties and forties. Objectives Our objective is to prospectively collect the clinical and serological characteristics of an Italian population of SLE patients with a recent disease onset. In this first report we describe the characteristics obtained at study entry of the patients as yet enrolled, and make comparison with the parameters of activity and damage obtained after 12 months of follow-up. Methods This is a multicentre prospective study. All patients with a diagnosis of SLE (1997 ACR criteria) and a disease duration lower than 12 months were consecutively enrolled in the study. The study started on 1st January 2012 and ended on 31st December 2013. Information on clinical and immunological characteristics at study entry and then every 6 months were collected into a specific electronic data base. Results We enrolled 122 patients (102 F, 20 M), 94.3% whites, 5.7% of other ethnicity. Mean age (SD) of patients at study entry was 37.3 (14.3) years, mean age at disease onset (first symptom of SLE) was 34.8 (14.3), mean age at diagnosis was 36.9 (14.3) years. Mean disease duration (from diagnosis until study entry) was 2.9 (3.9) months. The frequency (from onset until enrollment) of the manifestations included in the classification criteria was: ANA 94.3%, immunologic disorders 85.2%, arthritis 61.8%, hematologic disorders 55.7%, malar rash 31.1%, photosensitivity 29.5%, serositis 27%, renal disorders 27%, oral ulcers 11.5%, neurologic disorders 8.2%, discoid rash 5.7%. The cumulative frequency of mucocutaneous symptoms was 77.8%. Autoantibody frequency (at enrollment) was: ANA 89.3%, anti-dsDNA 77.8%, anti-SSA 31.9%, anticardiolipin 24.5%, anti-nRNP 17.2%, anti-beta2GI 17.2, Lupus anticoagulant 16.3%, anti-SSB 13.11%, anti-Sm 12.3%. Eighty-three patients had at least a hospitalization in the period from diagnosis until study entry. The mean (SD) hospitalization number was 1.54 (1.58) for the whole cohort, and the mean number of days of hospitalization was 14.4 (14.5). Median (range) disease activity (ECLAM) was 4 (0-10), median damage (SLICC) was 0 (0-3), median patient9s quality of life (VAS) was 53 (0-100). Fifty-nine patients completed 12 months of follow-up. Their ECLAM, SLICC and VAS were respectively 1 (0-4), 0 (0-4), 40 (0-100). Conclusions In our cohort, only 31.1% of patients presented with the typical malar rash at the onset. On the contrary, a great proportion of patients presented with nonspecific symptoms, such as arthritis. This could delay the final diagnosis of SLE. Mean age at onset of in our patients was about 35 years; at the fulfillment of the ACR criteria, the mean age was about 37 years. Therefore, the mean time between the first manifestations and the final classification of SLE was 2 years. Disease activity showed improvement during a 12 months period, probably reflecting the relatively short time duration between diagnosis and enrollment. However, this study confirm that SLE is a severe disease even at onset, because most patients have a poor quality of life and the majority of them require at least a hospitalization since the beginning. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.3347

Background We have recently demonstrated that miR-223 is up-regulated in peripheral blood and synovial CD3+T lymphocytes (TL) from Rheumatoid Arthritis (RA) patients compared to healthy controls (1,2) suggesting that miR-223 could contribute to the pathogenesis. Evidence exists that miRNAs may circulate in a highly stable form in plasma and serum (3). Objectives To evaluate miR-223 levels in peripheral CD3+TL of RA patients, at baseline (BL) and after 6 months of biological therapies; to evaluate miR-223 levels in sera from RA patients in comparison to healthy donors. Methods miR-223 expression in peripheral blood CD3+TL was analyzed in 8 RA patients treated with anti-TNFα agents (3: Etanercept; 2: Adalimumab; 1: Infliximab; 2: Golimumab) and 10 treated with IL6-R antagonist (Tocilizumab) at standard dosage for 6 months. Circulating CD3+TL were isolated with Lympholythe-H (Cederline) and Pan T Cell Isolation Kit (Milteny). Total RNA was extracted with TRIzol (Invitrogen). qPCR was performed following miScript PCR System (TaqMan microrna assay, Applied Biosystem). Wilcoxon test was used to perform statistical analysis. Serum samples were obtained from 11 RA patients and 7 healthy donors. Total serum RNA was purified with QIAamp Circulating Nucleic Acid Kit (Qiagen) using a supplementary protocol for biological fluids miRNA isolation. miR-223 expression was analyzed by qPCR following miScript PCR System (Qiagen). Kruskall-Wallis test was used for statistical analysis. The expression level of miR-223 from sera and TL was calculated with Vandesompele Method and miR-223 values was reported as fold change. Informed consent was obtained from all patients. Results The expression of miR-223 decreased significantly in RA patients after 6-month-therapy with anti-TNFα agents (mean 214.05±182.8 at BL vs. 86.94±52.9 after 6 months; p=0.05). In these patients, mean DAS28 was 6.12 at BL and 4.14 after 6 months (p=0.03). On the contrary, miR-223 levels varied from 394.86±445.5 at BL to 683.22±1258.1 in patients treated with IL6-R antagonist (p=0.55), while mean DAS28 was 5.097 at BL and 3.012 after 6 months (p=0.0039). A significant increase of miR-223 was found in serum compared to controls (7.69±5.1 vs. 1.05±0.8; p vs 0.58±0.22). Conclusions Weconfirm our previous results that showed an increased level of miR-223 in peripheral CD3+TL from active RA. An increased level of serum miR-223 was also demonstrated, for the first time. In addition, we found that anti-TNFα agents may reduce miR-223 levels, while, in tocilizumab-treated patients miR-223 remained essentially unchanged. This finding suggests thatmiR-223 level may be affected by the different mechanism of action of the used therapy and not by the disease activity status. Further studies are required to confirm our preliminary data, to clarify the role of miR-223 in RA and to validate miR-223 as a potential useful biomarker of disease Ackowledhements This study is supported by FIRA onlus 2009 (Fondazione Italiana per la Ricerca sull’Artrite) and Regione Toscana Progetto POR CReO FESR 2007-2013. References Fulci V et al. Hum Immunol 2010;71:206-11. Sebastiani GD et al. Clin Exp Rheumatol 2011;29:1058-1059. Kroh EM et al. Methods 2010;50298–301. Disclosure of Interest None Declared

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