Escalation in the use of biologic agents including tumor necrosis factor (TNF)-α inhibitors to treat immune-mediated inflammatory diseases (IMID) is linked to higher susceptibility of severe infections caused by intracellular pathogens, including Leishmania. This multicentric prospective study assessed the presence of Leishmania spp. infection among patients with IMID under treatment with biologic agents in two Italian clinical centers. We utilized a combination of diagnostic tests: real-time PCR for the detection of parasitic kinetoplast DNA in peripheral blood, Western blot for the identification of serum IgG antibodies, and a Whole blood assay to assess cytokine and chemokine responses following stimulation with parasitic antigen. A total of 126 patients residing in Italy were enrolled. Patients testing positive in at least one assay were classified as Leishmania-positive. Of the 125 asymptomatic individuals, 25 (20

Background: We provide the first prospective longitudinal multicenter experience on Upadacitinib efficacy and safety profile in Rheumatoid Arthritis (RA) in a real-life context, focusing on clinimetric and ultrasonographic (US) data. Methods: RA patients referred to three Italian tertiary Centers who started Upadacitinib were enrolled as per ACR/EULAR classification criteria and prospectively reviewed. The primary aim of this study was to assess changes in clinimetric and ultrasonographic scores through time (at baseline, after 1 month, 3 months, and 6 months from the beginning of the therapy). Secondary aims were to: (i) estimate the impact of biologic lines of treatment and concomitant therapies on response to therapy; (ii) explore changes in laboratory parameters; and (iii) find potential predictive factors associated with response to therapy. Results: Seventy-one patients (49 Females and 22 Males) were included. Clinimetric scores, including the Disease Activity Score (DAS28-CRP) and Simplified Clinical Disease Activity Index (SDAI), and US findings (synovial hypertrophy and power Doppler) significantly improved (p = 0.029, p = 0.001, p = 0.001, p = 0.001, respectively). Regression analysis revealed a significant association between the concomitant csDMARDs therapy at baseline and the lack of improvement in synovial hypertrophy [OR −4.824, p = 0.010] as well as with DAS28-CRP [OR −0.690, p = 0.045], whereas the presence of increased ESR or CRP at baseline was able to predict a significant improvement in SDAI [OR 8.481, p = 0.003]. No adverse events, such as deep venous thrombosis, pulmonary embolism, or herpes zoster virus infection, were reported during this study observation. Conclusion: Our real-life experience confirms the efficacy of Upadacitinib in terms of clinical and ultrasonographic improvement, as well as displaying a good safety profile.

Objective. In the last decades, the number of foreigners in Tuscany has considerably increased with a multiethnic distribution. We reviewed the main rheumatic diseases in the foreign population resident in Tuscany and also reported the experience at the Rheumatology Division of the University Hospital of Careggi, Florence, in order to identify the areas of origin of these patients and the main rheumatic diseases observed in them. Methods. The collaboration with the Tuscan Region provided data about foreign patients residing in Tuscany on January 1, 2021 (country of origin, chronic diseases). Moreover, we conducted a retrospective review of the clinical charts of our Rheumatologic Division from January 1, 2019, to December 31, 2020. Results. In Tuscany, on January 1, 2021, there were 61,373 patients with chronic inflammatory rheumatic diseases, and 3994 of them (6.51%) were foreigners. Most patients were born in Europe (39.03%), followed by the Balkans (15%), South America (11.27%), and North Africa (10.31%). Inflammatory joint diseases, Sjögren syndrome, and systemic lupus erythematosus were the most frequent diseases. In the period 2019-2020, 511 foreign patients visited our Rheumatology Division and mainly originated from the Balkans (34.64%), South America (18%), and European countries (16.44%). In these patients, chronic inflammatory joint diseases and connective tissue diseases (systemic sclerosis, Sjögren syndrome, and systemic lupus erythematosus) were the most prevalent diseases. Conclusions. This study provides a picture of the rheumatic diseases affecting foreign patients residing in Tuscany that are in agreement with the epidemiological data previously provided.

Background Patients with RA experience a decline in health-related quality of life, which is associated with increased illness severity and impairment of work abilities. Central sensitization (CS) emerges as an accurate predictor and correlate of poor pain experience. Objectives The purpose of this cross-sectional, multicentric study is to investigate the mediating role of CS in unfavorable relationships with disease activity levels, CS and work productivity loss due to presenteeism in women with RA, with the goal of identifying potential new targets for preventive interventions. Methods The study used a cross-sectional design and included 101 female workers with RA classified according to 2010American College of Rheumatology (ACR)/Europenan League Against Rhumatisms (EULAR) classification criteria. All patients filled out the italian version of the RAID, an assessment and evaluation tool that measures RA patient disease activity, progress, and outcomes. The Central sensitization Inventory (CSI) was used to measure CS, and the Work Productivity and Activity Impairment questionnaire-RA (WPAI-RA) was used to evaluate patients' employment status. RA patients were grouped into categories, based on their RAID total score. Multiple regression analysis was used to find out which factors were most likely to presenteeism. Results The patients' age ranged from 25 to 65 years, with a disease duration of 5.4 (SD 6.1) years. The CSI score was ≥ 40 in 39/101 patients (38.6%). 70 patients (69.3%) worked full-time, while 31 (30.7%) worked part-time. The majority of respondents (64.5%) reported a high degree of presenteeism with an average level of 31.8%. On the other hand, absenteeism was uncommon, with just 7.3% of respondents reporting it. %. Presenteeism was associated with higher CSI score (0.049), increased disease activity (0.0007), disease duration (0.0072) and age (0.0019) (Table 1). Conclusion CS disease activity and age were the factor most significantly associated with presenteeism-related productivity loss in RA patients. our findings have implications for health policy and emphasize the significance of identifying high-risk RA patients by monitoring CS as an indicator of presenteeism and severe disease activity. References [1]Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics 1993;4:353–365.[2]Salaffi F, Di Carlo M, Vojinovic J, Tincani A, Sulli A, Soldano S, Andreoli L, Dall'Ara F, Ionescu R, Simić Pašalić K, Balčune I, Ferraz-Amaro I, Tlustochowicz M, Butrimienė I, Punceviciene E, Toroptsova N, Grazio S, Morović-Vergles J, Masaryk P, Otsa K, Bernardes M, Boyadzhieva V, Cutolo M. Validity of the rheumatoid arthritis impact of disease (RAID) score and definition of cut-off points for disease activity states in a population-based European cohort of patients with rheumatoid arthritis. Joint Bone Spine. 2018 May;85(3):317-322.[3]Sakai R, Tanaka E, Inoue E, Sato M, Tanaka M, Ikari K, Yamanaka H, Harigai M. Association between patient-reported outcomes and impairments in work and activity in patients with rheumatoid arthritis in clinical remission: a retrospective analysis using the IORRA database. Mod Rheumatol. 2022 Sep 12:roac105. doi: 10.1093/mr/roac105. Epub ahead of print. PMID: 36094815. Acknowledgements: NIL. Disclosure of Interests None Declared.Table 1Multiple Regression Equation: Coefficients, Standard Errors and p valuesIndependent variablesCoefficientStd. ErrortP(Constant)39.8907mRDCI comorbidity score0.10490.16090.6520.5153DASS-210.069350.084910.8170.4151CSI score2.88301.26401.9940.0498ROAD score0.80981.38990.5830.5609RAID score4.47371.29033.4670.0007Kihon score-0.39210.5589-0.7020.4838Age, yrs-0.66240.2100-3.1550.0019Disease duration-0.035420.01303-2.7190.0072

Background Central sensitization (CS) assessed with Central sensitization Inventory (CSI) is significantly associated with functional disability and frailty in patients with rheumatoid arthritis (RA). Frailty is common in RA and associated with hospitalization and mortality. Frailty in RA is dynamic and, for some, may be ameliorated through controlling disease activity and functional disability. Objectives Our aim was to investigate the prevalence of CS in patients with RA and its association with measures of disease activity, functional disability, and frailty. Methods We administered to all the subjects in the study the CS inventory (CSI), a questionnaire that has been used for the diagnosis of CS. Demographic and clinical characteristics were collected as well as measures of disease activity [RAID), functional disability (ROAD) and Kihon Checklist (KCL) screening tool to identify community-dwelling adults vulnerable to frailty potentially at risk of becoming dependent. Patients with fibromyalgia were excluded from the study. Results Of the 192 included RA patients, mean CSI score was 36.7 ±15.5 and 36.5% scored >40, which indicates a high probability of CS. Mean CDAI score was 16.8 ± 12.4 and mean RAID 5.0 ± 2.0. A CSI score >40 was significantly associated with higher RAID (mean 5.7 vs. 4.6; F-ratio 12.28; p=0.001), higher ROAD (mean 4.3 vs. 3.0; F-ratio 17.37; p<0.001) and higher Kihon score (mean 9.1 vs. 5.7; F-ratio 29.88; p<0.001). Conclusion CS is strongly related to patient-reported disease activity, functional disability and frailty in patients with RA independently from other patient-and disease-related aspects. CS is an important determinant of functional disability in patients with chronic inflammatory arthritides. Therefore, special attention should be paid to RA patients, in whom the concomitant diagnosis of CS should be routinely ruled out. References [1] Chiarotto A, Viti C, Sulli A, Cutolo M, Testa M, Piscitelli D (2018) Cross-cultural adaptation and validity of the Italian version of the Central Sensitization Inventory. Musculoskelet Sci Pract 37:20-28.[2] Salaffi F, Di Matteo A, Farah S, Di Carlo M: Inflammaging and Frailty in Immune-Mediated Rheumatic Diseases: How to Address and Score the Issue. Clin Rev Allergy Immunol 2022; doi: 10.1007/s12016-022-08943-z.[3] Watanabe D, Yoshida T, Watanabe Y, Yamada Y, Miyachi M, Kimura M: Validation of the Kihon Checklist and the frailty screening index for frailty defined by the phenotype model in older Japanese adults. BMC Geriatr 2022; 22:478.[4] Salaffi F, Stancati A, Neri R, Grassi W, Bombardieri S. Measuring functional disability in early rheumatoid arthritis: the validity, reliability and responsiveness of the Recent-Onset Arthritis Disability (ROAD) index. Clin Exp Rheumatol. 2005 Sep-Oct;23(5 Suppl 39):S31-42. Acknowledgements: NIL. Disclosure of Interests None Declared.Figure 1Disease activity (RAID score), functional disability (ROAD score) and frailty (Kihon score) in patient with CSI < 40 (n° 122) and CSI > 40 (n° 70).

Background Affective distress (clinically significant depression, anxiety and stress) and central sensitization (CS) are consistently associated with the reported sensitivity and severity of pain, physical disability, poor treatment outcomes, and inflammatory disease activity, and potentially with early mortality in rheumatoid arthritis (RA). Objectives We aimed to explore affective distress in patients with RA and determine how they connected to CS. Methods Used the CSI to measure CS and the Depression, Anxiety and Stress Scale - 21 Items (DASS-21) to evaluate the negative emotional states of depression, anxiety and stress. The total CSI score ranges from 0 to 100, and a score of 40 or greater has been established to indicate CS. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. Multiple regression analysis was used to find out which factors were most likely to be linked to CS. Results Overall we included 192 RA patients (age ranging from 22 to 86 years) with a mean disease duration of 5.95 (SD 13.75) years. The CSI score was ≥ 40 in 70/192 patients (36.5%). In our RA cohort, the DASS-21 total score was 32.3 (SD29.8). The mean Anxiety score (Mean=10.68 and SD=8.92 was in the moderate range (10-14), whereas the mean Depression (Mean = 10.11 and SD = 11.66) and Stress (Mean = 15.8 and SD=12.05) scores were in the mild range (10-13 and 15-18, respectively). In the 70 patients with CSI score > 40, the mean Anxiety score (Mean=12.20 and SD=10.01) and the mean Depression (Mean = 14.01 and SD = 13.83) and Stress (Mean = 19.51 and SD=12.77) scores were all in the moderate range (10-14, 14-20 and 19-25, respectively). Conclusion Affective distress symptoms (clinically significant depression, anxiety and stress) and CS are common in RA patients. Screening and recognition of such psychosocial disorders may help patients achieve optimal disease control and a good outcome. Overall, our findings have implications for health policy and emphasize the significance of identifying high-risk fibromyalgia (FM) patients by monitoring CS as an indicator of severe disease. References [1]Bottesi G, Ghisi M, Altoè G, Conforti E, Melli G, Sica C. The Italian version of the Depression Anxiety Stress Scales-21: Factor structure and psychometric properties on community and clinical samples. Compr Psychiatry. 2015 Jul;60:170-81. [2]Ruhaila AR, Chong HC. Self-reported symptoms of depression, anxiety and stress among patients with Rheumatoid Arthritis in a Malaysian rheumatology centre - prevalence and correlates. Med J Malaysia. 2018 Aug;73(4):226-232. [3]Bacconnier L, Rincheval N, Flipo RM, Goupille P, Daures JP, Boulenger JP, Combe B. Psychological distress over time in early rheumatoid arthritis: results from a longitudinal study in an early arthritis cohort. Rheumatology (Oxford). 2015 Mar;54(3):520-7. Acknowledgements: NIL. Disclosure of Interests None Declared.

Background Upadacitinib (UPA), a JAK inhibitor engineered for a greater selectivity towards JAK1, has demonstrated a favourable benefit-to-risk profile in rheumatoid arthritis (RA) patients with an inadequate response to cDMARDs and biologic agents in randomized clinical trials. However, real-life data on its efficacy and safety are limited. We herein provide the first prospective multicentre experience on UPA efficacy and safety profile in RA in a real-life context, focusing on clinimetric and ultrasonographic (US) data. Objectives The primary aim of the study was to assess changes in clinimetric and US scores between different time point observations (baseline, 1 month, 3 months and 6 months). Secondary aims were to: (i) estimate the impact of biologic line of treatment and of concomitant therapies on response to therapy; (ii) explore changes in laboratory parameters; (iii) find potential predictive factors associated with response to therapy. Methods Medical records of consecutive RA patients treated with UPA and referred to three Italian tertiary Centers were prospectively reviewed. Adult patients meeting ACR/EULAR classification criteria for RA were enrolled. Results Our real-life experience confirms the efficacy in terms of clinical and US improvement as well as displaying a good safety profile. The combination therapy with a conventional immunosuppressants predicts a significantly lower clinical and US improvement, likely reflecting a more severe and aggressive course worthy of ad-hoc and more in-depth investigation. An improvement in the SDAI and DAS28CRP was observed, already from the first month of therapy and has been maintained over time.In conclusion, these results demonstrated the short term efficacy of Upadacitinib 15 mg for up to 6 months and providing a prompt improvement of PROs.Even if further studies are needed to clarify those results, these novel findings may provide new insight for the management of UPA treatment in clinical practice. Conclusion Our real-life experience confirms the efficacy in terms of clinical and US improvement as well as displaying a good safety profile. The combination therapy with a conventional immunosuppressants predicts a significantly lower clinical and US improvement, likely reflecting a more severe and aggressive course worthy of ad-hoc and more in-depth investigation.An improvement in the SDAI and DAS28CRP was observed, already from the first month of therapy and has been maintained over time.In conclusion, these results demonstrated the short term efficacy of Upadacitinib 15 mg for up to 6 months and providing a prompt improvement of PROs.Even if further studies are needed to clarify those results, these novel findings may provide new insight for the management of UPA treatment in clinical practice. REFERENCES: NIL. Acknowledgements: NIL. Disclosure of Interests None Declared.Figure 1Table 1Changes in clinimetric and ultrasonographic scores throughout the study period and significance levels (p values) for single comparisons between different observations in time.EndpointOverall significanceT0 vs T1T0 vs T3T0 vs T6T1 vs T3T1 vs T6T3 vs T6Synovitis grade< 0.0010.8040.090<0.001< 0.001< 0.001< 0.001PD signal grading0.0290.9140.3200.0260.0290.0090.066Tenosinovitis grading0.0120.9680.3700,0310,0180,0090,059DAS28-CRP0.0050.014< 0.001< 0.0010.2200.0150.035SDAI index< 0.0010.003< 0.001< 0.001< 0.001< 0.001< 0.001List of abbreviation: DAS28-CRP Disease Activity Score 28 – C-reactive protein, PD power Doppler, SDAI Simplified Clinical Activity Index, T0 baseline, T1 1 month evaluation, T3 3 month evaluation, T6 6 month evaluation

OBJECTIVES:Fibromyalgia (FM) is a chronic musculoskeletal pain syndrome of unknown aetiopathogenesis. Its development and maintenance are related to the interplay of biological, psychological, and contextual factors. Among the contextual factors, sociodemographic aspects are poorly elucidated. This study aimed to evaluate the relationships between sociodemographic/clinical factors and symptom severity measures using a web-based registry of patients with FM. METHODS:Adult patients with an ACR 2010/2011 diagnosis of FM underwent a clinical evaluation and were asked to complete questionnaires covering their sociodemographic data (gender, age, marital status, educational level), and disease-specific measures (the revised Fibromyalgia Impact Questionnaire (FIQR), and the Polysymptomatic Distress Scale (PDS)). RESULTS:Data relating to 3,221 patients (3001 women and 220 men) was collected. The ANOVA showed significant difference in mean FIQR scores when the five marital conditions (cohabiter, married, separated/divorced, single, widowed) were compared (F 3.321, p<0.01). While males and females were found to have comparable FIQR scores, the interaction between gender and marital status indicated that separated/divorced males have higher FIQR scores (F 5.684, p=0.001). The multiple regression analysis demonstrated that patients who reported lower educational level experienced more severe FM symptoms, as scored with FIQR (p<0.0001). CONCLUSIONS:Our results indicated that being male and separated/divorced is associated to higher severity of FM symptoms, as rated with FIQR. Furthermore, a relationship between educational level and FIQR scores has been detected. This study supports the importance of collecting simple SES measures to identify environmental risk factors for FM severity.

Background:In March this year, most of the routine activities were cancelled during the streaming of the pandemic in Italy. This prompted a pragmatic reorganization of the traditional care model of nursing and medicine, to quickly give an efficient clinical response. During the first phase of the pandemic, outpatient visits dropped by more than 60%, forcefully shifting to telemedicine to assure continuity of care despite the lockdown.Objectives:The aim of the present work was to describe the strategy adopted during and immediately after the lockdown to assure the follow up of patients and the maintenance of their treatment in an outpatient “virtual” telemedicine clinic dedicated to RDs.Methods:the patient flow to a rheumatology division during the lockdown was evaluated retrospectively from March to September 2020 in accordance with local restrictions, and three periods are described.Results:653/913 (71.5%), 542/542 (100%) and 1.048/1.048 (100%) infusion activities scheduled were performed at the centre for daily infusion and pre-infusion assessment, respectively during the 1st, 2nd and 3rd period. In the outpatient clinic during the 1st period, 96.96% of the cases was shifted to Telemedicine, which decreased to 52.45% in the 2nd period; while in the 3rd period, 97.6% of the performances were carried out at the clinic. Diagnostic procedures, such as ultrasound, capillaroscopy, and joint injection were generally postponed during the 1st period, reduced drastically during the 2nd and performed regularly during 3rd period. Ulcer treatment and the Clinical Trial Unit never stopped their activity. The flow of the activity of the outpatient clinic and the day hospital is represented as monthly trends in graph 1 (See Graph 1).Conclusion:Our data show the feasibility of Telemedicine in a lockdown condition. Shifting stable patients to Telemedicine has the potentiality to minimize the risk of contagion and allow continuity of care. In the future, the use of Telemedicine for specific clinical uses might assure patient assistance also in non-pandemic conditions.References:[1]Rawaf S, Allen LN, Stigler FL et al. Lessons on the COVID-19 pandemic, for and by primary care professionals worldwide. Eur J Gen Pract. 2020 Dec;26(1):129-133. doi: 10.1080/13814788.2020.1820479. PMID: 32985278.[2]McDougall JA, Ferucci ED, Glover J, et al. Telerheumatology: A Systematic Review. Arthritis Care Res (Hoboken). 2017 Oct;69(10):1546-1557. doi: 10.1002/acr.23153. Epub 2017 Aug 22. PMID: 27863164; PMCID: PMC5436947.[3]Romão VC, Cordeiro I, Macieira C, Oliveira-Ramos F, Romeu JC, Rosa CM, Saavedra MJ, Saraiva F, Vieira-Sousa E, Fonseca JE. Rheumatology practice amidst the COVID-19 pandemic: a pragmatic view. RMD Open. 2020 Jun;6(2):e001314. doi: 10.1136/rmdopen-2020-001314. PMID: 32584782; PMCID: PMC7425193.Characters from table content including title and footnotes:Graph 1.Monthly trend for telemedicine and visits during the SARS Cov2 emergencyAcknowledgements:The project (Telereuma) has been supported by an unrestricted grant of Biogen, BMS, and Novartis.Disclosure of Interests:None declared

Background:Fibromyalgia syndrome (FM) is characterised by a complex symptom spectrum, dominated by the presence of chronic widespread pain, fatigue and unrefreshing sleep. FM affects between 2 and 3% of the general population. It is a condition that mainly involves middle-aged women, although it is increasingly being diagnosed in younger people. The severity of symptoms can vary greatly between individual patients, and is influenced by many factors (e.g. sex, body mass index) [1]. To date, there is little information about changes in severity in accordance with patient age.Objectives:The aim of this study was to investigate variations in symptom severity in FM patients according to age categories.Methods:A cross-sectional study of adult FM patients diagnosed according to the American College of Rheumatology 2010/2011 criteria was performed. The case series was included from an Italian national registry [2]. Patients were grouped according to five age categories: 18-40 years, 41-50 years, 51-60 years, 61-70 years, over 71 years. Symptom severity was assessed through the revised Fibromyalgia Impact Questionnaire (FIQR) and domains, including FIQR physical function (items 1-9), FIQR health status (items 10-11), and FIQR symptoms (items 12-21). Between-group characteristics were analysed using one-way analysis of variance (ANOVA).Results:This study included a total of 2889 patients, 403 aged 18-40 years, 756 aged 40-50 years, 1035 aged 50-60 years, 528 aged 60-70 years, and 167 over 70 years, respectively. The mean (standard deviation [SD]) score of the total FIQR was 52.68 (11.82). Total FIQR and individual domains all showed a normal distribution. Analysing the data by age category, there were statistically significant differences between the categories for the total FIQR (p = 0.030). The age categories with the highest disease severity were those above 71 years (FIQR 62.14, SD 22.45), and between 51-60 years (FIQR 60.31, SD 22.89) (Table 1). Significant differences between age categories were also found for the domains physical function (p = 0.006) and health status (p = 0.012), but not for the domain symptoms (p = 0.164).Table 1.Mean values of FIQR total score and domains according to age categories.FIQR and domains18-40 years41-50 years51-60 years61-70 years≥71 yearsp*FIQR total, mean (SD)57.90 (21.76)59.25 (23.30)60.31 (22.89)57.13 (23.59)62.14 (22.45)0.030FIQR physical function, mean (SD)15.51 (7.56)16.44 (7.77)16.77 (7.51)15.96 (7.82)17.68 (7.26)0.006FIQR health status, mean (SD)11.19 (5.85)11.24 (5.99)11.49 (5.93)10.57 (6.11)12.21 (5.97)0.012FIQR symptoms, mean (SD)31.32 (10.48)31.56 (11.32)32.10 (11.01)30.68 (11.47)32.24 (11.34)0.164Abbreviations and legend. FIQR = revised Fibromyalgia Impact Questionnaire; SD = standard deviation; * = one-way analysis of variance (ANOVA).Conclusion:Distinguishing the disease severity in FM patients according to age categories, a bimodal distribution emerges, with the disease severity being greatest in patients over 71 years and in the 51-60 years decade. The main differences in severity, according to what can be detected through the FIQR, are attributable to the domains physical function and health status, which show higher scores in the two classes with higher severity.References:[1]Sarzi-Puttini P et al., Fibromyalgia: an update on clinical characteristics, aetiopathogenesis and treatment. Nat Rev Rheumatol 2020; 16: 645–660.[2]Salaffi F et al., The Italian Fibromyalgia Registry: a new way of using routine real-world data concerning patient-reported disease status in healthcare research and clinical practice. Clin Exp Rheumatol 2020; Suppl 123: 65-71.Acknowledgements:Società Italiana di Reumatologia (SIR) and Italian Ministry of HealthDisclosure of Interests:None declared

Background:Biologic and target synthetic disease modifying anti-rheumatic drugs (bDMARDs and tcDMARDs) are recommended to control RA disease activity, pain and steroid use. Following randomized clinical trials (RCTs) and their post-hoc analyses, the Janus Kinase Inhibitor tsDMARDs BARI was superior to reference bDMARD Adalimumab in reducing disease activity, pain and functional disability. In addition, BARI monotherapy also determined more significant pain reduction and functional improvement when compared to Tocilizumab monotherapy (3).Objectives:to confirm RCT results in a real-life clinical setting, with focus on disease activity, pain, functional disability and steroid tapering, when comparing BARI to bDMARDs for the treatment of active RA.Methods:RA patients starting BARI or a bDMARD for active RA were retrospectively evaluated from June 2019 to June 2020. Disease activity (DAS28CRP, SDAI, CDAI), pain visual analogic scale (pain_VAS), functional disability (HAQ) assessments and mean prednisone dosage (pred_dose) were collected at baseline (BL), 3 months (3M) and 6 months (6M) after BARI/bDMARD initiation. The changes of the outcome measures were evaluated between BL-3M, 3M-6M and BL-6M, as well as between BARI and bDMARDs groups. Finally, we assessed the variables associated with prednisone tapering in the whole population.Results:90 out of 100 RA patients evaluated (baseline: age 57±12 years, disease duration 131±100 months, DAS28PCR 4.8±1.0, pain_VAS 61±23 mm, prednisone dose 5.5±5.3 mg) were eligible for the study; 49 received BARI and 41 bDMARDs (17 abatacept, 12 TNF inhibitors, 11 tocilizumab, 1 rituximab). At BL, the two groups did not differ statistically in terms of age, sex, disease duration, disease activity, pain_VAS, previous bDMARD failure or ts/bDMARD naive, concomitant conventional synthetic DMARDs treatment, pred_dose. Both BARI and bDMARDs determined a significant reduction in activity scales and HAQ when comparing BL-3M and BL-6M, with only pain_VAS and pred_dose showing a significant decrease in the 3M-6M interval. When comparing the two groups, BARI showed a significantly higher reduction of pred_dose (-3.2±5.1 vs -1.7±3.7 mg at BL-3M, and -4.1±5.3 vs -1.9±4.6 mg at BL-6M), which was not significant after adjusting for BL pred_dose. No other difference was seen when the two groups, including the numerically higher reduction of pain_VAS in the BARI group (-29±28 vs -20±27 mm at BL-3M and -35±25 vs -30±28 mm at BL-6M comparison). The analysis of the predictors for steroid tapering (Δmean_pred) in the two intervals, showed that BL DAS28PCR, DAS28PCR BL-3M change and BL pred_dose were associated with BL-3M Δmean_pred, while 3M pain_VAS and 3M pred_dose were associated with 3M-6M Δmean_pred.Conclusion:Although limited by the small samples and the retrospective nature, our real-life comparison shows similar efficacy of BARI and bDMARDs in terms of disease activity control, functional disability and pain. In addition, the treatment with BARI or bDMARD did not influence the steroid tapering, which was driven mostly by its initial dose, disease activity and pain. Larger real-life multi-center studies are warranted to confirm our results.References:[1]Taylor PC et al. Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis. N Engl J Med. 2017 Feb 16;376(7):652-662.[2]Fautrel B et al. Effect of Baricitinib and Adalimumab in Reducing Pain and Improving Function in Patients with Rheumatoid Arthritis in Low Disease Activity: Exploratory Analyses from RA-BEAM. J Clin Med. 2019 Sep 5;8(9):1394.[3]Fautrel B et al. Comparative effectiveness of improvement in pain and physical function for baricitinib versus adalimumab, tocilizumab and tofacitinib monotherapies in rheumatoid arthritis patients who are naïve to treatment withDisclosure of Interests:Laura Cometi: None declared, Cosimo Bruni Speakers bureau: Actelion, Consultant of: Eli Lilly, Grant/research support from: Fondazione Italiana Ricerca sull’Artrite (FIRA), Gruppo Italiano lotta alla Sclerodermia (GILS), New Horizon Fellowship, European Scleroderma Trials and Research (EUSTAR) group, Foundation for Research in Rheumatology (FOREUM)., Lorenzo Tofani: None declared, Giulia Tesei: None declared, Francesca Nacci: None declared, Ginevra Fiori: None declared, Francesca Bartoli: None declared, Marco Matucci-Cerinic Speakers bureau: Biogen Italia, Actelion, Bayer, Boehringer Ingelheim, CSL Behring, Eli-Lilly, Consultant of: Biogen Italia, Actelion, Bayer, Boehringer Ingelheim, CSL Behring, Eli-Lilly, Grant/research support from: Biogen Italia, Actelion, Bayer, Boehringer Ingelheim, CSL Behring, Eli-Lilly,

Background: Fibromyalgia (FM) patients report chronic widespread pain, fatigue, cognitive difficulties and sleep disturbances, often associated with anxiety and/or depression (1). FM syndrome more frequently affects women and many papers describe gender-related differences in the perception, description and expression of pain (2), but up to now, the impact of gender on the clinical severity of FM is still a controversial topic. Objectives: The aim of this study was to analyse the data from a web-based registry of FM patients in order to detect a relationship between gender and disease severity. Methods: Adult patients with FM, diagnosed on the basis of the 2010/2011 American College of Rheumatology (ACR) diagnostic criteria (3), were recruited at 19 Italian rheumatology centres between November 2018 and April 2019. Those affected by other conditions that could interfere with the assessment of FM, e.g. psychiatric disorders, were excluded from the study. The severity of the disease was evaluated by validated FM-specific questionnaires: the revised Fibromyalgia Impact Questionnaire (FIQR) (4), the modified Fibromyalgia Assessment Status (ModFAS) questionnaire (5), and the Polysymptomatic Distress Scale (PDS) (6). The data obtained were collected in the Italian Fibromyalgia Registry, an online registry created with the support of the Italian Society of Rheumatology (SIR). Results: We analyse data from 2.381 patients affected by FM, 2.184 females (91.7%) and 197 males. No significant differences in mean age, disease duration, or BMI between the two genders were reported. The women expressed greater disease burden as indicated by higher scores for each completed test: higher mean ModFAS score (25.23 ± 8.83 Vs 23.37 ± 9.22; p = 0.005), mean FIQR score (58.62 ± 23.22 Vs 51.68 ± 23.06; p <0.001), and mean PDS score (18.77 ± 7.34 Vs 17.19 ± 7.25; p = 0.004). Figure 1 shows the mean scores of each item of the FIQR divided by gender. Women reported significantly higher values on all the items of FIQR except three (feeling overwhelmed, FIQR-11; depression, FIQR-16; and anxiety, FIQR-18). It is interesting to note that men self-reported higher levels of depression (FIQR-16). Figure 1. Mean scores for each FIQR item by gender. Conclusion: Our findings demonstrate that women with FM are globally more impaired than men (even if some psychological aspects of the disease are comparable), thus reinforcing the idea that gender plays a role in symptoms and functional impairments associated with the disease. References: [1]Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014;311:1547-55. [2]Nascimento, et al. Gender role in pain perception and expression: an integrative review. BrJP. 2020; 3: 58-62 [3]Wolfe F, et al. Fibromyalgia criteria and severity scales for clinical and epidemiological studies: A modification of the ACR preliminary diagnostic criteria for fibromyalgia. J Rheumatol 2011;38:1113–22. [4]Burckhardt CS, et al. The fibromyalgia impact questionnaire: development and validation. J Rheumatol 1991;18:728–33. [5]Salaffi F, et al. Diagnosis of fibromyalgia: comparison of 2011/2016 ACR and AAPT criteria and validation of the modified Fibromyalgia Assessment Status. Rheumatol 2020; 0:1-8. [6]Wolfe F, et al. Fibromyalgia prevalence, somatic symptom reporting, and the dimensionality of polysymptomatic distress: results from a survey of the general population. Arthritis Care Res. 2013; 65:777–85 Disclosure of Interests: None declared.

Background: Golimumab showed trial efficacy in subjects with active rheumatoid arthritis (RA) previously treated with TNF-inhibitors (TNFi); no trial data are available for psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). Objectives: To assess the effectiveness of golimumab after TNFi failure in patients with RA, PsA, or axSpA in a real-world setting. Methods: GO-BEYOND-Italy is an ongoing, multicenter, prospective, observational study of RA, PsA, or axSpA patients starting golimumab after TNFi failure. Patients were enrolled between July 2017 and December 2019, and followed for 1 year, with evaluations at 3, 6, and 12 months. This interim analysis estimates the effectiveness after 3 months of golimumab therapy. Differences from baseline were tested by paired t-tests. Results: 193 patients were enrolled: 38 (19.7%) with RA (median age 54 years; median disease duration 9.5 years), 91 (47.2%) with PsA (median age 53 years; median disease duration 9.0 years) and 64 (33.2%) with axSpA (median age 54 years; median disease duration 7.2 years). Majority of the RA (73.7%), PsA (51.6%) and axSpA (53.1%) were females. Previous TNFi treatment included etanercept (44.6% of patients), adalimumab (42.0%), infliximab (8.8%) and certolizumab (4.7%). The main reason for switching to golimumab was loss of efficacy of TNFi (78.9% in RA, 83.5% in PsA, 75% in axSpA). Comorbidities were highly prevalent (RA 65.8%, PsA 65.9%, axSpA 75%); hypertension (31.1%), dyslipidaemia (13.5%), fibromyalgia (10.4%) were the most common ones. DAS28-CRP significantly reduced in RA and PsA (p<0.01) after 3 months of treatment. In RA, rates of DAS28-CRP remission and low disease activity (LDA) were 29.6% and 22.2%, respectively, and 65.2% of patients achieved good/moderate EULAR response. As for PsA, good/moderate EULAR response was observed in 78.8% of patients and 28% of patients achieved minimal disease activity. In axSpA, ASDAS-CRP (p<0.01), BASDAI (p<0.01) and ASAS-HI (p=0.032) significantly reduced; rates of ASDAS-CRP inactive disease and LDA were 15.2% and 26.1%, respectively; 14% of patients had a ≥50% improvement in baseline BASDAI. After 3 months of golimumab treatment, there was a decrease in the prevalence of enthesitis (32.9% to 16.5%), nail (17.6% to 12.9%) and skin psoriasis (42.4% to 34.1%) in PsA patients; the frequency of extra articular manifestations tended to decrease also in axSpA patients. Conclusion: Preliminary results of the GO-BEYOND-Italy study showed a good short-term effectiveness of golimumab in RA, PsA and axSpA after TNFi failure. Table 1. Effectiveness of golimumab at 3 months in the GO-BEYOND-Italy study Rheumatoid arthritis (n=38 ) Psoriatic arthritis (n=91 ) Axial spondyloarthritis (n=64 ) DAS28-CRP, mean (SD) n=27 DAS28-CRP, mean (SD) n=47 ASDAS-CRP, mean (SD) n=44 V0 / V1 4.05 (0.8) / 3.10* (1.0) V0 / V1 3.66 (1.0) / 2.79* (1.2) V0 / V1 2.86 (1.0) / 2.33* (1.0) V1: DAS28-CRP disease activity, n (%) n=27 V1: EULAR response, n (%) n=33 V1: ASDAS-CRP disease activity, n (%) n=46 Remission 8 (29.6) Good 16 (48.5) Inactive disease 7 (15.2) Low disease activity 6 (22.2) Moderate 10 (30.3) Low disease activity 12 (26.1) Moderate disease activity 13 (48.1) No response 7 (21.2) High disease activity 22 (47.8) Very high disease activity 5 (10.9) V1: EULAR response, n (%) n=23 V1: MDA, n (%) n=75 Good 7 (30.4) Yes 21 (28.0) BASDAI, mean (SD) n=50 Moderate 8 (34.8) V0 / V1 5.99 (2.1) / 4.92 (2.3)* No response 8 (34.8) V1: BASDAI50, n (%) 7 (14.0) ASAS-HI, mean (SD) n=48 V0 / V1 10.67 (3.8) / 9.68 (4.6)^ *p value for the difference from V0 <0.01. ^ p for the difference from V0=0.032 Abbreviations: ASDAS: Ankylosing Spondylitis Disease Activity Score; ASAS-HI: Assessment of SpondyloArthritis international society Health Index; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; CRP: C-reactive protein; DAS: disease activity score; EULAR: European League Against Rheumatism; MDA: Minimal Disease Activity; SD: standard deviation; V0: baseline; V1: 3 months evaluation. Disclosure of Interests: Salvatore D’Angelo Speakers bureau: AbbVie, BMS, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, UCB, Consultant of: AbbVie, BMS, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, UCB, Enrico Tirri Speakers bureau: AbbVie, Eli Lilly, Novartis, Pfizer, Angela Maria Giardino Employee of: MSD Italia, Marco Matucci-Cerinic Speakers bureau: BMS, Pfizer, Actelion, Consultant of: Eli-Lilly, Celgene, Chemomab, CSL Behring, Grant/research support from: BMS, Pfizer, Celgene, CSL Behring, Lorenzo Dagna Consultant of: Abbvie, Amgen, Biogen, Bristol-Myers Squibb, Celltrion, Novartis, Pfizer, Roche, Sanofi-Genzyme, and SOBI, Leonardo Santo: None declared., francesco ciccia: None declared., Bruno Frediani: None declared., Marcello Govoni: None declared., Francesca Bobbio Pallavicini: None declared., Rosa Daniela Grembiale: None declared., Andrea Delle Sedie: None declared., Stefania Cercone Employee of: MSD Italia, RITA MULE’: None declared., Francesco Paolo Cantatore Speakers bureau: Pfizer, Sanofi Genzyme and Roche, Consultant of: Pfizer, Sanofi Genzyme and Roche outside this work., Rosario Foti: None declared., Elisa Gremese: None declared., Roberto Perricone: None declared., Fausto Salaffi: None declared., Ombretta Viapiana Speakers bureau: Novartis, UCB, Abbvie, MSD, Fresenius kabi, Gilead, Biogen, Consultant of: Novartis, Abbvie, Fresenius kabi, Gilead, Biogen, Alberto Cauli Speakers bureau: Abbvie, Alfa-Sigma, BMS, Celgene, Galapagos, Glaxo, MSD, Novartis, Janssen, Pfizer, Sanofi, UCB, Consultant of: Abbvie, Alfa-Sigma, BMS, Celgene, Galapagos, Glaxo, MSD, Novartis, Janssen, Pfizer, Sanofi, UCB, Rorberto Giacomelli: None declared., Luisa Arcarese: None declared., Giuliana Guggino Speakers bureau: Novartis, Celgene, Abbvie, Sandoz, Eli Lilly, Pfizer, Jansen, ROMUALDO RUSSO: None declared., Domenico Capocotta: None declared., Francesca Nacci: None declared., Maria Grazia Anelli: None declared., valentina picerno: None declared., Florenzo Iannone Speakers bureau: Pfizer, AbbVie, Janssen, Celgene, Novartis, MSD, BMS, UCB, Roche, Consultant of: Pfizer, AbbVie, Janssen, Celgene, Novartis, MSD, BMS, UCB, Roche outside this work.

Background:Remission or low disease activity (LDA) are the ultimate goals of both conventional synthetic (csDMARD), target synthetic and biologic disease-modifying anti-rheumatic drugs (bDMARD) in treating RA. Janus Kinase (JAK) inhibitors are nowadays part of tsDMARDs, with BARI as an oral selective JAK1-2 inhibitor. Ultrasound (US) is a valuable imaging tool for detecting inflammatory joint changes and monitoring RA patients. The US7 score (US7) is a semiquantitative score including grayscale (GS) and power Doppler (PD) measurements of synovitis and tenosynovitis in 7 joints of the clinically dominant hand and foot.Objectives:to evaluate real life efficacy and safety of BARI 4 mg in RA patients using clinical, clinimetric and US evaluation.Methods:adult RA patients starting BARI were eligible. DAS28ESR, CDAI, SDAI, painVAS, HAQ, COCHIN, laboratory parameters and US7 were performed/collected at baseline (BL) and after 3 and 6 months. Adverse events (AE) and concomitant medications were recorded. Responder/non responder status was determined using DAS28ESR improvement according to the EULAR Response Criteria at 3 months. Moreover, SDAI clinical remission or LDA (remission: SDAI≤3,3; LDA:3,3Results:43 patients (12 csDMARD and 31 bDMARD failure) were enrolled, with 30 patients starting BARI in combination with a csDMARDs. BL painVAS was 68±23mm and disease activity was moderate to severe according to DAS28VES, CDAI and SDAI. BARI determined a significant improvement of every disease activity composite score and US7 components, except tendon PD; steroid daily dosage was significantly reduced.28 patients were considered Responders at 3 months: responders used to have higher disease activity levels and synovitis scores at baseline.Table 1.Comparisons demographics and renal pathologies of responder and non-responder groupsBL3Mp value6Mp valueRNRRNRRNRpainVAS67,88±23,3758,18±22,7230,19±23,5245,64±25,48p=0.004030,19±20,4229,73±22,15p=0.2105Daily prednisone equivalent5,97±5,575,45±4,302,96±3,023,95±3,63p=0.22481,63±2,103,03±3,59p=0.1247GSS8,50±5,257,00±3,813,69±3,632,33±2,45p=0.93343,56±3,014,22±2,64p=0.2452GST2,88±2,333,11±2,090,88±0,891,56±1,59p=0.65011,00±1,372,78±1,72p=0.0831PDS8,00±7,113,33±3,463,00±3,482,44±3,36p=0.00663,25±3,135,00±4,56p=0,0006PDT2,81±2,462,44±3,360,88±1,541,33±1,50p=0.449901,06±1,533,78±3,19p=0.0156Erosions1,25±2,050,44±0,731,50±2,030,44±0,73p=0.07361,31±2,091,11±1,27p=0.0902Interestingly, painVAS and steroid dosage significantly decreased both in responders and non-responders, achieving similar value at 6 months. Non-responders showed both synovial and tendon involvement relapse at 6 months, with significantly higher PD score compared to responders. Remission was reached by 12,8% patients at 3 months and 21,6% at 6 months, while LDA patients were respectively 53,8% and 51,3%; combination with csDMARD was the only factor positively associated with remission/LDA at 3 months.The percentage of dropped-out patients due to AE was aligned with literature data (5% in 6 months) whereas the percentage of Herpes Zoster Virus (HZV) infections was higher (4,6% in 6 months in our population vs 4,3% in 1 year in RCTs). Corticosteroid dosage was directly associated with AE development at 6 months.Conclusion:Real life data confirmed BARI RCTs efficacy and safety data. Non responders showed both synovial and tendon PD disease relapse, despite painVAS and steroid reduction were comparable to responders. In our population, HZV infection prevalence was higher than in RCTs and corticosteroid dosage was positively associated with AE development at 6 months.Disclosure of Interests:Giulia Tesei: None declared, Cosimo Bruni Speakers bureau: Actelion, Eli Lilly, Laura Cometi: None declared, Francesca Nacci: None declared, Marco Capassoni: None declared, Riccardo Terenzi: None declared, Lorenzo Tofani: None declared, Francesca Bartoli: None declared, Ginevra Fiori: None declared, Marco Matucci-Cerinic Grant/research support from: Actelion, MSD, Bristol-Myers Squibb, Speakers bureau: Acetelion, Lilly, Boehringer Ingelheim

SB4 in now commonly used in the treatment of inflammatory joint diseases, with evidence of efficacy and persistence up to 12 months from switching in both randomized controlled trials in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS).we investigated the safety and retention rate of SB4 at 6, 12 and 18 months after switching from ETN in two rheumatology departments in our region.adult patients with RA, PsA, AS, Juvenile Idiopathic Arthritis (JIA) and other rheumatic diseases treated with ETN for at least 6 months, switched to SB4 in stable clinical conditions, were eligible for this retrospective evaluation. Data on adverse events (in particular infectious events), loss of efficacy (articular, cutaneous, ocular or intestinal disease re-activation) and persistence on treatment were collected since latest available follow-up. Retention rate, reason for discontinuation and subsequent management data were collected at 6, 12, 18 months.220 patients (142 females, mean age 58+-7 years, disease duration 12+-4 years, ETN duration 7+-4 years) were enrolled, with median follow up of 12.1 (9.7-15.8) months duration; ETN was used in different biologic DMARDs treatment lines (first 76.8%, second 17.7%, third 3.2 %, fourth 2.3%). Study population was composed of 85 RA, 81 PsA, 33 AS, 14 JIA and 7 other conditions (mostly scleroderma). In the follow-up, 50 patients (22.7%) presented with at least one non-serious adverse event, with 36 (16,4%) disease re-activation (mostly articular) and 30 (13,6% - 11 for safety and 19 loss of efficacy) SB4 interruptions. Retention rates were 99.1 (210/212) at 6, 90.9% (150/165) at 12 and 81.5% (53/65) at 18 months respectively. Back-switch to ETN was performed in 17/30 cases, the remaining cases were managed with change of bDMARD or csDMARD). Age was the only significant predictor of SB4 interruption at 6 months (OR 1.058, 95%CI 1.007-1.112, p=0.026), while disease, bDMARD line, csDMARD combination, gender, disease duration or ETN duration did not influence retention rates at 6, 12 or 18 months.our real-life data confirm the safety profile of switching from ETN to SB4. In our patients, the data show a higher retention rate, when compared to other-real life registries data (1,2)[1]Ebbers HC et al. Real-World evidence on Etanercept Biosimilar SB4 in Etanercept-Naïve or Switching Patients: A Systematic Review. Rheumatol Ther. 2019 Sep;6(3):317-338.Cosimo Bruni Speakers bureau: Actelion, Eli Lilly, Stefano Gentileschi: None declared, Marco Capassoni: None declared, Giovanni Pacini: None declared, Marco Bardelli: None declared, Caterina Baldi: None declared, Lorenzo Tofani: None declared, Laura Cometi: None declared, Francesca Nacci: None declared, Francesca Bartoli: None declared, Ginevra Fiori: None declared, Luca Cantarini: None declared, Serena Guiducci: None declared, Bruno Frediani: None declared, Marco Matucci-Cerinic Grant/research support from: Actelion, MSD, Bristol-Myers Squibb, Speakers bureau: Acetelion, Lilly, Boehringer Ingelheim

post-shock pacing feature is used in clinical practice, to assess the incidence of postshock pacing in a "real world" population, and to identify clinical factors predicting the need for post-shock pacing.Methods: The IMPLANTED is a multicentric registry prospectively collecting all data regarding remote-monitored cardiac implantable devices from seven high-volume arrhythmia centers.For the present analysis, 1068 consecutive transvenous ICD recipients were analyzed (22.4% single-chamber, 25.5% dual-chamber, 52.1% CRT-D).Post-shock programming after ICD implant was noted, and all appropriate shocks were checked through the remote monitoring in order to evaluate the rhythm after the shock (spontaneous vs. paced) and, in the case of paced rhythm, the time to recovery of spontaneous ventricular activity.Results: Out of 1068 total patients, 66.4% were male and mean age was 65614 years.Median NYHA class was II and mean LVEF was 35612%.39.1% of all patients presented an ischemic cardiomyopathy, 45.1% presented a dilated idiopathic cardiomyopathy and 15.8% other types of heart disease.In 589 patients (55.2%) the post-shock pacing was turned on.The programmed post-shock pacing rate was 70 bpm in 78.8% of cases, <70 bpm in 18.8% of cases and >70 bpm in 2.4% of cases.Median programmed post-shock pacing duration was 10 seconds.During a median follow-up of 19 months, 122 ventricular arrhythmias were detected and shocked in 80 patients.A paced rhythm was documented in 53 (43.4%) events.A multivariate logistic analysis the following factors as clinical predictors of a paced rhythm after a shock: age (p¼0.023),COPD (p¼0.028),ischemic cardiomyopathy (p¼0.002) and a paced rhythm prior to the shock (p<0.001).Conclusions: In a large, "real world", dataset post-shock pacing is considered useful and therefore turned on by the physician in half of the ICD patients.Another half of those patients present a spontaneous rhythm after an appropriate shock.Age, COPD, ischemic cardiomyopathy, and the need for permanent pacing predict the usefulness of post-shock pacing.

Background Over the past decade, it has been frequently suggested that the risk of cancer may be increased in patients with inflammatory rheumatic diseases treated with biologics. These drug have been considered as reducing immune surveillance. However, data from registries from different continents reported that treatment with TNF inhibitors did not increase the risk of malignancies, except for skin cancer (1). Objectives To evaluate the incidence of malignancies in a cohort of our patients with inflammatory rheumatic diseases treated with biological drugs. Methods The charts of 1468 patients with Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis treated with Adalimumab, Etanercept, Infliximab, Certolizumab, Golimumab, Tocilizumab and Abatacept followed up from 2005 to 2015 at the Department of Rheumatology, University of Florence, were reviewed. Patients who developed a cancer (excluding basal cell skin cancer) during biological therapy were identified. The incidence of malignancies in our patients was compared to the incidence of cancer in the general population in the same period, same geographic area and with same age. Results Out of 1468 patients, 828 (56,4%) were affected by Rheumatoid Arthritis, 290 (19.7%) by Ankylosing Spondylitis and 350 (23.9%) by Psoriatic Arthritis. Twenty-five out of 1468 patients (1.7%) (mean age 65±9 years), developed cancer: in details, we found 5 (20%) lung cancer, 5 (20%) melanoma, 2 (8%) breast cancer, 1 (4%) liposarcoma, 1 (4%) tongue cancer, 1 (4%) colo-rectal cancer, 1 (4%) liver cancer, 1 (4%) squamous cell skin cancer, 1 (4%) intestinal lymphoma, 1 (4%) myeloid leukemia, 1 (4%) endometrial cancer, 1 (4%) cervical intraepithelial neoplasia (CIN III), 1 (4%) gastric cancer, 1 (4%) bladder cancer, 1 (4%) laryngeal carcinoma and 1 (4%) follicular NHL of parotid gland. Incidence among patients resulted as follows: 2,05% Rheumatoid Arthritis, 1,37% Ankylosing Spondylitis and 1,14% Psoriatic Arthritis. The percentage of cancer in patients was respectively: Etanercept 2,31%, Adalimumab 1,46%, Infliximab 1,18%, Golimumab 1%, Abatacept 1%, Tocilizumab 3,92% and Certolizumab 2,43%. From 2005 to 2010, the incidence of malignancies (excluding basal cell skin cancer), in general population between the age of 60 and 70 years in the Florence area was 0.39%. Conclusions Our data suggest that in patients with inflammatory rheumatic diseases treated with biological drugs, cancer is increased of 289% compared to the general population. In these patients, the risk of malignancy still remains to be verified in larger cohorts in our area with a long-term controlled registry. References Codreanu C, Damjanov N. Safety of biologics in rheumatoid arthritis: data from randomized controlled trials and registries. Biologics. 2015 Jan 27;9:1–6. doi:10.2147/BTT.S68949. eCollection 2015. Review. Disclosure of Interest None declared