Background: Spreading data describe cardiovascular disease (CVD) as a growing cause of hospitalization in systemic sclerosis (SSc) patients. Although interstitial lung disease and pulmonary arterial hypertension (PAH) remain the principal causes of mortality, the presence of CVD has been shown to further increase mortality in SSc patients. Few and contrasting data are available on cardiovascular impairment, particularly of subclinical coronary arteries disease, in SSc patients. The aims of this study were: 1) to determine the demographic, clinical, and cardiovascular differences between the groups of SSc patients with and without subclinical coronary atherosclerosis (SCA) assessed by coronary calcium score; 2) to verify the performance of cardiovascular risk scores in SSc for detection of SCA major cardiovascular events (MCVE); 3) to evaluate the risk factors associated to MCVE in 5 years of follow-up in this study group of patients.Methods: Sixty-seven SSc patients were enrolled in this study. SCA was assessed using quantification of coronary calcium score by computerized tomography, reported as Agatson. Evaluation of common cardiovascular risk scores, carotid plaques by Doppler ultrasonography, the history of peripheral artery disease (PAD), lipid profiles, and clinical and laboratiristic characteristics of SSc were assessed at baseline visits for each patient. Factors associated with the presence of SCA were assessed by multivariate logistic analysis. A five years prospective study was performed for the evaluation of MCVE occurrence and its possible predictors.Results: The prevalence of SCA was 42% (Agatston scores of 266.04 & PLUSMN; 455.9 units) in our group of SSc patients. Patients with SCA were principally older (p = 0.0001) and had higher rates of CENP-B antibodies (57% vs 26%; p = 0.009), pulmonary arterial hypertension (PAH) (25% vs 3%; p = 0.008), dysphagia (86% vs 61%; p = 0.027), and users of statins (36% vs 8%; p = 0.004), carotid plaque (82% vs 13%; p = 0.0001), PAD (79% vs 18%; p = 0.0001), and metabolic syndrome (25% vs 0%; p = 0.002) than patients without SCA. Metabolic syndrome (OR: 8.2, p = 0.0001), presence of a PAD (OR: 5.98, p = 0.031), and carotid plaque (OR: 5.49, p = 0.010) were the main factors associated with SCA in SSc patients, by multivariate regression analysis. MCVE occurred in 7 patients. By multivariate COX regression analysis unique predictor of MCVE in 5 years of follow-up in our SSc patients was the presence of PAH (HR: 10.33, p = 0.009). Of note, the contemporary presence of PAH and SCA (defined as "not pure" pattern of PAH) was observed in 71% of patients with the occurrence of MCVEConclusion: This study evidenced the high presence of the new "not pure" pattern of PAH, which could worsen the outcome in SSc in a medium-term (5 years) observation period. Furthermore, our data confirmed a higher cardiovascular impairment in SSc due to the presence of both SCA, mainly associated with typical cardiovascular risk factors, and PAH, life-threatening complications of SSc, that is the principal cause of the occurrence of MCVE in our SSc patients. A careful assessment of cardiovascular involvement in SSc and a more aggressive therapeutic strategy for preventing CAD and treating PAH should be highly suggested to reduce MCVE in SSc patients.

Background Psoriatic arthritis is a chronic immune-mediated disease that may appear with arthritis and/or enthesitis and systemic manifestations, affecting 0.1-1% of the general population and up to 30% of patients with psoriasis. A greater understanding of the pathogenesis has led to an increase of therapeutic options, namely biotechnological drugs which may prevent the progression of the disease and improve the quality of life by acting on specific pathways. Among these drugs, anti-TNFα agents play an important role. Adalimumab (ADA) and Etanecept (ETA) were the first developed ones, indeed they are defined as “originator” drugs. Subsequently, “biosimilars” have been developed. They are defined by the EMA as highly similar to other biological agents already on the market in terms of qualitative characteristics, biological activity, safety, and efficacy. Spending review and pharmaco-economic policies have almost “imposed” the use of non-medical switching (NMS). Objectives The aim of this study is to evaluate the retention rate of ETA and ADA originators, compared to their biosimilar counterparts, in the first line and after NMS, detecting discontinuation for adverse events (AEs) or ineffectiveness, in patients with psoriatic arthritis. Methods Fifty-four patients diagnosed with psoriatic arthritis were enrolled (F: 61%; mean age 53.4±13 years, BMI 24.9±3.6), Baseline disease activity was 4, 1 ± 1.1. Inclusion criteria were age >18 years, fulfillment of CASPAR 2006 criteria for PsA, therapy with originators or biosimilar etanercept or adalimumab in the first line, with the possibility of no NMS, stable combined therapy with methotrexate during the observation time. Statistical significance was set at p⩽0.05. Results The retention rate of ETA and ADA originators was 541 ± 70 weeks and 486 ± 24 weeks, respectively. The retention rates of biosimilar ETA and biosimilar ADA in the first line were 265 ± 20 weeks and 79 ± 21 weeks, respectively (p=0.231). After NMS, the retention rate of biosimilar ETA and biosimilar ADA was 49.1 ± 13 weeks and 108 ± 12 weeks, respectively. Discontinuation due to AEs were recorded in 8.3% of patients receiving originator ETA, 5% of patients receiving originator ADA, and 31% of patients receiving biosimilar ADA. Discontinuation due to ineffectiveness occurred in 54% of patients treated with originator ETA, in 40% of patients treated with originator ADA, and in 44% of patients treated with biosimilar ADA. In patients treated with biosimilar ETA, no suspensions were recorded either for AEs or for ineffectiveness. Conclusion Our data show that the retention rate of originator drugs was higher than that of biosimilars, both when administered in the first line and after a NMS. A greater number of suspensions were recorded for AEs and, to a lesser extent, for ineffectiveness with biosimilar ADA compared to originator ADA, while in patients treated with biosimilar ETA no suspensions were recorded either for AEs or for ineffectiveness. References [1]Gossec L, Baraliakos X, Kerschbaumer A, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis. 2020;79(6):700-712. doi:10.1136/annrheumdis-2020-217159; [2]Veale DJ, Fearon U. The pathogenesis of psoriatic arthritis. Lancet. 2018;391(10136):2273-2284. doi:10.1016/S0140-6736(18)30830-4; [3]Taylor W, Gladman D, Helliwell P, et al. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum. 2006;54(8):2665-2673. doi:10.1002/art.21972 [4]Ogdie A, Coates LC, Gladman DD. Treatment guidelines in psoriatic arthritis. Rheumatology (Oxford). 2020;59(Suppl 1):i37-i46. doi:10.1093/rheumatology/kez383; [5]Gherghescu I, Delgado-Charro MB. The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA. Pharmaceutics. 2020;13(1):48. Published 2020 Dec 31. doi:10.3390/pharmaceutics13010048 Acknowledgements: NIL. Disclosure of Interests None Declared.

Background In recent times, safety and potential adverse effects (AEs) of Sars-CoV-2 vaccines have gained great relevance and have been a central topic in scientific discussion. Objectives The aim of this study was to evaluate the incidence of AEs after Sars-CoV-2 vaccine administration in patients affected by Connective Tissue Disease, Vasculitis or Polymyalgia Rheumatica. Moreover, we assessed patients’ adherence to the American College of Rheumatology (ACR) 1 or Italian Rheumatology Society (SIR) 2 recommendations. Methods 139 patients affected by Connective Tissue Disease, Vasculitis or Polymyalgia Rheumatica were enrolled at the Rheumatology Units of University Hospitals of Bari and Foggia. All patients were given a questionnaire to evaluate vaccine type and dose number, AEs, potential pre-vaccine prophylaxis, immunosuppressive therapy and its possible suspension according to the clinical guidance summary proposed by ACR or SIR. Results Among the 139 enrolled patients (120 females and 19 males, mean age 54 ± 14,7 year, mean disease duration 8,6 ± 7,4 years), 31 subjects (19%) received anti Sars-CoV-2 vaccination. 5 patients received the AstraZeneca COVID-19 vaccine, 23 the BioNTech-Pfizer COVID-19 vaccine and 3 the Moderna vaccine. Only 48% of subjects received two doses. 42% of patients reported non-severe AEs after the first dose of vaccine, specifically 45% of patients who received the BioNTech-Pfizer COVID-19 vaccine, 40% of those who were administered the AstraZeneca vaccine and 33% of those who received the Moderna vaccine. Most frequent AEs were site injection pain (19%), fatigue (13%), headache (13%), myalgia (6%), fever (6%), nausea (3%), rheumatic disease flare (3%) (the latest was reported only among the Polymyalgia Rheumatica patients). Considering the different diseases, the highest trend of AEs was observed in Polymialgya Rheumatica (66%), Systemic Sclerosis (57%), Sjogren Syndrome (40%) and undifferentiated connective tissue disease (23%) patients. 30% of patients who received the second vaccine dose reported AEs. All of them were administered the BioNTech-Pfizer COVID-19 vaccine. Most reported AEs after the second vaccine dose were site injection pain (6%), headache (3%), myalgia (6%), fever (6%). The highest trend of AEs was observed in undifferentiated connective tissue disease (60%) and Sjogren Syndrome (33%) patients. Only 13 % of subjects who reported AEs after the first vaccine administration, reported AEs also after the second dose. Only 9,7% of patients did not comply with the COVID-19 vaccine clinical guidance prosed by ACR or SIR regarding immunosuppressive treatment management before and after immunization. Conclusion Patients enrolled in this study developed mild AEs. Only among Polymyalgia Rheumatica patients were described disease flares and higher trend of AEs. Although patients affected by Systemic Lupus Erythematosus, Antiphospholipid Syndrome and Vasculitis were enrolled, none of them reported severe AEs, included the extensively discussed post-vaccine thrombosis. We found no significant dissimilarity of AEs relating to different types of vaccine and good patient compliance to physician recommendations about treatment management. References [1]Curtis JR, Johnson SR, Anthony DD, Arasaratnam RJ, Baden LR, Bass AR, et al. American College of Rheumatology Guidance for COVID-19 Vaccination in Patients with Rheumatic and Musculoskeletal Diseases – Version 1. Arthritis Rheumatol 2021. [2]A proposito della vaccinazione anti SARS-COV 2 nei pazienti reumatologici (aggiornamento del 13.03.2021). Disclosure of Interests None declared

BackgroundCoronavirus 19 disease (COVID-19) represents the most important pandemic of the last century. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection has produced more than 170 million cases and more than 3 million deaths. Due to the easy spread of the infection and the possibility of serious clinical manifestations, the role of anti-COVID 19 vaccination is essential. Vaccines with different mechanisms of action have been developed: mRNA-based, such as Biontech-Pfizer and Moderna, and viral vectored, such as AstraZeneca and Janssen. Despite possible adverse events, benefits afforded by these vaccines significantly outweigh potential risks associated with their administration in the general population.ObjectivesThis study aimed to evaluate incidence and severity of adverse events (AEs), secondary to vaccination, in patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Spondyloarthritis (SpA), immune-mediated diseases treated with immunomodulating drugs, by administering a questionnaire.Methods294 patients (201 f and 93 m) were enrolled with a diagnosis of arthritis (RA 28%, PsA 43%, SpA 28%).ResultsOf the 294 enrolled patients, 107 underwent COVID vaccination, 73% with Biontech-Pfizer vaccine, 20% Astrazeneca and 6% Moderna. 50% of patients completed the entire vaccination cycle.46% of patients presented AEs after the first dose of vaccine (45% of vaccinated with Biontech-Pfizer; 48% of vaccinated with Astrazeneca, 33% of vaccinated with Moderna). The most frequently observed AEs are: pain at the injection site (17%), fever (13%), headache (12%), myalgia (12%), fatigue (7.5%). Only 2.9% of patients had arthritis flares. The greatest trend of AEs was observed in patients with PsA (48%), and RA (26%).32% of patients receiving the second dose of vaccine presented AEs (40% Moderna, 32% Biontech-Pfizer). The most frequently observed AEs after the second dose are: pain at the injection site (4.7%), fever (9%), headache (2.8%), myalgia (6%). No patient had arthritis flare after the second dose. The greatest trend of AEs was observed in patients with SpA (66%).Only 11% of patients presented AEs after the administration of both doses.Thirteen percent of patients did not follow the clinician’s recommendations for immunomodulatory drug management, provided as per ACR or SIR recommendations.ConclusionThe incidence of adverse events in arthritis patients was in line with that of the general population, without presenting serious manifestations, such as thrombosis, and without indicating a preference on the type of vaccine.References[1]Tsai SC, Lu CC, Bau DT, Chiu YJ, Yen YT, Hsu YM, Fu CW, Kuo SC, Lo YS, Chiu HY, Juan YN, Tsai FJ, Yang JS. Approaches towards fighting the COVID‑19 pandemic (Review). Int J Mol Med. 2021 Jan;47(1):3-22. doi: 10.3892/ijmm.2020.4794. Epub 2020 Nov 20. PMID: 33236131; PMCID: PMC7723515.[2]Hodgson SH, Mansatta K, Mallett G, Harris V, Emary KRW, Pollard AJ. What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2. Lancet Infect Dis. 2021 Feb;21(2):e26-e35. doi: 10.1016/S1473-3099(20)30773-8. Epub 2020 Oct 27. PMID: 33125914; PMCID: PMC7837315.Disclosure of InterestsNone declared