An increased risk of developing severe infections has been evidenced in rheumatic disease (RD) patients, and anti-COVID-19 vaccination is strictly recommended for RD patients. However, up to now, no data are available on safety, immunogenicity and efficacy of COVID-19 vaccinations in RD patients. The possible development of adverse events (AEs), including the flare-up of underlying RD, represents a matter of growing importance. The aim of our study is to assess, in RD patients, the safety profile of different types of approved vaccines and the possible influence of immunosuppressive therapies and clinical or demographic characteristics of RD patients on development of AEs. Participants (n = 185; 30.7%) received anti-COVID-19 vaccinations, 137 with autoimmune/chronic inflammatory RD (Au/cIn-RD) and 48 with nonautoimmune/chronic inflammatory RD (no-Au/cIn-RD). AEs were recorded in 42% of patients after the first dose of vaccine, and in 26% of patients after the second dose. The most common reported AEs after anti-COVID 19 vaccines were site injection pain (17%), headache (12%), fever (12%), myalgia (10%) and fatigue (10%). Relapses of the underlying Au/c-In-RD were recorded in 2.2% of patients after the first dose of vaccine. In Au/c-In-RD the risk of developing AEs after the first dose of vaccine was lower in older patients (OR = 0.95; p = 0.001), and in the group of patients with complete control of RD (OR: 0.2; p = 0.010). A lower percentage of AEs was observed in patients with complete control of their Au/cIn-RD (29%) compared to those with low (57%) or moderate-high disease activity (63%) (p = 0.002 and p = 0.006 respectively). In this study all types of COVID-19 vaccines in use in Italy seemed safe in RD patients. The results of this study might provide reassuring information for Au/cIn RD patients and clinicians and could strengthen the data on vaccine safety to guide the use of COVID-19 vaccines in Au/cIn-RD on immunosuppressive agents.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by a wide variability of clinical manifestations due to the potential involvement of several tissues and internal organs, with a relapsing and remitting course. Dysregulation of innate and adaptive immune systems, due to genetic, hormonal and environmental factors, may be responsible for a broad spectrum of clinical manifestations, affecting quality of life, morbidity and mortality. Bone involvement represents one of the most common cause of morbidity and disability in SLE. Particularly, an increased incidence of osteoporosis, avascular necrosis of bone and osteomyelitis has been observed in SLE patients compared to the general population. Moreover, due to the improvement in diagnosis and therapy, the survival of SLE patient has improved, increasing long-term morbidities, including osteoporosis and related fractures. This review aims to highlight bone manifestations in SLE patients, deepening underlying etiopathogenetic mechanisms, diagnostic tools and available treatment.

A growing body of evidence on the importance of vitamin D in immune modulation has increased the interest in its possible impact on the course of rheumatological diseases. The scope of our study is to assess if the presence of different statuses of vitamin D could interfere in the clinical subsets, in methotrexate monotherapy discontinuation, and biological drug (b-DMARDs) survival in psoriatic arthritis patients (PsA). We conducted a retrospective study on PsA patients and split them into three groups based on their vitamin D status: the group with 25(OH)D ≤ 20 ng/mL, the group with levels of 25(OH)D between 20 and 30 ng/mL, and the group with serum levels of 25(OH)D ≥ 30 ng/mL. All patients were required to fulfill the CASPAR criteria for psoriatic arthritis and to have the evaluation of vitamin D serum levels at baseline visit and at clinical follow-up visits. The exclusion criteria were ages less than 18 years old, the presence of HLA B27, and satisfaction of rheumatoid arthritis classification criteria (during the study time). Statistical significance was set at p ≤ 0.05. Furthermore, 570 patients with PsA were screened and 233 were recruited. A level of 25(OH)D ≤ 20 ng/mL was present in 39% of patients; levels of 25(OH)D between 20 and 30 ng/mL presented in 25% of patients; 65% of patients with sacroiliitis presented 25 (OH)D ≤ 20 ng/mL. Methotrexate monotherapy discontinuation for failure was higher in the group with 25 (OH)D ≤ 20 ng/mL (survival time: 92 ± 10.3 weeks vs. 141.9 ± 24.1 weeks vs. 160.1 ± 23.6 weeks; p = 0.02) with higher discontinuation risk (HR = 2.168, 95% CI 1.334, 3.522; p = 0.002) than those with 25(OH)D between 20 and 30 ng/mL and those with 25(OH)D ≥ 30 ng/mL. Significantly shorter survival of first b-DMARDs was assessed in the group with 25 (OH)D ≤ 20 ng/mL versus the other groups (133.6 ± 11 weeks vs. 204.8 ± 35.8 weeks vs. 298.9 ± 35.4; p = 0,028) (discontinuation risk 2.129, 95% CI 1.186, 3.821; p = 0.011). This study highlights significant differences in clinical presentation, in particular sacroiliac involvement and on drug survival (methotrexate and b-DMARDs) in PsA patients with vitamin D deficiency. Further prospective studies, including a larger sample of patients, are needed to validate these data and to assess if the supplementation of vitamin D could improve the b-DMARDs response in PsA patients.

BackgroundPsoriatic 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).ObjectivesThe 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.MethodsFifty-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.ResultsThe 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.ConclusionOur 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/pharmaceutics13010048Acknowledgements:NIL.Disclosure of InterestsNone 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