ObjectiveData on the safety of anti-SARS-CoV-2 vaccines in patients with rare rheumatic diseases, such as systemic vasculitis (SV), are limited. The aim of this study was to evaluate the occurrence of a disease flare and the appearance of adverse events (AEs) following administration of anti-SARS-CoV-2 vaccine in a multicentre cohort of patients with SV. Methods Patients with SV and healthy controls (HC) from two different Italian rheumatology centres were asked to complete a questionnaire assessing disease flares occurrence, defined as new onset of clinical manifestations related to vasculitis needing an implementation of therapy, and local/systemic AEs appearance following anti SARS-CoV-2 vaccination.Results 107 patients with SV (57 ANCA-associated) and 107 HC were enrolled. A disease flare occurred in only one patient (0.93%) with microscopic polyangiitis after the first dose of an mRNA vaccine. After both the first and the second vaccine dose administration, no significant differences in AEs between patients with SV and HC were observed; no serious AEs were reported as well. ConclusionThese data suggest a good risk profile for anti-SARS-CoV-2 vaccine in patients with systemic vasculitis.
Objective: Data on the safety of anti-SARS-CoV-2 vaccines in patients with rare rheumatic diseases, such as systemic vasculitis (SV), are limited. Aim of this study was to evaluate the occurrence of a disease flare and the appearance of adverse events (AEs) following administration of anti-SARS-CoV-2 vaccine in a multicenter cohort of patients with SV. Methods: Patients with SV and healthy controls (HCs) from two different Italian rheumatology centers were asked to complete a questionnaire assessing disease flares occurrence, defined as new onset of clinical manifestations related to vasculitis needing an implementation of therapy, and local/systemic AEs appearance following anti SARS-CoV-2 vaccination.Results: 107 patients with SV (57 ANCA-associated) and 107 HCs were enrolled. A disease flare occurred in only one patient (0.93%) with microscopic polyangiitis after the first dose of an mRNA vaccine. Both after the first and the second vaccine dose administration, no significant differences in AEs between patients with SV and HCs were observed; no serious AEs were reported as well. Conclusions: This data suggest a good risk profile for anti-SARS-CoV-2 vaccine in patients with systemic vasculitis.
BackgroundVaccinations against SARS-CoV-2 represent a fundamental tool in controlling the pandemic. To date, data on the safety of anti-SARS-CoV-2 vaccines in patients with rare rheumatic diseases, such as systemic vasculitis, are limited.ObjectivesIn this study we aimed at evaluating the safety of anti-SARS-CoV-2 vaccines in a multicentric cohort of patients with systemic vasculitis.MethodsPatients with systemic vasculitis from two Rheumatology centres who had received anti-SARS-CoV-2 vaccine were retrospectively examined. The primary outcome was to evaluate, in this multi-centric cohort, the occurence of a disease flare after the administration of the vaccine, defined as development of clinical manifestations related to vasculitis with a concomitant increase in serum inflammatory markers. As a secondary outcome we aimed at evaluating, in a monocentric cohort of patients with vasculitis, the occurrence of adverse events (AEs) following vaccine administration compared to healthy controls (HC).ResultsWe examined 111 patients with systemic vasculitis (n=69 female, n=42 male), with a mean age of 64.3 (± 13) years. Sixty had ANCA-associated vasculitis (AAV), fourty-two had Giant-Cell Arterities (GCA), five had Periarteritis Nodosa, four had Takayasu’s arteritis. One-hundred and five patients received a mRNA vaccine and six a viral vector one. A disease flare occurred in only 2 patients (1.8%) after the first dose of a mRNA vaccine: both had AAV (microscopic poliangioitis) and developed a pulmunary disease flare (respiratory failure requiring hospitalization and treatment with high-dose glucocorticoids). Of note, one of these patients had multiple previous comorbidities, including a severe COPD. Multivaried analysis, adjusted for age and sex, performed in a single monocentric cohort of patients with systemic vasculitis [n=60 (39 AAV, 21 GCA), 37 female, 23 male, mean age 71 (± 12.5) years] demonstrated a statistically significant higher frequency of AEs in vasculitis patients compared to HC (p=0.015) after the first dose of vaccination. No significant differences in the frequency of AEs in vasculitis patients compared to HC after the second dose were detected. All the AEs were mild in both groups (malaise was the most frequently reported); no serious AEs were reported.ConclusionOur data show a very low incidence of disease flares after the administration of anti-SARS-CoV-2 vaccines in patients with systemic vasculitis. Patients with systemic vasculitis seem more prone to develop mild AEs after the first dose of the vaccine. Taken together, this data suggest a good risk profile for anti-SARS-CoV-2 vaccine in patients with systemic vasculitis.Disclosure of InterestsNone declared
BackgroundSalivary glands epithelial cells (SGECs) activation and loss of homeostasis play a key role in primary Sjogren Syndrome (pSS) [1]. High serum and saliva levels of β2-mycroglobulin (β2-M) have been described [2] in pSS, however, the exact origin of this molecule is still unclear. Our preliminary data from single cell analysis on pSS salivary glands treated with immunosuppressors show a downregulation of this protein in SGECs following treatment.ObjectivesAim of this study is to evaluate the expression of β2-M in pSS SGECs and to dissect its modulation in inflammatory conditions.MethodsTo mimic the inflammatory microenvironment of pSS, a human salivary gland (HSG) cell line was treated (48h) with 1) Poly-I:C (40 μg/ml), 2) LPS (50 μg/ml), 3) culture medium (untreated). The HSG expression of β2-M (Ab anti-β2-M) was evaluated by flow cytometry along with the expression of apoptotic [(annexin V (MBL)] and activation [ICAM-1 (Ab anti-CD54)] molecules. Ex vivo expression of β2-M was then assessed in SGECs deriving from both pSS patients (n=3) and sicca (controls) (n=3).ResultsIn the HSG cell line treated with both Poly I:C and LPS a significant increase in β2-M was documented [mean fluorescence index (MFI): untreated=1 (1-1), Poly-I:C=2.46 (1.5-3.9), LPS=1.3 (1-1.3); p=0.003]. The increased expression of β2-M was paralleled by an increase in ICAM-1 (MFI: untreated=1 (1-1), Poly-I:C=1.61 (1-2.5), LPS=1.26 (1-1.2); p=0.06) and annexin V (mean%: untreated=7.6% (5-9), Poly-I:C=14.3% (9-18), LPS=8% (6-11); p=0.003). In SGECs from pSS a higher expression of β2-M was detected as compared to controls (MFI: pSS=2.5 (2-3) vs sicca=1 (0.5–1.5) (Figure 1).ConclusionOur preliminary data suggest that β2-M is actively expressed by SGECs in pSS and that its exposure is driven by the local inflammatory milieu. Such expression is particularly interesting in view of the already demonstrated capacity of β2-M to activate pro-inflammatory pathways and to influence cellular viability and autoantigens exposure [3]. Functional studies are currently ongoing to dissect the potential pathogenic role of β2-M in pSS.References[1] Colafrancesco S, et al. Arthritis Rheumatol. 2022.[2] Gottenberg JE, et al. PLoS One. 2013.[3] Jin Xie et al. Trends Immunol. 2003.Acknowledgements:NIL.Disclosure of InterestsNone Declared.
BackgroundThe quality of sexual life (QSL) is a complex and multimodal experience influenced by endogenous and external factors, including age, gender, and cultural environment. Rheumatic diseases, with their burden of pain, fatigue, organ damage, and disability, can severely impair sexual life and this is true also for Sjögren’s Syndrome, where simple tools to assess the QSL in everyday clinical practice are needed.ObjectivesTo translate ad adapt into Italian the Qualisex, a new brief questionnaire originally created for Rheumatoid Arthritis patients, for women with primary Sjögren’s Syndrome (pSS) and evaluate the impact of the disease on their sexuality.MethodsConsecutive sexually active pSS (according to ACR/EULAR 2016 criteria) patients aged >18 were asked to participate in this study approved by the local bioethics committee. With the permission of the developer, the French original version of the Qualisex questionnaire (consisting of 10 items, the higher the score, the greater the negative impact of the disease on the QSL) was translated and adapted into Italian according to current guidelines. In the absence of a gold standard assessment for sexuality in pSS, face and content validity was assessed cross-sectionally by correlations with other disease aspects such as anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS), EULAR SS patient-reported index (ESSPRI), and quality of the relationship. As a measure of reliability, internal consistency was assessed through Cronbach’s Alpha coefficient. A Cronbach’s value >0.7 is generally regarded as satisfactory. The feasibility of the scale was indirectly assessed through missing data. To assess the factorial structure of the Italian version of the questionnaire an Exploratory Factor Analysis (EFA) was carried out. Moreover we also assessed the level of redundancy by means of intra-item correlation of the Qualisex questionnaire. ESSDAI (EULAR Sjögren’s Syndrome Disease Activity Index), and SSDDI (Sjogren’s Syndrome Disease Damage Index) were assessed as well. Analyses were carried out with IBM SPSS Statistics for Macintosh, version 22.0 (IBM Corp., Armonk, NY, USA).Results40 sexually active women with pSS and a median age of 53 (IQR 45.25-57.25) were enrolled. The EFA showed that the model with a single factor appeared to be highly significant (Chi235= 2943.10; p<0.05); the average inter-item correlation was found to be 0.392 (Min -0.479; Max 0.834) which is an acceptable value as for redundancy. There were no missing answers. Cronbach’s alpha coefficient resulted to be 0.86 which indicates an adequate internal consistency. The median Qualisex score was 4.65 (IQR 2.13–6.2). As far as correlations, age (Rho=0.39; p<0.05), menopause (Rho=0.41; p<0.05), relationship quality (Rho=0.55; p<0.05), anxiety (HADS-A; Rho=0.38; p<0.05), and depression (HADS-D; Rho=0.47; p<0.05) appeared to be positively correlated with Qualisex score. Also, a positive correlation with ESSPRI (Rho=0.43; p<0.05), and drug use (Rho=0.37; p<0.05) was demonstrated. On the contrary no significant correlation was found with education (Rho=-0.07; p=0.64), systemic disease activity (Rho=0.14; p=0.39), and damage (Rho=0.06; p=0,74).ConclusionThe Italian version of the Qualisex questionnaire is a valid, reliable and useful tool to assess the quality of sexual life in pSS. QSL in pSS women has an inverse relationship with age, menopause, drug use, ESSPRI, mood disorders, and dissatisfaction with the partner, while, as previously reported, no correlation was found with disease activity, damage, and educational status. This further highlights the impact of subjective symptoms such as dryness, pain, fatigue, and the overall psychological well-being on patients’ life. Thus, it is critical for the physician to consider patients’ perspective.Disclosure of InterestsNone declared
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