ABSTRACT
Background: Coronavirus 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-Pfzer and Moderna, and viral vectored, such as AstraZeneca and Janssen. Despite possible adverse events, benefts afforded by these vaccines signifcantly outweigh potential risks associated with their administration in the general population. Objectives: This 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. Methods: 294 patients (201 f and 93 m) were enrolled with a diagnosis of arthritis (RA 28%, PsA 43%, SpA 28%). Results: Of the 294 enrolled patients, 107 underwent COVID vaccination, 73% with Biontech-Pfzer vaccine, 20% Astrazeneca and 6% Moderna. 50% of patients completed the entire vaccination cycle. 46% of patients presented AEs after the frst dose of vaccine (45% of vaccinated with Biontech-Pfzer;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 fares. 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-Pfzer). 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 fare 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. Conclusion: The 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.
ABSTRACT
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, immuno-suppressive 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 Astra-Zeneca COVID-19 vaccine, 23 the BioNTech-Pfzer COVID-19 vaccine and 3 the Moderna vaccine. Only 48% of subjects received two doses. 42% of patients reported non-severe AEs after the frst dose of vaccine, specifcally 45% of patients who received the BioNTech-Pfzer 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 fare (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-Pfzer 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 frst 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 fares 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 signifcant dissimilarity of AEs relating to different types of vaccine and good patient compliance to physician recommendations about treatment management.
ABSTRACT
Background: Previous study evidenced a cross-reactivity between Sars-Cov-2 antibodies and autoimmune tissue antigen involved in connective tissue diseases, as nuclear antigen (NA), extractable nuclear antigen (ENA), histone and collagen (1). No study has been published about the titer of Sars-Cov-2 antibodies in non-infected patients with autoimmune disease. Objectives: To evaluate the titer of SARS-CoV-2 antibodies in non-COVID-19 patients and compare it between systemic sclerosis (SSc) patients and healthy controls (HC). Methods: A total of 58 patients with SSc (who fulfilled ACR/EULAR 2013 SSc classification criteria) and 18 HC were enrolled. Sera of all participants were collected, and SARS-CoV-2 antibodies (IgG and IgM) were evaluated by means ELISA. In all participants swabs for SARS-CoV-2 by real-time reverse-transcriptase-polymerase-chain-reaction assay were reported negative. Demographic, clinical, and autoimmune serological characteristics of SSc patients were recorded. The normal distribution was assessed using the Shapiro-Wilk's test. Exclusion criteria was previous or actual Sars-Cov-2 infection. Comparisons between study groups of patients were evaluated by the Student's t-test or Mann -Whitney U-test as appropriate. The differences between categorial variables were assessed by Pearson chi-square or Fisher's exact test, as opportune. Statistical significance was set at p ≤ 0.05. Results: We observed significant differences between SSc patients and HC in serum levels of Sars-Cov-2 antibodies (IgG: 1,4±2,1 AU/ml vs 0,36±0,19 AU/ml respectively (p=0,001);and IgM: 2,5±3,1 AU/ml vs 0,8±0,7 AU/ml (p=0,022)). In 5 SSc patients was found titer of Sars-Cov-2 antibodies (IgG) exceeding the cut-off, but the control of swabs for SARS-CoV-2 by real-time reverse-transcriptase-polymerase-chain-reaction assay were negative. No significative differences in Sars-Cov-2 autoantibodies titer were found in subgroup of SSc patients with or without ILD or PAH, limited or diffuse skin subset, and different autoantibodies profile. Furthermore, antibodies titer was not associated with different drugs (steroid, methotrexate, mofetil-mycophenolate and bosentan) in use. Conclusion: A cross mimicking between Sars-Cov-2 antibodies and antinuclear antibodies or anti ENA could be hypothesized. Further studies are necessary to unravel the reliability of Sars-Cov-2 antibodies detection in autoimmune disease.