SAFETY PROFILE of SARS COV-2 VACCINES in PATIENTS with CONNECTIVE TISSUE DISEASE, VASCULITIS and POLYMYALGIA RHEUMATICA. BI-CENTRIC STUDY

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.