ADVERSE EVENTS after TWO DOSES of BNT162B2 ANTI-SARS-COV-2 VACCINE in PATIENTS with RHEUMATIC MUSCULOSKELETAL DISEASES: RESULTS from A SINGLE CENTER ITALIAN STUDY

ABSTRACT

Background: Vaccination against COVID19 is the most important prevention tool against the current pandemic. However, since the approval of anti-COVID19 mRNA vaccines by EMA, safety and tolerability in patients with rheumatic musculoskeletal diseases has always been a much-discussed topic, given their novel, unprecedented mechanism of action and the concern for potential disease fares. Objectives: To assess the safety and type of adverse events after two doses of BNT162b2 anti-SARS-CoV-2 vaccine in patients affected by rheumatologic diseases. Methods: 241 patients who received two doses of BNT162b2 were invited to take part to a follow-up live visit 2 months after completion of the primary vaccination cycle. Data regarding age, sex, diagnosis, treatment and adverse events after vaccination were collected for each patient during the visit. Pearson chi-square and Fisher exact tests were used to compare the distribution of each type of adverse event between male and female and among Rheumatoid Arthritis, Spondyloarthritis and Connective Tissue Disease patients. Results: Mean age of recruited patients was 57 years (IQR 49-65) and FM ratio was 2.491 (172 F/69 M). Number and percentage of individuals for each disease category were represented as follows Rheumatoid Arthritis 87 (36,10%), Spondyloarthritides 72 (29,88%), Connective Tissue Diseases 65 (26,97%), Autoinfammatory Diseases 4 (1,66%), Vasculitides 13 (5,39%). 42 subjects (17,42%) reported no adverse events, whereas local reactions such as pain and swelling at injection site were the most commonly reported side effect, (154 subjects, 63,9%, Table 1). Constitutional symptoms, comprising fatigue, muscle and joint pain, fever, chills and headache, were described in 54,77% of the interviews (132 subjects, Table 1). No patient experienced severe allergic reactions after vaccination. Statistical comparison among disease categories showed no differences in the distribution of adverse events. When analysing for sex, joint pain appeared to be reported signifcantly more frequently in male patients (p=0.002), while chills were more present in female patients (p=0.033). None of the interviewed subjects reported any sign or symptom relatable to disease fares. Conclusion: Vaccination with two doses of BNT162b2 was safe and generally well tolerated. No reports of signs or symptoms of disease reactivation were found in our cohort.