• systemic autoimmune diseases
• vaccination
• COVID-19

The unexpected outbreak of the COVID-19 had significant repercussions on the healthcare systems in terms of number of infections, hospitalizations and deaths.
Patients with systemic autoimmune rheumatic disorders (SARDs) remain vulnerable in the era of the COVID‐19 pandemic due to the higher risk of respiratory infections which is attributed on one side to the underlying disease, on the other to the immunosuppressive therapy and glucocorticoids (GCs) use.
These facts have reinforced the awareness that the vulnerability of people living with SARDs requires from healthcare systems a growing commitment to increase their preparedness in the case of future health emergencies and to ensure that appropriate actions are taken.
Vaccinations are among the most important public health intervention to fight infective diseases but they may be less efficacious in patients with SARDs, as a result of their immunosuppressive therapy, and, moreover, could potentially lead to exacerbation of the underlying autoimmune disease. That’s why we need to study the vaccine effects and safety in this population.
The aims of the study are the following:
1. To evaluate the safety profile of COVID-19 vaccination in SARDs patients and to highlight possible disease-specific adverse events;
2. To evaluate the efficacy of COVID-19 vaccination in SARDs patients and to highlight potential variables that prevent an effective immunization against COVID-19;
255 patients with Systemic Autoimmune Rheumatic Diseases (SARDs) were enrolled in the study, including 222 females and 33 males. Age range was 23-58 years, mean age 40.60 (DS±10.51).
Mainly patients diagnosed with Systemic Lupus Erythematosus (32.6%), Inflammatory Arthritis (19.2%), Sjogren Syndrome (17.7%) and Systemic sclerosis (9.8%) were recruited.
We found out that most of AE occurred during 7 days after the second dose of vaccination (62.9%) and during the 7 days after the first dose (48.8%). A lower rate was found during the 7 days after the third dose (32.3%). Among early adverse events the most common were: fatigue, fever, headache, muscle pain and joint pain, while no severe advent event (SEA) or adverse event of special interest (AESI) was discovered.
In the following periods (from the days before the second dose and w48) were found a total of 9 AE and 44 disease flares, 12 of them were severe flares. The AE were mainly skin itchy swells, persistent urticaria, arthralgias and changes in EEC, while no SEA or AESI was found from the days before the second dose and W48 underlying the safety of COVID-19 vaccination in terms of severe or special event adverse.
In conclusion, COVID-19 vaccination showed a good safety profile in term of adverse events and risk of disease flares; moreover, in our patients the vaccination resulted protective against severe COVID-19.