SAFETY of SARS-COV-2 VACCINES in PATIENTS with AUTOIMMUNE DISEASES

ABSTRACT

Background: Patients (pts) with autoimmune diseases are at higher risk of infections, including those by SARS-COV-2. There is no general agreement regarding priority criteria for anti-COVID vaccine access for pts with autoimmune rheumatic diseases (ARD). Few studies have addressed the issue of anti-COVID vaccination in these pts, but many are available on the safety, immunogenicity, efficacy, and possible contraindications of traditional vaccines in pts with ARD. These studies may represent the basis on which to recommend the anti-COVID-19 vaccines. Objectives: Patients (pts) with autoimmune diseases are at higher risk of infections, including those by SARS-COV-2. There is no general agreement regarding priority criteria for anti-COVID vaccine access for pts with autoimmune rheumatic diseases (ARD). Few studies have addressed the issue of anti-COVID vaccination in these pts, but many are available on the safety, immunogenicity, efficacy, and possible contraindications of traditional vaccines in pts with ARD. These studies may represent the basis on which to recommend the anti-COVID-19 vaccines. Methods: A telephone survey investigating the AE of SARS-CoV-2 vaccinations on pts with systemic lupus erythematosus, systemic sclerosis, infammatory arthritis (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis), idiopathic infammatory myopathies, ANCA-associated vasculitis was administered. Data extraction included diagnosis, disease activity status, demographics, disease duration, therapy, comor-bidities, and laboratory tests. Vaccinated participants are asked to report whether they experienced any local or systemic AE following vaccination, and if so, to report on the severity and duration of the AE. Mild AE were defned as unpleasant reactions that did not limit daily activities, moderate AE as those that limited daily activities, and severe AE-required medical attention. Serious AE were defned as reactions that resulted in hospital admission. Results: ChAdOx1 nCoV-19 and BNT162b2 are the most common vaccines in our pts. 98 (39,84 %) of 246 pts received the BNT162b2 vaccine, 95 (38,62 %)-ChA-dOx1 nCoV-19 vaccine, 47 (19,10%)-CX-024414 and 6 (2,44 %) were vaccinated with Ad26.COV2-S. 127 (51,63%) pts had at least one mild AE and 51 (20,73 %) pts reported moderate AE. Severe AE were rare-4 (1,63 %) pts and no serious AE were reported. The most commonly reported AE is pain (40,24 %), redness (30,49 %), swelling (18,7 %) at the injection site, which was consistent across all vaccines for both frst and second doses. Systemic AE occurred in 104 (43,27 %) pts, most frequently fatigue (29,67 %), headache (27,13 %) and muscle ache (24,39 %). The symptoms started mostly during the frst day post-vaccination and lasted for no more than two days. Joint complaints were reported in 8,94 %, but only a small proportion of pts (2,84 %) reported a deterioration of their autoimmune disease up to 3 months after COVID-19 vaccination. Age was a signifcant effect modifer in the association between autoimmune status and the risk of moderate or severe AE. Vaccination with ChAdOx1 nCoV-19, female sex, age between 35-50 years were independently associated with an increased likelihood of reporting any AE. The current results support the safety of different COVID-19 vaccines in pts with ARD. This information can help fght vaccine hesitancy in this population. Conclusion: Our data indicated that COVID-19 vaccines are well tolerated by pts with ARD. We did not observe any serious AE, but the number of pts included in our study is too low to draw conclusions about rare serious events. Additionally, our data suggest that COVID-19 vaccinations do not seem to trigger autoimmune disease fares, which is in accordance with data from previous small studies that assessed consequences of vaccines in pts with ARD.