Background Patients with spondyloarthritis (SpA) probably have a high incidence of COVID-19. Vaccination remains one of the most effective methods of preventing infectious diseases. However, data on the safety of vaccines against COVID-19 in patients with SpA are few and relate to foreign vaccines that are not licensed in Russia.

Objectives To study the safety of COVID-19 vaccines in patients with SpA in real clinical practice.

Methods The study included 47 SpA patients (25 - ankylosing spondylitis, 13 - psoriatic arthritis, 9 - undifferentiated SpA, 19 women, 28 men, age 42.3±11.6 years, duration of the disease 11.8±9.2 years) - the main group and 97 people without any immuno-inflammatory rheumatic diseases (67 women, 30 men, age 43.7±13.1 years) - the control group. 20 patients received disease-modifying antirheumatic drugs (12 - methotrexate, 8 - sulfasalazine), 10 - biological drugs (8 – TNF-ɑ inhibitors, 2 - IL-17 inhibitors), 6 - glucocorticoids, 1 - tofacitinib, 12 - only nonsteroidal anti-inflammatory drugs, 8 - did not receive therapy. In the main group, 40 patients were vaccinated with Gam-COVID-Vac (Sputnik V), 3 – CoviVac and Sputnik Light, 1 – EpiVacCorona (both components of the vaccine were received by 44 patients). In the control group 69 were vaccinated with Sputnik V, 15 - CoviVac, 5 - Sputnik Light and BNT162b2, 2 - EpiVacCorona, 1 - mRNA-1273. (91 participants received both components of the vaccine). All participants were interviewed by a research doctor with a unified questionnaire, additional information was obtained from medical documentation.

Results The data obtained are reflected in the Table 1. Local adverse events (AEs) occurred relatively less frequently in patients with SpA than in the control group. After the introduction of the first component of the vaccine, there was a significant increase in the frequency of pain without restriction of movement and edema/hyperemia in the control group (p<0.001 and p=0.049, respectively), while after the introduction of the second component, a significant difference was registered only for the first indicated symptom (p<0.001). The most frequent systemic AEs were weakness, fever, arthralgia or myalgia, headache, and chills, which were significantly less common (p=0.008) in the main group after immunization with the first component. The proportion of SpA patients without any reactions was significantly higher after the introduction of the first component of the vaccine (59.6% and 29.9%, p<0.001), while after immunity with the second component there were no differences (59.1% and 44.0%, p>0.05). After complete immunization, the percentage of patients without any AEs was significantly higher in the main group than in the control (50.0% and 17.6%, p<0.001). There was no exacerbation of SpA or development of new autoimmune phenomena in the main group after full vaccination.

Conclusion According to preliminary data, the tolerability of vaccines against COVID-19 in patients with SpA is satisfactory. Further studies with an increased sample are needed to study the safety, immunogenicity and clinical efficacy of immunization against COVID-19 in patients of this cohort.

Disclosure of Interests None declared