Background: Patients with rheumatoid arthritis (RA) are at high risk of developing COVID-19. Vaccination should be an effective method of preventing this disease. However, vaccination may be unsafe in RA patients. At present, data on the safety of vaccines against COVID-19 in RA patients 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 RA in real clinical practice.

Methods: The study included 131 RA patients (120 women, 11 men, age 53.8±13.9 years, duration of disease 11.5±9.2 years) - the main group and 121 people without any immuno-inflammatory rheumatic diseases (87 women, 34 men, age 39.8±14.2 years) - the control group. 103 patients received disease-modifying antirheumatic drugs (54 - methotrexate, 30 - leflunomide, 10 - hydroxychloroquine, 8 - sulfasalazine, 1 - mofetil mycophenolate), 68 - biological drugs (58 - rituximab, 5 – TNF-α inhibitors, 4 - abatacept, 1 - tocilizumab), 64 - glucocorticoids, 10 - did not receive therapy. In the main group, 92 patients were vaccinated with Gam-COVID-Vac (Sputnik V), 21 with Sputnik Light, 16 with CoviVac, 2 with EpiVacCorona (110 patients received two components of the vaccine). In the control group, 91 were vaccinated with Sputnik V, 16 with CoviVac, 6 with BNT162b2, 5 with Sputnik Light, 2 with EpiVacCorona, 1 with mRNA-1273 (114 participants received two components of the vaccine). All participants were interviewed by a research doctor with a unified questionnaire, additional information was obtained from medical documentation.

Results: Local and systemic adverse events (AEs) were observed both in the main group and in the control group. After the introduction of the first component of the vaccine, local AEs (pain/hyperemia/edema) were noted in 12.2% of RA patients and in 10.7% of the control group, after the introduction of the second component of the vaccine - in 9.1% and 11.4% of respondents, respectively (in both groups p>0.05). There was a significant difference between the main group and the control group in the frequency of pain at the injection site without restriction of movements both after the first (24.4% and 40.5%, p=0.007) and after the second component (18.2% and 31.6%, p=0.021). The most frequent systemic AEs were weakness, fever, muscle or joint pain, headache, chills, which were observed in both groups after administration of both the first and second components of the vaccine. There was a significant difference between the main group and the control group in the frequency of fever (16.8% and 39.7%, p<0.001), weakness (26.0% and 38.8%, p=0.029), muscle and joint pain (9.2% and 25.6%, p<0.001) after administration of the first (but not the second) component of the vaccine. A significant difference was revealed between the main group and the control group in the number of patients with local and systemic AEs both after the introduction of the first component of the vaccine (19.1% and 43%, p<0.001) and after the second (15.5% and 30.7%, p=0.007). After administration of the two components of the vaccine, a higher number of patients without any AEs were detected in the main group compared to the control group (32.7% and 18.4%, p=0.014). Exacerbation of RA and the emergence of new autoimmune phenomena in main group are not marked.

Conclusion: According to preliminary data, the tolerance of vaccines against COVID-19 in RA patients is satisfactory. Further studies 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