ABSTRACT
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-infammatory 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-α inhibitors, 2-IL-17 inhibitors), 6-glucocorticoids, 1-tofacitinib, 12-only nonsteroidal anti-infammatory drugs, 8-did not receive therapy. In the main group, 40 patients were vaccinated with Gam-COVID-Vac (Sputnik V), 3-Covi-Vac 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 unifed questionnaire, additional information was obtained from medical documentation. Results: The data obtained are refilected 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.
ABSTRACT
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-infammatory 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-lefunomide, 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 Covi-Vac, 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 unifed 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 frst 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 signifcant 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 frst (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 frst and second components of the vaccine. There was a signifcant 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 frst (but not the second) component of the vaccine. A signifcant 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 frst 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.