Background: Considering the concerns regarding COVID-19 vaccine safety among patients with rheumatic diseases due to a lack of data, an urgent need for studies evaluating safety profiles of vaccines emerged.

Objectives: Vaccination against the coronavirus disease-2019 (COVID-19) started in March 2021 in the group using biological therapy in our country. In this study, post-vaccine real-life data of patients with spondyloarthritis (SpA) followed up with biological therapy were analyzed.

Methods: Adult patients diagnosed with SpA who were followed up under biological therapy and vaccinated by CoronaVac inactive SARS-CoV-2 orBNT162b2 messenger RNA (mRNA) COVID-19 (Pfizer-BioNTech) vaccine were included in our observational, multicenter, prospective study.

Results: A total of 287 patients (58.2% male; mean age: 47) were included in the study. 202 (%70,4) of patients were being followed up with the diagnosis of AS, 40 (%13,9) of them with PsA, 32 (%11,1) of them with nr-axSpA, 11 (%3,8) of them with enteropathic arthritis, and 2 (%0,7) of them with uSpA. The most common comorbidities were found to be HT (n:65; 22.6%) and DM (n:38; 13.2%). While 221 (77%) of the patients were receiving biological therapy alone, 27 (9.4%) patients were using methotrexate, 25 (8.7%) patients were using sulfasalazine, and 12 (4.2%) patients were using leflunomide. The median duration of biological therapy was 40 weeks (19-75 IQR). The most commonly used treatment was infliximab (26.8%), adalimumab (23.3%) was the second (Table 1).

It was determined that 207 (72.1%) of the patients preferred inactivated virus vaccine, while 80 (27.9%) preferred mRNA vaccine. When the time between the biological treatment and the day of vaccination is examined, detected median time between biological treatment and the first dose of vaccination is 11.5 days (5-19 IQR), between the first dose of vaccination and biological treatment is 14 days (7-21 IQR), between treatment and the second dose of vaccine is 14 days (5-23.5 IQR), and between the second dose of vaccine and the next biological treatment is 12.5 days (7-15 IQR). While 25 (8.7%) of the patients had COVID-19 infection before vaccination, 7 (2.4%) patients were found to have COVID-19 after vaccination (p<0.001). While two of the patients who had COVID-19 infection in the pre-vaccination period required hospitalization, none of the patients who had COVID-19 in the post-vaccination period required hospitalization.

The rate of patients who developed side effects after the first dose of the vaccine was 20.6%. The side effects seen, respectively, were detected as pain-redness at the injection site (16%), fatigue (11.8%), headache (8.4%), muscle-joint pain (7.3%) and fever (5.6%). The rate of patients reporting side effects after the second dose of the vaccine was 17.1%. The incidence of side effects after mRNA vaccine was found to be statistically significant compared to inactivated virus vaccine in terms of both doses (p=0.011, p<0.001). Major side effects such as myocarditis, anaphylaxis-angioedema, myocardial infarction, and thrombosis were not observed in any of the patients included in the study. There was no evidence of disease activation in the median follow-up of 209 days (145-280 IQR) after vaccination.

Conclusion: During the follow-up of the patients during the study, no major vaccine-related side effects, post-vaccine disease activation and the need for treatment change were not detected. In order to more accurately evaluate the efficacy of the vaccination program in the patient population using biologic agents, larger-scale studies including unvaccinated individuals are needed.

REFERENCES:

[1]Sattui SE, Liew JW, Kennedy K, et al. Early experience of COVID-19 vaccination in adults with systemic rheumatic diseases: results from the COVID-19 global rheumatology alliance vaccine survey. RMD Open. 2021;7(3):e001814.

[2]Shenoy P, Ahmed S, Paul A, et al. Inactivated vaccines may not provide adequate protection in immunosuppressed patients with rheumatic diseases. Ann Rheum Dis. 2021. doi:10.1136/annrheumdi s-2021-221496

Disclosure of Interests: None declared