EFFECTS of ANTI-SARS-COV-2 VACCINATION on SAFETY and DISEASE EXACERBATION in BEHCET'S DISEASE PATIENTS: A SINGLE CENTRE STUDY

ABSTRACT

Background: Pandemic of coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2), has become a major global health issue since December 2019. Patients affected by systemic rheumatic disorders represent a high-risk group for severe COVID-19. During the COVID-19 pandemic, vaccination has become one of the cornerstones of the fght against this disease. The EULAR and the ACR recommend vaccination in all patients with rheumatological diseases. There is a paucity of data regarding the safety of COVID-19 vaccines in patients with rheumatic and musculoskeletal diseases such as BehÇet's disease (BD). Objectives: In this study, we evaluated the safety and tolerance of COVID-19 vaccines, post-vaccine BD exacerbation and discontinuation of BD therapy in BD patients by retrospectively examining our BD cohort, from the patients' perspective. Methods: We retrospectively evaluated 450 BD patients followed in our clinic using hospital records and formed a retrospective cohort of patients who met the International Study Group (ISG) criteria. COVID-19 vaccination status, vaccine type (inactivated or mRNA), post-vaccine side effects and exacerbations, drug compliance, change in treatment after exacerbation, and post-vaccine COVID-19 occurrence were evaluated by interviewing patients over the phone or face to face. Patient demographics, comorbid diseases, and active BD treatments were collected from our hospital records. Disease activity was measured using the BSAS and the BDCAF form. Results: Our cohort consisted of a total of 450 BD patients. Two hundred and eighty seven patients had at least 1 dose of the COVID-19 vaccine. Of the total number of COVID-19 vaccines (n= 639), 379 (59%) were Pfzer-BionTech vaccines and 257 (41%) were Sinovac vaccines. The side-effects after frst, second, third and fourth vaccine dose were 151 (52.6%), 135 (47%), 29 (10.1%) and 3 (1%), respectively. BehÇet fare after frst, second, third and fourth vaccine dose were 151 (52.6%), 135 (47%), 16 (22.9%) and 3 (33.3%), respectively. The most common side effects were arm pain, joint pains or arthritis, malaise, while the most common BD exacerbations were arthralgia or arthritis, oral aphthae, pap-ulopustular eruption Pfzer-BionTech and Sinovac vaccines were compared in terms of side effects, there was a signifcant difference after the 1st (p<0.001) and 2nd doses (p<0.001), but no signifcant difference was found at the 3rd dose (p= 0.353) (Table 1). When Pfzer-BionTech and Sinovac vaccines were compared in terms of BD exacerbations, no signifcant difference was found after the 1st (p= 0.417), 2nd (p= 0.465) and 3rd doses (p= 0.565). Only 4 patients (1.3%) developed exacerbation with organ involvement after COVID-19 vaccine. Anterior uveitis developed in 2 patients, panuveitis in 1 patient, panuveitis and deep vein thrombosis in one patient. Conclusion: In conclusion, our study shows that the COVID-19 vaccine is well tolerated in BD patients, and that post-vaccine BehÇet's exacerbation predominantly includes mucocutaneous and articuler fndings, and exacerbations with organ involvement are rare. According to the COVID-19 vaccines, although the side effects were more in the Pfzer-BioNTech group compared to the Sinovac group, there was no difference between BehÇet's fare compared to the COVID-19 vaccines.