Abstract
BackgroundPandemic 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 fight 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).ObjectivesIn 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.MethodsWe 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.ResultsOur 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 Pfizer-BionTech vaccines and 257 (41%) were Sinovac vaccines. The side-effects after first, second, third and fourth vaccine dose were 151 (52.6%), 135 (47%), 29 (10.1%) and 3 (1%), respectively. Behçet flare after first, 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, papulopustular eruption Pfizer-BionTech and Sinovac vaccines were compared in terms of side effects, there was a significant difference after the 1st (p<0.001) and 2nd doses (p<0.001), but no significant difference was found at the 3rd dose (p= 0.353) (Table 1). When Pfizer-BionTech and Sinovac vaccines were compared in terms of BD exacerbations, no significant 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.Table 1.Side effects and Behçet’s flare according to COVID vaccinesSide effects according to COVID vaccinesCOVID vaccine, n/ NSide effects afterfirst dose of vaccinepSide effects after second dose of vaccinepSide effects afterthird dose of vaccinepSide effects after fourth dose of vaccinepSinovac47 (39.5)<0.00134 (30.1)<0.0019 (36)0.353None-Biontech104 (61.9)101 (63.1)20 (47.6)3 (33.3)Behçet flare according to COVID vaccinesCOVID vaccine, n/NFlare after first dose of vaccinepFlare after seconddose of vaccinepFlare after third dose of vaccinepFlare after fourth dose of vaccinepSinovac13 (11.0%)0.41718 (15.9%)0.4655 (20.0%)0.565None-Biontech24 (14.3%)31 (19.4%)11 (26.2 %)3 (33.3)ConclusionIn 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 findings, and exacerbations with organ involvement are rare. According to the COVID-19 vaccines, although the side effects were more in the Pfizer-BioNTech group compared to the Sinovac group, there was no difference between Behçet’s flare compared to the COVID-19 vaccines.Disclosure of InterestsNone declared
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