EVALUATION AFTER COVID-19 VACCINATION IN PATIENTS WITH ANTIPHOSPHOLIPID SYNDROME: A RETROSPECTIVE COHORT STUDY.

BackgroundAnti-phospholipid syndrome (APS) is an autoimmune disorder characterized by presence of anti-phospholipid antibodies (aPL) comprising lupus anticoagulant, anti-β2-glycoprotein I and/or anti-cardiolipin antibodies together with recurrent thrombosis and/or obstetric morbidity. In the course of COVID-19, thromboembolism may ocur due to endothelial dysfunction directly related to the viral factor and systemic inflammatory response. Concerns about COVID-19 vaccines began to arise after unexpected thromboembolic events were launched with the launch of vaccine campaigns around the world to prevent the disease.ObjectivesThe purpose of the study is to contribute to the literature on this subject by evaluating the development of any side effects or activation of the disease after the COVID-19 vaccine in our APS patients.MethodsThis study was designed as a cross-sectional, retrospective cohort study. The patients who meet the Sapporo Criteria for APS which are followed up in Ankara City Hospital Rheumatology Clinic, 18 years and over and vaccinated with any of the COVID-19 vaccines, were included into the study. The files of the patients were examined in order to evaluate the side effects and APS disease activation (thrombosis, embolism or pregnancy complications) in the 3-month period after the last dose of the COVID-19 vaccines (CoronaVac and BNT162b2). Also, information of the patients was collected via telephone or reviewed at regular follow-up visits.ResultsA total of 35 patients were included into the study (Table 1). In our patients, we did not observe any new thrombotic events or pregnancy complications during the 3-months observation period after COVID-19 vaccinations. The most common side effects after vaccinations were as follows; myalgia (30%), weakness (16.7%) and fever (10%) (Table 2). No patient became pregnant or gave birth during the follow-up.Table 1.Demographic and clinical characteristics of patients with Antiphospholipid antibody syndrome who received Covid-19 vaccineN=35Age, years, meadian (min-max)43 (28-63)Gender, female, number (%)33 (94.3)Active smokers, number (%)2 (5.7)Comorbidities, number (%) Hypertension6 (17.1) Chronic kidney disease2 (5.7) Sjogren syndrome2 (5.7) Diabetes mellitus0 Coronary artery disease0 Other4 (11.4)Time from diagnosis, years, median (min – max)7.0 (1.0 – 27.0)APS characteristics, number (%) Thrombotic APS22 (62.9)Cerebrovascular event11 (52.4)Deep vein thrombosis10 (47.7)Pulmonary thromboembolism2 (9.6) Obstetric APS21 (63.6)Treatment agents, number (%) Hydroxychloroquine28 (82.4) Acetylsalicylic acid16 (59.3) Varfarin16 (48.5) Corticosteroids15 (50)Adherence to APS drugs during vaccination32 (97)Table 2.Adverse events in vaccine recipientsBNT162b2CoronaVacPatients ever vaccinated with BNT162b2 or CoronaVac, n1715Dose per patient, median (min-max)2 (1-2)2 (1-3)Patients vaccinated with BNT162b2 or CoronaVac alone, n(%)17 (48.6)15 (42.9)Patients with an adverse effect after a dose of BNT162b2 or CoronaVac, n (%)6 (40)6 (50) Fever3 (18.7)0 (0) Malaise2 (12.5)4 (30.7) Local pain/arm pain2 (12.5)2 (15.3) Myalgia4 (25)4 (30.7)Patients with an adverse effect after 1stdose of BNT162b2 or CoronaVac, n (%) Fever00 Malaise00 Local pain/arm pain1 (16.6)0 Myalgia00Patients with an adverse effect after 2nddose of BNT162b2 or CoronaVac, n (%) Fever3 (20)0 Malaise2 (13.3)1 (14.2) Local pain/arm pain00 Myalgia4 (26.6)1 (14.2)Patients with an adverse effect after 3rddose of BNT162b2 or CoronaVac, n (%) Fever00 Malaise03 (50) Local pain/arm pain00 Myalgia03 (50)ConclusionAccording to our results, no thrombotic events or pregnancy complications were observed after CoronaVac and BNT162b2 vaccines in APS patients. Apart from this, minor side effects related to COVID-19 vaccines were clinically acceptable level.References[1]Talotta, R. and E.S. Robertson, Antiphospholipid antibodies and risk of post-COVID-19 vaccination thrombophilia: The straw that breaks the camel’s back? Cytokine & Growth Factor Reviews, 2021.Disclosure of InterestsNone declared