POS1236 THE IMPACT OF ANTI-SARS-COV-2 VACCINES IN A MULTICENTER COHORT STUDY OF PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

Abstract

BackgroundVulnerable subjects, including systemic lupus erythematosus (SLE) patients have been prioritised to receive anti-SARS-CoV-2 vaccine. Questions have been raised about the effect of vaccines on immunity and their potential role as trigger for flare. Few data about the safety of these vaccines in SLE are availableObjectivesTo investigate the safety of different anti-SARS-CoV-2 vaccines in SLEMethodsData on SLE patients who have received anti-SARS-CoV-2 vaccine (from 12/2020 to 10/2021) were collected. Patients referred to 7 SLE tertiary centres (Lupus Clinic, ASST Pini-CTO, Milan; Nephrology Unit of Ospedale Giovanni Bosco, Turin; IRCCS Humanitas Research Hospital; Renal and Rheumatology Units, San Gerardo Hospital, Monza; ASST Spedali Civili Brescia; Lupus Clinic IRCCS Ospedale S. Raffaele, Milan, Italy; IRCCS Policlinico, Milan)Results452 SLE patients who had received anti-SARS-CoV-2 vaccines were included (91% BNT162b2 mRNA, 8% mRNA-1273, 1% ChAdOx1-S). 12 (3%) were off therapy, 71% were on low-medium dose prednisone, 83% on anti-malarials, 50% were treated with an immunosuppressant. 9 patients transiently discontinued therapy. 119 (26%) reported adverse symptoms after the first/second shot (12% and 21%) The most frequent were fever, local reaction, fatigue and arthralgias. Nineteen (4%) patients flared up after immunisation with a 7 days median time to relapse. Baseline demographics, SLE characteristics and therapy stratified by adverse events and disease flare are reported in Table 1. Anti-dsDNA positivity, moderate/high DAS before vaccine and use of Belimumab were significantly more frequent in the group of patients flared. These patients displayed a significantly higher rate of adverse events after vaccination. Flares consisted mainly musculoskeletal and constitutional manifestations (32%), involvement of renal (21%), cardio-respiratory (16%), hematological (16%) or mucocutaneous domains (10%) was less frequentTable 1.distribution of demographic and SLE characteristics according to sides effects and disease flares after vaccinationSide effects (n=119)No side effects (n=333)p-value (<0.05)Disease flare (n=19)No disease flare (n=430)p-value (<0.05)Age, years, median (IQR)46 (33.5-54)48 (35.7-57)0.1852 (39.5-56.0)48 (35.0-56.9)0.849Disease duration, months, median (IQR)138 (76-262)126 (73-193)0.30144 (122-242)127 (73-195)0.249MSK, %84.984.41.0078.984.80.514Mucocutaneus, %71.462.80.09457.964.50.624Renal, %42.052.30.06952.649.40.819NPSLE, %13.490.2155.310.40.708Cardiopulmonary %22.719.80.51026.320.30.562Hematological, %32.8331.0042.132.60.455Constitutional symptoms %48.7300.0003*26.335.30.473Gastrointestinal %4.23.30.7725.33.50.503Ophthalmic %0.83.30.19702.81.00Secondary APS %10.910.50.8645.310.90.708aPL positivity %26.233.60.13726.331.90.802Anti-dsDNA positivity %30.727.40.54555.627.10.0142*ESR, mm/h, median (IQR)14 (7-19)13 (7-22)0.73019 (10-24)13 (7-21)0.125CRP, mg/dL, median (IQR)0.5 (0.1-0.5)0.5 (0.3-0.6)0.3120.42 (0.13-0.50)0.50 (0.30-0.5)0.464Urinary abnormalities, %9.221.90.002321.118.50.764Moderate or high DAS before vaccine, %169.30.06026.310.40.0474*No therapy before vaccine, %03.60.0419*02.81.00At least 1 immunosuppressant, %6346.80.0027*73.750.10.059Mycophenolate, %31.923.10.06642.124.70.106Methotrexate, %5.96.61.005.36.51.00Belimumab, %21.813.50.0396*36.814.80.0184*Rituximab ever, %11.813.50.7515.313.40.490Prednisone, %74.8700.34778.970.90.607Conclusionour reassuring data confirm that anti-SARS-CoV-2 vaccine is safe in SLE patients and should be recommended in this clinical setting, as potential benefits widely outweigh the risk of adverse events. Treatment adjustment might be considered with the aim of minimizing the risk of side effects and/or flare, while ensuring a satisfying protection against infectionReferences[1]Tang W et al. The Use of COVID-19 Vaccines in Patients with SLE. Curr Rheumatol Rep. 2021 12;23:79.Disclosure of InterestsNone declared