THE IMPACT of ANTI-SARS-COV-2 VACCINES in A MULTICENTER COHORT STUDY of PATIENTS with SYSTEMIC LUPUS ERYTHEMATOSUS

ABSTRACT

Background: Vulnerable 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 fare. Few data about the safety of these vaccines in SLE are available Objectives: To investigate the safety of different anti-SARS-CoV-2 vaccines in SLE Methods: Data 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) Results: 452 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-ma-larials, 50% were treated with an immunosuppressant. 9 patients transiently discontinued therapy. 119 (26%) reported adverse symptoms after the frst/second shot (12% and 21%) The most frequent were fever, local reaction, fatigue and arthralgias. Nineteen (4%) patients fared up after immunisation with a 7 days median time to relapse. Baseline demographics, SLE characteristics and therapy stratifed by adverse events and disease fare are reported in Table 1. Anti-dsDNA positivity, moderate/high DAS before vaccine and use of Belimumab were sig-nifcantly more frequent in the group of patients fared. These patients displayed a signifcantly 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 frequent Conclusion: our reassuring data confrm that anti-SARS-CoV-2 vaccine is safe in SLE patients and should be recommended in this clinical setting, as potential benefts widely outweigh the risk of adverse events. Treatment adjustment might be considered with the aim of minimizing the risk of side effects and/or fare, while ensuring a satisfying protection against infection.