Article Text

Download PDFPDF

  1. M. Gerosa1,2,
  2. T. Schioppo3,
  3. L. M. Argolini2,
  4. S. Sciascia4,5,
  5. G. A. Ramirez6,
  6. G. Moroni7,
  7. R. A. Sinico8,
  8. F. Alberici9,
  9. L. Moroni6,
  10. F. Tamborini10,
  11. P. Miraglia5,
  12. C. Bellocchi11,
  13. L. Beretta11,
  14. D. Roccatello5,
  15. L. Dagna12,
  16. E. Bozzolo12,
  17. R. Caporali1,2
  1. 1University of Milan, Milan, Italy, Research Center for Adult and Pediatric Rheumatic Diseases, Department of Clinical Sciences and Community Health, Milan, Italy
  2. 2ASST Pini CTO, Lupus Clinic, Division of Clinical Rheumatology, Milan, Italy
  3. 3ASST Santi Paolo e Carlo, Medicina generale I, Milan, Italy
  4. 4University of Turin, Department of Clinical and Biological Sciences, Turin, Italy
  5. 5San Giovanni Bosco Hub Hospital, CMID- Nephrology and Dialysis Unit (ERK-net member), Research Center of Immunopathology Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, Turin, Italy
  6. 6IRCCS Ospedale San Raffaele, Unit of Immunology, Rheumatology, Allergy and Rare Diseases, Milan, Italy
  7. 7Humanitas University, IRCCS Humanitas Research Hospital, Department of Biomedical Sciences, Milan, Italy
  8. 8Universita` degli Studi di Milano Bicocca and ASST-Monza, Department of Medicine and Surgery, Renal Unit, Monza, Italy
  9. 9University of Brescia, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, Brescia, Italy
  10. 10Fondazione Ca’ Granda IRCCS Ospedale Maggiore Policlinico Milano, Divisione di Nefrologia e Dialisi, Milan, Italy
  11. 11Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico di Milano, Referral Center for Systemic Autoimmune Diseases, Milan, Italy
  12. 12IRCCS Ospedale San Raffaele, Unit of Immunology, Rheumatology, Allergy and Rare Diseases, Milan, Italy


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 flare. 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-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 frequent

Table 1.

distribution of demographic and SLE characteristics according to sides effects and disease flares after vaccination

Conclusion our 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 infection

References [1]Tang W et al. The Use of COVID-19 Vaccines in Patients with SLE. Curr Rheumatol Rep. 2021 12;23:79.

Disclosure of Interests None declared

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.