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Chronic glucocorticoid maintenance treatment is associated with the risk of SARS-CoV-2 infection in patients with systemic lupus erythematosus who received vaccination
  1. Giuseppe A Ramirez1,2,
  2. Lorenza Maria Argolini3,4,
  3. Tommaso Schioppo3,4,
  4. Savino Sciascia5,6,
  5. Luca Moroni1,2,
  6. Gabriella Moroni7,8,
  7. Renato Alberto Sinico9,10,
  8. Grazia Bonelli10,
  9. Federico Alberici11,12,
  10. Federica Mescia11,12,
  11. Francesco Tamborini13,
  12. Paolo Miraglia5,
  13. Chiara Bellocchi14,15,
  14. Lorenzo Beretta14,
  15. Dario Roccatello5,6,
  16. Enrica Paola Bozzolo2,
  17. Roberto Caporali3,4,
  18. Maria Gerosa3,4,
  19. Lorenzo Dagna1,2
  20. On behalf of SMILE, Milan Lupus Consortium
  1. 1 Università Vita-Salute San Raffaele, Milano, Italy
  2. 2 Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS Ospedale San Raffaele, Milano, Italy
  3. 3 Department of Clinical Science of Community Health and Research Center for Adult and Pediatric Rheumatic Diseases, Università degli Studi di Milano, Milano, Lombardia, Italy
  4. 4 Unit of Rheumatology, ASST Gaetano Pini, Milano, Italy
  5. 5 Research Centre of Immunopathology coordinating Centre of the Network for Rare Diseases of Piedmont and Aosta Valley, Ospedale San Giovanni Bosco, Torino, Piemonte, Italy
  6. 6 Department of Clinical and Biological Sciences, Università degli Studi di Torino, Torino, Italy
  7. 7 Department of Internal Medicine, Humanitas University, Milan, Italy
  8. 8 Department of Biomedical Sciences, IRCCS Humanitas Research Hospital, Rozzano, Lombardia, Italy
  9. 9 Nephrology Unit, University of Milano Bicocca, Milano, Italy
  10. 10 Unit of Nephrology, ASST di Monza, Monza, Lombardia, Italy
  11. 11 Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy
  12. 12 Unit of Nephrology, Spedali Civili Hospital, Brescia, Italy
  13. 13 Nephrological Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, milano, Italy
  14. 14 Referral Center for Systemic Autoimmune Diseases, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy
  15. 15 Department of Clinical Science of Community Health, Section of Internal Medicine, Università degli Studi di Milano, Milano, Italy
  1. Correspondence to Dr Giuseppe A Ramirez, Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS Ospedale San Raffaele, via Olgettina 60, 20132 Milano, Italy; ramirez.giuseppealvise{at}

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SARS-CoV-2-related disease (COVID-19) constitutes an ongoing challenge for public health. Vaccination campaigns have effectively reduced COVID-19-related morbidity and mortality, leading to less restrictive preventive measures. This has, however, led to worldwide absolute increasing rates of COVID-19 cases during the last months. Patients with multiorgan autoimmune disorders, including systemic lupus erythematosus (SLE) are at increased risk of morbidity due to SARS-CoV-2 infection and pandemic-related disruptions in public health services. Vaccination also constitutes a challenge for patients with SLE and other rheumatic disorders, who might develop dysfunctional immunisation responses due to disease-related and treatment-related factors. Poor humoral and cellular immunogenicity of current anti-SARS-COV-2 vaccines has been reported in patients with SLE and other immune-mediated diseases.1 2 However, less is known about the incidence and risk factors for breakthrough COVID-19 following vaccination.3 4

To address this issue, we analysed data from 452 patients with SLE (93% women) followed in seven Italian tertiary referral centres, who completed a primary vaccination cycle between January and November 2021. Data from patient history and status were collected during the last visit before and the first visit after the primary vaccination cycle. Postvaccination evaluations took place after a median (IQR) time of 3.9 (3.6–4.8) …

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  • Handling editor Josef S Smolen

  • Contributors GAR, MG, TS, RC and LD designed the study. All authors contributed to data collection. GAR, MG, TS and LMA analysed the data. GAR drafted the manuscript. All authors contributed to the design of the study and to revise it critically for important intellectual content. All authors contributed to revising the manuscript and approved its final version.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.