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Response to SARS-CoV-2 vaccination in systemic autoimmune rheumatic disease depends on immunosuppressive regimen: a matched, prospective cohort study
  1. Peter Mandl1,
  2. Selma Tobudic2,
  3. Helmut Haslacher3,
  4. Thomas Karonitsch1,
  5. Daniel Mrak1,
  6. Thomas Nothnagl4,
  7. Thomas Perkmann3,
  8. Helga Radner1,
  9. Judith Sautner4,
  10. Elisabeth Simader1,
  11. Florian Winkler1,2,
  12. Heinz Burgmann2,
  13. Daniel Aletaha1,
  14. Stefan Winkler2,
  15. Stephan Blüml1
  1. 1 Rheumatology, Medical University of Vienna, Vienna, Austria
  2. 2 Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria
  3. 3 Department of Laboratory Medicine, Medical University of Vienna, Wien, Austria
  4. 4 Second Medical Department, Lower Austrian Centre for Rheumatology, Stockerau, Austria
  1. Correspondence to Dr Peter Mandl, Rheumatology, Medical University of Vienna, Wien, Austria; peter.mandl{at}


Objective To assess the humoral response to messenger RNA (mRNA) vaccine of patients with systemic autoimmune rheumatic disease (SARD) and the effect of immunosuppressive medication in a matched cohort study.

Methods Patients with SARD were enrolled and matched 1:1 for sex and age with healthy control (HC) subjects. Differences in humoral response to two doses of an mRNA vaccine in terms of seroconversion rate (SCR) and SARS-CoV-2 antibody level between the two groups and the impact of treatment within patients with SARD were assessed.

Results We enrolled 82 patients with SARD and 82 matched HC. SCR after the first dose was lower among the patient group than that of HC (65% compared with 100% in HC, p<0.0001) but levelled up after the second dose (94% vs 100%). After the second dose, SCR was lower for patients on combination disease-modifying antirheumatic drug (DMARD) therapy compared with all other groups (81% compared with 95% for monotherapy, p=0.01; 100% for both no DMARD therapy and HC, both p<0.0001). In addition, antibody levels after both doses were lower in patients compared with HC. We found that vaccination response was determined primarily by the number of DMARDs and/or glucocorticoids received, with patients receiving combination therapy (dual and triple therapy) showing the poorest response.

Conclusions Patients with SARD showed a good response after the second vaccination with an mRNA vaccine. However, the choice of immunosuppressive medication has a marked effect on both SCR and overall antibody level, and the number of different immunomodulatory therapies determines vaccination response.

  • vaccination
  • immune system diseases
  • systemic vasculitis
  • COVID-19

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Data are available upon reasonable request. Unpublished data are available upon reasonable request.

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Data availability statement

Data are available upon reasonable request. Unpublished data are available upon reasonable request.

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  • Handling editor Johannes WJ Bijlsma

  • PM and ST contributed equally.

  • SW and SB contributed equally.

  • Contributors PM, ST, HB, SW, JS, DA and SB designed the study. PM, ST, TK, TN, JS, SB, ES, HH, HR and TP analysed the data. PM, ST, ES, HH, TP, JS, HB, DA, SW and SB interpreted the results. PM, ST, DA, JS, TK and SB wrote the paper. All authors revised the manuscript and were involved in editing or quality control. SB and PM had access to all ther data and accept full responsibility for the work and conduct of the study and controlled the decision to publish.

  • 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 PM reports speaker fees from AbbVie, Janssen and Novartis and research grants from AbbVie, BMS, Novartis, Janssen, MSD and UCB, outside the submitted work. HH received grants from Glock Health, BlueSky Immunotherapies and Neutrolis. JS is the President of the Austrian Society of Rheumatology and Rehabilitation (unpaid position). HB received consulting fees from MSD, Pfizer, Takeda and Gilead, speaker fees from Shionogi, Pfizer and MSD, and advisory boards for Valneva, MSD and Gilead. DA reports grants from AbbVie, Amgen, Lilly, Novartis, Roche, SoBi and Sanofi, and other from AbbVie, Amgen, Lilly, Merck, Novartis, Pfizer, Roche and Sandoz, outside the submitted work. SB reports personal fees from AbbVie and Novartis, outside the submitted work. ES reports support for meeting attendances from Pfizer and Bristol Myers Squibb. HR, TK, DM, TN, TP, FW, SW and ST have nothing to declare.

  • 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.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.