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  • Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases and in the general population: a multicentre study

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Epidemiology
Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases and in the general population: a multicentre study
  1. Victoria Furer1,2,
  2. Tali Eviatar1,2,
  3. Devy Zisman3,4,
  4. Hagit Peleg5,
  5. Daphna Paran1,2,
  6. David Levartovsky1,
  7. Michael Zisapel1,
  8. Ofir Elalouf1,2,
  9. Ilana Kaufman1,2,
  10. Roni Meidan2,6,
  11. Adi Broyde1,2,
  12. Ari Polachek1,2,
  13. Jonathan Wollman1,2,
  14. Ira Litinsky1,2,
  15. Katya Meridor1,2,
  16. Hila Nochomovitz1,2,
  17. Adi Silberman1,2,
  18. Dana Rosenberg1,2,
  19. Joy Feld3,
  20. Amir Haddad3,
  21. Tal Gazzit3,
  22. Muna Elias3,
  23. Nizar Higazi3,
  24. Fadi Kharouf5,7,
  25. Gabi Shefer8,
  26. Orly Sharon8,
  27. Sara Pel1,
  28. Sharon Nevo1,
  29. Ori Elkayam1,2
  1. 1 Rheumatology Department, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
  2. 2 Tel Aviv University Sackler Faculty of Medicine, Tel Aviv, Israel
  3. 3 Rheumatology Unit, Carmel Hospital, Haifa, Israel
  4. 4 Medicine, Technion Israel Institute of Technology, Haifa, Israel
  5. 5 Rheumatology Unit, Hadassah University Hospital, Jerusalem, Israel
  6. 6 Internal Medicine, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
  7. 7 The Hebrew University of Jerusalem Faculty of Medicine, Jerusalem, Jerusalem, Israel
  8. 8 Endocrinology Department, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
  1. Correspondence to Dr Victoria Furer, Rheumatology Department, Tel Aviv University, Tel Aviv, Israel; furer.rheum{at}gmail.com

Abstract

Introduction Vaccination represents a cornerstone in mastering the COVID-19 pandemic. Data on immunogenicity and safety of messenger RNA (mRNA) vaccines in patients with autoimmune inflammatory rheumatic diseases (AIIRD) are limited.

Methods A multicentre observational study evaluated the immunogenicity and safety of the two-dose regimen BNT162b2 mRNA vaccine in adult patients with AIIRD (n=686) compared with the general population (n=121). Serum IgG antibody levels against SARS-CoV-2 spike S1/S2 proteins were measured 2–6 weeks after the second vaccine dose. Seropositivity was defined as IgG ≥15 binding antibody units (BAU)/mL. Vaccination efficacy, safety, and disease activity were assessed within 6 weeks after the second vaccine dose.

Results Following vaccination, the seropositivity rate and S1/S2 IgG levels were significantly lower among patients with AIIRD versus controls (86% (n=590) vs 100%, p<0.0001 and 132.9±91.7 vs 218.6±82.06 BAU/mL, p<0.0001, respectively). Risk factors for reduced immunogenicity included older age and treatment with glucocorticoids, rituximab, mycophenolate mofetil (MMF), and abatacept. Rituximab was the main cause of a seronegative response (39% seropositivity). There were no postvaccination symptomatic cases of COVID-19 among patients with AIIRD and one mild case in the control group. Major adverse events in patients with AIIRD included death (n=2) several weeks after the second vaccine dose, non-disseminated herpes zoster (n=6), uveitis (n=2), and pericarditis (n=1). Postvaccination disease activity remained stable in the majority of patients.

Conclusion mRNA BNTb262 vaccine was immunogenic in the majority of patients with AIIRD, with an acceptable safety profile. Treatment with glucocorticoids, rituximab, MMF, and abatacept was associated with a significantly reduced BNT162b2-induced immunogenicity.

  • Covid-19
  • methotrexate
  • vaccination
  • biological therapy
  • rituximab

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information. The data used to support the findings of this study are included within the article.

This article is made freely available for use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

https://bmj.com/coronavirus/usage

https://doi.org/10.1136/annrheumdis-2021-220647

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    Data availability statement

    All data relevant to the study are included in the article or uploaded as supplementary information. The data used to support the findings of this study are included within the article.

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    Footnotes

    • Handling editor Josef S Smolen

    • Correction notice This article has been corrected since it published Online First. The author affiliations have been amended.

    • Contributors The study was designed, directed and coordinated by OE, the principle investigator. VF, TE, DZ and HP, the sub-investigators, were in charge of the study conducted at all stages. All the MD co-authors recruited participants into the study and evaluated predisease and postdisease activity measures in patients. GS and OS performed the serology tests. SP and SN served as main study coordinators and questioned the study participants regarding the adverse events of vaccination. OE, VF and TE had full access to the study’s data and wrote the article, which was critically reviewed by DP, DZ and HP.

    • Funding The study was funded by the department’s fund of each medical centre participating in the study.

    • Competing interests None declared.

    • 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.

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