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Original article
Efficacy, immunogenicity and safety of vaccination in adult patients with autoimmune inflammatory rheumatic diseases: a systematic literature review for the 2019 update of EULAR recommendations
  1. Christien Rondaan1,2,
  2. Victoria Furer3,4,
  3. Marloes W Heijstek5,
  4. Nancy Agmon-Levin4,6,
  5. Marc Bijl7,
  6. Ferdinand C Breedveld8,
  7. Raffaele D’Amelio9,
  8. Maxime Dougados10,11,
  9. Meliha C Kapetanovic12,
  10. Jacob M van Laar13,
  11. Annette Ladefoged de Thurah14,
  12. Robert Landewé15,16,
  13. Anna Molto10,
  14. Ulf Müller-Ladner17,
  15. Karen Schreiber18,19,
  16. Leo Smolar20,
  17. Jim Walker21,
  18. Klaus Warnatz22,
  19. Nico M Wulffraat23,
  20. Sander van Assen24 and
  21. Ori Elkayam3,4
  1. 1 Medical microbiology and infection prevention, UMCG, Groningen, The Netherlands
  2. 2 Rheumatology and Clinical Immunology, UMCG, Groningen, The Netherlands
  3. 3 Rheumatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
  4. 4 Faculty of Medicine, Tel Aviv University Sackler, Tel Aviv, Israel
  5. 5 Internal Medicine and Allergology, Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands
  6. 6 Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel Hashomer, Israel
  7. 7 Internal Medicine, Martini Hospital, Groningen, The Netherlands
  8. 8 Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands
  9. 9 Dipartimento di Medicina Clinica e Molecolare, Sapienza University of Rome, Roma, Italy
  10. 10 Hopital Cochin, Rheumatology, Université Paris Descartes, Paris, France
  11. 11 Clinical epidemiology and biostatistics, PRES Sorbonne Paris- Cité, Paris, France
  12. 12 Department of Clinical Sciences, Section for Rheumatology, Lund University, Lund and Skåne University Hospital, Lund, Sweden
  13. 13 Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands
  14. 14 Rheumatology, Aarhus University Hospital, Aarhus, Denmark
  15. 15 Clinical Immunology & Rheumatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
  16. 16 Rheumatology, Zuyderland Medical Centre, Sittard-Geleen - Heerlen, The Netherlands
  17. 17 Rheumatology and Clinical Immunology, Giessen University, Giessen, Germany
  18. 18 Department of Thrombosis and Haemophilia, Guy's and Saint Thomas’ Hospitals NHS Trust, London, UK
  19. 19 Rheumatology, King Christian X's Hospital for Rheumatic Diseases in Gråsten, Graasten, Denmark
  20. 20 Patient Research Partner, Tel Aviv, Israel
  21. 21 Patient Research Partner, Elgin, Scotland
  22. 22 Centre for Chronic Immunodeficiency, University Medical Centre Freiburg, Freiburg, Germany
  23. 23 Pediatric Rheumatology, Wilhelmina Kinderziekenhuis, Utrecht, The Netherlands
  24. 24 Internal medicine (infectious diseases), Treant Care Group, Hoogeveen, The Netherlands
  1. Correspondence to Dr Christien Rondaan; c.rondaan{at}umcg.nl

Abstract

Aim To present a systematic literature review (SLR) on efficacy, immunogenicity and safety of vaccination in adult patients with autoimmune inflammatory rheumatic diseases (AIIRD), aiming to provide a basis for updating the EULAR evidence-based recommendations.

Methods An SLR was performed according to the standard operating procedures for EULAR-endorsed recommendations. Outcome was determined by efficacy, immunogenicity and safety of vaccination in adult patients with AIIRD, including those receiving immunomodulating therapy. Furthermore, a search was performed on the effect of vaccinating household members of patients with AIIRD on the occurrence of vaccine-preventable infections in patients and their household members (including newborns). The literature search was performed using Medline, Embase and the Cochrane Library (October 2009 to August 2018).

Results While most investigated vaccines were efficacious and/or immunogenic in patients with AIIRD, some were less efficacious than in healthy control subjects, and/or in patients receiving immunosuppressive agents. Adverse events of vaccination were generally mild and the rates were comparable to those in healthy persons. Vaccination did not seem to lead to an increase in activity of the underlying AIIRD, but insufficient power of most studies precluded arriving at definite conclusions. The number of studies investigating clinical efficacy of vaccination is still limited. No studies on the effect of vaccinating household members of patients with AIIRD were retrieved.

Conclusion Evidence on efficacy, immunogenicity and safety of vaccination in patients with AIIRD was systematically reviewed to provide a basis for updated recommendations.

  • infections
  • vaccination
  • autoimmune diseases

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • CR and VF contributed equally.

  • Contributors CR, in collaboration with SvA, reviewed articles on efficacy, immunogenicity and safety of vaccination for influenza, hepatitis A, hepatitis B, tetanus toxoid, herpes zoster, yellow fever and tickborne encephalitis in patients with AIIRD, and drafted the first version of the manuscript. VF, in collaboration with OE, performed the literature search and reviewed articles on vaccination in patients with AIIRD on the various immunomodulating therapies. MH reviewed articles on efficacy, immunogenicity and safety of vaccination of human papillomavirus vaccination in patients with AIIRD. OE initiated the project, reviewed articles on efficacy, immunogenicity and safety of vaccination for pneumococcal disease in patients with AIIRD, and wrote the paragraphs on pneumococcal vaccination. All authors collaborated in discussions during two meetings, and read and approved the final manuscript.

  • Funding This project was supported by EULAR.

  • Competing interests KW reports personal fees from Pfizer, during the conduct of the study; grants and personal fees from Biotest, CSL Behring, personal fees from LFB, Grifols, Baxter, Roche, Octapharma, grants from BMS, outside the submitted work. AM reports grants and personal fees from ABBVIE, Pfizer, BMS, UCB, MERCK, during the conduct of the study. MD reports grants and personal fees from PFIZER, ABBVIE, UCB, NOVARTIS, LILLY, MERCK, ROCHE, grants from BMS, outside the submitted work. OE reports grants and personal fees from Pfizer, Abbvie, Roche, Janssen, personal fees from Novartis and Lilly. All other authors have no conflicts of interests to declare.

  • Patient consent for publication Not required.

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

  • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.

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