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

Christien Rondaan, Victoria Furer, Marloes W Heijstek, Nancy Agmon-Levin, Marc Bijl, Ferdinand C Breedveld, Raffaele D'Amelio, Maxime Dougados, Meliha C Kapetanovic, Jacob M van Laar, Annette Ladefoged de Thurah, Robert Landewé, Anna Molto, Ulf Müller-Ladner, Karen Schreiber, Leo Smolar, Jim Walker, Klaus Warnatz, Nico M Wulffraat, Sander van Assen, Ori Elkayam, Christien Rondaan, Victoria Furer, Marloes W Heijstek, Nancy Agmon-Levin, Marc Bijl, Ferdinand C Breedveld, Raffaele D'Amelio, Maxime Dougados, Meliha C Kapetanovic, Jacob M van Laar, Annette Ladefoged de Thurah, Robert Landewé, Anna Molto, Ulf Müller-Ladner, Karen Schreiber, Leo Smolar, Jim Walker, Klaus Warnatz, Nico M Wulffraat, Sander van Assen, Ori Elkayam

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.

Keywords: autoimmune diseases; infections; vaccination.

Conflict of interest statement

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.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow chart displaying the search strategy for PICO 2 and 3. DMARDs, disease-modifying antirheumatic drugs; IS, immunosuppressives; PICO, population-intervention-comparison-outcome.

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