Efficacy and safety of mRNA and AstraZeneca COVID-19 vaccines in patients with autoimmune rheumatic diseases: A systematic review

Abstract

Background: Patients with autoimmune rheumatic diseases (ARD) are at a potentially higher risk for COVID-19 infection complications. Given their inherent altered immune system and the use of immunomodulatory medications, vaccine immunogenicity could be unpredictable with a suboptimal or even an exaggerated immunological response. The aim of this study is to provide real-time data on the emerging evidence of COVID-19 vaccines' efficacy and safety in patients with ARDs.

Methods: We performed a literature search of the PubMed, EMBASE, and OVID databases up to 11-13 April 2022 on the efficacy and safety of both types of the mRNA-vaccines and the AstraZeneca COVID-19 vaccines in patients with ARD. The risk of bias in the retrieved studies was evaluated using the Quality in Prognostic Studies tool. Also, current clinical practice guidelines from multiple international professional societies were reviewed.

Results: We identified 60 prognostic studies, 69 case reports and case series, and eight international clinical practice guidelines. Our results demonstrated that most patients with ARDs were able to mount humoral and/or cellular responses after two doses of COVID-19 vaccine although this response was suboptimal in patients receiving certain disease-modifying medications including rituximab, methotrexate, mycophenolate mofetil, daily glucocorticoids >10 mg, abatacept, as well as in older individuals, and those with comorbid interstitial lung diseases. Safety reports on COVID-19 vaccines in patients with ARDs were largely reassuring with mostly self-limiting adverse events and very minimal post-vaccination disease flares.

Conclusion: Both types of the mRNA-vaccines and the AstraZeneca COVID-19 vaccines are highly effective and safe in patients with ARD. However, due to their suboptimal response in some patients, alternative mitigation strategies such as booster vaccines and shielding practices should also be followed. Management of immunomodulatory treatment regimens during the peri vaccination period should be individualized through shared decision making with patients and their attending rheumatologists.

Keywords: Adverse events; Autoimmune Rheumatic Disease; COVID-19 vaccine; Disease flare; Immunogenicity; Safety.

Fig. 1

The bidirectional relationship of COVID-19 with autoimmune rheumatic diseases. Reproduced from [Rheumatology and COVID-19 at 1 year: facing the unknowns, Calabrese et al., 80, 2022] with permission from BMJ Publishing Group Ltd.

Fig. 2

Mechanism of action of different types of vaccines against SARS-CoV-2, modes of antigen presentation and generation of protective immunity. This image is licensed under the Creative Commons Attribution 4.0 International License found at http://creativecommons.org/licenses/by/4.0/.

Fig. 3

Causality assessment of post-COVID-19 vaccination adverse events and autoimmune phenomena based on the WHO (2022) guidelines .

Fig. 4

Study flow diagram (adapted from updated 2020 PRISMA guideline [26]).