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Observational Study
. 2021 Oct;80(10):1330-1338.
doi: 10.1136/annrheumdis-2021-220647. Epub 2021 Jun 14.

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

Victoria Furer  1   2 , Tali Eviatar  3   2 , Devy Zisman  4   5 , Hagit Peleg  6 , Daphna Paran  3   2 , David Levartovsky  3 , Michael Zisapel  3 , Ofir Elalouf  3   2 , Ilana Kaufman  3   2 , Roni Meidan  2   7 , Adi Broyde  3   2 , Ari Polachek  3   2 , Jonathan Wollman  3   2 , Ira Litinsky  3   2 , Katya Meridor  3   2 , Hila Nochomovitz  3   2 , Adi Silberman  3   2 , Dana Rosenberg  3   2 , Joy Feld  4 , Amir Haddad  4 , Tal Gazzit  4 , Muna Elias  4 , Nizar Higazi  4 , Fadi Kharouf  6   8 , Gabi Shefer  9 , Orly Sharon  9 , Sara Pel  3 , Sharon Nevo  3 , Ori Elkayam  3   2
Affiliations
Observational Study

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

Victoria Furer et al. Ann Rheum Dis. 2021 Oct.

Erratum in

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.

Keywords: Covid-19; biological therapy; methotrexate; rituximab; vaccination.

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Conflict of interest statement

Competing interests: None declared.

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