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

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

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.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Viral / blood
  • Antibodies, Viral / immunology
  • Autoimmune Diseases / drug therapy
  • Autoimmune Diseases / immunology*
  • BNT162 Vaccine
  • COVID-19 / prevention & control*
  • COVID-19 Vaccines / adverse effects
  • COVID-19 Vaccines / immunology*
  • Female
  • Humans
  • Immunocompromised Host / immunology*
  • Immunogenicity, Vaccine / immunology*
  • Immunoglobulin G / blood
  • Immunoglobulin G / immunology
  • Immunosuppressive Agents / therapeutic use
  • Male
  • Middle Aged
  • Rheumatic Diseases / drug therapy
  • Rheumatic Diseases / immunology*
  • SARS-CoV-2
  • Young Adult

Substances

  • Antibodies, Viral
  • COVID-19 Vaccines
  • Immunoglobulin G
  • Immunosuppressive Agents
  • BNT162 Vaccine