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.
- biological therapy
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Handling editor Josef S Smolen
Correction notice This article has been corrected since it published Online First. The author affiliations have been amended.
Contributors The study was designed, directed and coordinated by OE, the principle investigator. VF, TE, DZ and HP, the sub-investigators, were in charge of the study conducted at all stages. All the MD co-authors recruited participants into the study and evaluated predisease and postdisease activity measures in patients. GS and OS performed the serology tests. SP and SN served as main study coordinators and questioned the study participants regarding the adverse events of vaccination. OE, VF and TE had full access to the study’s data and wrote the article, which was critically reviewed by DP, DZ and HP.
Funding The study was funded by the department’s fund of each medical centre participating in the study.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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