Immunogenicity induced by two and three doses of the BNT162b2 mRNA vaccine in patients with autoimmune inflammatory rheumatic diseases and immunocompetent controls: a longitudinal multicentre study

Abstract

ObjectivesTo evaluate long-term kinetics of the BNT162b2 mRNA vaccine-induced immune response in adult patients with autoimmune inflammatory rheumatic diseases (AIIRD) and immunocompetent controls.MethodsA prospective multicentre study investigated serum anti-SARS-CoV-2 S1/S2 IgG titre at 2–6 weeks (AIIRD n=720, controls n=122) and 6 months (AIIRD n=628, controls n=116) after the second vaccine, and 2–6 weeks after the third vaccine dose (AIIRD n=169, controls n=45). T-cell immune response to the third vaccine was evaluated in a small sample.ResultsThe two-dose vaccine regimen induced a higher humoral response in controls compared with patients, postvaccination seropositivity rates of 100% versus 84.72%, p<0.0001, and 96.55% versus 74.26%, p<0.0001 at 2–6 weeks and at 6 months, respectively. The third vaccine dose restored the seropositive response in all controls and 80.47% of patients with AIIRD, p=0.0028. All patients treated with methotrexate monotherapy, anticytokine biologics, abatacept and janus kinase (JAK) inhibitors regained the humoral response after the third vaccine, compared with only a third of patients treated with rituximab, entailing a 16.1-fold risk for a negative humoral response, p≤0.0001. Cellular immune response in rituximab-treated patients was preserved before and after the third vaccine and was similar to controls. Breakthrough COVID-19 rate during the Delta surge was similar in patients and controls, 1.83% versus 1.43%, p=1.ConclusionsThe two-dose BNTb262 regimen was associated with similar clinical efficacy and similar waning of the humoral response over 6 months among patients with AIIRD and controls. The third vaccine dose restored the humoral response in all of the controls and the majority of patients.

The accelerated waning of immunity and reduced effect of booster in patients treated with bDMARD and tsDMARD after SARS-CoV-2 mRNA vaccination

“…Our data suggest that csDMARDs do not affect the duration of the humoral immune response after SARS-CoV-2 vaccination, whereas b/tsDMARD therapy clearly does so. This is in line with some other reports (11,28), while others did find an influence of csDMARDs, especially MTX, in the humoral immune response after SARS-Cov-2 vaccination (10, 29). These discrepancies are possibly due to the time of analysis and age differences in the populations studied (30).…”

Outcomes with and without outpatient SARS-CoV-2 treatment for patients with COVID-19 and systemic autoimmune rheumatic diseases: a retrospective cohort study

“…For patients who had received vaccines, we also calculated time from last dose to the index date, because immunity wanes over time. 22 Electronic query identified previous COVID-19 before the current episode. Medical record review determined tixagevimab–cilgavimab use.…”

Outcomes with and without outpatient SARS-CoV-2 treatment for patients with COVID-19 and systemic autoimmune rheumatic diseases: A retrospective cohort study

“…For patients initially classified as unvaccinated or partially vaccinated, we performed medical record review to accurately classify patients who may have received vaccines outside of Massachusetts. For patients who had received vaccines, we also classified whether their most recent vaccine dose before index date was < or ≥6 months, since humoral immunity wanes (29,30). We used electronic query to identify previous COVID-19 prior to the current episode.…”