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November 08, 2022
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Omicron breakthrough cases in patients with IMIDs on immunosuppressants ‘mild’

Fact checked byShenaz Bagha
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The incidence of omicron breakthrough cases of COVID-19 in patients with immune-mediated inflammatory diseases on immunosuppressants is high, but similar to controls, while disease severity is mild, according to data.

“The emergence of the SARS-CoV-2 variant omicron has led to an unprecedented number of SARS-CoV-2 cases worldwide,” Eileen W. Stalman, MD, PhD, of the department of neurology and neurophysiology at Amsterdam UMC, and colleagues wrote in the Annals of the Rheumatic Diseases. “Multiple mutations in the receptor binding domain (RBD) of the spike (S) protein of this variant increased transmissibility and infectivity, and reduced effectiveness of standard SARS-CoV-2 vaccination regimens.”

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The incidence of omicron breakthrough cases of COVID-19 in patients with IMIDs on immunosuppressants is high, but similar to controls, while disease severity is mild, according to data derived from Stalman EW, et al. Ann Rheum Dis. 2022;doi:10.1136/ard-2022-222904.

To investigate the prevalence and severity of omicron SARS-CoV-2 infections in patients with and without immune-mediated inflammatory diseases (IMIDs), Stalman and colleagues used data from Target-to-B! (T2B!), a prospective, multi-arm, multicenter cohort study. Patients with an IMID who were receiving immunosuppressants — and those with an IMID who were not receiving immunosuppressants, as well as healthy controls — during their original vaccination course against COVID-19 were eligible for the analysis. All included patients were enrolled in the original T2B! study between Feb. 2, 2021, and Oct. 1, 2021.

Patients received electronic surveys every 2 months following their initial vaccination series. Collected data included demographic and COVID-19 infection information. If patients determined COVID-19 positivity through a PCR test, they were contacted by a researcher to further discuss disease severity and outcomes. The main outcome was the cumulative incidence of reported breakthrough infections with the omicron variant in patients with IMID on immunosuppressants, compared with controls.

Patients with IMIDs who were not receiving immunosuppressive therapies were combined into a single group with healthy controls due to a lack in difference regarding humoral responses to vaccination. Disease severity, as well as breakthrough determinants, were considered secondary outcomes.

A total of 1,593 patients with IMIDs receiving immunosuppressives, and 579 controls, were included in the analysis. In patients with IMIDs receiving immunosuppressants, the cumulative incidence of breakthrough infections was 29.6% (95% CI, 27% to 32%), compared with 31.3% (95% CI, 28%-35%) in the control group, according to the researchers. Just three patients developed severe disease.

Seroconversion after primary immunization (RR = 0.71; 95% CI, 0.52-0.96), additional vaccinations (RR = 0.61; 95% CI, 0.49-0.76) and prior COVID-19 infection (RR = 0.6; 95% CI, 0.48-0.75) were associated with a decreased risk for breakthrough infection.

“A cumulative incidence of reported SARS-CoV-2 omicron breakthrough infections of 30% was found that did not differ between patients with IMID on immunosuppressants and controls,” Stalman and colleagues wrote. “Overall disease severity of SARS-CoV-2 infections was mild as hospitalization was seen in only a few cases and disease severity did not differ between patients with IMID on immunosuppressants and controls.

“Our findings suggest that offering additional vaccinations can be an effective strategy to reduce risks of (future) breakthrough infections also in patients with IMID,” they added.