Biomarkers vary by sex, race, ethnicity among patients with severe asthma
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LOUISVILLE, Ky. — Sex, race and ethnicity were associated with varying biomarker test results among adults with severe asthma, according to a presentation at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting.
“Biomarker testing is a routine part of specialist management for severe asthma, as it can be used to predict response to treatment and the course of disease,” Donna Carstens, MD, senior medical director of respiratory, Fasenra at AstraZeneca, said during her presentation.
“However, currently, there are few data that describe real-world biomarker test results for patients with severe asthma in routine practice within the specialist setting and how they may vary by demographic characteristics,” Carstens continued.
The researchers examined findings from 3,222 adults (mean age, 54.3 years; 73.6% white; 57.2% commercially insured) diagnosed with severe asthma but not receiving biologics or systemic corticosteroids enrolled in the ongoing CHRONICLE observational study between February 2018 and February 2022.
During the 12 months before enrollment, 3,204 patients had biomarker testing, including 57% with one or more blood eosinophil count (BEC) tests, 28% with one or more fractional exhaled nitric oxide (FeNO) tests, and 42% with one or more total IgE tests performed.
At any point during the study, 2,180 patients had biomarker testing, including 68% with one or more BEC tests, 32% with one or more FeNO tests, and 46% with one or more total IgE level tests.
BEC results showed 36% of patients had 300 cells/µL or more, 24% with 150 cells/µL to 299 cells/µL and 40% with less than 150 cells/µL.
FeNO results showed 58% of patients at 50 ppb or higher, 25% at 25 to 49 ppb and 17% at less than 25 ppb.
Total IgE results showed 23% of patients at 400 IU/mL or higher, 23% at 150 to 399 IU/mL, 33% at 30 to 149 IU/mL, and 21% at less than 30 IU/mL.
Men had higher median BEC (299 cells/µL vs. 221 cells/µL), FeNO (26 ppb vs. 19 ppb) and total IgE (230 IU/mL vs. 110 IU/mL) test results than women.
Also, Black patients had lower median BEC (180 cells/µL) than non-Hispanic white patients (241 cells/µL) and Hispanic patients (272 cells/µL). Hispanic patients had lower median FeNO (16 ppb vs. 20 ppb vs. 21 ppb) compared with Black and non-Hispanic white patients, whereas the latter had lower median total IgE (102 IU/mL vs. 185 IU/mL vs. 226 IU/mL) compared with Black and Hispanic patients.
“We believe these differences may be explained in part by the differential prevalence of allergic eosinophilic and T2-low phenotypes among subgroups,” Carstens said.
Perspective
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Christopher O'Brien, MD, PhD, FCCP
The CHRONICLE study is a nice example of a recent real-world observational study that helps draw a bridge between guideline-recognized biomarker strategies (BEC, FeNO and IgE, for example) and real-world practice and demographic patterns seen in the care of patients with severe and uncontrolled asthma.
Overall, the findings corroborate the significant prevalence of both T2- and non-T2-driven mechanisms in severe asthma seen in other trials and present some intriguing findings among subpopulations identified as being at particular at risk.
Differences in prevalence of low vs. moderate or high BEC, low vs. moderate or high FeNO, and gradations in IgE levels across subpopulations reflect prior observations in clinical trials and studies evaluating asthma phenotypes and highlight the potential for better tailoring treatment options to mechanism.
Perhaps one of the most interesting findings, however, was the large percentage of patients with severe asthma without biomarker assessments in their records in the 12 months prior to a significant change in therapy.
Although this may reflect the study’s methodology, it also highlights an opportunity for continued education as well as evolution in clinical practice patterns and therapeutic decision-making as development programs now routinely employ biomarker strategies both to address asthma populations with unmet need and identify patient populations most likely to benefit.
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Carstens D, et al. Poster P109. Presented at: ACAAI Annual Scientific Meeting; Nov. 10-14, 2022; Louisville, Ky.
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