Managing T2-High Inflammation in Severe Asthma - Are Biomarkers Better Than Clinician Judgement?

Abstract

Introduction: Biomarkers are used to select patients for therapy in severe asthma, but not to regularly adjust therapy, especially oral corticosteroids (OCS). Our goal was to test the efficacy of an algorithm to guide the titration of OCS in adults with severe asthma using blood eosinophil count and fraction of exhaled nitric oxide levels (FeNO). Methods: This proof-of-concept randomized controlled trial assigned severe asthma participants (n=32) to an inflammation arm; where OCS dose was adjusted based on blood eosinophil count and FeNO, or a best-practice clinical care arm. The primary outcome was number of severe exacerbations and time to first severe exacerbation assessed over 12 months. Results: The relative risk of a severe exacerbation in the inflammation versus control arms was 0.88 (Adj.; 95%CI:0.47, 1.62; p=0.675) with a mean exacerbation rate per year of 2.5 and 3.5, respectively. There was a trend toward a longer median time to first severe exacerbation in the inflammation arm (73 vs. 32 days, Adj. HR:0.714; 95%CI:0.25, 2.06; p=0.533). The odds ratio of an emergency department (ED) or hospital admission in the inflammation management arm was 0.177 (Adj; 95%CI: 0.023, 1.361; p=0.0961). There was no significant difference in mean OCS dose used over the course of the study between the two groups, with both groups decreasing their doses by 0.1mg/day/visit. Conclusion: A treatment algorithm to adjust oral corticosteroids using blood eosinophil count and FeNO is feasible in a clinical setting and resulted in a longer time to exacerbation and reduced odds of a hospital admission or ED visit. This warrants further study to optimize the use of oral corticosteroids in the future.