Abstract

<h3>Introduction</h3> Patients with uncontrolled, severe allergic asthma may be prescribed biologic therapies to reduce exacerbations and improve disease control. Randomized controlled trials (RCTs) of these therapies have differed in design, with varying results overall and by baseline blood eosinophil count (BEC). Here we describe annualized asthma exacerbation rate (AAER) reductions from RCTs in patients with severe allergic asthma overall and by baseline BEC category. <h3>Methods</h3> A literature search was performed to identify published phase 3 RCT data of FDA-approved biologics in patients with severe, uncontrolled asthma with confirmed allergy to perennial aeroallergens, where AAER reduction versus placebo was measured in the overall population and/or in those with a high or low BEC at baseline or screening. <h3>Results</h3> The serum total immunoglobulin E levels varied between biologic RCT analyses. In the overall allergic population, data were available for tezepelumab, dupilumab and omalizumab only; the greatest AAER reduction was observed with tezepelumab. In patients with allergy and BECs of at least 260 cells/μL or at least 300 cells/μL or higher, AAER reductions were observed with all biologics; the smallest AAER reduction was observed with omalizumab. In patients with allergy and BEC less than 300 cells/μL (regardless of historical BEC), an AAER reduction was observed with tezepelumab but not with mepolizumab, benralizumab or omalizumab. (<b>Figure</b>). <h3>Conclusion</h3> Among patients with severe allergic asthma, tezepelumab was the only biologic to demonstrate reductions consistently in AAER across all subgroups. The efficacy of biologics varies considerably overall and by BEC. These differences can inform provider treatment decisions.

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