Effect of tezepelumab on asthma exacerbations co-occurring with infection-attributed acute respiratory illnesses

Feleszko W, Caminati M, Gern JE et al.  Ann Allergy Asthma Immunol. 2025 Oct 8:S1081-1206(25)01201-3. doi: 10.1016/j.anai.2025.09.015. 

Abstract

Background

Tezepelumab, a human monoclonal antibody, blocks the activity of thymic stromal lymphopoietin (TSLP). In the phase 2b PATHWAY (NCT02054130) and phase 3 NAVIGATOR (NCT03347279) studies, tezepelumab reduced exacerbations and improved lung function, asthma control, and health-related quality of life versus placebo in patients with severe, uncontrolled asthma.

Objective

This post hoc analysis of PATHWAY and NAVIGATOR evaluated the incidence of asthma exacerbations co-occurring with documented acute respiratory illnesses attributed to infections.

Methods

Patients were randomized 1:1 to receive tezepelumab 210 mg subcutaneously or placebo every 4 weeks for 52 weeks. The incidence of asthma exacerbations co-occurring with respiratory illness-related adverse events (AEs) was assessed. Co-occurrence was defined as at least 1 day of overlap between a respiratory illness-related AE and the asthma exacerbation period beginning 7 days before the start of the exacerbation until the end of the asthma exacerbation.

Results

Respiratory illness-related AEs occurred at an incidence of
 ≥ 1 per 100 patient-years in either treatment group

Of the 1334 patients (tezepelumab, n = 665; placebo, n = 669) included, 312 experienced at least one asthma exacerbation co-occurring with a respiratory illness-related AE attributed to an infection.

The incidence of asthma exacerbation co-occurring with a respiratory illness-related AE was lower in the tezepelumab group than the placebo group overall (18.2% vs 28.6%; exposure-adjusted incidence difference [EAID]: −11.1 [95% CI: −15.75, −6.41]) and among patients with perennial allergy (EAID, −11.6 [95% CI: −17.44, −5.69]) and without perennial allergy (EAID, −10.2 [95% CI: −18.16, −2.10]).

Conclusion

Tezepelumab reduced asthma exacerbations attributed to respiratory infections in patients with severe, uncontrolled asthma compared with placebo, irrespective of perennial allergy status.

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