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

BACKGROUND

Tezepelumab, a human monoclonal antibody, blocks the activity of thymic stromal lymphopoietin. 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 vs placebo in patients with severe, uncontrolled asthma.

OBJECTIVE

To evaluate 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

Of the 1334 patients (tezepelumab, n = 665; placebo, n = 669) included, 312 experienced at least 1 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 in 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.

TRIAL REGISTRATION: This is a pooled analysis of 2 studies registered at Clinicaltrials.gov: PATHWAY (NCT02054130) and NAVIGATOR (NCT03347279).