Tezepelumab reduces exacerbations across all seasons in patients with severe, uncontrolled asthma (NAVIGATOR).
Pavord ID., Hoyte FCL., Lindsley AW., Ambrose CS., Spahn JD., Roseti SL., Cook B., Griffiths JM., Hellqvist Å., Martin N., Llanos J-P., Martin N., Colice G., Corren J.
BACKGROUND: Asthma exacerbation frequencies vary throughout the year owing to seasonal triggers. Tezepelumab is a human monoclonal antibody that targets thymic stromal lymphopoietin. In the phase 3 NAVIGATOR study (NCT03347279), tezepelumab significantly reduced the annualized asthma exacerbation rate (AAER) versus placebo in patients with severe, uncontrolled asthma. OBJECTIVE: This post hoc analysis evaluated the effect of tezepelumab on asthma exacerbations across all seasons in NAVIGATOR patients. METHODS: NAVIGATOR was a multicenter, randomized, double-blind, placebo-controlled study. Patients (1280 years) were randomized 1:1 to tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks. AAER over 52 weeks was assessed by season. Data from patients in the Southern Hemisphere were transformed to align with Northern Hemisphere seasons. RESULTS: Tezepelumab reduced the AAER versus placebo by 63% (95% confidence interval [CI]: 52, 72) in winter, 46% (95% CI: 26, 61) in spring, 62% (95% CI: 48, 73) in summer and 54% (95% CI: 41, 64) in fall. In matched climates, during spring (March 1 to June 15) and ragweed (September) allergy seasons, tezepelumab reduced the AAER versus placebo in patients with seasonal allergy by 59% (95% CI: 29, 77) and 70% (95% CI: 33, 87), respectively. In patients with perennial allergy and in those with seasonal allergy, tezepelumab reduced the AAER versus placebo across all seasons. CONCLUSION: Tezepelumab reduced exacerbations across all seasons versus placebo in patients with severe, uncontrolled asthma, including patients with seasonal and perennial allergies. These data further support the efficacy of tezepelumab in a broad population of patients with severe, uncontrolled asthma.