Use of tezepelumab reduced asthma exacerbations in severe, uncontrolled asthma across all seasons, including among patients with perennial and seasonal allergies, according to a post hoc analysis published in Annals of Allergy, Asthma & Immunology.
Tezepelumab (a human monoclonal antibody) may have enhanced efficacy during specific allergy seasons in patients sensitized to specific seasonal allergens. Researchers therefore assessed the effect of tezepelumab on exacerbations by season in patients with severe asthma, including patients stratified by seasonal or perennial allergy through a post hoc analysis of the phase 3 NAVIGATOR study (ClinicalTrials.gov Identifier: NCT03347279).
NAVIGATOR was a randomized, double-blind, placebo-controlled study of participants aged 12 to 80 years. The trial, conducted from November 2017 to September 2020 across almost 300 sites in 18 countries, defined asthma exacerbation as worsening of asthma symptoms that led to use of systemic corticosteroids for at least 3 days or hospitalization. Researchers in NAVIGATOR concluded tezepelumab improved lung function, asthma symptom control, and reduced the annualized asthma exacerbation rate (AAER) vs placebo in patients with and without perennial allergy.
In the current post hoc analysis, authors found the AAER was reduced with tezepelumab vs placebo in winter by 63% (95% CI, 52%-72%), in spring by 46% (95% CI, 26%-61%), in summer by 62% (95% CI, 48%-73%), and in fall by 54% (95% CI, 41%-64%). Notably, the researchers had differing seasonal definitions for the Northern hemisphere (winter: January-March; spring: April-June; summer: July-September; fall: October-December) and the Southern hemisphere (seasons shifted by 6 months from Northern hemisphere).
In this post hoc analysis of NAVIGATOR, tezepelumab treatment resulted in reductions in asthma exacerbations across all seasons, irrespective of sensitivity to perennial and seasonal aeroallergens.
The proportion of patients who experienced at least 1 exacerbation was lower across winter, spring, summer, fall in the tezepelumab group vs placebo (18% vs 33%; 16% vs 24%; 13% vs 27%; 21% vs 33%), respectively.
The researchers found 64% of patients had perennial aeroallergen sensitivity, 38% had seasonal sensitivity, and 34% had both (30% were not sensitized to any of the assessed seasonal or perennial aeroallergens).
In matched climates during the spring and during ragweed season, the AAER in patients with seasonal allergies was reduced by tezepelumab vs placebo by 59% (95% CI, 29%-77%) and 70% (95% CI, 33%-87%), respectively.
Among all patients with seasonal allergy or perennial allergy, AAER was reduced with tezepelumab vs placebo across all seasons.
Post hoc analysis limitations include underpowered sample size in some subgroup analyses.
“In the NAVIGATOR phase 3 study, tezepelumab significantly reduced the AAER compared with placebo in adults and adolescents with severe, uncontrolled asthma,” analysis authors stated, and went on to conclude, “In this post hoc analysis of NAVIGATOR, tezepelumab treatment resulted in reductions in asthma exacerbations across all seasons, irrespective of sensitivity to perennial and seasonal aeroallergens.”
Disclosures: This research was supported by AstraZeneca and Amgen, Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.