Tezepelumab reduces asthma exacerbations across all seasons

PHOENIX — Tezepelumab consistently reduced exacerbations in adults and adolescents with severe asthma across all seasons, according to NAVIGATOR trial results presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting.

Results from the NAVIGATOR phase 3 trial contributed to the FDA approval of tezepelumab (Tezspire, Amgen/AstraZeneca) — a human monoclonal antibody that targets thymic stromal lymphopoietin — as an add-on maintenance treatment of adults and children aged 12 years and older with severe asthma.

“Seasonal variations in the frequency of asthma exacerbations can occur owing to the presence of different exacerbation triggers (eg, allergens and viruses) during different seasons. This prespecified exploratory analysis evaluated the effect of tezepelumab on asthma exacerbations across all seasons in patients from NAVIGATOR,” Flavia Cecilia Lega Hoyte, MD, allergist and immunologist at National Jewish Health in Denver, and colleagues wrote in the abstract.

The multicenter, double-blind, placebo-controlled, phase 3 study included 1,059 individuals aged 12 to 80 years who researchers randomly assigned 1:1 to treatment with either a subcutaneous injection of 210 mg tezepelumab (n = 528) or placebo (n = 531) every 4 weeks for 52 weeks.

In the winter, the annualized asthma exacerbation rate (AAER) was reduced by 63% (95% CI, 52-72) in the tezepelumab group compared with the AAER observed in the placebo group. AAER showed reductions of 46% in the spring (95% CI, 26-61), 62% in the summer (95% CI, 48-73) and 54% in the fall (95% CI, 41-64) in the tezepelumab group vs. the placebo group.

Across all four seasons, there was a greater proportion of individuals in the tezepelumab group without exacerbations compared with the placebo group: winter, 81.7% vs. 66.6%; spring, 84.3% vs. 76.3%; summer, 86.8% vs. 73.1%; and fall, 79.4% vs. 66.6%.

“We know that different seasons can impact asthma severity and control,” Hoyte, who is also an associate professor and director of the allergy and clinical immunology fellowship at National Jewish Health, said in an AAAAI-issued press release. “These promising data confirm that tezepelumab is effective not only regardless of asthma phenotype, but also regardless of the season. For patients with uncontrolled, severe asthma, it is vital to have effective medications that can improve symptoms at all times of year.”

The researchers altered data to align Southern Hemisphere and Northern Hemisphere seasonal data, according to the release.

Reference:

• Tezepelumab reduces asthma exacerbations in patients with severe, uncontrolled asthma regardless of season. https://www.aaaai.org/About/News/News/tezepelumab. Published Feb. 1, 2022. Accessed Feb. 25, 2022.