Tezepelumab Produces Meaningful AAER Reductions in Real World Asthma Data

Tezepelumab yielded meaningful improvements in annualized asthma exacerbation rate (AAER) after 6 months in real-world data.1

These findings, from the phase 4 multicenter, single-arm, open-label PASSAGE study (NCT05329194, will be presented at the 2025 American Academy of Allergy, Asthma, and Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress, February 28-March 3, in San Diego, California, by Praveen Akuthota, MD, Professor of Clinical Medicine and physician scientist of Pulmonary and Critical Care Medicine at the University of California, San Diego.

“Randomized clinical trials for severe asthma often underrepresent or exclude key patient populations, such as Black/African American patients and those with COPD or a prolonged smoking history,” Akuthota and colleagues wrote, noting that PASSAGE aimed “to assess the effectiveness and safety of tezepelumab in a diverse, real-world population of patients with severe asthma in the USA.”1

PASSAGE enrolled patients of at least 12 years of age with severe asthma who have had at least 2 exacerbations in the past year that were to receive tezepelumab 210 mg subcutaneously Q4W for up to 52 weeks.1

These data, from an interim analysis, are from 116 participants with a mean age of 53 years (standard deviation [SD], 16), 65% of which were female, 42% of which had clinically relevant perennial allergy (CRPA), 10% of which had mild-to-moderate chronic obstructive pulmonary disease (COPD), and 18% of which had a smoking history of at least 10 pack-years.1

Investigators found that there was a 79% (95% CI, 69–85) relative reduction in the AAER in the 6-month follow-up period compared with the 6-month baseline period in patients treated with tezepelumab, at which time participants with CRPA had an AAER of 4.11 and those without CRPA had an AAER of 3.88. Furthermore, in patients treated with tezepelumab, there was a relative reduction of 95% (95% CI, 56–99) in the annualized rate of exacerbations resulting in hospitalization or an emergency department/urgent care visit in patients with CRPA and a relative reduction of 77% (95% CI, 47-90) in those without CRPA from the 6-month baseline period to the 6-month follow-up period.1

“This interim analysis of PASSAGE provides evidence of substantial improvements in the AAER and the annualized rate of exacerbations resulting in hospitalization or an ED/UC visit after 6 months of tezepelumab treatment in patients with severe asthma with or without clinically relevant perennial allergy,” Akuthota and colleagues concluded.1 “The findings demonstrate the real-world effectiveness of tezepelumab, regardless of clinically relevant perennial allergy status.”

Other research on tezepelumab presented at AAAAI, led by Flavia Hoyte, MD, Professor and Director, Allergy & Clinical Immunology Fellowship, Department of Medicine, Division of Allergy & Clinical Immunology, National Jewish Health. found that tezepelumab yielded greater reductions in asthma exacerbations in patients with severe, uncontrolled asthma with elevated serum IL-5 and IL-13 levels than those without elevated levels compared to placebo.2 Read more about this research here.

REFERENCES

1. Akuthota P, Lugogo N, Sumino K, et al. Substantial Reduction In Asthma Exacerbations In Patients With Severe Asthma With Or Without Clinically Relevant Perennial Allergy After 6 Months Of Tezepelumab Use: Interim Results From The Phase 4 PASSAGE Study. Presented at: 2025 AAAAI/WAO Joint Congress, February 28-March 3. Abstract 711

2. Hoyte F, Mathur S, Carr T, et al. Efficacy Of Tezepelumab In Patients With Severe, Uncontrolled Asthma Grouped By Median Baseline Serum IL-5 And IL-13 Levels: Results From The Phase 3 NAVIGATOR Study. Presented at: 2025 AAAAI/WAO Joint Congress, February 28-March 3. Abstract 935