PASSAGE Study Expands Tezepelumab Data in Severe Asthma: Njira L. Lugogo, MD, MS

Real-world clinical trial data from PASSAGE (NCT05329194), assessing the safety and efficacy of tezepelumab (Tezspire; AstraZeneca) in patients with severe asthma, included underrepresented populations, often omitted from clinical studies.¹

Data presented at the American Thoracic Society 2026 International Conference in Orlando, Florida, in the abstract “Tezepelumab in Diverse Real-World Patients With Severe Asthma Across Different Phenotypes and Underrepresented Populations: Final Results from the US Phase 4 PASSAGE Study” emphasized the importance of including underrepresented populations, especially within asthma clinical trials.²

The real-world cohort included phenotypes of patients with severe uncontrolled asthma, like those with comorbid chronic obstructive pulmonary disease (COPD) or those who smoke. Additional underrepresented populations highlighted in the abstract include African-American patients, those with blood eosinophil counts greater or less than 300, and adolescents. These findings can potentially expand clinical expertise when treating this particular patient subtype and have increased the number of therapies available to them.

In an interview with The American Journal of Managed Care^®, Njira Lugogo, MD, MS, lead study author and the director of the Division of Pulmonary & Critical Care Medicine's Asthma Program at the University of Michigan Health, said that the biologics like tezepelumab tested in clinical trials often work better in real-world evidence because of the larger patient population.

“Because we’re able to have people who, for example, have more normal lung function…who are not quite as sick, or maybe too sick,” she said. “So, we’re really able to detect signals there, and that’s why [this study] is so important.”

Even minimal changes in lung function can be viewed as improvement, especially when patients measure their therapy’s success by how it improves their quality of life, Lugogo continued.

“If you can reduce exacerbations or improve lung function, but the patient didn’t really perceive a benefit, they’re highly unlikely to want to continue the treatment,” she said. “So, it’s really important to see an effect on their quality-of-life measure and reassure the patient that the treatment is going to improve not only exacerbations and lung function but also help them to have a better quality of life.”

References

1. Effectiveness and safety study of tezepelumab in adults & adolescent participants with severe asthma in the United States (PASSAGE). ClinicalTrials.gov. Last updated October 14, 2025. Accessed May 18, 2026. https://clinicaltrials.gov/study/NCT05329194
2. Lugogo NL, Akuthota P, Sumino K, et al. Tezepelumab in diverse real-world patients with severe asthma across different phenotypes and underrepresented populations: final results from the US phase 4 PASSAGE study. Presented at: American Thoracic Society 2026 International Conference. May 17-20, 2026; Orlando, Florida. Poster P1428