The drug tezepelumab has been shown to significantly reduce exacerbations in patients with severe asthma in clinical trials. Now, new research presented at the 2026 ATS International Conference shows it is safe and effective in real patients as well. “Tezepelumab in real-world US patients with severe asthma across phenotypes and underrepresented populations: the Phase 4 PASSAGE study” American Journal of Respiratory and Critical Care Medicine Online on May 18th.
PASSAGE found that tezepelumab was associated with better outcomes in smokers, patients with coexisting asthma and COPD, adolescents, and black/African American patients, all groups typically excluded or underrepresented in clinical trials.
The premise of PASSAGE was to focus on underrepresented populations and gather more evidence so that tezepelumab could be used with more confidence in these patients. The results of this study were really reassuring in terms of both safety and efficacy. ”
Dr. Njira Lugogo, first author, Professor of Clinical Medicine, Department of Respiratory and Critical Care Medicine, University of Michigan
Tezepelumab is a monoclonal antibody therapy approved in 2021 for the treatment of severe asthma. PASSAGE was designed as a Phase 4 multicenter clinical trial to evaluate use in a broader patient population.
Researchers enrolled 286 adults and adolescents in the study, and patients were treated for 12 months. Tezepelumab reduced asthma exacerbations in patients by 70%, with benefits observed in all patient subgroups. Other outcomes include improved lung function, better asthma control, higher quality of life scores, and reduced dependence on systemic corticosteroids for symptom management.
The treatment was safe and had no new or unexpected side effects. In qualitative interviews, patients reported that they were satisfied with their treatment.
Dr. Lugogo noted that although the drug reduced exacerbations in all asthma phenotypes, it was particularly effective in patients with type 2 asthma, a common and severe subtype caused by systemic inflammation.
She was also encouraged to learn that tezepelumab is effective in patients with other factors that affect lung function.
“It was effective for smokers and people with COPD,” she says. “This was very important to me because I see these patients in a clinical setting and wanted to be confident that treatment with tezepelumab would be successful.”
Treatment options are critically needed for patients whose asthma and COPD overlap, as they tend to have more severe symptoms and more complications, he said. Still, these patients are often “orphaned” by research, Dr. Lugogo added.
“In clinical trials, they’re always excluded. They’re excluded from asthma studies, they’re excluded from COPD studies,” she said.
While controlled clinical trials remain the gold standard in research, PASSAGE highlights the importance of studying underrepresented populations, she added.
“Real-world evidence is very important,” she said.
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American Thoracic Society
