Tezepelumab reduces asthma exacerbations in diverse patient population

The drug tezepelumab was shown to significantly reduce exacerbations in people with severe asthma in clinical trials. Now, a new study presented at the 2026 ATS International Conference shows that it is also safe and effective in real-world patients. "Tezepelumab in Real-World U.S. Patients with Severe Asthma Across Phenotypes and Underrepresented Populations: The Phase 4 PASSAGE Study" will be published in the American Journal of Respiratory and Critical Care Medicine online on May 18.

PASSAGE found that tezepelumab was linked with better outcomes in smokers, patients with overlapping asthma and COPD, as well as adolescents and Black/African American patients - all groups that are typically excluded from or underrepresented in clinical trials.

The premise of PASSAGE was to focus on underrepresented populations, and to gather more evidence so that we can be more confident in using tezepelumab in these patients. The study results were really reassuring in terms of both safety and efficacy."

Njira Lugogo, MD, first author, clinical professor of medicine in the Division of Pulmonary 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 its use in a broader patient population.

Researchers enrolled 286 adults and adolescents in the study, and patients were treated for 12 months. Patients had 70 percent fewer asthma exacerbations with tezepelumab, a benefit observed across all patient subgroups. Other outcomes included improved lung function, better asthma control, higher quality of life scores, and less reliance on systemic corticosteroids to manage symptoms.

The therapy was safe, with no new or unexpected side effects. In qualitative interviews, patients reported being satisfied with the treatment.

Dr. Lugogo noted that the drug reduced exacerbations in all asthma phenotypes but was particularly effective in patients with Type 2 asthma, a common and severe subtype driven by systemic inflammation.

She was also encouraged to see that tezepelumab was effective in patients with other factors impacting their lung function.

"It worked well in smokers and people with comorbid COPD," she said. "That was very important to me, because I see these patients in clinical practice, and I wanted to feel confident that treating them with tezepelumab would be successful."

There is a significant need for treatment options for patients with overlapping asthma and COPD, who tend to be sicker and have more complications, she said. And yet these patients are often "orphaned" by research, added Dr. Lugogo.

"In clinical trials, they're always excluded - they're excluded from asthma studies, and they're excluded from COPD studies," she said.

While controlled clinical trials remain the gold standard of research, PASSAGE highlights the importance of studying underrepresented populations, she added.

"Real-world evidence is extremely important," she said.