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Tezepelumab Shows 79% Reduction in Severe Asthma Exacerbations in Real-World Study

• Phase 4 PASSAGE study demonstrates tezepelumab reduced annualized asthma exacerbation rates by 79% in real-world patients with severe asthma after 6 months of treatment.

• The study included diverse patient populations often excluded from clinical trials, including those with COPD and smoking history, with significant benefits observed regardless of perennial allergy status.

• Emergency department visits and hospitalizations decreased dramatically, with up to 95% reduction in patients with clinically relevant perennial allergies and 77% in those without.

The phase 4 PASSAGE study has revealed compelling real-world evidence for tezepelumab's effectiveness in treating severe asthma, showing a 79% reduction in annualized asthma exacerbation rates (AAER) after 6 months of treatment.
Dr. Praveen Akuthota from the University of California, San Diego, will present these findings at the 2025 AAAAI/WAO Joint Congress in San Diego. The results are particularly significant as they represent outcomes from a diverse patient population often excluded from traditional clinical trials.

Real-World Study Design and Patient Population

The PASSAGE trial (NCT05329194) enrolled 116 patients aged 12 years and older with severe asthma who had experienced at least two exacerbations in the previous year. Participants received tezepelumab 210 mg subcutaneously every four weeks for up to 52 weeks.
The study population had a mean age of 53 years, with 65% being female. Notably, the trial included patients typically underrepresented in clinical studies:
  • 42% had clinically relevant perennial allergy (CRPA)
  • 10% had mild-to-moderate chronic obstructive pulmonary disease
  • 18% had a smoking history of at least 10 pack-years

Significant Reduction in Exacerbations

The interim analysis revealed remarkable improvements across different patient subgroups. At baseline, patients with CRPA had an AAER of 4.11, while those without CRPA had an AAER of 3.88. After six months of tezepelumab treatment:
  • Overall AAER reduction: 79% (95% CI, 69-85)
  • Patients with CRPA: 95% reduction in hospitalizations and emergency department visits
  • Patients without CRPA: 77% reduction in hospitalizations and emergency department visits

Clinical Implications

"This interim analysis provides evidence of substantial improvements in AAER and exacerbations requiring hospitalization or emergency care," noted Dr. Akuthota and colleagues. The findings demonstrate tezepelumab's effectiveness regardless of perennial allergy status, making it a promising option for a broad range of severe asthma patients.
Additional research presented at the congress by Dr. Flavia Hoyte from National Jewish Health showed that tezepelumab's efficacy was particularly pronounced in patients with elevated serum IL-5 and IL-13 levels, further supporting its role in personalized asthma treatment approaches.
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