Description
Clinical trials of severe asthma therapies often exclude or underrepresent key patient populations.To evaluate the effectiveness and safety of tezepelumab in a diverse, real-world U.S. population with severe, uncontrolled asthma (SUA).PASSAGE was a phase 4, multicenter, single-arm, open-label, 12-month study enrolling patients with SUA (≥12 years old), including different phenotypes (blood eosinophil count ≥/Among 286 participants, AAER decreased 70% (95% CI: 63, 75) from 2.88 (baseline period) to 0.87 (treatment period) and by 54-77% across phenotypes and underrepresented populations. At week 52, least-squares mean pre-bronchodilator FEV1 increased from baseline by 0.122 L (95% CI: 0.07, 0.17) overall and by 0.212 L (95% CI: 0.15, 0.28) among participants with percent predicted pre-bronchodilator FEV1 ≤ 80% at baseline. Clinically meaningful improvements in Asthma Control Questionnaire-6, Asthma Impairment and Risk Questionnaire, and St George's Respiratory Questionnaire scores were observed in 51-91% of participants across phenotypes and underrepresented populations at week 52. No new safety signals were identified.The PASSAGE study of a diverse, real-world U.S. population with SUA treated with tezepelumab demonstrated substantial reductions in asthma exacerbations across phenotypes and underrepresented populations, and clinically meaningful improvements in lung function, asthma control, and health-related quality of life.Clinical trial registered with www.clinicaltrials.gov (NCT05329194).
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