Real-World Effectiveness of Tezepelumab for Patients with Severe Asthma in the United States: CROSSROADS-3.

BACKGROUND: Tezepelumab was approved in the United States (US) in December 2021 for patients aged 12 years and older with severe asthma. Efficacy has been demonstrated in clinical trials, but real-world evidence of its impact in severe asthma management is more limited. OBJECTIVE: To describe US patients receiving tezepelumab and to assess real-world treatment patterns and outcomes before and after tezepelumab initiation. METHODS: This retrospective, single-arm, self-controlled, observational study analyzed US patients 12 and older with severe asthma who initiated tezepelumab between December 2021 and August 2022 using insurance claims data. The overall cohort included patients with at least two asthma exacerbations in the 12 months prior to initiating tezepelumab. Annualized asthma exacerbation rates (AAER), cumulative oral corticosteroid (OCS) use, and exacerbation-related healthcare resource utilization (HCRU) were compared 12 months pre- and post-tezepelumab initiation. RESULTS: Among tezepelumab recipients (n=321), 45% had received another biologic in the 12 months prior, and among those with available data (n=143), 68% had blood eosinophil count <300 cells/uL. AAER was reduced by 58% (95% confidence interval [CI]: 53%-62%) following tezepelumab initiation. Average annual cumulative OCS dose (prednisone-equivalent) was reduced from 1,295 mg to 770 mg (p < 0.001). Asthma exacerbation-related inpatient, emergency department (ED), and outpatient visits also decreased. Reductions in asthma-related outcomes were seen in biologic-naïve and biologic-experienced cohorts and across multiple clinical subgroups of interest. CONCLUSION: Patients with severe asthma treated with tezepelumab in the first 9 months post US approval experienced meaningful clinical benefits.