ATS 2021 will feature presentations of original research from accepted abstracts. Mini Symposia and Thematic Poster Sessions are abstract based sessions.
Please use the form below to browse scientific abstracts and case reports accepted for ATS 2021. Abstracts presented at the ATS 2021 will be published in the Online Abstract Issue of the American Journal of Respiratory and Critical Care Medicine, Volume 203, May 3, 2021.
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Real-World Effectiveness of Benralizumab on Asthma Exacerbations: Results from the ZEPHYR 1 Study
Session Title
TP15 - TP015 UPDATES IN ADHERENCE AND TREATMENT OF LUNG DISEASE
Abstract
A1612 - Real-World Effectiveness of Benralizumab on Asthma Exacerbations: Results from the ZEPHYR 1 Study
Author Block: D. D. Carstens1, R. Katial1, J. Young2, E. E. Cook2, F. Mu2, K. A. Betts3, D. Yang2, Y. Chung1; 1AstraZeneca, Wilmington, DE, United States, 2Analysis Group, Inc, Boston, MA, United States, 3Analysis Group, Inc, Los Angeles, CA, United States.
Rationale: Although randomized clinical trials have demonstrated the impact of benralizumab on reducing asthma exacerbations, there are few studies describing the impact of benralizumab on asthma exacerbations in a real-world setting. This is one of the first studies to characterize US patients taking benralizumab in a real-world setting and to identify the impact on asthma exacerbations. Methods: This retrospective cohort study utilized data from a large medical and pharmacy claims data source between November 2016 and November 2019. A pre-post design was implemented, in which the index date was the day after benralizumab initiation. Eligible patients initiating benralizumab were diagnosed with asthma, aged ≥12 years at index, biologic-naïve in the pre-index period, had 24 months of continuous insurance enrollment, and had ≥2 asthma exacerbations in the pre-index period. The primary cohort focused on patients with ≥2 records of benralizumab, and a secondary cohort examined persistent benralizumab users (≥6 records of benralizumab including the index record in the 12 months post-index). Asthma exacerbations in the 12-month periods pre- and post-index were analyzed and compared using generalized estimating equations. Results: Among the 204 patients in the primary cohort with ≥2 records of benralizumab, the mean age at index was 45.3 years old, 68.6% were female, 45.1% had commercial medical insurance, and 40.7% had Medicaid. The most common pre-index comorbidities included allergic rhinitis (77.5%), mental disorders (49.5%), and hypertension (45.6%). Additionally, 33.8% of patients had chronic sinusitis, 30.9% of patients had chronic obstructive pulmonary disease, and 16.7% of patients had nasal polyps. Almost all patients used oral corticosteroids at some point during the pre-index period (99.0%), and the majority of patients had also used inhaled corticosteroids with long-acting beta-agonists (77.9%) and leukotriene modifiers (83.3%). The rate of asthma exacerbations decreased with statistical significance from 3.25 exacerbations per person-year in the pre-index period to 1.47 exacerbations per person-year in the post-index period, representing a 55% reduction (p<0.001) (Figure). Furthermore, 41% of patients had no exacerbations in the post-index period. Greater exacerbation reductions were observed among persistent benralizumab users (n=103), with a statistically significant 62% reduction (3.23 asthma exacerbations per person-year pre-index to 1.23 asthma exacerbations per person-year post-index, p<0.001), and 43% of patients had no exacerbations in the post-index period. Conclusion: Patients treated with benralizumab in this real-world analysis experienced a significant reduction in asthma exacerbations consistent with the reduction observed in the pivotal randomized clinical trials of benralizumab.
Author Block: D. D. Carstens1, R. Katial1, J. Young2, E. E. Cook2, F. Mu2, K. A. Betts3, D. Yang2, Y. Chung1; 1AstraZeneca, Wilmington, DE, United States, 2Analysis Group, Inc, Boston, MA, United States, 3Analysis Group, Inc, Los Angeles, CA, United States.
Rationale: Although randomized clinical trials have demonstrated the impact of benralizumab on reducing asthma exacerbations, there are few studies describing the impact of benralizumab on asthma exacerbations in a real-world setting. This is one of the first studies to characterize US patients taking benralizumab in a real-world setting and to identify the impact on asthma exacerbations. Methods: This retrospective cohort study utilized data from a large medical and pharmacy claims data source between November 2016 and November 2019. A pre-post design was implemented, in which the index date was the day after benralizumab initiation. Eligible patients initiating benralizumab were diagnosed with asthma, aged ≥12 years at index, biologic-naïve in the pre-index period, had 24 months of continuous insurance enrollment, and had ≥2 asthma exacerbations in the pre-index period. The primary cohort focused on patients with ≥2 records of benralizumab, and a secondary cohort examined persistent benralizumab users (≥6 records of benralizumab including the index record in the 12 months post-index). Asthma exacerbations in the 12-month periods pre- and post-index were analyzed and compared using generalized estimating equations. Results: Among the 204 patients in the primary cohort with ≥2 records of benralizumab, the mean age at index was 45.3 years old, 68.6% were female, 45.1% had commercial medical insurance, and 40.7% had Medicaid. The most common pre-index comorbidities included allergic rhinitis (77.5%), mental disorders (49.5%), and hypertension (45.6%). Additionally, 33.8% of patients had chronic sinusitis, 30.9% of patients had chronic obstructive pulmonary disease, and 16.7% of patients had nasal polyps. Almost all patients used oral corticosteroids at some point during the pre-index period (99.0%), and the majority of patients had also used inhaled corticosteroids with long-acting beta-agonists (77.9%) and leukotriene modifiers (83.3%). The rate of asthma exacerbations decreased with statistical significance from 3.25 exacerbations per person-year in the pre-index period to 1.47 exacerbations per person-year in the post-index period, representing a 55% reduction (p<0.001) (Figure). Furthermore, 41% of patients had no exacerbations in the post-index period. Greater exacerbation reductions were observed among persistent benralizumab users (n=103), with a statistically significant 62% reduction (3.23 asthma exacerbations per person-year pre-index to 1.23 asthma exacerbations per person-year post-index, p<0.001), and 43% of patients had no exacerbations in the post-index period. Conclusion: Patients treated with benralizumab in this real-world analysis experienced a significant reduction in asthma exacerbations consistent with the reduction observed in the pivotal randomized clinical trials of benralizumab.
