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.
Search Tips:
- Use the keyword search to search by keyword or author's name.
- Filter your search results by selecting the checkboxes that apply.
- Click on "Clear" to clear the form and start a new search. .
Search results will display below the form.
Integrated Safety and Efficacy Among Patients with Severe Asthma Receiving Benralizumab for Up to Five Years
Session Title
D7 - D007 ADVANCES IN ASTHMA THERAPIES
Abstract
A1205 - Integrated Safety and Efficacy Among Patients with Severe Asthma Receiving Benralizumab for Up to Five Years
Author Block: A. Bourdin1, S. Korn2, G. L. Chupp3, B. Cosio4, D. Arbetter5, M. Shah6, E. Garcia Gil7; 1Département de Pneumologie et Addictologie, PhyMedExp, Université de Montpellier, INSERM, CNRS, Montpellier, France, 2Thoraxklinik Heidelberg and IKF Pneumologie, Mainz, Germany, 3Pulmonary Medicine, Yales Univ Sch of Med, New Haven, CT, United States, 4Hospital Universitario Son Espases-IdISBa, Palma de Mallorca, Spain, 5AstraZeneca, Boston, MA, United States, 6AstraZeneca, Gaithersburg, MD, United States, 7Global Medical Affairs, Astrazeneca, Barcelona, Spain.
Rationale: Benralizumab is an interleukin-5 receptor monoclonal antibody indicated for patients with severe eosinophilic asthma. Previous long-term results are limited to two years. We present results for patients receiving benralizumab up to five years.Methods: This study included adults with asthma receiving medium-to-high dosage inhaled corticosteroids/long-acting β2-agonists (ICS/LABA) at baseline, who completed one of three randomized, double-blind, placebo-controlled benralizumab predecessor studies (SIROCCO [NCT01928771], CALIMA [NCT01914757], ZONDA [NCT02075255]), enrolled in BORA (NCT02258542) for ≥16 and <40 weeks, and subsequently transitioned to the MELTEMI open-label extension study. In predecessor studies, patients received placebo or benralizumab 30 mg SC, either Q4W or Q8W (first three doses Q4W); in BORA, patients receiving placebo were randomized to benralizumab Q4W or Q8W and continued on the same treatment in MELTEMI until benralizumab was commercially available in their local market. Efficacy results are presented for patients with blood eosinophil counts (bEOS) ≥300 cells/μL and receiving high dosage ICS (HD ICS) at baseline (bEOS ≥300 μL/HD ICS); all other results are presented for the overall population.Results: The MELTEMI full analysis set includes 446 patients: N=150 and N=159 patients received benralizumab Q4W or Q8W, respectively, for the duration of treatment, and N=137 patients who received placebo in predecessor studies and were randomized to benralizumab Q4W (placebo/Q4W, N=70) or Q8W (placebo/Q8W, N=67) in BORA. The bEOS ≥300 μL/HD ICS subset included 306 patients: N=105 (Q4W), N=110 (Q8W), N=49 (placebo/Q4W), and N=42 (placebo/Q8W). Baseline characteristics were similar across groups. Overall, 86% of patients completed the study. Mean (SD) benralizumab exposures were 3.9 (0.9), 3.7 (0.9), 3.0 (0.9), and 3.1 (0.8) years for Q4W, Q8W, placebo/Q4W, and placebo/Q8W groups, respectively; among Q4W and Q8W, 16% received benralizumab for ≥5 years. Among patients with bEOS ≥300 μL/HD ICS receiving benralizumab Q8W, annualized exacerbation rates decreased (0.5 to 0.2 exacerbation/year) and the percentage of patients with zero exacerbations increased (from 76% to 87%) from the predecessor study through the open-label treatment period (Figure). Results were similar for patients receiving benralizumab Q4W. Adverse events (AEs), serious AEs, and AEs leading to
discontinuation (event rate per follow-up period) did not increase over time with benralizumab. Serious infection, hypersensitivity, immunogenicity, and malignancy rates were low and similar across all groups.Conclusions: Benralizumab was well-tolerated, the long-term safety profile was consistent with previous Phase 3 studies, and reductions in exacerbations observed during predecessor studies were sustained throughout treatment. There were no new safety signals, including malignancies, hypersensitivities, or opportunistic infections.
Author Block: A. Bourdin1, S. Korn2, G. L. Chupp3, B. Cosio4, D. Arbetter5, M. Shah6, E. Garcia Gil7; 1Département de Pneumologie et Addictologie, PhyMedExp, Université de Montpellier, INSERM, CNRS, Montpellier, France, 2Thoraxklinik Heidelberg and IKF Pneumologie, Mainz, Germany, 3Pulmonary Medicine, Yales Univ Sch of Med, New Haven, CT, United States, 4Hospital Universitario Son Espases-IdISBa, Palma de Mallorca, Spain, 5AstraZeneca, Boston, MA, United States, 6AstraZeneca, Gaithersburg, MD, United States, 7Global Medical Affairs, Astrazeneca, Barcelona, Spain.
Rationale: Benralizumab is an interleukin-5 receptor monoclonal antibody indicated for patients with severe eosinophilic asthma. Previous long-term results are limited to two years. We present results for patients receiving benralizumab up to five years.Methods: This study included adults with asthma receiving medium-to-high dosage inhaled corticosteroids/long-acting β2-agonists (ICS/LABA) at baseline, who completed one of three randomized, double-blind, placebo-controlled benralizumab predecessor studies (SIROCCO [NCT01928771], CALIMA [NCT01914757], ZONDA [NCT02075255]), enrolled in BORA (NCT02258542) for ≥16 and <40 weeks, and subsequently transitioned to the MELTEMI open-label extension study. In predecessor studies, patients received placebo or benralizumab 30 mg SC, either Q4W or Q8W (first three doses Q4W); in BORA, patients receiving placebo were randomized to benralizumab Q4W or Q8W and continued on the same treatment in MELTEMI until benralizumab was commercially available in their local market. Efficacy results are presented for patients with blood eosinophil counts (bEOS) ≥300 cells/μL and receiving high dosage ICS (HD ICS) at baseline (bEOS ≥300 μL/HD ICS); all other results are presented for the overall population.Results: The MELTEMI full analysis set includes 446 patients: N=150 and N=159 patients received benralizumab Q4W or Q8W, respectively, for the duration of treatment, and N=137 patients who received placebo in predecessor studies and were randomized to benralizumab Q4W (placebo/Q4W, N=70) or Q8W (placebo/Q8W, N=67) in BORA. The bEOS ≥300 μL/HD ICS subset included 306 patients: N=105 (Q4W), N=110 (Q8W), N=49 (placebo/Q4W), and N=42 (placebo/Q8W). Baseline characteristics were similar across groups. Overall, 86% of patients completed the study. Mean (SD) benralizumab exposures were 3.9 (0.9), 3.7 (0.9), 3.0 (0.9), and 3.1 (0.8) years for Q4W, Q8W, placebo/Q4W, and placebo/Q8W groups, respectively; among Q4W and Q8W, 16% received benralizumab for ≥5 years. Among patients with bEOS ≥300 μL/HD ICS receiving benralizumab Q8W, annualized exacerbation rates decreased (0.5 to 0.2 exacerbation/year) and the percentage of patients with zero exacerbations increased (from 76% to 87%) from the predecessor study through the open-label treatment period (Figure). Results were similar for patients receiving benralizumab Q4W. Adverse events (AEs), serious AEs, and AEs leading to
discontinuation (event rate per follow-up period) did not increase over time with benralizumab. Serious infection, hypersensitivity, immunogenicity, and malignancy rates were low and similar across all groups.Conclusions: Benralizumab was well-tolerated, the long-term safety profile was consistent with previous Phase 3 studies, and reductions in exacerbations observed during predecessor studies were sustained throughout treatment. There were no new safety signals, including malignancies, hypersensitivities, or opportunistic infections.
