2026-04-29T02:37:38Zhttps://repisalud.isciii.es/rest/oai/requestoai:repisalud.isciii.es:20.500.12105/231882024-11-28T21:36:22Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16967
Repisalud
author
Korn, Stephanie
author
Bourdin, Arnaud
author
Chupp, Geoffrey
author
García-Cosío, Borja
author
Arbetter, Doug
author
Shah, Mihir
author
Garcia Gil, Esther
2024-09-18T06:42:17Z
2024-09-18T06:42:17Z
2021-12
Korn S, Bourdin A, Chupp G, Cosio BG, Arbetter D, Shah M, et al. Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 Years. J Allergy Clin Immunol-Pract. 2021 Dec;9(12):4381.e4-92. Epub 2021 Sep 4.
2213-2198
https://hdl.handle.net/20.500.13003/19654
https://hdl.handle.net/20.500.12105/23188
34487870
10.1016/j.jaip.2021.07.058
2213-2201
Journal of Allergy and Clinical Immunology in Practice
2-s2.0-85115981870
729499700028
L2014768505
BACKGROUND: Benralizumab is an IL-5R alpha-directed monoclonal antibody indicated for patients with severe, uncontrolled eosinophilic asthma. OBJECTIVE: To evaluate the long-term safety and tolerability of benralizumab among adults treated for up to 5 years. METHODS: This analysis included adults treated with placebo or subcutaneous benralizumab 30 mg every 4 or 8 weeks in the 48-week SIROCCO, 56-week CALIMA, and 28-week ZONDA pivotal trials, who were subsequently enrolled in the 56-week double-blind BORA extension and continued assigned regimens or initiated benralizumab (if previously on placebo) for 16 to 40 weeks, before entering the open-label MELTEMI extension. Safety was measured by adverse and serious adverse event rates. Exacerbations were evaluated in patients with blood eosinophils greater than or equal to 300 cells/mu L receiving high-dose inhaled corticosteroids at baseline. RESULTS: Overall, 446 received treatment and 384 (86.1%) completed the study; 157 (35.2%) received benralizumab for 4 or more years. Adverse and serious adverse event rates (28.5-32.4 and 6.3-8.4 per 100 patient-years, respectively) were low, stable over time, and did not increase with exposure; few (n = 8) discontinued because of adverse events. Serious infections and hypersensitivity event rates were consistent with those in previous studies. Among patients with blood eosinophils greater than or equal to 300 cells/mu L-high-dosage inhaled corticosteroids receiving benralizumab every 8 weeks, at least 75% had zero exacerbations annually during the integrated analysis period. CONCLUSIONS: In patients with severe, uncontrolled eosinophilic asthma, long-term benralizumab was safe and well tolerated for up to 5 years. There were no new safety signals, and exacerbations were eliminated in similar percentages of patients as in predecessor studies.
eng
Asthma
Exacerbation
Benralizumab
Integrated analysis
Eosinophils
Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 Years
research article