2026-04-29T02:37:33Zhttps://repisalud.isciii.es/rest/oai/request

oai:repisalud.isciii.es:20.500.12105/231882024-11-28T21:36:22Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16967

00925njm 22002777a 4500 dc Korn, Stephanie author Bourdin, Arnaud author Chupp, Geoffrey author García-Cosío, Borja author Arbetter, Doug author Shah, Mihir author Garcia Gil, Esther author 2021-12 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. 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 Asthma Exacerbation Benralizumab Integrated analysis Eosinophils Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 Years