Stephanie Korn1, Arnaud Bourdin2, Geoffrey Chupp3, Borja G Cosio4, Doug Arbetter5, Mihir Shah6, Esther Garcia Gil7. 1. Thoraxklinik Heidelberg and IKF Pneumologie, Heidelberg and Mainz, Germany. Electronic address: korn@ikf-pneumologie.de. 2. PhyMedExp, Université de Montpellier, INSERM, CNRS, Département de Pneumologie et Addictologie, CHU de Montpellier, Montpellier, France. 3. Yale University, New Haven, Conn. 4. Hospital Universitario Son Espases-IdISBa-CIBERES, Palma de Mallorca, Spain. 5. AstraZeneca and Cytel Inc, Waltham, Mass. 6. AstraZeneca, Gaithersburg, Md. 7. AstraZeneca, Barcelona, Spain.
Abstract
BACKGROUND: Benralizumab is an IL-5Rα-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/μL 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/μL-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.
BACKGROUND: Benralizumab is an IL-5Rα-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/μL 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/μL-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.
Authors: Andrew Menzies-Gow; Flavia L Hoyte; David B Price; David Cohen; Peter Barker; James Kreindler; Maria Jison; Christopher L Brooks; Peggy Papeleu; Rohit Katial Journal: Adv Ther Date: 2022-03-14 Impact factor: 4.070
Authors: Charles H R Francis; Andrew P Hearn; Sharenja Ratnakumar; Alexander Taylor; Jordan Duckitt; Usmaan Ahmed; Jaideep Dhariwal; Alexandra M Nanzer; David J Jackson Journal: Allergy Date: 2022-05-11 Impact factor: 14.710
Authors: Maria D'Amato; Francesco Menzella; Elena Altieri; Elena Bargagli; Pietro Bracciale; Luisa Brussino; Maria Filomena Caiaffa; Giorgio Walter Canonica; Cristiano Caruso; Stefano Centanni; Fausto De Michele; Fabiano Di Marco; Elide Anna Pastorello; Girolamo Pelaia; Paola Rogliani; Micaela Romagnoli; Pietro Schino; Gianenrico Senna; Alessandra Vultaggio; Alessandra Ori; Lucia Simoni; Silvia Boarino; Gianfranco Vitiello; Maria Aliani; Stefano Del Giacco Journal: Front Allergy Date: 2022-05-18