Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 Years
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 tr...
| Autores: | , , , , , , |
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| Formato: | artículo |
| Fecha de publicación: | 2021 |
| País: | España |
| Recursos: | Conselleria de Salut i Consum del Govern de les Illes Balears |
| Repositorio: | Docusalut |
| Idioma: | inglés |
| OAI Identifier: | oai:docusalut.com:20.500.13003/19654 |
| Acesso em linha: | https://hdl.handle.net/20.500.13003/19654 |
| Access Level: | acceso abierto |
| Palavra-chave: | Asthma Disease Progression Eosinophils Anti-Asthmatic Agents Humans Antibodies, Monoclonal, Humanized Double-Blind Method Método Doble Ciego Humanos Antiasmáticos Asma Progresión de la Enfermedad Eosinófilos Anticuerpos Monoclonales Humanizados Exacerbation Benralizumab Integrated analysis |
| Resumo: | 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. (C) 2021 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology. |
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