Long-Term Eosinophil Depletion: A Real-World Perspective on the Safety and Durability of Benralizumab Treatment in Severe Eosinophilic Asthma
Year: 2024
Type: article
Study design: Observational Study
Abstract: Background/Objectives: Benralizumab is an anti-IL-5 receptor alpha monoclonal antibody that induces near-complete depletion of eosinophils. This study aimed to evaluate the long-term safety and effectiveness of benralizumab in patients with severe eosinophilic asthma (SEA) over a 48-month period. Methods: This was a single-arm, retrospective, observational, multicenter study involving 123 SEA patients treated with benralizumab at a dosage of 30 mg every 4 weeks for the first three doses and then every 8 weeks. The safety endpoints focused on the frequency and nature of adverse events and the likelihood that they were induced by benralizumab. The efficacy endpoints focused on lung function, asthma exacerbations and control, and oral corticosteroid use. Results: Benralizumab, consistent with its mechanism of action, led to rapid and nearly complete depletion of eosinophils. In total, 26 adverse events (21.1%) were observed, with 1.6% related to the treatment and 0.8% categorized as serious (vagal hypotension). Bronchitis was the most common unrelated adverse event (15.4%), occurring between months 36 and 38. Of note, benralizumab maintained its effectiveness over the 48-month period, resulting in significant improvements in lung function and reductions in oral corticosteroid use and exacerbation frequency. Conclusions: Benralizumab demonstrated a favorable safety profile comparable to previously published studies with perdurable effectiveness in controlling SEA and reducing oral corticosteroid use. Finally, this study provides evidence that near-complete eosinophil depletion does not increase long-term safety risks and supports benralizumab as a reliable treatment option for SEA patients.
Source: Journal of Clinical Medicine
DOI: 10.3390/jcm14010191
Authors: Francesco Menzella, Mariarita Marchi, Marco Caminati, Micaela Romagnoli, Claudio Micheletto, Matteo Bonato, Giuseppe Idotta, Manuele Nizzetto, Giuseppina D’Alba, Massimiliano Cavenaghi, Michela Bortoli, Bianca Beghè, Laura Pini, Roberto Benoni, Gianluca Casoni, Rodolfo Muzzolon, Lucio Michieletto, Annamaria Bosi, Andrea Mastrototaro, Adela Diamandi, Mara Nalin, Gianenrico Senna
Institutions: AULSS 2 Marca Trevigiana, University of Verona, Ca' Foncello Hospital, Azienda Ospedaliera Universitaria Integrata Verona, Ospedale San Bortolo, University of Modena and Reggio Emilia, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Istituto Superiore di Sanità, Sapienza University of Rome, Ospedale Santa Maria della Misericordia di Rovigo, Azienda ULSS n. 1 Dolomiti, Ospedale dell' Angelo
Language: English
Subfield: Physiology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,955
Funder: AstraZeneca
OpenAlex ID: W4405942305
