Academic Journal
MELTEMI and COLUMBA: 5-Year Comparative Safety Analysis of Benralizumab and Mepolizumab
| العنوان: | MELTEMI and COLUMBA: 5-Year Comparative Safety Analysis of Benralizumab and Mepolizumab |
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| المؤلفون: | Bourdin, Arnaud, Chupp, Geoffrey, Jackson, David, Cohen, David, Emerath, Ulrika, Shavit, Anat, Kurdyukova, Yulia, Menzies-Gow, Andrew |
| المساهمون: | Physiologie & médecine expérimentale du Cœur et des Muscles U 1046 (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier), Yale University New Haven, Department of Infectious Diseases London, UK (School of Immunology and Microbial Sciences), King‘s College London |
| المصدر: | ISSN: 2213-2198 ; EISSN: 2213-2201. |
| بيانات النشر: | HAL CCSD Elsevier / American Academy of Allergy, Asthma & Immunology / American Academy of Allergy, Asthma and Immunology |
| سنة النشر: | 2024 |
| المجموعة: | Université de Montpellier: HAL |
| مصطلحات موضوعية: | Adverse events, Asthma, Biologic agents, Eosinophils, Injection site adverse reaction, Patient safety, Respiratory infections, [SDV.IMM.ALL]Life Sciences [q-bio]/Immunology/Allergology, [SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapy, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie |
| الوصف: | International audience ; Background: Benralizumab and mepolizumab are interleukin (IL)-5Rα/interleukin-5–targeted monoclonal antibodies indicated as add-on treatments for patients with uncontrolled severe eosinophilic asthma (SEA).Objective: To evaluate and compare the safety of benralizumab and mepolizumab among patients with SEA treated in MELTEMI and COLUMBA open-label, long-term extension studies, respectively.Methods: MELTEMI was an extension study of benralizumab every 4 weeks (q4w) or every 8 weeks (q8w) for adults (aged 18–75 y) with SEA. MELTEMI participants transitioned from the BORA extension, preceded by participation in 1 of 3 placebo-controlled studies (SIROCCO, CALIMA, or ZONDA). COLUMBA was an extension study of mepolizumab for patients (aged ≥ 12 y) with SEA who transitioned from the dose-ranging DREAM study. Safety endpoints were presented as drug exposure patient-years (MELTEMI, q4w 784.28, q8w 797.03; COLUMBA 1,201) for nonserious adverse events, serious adverse events, and infections; malignancies were counted numerically.Results: This analysis included 446 MELTEMI patients (benralizumab q4w 220; benralizumab q8w 226) and 347 COLUMBA patients (mepolizumab q4w). Viral upper respiratory tract infection was the most common nonserious adverse event in both studies (MELTEMI q8w 46.5%; q4w 47.3%; COLUMBA, 48.7%). Asthma-related events were the most common serious adverse events in both studies: MELTEMI 8.0% (q8w) and 8.6% (q4w) and COLUMBA 9.5%. Serious infections included pneumonia (MELTEMI q8w, 2 [0.9%]; COLUMBA, 6 [1.7%]); cellulitis (MELTEMI q8w, 1 [0.4%]; COLUMBA, 2 [0.6%]); and respiratory tract infections (COLUMBA, 2 [0.6%]). COLUMBA reported 6 malignancies and MELTEMI reported 4 malignancies in each group.Conclusions: This analysis demonstrated generally similar safety events between mepolizumab and benralizumab in patients with SEA. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1016/j.jaip.2024.04.033 |
| الاتاحة: | https://hal.science/hal-04561866 https://hal.science/hal-04561866v1/document https://hal.science/hal-04561866v1/file/2024%20Bourdin%20et%20al.,%20MELTEMI%20and%20COLUMBA.pdf https://doi.org/10.1016/j.jaip.2024.04.033 |
| Rights: | info:eu-repo/semantics/OpenAccess |
| رقم الانضمام: | edsbas.493C8DEF |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/j.jaip.2024.04.033 |
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