BIOLOGICAL TREATMENT OF SEVERE ASTHMA: A COMPARATIVE ANALYSIS OF TEZEPELUMAB, MEPOLIZUMAB, BENRALIZUMAB, AND DUPILUMAB
DOI:
https://doi.org/10.31435/ijitss.3(51).2026.5868Keywords:
Severe Asthma, Biologic Therapy, Tezepelumab, Mepolizumab, Benralizumab, Dupilumab, Eosinophilic Asthma, Biologic Treatment, Clinical Remission, Monoclonal AntibodiesAbstract
Introduction: Bronchial asthma remains a significant clinical problem despite advances in pharmacological treatment. Approximately 5–10% of asthma patients suffer from a severe, uncontrolled form of the disease associated with frequent exacerbations, impaired lung function, reduced quality of life, and increased hospitalization rates. The introduction of biologic therapies targeting Th2-dependent inflammatory pathways has significantly improved treatment outcomes in this group of patients.
Aim of the Study: The aim of this study was to analyze and compare the efficacy and safety of biologic therapies used in the treatment of severe asthma, with particular emphasis on tezepelumab, mepolizumab, benralizumab, and dupilumab, based on clinical trials and real-world studies.
Materials and Methods: A literature review was conducted using the PubMed database. Original clinical trials, prospective studies, and real-world observational studies published between 2020 and 2026 were included in the analysis. The effects of biologic therapies on asthma exacerbation reduction, improvement in lung function, reduction in oral corticosteroid use, achievement of clinical remission, and long-term treatment safety were evaluated.
Results: All analyzed biologic therapies demonstrated significant clinical efficacy in the treatment of severe asthma. Tezepelumab led to a substantial reduction in the number of exacerbations, improvement in pulmonary function parameters, and reduction in oral corticosteroid use regardless of eosinophil levels. Mepolizumab and benralizumab showed comparable efficacy, particularly in patients with eosinophilic asthma. Dupilumab demonstrated high efficacy in patients with type 2 inflammation, especially regarding improvement in lung function. Real-world studies confirmed the effectiveness and favorable safety profile of biologic therapies observed in randomized clinical trials.
Conclusions: Biologic therapies constitute an effective and safe treatment option for severe asthma and significantly improve disease control and patients’ quality of life. The strongest clinical evidence concerns tezepelumab, mepolizumab, benralizumab, and dupilumab; however, treatment efficacy may depend on the disease phenotype and inflammatory biomarkers. Further studies are needed to optimize the personalization of biologic therapies and to standardize remission criteria in severe asthma.
References
Jackson, D. J., Lugogo, N. L., Gurnell, M., Heaney, L. G., Korn, S., Brusselle, G., Chanez, P., del Olmo, R., Llanos, J.-P., Keeling, N., Sałapa, K., Cook, B., Parulekar, A. D., Kostikas, K., Fogel, R., Martin, N., & Chandarana, S. N. (2026). Oral corticosteroid reduction and discontinuation in adults with corticosteroid-dependent, severe, uncontrolled asthma treated with tezepelumab (WAYFINDER): A multicentre, single-arm, phase 3b trial. The Lancet Respiratory Medicine, 14, 129–140. https://doi.org/10.1016/S2213-2600(25)00359-5
Maspero, J. F., Cardona, G., Schonffeldt, P., Tolcachier, A., González-Diaz, S. N., Yañez, A., Galvao, C. E., Msihid, J., Gall, R., Siddiqui, S., Rowe, P. J., Deniz, Y., Jacob-Nara, J. A., & Djandji, M. (2023). Dupilumab efficacy and safety in Latin American patients with uncontrolled, moderate-to-severe asthma: Phase 3 LIBERTY ASTHMA QUEST study. Journal of Asthma, 60(5), 981–990. https://doi.org/10.1080/02770903.2022.2115927
Real-world comparative effectiveness of biologic therapies in severe asthma: EU-ADVANTAGE. (2024). European Respiratory Journal. Advance online publication.
Clinical remission in severe asthma: A comparative analysis of patients with and without biologics from the Swiss Severe Asthma Registry. (2025). Biomedicines, 13, 3074. https://doi.org/10.3390/biomedicines13123074
Papi, A., Chipps, B. E., Beasley, R., Panettieri, R. A., Jr., Israel, E., Cooper, M., Dunsire, L., Jeynes-Ellis, A., Johnsson, E., Rees, R., Cappelletti, C., & Albers, F. C. (2022). Albuterol–budesonide fixed-dose combination rescue inhaler for asthma. The New England Journal of Medicine, 386(22), 2071–2083. https://doi.org/10.1056/NEJMoa2203163
Erroz Ferrer, M., Paniagua García, M., Sánchez, N. V., & Moreno-Galarraga, L. (2025). The role of biologic therapy switching to optimize the treatment of severe pediatric asthma: Tezepelumab is a new therapeutic alternative for adolescents. Children, 12(8), 1092. https://doi.org/10.3390/children12081092
Kayser, M. Z., Suhling, H., Fuge, J., Hinze, C. A., Drick, N., Kneidinger, N., Behr, J., Taube, C., Welte, T., Haasler, I., & Milger, K. (2024). Long-term multicenter comparison shows equivalent efficacy of monoclonal antibodies in severe asthma therapy. BMC Pulmonary Medicine, 24, 149. https://doi.org/10.1186/s12890-024-02964-4
Bonato, M., Savoia, F., Orzes, E., Favero, E., Senna, G., & Romagnoli, M. (2025). Mepolizumab-related blood eosinophil decreases are associated with clinical remission in severe asthmatic patients: A real-world study. Antibodies, 14(3), 61. https://doi.org/10.3390/antib14030061
Kim, M.-A., Lee, J.-H., Kim, E.-K., Kim, J.-H., Park, J., Lee, S. H., & Kim, T.-B. (2026). Effectiveness of low-dose mepolizumab in refractory eosinophilic granulomatosis with polyangiitis: Systemic steroid use and remission. Korean Journal of Internal Medicine, 41, 163–174. https://doi.org/10.3904/kjim.2025.130
Ramakrishnan, S., Russell, R. E. K., Mahmood, H. R., Krassowska, K., Melhorn, J., Mwasuku, C., Pavord, I. D., Bermejo-Sanchez, L., Howell, I., Mahdi, M., Peterson, S., Bengtsson, T., & Bafadhel, M. (2025). Treating eosinophilic exacerbations of asthma and COPD with benralizumab (ABRA): A double-blind, double-dummy, active placebo-controlled randomised trial. The Lancet Respiratory Medicine, 13, 59–68. https://doi.org/10.1016/S2213-2600(24)00299-6
Bourdin, A., Chupp, G., Jackson, D. J., Cohen, D., Emerath, U., Shavit, A., Kurdyukova, Y., & Menzies-Gow, A. (2024). MELTEMI and COLUMBA: 5-year comparative safety analysis of benralizumab and mepolizumab. The Journal of Allergy and Clinical Immunology: In Practice. Advance online publication. https://doi.org/10.1016/j.jaip.2024.04.033
Okuducu, Y. K., & Kinane, T. B. (2025). Biologic therapies in severe asthma: Current landscape, clinical evidence, and future directions. Current Pediatrics Reports, 13, 38. https://doi.org/10.1007/s40124-025-00373-7
Korn, S., Bourdin, A., Chupp, G., Cosio, B. G., Arbetter, D., Shah, M., & Garcia Gil, E. (2021). Integrated safety and efficacy among patients receiving benralizumab for up to 5 years. The Journal of Allergy and Clinical Immunology: In Practice, 9(12), 4381–4392. https://doi.org/10.1016/j.jaip.2021.07.058
Lupia, C., Battaglia, C., Pastore, D., Lee, Y., Piazzetta, G. L., Chiarella, E., Lobello, N., Sireno, G., Pullano, A., Crimi, C., Vatrella, A., Manti, F., Arcuri, P. P., Laganà, D., Pelaia, G., & Pelaia, C. (2026). Tezepelumab in severe asthma: Chest computed tomography assessment of airway remodeling and clinical remission. Frontiers in Pharmacology, 17, 1757754. https://doi.org/10.3389/fphar.2026.1757754
Crimi, C., Nolasco, S., Noto, A., Maglio, A., Quaranta, V. N., Di Bona, D., Scioscia, G., Papi, F., Caiaffa, M. F., Calabrese, C., D’Amato, M., Pelaia, C., Campisi, R., Vitale, C., Ciampo, L., Dragonieri, S., Minenna, E., Massaro, F., Gallotti, L., … Crimi, N. (2024). Long-term clinical and sustained REMIssion in severe eosinophilic asthma treated with mepolizumab: The REMI-M study. The Journal of Allergy and Clinical Immunology: In Practice. Advance online publication. https://doi.org/10.1016/j.jaip.2024.08.033
Kobayashi, K., Nagase, H., Sugimoto, N., Yamamoto, S., Tanaka, A., Fukunaga, K., Atsuta, R., Tagaya, E., Hojo, M., & Gon, Y. (2021). Mepolizumab decreased the levels of serum galectin-10 and eosinophil cationic protein in asthma. Asia Pacific Allergy, 11(3), e31. https://doi.org/10.5415/apallergy.2021.11.e31
Laorden, D., Hernández, I., Domínguez-Ortega, J., Romero, D., Álvarez-Sala, R., & Quirce, S. (2024). A real-life cohort of mepolizumab treatment in severe eosinophilic asthma. European Annals of Allergy and Clinical Immunology, 56(4), 169–175. https://doi.org/10.23822/EurAnnACI.1764-1489.289
Jesenak, M., Vanecek, V., Ondrusova, M., Urdova, V., Dostalova, K., & Hochmuth, L. (2023). Real-world outcomes of mepolizumab treatment in severe eosinophilic asthma patients—Retrospective cohort study in Slovakia. Biomedical Papers of the Medical Faculty of the University Palacky, Olomouc, Czech Republic, 167(3), 272–280. https://doi.org/10.5507/bp.2023.029
Menzies-Gow, A., Ambrose, C. S., Colice, G., Hunter, G., Cook, B., Molfino, N. A., Llanos, J.-P., & Israel, E. (2023). Effect of tezepelumab on lung function in patients with severe, uncontrolled asthma in the phase 3 NAVIGATOR study. Advances in Therapy, 40, 4957–4971. https://doi.org/10.1007/s12325-023-02659-y
Izumo, T., Tone, M., Kuse, N., Awano, N., Tanaka, A., Jo, T., Yoshimura, H., Minami, J., Takada, K., & Inomata, M. (2020). Effectiveness and safety of benralizumab for severe asthma in clinical practice (J-BEST): A prospective study. Annals of Translational Medicine, 8(7), 438. https://doi.org/10.21037/atm.2020.04.01
Menzies-Gow, A., Corren, J., Bourdin, A., Chupp, G., Israel, E., Wechsler, M. E., Brightling, C. E., Griffiths, J. M., Hellqvist, Å., Bowen, K., Colice, G., Acosta, G., Ponnarambil, S., Kaur, P., & Pavord, I. D. (2021). Tezepelumab in adults and adolescents with severe, uncontrolled asthma. The New England Journal of Medicine, 384(19), 1800–1809. https://doi.org/10.1056/NEJMoa2034975
Gates, J., Haris, F., Cefaloni, F., Khooshemehri, P., Green, L., Fernandes, M., Thomson, L., Roxas, C., Lam, J., d’Ancona, G., Nanzer, A. M., Dhariwal, J., & Jackson, D. J. (2025). Clinical and biological remission with tezepelumab: The real-world response in severe uncontrolled asthma. Allergy, 80, 1669–1676. https://doi.org/10.1111/all.16590
Pelaia, C., Greco, M., Iaccino, E., Crimi, C., Biafora, M., Dragone, F., Vatrella, A., & Pelaia, G. (2025). Short-term therapeutic effectiveness of tezepelumab in patients with severe asthma: A real-world study. International Immunopharmacology, 162, 115185. https://doi.org/10.1016/j.intimp.2025.115185
Corren, J., Garcia Gil, E., Griffiths, J. M., Parnes, J. R., van der Merwe, R., Sałapa, K., & O’Quinn, S. (2021). Tezepelumab improves patient-reported outcomes in patients with severe, uncontrolled asthma in PATHWAY. Annals of Allergy, Asthma & Immunology, 126(2), 187–193. https://doi.org/10.1016/j.anai.2020.10.008
Lin, F., Yu, B., Deng, B., & He, R. (2023). The efficacy and safety of tezepelumab in the treatment of uncontrolled asthma: A systematic review and meta-analysis of randomized controlled trials. Medicine, 102(32), e34746. https://doi.org/10.1097/MD.0000000000034746
Akenroye, A., Lassiter, G., Jackson, J. W., Keet, C., Segal, J., Alexander, G. C., & Hong, H. (2022). Comparative efficacy of mepolizumab, benralizumab, and dupilumab in eosinophilic asthma: A Bayesian network meta-analysis. Journal of Allergy and Clinical Immunology, 150(5), 1097–1105.e12. https://doi.org/10.1016/j.jaci.2022.05.024
Kyriakopoulos, C., Gogali, A., Markozannes, G., & Kostikas, K. (2024). Biologic agents licensed for severe asthma: A systematic review and meta-analysis of randomised controlled trials. European Respiratory Review, 33, 230238. https://doi.org/10.1183/16000617.0238-2023
Xiao, Q., Huang, Y., Xue, B., & Wang, M. (2025). The efficacy and safety of biologics for patients with severe asthma: An umbrella review of systematic reviews and meta-analyses. Frontiers in Medicine, 12, 1573596. https://doi.org/10.3389/fmed.2025.1573596
Charles, D., Shanley, J., Temple, S.-N., Rattu, A., Khaleva, E., & Roberts, G. (2022). Real-world efficacy of treatment with benralizumab, dupilumab, mepolizumab and reslizumab for severe asthma: A systematic review and meta-analysis. Clinical & Experimental Allergy, 52(5), 616–627. https://doi.org/10.1111/cea.14112
Kearney, C. M., Sangani, R., Shankar, D., O’Connor, G. T., Law, A. C., Walkey, A. J., & Bosch, N. A. (2024). Comparative effectiveness of mepolizumab, benralizumab, and dupilumab among patients with difficult-to-control asthma: A multicenter retrospective propensity-matched analysis. Annals of the American Thoracic Society, 21(6), 866–874. https://doi.org/10.1513/AnnalsATS.202306-566OC
Downloads
Published
Issue
Section
License
Copyright (c) 2026 Agnieszka Filarecka, Piotr Przybyszewski, Emilia Przybyszewska, Julia Gatniejewska , Martyna Sienicka , Paulina Prudzic, Weronika Winiarska, Wiktoria Bełcikowska-Skowron, Aleksandra Siegmund, Marzena Chrapczyńska

This work is licensed under a Creative Commons Attribution 4.0 International License.
All articles are published in open-access and licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0). Hence, authors retain copyright to the content of the articles.
CC BY 4.0 License allows content to be copied, adapted, displayed, distributed, re-published or otherwise re-used for any purpose including for adaptation and commercial use provided the content is attributed.

