222
Views
0
CrossRef citations to date
0
Altmetric
ORIGINAL RESEARCH

Sustained Effectiveness of Benralizumab in Naïve and Biologics-Experienced Severe Eosinophilic Asthma Patients: Results from the ANANKE Study

ORCID Icon, , , , ORCID Icon, , ORCID Icon, , , , , , ORCID Icon, ORCID Icon, ORCID Icon, , , , , , , & ORCID Icon show all
Pages 273-290 | Received 08 Nov 2023, Accepted 16 Mar 2024, Published online: 26 Mar 2024

References

  • Bakakos A, Loukides S, Bakakos P. Severe eosinophilic asthma. J Clin Med. 2019;8(9). doi:10.3390/jcm8091375
  • de Groot JC, Ten Brinke A, Bel EHD. Management of the patient with eosinophilic asthma: a new era begins. ERJ Open Res. 2015;1(1):00024–02015. doi:10.1183/23120541.00024-2015
  • Heaney LG, Perez de Llano L, Al-Ahmad M, et al. Eosinophilic and noneosinophilic asthma: an expert consensus framework to characterize phenotypes in a global real-life severe asthma cohort. Chest. 2021;160(3):814–830. doi:10.1016/j.chest.2021.04.013
  • Coumou H, Westerhof GA, de Nijs SB, Amelink M, Bel EH. Diagnosing persistent blood eosinophilia in asthma with single blood eosinophil or exhaled nitric oxide level. Respir Med. 2018;141:81–86. doi:10.1016/j.rmed.2018.06.025
  • Matucci A, Maggi E, Vultaggio A. Eosinophils, the IL-5/IL-5Rα axis, and the biologic effects of benralizumab in severe asthma. Respir Med. 2019;160:105819. doi:10.1016/j.rmed.2019.105819
  • Pelaia C, Paoletti G, Puggioni F, et al. Interleukin-5 in the Pathophysiology of Severe Asthma. Front Physiol. 2019;10:1514. doi:10.3389/fphys.2019.01514
  • Chen M, Shepard K, Yang M, et al. Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate-to-severe asthma. Clin Exp Allergy. 2021;51(4):546–555. doi:10.1111/cea.13790
  • 2023 Gina Main Report. Available from: https://ginasthma.org/wp-content/uploads/2023/05/GINA-2023-Full-Report-2023-WMS.pdf. Accessed March 19, 2024.
  • European Medicines Agency. Overview of Xolair (omalizumab). EMA/375834/2020. Available from: https://www.ema.europa.eu/en/documents/overview/xolair-epar-medicine-overview_en.pdf. Accessed March 19, 2024.
  • European Medicines Agency. Cinqaero - Product information. Available from: https://www.ema.europa.eu/en/documents/product-information/cinqaero-epar-product-information_en.pdf. Accessed March 19, 2024.
  • European Medicines Agency. Nucala - Product Information. Available from: https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf. Accessed March 19, 2024.
  • European Medicines Agency. Fasenra - Product Information. Available from: https://www.ema.europa.eu/en/documents/product-information/fasenra-epar-product-information_en.pdf. Accessed March 19, 2024.
  • European Medicines Agency. Dupixent - Product Information. Available from: https://www.ema.europa.eu/en/documents/product-information/dupixent-epar-product-information_en.pdf. Accessed March 19, 2024.
  • European Medicines Agency. Tezspire - Product Information. Available from: https://www.ema.europa.eu/en/documents/product-information/tezspire-epar-product-information_en.pdf. Accessed March 19, 2024.
  • Kayser MZ, Drick N, Milger K, et al. Real-world multicenter experience with mepolizumab and benralizumab in the treatment of uncontrolled severe eosinophilic asthma over 12 months. JAA. 2021;14:863–871. doi:10.2147/JAA.S319572
  • Maglio A, Vitale C, Pelaia C, et al. Severe asthma remissions induced by biologics targeting IL5/IL5r: results from a multicenter real-life study. IJMS. 2023;24(3):2455. doi:10.3390/ijms24032455
  • Lanario JW, Cartwright L, Jones RC, Sayers R, Hyland ME, Masoli M. “Life-changing”: the experience of super-responders to biologics in severe asthma. BMC Pulm Med. 2022;22(1):445. doi:10.1186/s12890-022-02241-2
  • Pepper AN, Hanania NA, Humbert M, Casale TB. How to Assess Effectiveness Of Biologics For Asthma And What Steps To Take When There Is Not Benefit. J Allergy Clin Immunol. 2021;9(3):1081–1088. doi:10.1016/j.jaip.2020.10.048
  • Bleecker ER, Wechsler ME, FitzGerald JM, et al. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018;52(4):1800936. doi:10.1183/13993003.00936-2018
  • D’Amato M, Menzella F, Altieri E, et al. Benralizumab in patients with severe eosinophilic asthma with and without chronic rhinosinusitis with nasal polyps: an ANANKE Study post-hoc Analysis. Front Allergy. 2022;3:881218. doi:10.3389/falgy.2022.881218
  • Harrison TW, Chanez P, Menzella F, et al. Onset of effect and impact on health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms for patients with severe eosinophilic asthma treated with benralizumab (ANDHI): a randomised, controlled, Phase 3b trial. Lancet Respir Med. 2021;9(3):260–274. doi:10.1016/S2213-2600(20)30414-8
  • Nolasco S, Crimi C, Pelaia C, et al. Benralizumab effectiveness in severe eosinophilic asthma with and without chronic rhinosinusitis with nasal polyps: a real-world multicenter study. J Allergy Clin Immunol. 2021;9(12):4371–4380.e4. doi:10.1016/j.jaip.2021.08.004
  • Pavord ID, Deniz Y, Corren J, et al. Baseline FeNO independently predicts the dupilumab response in patients with moderate-to-severe asthma. J Allergy Clin Immunol. 2022:S2213219822013034. doi:10.1016/j.jaip.2022.11.043
  • Jackson DJ, Humbert M, Hirsch I, Newbold P, Garcia Gil E. Ability of Serum IgE concentration to predict exacerbation risk and benralizumab efficacy for patients with severe eosinophilic asthma. Adv Ther. 2020;37(2):718–729. doi:10.1007/s12325-019-01191-2
  • Corren J, Castro M, O’Riordan T, et al. Dupilumab efficacy in patients with uncontrolled, moderate-to-severe allergic asthma. J Allergy Clin Immunol. 2020;8(2):516–526. doi:10.1016/j.jaip.2019.08.050
  • Pelaia C, Crimi C, Pelaia G, et al. Real‐life evaluation of mepolizumab efficacy in patients with severe eosinophilic asthma, according to atopic trait and allergic phenotype. Clin Exp Allergy. 2020;50(7):780–788. doi:10.1111/cea.13613
  • Corren J, Ambrose CS, Griffiths JM, et al. Efficacy of tezepelumab in patients with evidence of severe allergic asthma: results from the phase 3 NAVIGATOR study. Clin Exper Aller. 2022:cea.14256. doi:10.1111/cea.14256
  • Pelaia C, Crimi C, Nolasco S, et al. Switch from omalizumab to benralizumab in allergic patients with severe eosinophilic asthma: a real-life experience from Southern Italy. Biomedicines. 2021;9(12):1822. doi:10.3390/biomedicines9121822
  • Menzies-Gow AN, McBrien C, Unni B, et al. Real world biologic use and switch patterns in severe asthma: data from the international severe asthma registry and the US CHRONICLE Study. JAA. 2022;15:63–78. doi:10.2147/JAA.S328653
  • Jackson DJ, Burhan H, Menzies-Gow A, et al. Benralizumab effectiveness in severe asthma is independent of previous biologic use. J Allergy Clin Immunol. 2022;10(6):1534–1544.e4. doi:10.1016/j.jaip.2022.02.014
  • Numata T, Araya J, Miyagawa H, et al. Effectiveness of switching biologics for severe asthma patients in Japan: a single-center retrospective study. JAA. 2021;14:609–618. doi:10.2147/JAA.S311975
  • Dagher R, Kumar V, Copenhaver AM, et al. Novel mechanisms of action contributing to benralizumab’s potent anti-eosinophilic activity. Eur Respir J. 2022;59(3):2004306. doi:10.1183/13993003.04306-2020
  • Bergantini L, d’Alessandro M, Pianigiani T, Cekorja B, Bargagli E, Cameli P. Benralizumab affects NK cell maturation and proliferation in severe asthmatic patients. Clin Immunol. 2023;253:109680. doi:10.1016/j.clim.2023.109680
  • Characterisation of Italian severe uncontrolled asthmatic patieNts key features when receiving benralizumab (ANANKE). Available from: https://clinicaltrials.gov/ct2/show/NCT04272463. Accessed March 19, 2024.
  • Menzella F, Bargagli E, Aliani M, et al. Characterization of Italian severe uncontrolled Asthmatic patieNts Key features when receiving Benralizumab in a real-life setting: the observational rEtrospective ANANKE study. Respir Res. 2022;23(1):36. doi:10.1186/s12931-022-01952-8
  • Caruso C, Cameli P, Altieri E, et al. Switching from one biologic to benralizumab in patients with severe eosinophilic asthma: an ANANKE study post hoc analysis. Front Med. 2022;9:950883. doi:10.3389/fmed.2022.950883
  • Vultaggio A, Aliani M, Altieri E, et al. Long-term effectiveness of benralizumab in severe eosinophilic asthma patients treated for 96-weeks: data from the ANANKE study. Respir Res. 2023;24(1):135. doi:10.1186/s12931-023-02439-w
  • Reimbursement decree for human use of Dupixent - Italian Medicines Agency. Available from: https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2020-12-09&atto.codiceRedazionale=20A06599&elenco30giorni=true. Accessed March 19, 2024.
  • Kavanagh JE, d’Ancona G, Elstad M, et al. Real-world effectiveness and the characteristics of a “super-responder” to mepolizumab in severe eosinophilic asthma. Chest. 2020;158(2):491–500. doi:10.1016/j.chest.2020.03.042
  • Seccia V, D’Amato M, Scioscia G, et al. Management of patients with severe asthma and chronic rhinosinusitis with nasal polyps: a multidisciplinary shared approach. JPM. 2022;12(7):1096. doi:10.3390/jpm12071096
  • Caminati M, Marcon A, Guarnieri G, et al. Benralizumab efficacy in late non-responders to mepolizumab and variables associated with occurrence of switching: a real-word perspective. JCM. 2023;12(5):1836. doi:10.3390/jcm12051836
  • Kraft M, Brusselle G, FitzGerald JM, et al. Patient characteristics, biomarkers and exacerbation risk in severe, uncontrolled asthma. Eur Respir J. 2021;58(6):2100413. doi:10.1183/13993003.00413-2021
  • Zeiger RS, Schatz M, Dalal AA, et al. Blood eosinophil count and outcomes in severe uncontrolled asthma: a prospective study. J Allergy Clin Immunol. 2017;5(1):144–153.e8. doi:10.1016/j.jaip.2016.07.015
  • Gómez-Bastero Fernández A, Medina Gallardo JF, Delgado Romero J, et al. Effectiveness of switching to benralizumab in severe refractory eosinophilic asthma. JAA. 2022;15:727–735. doi:10.2147/JAA.S358705
  • Kavanagh JE, Hearn AP, d’Ancona G, et al. Benralizumab after sub‐optimal response to mepolizumab in severe eosinophilic asthma. Allergy. 2021;76(6):1890–1893. doi:10.1111/all.14693
  • Soremekun S, Heaney LG, Skinner D, et al. Asthma exacerbations are associated with a decline in lung function: a longitudinal population-based study. Thorax. 2022:217032. doi:10.1136/thorax-2021-217032
  • Ortega H, Chupp G, Bardin P, et al. The role of mepolizumab in atopic and nonatopic severe asthma with persistent eosinophilia. Eur Respir J. 2014;44(1):239–241. doi:10.1183/09031936.00220413
  • Jatakanon A, Lim S, Barnes PJ. Changes in sputum eosinophils predict loss of asthma control. Am J Respir Crit Care Med. 2000;161(1):64–72. doi:10.1164/ajrccm.161.1.9809100
  • Laviolette M, Gossage DL, Gauvreau G, et al. Effects of benralizumab on airway eosinophils in asthmatic patients with sputum eosinophilia. J Allergy Clin Immunol. 2013;132(5):1086–1096.e5. doi:10.1016/j.jaci.2013.05.020
  • Poznanski SM, Mukherjee M, Zhao N, et al. Asthma exacerbations on benralizumab are largely non‐eosinophilic. Allergy. 2021;76(1):375–379. doi:10.1111/all.14514
  • Menzies-Gow A, Gurnell M, Heaney LG, et al. Oral corticosteroid elimination via a personalised reduction algorithm in adults with severe, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study. Lancet Respir Med. 2022;10(1):47–58. doi:10.1016/S2213-2600(21)00352-0
  • Chan JSK, Murray RB, Price D. Oral corticosteroids in asthma and beyond: moving forward. Eur Respir J. 2022;60(3):2200776. doi:10.1183/13993003.00776-2022
  • Gurnell M, Heaney LG, Price D, Menzies‐Gow A. Long‐term corticosteroid use, adrenal insufficiency and the need for steroid‐sparing treatment in adult severe asthma. J Intern Med. 2021;290(2):240–256. doi:10.1111/joim.13273
  • Li H, Zhang Q, Wang J, et al. Variability of Type 2 inflammatory markers guiding biologic therapy of severe asthma: a 5-year retrospective study from a single tertiary hospital. World Allergy Organ J. 2021;14(9):100547. doi:10.1016/j.waojou.2021.100547
  • Flood-Page PT, Menzies-Gow AN, Kay AB, Robinson DS. Eosinophil’s role remains uncertain as anti–interleukin-5 only partially depletes numbers in asthmatic airway. Am J Respir Crit Care Med. 2003;167(2):199–204. doi:10.1164/rccm.200208-789OC
  • McDowell PJ, Diver S, Yang F, et al. The inflammatory profile of exacerbations in patients with severe refractory eosinophilic asthma receiving mepolizumab (the MEX study): a prospective observational study. Lancet Respir Med. 2021;9(10):1174–1184. doi:10.1016/S2213-2600(21)00004-7