دورية أكاديمية
Efficacy of tezepelumab in patients with evidence of severe allergic asthma: Results from the phase 3 NAVIGATOR study.
| العنوان: | Efficacy of tezepelumab in patients with evidence of severe allergic asthma: Results from the phase 3 NAVIGATOR study. |
|---|---|
| المؤلفون: | Corren J; David Geffen School of Medicine, University of California Los Angeles (UCLA), Los Angeles, California, USA., Ambrose CS; Respiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, Maryland, USA., Griffiths JM; Translational Science and Experimental Medicine, Research and Early Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA., Hellqvist Å; Biometrics, Late-stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden., Lindsley AW; US Medical Affairs, Amgen, Thousand Oaks, California, USA., Llanos JP; Global Medical Affairs, Amgen, Thousand Oaks, California, USA., Colice G; Late-stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA., Menzies-Gow A; Royal Brompton and Harefield Hospitals, School of Immunology & Microbial Sciences, King's College, London, UK. |
| المصدر: | Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology [Clin Exp Allergy] 2023 Apr; Vol. 53 (4), pp. 417-428. Date of Electronic Publication: 2022 Dec 12. |
| نوع المنشور: | Randomized Controlled Trial; Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Blackwell Scientific Publications Country of Publication: England NLM ID: 8906443 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2222 (Electronic) Linking ISSN: 09547894 NLM ISO Abbreviation: Clin Exp Allergy Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Oxford : Blackwell Scientific Publications, c1989- |
| مواضيع طبية MeSH: | Anti-Asthmatic Agents*/adverse effects , Asthma*/diagnosis , Asthma*/drug therapy, Humans ; Omalizumab/therapeutic use ; Adrenal Cortex Hormones/therapeutic use ; Double-Blind Method |
| مستخلص: | Background: Allergic asthma is the most common phenotype among patients with severe asthma. In the phase 3 NAVIGATOR study (NCT03347279), tezepelumab significantly reduced the annualized asthma exacerbation rate (AAER) versus placebo in patients with severe, uncontrolled asthma. This exploratory analysis evaluated the efficacy of tezepelumab in NAVIGATOR participants with evidence of severe allergic asthma. Methods: Patients (12-80 years old) receiving medium- or high-dose inhaled corticosteroids and ≥ 1 additional controller medication, with or without oral corticosteroids, were randomized to tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks in NAVIGATOR. In this analysis, the AAER, forced expiratory volume in 1 second (FEV Results: Of 1059 patients who received treatment in NAVIGATOR, 680 (64%) had perennial aeroallergen sensitivity and 318 (30%) had confirmed symptomatic allergy; 379 (36%) and 359 (34%) patients were OMA-US- and OMA-EU-eligible, respectively. Tezepelumab reduced the AAER over 52 weeks versus placebo by 58% (95% confidence interval [CI]: 47-67) to 68% (95% CI: 55-77) across these subgroups. Among omalizumab-eligible patients, AAERs were reduced in patients across baseline blood eosinophil counts and FeNO levels. Tezepelumab improved FEV Conclusions: Tezepelumab was efficacious in patients with severe, uncontrolled asthma with evidence of allergic inflammation, defined by multiple clinically relevant definitions. These findings further support the benefits of tezepelumab in a broad population of patients with severe asthma, including those with severe allergic asthma. (© 2022 John Wiley & Sons Ltd.) |
| References: | Global Initative for Asthma. Global strategy for asthma management and prevention. 2021. Accessed July 8, 2021. https://ginasthma.org/wp-content/uploads/2021/05/GINA-Main-Report-2021-V2-WMS.pdf. Genentech Inc. Xolair (omalizumab) prescribing information. 2003. Accessed July 14, 2021. https://www.gene.com/download/pdf/xolair_prescribing.pdf. AstraZeneca. Fasenra® (benralizumab) prescribing information. 2018. Accessed July 9, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761070s000lbl.pdf. Regeneron Pharmaceuticals Inc. Dupixent (dupilumab) prescribing information 2019. Accessed July 9, 2021. https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf. GlaxoSmithKline. Mepolizumab prescribing information. 2015. Accessed January 18, 2022. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL-IFU-COMBINED.PDF. 2015;2022(18 January). Platts-Mills TA. The role of immunoglobulin E in allergy and asthma. Am J Respir Crit Care Med. 2001;164(8 Pt 2):S1-S5. Schatz M, Rosenwasser L. The allergic asthma phenotype. J Allergy Clin Immunol Pract. 2014;2(6):645-648. quiz 649. Chen M, Shepard K 2nd, 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. Tran TN, Zeiger RS, Peters SP, et al. Overlap of atopic, eosinophilic, and TH2-high asthma phenotypes in a general population with current asthma. Ann Allergy Asthma Immunol. 2016;116(1):37-42. Chipps BE, Jarjour N, Calhoun WJ, et al. A comprehensive analysis of the stability of blood eosinophil levels. Ann Am Thorac Soc. 2021;18(12):1978-1987. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention 2022. Accessed September 8, 2022. https://ginasthma.org/wp-content/uploads/2022/07/GINA-Main-Report-2022-FINAL-22-07-01-WMS.pdf. Hanania NA, Wenzel S, Rosen K, et al. Exploring the effects of omalizumab in allergic asthma: an analysis of biomarkers in the EXTRA study. Am J Respir Crit Care Med. 2013;187(8):804-811. Gauvreau GM, Sehmi R, Ambrose CS, Griffiths JM. Thymic stromal lymphopoietin: its role and potential as a therapeutic target in asthma. Expert Opin Ther Targets. 2020;8:777-792. Wang Q, Du J, Zhu J, Yang X, Zhou B. Thymic stromal lymphopoietin signaling in CD4(+) T cells is required for TH2 memory. J Allergy Clin Immunol. 2015;135(3):781-791. e783. Diver S, Khalfaoui L, Emson C, et al. Effect of tezepelumab on airway inflammatory cells, remodelling, and hyperresponsiveness in patients with moderate-to-severe uncontrolled asthma (CASCADE): a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet Respir Med. 2021;9(11):1299-1312. Gauvreau GM, O'Byrne PM, Boulet LP, et al. Effects of an anti-TSLP antibody on allergen-induced asthmatic responses. N Engl J Med. 2014;370(22):2102-2110. US Food and Drug Administration. FDA approves maintenance treatment for severe asthma. 2021. Accessed February 21, 2022. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-maintenance-treatment-severe-asthma. Corren J, Ambrose CS, Salapa K, et al. Efficacy of tezepelumab in patients with severe, uncontrolled asthma and perennial allergy. J Allergy Clin Immunol Pract. 2021;9(12):4334-4342. Menzies-Gow A, Corren J, Bourdin A, et al. Tezepelumab in adults and adolescents with severe, Uncontrolled Asthma. N Engl J Med. 2021;384(19):1800-1809. Genentech Inc. XOLAIR® (omalizumab) for injection, for subcutaneous use: highlights of the prescribing information (revised July 2016). Accessed December 23, 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103976s5225lbl.pdf. Xolair 75 mg powder and solvent for solution for injection: summary of product characteristics (revised July 2020). Accessed February 28, 2022. https://www.ema.europa.eu/en/documents/product-information/xolair-epar-product-information_en.pdf. American Thoracic S, European Respiratory S. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005;171(8):912-930. Tepper RS, Wise RS, Covar R, et al. Asthma outcomes: pulmonary physiology. J Allergy Clin Immunol. 2012;129(3 Suppl):S65-S87. Asthma Control Questionnaire. American Thoracic Society. Accessed January 4,2021 http://www.thoracic.org/members/assemblies/assemblies/srn/questionaires/acq.php. Juniper EF, Buist AS, Cox FM, Ferrie PJ, King DR. Validation of a standardized version of the asthma quality of life questionnaire. Chest. 1999;115(5):1265-1270. Globe G, Martin M, Schatz M, et al. Symptoms and markers of symptom severity in asthma - content validity of the asthma symptom diary. Health Qual Life Outcomes. 2015;13:21. Globe G, Wiklund I, Lin J, et al. Psychometric properties of the asthma symptom diary (ASD), a diary for use in clinical trials of persistent asthma. J Allergy Clin Immunol Pract. 2016;4(1):60-66. Globe G, Wiklund I, Mattera M, Zhang H, Revicki DA. Evaluating minimal important differences and responder definitions for the asthma symptom diary in patients with moderate to severe asthma. J Patient Rep Outcomes. 2019;3(1):22. Jones PW. St. George's respiratory questionnaire: MCID. COPD. 2005;2(1):75-79. Olin AC, Rosengren A, Thelle DS, Lissner L, Bake B, Toren K. Height, age, and atopy are associated with fraction of exhaled nitric oxide in a large adult general population sample. Chest. 2006;130(5):1319-1325. Matucci A, Vultaggio A, Maggi E, Kasujee I. Is IgE or eosinophils the key player in allergic asthma pathogenesis? Are we asking the right question? Respir Res. 2018;19(1):113. Sonntag HJ, Filippi S, Pipis S, Custovic A. Blood biomarkers of sensitization and asthma. Front Pediatr. 2019;7:251. Bacharier LB, Geha RS. Molecular mechanisms of IgE regulation. J Allergy Clin Immunol. 2000;105(2 Pt 2):S547-S558. West EE, Kashyap M, Leonard WJ. TSLP: a key regulator of asthma pathogenesis. Drug Discov Today Dis Mech. 2012;9(3-4):e83-e88. |
| فهرسة مساهمة: | Keywords: asthma; omalizumab; perennial aeroallergens; tezepelumab; thymic stromal lymphopoietin |
| المشرفين على المادة: | RJ1IW3B4QX (tezepelumab) 2P471X1Z11 (Omalizumab) 0 (Anti-Asthmatic Agents) 0 (Adrenal Cortex Hormones) |
| تواريخ الأحداث: | Date Created: 20221212 Date Completed: 20230417 Latest Revision: 20230421 |
| رمز التحديث: | 20231215 |
| DOI: | 10.1111/cea.14256 |
| PMID: | 36507576 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1365-2222 |
|---|---|
| DOI: | 10.1111/cea.14256 |