Top

Published in:

Open Access 07-12-2023 | Bronchial Asthma | Adis Drug Q&A

Tezepelumab in severe asthma: a profile of its use

Author: Yahiya Y. Syed

Published in: Drugs & Therapy Perspectives | Issue 12/2023

Abstract

Tezepelumab (tezepelumab-ekko; TEZSPIRE^®), a first-in-class monoclonal antibody targeting thymic stromal lymphopoietin, represents a novel, effective and generally well tolerated treatment option for patients with severe asthma across a wide range of phenotypes. In randomized, double-blind, phase 2 (PATHWAY) and phase 3 (NAVIGATOR) trials, subcutaneous tezepelumab demonstrated a significant reduction in annualized asthma exacerbation rate among patients with severe uncontrolled asthma. The efficacy was seen across a broad range of patients with different asthma endotypes and phenotypes, including eosinophilic and noneosinophilic asthma, allergic asthma, and type-2 low asthma. The efficacy was sustained over up to 104 weeks. Tezepelumab is generally well tolerated, with the most common adverse reactions being pharyngitis, arthralgia and back pain.

Available only for authorised users

Global Initiative for Asthma. Global strategy for asthma management and prevention (2023 update). 2023. https://ginasthma.org. Accessed 16 Oct 2023.

Reibman J, Tan L, Ambrose C, et al. Clinical and economic burden of severe asthma among US patients treated with biologic therapies. Ann Allergy Asthma Immunol. 2021;127(3):318-25e2.CrossRefPubMed

Gauvreau GM, Sehmi R, Ambrose CS, et al. Thymic stromal lymphopoietin: its role and potential as a therapeutic target in asthma. Expert Opin Ther Targets. 2020;24(8):777–92.CrossRefPubMed

Lambrecht BN, Hammad H. The immunology of asthma. Nat Immunol. 2015;16(1):45–56.CrossRefPubMed

Lambrecht BN, Hammad H, Fahy JV. The cytokines of asthma. Immunity. 2019;50(4):975–91.CrossRefPubMed

Kuruvilla ME, Lee FE, Lee GB. Understanding asthma phenotypes, endotypes, and mechanisms of disease. Clin Rev Allergy Immunol. 2019;56(2):219–33.CrossRefPubMedPubMedCentral

Hinks TSC, Levine SJ, Brusselle GG. Treatment options in type-2 low asthma. Eur Respir J. 2021;57(1):2000528.CrossRefPubMedPubMedCentral

Chan R, Stewart K, Misirovs R, et al. Targeting downstream type 2 cytokines or upstream epithelial alarmins for severe asthma. J Allergy Clin Immunol Pract. 2022;10(6):1497–505.CrossRefPubMed

AstraZeneca. TEZSPIRE^® (tezepelumab-ekko) injection, for subcutaneous use: US prescribing informaton. 2021. https://www.fda.gov. Accessed 16 Oct 2023.

10.

AstraZeneca. TEZSPIRE^® 210 mg solution for injection: EU summary of product characteristics. 2022. https://www.ema.europa.eu/. Accessed 16 Oct 2023.

11.

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):2102–10.CrossRefPubMed

12.

Brusselle G, Riemann S. Is efficacy of tezepelumab independent of severe asthma phenotype? Am J Respir Crit Care Med. 2023;208(1):1–12.CrossRef

13.

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):1299–312.CrossRefPubMed

14.

Nordenmark LH, Hellqvist Å, Emson C. Tezepelumab and mucus plugs in patients with moderate-to-severe asthma. NEJM Evidence. 2023;2(10). https://doi.org/10.1056/EVIDoa2300135

15.

Sverrild A, Hansen S, Hvidtfeldt M, et al. The effect of tezepelumab on airway hyperresponsiveness to mannitol in asthma (UPSTREAM). Eur Respir J. 2022;59(1):1–11.CrossRef

16.

Sverrild A, Cerps S, Nieto-Fontarigo J, et al. Effects of tezepelumab on host epithelial tolerance to virus in patients with uncontrolled asthma [abstract no. OA1492]. Eur Respir J. 2021;58(Suppl 65).

17.

Corren J, Parnes JR, Wang L, et al. Tezepelumab in adults with uncontrolled asthma. N Engl J Med. 2017;377(10):936–46.CrossRefPubMed

18.

Pham TH, Chen C, Colice G, et al. Tezepelumab normalizes serum interleukin-5 and -13 levels in patients with severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2021;127(6):689–91.CrossRefPubMed

19.

Corren J, Pham TH, Garcia Gil E, et al. Baseline type 2 biomarker levels and response to tezepelumab in severe asthma. Allergy. 2022;77(6):1786–96.CrossRefPubMed

20.

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):1800–9.CrossRefPubMed

21.

Ly N, Zheng Y, Griffiths JM, et al. Pharmacokinetic and pharmacodynamic modeling of tezepelumab to guide phase 3 dose selection for patients with severe asthma. J Clin Pharmacol. 2021;61(7):901–12.CrossRefPubMed

22.

Alpizar S, Megally A, Chen C, et al. Functionality and performance of an accessorized pre-filled syringe and an autoinjector for at-home administration of tezepelumab in patients with severe, uncontrolled asthma. J Asthma Allergy. 2021;14:381–92.CrossRefPubMedPubMedCentral

23.

Zheng Y, Abuqayyas L, Megally A, et al. Tezepelumab pharmacokinetics, safety, and tolerability after administration via vial-and-syringe, accessorized prefilled syringe, or autoinjector: a randomized trial in healthy volunteers. Clin Ther. 2021;43(1):142-55.e5.CrossRefPubMed

24.

Corren J, Menzies-Gow A, Chupp G, et al. Efficacy of tezepelumab in severe, uncontrolled asthma: pooled analysis of PATHWAY and NAVIGATOR studies. Am J Respir Crit Care Med. 2023;208(1):13–24.CrossRefPubMed

25.

Menzies-Gow A, Bourdin A, Chupp G, et al. Effect of tezepelumab on healthcare utilization in patients with severe, uncontrolled asthma: the NAVIGATOR study. Ann Allergy Asthma Immunol. 2023;131(3):343-8.e2.CrossRefPubMed

26.

Pavord ID, Hoyte FCL, Lindsley AW, et al. Tezepelumab reduces exacerbations across all seasons in patients with severe, uncontrolled asthma (NAVIGATOR). Ann Allergy Asthma Immunol. 2023. https://doi.org/10.1016/j.anai.2023.08.015.CrossRefPubMed

27.

Shinkai M, Ebisawa M, Fukushima Y, et al. One-year safety and tolerability of tezepelumab in Japanese patients with severe uncontrolled asthma: results of the NOZOMI study. J Asthma. 2023;60(3):616–24.CrossRefPubMed

28.

Ishizuka T, Menzies-Gow A, Okada H, et al. Efficacy and safety of tezepelumab in patients recruited in Japan who participated in the phase 3 NAVIGATOR study. Allergol Int. 2023;72(1):82–8.CrossRefPubMed

29.

Corren J, Garcia Gil E, Griffiths JM, et al. Tezepelumab improves patient-reported outcomes in patients with severe, uncontrolled asthma in PATHWAY. Ann Allergy Asthma Immunol. 2021;126(2):187–93.CrossRefPubMed

30.

Lugogo NL, Ambrose CS, Colice G, et al. Clinical responses to treatment with tezepelumab among patients with severe, uncontrolled asthma in the phase 3 NAVIGATOR study [abstract no. A3419]. Am J Respir Crit Care Med. 2022;205.

31.

Wechsler ME, Menzies-Gow A, Brightling CE, et al. Evaluation of the oral corticosteroid-sparing effect of tezepelumab in adults with oral corticosteroid-dependent asthma (SOURCE): a randomised, placebo-controlled, phase 3 study. Lancet Respir Med. 2022;10(7):650–60.CrossRefPubMed

32.

Menzies-Gow A, Wechsler ME, Brightling CE, et al. Long-term safety and efficacy of tezepelumab in people with severe, uncontrolled asthma (DESTINATION): a randomised, placebo-controlled extension study. Lancet Respir Med. 2023;11(5):425–38.CrossRefPubMed

33.

Caminati M, Llanos JP, Spahn JD, et al. Changes in serum total IgE after cessation of tezepelumab after 2 years of treatment (DESTINATION) [oral presentation plus poster]. In: European Respiratory Society International Congress. 2023.

34.

Brightling CE, Jackson DJ, Kotalik A, et al. Biomarkers and clinical outcomes after cessation of tezepelumab after 2 years of treatment (DESTINATION) [oral presentation plus poster]. In: European Respiratory Society International Congress. 2023.

35.

Wechsler ME, Brusselle G, Virchow JC, et al. On-treatment clinical remission with tezepelumab in patients with severe, uncontrolled asthma in the phase 3 DESTINATION study [oral presentation plus poster]. In: European Respiratory Society International Congress. 2023.

36.

Menzies-Gow A, Wechsler ME, Brightling CE, et al. Oral corticosteroid-sparing effect of tezepelumab in adults with severe asthma: results from the DESTINATION study [abstract no. A5987]. Am J Respir Crit Care Med. 2023;207.

37.

Brusselle G, Cook B, Lawson K, et al. Long-term safety and efficacy of tezepelumab in adolescents with severe, uncontrolled asthma [oral presentation plus poster]. In: European Respiratory Society International Congress. 2023.

38.

European Medicines Agency. Tezspire (tezepelumab): EU assessment report. 2022. https://www.ema.europa.eu. Accessed 16 Oct 2023.

39.

Korn S, Cook B, Simpson LJ, et al. Efficacy of biologics in severe, uncontrolled asthma stratified by blood eosinophil count: a systematic review. Adv Ther. 2023;40(7):2944–64.CrossRefPubMedPubMedCentral

40.

Nopsopon T, Lassiter G, Chen ML, et al. Comparative efficacy of tezepelumab to mepolizumab, benralizumab, and dupilumab in eosinophilic asthma: a Bayesian network meta-analysis. J Allergy Clin Immunol. 2023;151(3):747–55.CrossRefPubMed

41.

Pitre T, Jassal T, Angjeli A, et al. A comparison of the effectiveness of biologic therapies for asthma: a systematic review and network meta-analysis. Ann Allergy Asthma Immunol. 2022;130(5):595–606.CrossRefPubMed

42.

Menzies-Gow A, Steenkamp J, Singh S, et al. Tezepelumab compared with other biologics for the treatment of severe asthma: a systematic review and indirect treatment comparison. J Med Econ. 2022;25(1):679–90.CrossRefPubMed

43.

Ando K, Fukuda Y, Tanaka A, et al. Comparative efficacy and safety of tezepelumab and other biologics in patients with inadequately controlled asthma according to thresholds of type 2 inflammatory biomarkers: a systematic review and network meta-analysis. Cells. 2022;11(5):1–19.CrossRef

44.

National Institute for Health and Care Excellence. Tezepelumab for treating severe asthma: technology appraisal guidance [TA880]. 2023. https://www.nice.org.uk. Accessed 16 Oct 2023.

45.

Scottish Medicines Consortium. Tezepelumab (Tezspire^®) is accepted for restricted use within NHSScotland. 2023. https://www.scottishmedicines.org.uk. Accessed 16 Oct 2023.

46.

Rind DM, McQueen RB, Herron-Smith S, et al. The effectiveness and value of tezepelumab for severe asthma. J Manag Care Spec Pharm. 2022;28(5):577–80.PubMed

47.

Habash M, Guiang H, Mayers I, et al. Cost-effectiveness of tezepelumab in Canada for severe asthma. J Med Econ. 2023. https://doi.org/10.1080/13696998.2023.2234235.CrossRefPubMed

48.

Milger-Kneidinger K, Dorscheid D, Gessner C, et al. Asthma control in severe asthma patients treated with tezepelumab: a prospective, observational, real-world evidence study in Europe and Canada (ASCENT) [oral presentation plus poster]. In: European Respiratory Society International Congress. 2023.

49.

Genentech. XOLAIR^® (omalizumab) injection, for subcutaneous use: US prescribing informaion. 2003. https://www.fda.gov. Accessed 16 Oct 2023.

50.

GlaxoSmithKline. NUCALA^® (mepolizumab) injection, for subcutaneous use: US prescribing information. 2015. https://www.fda.gov. Accessed 16 Oct 2023.

51.

Teva Pharmaceuticals. CINQAIR^® (reslizumab) injection, for intravenous use: US prescribing information. 2023. https://www.fda.gov. Accessed 16 Oct 2023.

52.

AstraZeneca. FASENRA^® (benralizumab) injection, for subcutaneous use: US prescribing information. 2017. https://www.fda.gov. Accessed 16 Oct 2023.

53.

Regeneron. DUPIXENT^® (dupilumab) injection, for subcutaneous use: US prescribing information. 2017. https://www.fda.gov Accessed 16 Oct 2023.

Title: Tezepelumab in severe asthma: a profile of its use
Author: Yahiya Y. Syed
Publication date: 07-12-2023
Publisher: Springer International Publishing
Keyword: Bronchial Asthma
Published in: Drugs & Therapy Perspectives / Issue 12/2023
Print ISSN: 1172-0360
Electronic ISSN: 1179-1977
DOI: https://doi.org/10.1007/s40267-023-01033-w

2024 ASCO Annual Meeting

Springer Medicine

Tezepelumab in severe asthma: a profile of its use

Abstract

2024 ASCO Annual Meeting

Springer Medicine

Abstract

Please log in to get access to this content

Other articles of this Issue 12/2023

The PHASTER Study: Economic and Organizational Impact of Subcutaneous (SC) Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Treatment of HER2+ Breast Cancer Patients

Acknowledgement to Referees

Correction to: RBX2660 (REBYOTA®) in preventing recurrence of Clostridioides difficile infection: a profile of its use in the USA

Nirsevimab in the prevention of respiratory syncytial virus lower respiratory tract disease: a profile of its use

Understand the benefits and risks of intravenous methadone for perioperative and chronic cancer pain management

Spesolimab in generalised pustular psoriasis flares: a profile of its use