248
Views
10
CrossRef citations to date
0
Altmetric
Original Research

Functionality and Performance of an Accessorized Pre-Filled Syringe and an Autoinjector for At-Home Administration of Tezepelumab in Patients with Severe, Uncontrolled Asthma

ORCID Icon, , , , &
Pages 381-392 | Published online: 19 Apr 2021

References

  • Gauvreau GM, O’Byrne PM, Boulet L-P, et al. Effects of an anti-TSLP antibody on allergen-induced asthmatic responses. N Engl J Med. 2014;370(22):2102–2110. doi:10.1056/NEJMoa1402895
  • Corren J, Parnes J, Wang L, et al. Tezepelumab in adults with uncontrolled asthma. N Engl J Med. 2017;377(10):936–946. doi:10.1056/NEJMoa1704064
  • 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;24(8):777–792. doi:10.1080/14728222.2020.1783242
  • Soumelis V, Reche PA, Kanzler H, et al. Human epithelial cells trigger dendritic cell-mediated allergic inflammation by producing TSLP. Nat Immunol. 2002;3(7):673–680. doi:10.1038/ni805
  • Allakhverdi Z, Comeau MR, Jessup HK, et al. Thymic stromal lymphopoietin is released by human epithelial cells in response to microbes, trauma, or inflammation and potently activates mast cells. J Exp Med. 2007;204(2):253–258. doi:10.1084/jem.20062211
  • Kitajima M, Lee H-C, Nakayama T, Ziegler SF. TSLP enhances the function of helper type 2 cells. Eur J Immunol. 2011;41(7):1862–1871. doi:10.1002/eji.201041195
  • Ying S, O’Connor B, Ratoff J, et al. Expression and cellular provenance of thymic stromal lymphopoietin and chemokines in patients with severe asthma and chronic obstructive pulmonary disease. J Immunol. 2008;181(4):2790–2798. doi:10.4049/jimmunol.181.4.2790
  • Ying S, O’Connor B, Ratoff J, et al. Thymic stromal lymphopoietin expression is increased in asthmatic airways and correlates with expression of Th2-attracting chemokines and disease severity. J Immunol. 2005;174(12):8183–8190. doi:10.4049/jimmunol.174.12.8183
  • Ly N, Zheng Y, Griffiths JM, van der Merwe R, Agoram B, Roskos L. Exposure-response analysis of tezepelumab in patients with severe asthma to guide phase 3 dose selection. Eur Respir J. 2018;52:PA1688.
  • Zheng Y, Abuqayyas L, Megally M, et al. Tezepelumab pharmacokinetics, safety and tolerability after administration via vial-and-syringe, accessorized pre-filled syringe, or autoinjector: a randomized trial in healthy volunteers. Clin Ther. 2020.
  • Global Initative for Asthma. Global strategy for asthma management and prevention; 2018. Available from: https://ginasthma.org/wp-content/uploads/2019/01/2018-GINA.pdf. Accessed October 12, 2020.
  • Menzies-Gow A, Colice G, Griffiths JM, et al. NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Respir Res. 2020;21(1):266. doi:10.1186/s12931-020-01526-6
  • Wechsler ME, Colice G, Griffiths JM, et al. SOURCE: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of tezepelumab in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma. Respir Res. 2020;21(1):264. doi:10.1186/s12931-020-01503-z
  • International Organization for Standardization. ISO 11608-1:2014. Needle-based injection systems for medical use – requirements and test methods – part 1: needle-based injection systems; 2014. Available from: https://www.iso.org/standard/65021.html. Accessed November 17, 2020.
  • American Thoracic Society. Asthma control questionnaire. Available from: http://www.thoracic.org/members/assemblies/assemblies/srn/questionaires/acq.php. Accessed October 13, 2020.
  • Juniper EF, Bousquet J, Abetz L, Bateman ED; GOAL Committee. Identifying ‘well-controlled’ and ‘not well-controlled’ asthma using the asthma control questionnaire. Respir Med. 2006;100(4):616–621. doi:10.1016/j.rmed.2005.08.012
  • Ferguson GT, Cole J, Aurivillius M, et al. Single-use autoinjector functionality and reliability for at-home administration of benralizumab for patients with severe asthma: GRECO trial results. J Asthma Allergy. 2019;12:363–373. doi:10.2147/JAA.S224266
  • Ferguson GT, Mansur AH, Jacobs JS, et al. Assessment of an accessorized pre-filled syringe for home-administered benralizumab in severe asthma. J Asthma Allergy. 2018;11:63–72. doi:10.2147/JAA.S157762
  • 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. 2020:S1081-1206(1020)31108-X.
  • Parnes JR, Sullivan JT, Chen L, Dias C. Pharmacokinetics, safety, and tolerability of tezepelumab (AMG 157) in healthy and atopic dermatitis adult subjects. Clin Pharmacol Ther. 2019;106(2):441–449. doi:10.1002/cpt.1401
  • Sakamoto K, Matsuki S, Irie S, et al. A phase 1, randomized, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of subcutaneous tezepelumab in healthy Japanese men. Clin Pharmacol Drug Dev. 2020;9(7):833–840. doi:10.1002/cpdd.775
  • AstraZeneca. Fasenra® (benralizumab) prescribing information. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761070s000lbl.pdf. Accessed November 17, 2020.
  • Genentech Inc. Xolair®(omalizumab) prescribing information; 2003. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/omalgen062003LB.pdf. Accessed November 17, 2020.
  • GlaxoSmithKline. Nucala®(mepolizumab) prescribing information; 2015. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125526Orig1s000Lbl.pdf. Accessed November 17, 2020.
  • Pham TH, Ren P, Parnes JR, Griffiths JM. Tezepelumab reduces multiple key inflammatory biomarkers in patients with severe, uncontrolled asthma in the Phase 2b PATHWAY Study. Am J Respir Crit Care Med. 2019;199:A2677.
  • 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. 2020. doi:10.1016/S2213-2600(1020)30414-30418