One-year safety and tolerability of tezepelumab in Japanese patients with severe uncontrolled asthma: results of the NOZOMI study

References

• Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention (2021 update). Available from: https://ginasthma.org/wp-content/uploads/2021/05/GINA-Main-Report-2021-V2-WMS.pdf.
   Google Scholar
• World Health Organization. Key facts – asthma. Available from: https://www.who.int/news-room/fact-sheets/detail/asthma.
   Google Scholar
• Ichinose M, Sugiura H, Nagase H, Yamaguchi M, Inoue H, Sagara H, Tamaoki J, Tohda Y, Munakata M, Yamauchi K, Japanese Society of Allergology, et al. Japanese guidelines for adult asthma 2017. Allergol Int. 2017;66(2):163–189. doi:10.1016/j.alit.2016.12.005.
   PubMed Web of Science ®Google Scholar
• Japanese Society of Allergology. Asthma prevention and management guideline. Kyowakikaku, Tokyo, Japan; 2021 (in Japanese).
   Google Scholar
• Yoshihara S. The Japanese Respiratory Society Guidelines 2019 for refractory asthma in children. Arerugi. 2021;70(2):95–99 (in Japanese). doi:10.15036/­arerugi.70.95.
   PubMedGoogle Scholar
• Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, Adcock IM, Bateman ED, Bel EH, Bleecker ER, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014;43(2):343–373. doi:10.1183/09031936.00202013.
   PubMed Web of Science ®Google Scholar
• Holguin F, Cardet JC, Chung KF, Diver S, Ferreira DS, Fitzpatrick A, Gaga M, Kellermeyer L, Khurana S, Knight S, et al. Management of severe asthma: a European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2020;55(1):1900588. doi:10.1183/13993003.00588-2019.
   PubMed Web of Science ®Google Scholar
• Jarjour NN, Erzurum SC, Bleecker ER, Calhoun WJ, Castro M, Comhair SA, Chung KF, Curran-Everett D, Dweik RA, Fain SB, NHLBI Severe Asthma Research Program (SARP), et al. Severe asthma: lessons learned from the National Heart, Lung, and Blood Institute Severe Asthma Research Program. Am J Respir Crit Care Med. 2012;185(4):356–362. doi:10.1164/­rccm.201107-1317PP.
   PubMed Web of Science ®Google Scholar
• GINA. Difficult-to-treat & severe asthma in adolescents and adult patients: diagnosis and management. A GINA pocket guide for health professionals, V2.0 April 2019. Available from: https://ginasthma.org/wp-content/­uploads/2019/04/GINA-Severe-asthma-Pocket-­­Guide-v2.0-wms-1.pdf.
   Google Scholar
• Hekking PW, Wener RR, Amelink M, Zwinderman AH, Bouvy ML, Bel EH. The prevalence of severe refractory asthma. J Allergy Clin Immunol. 2015;135(4):896–902. doi:10.1016/j.jaci.2014.08.042.
   PubMed Web of Science ®Google Scholar
• Nagase H. Severe asthma in Japan. Allergol Int. 2019;68(2):167–171. doi:10.1016/j.alit.2019.02.004.
   PubMed Web of Science ®Google Scholar
• Côté A, Godbout K, Boulet LP. The management of severe asthma in 2020. Biochem Pharmacol. 2020;179:114112. doi:10.1016/j.bcp.2020.114112.
   PubMed Web of Science ®Google Scholar
• Jansson SA, Backman H, Andersson M, Telg G, Lindberg A, Stridsman C, Lundbäck B, Rönmark E. Severe asthma is related to high societal costs and decreased health related quality of life. Respir Med. 2020;162:105860. doi:10.1016/j.rmed.2019.105860.
   PubMed Web of Science ®Google Scholar
• Soumelis V, Reche PA, Kanzler H, Yuan W, Edward G, Homey B, Gilliet M, Ho S, Antonenko S, Lauerma A, 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.
   PubMed Web of Science ®Google Scholar
• Allakhverdi Z, Comeau MR, Jessup HK, Yoon BR, Brewer A, Chartier S, Paquette N, Ziegler SF, Sarfati M, Delespesse G. 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.
   PubMed Web of Science ®Google Scholar
• Corren J, Parnes JR, Wang L, Mo M, Roseti SL, Griffiths JM, van der Merwe R. Tezepelumab in adults with uncontrolled asthma. N Engl J Med. 2017;377(10):936–946. doi:10.1056/NEJMoa1704064.
   PubMed Web of Science ®Google Scholar
• Gauvreau GM, O’Byrne PM, Boulet LP, Wang Y, Cockcroft D, Bigler J, FitzGerald JM, Boedigheimer M, Davis BE, Dias C, 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.
   PubMed Web of Science ®Google Scholar
• Pham T, Ren P, Parnes JR, Griffiths JM. Tezepelumab reduces multiple key inflammatory biomarkers in patients with severe, uncontrolled asthma in the phase 2b PATHWAY study. AJRCCM. 2019;199:A2677.
   Google Scholar
• Menzies-Gow A, Corren J, Bourdin A, Chupp G, Israel E, Wechsler ME, Brightling CE, Griffiths JM, Hellqvist Å, Bowen K, et al. Tezepelumab in adults and adolescents with severe, uncontrolled asthma. N Engl J Med. 2021;384(19):1800–1809. doi:10.1056/NEJMoa2034975.
   PubMed Web of Science ®Google Scholar
• Menzies-Gow A, Corren J, Bourdin A, Chupp G, Israel E, Griffiths J, Hellqvist Å, Bowen K, Kaur P, Almqvist G, et al. Efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma: results from the phase 3 NAVIGATOR study. J Allergy Clin Immunol. 2021;147(2 suppl):AB249. doi:10.1016/j.jaci.2020.12.050.
   Web of Science ®Google Scholar
• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: the extent of population exposure to assess clinical safety for drugs intended for long-term treatment of non-life-threatening conditions. 1994. Available from: https://www.pmda.go.jp/files/000156791.pdf.
   Google Scholar
• American Thoracic Society. Sleep related questionnaires. Available from: https://www.thoracic.org/members/­assemblies/assemblies/srn/questionaires/acq.php.
   Google Scholar
• Juniper EF, O’Byrne PM, Guyatt G, Ferrie P, King D. Development and validation of a questionnaire to ­measure asthma control. Eur Respir J. 1999;14(4):902–907. doi:10.1034/j.1399-3003.1999.14d29.x.
   PubMed Web of Science ®Google Scholar
• Juniper EF, Svensson K, Mörk AC, Ståhl E. Measurement properties and interpretation of three shortened versions of the asthma control questionnaire. Respir Med. 2005;99(5):553–558. doi:10.1016/j.rmed.2004.10.008.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Diver S, Khalfaoui L, Emson C, Wenzel SE, Menzies-Gow A, Wechsler ME, Johnston J, Molfino N, Parnes JR, Megally A, et al. Effect of tezepelumab on airway inflammatory cells, remodelling, and ­hyperresponsiveness in patients with moderate-to-severe uncontrolled asthma (CASCADE): a double-blind, randomized, placebo-controlled, phase 2 trial. Lancet Respir Med. 2021;9(11):1299–1312. doi:10.1016/S2213-2600(21)00226-5.
   PubMed Web of Science ®Google Scholar