{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T16:04:25Z","timestamp":1791993865845,"version":"4.4.0"},"reference-count":40,"publisher":"European Respiratory Society (ERS)","issue":"6","license":[{"start":{"date-parts":[[2024,9,26]],"date-time":"2024-09-26T00:00:00Z","timestamp":1727308800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"This study was funded by AstraZeneca and Amgen Inc.","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["publications.ersnet.org"],"crossmark-restriction":true},"short-container-title":["Eur Respir J"],"accepted":{"date-parts":[[2024,8,23]]},"published-print":{"date-parts":[[2024,12]]},"abstract":"\n Background<\/jats:title>\n \n In asthma, clinical response is characterised by disease improvement with treatment, whereas clinical remission is characterised by long-term disease stabilisation with or without ongoing treatment. The proportions of patients receiving tezepelumab who responded to treatment and who achieved on-treatment clinical remission were assessed in the NAVIGATOR (ClinicalTrials.gov identifier\n NCT03347279<\/jats:ext-link>\n ) and DESTINATION (ClinicalTrials.gov identifier\n NCT03706079<\/jats:ext-link>\n ) studies of severe, uncontrolled asthma.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n NAVIGATOR and DESTINATION were phase 3, randomised, double-blind, placebo-controlled studies; DESTINATION was an extension of NAVIGATOR. Complete clinical response was defined as achieving all of the following: \u226550% reduction in exacerbations\n versus<\/jats:italic>\n the previous year, improvements in pre-bronchodilator (BD) forced expiratory volume in 1\u2005s (FEV\n 1<\/jats:sub>\n ) of \u2265100\u2005mL or \u22655%, improvements in Asthma Control Questionnaire (ACQ)-6 score of \u22650.5 and physician's assessment of asthma improvement. On-treatment clinical remission was defined as an ACQ-6 total score \u22641.5, stable lung function (pre-BD FEV\n 1<\/jats:sub>\n >95% of baseline) and no exacerbations or use of oral corticosteroids during the time periods assessed.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Higher proportions of tezepelumab than placebo recipients achieved complete clinical response over weeks 0\u201352 (46%\n versus<\/jats:italic>\n 24%; OR 2.83, 95% CI 2.10\u20133.82) and on-treatment clinical remission over weeks 0\u201352 (28.5%\n versus<\/jats:italic>\n 21.9%; OR 1.44, 95% CI 0.95\u20132.19) and weeks >52\u2013104 (33.5%\n versus<\/jats:italic>\n 26.7%; OR 1.44, 95% CI 0.97\u20132.14). Tezepelumab recipients who achieved on-treatment clinical remission\n versus<\/jats:italic>\n complete clinical response at week 52 had better preserved lung function and lower inflammatory biomarker levels at baseline, and fewer exacerbations in the 12\u2005months before the study.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n Among patients with severe, uncontrolled asthma, tezepelumab treatment was associated with an increased likelihood of achieving complete clinical response and on-treatment clinical remission compared with placebo. Both are clinically important outcomes, but may be driven by different patient characteristics.<\/jats:p>\n <\/jats:sec>","DOI":"10.1183\/13993003.00316-2024","type":"journal-article","created":{"date-parts":[[2024,9,26]],"date-time":"2024-09-26T11:40:06Z","timestamp":1727350806000},"page":"2400316","update-policy":"https:\/\/doi.org\/10.1183\/ers-crossmark-policy","source":"Crossref","is-referenced-by-count":52,"title":["Clinical response and on-treatment clinical remission with tezepelumab in a broad population of patients with severe, uncontrolled asthma: results over 2 years from the NAVIGATOR and DESTINATION studies"],"prefix":"10.1183","volume":"64","author":[{"given":"Michael E.","family":"Wechsler","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7021-8505","authenticated-orcid":false,"given":"Guy","family":"Brusselle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4291-1956","authenticated-orcid":false,"given":"J. Christian","family":"Virchow","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4645-5209","authenticated-orcid":false,"given":"Arnaud","family":"Bourdin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0774-3942","authenticated-orcid":false,"given":"Konstantinos","family":"Kostikas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7785-6881","authenticated-orcid":false,"given":"Jean-Pierre","family":"Llanos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie L.","family":"Roseti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher S.","family":"Ambrose","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gillian","family":"Hunter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David J.","family":"Jackson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mario","family":"Castro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Njira","family":"Lugogo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian D.","family":"Pavord","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neil","family":"Martin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher E.","family":"Brightling","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"81","published-online":{"date-parts":[[2024,9,26]]},"reference":[{"key":"2024123107450505000_64.6.2400316.1","unstructured":"World Health Organization . Asthma. www.who.int\/news-room\/fact-sheets\/detail\/asthma. Date last accessed: 19 August 2022. Date last updated: 6 May 2024."},{"key":"2024123107450505000_64.6.2400316.2","unstructured":"Global Asthma Network . The Global Asthma Report 2022. https:\/\/globalasthmareport.org\/. Date last accessed: 12 October 2023."},{"key":"2024123107450505000_64.6.2400316.3","doi-asserted-by":"crossref","first-page":"4721","DOI":"10.1007\/s12325-023-02647-2","article-title":"Efficacy of biologics in patients with allergic severe asthma, overall and by blood eosinophil count: a literature review","volume":"40","author":"Bernstein","year":"2023","journal-title":"Adv Ther"},{"key":"2024123107450505000_64.6.2400316.4","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00202013"},{"key":"2024123107450505000_64.6.2400316.5","unstructured":"Global Initiative for Asthma . Global Strategy for Asthma Management and Prevention 2023. https:\/\/ginasthma.org\/wp-content\/uploads\/2023\/05\/GINA-2023-Full-Report-2023-WMS.pdf. Date last accessed 3 May 2023."},{"key":"2024123107450505000_64.6.2400316.6","doi-asserted-by":"publisher","DOI":"10.1080\/14728222.2020.1783242"},{"key":"2024123107450505000_64.6.2400316.7","doi-asserted-by":"crossref","first-page":"1299","DOI":"10.1016\/S2213-2600(21)00226-5","article-title":"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","volume":"9","author":"Diver","year":"2021","journal-title":"Lancet Respir Med"},{"key":"2024123107450505000_64.6.2400316.8","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.01296-2021"},{"key":"2024123107450505000_64.6.2400316.9","doi-asserted-by":"crossref","first-page":"EVIDoa2300135","DOI":"10.1056\/EVIDoa2300135","article-title":"Tezepelumab and mucus plugs in patients with moderate-to-severe asthma","volume":"2","author":"Nordenmark","year":"2023","journal-title":"NEJM Evid"},{"key":"2024123107450505000_64.6.2400316.10","unstructured":"European Medicines Agency (EMA) . Tezspire (Tezepelumab) Medicine Overview. 2022. www.ema.europa.eu\/en\/documents\/overview\/tezspire-epar-medicine-overview_en.pdf. Date last accessed: 14 April 2023."},{"key":"2024123107450505000_64.6.2400316.11","unstructured":"U.S. Food and Drug Administration (FDA). Tezspire (Tezepelumab) Prescribing Information. 2021. www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/761224s000lbl.pdf. 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