{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T13:47:30Z","timestamp":1782827250413,"version":"3.54.5"},"reference-count":27,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T00:00:00Z","timestamp":1782777600000},"content-version":"unspecified","delay-in-days":29,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"AstraZeneca Farmac\u00e9utica Spain SA","award":["NA"],"award-info":[{"award-number":["NA"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,6,12]]},"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Asthma is a prevalent chronic respiratory disease characterised by airway inflammation, reversible airflow obstruction and airway hyper-responsiveness. Most patients with severe asthma (SA) remain uncontrolled despite the availability of multiple therapies, representing a significant global health burden.<\/jats:p>\n                    <jats:p>Thymic stromal lymphopoietin (TSLP) is an epithelial cell-derived cytokine that plays a central role in asthma initiation via both allergic and non-allergic mechanisms as well as in the persistence of airway inflammation in patients with asthma, acting upstream in the inflammatory cascade.<\/jats:p>\n                    <jats:p>Tezepelumab, a monoclonal antibody that targets TSLP, has shown clinical efficacy and safety in pivotal trials in patients with T2 and non-T2 asthma. Tezepelumab was approved for use in Europe in October 2022, and the marketing authorisation was issued in Spain in October 2023.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods\/design<\/jats:title>\n                    <jats:p>The T-ROSS II study is a retrospective, observational, single-arm, multicentre study planned to include 400 patients aged \u226512 years treated in SA units. T-ROSS II will represent the largest published series of patients with SA who initiated tezepelumab after its market authorisation.<\/jats:p>\n                    <jats:p>Eligible patients must have at least 12 months of medical history prior to treatment initiation and a minimum of 3 months of follow-up data recorded in the electronic health records.<\/jats:p>\n                    <jats:p>The co-primary outcomes are to describe baseline patient demographics and clinical characteristics and evaluate changes in the annualised asthma exacerbation rate before and after the initiation of tezepelumab.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>These findings will complement clinical trial data and inform physicians and healthcare decision-makers about the real-world effectiveness and utilization of tezepelumab in patients with SA. This study is expected to provide valuable insights into the clinical outcomes and treatment patterns of this population.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The final protocol of the study has been approved by the ethics committee\/Institutional Review Board (EC\/IRB) of the University Hospital 12 de Octubre (Madrid, Spain) (EC\/IRB number: 25\/226). The results will be disseminated through scientific publications, including manuscripts submitted to peer-reviewed journals and presentations at national and international congresses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT07013760\">NCT07013760<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-115512","type":"journal-article","created":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T13:19:56Z","timestamp":1782825596000},"page":"e115512","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Characteristics and clinical outcomes of patients with severe asthma receiving tezepelumab after marketing approval in Spain (T-ROSS II study): an observational study protocol"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct07013760","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06487065","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Christian","family":"Domingo","sequence":"first","affiliation":[{"name":"Pneumology Service, Hospital Parc Taul\u00ed, Sabadell, Universidad Aut\u00f3noma de Barcelona, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gema","family":"Monteagudo","sequence":"additional","affiliation":[{"name":"Biopharmaceuticals Medical, AstraZeneca Farmac\u00e9utica Spain, SA, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-4799-6429","authenticated-orcid":false,"given":"Francisco","family":"Ramos-Lima","sequence":"additional","affiliation":[{"name":"Biopharmaceuticals Medical, AstraZeneca Farmac\u00e9utica Spain, SA, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-4755-4584","authenticated-orcid":false,"given":"Marta","family":"Alegr\u00eda","sequence":"additional","affiliation":[{"name":"Biopharmaceuticals Medical, AstraZeneca Farmac\u00e9utica Spain, SA, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriel","family":"Niza","sequence":"additional","affiliation":[{"name":"Biopharmaceuticals Medical, AstraZeneca Farmac\u00e9utica Spain, SA, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marta","family":"Robles","sequence":"additional","affiliation":[{"name":"Biopharmaceuticals Medical, AstraZeneca Farmac\u00e9utica Spain, SA, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Dom\u00ednguez-Ortega","sequence":"additional","affiliation":[{"name":"Department of Allergy, Institute for Health Research (IdiPAZ), Hospital Universitario La Paz, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,6,30]]},"reference":[{"key":"2026063005552366000_16.6.e115512.1","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201804-0682CI"},{"key":"2026063005552366000_16.6.e115512.2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)30925-9"},{"key":"2026063005552366000_16.6.e115512.3","unstructured":"Global strategy for asthma management and prevention. 2025. 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