Kai-Michael Beeh, Karl Scheithe, Heike Schmutzler, Saskia Krüger
{"title":"在ELLITHE试验中，糠酸氟替卡松/乌莫替尼/维兰特罗每日一次单吸入三联疗法的临床重要改善和疾病稳定性：事后反应分析","authors":"Kai-Michael Beeh, Karl Scheithe, Heike Schmutzler, Saskia Krüger","doi":"10.1007/s41030-025-00306-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Responder analyses provide information about characteristics associated with therapeutic benefits. Short-term responses may predict long-term benefits. We evaluated responders, clinically important improvement (CII), disease stability (DS), and the relation of short- to long-term responses in patients with chronic obstructive pulmonary disease (COPD) in ELLITHE.</p><p><strong>Methods: </strong>ELLITHE was a multicenter, open-label, non-interventional effectiveness study between 2020 and 2022 evaluating the effects of treatment initiation with once-daily single-inhaler triple therapy (odSITT) FF/UMEC/VI (100/62.5/25 µg via ELLIPTA) on COPD Assessment Test (CAT), forced expiratory volume in 1 s (FEV<sub>1</sub>), and exacerbations over 12 months. Post hoc responder analyses for CAT (≥ 2 units improvement), FEV<sub>1</sub> (≥ 100 ml change), and exacerbations (no event) were performed. Composite endpoints CII and DS (CII = response to at least two outcomes; DS = absence of clinically important deterioration for all outcomes) were also evaluated.</p><p><strong>Results: </strong>A total of 786 patients had available data for any analysis. At study completion, 53.3% of patients were CAT, 36.7% FEV<sub>1</sub>, and 90.2% exacerbation responders, with 22.1% responding to all outcomes; 64.3% had a CII, and 52.7% showed DS. CII and DS were more frequent in subjects with higher baseline CAT score, and DS in patients on prior ICS/LABA therapy (all p < 0.05). Early (3 months) CAT, FEV<sub>1</sub> and CII response strongly predicted respective responses at study end (odds ratios = OR ranging from 6.3 to 7.4), and DS (OR from 3.0 to 4.2). In the patient subset with available baseline eosinophil counts, response was generally similar at < 150 versus ≥ 150 cells/μl.</p><p><strong>Conclusions: </strong>Despite overlapping responses to single and composite outcomes with odSITT, individual patterns support a multidimensional approach to evaluate benefits in COPD. Responders had higher baseline CAT scores and frequency of prior dual therapies. Short-term responses of FEV<sub>1</sub> and/or CAT were reasonable predictors of long-term responses, including DS. DS was achievable for the majority of patients and may represent a useful outcome for future COPD research and management.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"443-459"},"PeriodicalIF":3.0000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12373607/pdf/","citationCount":"0","resultStr":"{\"title\":\"Clinically Important Improvements and Disease Stability with Fluticasone Furoate/Umeclidinium/Vilanterol Once-Daily Single-Inhaler Triple Therapy in the ELLITHE Trial: A Post Hoc Responder Analysis.\",\"authors\":\"Kai-Michael Beeh, Karl Scheithe, Heike Schmutzler, Saskia Krüger\",\"doi\":\"10.1007/s41030-025-00306-1\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Responder analyses provide information about characteristics associated with therapeutic benefits. Short-term responses may predict long-term benefits. We evaluated responders, clinically important improvement (CII), disease stability (DS), and the relation of short- to long-term responses in patients with chronic obstructive pulmonary disease (COPD) in ELLITHE.</p><p><strong>Methods: </strong>ELLITHE was a multicenter, open-label, non-interventional effectiveness study between 2020 and 2022 evaluating the effects of treatment initiation with once-daily single-inhaler triple therapy (odSITT) FF/UMEC/VI (100/62.5/25 µg via ELLIPTA) on COPD Assessment Test (CAT), forced expiratory volume in 1 s (FEV<sub>1</sub>), and exacerbations over 12 months. Post hoc responder analyses for CAT (≥ 2 units improvement), FEV<sub>1</sub> (≥ 100 ml change), and exacerbations (no event) were performed. Composite endpoints CII and DS (CII = response to at least two outcomes; DS = absence of clinically important deterioration for all outcomes) were also evaluated.</p><p><strong>Results: </strong>A total of 786 patients had available data for any analysis. At study completion, 53.3% of patients were CAT, 36.7% FEV<sub>1</sub>, and 90.2% exacerbation responders, with 22.1% responding to all outcomes; 64.3% had a CII, and 52.7% showed DS. CII and DS were more frequent in subjects with higher baseline CAT score, and DS in patients on prior ICS/LABA therapy (all p < 0.05). Early (3 months) CAT, FEV<sub>1</sub> and CII response strongly predicted respective responses at study end (odds ratios = OR ranging from 6.3 to 7.4), and DS (OR from 3.0 to 4.2). 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Clinically Important Improvements and Disease Stability with Fluticasone Furoate/Umeclidinium/Vilanterol Once-Daily Single-Inhaler Triple Therapy in the ELLITHE Trial: A Post Hoc Responder Analysis.
Introduction: Responder analyses provide information about characteristics associated with therapeutic benefits. Short-term responses may predict long-term benefits. We evaluated responders, clinically important improvement (CII), disease stability (DS), and the relation of short- to long-term responses in patients with chronic obstructive pulmonary disease (COPD) in ELLITHE.
Methods: ELLITHE was a multicenter, open-label, non-interventional effectiveness study between 2020 and 2022 evaluating the effects of treatment initiation with once-daily single-inhaler triple therapy (odSITT) FF/UMEC/VI (100/62.5/25 µg via ELLIPTA) on COPD Assessment Test (CAT), forced expiratory volume in 1 s (FEV1), and exacerbations over 12 months. Post hoc responder analyses for CAT (≥ 2 units improvement), FEV1 (≥ 100 ml change), and exacerbations (no event) were performed. Composite endpoints CII and DS (CII = response to at least two outcomes; DS = absence of clinically important deterioration for all outcomes) were also evaluated.
Results: A total of 786 patients had available data for any analysis. At study completion, 53.3% of patients were CAT, 36.7% FEV1, and 90.2% exacerbation responders, with 22.1% responding to all outcomes; 64.3% had a CII, and 52.7% showed DS. CII and DS were more frequent in subjects with higher baseline CAT score, and DS in patients on prior ICS/LABA therapy (all p < 0.05). Early (3 months) CAT, FEV1 and CII response strongly predicted respective responses at study end (odds ratios = OR ranging from 6.3 to 7.4), and DS (OR from 3.0 to 4.2). In the patient subset with available baseline eosinophil counts, response was generally similar at < 150 versus ≥ 150 cells/μl.
Conclusions: Despite overlapping responses to single and composite outcomes with odSITT, individual patterns support a multidimensional approach to evaluate benefits in COPD. Responders had higher baseline CAT scores and frequency of prior dual therapies. Short-term responses of FEV1 and/or CAT were reasonable predictors of long-term responses, including DS. DS was achievable for the majority of patients and may represent a useful outcome for future COPD research and management.
期刊介绍：
Aims and Scope
Pulmonary Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from pre-clinical, clinical (all phases), observational, real-world, and health outcomes research around the use of pulmonary therapies, devices, and surgical techniques.
Areas of focus include, but are not limited to: asthma; chronic obstructive pulmonary disease; idiopathic pulmonary fibrosis; pulmonary hypertension; cystic fibrosis; lung cancer; respiratory tract disorders; allergic rhinitis and other respiratory allergies; influenza, pneumococcal infection, respiratory syncytial virus and other respiratory infections; and inhalers and other device therapies.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Pulmonary Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals.
Rapid Publication
The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of pulmonary therapies.
Open Access
All articles published by Pulmonary Therapy are open access.
Personal Service
The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning authors will always have an editorial contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research.
Digital Features and Plain Language Summaries
Pulmonary Therapy offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by key summary points, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand the scientific content and overall implications of the article. The journal also provides the option to include various types of digital features including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations. All additional features are peer reviewed to the same high standard as the article itself. If you consider that your paper would benefit from the inclusion of a digital feature, please let us know. Our editorial team are able to create high-quality slide decks and infographics in-house, and video abstracts through our partner Research Square, and would be happy to assist in any way we can. For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’.
For examples of digital features please visit our showcase page https://springerhealthcare.com/expertise/publishing-digital-features/
Publication Fees
Upon acceptance of an article, authors will be required to pay the mandatory Rapid Service Fee of €4500/ $5100/ £3650. The journal will consider fee discounts and waivers for developing countries and this is decided on a case by case basis.
Peer Review Process
Upon submission, manuscripts are assessed by the editorial team to ensure they fit within the aims and scope of the journal and are also checked for plagiarism. All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria.
At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials, and Letters which are generally reviewed by one member of the Editorial Board. Where reviewer recommendations are conflicted, the editorial board will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed). Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case-by-case basis and should be sent to the journal editor.
Preprints
We encourage posting of preprints of primary research manuscripts on preprint servers, authors’ or institutional websites, and open communications between researchers whether on community preprint servers or preprint commenting platforms. Posting of preprints is not considered prior publication and will not jeopardize consideration in our journals. Authors should disclose details of preprint posting during the submission process or at any other point during consideration in one of our journals. Once the manuscript is published, it is the author’s responsibility to ensure that the preprint record is updated with a publication reference, including the DOI and a URL link to the published version of the article on the journal website.
Please follow the link for further information on preprint sharing:
https://www.springer.com/gp/authors-editors/journal-author/journal-author-helpdesk/submission/1302#c16721550
Copyright
Pulmonary Therapy''s content is published open access under the Creative Commons Attribution-Noncommercial License, which allows users to read, copy, distribute, and make derivative works for non-commercial purposes from the material, as long as the author of the original work is cited. The author assigns the exclusive right to any commercial use of the article to Springer. For more information about the Creative Commons Attribution-Noncommercial License, click here: http://creativecommons.org/licenses/by-nc/4.0.
Contact
For more information about the journal, including pre-submission enquiries, please contact christopher.vautrinot@springer.com.
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