Martin Desrosiers, Scott Nash, Andrew Lane, Stella E Lee, Eugenio De Corso, Changming Xia, Mark Corbett, Amr Radwan, Paul J Rowe, Yamo Deniz
{"title":"来自us -24/-52研究的严重CRSwNP患者的峰值鼻吸入流量及其与鼻塞的关系","authors":"Martin Desrosiers, Scott Nash, Andrew Lane, Stella E Lee, Eugenio De Corso, Changming Xia, Mark Corbett, Amr Radwan, Paul J Rowe, Yamo Deniz","doi":"10.1007/s12325-025-03378-2","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Nasal congestion/obstruction (NC) contributes to the high disease burden in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP). Patient perception of NC may not accurately reflect nasal patency, while peak nasal inspiratory flow (PNIF) is an objective method with established thresholds for normal nasal airflow. This analysis evaluated the association between NC and PNIF and the impact of baseline PNIF on dupilumab efficacy in patients with severe CRSwNP.</p><p><strong>Methods: </strong>This was a post hoc analysis of patients treated with placebo or dupilumab 300 mg every 2 weeks in the SINUS-24 (NCT02912468) and SINUS-52 (NCT02898454) phase III studies. Patients provided daily e-diary measures of PNIF (L/min) using PNIF meters, and NC by patient-reported evaluation of severity (scored 0-3). Other assessed outcomes were nasal polyp score (NPS), 22-item Sinonasal Outcome Test (SNOT-22), loss of smell (LoS), University of Pennsylvania Smell Identification Test (UPSIT), and Lund-Mackay computed tomography. Outcomes were assessed in two subgroups: baseline PNIF < 120 L/min and ≥ 120 L/min.</p><p><strong>Results: </strong>Of 724 patients, 552 (76%) had PNIF < 120 L/min and 172 (24%) had PNIF ≥ 120 L/min at baseline. The PNIF < 120 L/min subgroup had higher mean scores for NPS and SNOT-22 and more smell impairment (LoS and UPSIT). PNIF weakly correlated with NC at baseline (Spearman coefficient - 0.348 [95% CI - 0.410, - 0.282], P < 0.0001). Correlations between change from baseline in PNIF and NC at week 24 were weak in the dupilumab group (- 0.390 [- 0.468, - 0.305], P < 0.0001) and moderate in the placebo group (- 0.497 [- 0.582, - 0.399], P < 0.0001).</p><p><strong>Conclusion: </strong>These results confirm PNIF as a valuable method for assessing nasal obstruction in patients with severe CRSwNP. The degree of nasal flow impairment at baseline does not impact dupilumab's efficacy. A graphical abstract and video abstract are available for this article.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0000,"publicationDate":"2025-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Peak Nasal Inspiratory Flow and the Association with Nasal Obstruction in Patients with Severe CRSwNP from the SINUS-24/-52 Studies.\",\"authors\":\"Martin Desrosiers, Scott Nash, Andrew Lane, Stella E Lee, Eugenio De Corso, Changming Xia, Mark Corbett, Amr Radwan, Paul J Rowe, Yamo Deniz\",\"doi\":\"10.1007/s12325-025-03378-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Nasal congestion/obstruction (NC) contributes to the high disease burden in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP). Patient perception of NC may not accurately reflect nasal patency, while peak nasal inspiratory flow (PNIF) is an objective method with established thresholds for normal nasal airflow. This analysis evaluated the association between NC and PNIF and the impact of baseline PNIF on dupilumab efficacy in patients with severe CRSwNP.</p><p><strong>Methods: </strong>This was a post hoc analysis of patients treated with placebo or dupilumab 300 mg every 2 weeks in the SINUS-24 (NCT02912468) and SINUS-52 (NCT02898454) phase III studies. Patients provided daily e-diary measures of PNIF (L/min) using PNIF meters, and NC by patient-reported evaluation of severity (scored 0-3). Other assessed outcomes were nasal polyp score (NPS), 22-item Sinonasal Outcome Test (SNOT-22), loss of smell (LoS), University of Pennsylvania Smell Identification Test (UPSIT), and Lund-Mackay computed tomography. Outcomes were assessed in two subgroups: baseline PNIF < 120 L/min and ≥ 120 L/min.</p><p><strong>Results: </strong>Of 724 patients, 552 (76%) had PNIF < 120 L/min and 172 (24%) had PNIF ≥ 120 L/min at baseline. The PNIF < 120 L/min subgroup had higher mean scores for NPS and SNOT-22 and more smell impairment (LoS and UPSIT). PNIF weakly correlated with NC at baseline (Spearman coefficient - 0.348 [95% CI - 0.410, - 0.282], P < 0.0001). Correlations between change from baseline in PNIF and NC at week 24 were weak in the dupilumab group (- 0.390 [- 0.468, - 0.305], P < 0.0001) and moderate in the placebo group (- 0.497 [- 0.582, - 0.399], P < 0.0001).</p><p><strong>Conclusion: </strong>These results confirm PNIF as a valuable method for assessing nasal obstruction in patients with severe CRSwNP. The degree of nasal flow impairment at baseline does not impact dupilumab's efficacy. A graphical abstract and video abstract are available for this article.</p>\",\"PeriodicalId\":7482,\"journal\":{\"name\":\"Advances in Therapy\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":4.0000,\"publicationDate\":\"2025-09-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Advances in Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s12325-025-03378-2\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s12325-025-03378-2","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
Peak Nasal Inspiratory Flow and the Association with Nasal Obstruction in Patients with Severe CRSwNP from the SINUS-24/-52 Studies.
Introduction: Nasal congestion/obstruction (NC) contributes to the high disease burden in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP). Patient perception of NC may not accurately reflect nasal patency, while peak nasal inspiratory flow (PNIF) is an objective method with established thresholds for normal nasal airflow. This analysis evaluated the association between NC and PNIF and the impact of baseline PNIF on dupilumab efficacy in patients with severe CRSwNP.
Methods: This was a post hoc analysis of patients treated with placebo or dupilumab 300 mg every 2 weeks in the SINUS-24 (NCT02912468) and SINUS-52 (NCT02898454) phase III studies. Patients provided daily e-diary measures of PNIF (L/min) using PNIF meters, and NC by patient-reported evaluation of severity (scored 0-3). Other assessed outcomes were nasal polyp score (NPS), 22-item Sinonasal Outcome Test (SNOT-22), loss of smell (LoS), University of Pennsylvania Smell Identification Test (UPSIT), and Lund-Mackay computed tomography. Outcomes were assessed in two subgroups: baseline PNIF < 120 L/min and ≥ 120 L/min.
Results: Of 724 patients, 552 (76%) had PNIF < 120 L/min and 172 (24%) had PNIF ≥ 120 L/min at baseline. The PNIF < 120 L/min subgroup had higher mean scores for NPS and SNOT-22 and more smell impairment (LoS and UPSIT). PNIF weakly correlated with NC at baseline (Spearman coefficient - 0.348 [95% CI - 0.410, - 0.282], P < 0.0001). Correlations between change from baseline in PNIF and NC at week 24 were weak in the dupilumab group (- 0.390 [- 0.468, - 0.305], P < 0.0001) and moderate in the placebo group (- 0.497 [- 0.582, - 0.399], P < 0.0001).
Conclusion: These results confirm PNIF as a valuable method for assessing nasal obstruction in patients with severe CRSwNP. The degree of nasal flow impairment at baseline does not impact dupilumab's efficacy. A graphical abstract and video abstract are available for this article.
期刊介绍：
Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in 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 all scientifically and ethically sound research.
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