Clinical effectiveness and potential predictability of omalizumab in patients with difficult-to-treat chronic rhinosinusitis with nasal polyps and asthma based on the noninvasive markers – A real-life prospective study

Background: Clinical studies on the effectiveness of omalizumab in patients with difficult-to-treat chronic rhinosinusitis with nasal polyps (CRSwNP) and asthma are scarce in China. Moreover, identifying potential biomarkers predicting its efficacy remains a great challenge. Methods: In this prospec...

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Main Authors: Ming Zheng, MD, PhD, Yutong Sima, MD, Chengyao Liu, MD, PhD, Jinming Zhao, MD, Shan Shao, MD, Xinmao Wang, MD, Yue Wang, MD, Feifei Cao, BS, Wei Xiong, BS, Xiangdong Wang, MD, PhD, Luo Zhang, MD, PhD
Format: Article
Language:English
Published: Elsevier 2022-10-01
Series:World Allergy Organization Journal
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Online Access:http://www.sciencedirect.com/science/article/pii/S1939455122000783
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author Ming Zheng, MD, PhD
Yutong Sima, MD
Chengyao Liu, MD, PhD
Jinming Zhao, MD
Shan Shao, MD
Xinmao Wang, MD
Yue Wang, MD
Feifei Cao, BS
Wei Xiong, BS
Xiangdong Wang, MD, PhD
Luo Zhang, MD, PhD
author_facet Ming Zheng, MD, PhD
Yutong Sima, MD
Chengyao Liu, MD, PhD
Jinming Zhao, MD
Shan Shao, MD
Xinmao Wang, MD
Yue Wang, MD
Feifei Cao, BS
Wei Xiong, BS
Xiangdong Wang, MD, PhD
Luo Zhang, MD, PhD
author_sort Ming Zheng, MD, PhD
collection DOAJ
description Background: Clinical studies on the effectiveness of omalizumab in patients with difficult-to-treat chronic rhinosinusitis with nasal polyps (CRSwNP) and asthma are scarce in China. Moreover, identifying potential biomarkers predicting its efficacy remains a great challenge. Methods: In this prospective trial, all enrolled patients underwent endoscopic examination, computed tomography, blood tests, etc, and they completed a 22-item sino-nasal outcome test (SNOT-22), visual analogue scale (VAS), and asthma control test (ACT) evaluation, at baseline and after 24-week omalizumab therapy. Results: Twenty-two patients were finally recruited. Their VAS scores were significantly better including nasal congestion, anterior rhinorrhea, postnasal drip, and loss of smell (P < 0.01). Seventeen patients reported a reduction in SNOT-22 scores of ≥8.9 and 19 patients achieved ACT scores >20. The median change in the Lund-MacKay score (LMS) was 6. Both the Lund-Kennedy score (LKS) and nasal polyp score showed significant improvement (P < 0.01). Only 3 parameters in the pulmonary function test showed evident amelioration (P < 0.05). The eosinophilic CRSwNP and the male subgroups showed better improvements in subjective and objective evaluation. A receiver operating characteristic curve indicated a cutoff value of 17.5 and 16.5 in LMS had the moderate predictive value (AUC = 0.706) for the decline in the SNOT-22 (more than 8.9 points) and reduction in anterior rhinorrhea VAS (more than 2 cm), respectively. A cutoff value of 18.5 in ACT could provide the moderate predictive value (AUC = 0.771) for the reduction of loss of smell VAS (more than 2 cm). Conclusions: The beneficial effectiveness of omalizumab in the patients with difficult-to-treat CRSwNP and asthma was confirmed. ECRSwNP and male patients were more likely to have positive responses. The multiple cutoff values for the LMS and ACT may serve as useful predictors for improvement acceptable to difficult-to-treat CRSwNP patients.
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spelling doaj.art-606e44a5fabf49928e8fe670ae2564ac2022-12-22T02:34:36ZengElsevierWorld Allergy Organization Journal1939-45512022-10-011510100702Clinical effectiveness and potential predictability of omalizumab in patients with difficult-to-treat chronic rhinosinusitis with nasal polyps and asthma based on the noninvasive markers – A real-life prospective studyMing Zheng, MD, PhD0Yutong Sima, MD1Chengyao Liu, MD, PhD2Jinming Zhao, MD3Shan Shao, MD4Xinmao Wang, MD5Yue Wang, MD6Feifei Cao, BS7Wei Xiong, BS8Xiangdong Wang, MD, PhD9Luo Zhang, MD, PhD10Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, ChinaDepartment of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China; Beijing Laboratory of Allergic Diseases and Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otorhinolaryngology, Beijing, ChinaDepartment of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, ChinaDepartment of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China; Beijing Laboratory of Allergic Diseases and Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otorhinolaryngology, Beijing, ChinaDepartment of Otolaryngology Head and Neck Surgery, Beijing Youan Hospital, Capital Medical University, Beijing, ChinaRespiratory Department, Beijing TongRen Hospital, Capital Medical University, Beijing, ChinaDepartment of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China; Beijing Laboratory of Allergic Diseases and Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otorhinolaryngology, Beijing, ChinaDepartment of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, ChinaDepartment of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, ChinaDepartment of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China; Beijing Laboratory of Allergic Diseases and Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otorhinolaryngology, Beijing, China; Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, China; Corresponding author. Department of Otorhinolaryngology Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University, Beijing, China. Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing 100005, China.Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China; Beijing Laboratory of Allergic Diseases and Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otorhinolaryngology, Beijing, China; Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, China; Research Unit of Diagnosis and Treatment of Chronic Nasal Diseases, Chinese Academy of Medical Sciences, Beijing, China; Corresponding author. Department of Otorhinolaryngology Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University, Beijing, China. Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing 100005, China.Background: Clinical studies on the effectiveness of omalizumab in patients with difficult-to-treat chronic rhinosinusitis with nasal polyps (CRSwNP) and asthma are scarce in China. Moreover, identifying potential biomarkers predicting its efficacy remains a great challenge. Methods: In this prospective trial, all enrolled patients underwent endoscopic examination, computed tomography, blood tests, etc, and they completed a 22-item sino-nasal outcome test (SNOT-22), visual analogue scale (VAS), and asthma control test (ACT) evaluation, at baseline and after 24-week omalizumab therapy. Results: Twenty-two patients were finally recruited. Their VAS scores were significantly better including nasal congestion, anterior rhinorrhea, postnasal drip, and loss of smell (P < 0.01). Seventeen patients reported a reduction in SNOT-22 scores of ≥8.9 and 19 patients achieved ACT scores >20. The median change in the Lund-MacKay score (LMS) was 6. Both the Lund-Kennedy score (LKS) and nasal polyp score showed significant improvement (P < 0.01). Only 3 parameters in the pulmonary function test showed evident amelioration (P < 0.05). The eosinophilic CRSwNP and the male subgroups showed better improvements in subjective and objective evaluation. A receiver operating characteristic curve indicated a cutoff value of 17.5 and 16.5 in LMS had the moderate predictive value (AUC = 0.706) for the decline in the SNOT-22 (more than 8.9 points) and reduction in anterior rhinorrhea VAS (more than 2 cm), respectively. A cutoff value of 18.5 in ACT could provide the moderate predictive value (AUC = 0.771) for the reduction of loss of smell VAS (more than 2 cm). Conclusions: The beneficial effectiveness of omalizumab in the patients with difficult-to-treat CRSwNP and asthma was confirmed. ECRSwNP and male patients were more likely to have positive responses. The multiple cutoff values for the LMS and ACT may serve as useful predictors for improvement acceptable to difficult-to-treat CRSwNP patients.http://www.sciencedirect.com/science/article/pii/S1939455122000783Chronic rhinosinusitis with nasal polypsAsthmaOmalizumabDifficult-to-treatReceiver operating characteristic curves
spellingShingle Ming Zheng, MD, PhD
Yutong Sima, MD
Chengyao Liu, MD, PhD
Jinming Zhao, MD
Shan Shao, MD
Xinmao Wang, MD
Yue Wang, MD
Feifei Cao, BS
Wei Xiong, BS
Xiangdong Wang, MD, PhD
Luo Zhang, MD, PhD
Clinical effectiveness and potential predictability of omalizumab in patients with difficult-to-treat chronic rhinosinusitis with nasal polyps and asthma based on the noninvasive markers – A real-life prospective study
World Allergy Organization Journal
Chronic rhinosinusitis with nasal polyps
Asthma
Omalizumab
Difficult-to-treat
Receiver operating characteristic curves
title Clinical effectiveness and potential predictability of omalizumab in patients with difficult-to-treat chronic rhinosinusitis with nasal polyps and asthma based on the noninvasive markers – A real-life prospective study
title_full Clinical effectiveness and potential predictability of omalizumab in patients with difficult-to-treat chronic rhinosinusitis with nasal polyps and asthma based on the noninvasive markers – A real-life prospective study
title_fullStr Clinical effectiveness and potential predictability of omalizumab in patients with difficult-to-treat chronic rhinosinusitis with nasal polyps and asthma based on the noninvasive markers – A real-life prospective study
title_full_unstemmed Clinical effectiveness and potential predictability of omalizumab in patients with difficult-to-treat chronic rhinosinusitis with nasal polyps and asthma based on the noninvasive markers – A real-life prospective study
title_short Clinical effectiveness and potential predictability of omalizumab in patients with difficult-to-treat chronic rhinosinusitis with nasal polyps and asthma based on the noninvasive markers – A real-life prospective study
title_sort clinical effectiveness and potential predictability of omalizumab in patients with difficult to treat chronic rhinosinusitis with nasal polyps and asthma based on the noninvasive markers a real life prospective study
topic Chronic rhinosinusitis with nasal polyps
Asthma
Omalizumab
Difficult-to-treat
Receiver operating characteristic curves
url http://www.sciencedirect.com/science/article/pii/S1939455122000783
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