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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Elsevier
2022-10-01
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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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