Asia Pacific Allergy最新文献

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New-onset autoimmune thyroid disease following COVID-19. COVID-19 后新发自身免疫性甲状腺疾病。
IF 1.6
Asia Pacific Allergy Pub Date : 2024-08-01 Epub Date: 2024-05-30 DOI: 10.5415/apallergy.0000000000000145
Öner Özdemir
{"title":"New-onset autoimmune thyroid disease following COVID-19.","authors":"Öner Özdemir","doi":"10.5415/apallergy.0000000000000145","DOIUrl":"10.5415/apallergy.0000000000000145","url":null,"abstract":"","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"14 3","pages":"151"},"PeriodicalIF":1.6,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11365652/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142103853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Strategic testing following toxic epidermal necrolysis allows reintroduction of chemotherapy in a patient with progressive myeloma. 在发生毒性表皮坏死后进行策略性检测,可使进展期骨髓瘤患者重新接受化疗。
IF 1.7
Asia Pacific Allergy Pub Date : 2024-06-01 Epub Date: 2023-12-18 DOI: 10.5415/apallergy.0000000000000125
Daniel Soon Lee Goh, Ramon Yuson, Praveen Gounder, James Yun, Sandhya Limaye
{"title":"Strategic testing following toxic epidermal necrolysis allows reintroduction of chemotherapy in a patient with progressive myeloma.","authors":"Daniel Soon Lee Goh, Ramon Yuson, Praveen Gounder, James Yun, Sandhya Limaye","doi":"10.5415/apallergy.0000000000000125","DOIUrl":"10.5415/apallergy.0000000000000125","url":null,"abstract":"<p><p>Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome belong to a family of severe cutaneous adverse reactions that can be life-threatening and carry a risk of significant morbidity and potential mortality in the event of re-exposure. Lifelong avoidance of the culprit agent is mandated, which can lead to the exclusion of multiple medications if the trigger is unclear. This can result in adverse health outcomes analogous to that of a penicillin allergy label. We present a case in which the patient would progress to fatal myeloma in the absence of treatment, however, multiple medications were administered prior to the occurrence of TEN following previous chemotherapy. Available risk stratification tools including human leucocyte antigen assessment and the algorithm of drug causality for epidermal necrolysis scoring system were utilized followed by patch testing which identified a lesser-suspected agent as possibly causative. Further evidence-based in vivo testing and subsequent challenges allowed for the reintroduction of life-saving chemotherapy.</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"14 2","pages":"90-92"},"PeriodicalIF":1.7,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11142759/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141199448","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Unusual anaphylaxis induced by food allergen inhalation or skin contact. 食物过敏原吸入或皮肤接触引起的异常过敏性休克。
IF 1.7
Asia Pacific Allergy Pub Date : 2024-06-01 Epub Date: 2023-10-09 DOI: 10.5415/apallergy.0000000000000118
Nan Nan Jiang, Li Xiang, Hui Jie Huang, Xiao Ling Hou
{"title":"Unusual anaphylaxis induced by food allergen inhalation or skin contact.","authors":"Nan Nan Jiang, Li Xiang, Hui Jie Huang, Xiao Ling Hou","doi":"10.5415/apallergy.0000000000000118","DOIUrl":"10.5415/apallergy.0000000000000118","url":null,"abstract":"","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"14 2","pages":"93-96"},"PeriodicalIF":1.7,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11142753/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141199451","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Artificial intelligence applications in allergic rhinitis diagnosis: Focus on ensemble learning. 人工智能在过敏性鼻炎诊断中的应用:聚焦集合学习。
IF 1.7
Asia Pacific Allergy Pub Date : 2024-06-01 Epub Date: 2023-12-18 DOI: 10.5415/apallergy.0000000000000126
Dai Fu, Zhao Chuanliang, Yang Jingdong, Meng Yifei, Tan Shiwang, Qian Yue, Yu Shaoqing
{"title":"Artificial intelligence applications in allergic rhinitis diagnosis: Focus on ensemble learning.","authors":"Dai Fu, Zhao Chuanliang, Yang Jingdong, Meng Yifei, Tan Shiwang, Qian Yue, Yu Shaoqing","doi":"10.5415/apallergy.0000000000000126","DOIUrl":"10.5415/apallergy.0000000000000126","url":null,"abstract":"<p><strong>Background: </strong>The diagnosis of allergic rhinitis (AR) primarily relies on symptoms and laboratory examinations. Due to limitations in outpatient settings, certain tests such as nasal provocation tests and nasal secretion smear examinations are not routinely conducted. Although there are clear diagnostic criteria, an accurate diagnosis still requires the expertise of an experienced doctor, considering the patient's medical history and conducting examinations. However, differences in physician knowledge and limitations of examination methods can result in variations in diagnosis.</p><p><strong>Objective: </strong>Artificial intelligence is a significant outcome of the rapid advancement in computer technology today. This study aims to present an intelligent diagnosis and detection method based on ensemble learning for AR.</p><p><strong>Method: </strong>We conducted a study on AR cases and 7 other diseases exhibiting similar symptoms, including rhinosinusitis, chronic rhinitis, upper respiratory tract infection, etc. Clinical data, encompassing medical history, clinical symptoms, allergen detection, and imaging, was collected. To develop an effective classifier, multiple models were employed to train on the same batch of data. By utilizing ensemble learning algorithms, we obtained the final ensemble classifier known as adaptive random forest-out of bag-easy ensemble (ARF-OOBEE). In order to perform comparative experiments, we selected 5 commonly used machine learning classification algorithms: Naive Bayes, support vector machine, logistic regression, multilayer perceptron, deep forest (GC Forest), and extreme gradient boosting (XGBoost).To evaluate the prediction performance of AR samples, various parameters such as precision, sensitivity, specificity, G-mean, F1-score, and area under the curve (AUC) of the receiver operating characteristic curve were jointly employed as evaluation indicators.</p><p><strong>Results: </strong>We compared 7 classification models, including probability models, tree models, linear models, ensemble models, and neural network models. The ensemble classification algorithms, namely ARF-OOBEE and GC Forest, outperformed the other algorithms in terms of the comprehensive classification evaluation index. The accuracy of G-mean and AUC parameters improved by nearly 2% when compared to the other algorithms. Moreover, these ensemble classifiers exhibited excellent performance in handling large-scale data and unbalanced samples.</p><p><strong>Conclusion: </strong>The ARF-OOBEE ensemble learning model demonstrates strong generalization performance and comprehensive classification abilities, making it suitable for effective application in auxiliary AR diagnosis.</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"14 2","pages":"56-62"},"PeriodicalIF":1.7,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11142760/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141199433","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pembrolizumab-induced Stevens-Johnson syndrome/Toxic Epidermal Necrolysis in a Vietnamese patient with nonsmall-cell lung cancer. 一名越南非小细胞肺癌患者因彭博利珠单抗诱发史蒂文斯-约翰逊综合征/毒性表皮坏死溶解症。
IF 1.7
Asia Pacific Allergy Pub Date : 2024-06-01 Epub Date: 2023-12-18 DOI: 10.5415/apallergy.0000000000000131
Yen T H Pham, Mai T Vu, Anh Q Nguyen, Phat N Trinh, Mai H Tran, Hieu C Chu, Nguyet T M Nguyen, Chi H V Vu, Dinh V Nguyen
{"title":"Pembrolizumab-induced Stevens-Johnson syndrome/Toxic Epidermal Necrolysis in a Vietnamese patient with nonsmall-cell lung cancer.","authors":"Yen T H Pham, Mai T Vu, Anh Q Nguyen, Phat N Trinh, Mai H Tran, Hieu C Chu, Nguyet T M Nguyen, Chi H V Vu, Dinh V Nguyen","doi":"10.5415/apallergy.0000000000000131","DOIUrl":"10.5415/apallergy.0000000000000131","url":null,"abstract":"<p><p>Chemoimmunotherapy is an effective therapy for an individual with nonsmall-cell lung cancer (NSCLC) without anaplastic lymphoma kinase or epidermal growth factor receptor mutations. However, it can also be related to adverse cutaneous reactions such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) with high morbidities and mortality rates. We present a case of a 65-year-old male with NSCLC who underwent first-line chemotherapy with paclitaxel, carboplatin, and pembrolizumab, which was later followed by a second cycle of the same therapies. The patient developed a fever and rash 12 days after the second cycle. Pembrolizumab was strongly suspected as the culprit medication because cutaneous reactions to this drug have been frequently reported and threw other medications used as less likely candidates. This is the first case reported in Vietnam of SJS/TEN related to pembrolizumab and contributes to our knowledge of severe skin reactions associated with immune checkpoint inhibitors.</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"14 2","pages":"84-89"},"PeriodicalIF":1.7,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11142754/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141199435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The treatment efficacy of dupilumab in autosomal dominant hyper-immunoglobulin E syndrome with severe atopic dermatitis. 杜匹鲁单抗对常染色体显性高免疫球蛋白 E 综合征伴严重特应性皮炎的治疗效果。
IF 1.7
Asia Pacific Allergy Pub Date : 2024-03-01 Epub Date: 2023-10-09 DOI: 10.5415/apallergy.0000000000000121
Weifeng Li, Qiqi Qi, Weipeng Wang, Dongqin Li
{"title":"The treatment efficacy of dupilumab in autosomal dominant hyper-immunoglobulin E syndrome with severe atopic dermatitis.","authors":"Weifeng Li, Qiqi Qi, Weipeng Wang, Dongqin Li","doi":"10.5415/apallergy.0000000000000121","DOIUrl":"10.5415/apallergy.0000000000000121","url":null,"abstract":"<p><p>Hyper-immunoglobulin E syndrome (HIES) is a primary immunodeficiency disease characterized by atopic dermatitis, recurrent skin and lung infections, and significantly elevated serum immunoglobulin E levels. Autosomal dominant and loss-of-function pathogenic variants in the <i>STAT3</i> gene are the most common causes of the disease and studies have shown that the presence of IL-4 receptor (IL-4R) is upregulated in patients with dominant-negative mutations in the <i>STAT3</i> gene expression. Dupilumab is a monoclonal antibody that targets the IL-4α receptor and improves the symptoms of atopic dermatitis by inhibiting IL-4 and IL-13. We used dupilumab to treat severe dermatitis in a patient with STAT3-HIES and achieved satisfactory results.</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"14 1","pages":"39-41"},"PeriodicalIF":1.7,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10932477/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140118676","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A prospective observational study correlating possible novel biomarkers with disease severity and antihistamine response in chronic spontaneous urticaria. 一项前瞻性观察研究,将可能的新型生物标记物与慢性自发性荨麻疹的疾病严重程度和抗组胺药反应相关联。
IF 1.7
Asia Pacific Allergy Pub Date : 2024-03-01 Epub Date: 2024-01-11 DOI: 10.5415/apallergy.0000000000000132
Divya Bhatia, Hitaishi Mehta, Anuradha Bishnoi, Niharika Srivastava, Keshavamurthy Vinay, Davinder Parsad, Muthu Sendhil Kumaran
{"title":"A prospective observational study correlating possible novel biomarkers with disease severity and antihistamine response in chronic spontaneous urticaria.","authors":"Divya Bhatia, Hitaishi Mehta, Anuradha Bishnoi, Niharika Srivastava, Keshavamurthy Vinay, Davinder Parsad, Muthu Sendhil Kumaran","doi":"10.5415/apallergy.0000000000000132","DOIUrl":"10.5415/apallergy.0000000000000132","url":null,"abstract":"<p><strong>Background: </strong>Role of complement fraction 5a (C5a), interleukin (IL)-9, and apolipoprotein (apo) A-IV as biomarkers of disease severity and antihistamine response in chronic spontaneous urticaria (CSU) remains elusive.</p><p><strong>Objective: </strong>To identify the role of C5a, IL-9, and apo A-IV as potential biomarkers in predicting disease severity and antihistamine response in CSU patients.</p><p><strong>Methods: </strong>This was a prospective observational study of 95 patients and 42 controls. Serum analysis of C5a, IL-9, and apo A-IV was done using enyzme linked immunosorbent assay kits. Also, serum IgE and anti-thyroid peroxidase (TPO) levels were assessed in all patients. All patients were started on oral levocetirizine 5 mg at baseline and dose was titrated upwards to maximum of 20 mg based on response. Patients were categorized into antihistamine responders or nonresponders as per their disease response. Serological markers, serum IgE, and anti-TPO were correlated with baseline disease severity and antihistamine response.</p><p><strong>Results: </strong>C5a levels were significantly higher in cases as compared to controls (<i>P</i> = 0.004). Significantly higher IL-9 levels were observed in antihistamine responders than nonresponders (<i>P</i> = 0.008). Baseline urticaria severity demonstrated a statistically significant positive and negative correlations with IL-9 (<i>ρ</i> = 0.277, <i>P</i> = 0.007) and apo A-IV (<i>ρ</i> = -0.271, <i>P</i> = 0.008) levels, respectively. Levels of serum IgE (<i>P</i> = 0.031) and anti-TPO (<i>P</i> = 0.039) were significantly higher in antihistamine nonresponders compared to responders.</p><p><strong>Conclusions: </strong>IL-9 and apo A-IV might be potential novel biomarkers to predict urticaria severity. Higher IL-9 might be a predictor of antihistamine response. Elevated anti-TPO and serum IgE might predict poor antihistamine response.</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"14 1","pages":"5-11"},"PeriodicalIF":1.7,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10932479/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140118670","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Correlation of Blomia tropicalis-specific immunoglobulin epsilon profiles with family history of atopy in a Filipino population. 菲律宾人口中热带布洛莫氏菌特异性免疫球蛋白ε谱与家族过敏史的相关性。
IF 1.6
Asia Pacific Allergy Pub Date : 2024-03-01 Epub Date: 2024-01-11 DOI: 10.5415/apallergy.0000000000000133
Chanie Y Patanindagat, Jamie Ezra B Tarun, Ryla Jasmine T Pajaro, Jhon Jerald D Pintucan, Patricia Nichole M Quilang, Maureen B Sabit, John Donnie A Ramos
{"title":"Correlation of <i>Blomia tropicalis</i>-specific immunoglobulin epsilon profiles with family history of atopy in a Filipino population.","authors":"Chanie Y Patanindagat, Jamie Ezra B Tarun, Ryla Jasmine T Pajaro, Jhon Jerald D Pintucan, Patricia Nichole M Quilang, Maureen B Sabit, John Donnie A Ramos","doi":"10.5415/apallergy.0000000000000133","DOIUrl":"10.5415/apallergy.0000000000000133","url":null,"abstract":"<p><strong>Background: </strong>House dust mites are the major source of indoor allergens in the tropical and subtropical regions with <i>Blomia tropicalis</i> (Bt) allergens as one of the leading causative agents of sensitization among patients from the tropics. Despite the clinical importance of Bt in various populations, its allergenicity remains unclear among Filipino allergic patients.</p><p><strong>Objective: </strong>This study determined the sensitization profiles of allergic Filipinos against Bt allergens and its correlation with atopy.</p><p><strong>Methods: </strong>Total immunoglobulin epsilon (IgE) (n = 960), Bt-specific IgE (n = 247), and <i>Blomia tropicalis</i> 5 (Blo t 5)-specific IgE (n = 87) profiles of allergic and nonallergic subjects were measured through enzyme-linked immunosorbent assay (ELISA). Point-biserial correlation coefficient was used to determine the association between Bt-specific IgE levels and selected demographics. Inhibition ELISA was performed to measure the inhibition capacity of recombinant Blo t 5 (rBlo t 5) against Bt allergen extracts.</p><p><strong>Results: </strong>Mean total IgE levels of allergic cases (n = 171) were significantly higher (<i>P</i> < 0.001) compared to the mean IgE levels of nonallergic controls (n = 76). Among allergic subjects, 58% were sensitized to Blo t extract and 80% of which were sensitized to rBlo t 5 allergen. A positive correlation was observed between Bt-specific IgE and family history of atopic disease (<i>P</i> = 0.031). Inhibition assay revealed that 54% mean reactivity of 7 plasma samples was caused by rBlo t 5, validating that rBlo t 5 is a major allergen in Bt.</p><p><strong>Conclusions: </strong>This study has shown the importance of Bt as an allergen source that sensitizes atopic Filipino subjects. Hence, inclusion of Bt allergen extract and rBlo t 5 in the panel for allergy diagnosis and immunotherapy in Filipino populations is strongly recommended.</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"14 1","pages":"12-20"},"PeriodicalIF":1.6,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10932478/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140118673","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Does omalizumab increase the risk of malignancy? A retrospective case-control study in a single tertiary hospital. 奥马珠单抗会增加恶性肿瘤风险吗?一家三甲医院的回顾性病例对照研究。
IF 1.7
Asia Pacific Allergy Pub Date : 2024-03-01 Epub Date: 2024-03-05 DOI: 10.5415/apallergy.0000000000000137
Hyun Jee Kim, Suh Young Lee, Sang-Heon Cho, Hye-Ryun Kang
{"title":"Does omalizumab increase the risk of malignancy? A retrospective case-control study in a single tertiary hospital.","authors":"Hyun Jee Kim, Suh Young Lee, Sang-Heon Cho, Hye-Ryun Kang","doi":"10.5415/apallergy.0000000000000137","DOIUrl":"10.5415/apallergy.0000000000000137","url":null,"abstract":"","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"14 1","pages":"42-43"},"PeriodicalIF":1.7,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10932485/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140118674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Anti-thymic stromal lymphopoietin monoclonal antibody in patients with chronic rhinosinusitis with nasal polyps (DUBHE): Rationale and design of a multicenter, randomized, double-blind, placebo-controlled study. 抗胸腺基质淋巴细胞生成素单克隆抗体在慢性鼻炎伴鼻息肉(DUBHE)患者中的应用:多中心、随机、双盲、安慰剂对照研究的原理与设计。
IF 1.7
Asia Pacific Allergy Pub Date : 2024-03-01 Epub Date: 2024-01-25 DOI: 10.5415/apallergy.0000000000000135
Shen Shen, Mu Xian, Bing Yan, Feng Lan, Chengshuo Wang, Luo Zhang
{"title":"Anti-thymic stromal lymphopoietin monoclonal antibody in patients with chronic rhinosinusitis with nasal polyps (DUBHE): Rationale and design of a multicenter, randomized, double-blind, placebo-controlled study.","authors":"Shen Shen, Mu Xian, Bing Yan, Feng Lan, Chengshuo Wang, Luo Zhang","doi":"10.5415/apallergy.0000000000000135","DOIUrl":"10.5415/apallergy.0000000000000135","url":null,"abstract":"<p><strong>Background: </strong>Chronic rhinosinusitis with nasal polyps (CRSwNP) has a complex pathogenesis and is difficult to treat, which brings a huge economic burden to society. Despite all the progress in the treatment of CRSwNP, some patients with CRSwNP still experience recurrence. Therefore, there is an urgent need to develop novel drugs and treatments for CRSwNP. Thymic stromal lymphopoietin (TSLP) is produced by epithelial cells and mediates type 2 and nontype 2 inflammation through various downstream cellular immune and inflammatory pathways. Anti-TSLP treatment with tezepelumab has been proven to be effective in treating patients with uncontrolled asthma, regardless of their peripheral blood eosinophil levels being low or high. However, there is no relevant research on the usage of anti-TSLP monoclonal antibodies for the treatment of uncontrolled CRSwNP.</p><p><strong>Objective: </strong>This is the first phase Ib/IIa study for subjects with uncontrolled CRSwNP, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of multiple ascending doses (MAD) of anti-TSLP monoclonal antibody.</p><p><strong>Methods: </strong>The DUBHE is a multicenter, randomized, double-blind, placebo-controlled, phase Ib/IIa clinical study. The study will be composed of 3 periods: a screening/run-in period of 4 weeks, a treatment period of 52 weeks (16 weeks of double-blind treatment period +36 weeks of open-label treatment period), and a safety follow-up period of 12 weeks. No more than 113 subjects with uncontrolled CRSwNP will be divided into 4 groups to receive different doses of CM326 or placebo treatments (55 mg every two weeks [Q2W] group, 110 mg Q2W group, 220 mg Q2W group, and 220 mg every four weeks [Q4W] group). Enrolled patients will be stratified by tissue eosinophil count (TEC).</p><p><strong>Results: </strong>The safety of the monoclonal antibody that targets TSLP in uncontrolled CRSwNP and its preliminary efficacy at 16 weeks of treatment.</p><p><strong>Conclusion: </strong>In this study, for the first time, the safety and preliminary efficacy of MAD of CM326 will be verified. The efficacy of CM326 in patients with eosinophilic CRSwNP (TEC ≥55/high power field [HPF]), as well as noneosinophilic CRSwNP (TEC <55/HPF) will be testified.</p><p><strong>Trial registration: </strong>NCT05324137.</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"14 1","pages":"26-31"},"PeriodicalIF":1.7,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10932481/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140118671","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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