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Phase II multicenter clinical trial of hypoallergenic 1BS-18 Hokushin bread oral immunotherapy for wheat-dependent exercise-induced anaphylaxis. 低致敏性1BS-18北心面包口服免疫疗法治疗小麦依赖性运动致过敏反应的II期多中心临床试验
IF 2.1 Q3 ALLERGY Pub Date : 2025-06-01 Epub Date: 2025-02-05 DOI: 10.5415/apallergy.0000000000000180
Kunie Kohno, Yuko Chinuki, Akiko Sugiyama, Reiko Kishikawa, Mayumi Okamoto, Michihiro Hide, Yoshiko Oda, Atsushi Fukunaga, Ritsuro Suzuki, Eishin Morita

Background: Therapies for desensitizing wheat-dependent exercise-induced anaphylaxis (WDEIA), a severe allergic response to wheat ingestion and exercise, remain unestablished. This study aimed to investigate whether continuous ingestion of hypoallergenic 1BS-18 Hokushin bread, which lacks the Gli-B1 locus encoding the ω5-gliadin allergen, could achieve desensitization in adult patients with WDEIA sensitized to ω5-gliadin.

Methods: Sixteen adult patients diagnosed with WDEIA participated in this study. Each patient was administered a safety dose of bread made from 1BS-18 Hokushin wheat, a hypoallergenic wheat that defects the Gli-B1 locus responsible for encoding the ω5-gliadin allergen, over a 12-week period. The safe dose for each individual was determined through a stepwise increase in bread intake and monitored to prevent allergic reactions. Desensitization efficacy was evaluated by measuring basophil activation rates and serum allergen-specific IgE levels specific to wheat proteins using the basophil activation test and ImmunoCAP serum testing.

Results: Fourteen of the 16 patients (87.5%) successfully completed the 12-week regimen of 1BS-18 Hokushin bread, with 2 patients (12.5%) discontinuing due to allergic reactions associated with the bread. Evaluation of basophil activation rates and serum allergen-specific IgE levels indicated no significant desensitization effects in any patient.

Conclusions: Approximately 80% of patients with WDEIA were able to safely consume 1BS-18 Hokushin bread at least up to 60 g per day for 12 weeks without severe adverse reactions. However, this regimen did not achieve desensitization, suggesting that further studies may be necessary to explore alternative dosing, duration, or combinations with adjunct therapies for effective desensitization in patients with WDEIA.

背景:脱敏小麦依赖运动诱导的过敏反应(WDEIA)是一种对小麦摄入和运动的严重过敏反应,治疗方法尚未建立。本研究旨在探讨持续食用低致敏性的1BS-18北心面包(缺乏编码ω5-麦胶蛋白过敏原的Gli-B1基因座)是否能使ω5-麦胶蛋白致敏的成年WDEIA患者脱敏。方法:16例确诊为WDEIA的成年患者参与本研究。在12周的时间里,每位患者都服用了由1BS-18北心小麦制成的安全剂量的面包,这是一种低致敏性的小麦,其缺陷是负责编码ω5-麦胶蛋白过敏原的Gli-B1位点。每个人的安全剂量是通过逐步增加面包摄入量来确定的,并监测以防止过敏反应。采用嗜碱性粒细胞活化试验和免疫cap血清试验,测定小麦蛋白的嗜碱性粒细胞活化率和血清过敏原特异性IgE水平,评估脱敏效果。结果:16例患者中有14例(87.5%)成功完成了为期12周的1BS-18北心面包治疗方案,2例(12.5%)患者因面包相关的过敏反应而停止治疗。对嗜碱性粒细胞活化率和血清过敏原特异性IgE水平的评估表明,在任何患者中没有明显的脱敏作用。结论:大约80%的WDEIA患者能够安全地食用1BS-18北心面包,每天至少60克,持续12周,没有严重的不良反应。然而,该方案没有达到脱敏效果,这表明可能需要进一步的研究来探索替代剂量、持续时间或与辅助治疗的组合,以实现WDEIA患者的有效脱敏。
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引用次数: 0
Serum neuropilin-1 level may predict airway remodeling based on age and smoking status in asthma. 血清神经匹林-1水平可预测哮喘患者基于年龄和吸烟状况的气道重塑。
IF 2.1 Q3 ALLERGY Pub Date : 2025-06-01 Epub Date: 2025-03-17 DOI: 10.5415/apallergy.0000000000000192
Ji-Yoon Oh, Chae Eun Lee, Seo Young Kim, Hyunkyoung Kim, Yu Ri Kang, Ji-Hyang Lee, Woo-Jung Song, Hyouk-Soo Kwon, You Sook Cho, Tae-Bum Kim

Background: Airway remodeling in asthma is induced by the production of vascular endothelial growth factor, and this process is mediated by neuropilin-1 (NRP-1).

Objective: To investigate the association between the serum level of NRP-1 and clinical characteristics in asthma.

Methods: We measured the serum level of NRP-1 and performed subgroup analysis of NRP-1 according to the clinical characteristics of 421 asthma patients registered in the Cohort for Reality and Evolution of Adult Asthma in Korea.

Results: The serum level of NRP-1 was significantly higher in the group under 65 years of age than in the group over 65 years of age (1628.36 ± 589.51 vs 1416.75 ± 671.42; P < 0.001). Current smokers and ex-smokers had a significantly higher serum NRP-1 level compared with that of never smokers (1647.16 ± 572.34 vs 1528.5 ± 579.37; P = 0.041). Medium- and high-inhaled corticosteroid users had a higher serum NRP-1 level compared with that of low-inhaled corticosteroid users (1589.87 ± 591.7 vs 1436.12 ± 419.21; P = 0.049). The serum NRP-1 level was significantly higher in the group with a forced vital capacity (FVC) of 70% or higher than in the group with an FVC of 70% or lower. In univariate analysis, age was a factor influencing serum NRP-1 with a negative correlation (coefficient=-260.90; P < 0.001). Ex-smokers and current smokers were factors influencing serum NRP-1 with a positive correlation (coefficient = 118.66; P = 0.0412). An FVC of 70% or higher was a factor affecting serum NRP-1 with a positive correlation (coefficient = 173.86; P = 0.0224). Multivariable analysis revealed that age (coefficient = -233.53; P < 0.001) and smoking history (coefficient = -122.4; P = 0.0358) were significant variables affecting serum NRP-1.

Conclusion: Serum NRP-1 level was high in asthma patients with a younger age and smoking history, suggesting its potential as a clinical marker for predicting early-stage airway remodeling based on the age and smoking status.

背景:哮喘气道重构是由血管内皮生长因子的产生诱导的,这一过程是由神经肽-1 (neuropilin-1, NRP-1)介导的。目的:探讨哮喘患者血清NRP-1水平与临床特征的关系。方法:根据韩国成人哮喘现实与演变队列登记的421例哮喘患者的临床特征,测定血清NRP-1水平,并进行NRP-1亚组分析。结果:65岁以下患者血清NRP-1水平明显高于65岁以上患者(1628.36±589.51 vs 1416.75±671.42);P < 0.001)。当前吸烟者和已戒烟者血清NRP-1水平明显高于未吸烟者(1647.16±572.34 vs 1528.5±579.37);P = 0.041)。中、高吸入性皮质类固醇使用者血清NRP-1水平高于低吸入性皮质类固醇使用者(1589.87±591.7 vs 1436.12±419.21;P = 0.049)。肺活量(FVC)≥70%组血清NRP-1水平显著高于FVC≤70%组。单因素分析中,年龄是影响血清NRP-1的因素,且呈负相关(系数=-260.90;P < 0.001)。戒烟者和吸烟者是影响血清NRP-1的因素,两者呈正相关(系数= 118.66;P = 0.0412)。FVC≥70%与血清NRP-1呈正相关(系数= 173.86;P = 0.0224)。多变量分析显示,年龄(系数= -233.53;P < 0.001)和吸烟史(系数= -122.4;P = 0.0358)是影响血清NRP-1的显著变量。结论:年龄小、有吸烟史的哮喘患者血清NRP-1水平较高,提示其可作为基于年龄和吸烟状况预测早期气道重构的临床指标。
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引用次数: 0
Garlic allergy in an infant: Identification of alliin lyase 1 and 2 as causative allergens. 婴儿大蒜过敏:蒜素裂解酶1和2作为致敏原的鉴定。
IF 2.1 Q3 ALLERGY Pub Date : 2025-06-01 Epub Date: 2025-03-17 DOI: 10.5415/apallergy.0000000000000201
Yoshinori Morita, Karin Tsuchiya, Kazuyuki Sogawa, Naoki Shimojo

Garlic allergy is rare and is infrequently reported as a food allergy. This report details the case of a 13-month-old girl who developed an allergy to garlic. The consumption of a stew containing undercooked garlic triggered her allergic reaction. Blood tests revealed a garlic-specific IgE level of 10.3 kUA/L. In addition, in the skin prick test, a 4 × 4 mm, 2 × 2 mm, and 1 × 1 mm wheal was induced by raw garlic, garlic heated for 5 min, and garlic heated for 10 min, respectively. She had a known history of egg allergy. The foods consumed at the time did not contain eggs and included all other foods she had previously tolerated, except garlic. Therefore, we diagnosed her with a garlic allergy. We performed western blotting and mass spectrometric analysis and identified alliin lyase 1 and alliin lyase 2 as the major allergens. We further confirmed that the patient's sera reacted with recombinant alliin lyase 1 and 2. To our knowledge, this is the first report to accurately demonstrate the involvement of alliin lyase 1 and alliin lyase 2 in a patient with garlic allergy. Moreover, it highlights the differences in reactivity to garlic heated for different durations. In patients with garlic allergy, reactivity to heating time should be examined with skin prick tests.

大蒜过敏是罕见的,很少被报道为食物过敏。这份报告详细介绍了一个13个月大的女孩对大蒜过敏的病例。食用含有未煮熟大蒜的炖菜引发了她的过敏反应。血液检查显示大蒜特异性IgE水平为10.3 kUA/L。另外,在刺皮试验中,用生大蒜、大蒜加热5 min、大蒜加热10 min分别诱导4 × 4 mm、2 × 2 mm、1 × 1 mm的大鼠轮。她有鸡蛋过敏史。当时她吃的食物不含鸡蛋,除了大蒜,她还吃了其他所有她以前能忍受的食物。因此,我们诊断她对大蒜过敏。经western blotting和质谱分析,确定alliin裂解酶1和alliin裂解酶2为主要过敏原。我们进一步证实患者的血清与重组蒜素裂解酶1和2反应。据我们所知,这是第一份准确证明大蒜过敏患者参与蒜素裂解酶1和蒜素裂解酶2的报告。此外,它还强调了对加热时间不同的大蒜的反应性的差异。对大蒜过敏的患者,应通过皮肤点刺试验检查对加热时间的反应。
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引用次数: 0
Intensive bronchial dilation test: A modified method for evaluating airway reversibility. 强化支气管扩张试验:一种评估气道可逆性的改进方法。
IF 2.1 Q3 ALLERGY Pub Date : 2025-06-01 Epub Date: 2025-02-05 DOI: 10.5415/apallergy.0000000000000178
Yujuan Yang, Ningbo Tang, Yuemei Sun, Liping Liu, Jianwei Wang, Pengyi Yu, Jiayu Cao, Yu Zhang, Xicheng Song

Background: A negative bronchial dilatation test (BDT) does not fully reflect the status of airway irreversibility in patients with severe obstructive or mixed ventilation dysfunction due to severe bronchospasm, mucus blockage, or insensitivity to bronchodilators, which will directly affect the subsequent diagnosis and treatment of those patients.

Objective: We retrospectively examined the feasibility of using the "intensive bronchial dilation test" (IBDT) for excluding false-negative BDT.

Methods: We retrospectively analyzed the clinical data of 82 patients with severe obstructive or mixed ventilation dysfunction in the Allergy department of Yantai Yuhuangding Hospital of Qingdao University. After the BDT, they all inhaled the triple atomized drugs (2 mg salbutamol, 1 mg budesonide, and 0.25 mg ipratropium) every 20 minutes in one hour and the lung function test was performed 15 minutes later, which was named as IBDT. All patients received another lung function test after 2 to 4 weeks of regular anti-inflammatory treatment. We compared the improvement of lung function indexes and the proportion of patients with reversible airway obstruction between BDT, IBDT, and 2 to 4 weeks of treatment groups.

Results: The lung function indexes were significantly improved after the IBDT than those after the BDT (all P values < 0.01) and the number of patients with reversible airway obstruction significantly increased from 31 to 61 after the IBDT (P < 0.001), but the proportion of patients with reversible airway obstruction after the IBDT did not differ from that of patients with reversible airway obstruction after 2 to 4 weeks of treatment. The accuracy and sensitivity of the IBDT in evaluating airway reversibility reached 91.46% and 89.71%, respectively, both of which were significantly higher than for the BDT (54.88% and 45.59%, respectively).

Conclusion: Our finding suggests that IBDT can more accurately and rapidly evaluate airway reversibility in patients with severe obstructive or mixed ventilation dysfunction when compared to BDT.

背景:支气管扩张试验(BDT)阴性不能完全反映严重支气管痉挛、粘液堵塞或对支气管扩张剂不敏感导致的严重阻塞性或混合性通气功能障碍患者的气道不可逆性状态,这将直接影响患者的后续诊断和治疗。目的:回顾性探讨“强化支气管扩张试验”(IBDT)用于排除假阴性支气管扩张试验的可行性。方法:回顾性分析青岛大学烟台玉皇顶医院变态反应科收治的82例重度阻塞性或混合性通气功能障碍患者的临床资料。BDT后,患者在1小时内每20分钟吸入三雾化药物(沙丁胺醇2 mg、布地奈德1 mg、异丙托品0.25 mg), 15分钟后进行肺功能检查,称为IBDT。所有患者在常规抗炎治疗2至4周后接受另一次肺功能检查。我们比较了BDT组、IBDT组和2 ~ 4周治疗组肺功能指标的改善情况和可逆性气道阻塞患者的比例。结果:IBDT术后肺功能指标较BDT术后明显改善(P值均< 0.01),出现可逆性气道阻塞的患者从31例显著增加至61例(P < 0.001),但IBDT术后出现可逆性气道阻塞的患者比例与治疗2 ~ 4周出现可逆性气道阻塞的患者比例无显著差异。IBDT评估气道可逆性的准确性和敏感性分别达到91.46%和89.71%,均显著高于BDT(54.88%和45.59%)。结论:我们的研究结果表明,与BDT相比,IBDT可以更准确、更快速地评估严重阻塞性或混合性通气功能障碍患者的气道可逆性。
{"title":"Intensive bronchial dilation test: A modified method for evaluating airway reversibility.","authors":"Yujuan Yang, Ningbo Tang, Yuemei Sun, Liping Liu, Jianwei Wang, Pengyi Yu, Jiayu Cao, Yu Zhang, Xicheng Song","doi":"10.5415/apallergy.0000000000000178","DOIUrl":"10.5415/apallergy.0000000000000178","url":null,"abstract":"<p><strong>Background: </strong>A negative bronchial dilatation test (BDT) does not fully reflect the status of airway irreversibility in patients with severe obstructive or mixed ventilation dysfunction due to severe bronchospasm, mucus blockage, or insensitivity to bronchodilators, which will directly affect the subsequent diagnosis and treatment of those patients.</p><p><strong>Objective: </strong>We retrospectively examined the feasibility of using the \"intensive bronchial dilation test\" (IBDT) for excluding false-negative BDT.</p><p><strong>Methods: </strong>We retrospectively analyzed the clinical data of 82 patients with severe obstructive or mixed ventilation dysfunction in the Allergy department of Yantai Yuhuangding Hospital of Qingdao University. After the BDT, they all inhaled the triple atomized drugs (2 mg salbutamol, 1 mg budesonide, and 0.25 mg ipratropium) every 20 minutes in one hour and the lung function test was performed 15 minutes later, which was named as IBDT. All patients received another lung function test after 2 to 4 weeks of regular anti-inflammatory treatment. We compared the improvement of lung function indexes and the proportion of patients with reversible airway obstruction between BDT, IBDT, and 2 to 4 weeks of treatment groups.</p><p><strong>Results: </strong>The lung function indexes were significantly improved after the IBDT than those after the BDT (all <i>P</i> values < 0.01) and the number of patients with reversible airway obstruction significantly increased from 31 to 61 after the IBDT (<i>P</i> < 0.001), but the proportion of patients with reversible airway obstruction after the IBDT did not differ from that of patients with reversible airway obstruction after 2 to 4 weeks of treatment. The accuracy and sensitivity of the IBDT in evaluating airway reversibility reached 91.46% and 89.71%, respectively, both of which were significantly higher than for the BDT (54.88% and 45.59%, respectively).</p><p><strong>Conclusion: </strong>Our finding suggests that IBDT can more accurately and rapidly evaluate airway reversibility in patients with severe obstructive or mixed ventilation dysfunction when compared to BDT.</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"15 2","pages":"45-48"},"PeriodicalIF":2.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12289092/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144726914","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 association of environmental house dust mite allergens and crustacean allergy: The Japan Environment and Children's Study (JECS). 环境屋尘螨过敏原与甲壳类动物过敏的关系:日本环境与儿童研究(JECS)。
IF 2.1 Q3 ALLERGY Pub Date : 2025-06-01 Epub Date: 2025-01-08 DOI: 10.5415/apallergy.0000000000000169
Reiji Kojima, Ryoji Shinohara, Megumi Kushima, Hideki Yui, Sanae Otawa, Sayaka Horiuchi, Kunio Miyake, Hiroshi Yokomichi, Yuka Akiyama, Tadao Ooka, Zentaro Yamagata

Background: The higher crustacean allergy prevalence in Asia than in Western regions may be due to a shrimp-mite cross-reaction. A high environmental house dust mite prevalence may lead to increased house dust mite sensitization and thereby increase the prevalence of crustacean allergy.

Objective: To determine the association between environmental house dust mite allergens and crustacean allergy in Japanese preschool children.

Methods: We used data from 4,242 mother-infant dyads who participated in the subcohort study of the Japan Environment and Children's Study, a prospective birth cohort study. A logistic regression model was used to analyze the association between house dust mite allergens in dust at 18 months and 3 years of age and crustacean allergy at the age of 4 years.

Results: The crustacean allergy prevalence was 0.4%. Greater house dust mite exposure at 18 months of age was associated with a higher prevalence of crustacean allergy, although this association was not statistically significant. However, there was no positive association between house dust mite exposure at 3 years of age and crustacean allergy.

Conclusions: No association between house dust mite allergen exposure in infancy and the risk of crustacean allergy at preschool age was apparent. Follow-up studies, including investigation of tropomyosin sensitization in schoolchildren, are required.

背景:亚洲甲壳类动物过敏发生率高于西方地区,可能是虾螨交叉反应所致。室内尘螨的高环境患病率可能导致室内尘螨致敏性增加,从而增加甲壳类动物过敏的患病率。目的:探讨日本学龄前儿童环境尘螨过敏原与甲壳类动物过敏的关系。方法:我们使用了4242对参与日本环境与儿童研究亚队列研究的母婴对的数据,这是一项前瞻性出生队列研究。采用logistic回归模型分析18月龄和3岁儿童粉尘中尘螨过敏原与4岁儿童甲壳类过敏原的关系。结果:甲壳类动物过敏发生率为0.4%。18个月大的室内尘螨暴露与甲壳类动物过敏的高发率相关,尽管这种关联没有统计学意义。然而,3岁室内尘螨暴露与甲壳类动物过敏之间没有正相关。结论:婴幼儿屋尘螨过敏原暴露与学龄前甲壳类动物过敏风险无明显相关性。后续研究,包括调查小学生原肌球蛋白致敏,是必要的。
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引用次数: 0
Stapokibart (CM310) in patients with uncontrolled seasonal allergic rhinitis (PHECDA): Rationale and design of a multicentre, randomized, double-blind, placebo-controlled study. Stapokibart (CM310)用于不受控制的季节性变应性鼻炎(PHECDA)患者:一项多中心、随机、双盲、安慰剂对照研究的基本原理和设计。
IF 1.6 Q3 ALLERGY Pub Date : 2025-03-01 Epub Date: 2025-01-13 DOI: 10.5415/apallergy.0000000000000174
Menglin Wang, Yuan Zhang, Jingyun Li, Chengshuo Wang, Luo Zhang

Background: Seasonal allergic rhinitis (SAR) is a global health issue, and the current standard of care (SoC) has limited effectiveness in controlling the disease. There is a need for innovative treatments to better manage uncontrolled SAR and advance beyond the uniform SoC, and biologics targeting type 2 inflammation driving allergic rhinitis is promising.

Objective: To evaluate the efficacy and safety of Stapokibart, a humanized monoclonal antibody targeting interleukin-4 receptor subunit alpha, as an add-on therapy in patients with uncontrolled SAR.

Methods: The PHECDA is a multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical study designed to evaluate the efficacy and safety of Stapokibart in treating uncontrolled SAR in adults. Conducted across 18 centers in China during the pollen season, the study plans to recruit 108 adult patients with moderate to severe nasal symptoms despite receiving SoC during the previous seasonal pollen period, along with a 1-week run-in period and a baseline blood eosinophil count of at least 300 cells·μL-1. The study consists of a screening/run-in period (1 week), treatment period (4 weeks), and follow-up period (8 weeks). In addition to SoC, which includes mometasone furoate nasal spray and loratadine, participants are randomly assigned using a centralized interactive-web-response-system to receive either subcutaneous Stapokibart 600 (loading dose)-300 mg or a placebo every 2 weeks for 4 weeks. The primary endpoint of the study is the mean change from baseline in the daily reflective total nasal symptom score over the first 2 weeks of treatment. Subjects who have been administered at least 1 dose of the investigational drug will be included in the assessments of both efficacy and safety.

Results: This article outlines the methodology utilized in a multicenter trial studying Stapokibar for seasonal allergic rhinitis, with expectations to discuss its significant effects in subsequent analyses based on trial outcomes.

Conclusion: The PHECDA study is for the first time to provide insight into the efficacy and safety of a seasonal add-on Stapokibart for patients with uncontrolled SAR during pollen exposure.

Trial registration: NCT05908032.

背景:季节性变应性鼻炎(SAR)是一个全球性的健康问题,目前的护理标准(SoC)在控制疾病方面的效果有限。需要创新的治疗方法来更好地控制不受控制的SAR,并超越统一的SoC,针对2型炎症驱动的变应性鼻炎的生物制剂是有希望的。目的:评价Stapokibart(一种靶向白细胞介素-4受体亚单位α的人源化单克隆抗体)作为非控制型sars患者附加治疗的疗效和安全性。方法:PHECDA是一项多中心、随机、双盲、安慰剂对照的3期临床研究,旨在评价Stapokibart治疗非控制型成人SAR的疗效和安全性。该研究于花粉季节在中国的18个中心进行,计划招募108名中度至重度鼻症状的成年患者,尽管在上一个季节性花粉季节接受了SoC,并且有1周的磨合期,基线血嗜酸性粒细胞计数至少为300个细胞·μL-1。研究包括筛选/磨合期(1周)、治疗期(4周)和随访期(8周)。除了SoC,包括糠酸莫米松鼻喷雾剂和氯雷他定,参与者被随机分配使用一个集中的互动网络反应系统,接受皮下Stapokibart 600(负荷剂量)-300 mg或安慰剂,每2周一次,持续4周。该研究的主要终点是治疗前两周每日反射性总鼻症状评分与基线相比的平均变化。已服用至少1剂研究药物的受试者将被纳入疗效和安全性评估。结果:本文概述了在一项研究Stapokibar治疗季节性变应性鼻炎的多中心试验中使用的方法,并期望在基于试验结果的后续分析中讨论其显著效果。结论:PHECDA研究首次揭示了季节性附加Stapokibart对花粉暴露期间不受控制的SAR患者的有效性和安全性。试验注册:NCT05908032。
{"title":"Stapokibart (CM310) in patients with uncontrolled seasonal allergic rhinitis (PHECDA): Rationale and design of a multicentre, randomized, double-blind, placebo-controlled study.","authors":"Menglin Wang, Yuan Zhang, Jingyun Li, Chengshuo Wang, Luo Zhang","doi":"10.5415/apallergy.0000000000000174","DOIUrl":"10.5415/apallergy.0000000000000174","url":null,"abstract":"<p><strong>Background: </strong>Seasonal allergic rhinitis (SAR) is a global health issue, and the current standard of care (SoC) has limited effectiveness in controlling the disease. There is a need for innovative treatments to better manage uncontrolled SAR and advance beyond the uniform SoC, and biologics targeting type 2 inflammation driving allergic rhinitis is promising.</p><p><strong>Objective: </strong>To evaluate the efficacy and safety of Stapokibart, a humanized monoclonal antibody targeting interleukin-4 receptor subunit alpha, as an add-on therapy in patients with uncontrolled SAR.</p><p><strong>Methods: </strong>The PHECDA is a multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical study designed to evaluate the efficacy and safety of Stapokibart in treating uncontrolled SAR in adults. Conducted across 18 centers in China during the pollen season, the study plans to recruit 108 adult patients with moderate to severe nasal symptoms despite receiving SoC during the previous seasonal pollen period, along with a 1-week run-in period and a baseline blood eosinophil count of at least 300 cells·μL<sup>-1</sup>. The study consists of a screening/run-in period (1 week), treatment period (4 weeks), and follow-up period (8 weeks). In addition to SoC, which includes mometasone furoate nasal spray and loratadine, participants are randomly assigned using a centralized interactive-web-response-system to receive either subcutaneous Stapokibart 600 (loading dose)-300 mg or a placebo every 2 weeks for 4 weeks. The primary endpoint of the study is the mean change from baseline in the daily reflective total nasal symptom score over the first 2 weeks of treatment. Subjects who have been administered at least 1 dose of the investigational drug will be included in the assessments of both efficacy and safety.</p><p><strong>Results: </strong>This article outlines the methodology utilized in a multicenter trial studying Stapokibar for seasonal allergic rhinitis, with expectations to discuss its significant effects in subsequent analyses based on trial outcomes.</p><p><strong>Conclusion: </strong>The PHECDA study is for the first time to provide insight into the efficacy and safety of a seasonal add-on Stapokibart for patients with uncontrolled SAR during pollen exposure.</p><p><strong>Trial registration: </strong>NCT05908032.</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"15 1","pages":"15-20"},"PeriodicalIF":1.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11882218/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143571837","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 systematic review for improper application of nasal spray in allergic rhinitis: A proposed role of community pharmacist for patient education and counseling in practical setting. 对变应性鼻炎中鼻喷雾剂应用不当的系统回顾:建议社区药剂师在实际环境中对患者进行教育和咨询。
IF 1.6 Q3 ALLERGY Pub Date : 2025-03-01 Epub Date: 2025-01-13 DOI: 10.5415/apallergy.0000000000000173
Anmar Al-Taie

The application of nasal spray is encountered with technique errors, which can lead to decreased therapeutic response and treatment failure. Community pharmacists can play a pivotal role in providing appropriate knowledge and counseling services for the proper and effective use of these topical drugs. The aim of this systematic review was to assess the most important aspects of application technique errors and the impact of community pharmacist-led interventions on the provision of patient education and counseling regarding the application of these topical preparations in clinical practice. Preferred reporting items for systematic review and meta-analysis (PRISMA) criteria were used to set up a systematic search through different databases, including Scopus, Web of Science, and PubMed. A total of 10 articles were included in this study. Nearly three-quarters of the publications discussed improper technique, poor knowledge about installation technique, and poor adherence. Only 2 studies discussed pharmacist intervention, which comprised individualized brief education and training on the correct use of the nasal spray. The study highlights that there are many different aspects of application errors encountered by patients while using nasal spray. The study also highlights that there is a dearth of involvement of community pharmacists and pharmacist-led interventions for proper technique and application of these topical preparations.

鼻喷雾剂的应用经常遇到技术错误,导致治疗效果下降和治疗失败。社区药师可以发挥关键作用,提供适当的知识和咨询服务,以正确和有效地使用这些外用药物。本系统综述的目的是评估应用技术错误的最重要方面,以及社区药剂师主导的干预措施对在临床实践中应用这些局部制剂的患者教育和咨询的影响。采用系统评价和荟萃分析(PRISMA)标准的首选报告项,通过不同的数据库(包括Scopus、Web of Science和PubMed)建立系统搜索。本研究共纳入10篇文章。近四分之三的出版物讨论了不当的技术,关于安装技术的知识贫乏,以及不良的依从性。只有2项研究讨论了药剂师的干预,包括个体化的简短教育和正确使用鼻喷雾剂的培训。该研究强调了患者在使用鼻喷雾剂时遇到的许多不同方面的应用错误。该研究还强调,缺乏社区药剂师的参与和药剂师主导的干预措施,以适当的技术和应用这些局部制剂。
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引用次数: 0
A retrospective analysis of factors influencing response to omalizumab treatment in Indian patients with antihistamine refractory chronic spontaneous urticaria. 印度抗组胺难治性慢性自发性荨麻疹患者对奥玛珠单抗治疗反应的影响因素回顾性分析
IF 1.6 Q3 ALLERGY Pub Date : 2025-03-01 Epub Date: 2025-02-10 DOI: 10.5415/apallergy.0000000000000184
Thammannagowda Prarthana, Hitaishi Mehta, Anuradha Bishnoi, Davinder Parsad, Muthu Sendhil Kumaran

Background: Chronic spontaneous urticaria (CSU) presents as a persistent and distressing condition, with varying treatment responses. Omalizumab, a monoclonal anti-IgE antibody, has shown efficacy in managing antihistamine (AH1)-refractory CSU, but its varied response patterns and associated factors remain understudied, particularly in India.

Methods: We conducted a retrospective study involving 81 antihistamine-resistant CSU patients treated with omalizumab at a tertiary care center in Northern India between 2018 and 2023. Baseline characteristics, treatment response, and adverse effects were analyzed. Patients were categorized into various response groups based on treatment timelines and biomarker correlations.

Results: We observed 65% achieved symptom cessation (group 1) following a single omalizumab dose, while 21% responded between second and third doses (group 2). A subset (7.4%) necessitated increased dosing frequency (group 3) for symptom control. Additionally, 6.2% showed persistent symptoms despite increased dosing frequency (group 4), exhibiting distinctive biomarker profiles indicative of an autoimmune endotype. Notably, 27.1% experienced exacerbations during treatment, emphasizing the need for tailored management approaches and response expectations.

Conclusion: Omalizumab demonstrated remarkable efficacy in the treatment of AH1-refractory CSU, with a good safety profile. This study highlights the complexity of treatment response to omalizumab and the potential utility of biomarkers in guiding personalized therapeutic strategies. Further research into biomarker-based endotypes is warranted to optimize CSU management.

背景:慢性自发性荨麻疹(CSU)是一种持续且令人痛苦的疾病,治疗效果不同。Omalizumab是一种单克隆抗ige抗体,已显示出治疗抗组胺(AH1)难治性CSU的疗效,但其不同的反应模式和相关因素仍未得到充分研究,特别是在印度。方法:我们进行了一项回顾性研究,纳入了2018年至2023年在印度北部一家三级医疗中心接受omalizumab治疗的81例抗组胺耐药性CSU患者。分析基线特征、治疗反应和不良反应。根据治疗时间和生物标志物相关性将患者分为不同的反应组。结果:我们观察到65%的患者在单次给药后症状停止(第一组),而21%的患者在第二次和第三次给药期间缓解(第二组)。一个子集(7.4%)需要增加给药频率(第三组)来控制症状。此外,尽管增加给药频率,6.2%的患者仍表现出持续的症状(第4组),表现出独特的生物标志物特征,表明自身免疫性内型。值得注意的是,27.1%的患者在治疗期间出现了病情恶化,这强调了定制管理方法和反应预期的必要性。结论:Omalizumab治疗ah1难治性CSU疗效显著,安全性良好。这项研究强调了omalizumab治疗反应的复杂性,以及生物标志物在指导个性化治疗策略方面的潜在效用。进一步研究基于生物标志物的内源性疾病是优化CSU管理的必要条件。
{"title":"A retrospective analysis of factors influencing response to omalizumab treatment in Indian patients with antihistamine refractory chronic spontaneous urticaria.","authors":"Thammannagowda Prarthana, Hitaishi Mehta, Anuradha Bishnoi, Davinder Parsad, Muthu Sendhil Kumaran","doi":"10.5415/apallergy.0000000000000184","DOIUrl":"10.5415/apallergy.0000000000000184","url":null,"abstract":"<p><strong>Background: </strong>Chronic spontaneous urticaria (CSU) presents as a persistent and distressing condition, with varying treatment responses. Omalizumab, a monoclonal anti-IgE antibody, has shown efficacy in managing antihistamine (AH<sub>1</sub>)-refractory CSU, but its varied response patterns and associated factors remain understudied, particularly in India.</p><p><strong>Methods: </strong>We conducted a retrospective study involving 81 antihistamine-resistant CSU patients treated with omalizumab at a tertiary care center in Northern India between 2018 and 2023. Baseline characteristics, treatment response, and adverse effects were analyzed. Patients were categorized into various response groups based on treatment timelines and biomarker correlations.</p><p><strong>Results: </strong>We observed 65% achieved symptom cessation (group 1) following a single omalizumab dose, while 21% responded between second and third doses (group 2). A subset (7.4%) necessitated increased dosing frequency (group 3) for symptom control. Additionally, 6.2% showed persistent symptoms despite increased dosing frequency (group 4), exhibiting distinctive biomarker profiles indicative of an autoimmune endotype. Notably, 27.1% experienced exacerbations during treatment, emphasizing the need for tailored management approaches and response expectations.</p><p><strong>Conclusion: </strong>Omalizumab demonstrated remarkable efficacy in the treatment of AH<sub>1</sub>-refractory CSU, with a good safety profile. This study highlights the complexity of treatment response to omalizumab and the potential utility of biomarkers in guiding personalized therapeutic strategies. Further research into biomarker-based endotypes is warranted to optimize CSU management.</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"15 1","pages":"21-28"},"PeriodicalIF":1.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11882220/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143571814","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
Efficacy and safety of azelastine hydrochloride and fluticasone propionate nasal spray in treating allergic rhinitis: A randomized controlled trial. 盐酸氮唑elastine和丙酸氟替卡松鼻喷雾剂治疗变应性鼻炎的疗效和安全性:一项随机对照试验。
IF 1.6 Q3 ALLERGY Pub Date : 2025-03-01 Epub Date: 2024-10-29 DOI: 10.5415/apallergy.0000000000000161
Xinling Han, Chengshuo Wang, Qinna Zhang, Bing Guan, Hua Zhang, Yafeng Yu, Jinyong Tang, Xiaoping Gao, Juan Meng, Chao Li, Huifang Zhou, Xinsheng Huang, Haiyun Shi, Tao Bian, Guohua Hu, Qingshan Jiang, Huabin Li, Lingbo Li, Xianhua Li, Chang Lin, Dingrong Liu, Jixiang Liu, Huaan Ma, Guolin Tan, Lijia Wan, Jiao Xia, Shuifang Xiao, Jinghua Xie, Zhimin Xing, Shenhong Qu, Changqing Zhao, Li Zhu, Yuan Zhang, Luo Zhang

Background: MP-AzeFlu (Dymista; Meda Pharma GmbH & Co., KG), a formulation combining azelastine hydrochloride and fluticasone propionate in a single spray, is superior to fluticasone propionate alone in relieving symptoms and improving the quality of life of patients with allergic rhinitis.

Objectives: In this study, we evaluated whether the effect of AzeFlu, a generic drug manufactured from China, is equivalent to that of MP-AzeFlu.

Methods: In total, 679 patients were recruited for a multicentre, randomized, double-blind, original drug-controlled, and parallel-group clinical trial. Overall, 339 and 340 patients were administered with AzeFlu and MP-AzeFlu, respectively. Efficacy was assessed by changes in the reflective total nasal symptom score, the area under the curve of reflective total nasal symptom score changes over time, changes from baseline in individual nasal symptom scores, and the Rhinoconjunctivitis Quality of Life Questionnaire. In addition, a safety evaluation was simultaneously performed.

Results: AzeFlu and MP-AzeFlu reduced the reflective total nasal symptom score from baseline (AzeFlu -6.7 [standard deviation, 2.59]; MP-AzeFlu -6.7 [standard deviation, 2.76]; P = 0.905) and improved nasal symptoms and quality of life (AzeFlu -62.3 [standard deviation, 33.59]; MP-AzeFlu -64.7 [standard deviation, 33.73]; P = 0.394) in patients with allergic rhinitis. Significant differences were not observed between groups.

Conclusion: AzeFlu showed effects equivalent to those of MP-AzeFlu in this clinical trial and may benefit Chinese patients with allergic rhinitis.Registration number: CTR20190189 (chinadrugtrials.org.cn/index.html).

背景:MP-AzeFlu;美达制药有限公司(Meda Pharma GmbH & Co., KG)是一种将盐酸氮唑elastine和丙酸氟替卡松联合使用的单喷雾制剂,在缓解变应性鼻炎患者的症状和改善患者的生活质量方面优于丙酸氟替卡松。目的:在本研究中,我们评估了中国生产的仿制药AzeFlu的疗效是否等同于MP-AzeFlu。方法:共招募679例患者进行多中心、随机、双盲、原始药物对照、平行组临床试验。总体而言,分别有339名和340名患者接受了AzeFlu和MP-AzeFlu治疗。通过反射性总鼻症状评分的变化、反射性总鼻症状评分曲线下面积随时间的变化、个体鼻症状评分与基线的变化以及鼻结膜炎生活质量问卷来评估疗效。此外,还进行了安全性评估。结果:AzeFlu和MP-AzeFlu较基线降低了反射性鼻症状总评分(AzeFlu -6.7[标准差,2.59];MP-AzeFlu -6.7[标准差,2.76];P = 0.905),改善鼻部症状和生活质量(AzeFlu -62.3[标准差,33.59];MP-AzeFlu -64.7[标准差,33.73];P = 0.394)。各组间无显著差异。结论:在本临床试验中,AzeFlu的疗效与MP-AzeFlu相当,可能使中国变应性鼻炎患者受益。注册号:CTR20190189 (chinadrugtrials.org.cn/index.html)。
{"title":"Efficacy and safety of azelastine hydrochloride and fluticasone propionate nasal spray in treating allergic rhinitis: A randomized controlled trial.","authors":"Xinling Han, Chengshuo Wang, Qinna Zhang, Bing Guan, Hua Zhang, Yafeng Yu, Jinyong Tang, Xiaoping Gao, Juan Meng, Chao Li, Huifang Zhou, Xinsheng Huang, Haiyun Shi, Tao Bian, Guohua Hu, Qingshan Jiang, Huabin Li, Lingbo Li, Xianhua Li, Chang Lin, Dingrong Liu, Jixiang Liu, Huaan Ma, Guolin Tan, Lijia Wan, Jiao Xia, Shuifang Xiao, Jinghua Xie, Zhimin Xing, Shenhong Qu, Changqing Zhao, Li Zhu, Yuan Zhang, Luo Zhang","doi":"10.5415/apallergy.0000000000000161","DOIUrl":"10.5415/apallergy.0000000000000161","url":null,"abstract":"<p><strong>Background: </strong>MP-AzeFlu (Dymista; Meda Pharma GmbH & Co., KG), a formulation combining azelastine hydrochloride and fluticasone propionate in a single spray, is superior to fluticasone propionate alone in relieving symptoms and improving the quality of life of patients with allergic rhinitis.</p><p><strong>Objectives: </strong>In this study, we evaluated whether the effect of AzeFlu, a generic drug manufactured from China, is equivalent to that of MP-AzeFlu.</p><p><strong>Methods: </strong>In total, 679 patients were recruited for a multicentre, randomized, double-blind, original drug-controlled, and parallel-group clinical trial. Overall, 339 and 340 patients were administered with AzeFlu and MP-AzeFlu, respectively. Efficacy was assessed by changes in the reflective total nasal symptom score, the area under the curve of reflective total nasal symptom score changes over time, changes from baseline in individual nasal symptom scores, and the Rhinoconjunctivitis Quality of Life Questionnaire. In addition, a safety evaluation was simultaneously performed.</p><p><strong>Results: </strong>AzeFlu and MP-AzeFlu reduced the reflective total nasal symptom score from baseline (AzeFlu -6.7 [standard deviation, 2.59]; MP-AzeFlu -6.7 [standard deviation, 2.76]; <i>P</i> = 0.905) and improved nasal symptoms and quality of life (AzeFlu -62.3 [standard deviation, 33.59]; MP-AzeFlu -64.7 [standard deviation, 33.73]; <i>P</i> = 0.394) in patients with allergic rhinitis. Significant differences were not observed between groups.</p><p><strong>Conclusion: </strong>AzeFlu showed effects equivalent to those of MP-AzeFlu in this clinical trial and may benefit Chinese patients with allergic rhinitis.<b>Registration number:</b> CTR20190189 (chinadrugtrials.org.cn/index.html).</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"15 1","pages":"7-14"},"PeriodicalIF":1.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11882219/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143571876","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
Retracted: Dermatological dichotomy: Atopic dermatitis or mycosis fungoides? 撤下:皮肤病学的二分法:特应性皮炎还是蕈样真菌病?
IF 1.6 Q3 ALLERGY Pub Date : 2025-03-01 Epub Date: 2024-12-20 DOI: 10.5415/apallergy.0000000000000176

[This retracts the article DOI: 10.5415/apallergy.0000000000000166.].

[本文撤回文章DOI: 10.5415/apallergy.0000000000000166.]。
{"title":"Retracted: Dermatological dichotomy: Atopic dermatitis or mycosis fungoides?","authors":"","doi":"10.5415/apallergy.0000000000000176","DOIUrl":"10.5415/apallergy.0000000000000176","url":null,"abstract":"<p><p>[This retracts the article DOI: 10.5415/apallergy.0000000000000166.].</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"15 1","pages":"43"},"PeriodicalIF":1.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11882213/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143571830","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
期刊
Asia Pacific Allergy
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