Journal of Asthma and Allergy最新文献

{"title":"The Plasticene Paradigm: Microplastics, Gut Dysbiosis, and Food Allergy - A Critical Commentary.","authors":"Lindong Shi, Peiqin Wang, Bin Wu, Congfu Huang","doi":"10.2147/JAA.S625708","DOIUrl":"10.2147/JAA.S625708","url":null,"abstract":"<p><strong>Background: </strong>The increasing prevalence of food allergy (FA) in industrialized regions cannot be fully explained by traditional hygiene and biodiversity frameworks, suggesting the involvement of new environmental triggers. Microplastics (MPs), which are dietary contaminants now consistently found in human biological samples, have been proposed as a potential threat to gut-immune balance. However, direct evidence for this link in humans is still lacking.</p><p><strong>Main body: </strong>This commentary critically examines and advances the \"Plasticene Paradigm\", which hypothesizes that dietary MP exposure disrupts the beneficial relationship between the host and its microbiota, thereby promoting the development of FA through microbiota-dependent mechanisms. The central mechanism proposed involves MP-induced dysbiosis, characterized by a reduction in short-chain fatty acid (SCFA) -producing bacteria. This reduction subsequently impairs the differentiation of regulatory T cells (Tregs), disrupts the balance between Th2 and Treg cells, and compromises the integrity of the intestinal barrier. While studies involving fecal microbiota transplantation in animal models offer causal evidence under experimental conditions, this evidence primarily comes from studies using supraphysiological doses of pristine polymers (mg/kg/day range). These doses exceed mass-based estimates of human daily intake (μg/kg/day range) by several orders of magnitude, although direct quantitative comparison is complicated by the use of heterogeneous exposure metrics (mass-based vs particle-count-based) across different estimation approaches. This significant difference in dosage fundamentally limits the applicability of these findings to human exposure levels found in the environment. We identify four obstacles to translating these findings: dose relevance, exposure complexity, challenges in model extrapolation, and analytical constraints. These barriers currently prevent drawing definitive conclusions about human risk.</p><p><strong>Conclusion: </strong>The current evidence, which is predominantly preclinical, is constrained by issues of dose relevance, exposure complexity, and gaps in model extrapolation, with human data largely showing only associations. We propose a three-pronged research agenda: (I) establishing prospective birth cohorts with specific biomonitoring for polymers; (II) conducting mechanistic studies using environmentally relevant MP mixtures in FA models; and (III) developing microbiome-targeted interventions as needed. This framework aims to transform the Plasticene Paradigm from a hypothesis-driven mechanistic narrative into one supported by a stronger evidence base. This evidence may ultimately inform public health policy, food safety regulations, and precise prevention strategies for FA in an era of widespread plastic contamination.</p>","PeriodicalId":15079,"journal":{"name":"Journal of Asthma and Allergy","volume":"19 ","pages":"625708"},"PeriodicalIF":3.3,"publicationDate":"2026-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13640986/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110030","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimized In-House Basophil Activation Test for Pediatric Egg Allergy: Agreement with a Structured Composite Clinical Classification.","authors":"Xuanyue Qu, Limin Wang, Yiting Cai, Zhen Qin, Juan Wang, Weize Li, Jiaying Wu, Rujia Wang, Lihui Lin, Jinyan Zhao, Yuxuan Zhang, Xiaojian Zhou, Li Li, Xia Peng","doi":"10.2147/JAA.S624966","DOIUrl":"https://doi.org/10.2147/JAA.S624966","url":null,"abstract":"<p><strong>Background: </strong>Accurate diagnosis of IgE-mediated egg allergy in young children remains challenging. While basophil activation test (BAT) offers a functional readout, methodological heterogeneity and limited real-world pediatric validation have hindered its standardized use.</p><p><strong>Purpose: </strong>To develop and evaluate an optimized in-house BAT protocol for pediatric egg allergy, and to assess its agreement with structured clinical classification and its exploratory adjunctive role in diagnostically challenging cases.</p><p><strong>Methods: </strong>Children aged 0-6 years with suspected food allergy were prospectively enrolled in a cross-sectional agreement study without longitudinal follow-up and classified by a structured composite reference standard integrating clinical history, egg-specific IgE (sIgE), documented tolerance, and expert panel consensus as egg-allergic (EA, n=28), egg non-allergic (NEA, n=68), or diagnostically indeterminate (IND, n=6). BAT was performed using stimulation with egg extract. The stimulation index (SI) was defined as the ratio of median fluorescence intensity after stimulation to that of the unstimulated control. Marker-specific thresholds were defined as the 95th percentiles of the corresponding parameters in the NEA group. Agreement with the EA/NEA classification, utility in the IND group, and correlation with sIgE were measured and evaluated.</p><p><strong>Results: </strong>The conjunctive CD63 SI and CD203c SI rule was selected as the primary BAT interpretation rule. In 96 EA and NEA cases, BAT showed 88.5% overall agreement as evaluated against the structured composite clinical classification (positive percent agreement 64.3%, negative percent agreement 98.5%; Cohen's κ= 0.694, 95% CI 0.530-0.858). Among 6 IND children with suggestive histories but undetectable egg-specific IgE, BAT was positive in 3 cases; however, this finding was not confirmatory of clinical allergy without oral food challenge (OFC). BAT activation parameters correlated moderately with sIgE in the overall cohort (r=0.4238-0.5126, all <i>p</i><0.001), but not within the EA group alone.</p><p><strong>Conclusion: </strong>This optimized in-house BAT, using a CD63 SI and CD203c SI conjunctive rule, showed substantial agreement with the structured composite clinical classification and provided functional evidence in seronegative, clinically suspected cases. However, without OFC confirmation, a positive BAT cannot establish clinical egg allergy. BAT may serve as an adjunctive functional test when first-line assessments are discordant or inconclusive, but should not be considered a replacement for OFC.</p>","PeriodicalId":15079,"journal":{"name":"Journal of Asthma and Allergy","volume":"19 ","pages":"624966"},"PeriodicalIF":3.3,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13637511/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110059","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dupilumab Treatment is Associated with Improvement in Small Airway Dysfunction in Children with Moderate to Severe Asthma: A Retrospective Analysis.","authors":"Lihong Sun, Lijun Zeng, Lanying Cheng, Xu Qin, Kaijia Yang, Yueying Yang, Fengyi Gong, Jinping Zheng, Nanshan Zhong","doi":"10.2147/JAA.S629376","DOIUrl":"https://doi.org/10.2147/JAA.S629376","url":null,"abstract":"<p><strong>Background: </strong>Small airway dysfunction (SAD) is common in pediatric asthma and is associated with poor disease control and frequent exacerbations. Current therapies show limited efficacy in improving small airway function. Dupilumab suppresses type 2 inflammation and may provide benefit; however, real-world evidence in Chinese children is limited. This study evaluated the association between dupilumab and improvements in SAD in children with uncontrolled moderate-to-severe asthma.</p><p><strong>Methods: </strong>This retrospective cohort study without a concurrent comparator group included 106 children (aged 6-14 years) with uncontrolled moderate-to-severe asthma treated with dupilumab between January 2022 and March 2025. Dupilumab was generally administered at a dose of 300 mg every 4 weeks. The primary outcome was the proportion of patients with SAD at 6 months, defined as ≥2 of maximal mid-expiratory flow (MMEF_25-75), MEF₂₅, or MEF₅₀ <65% predicted. Secondary outcomes included changes in small airway function, type 2 inflammatory biomarkers, lung function, and exacerbation rates. Longitudinal changes were assessed using paired analyses, with mixed-effects models as sensitivity analyses.</p><p><strong>Results: </strong>Among the 106 children included in the study, the proportion of patients with SAD decreased from 63.2% at baseline to 27.0% at 6 months. Small airway indices improved significantly, including MMEF_25-75% predicted (57.2% to 75.8%), MEF₂₅% predicted (48.3% to 66.4%), and MEF₅₀% predicted (58.7% to 76.1%) (all p<0.01). Type 2 inflammatory biomarkers were reduced, including fractional exhaled nitric oxide and serum IgE. Annualized exacerbation rates declined, accompanied by improved lung function and symptom control. Improvement in SAD was associated with greater increases in FEV₁/FVC and larger reductions in FeNO.</p><p><strong>Conclusion: </strong>Dupilumab treatment is associated with amelioration of SAD in children with moderate-to-severe asthma, accompanied by reductions in type 2 inflammatory biomarkers.</p>","PeriodicalId":15079,"journal":{"name":"Journal of Asthma and Allergy","volume":"19 ","pages":"629376"},"PeriodicalIF":3.3,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13634228/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110080","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adherence to Inhaled Corticosteroids and Inflammatory Phenotypes in Asthma.","authors":"Christiane Hammershaimb Mosbech, Kjell Erik Julius Håkansson, Erik Sören Halvard Hansen, Howraman Meteran, Peter Ascanius Jacobsen, Nicklas Brustad, Erica Woer Brask, Laurits Janns, Christian Grabow Westergaard, Nina Skavlan Godtfredsen, Charlotte Suppli Ulrik","doi":"10.2147/JAA.S609810","DOIUrl":"https://doi.org/10.2147/JAA.S609810","url":null,"abstract":"<p><strong>Background and aim: </strong>Adherence to inhaled corticosteroids (ICS) is essential for asthma control, yet little is known about whether adherence differs across inflammatory phenotypes. Patients with type 2 (T2)-low biomarkers have reduced corticosteroid responsiveness, which may influence adherence. We aimed to evaluate adherence to ICS across inflammatory phenotypes and to examine whether associations between adherence and clinical risk factors differ by inflammatory phenotype.</p><p><strong>Material and methods: </strong>This retrospective cohort study included adult asthma patients managed at a respiratory outpatient clinic between May 2020 and May 2022. Inflammatory phenotype was defined using blood eosinophils (cut-off 0.15×10⁹/L) and FeNO (cut-off 25 ppb). Patients were categorized into T2-low (two negative T2-biomarkers), possible T2-high (one positive T2-biomarker), and T2-high (two positive T2-biomarkers). Adherence was calculated as medication possession ratio (MPR), with >0.8 defining good adherence. Data was obtained from electronic health records and national registries. Logistic regression models adjusted for relevant covariates were performed.</p><p><strong>Results: </strong>Of 960 phenotyped patients (165 T2-low, 538 possible T2-high, 257 T2-high), 484 were included in the adherence analysis. Adherence did not differ significantly between phenotypes, although patients with T2-low asthma showed a tendency towards lower adherence (0.66) than patients with possible T2-high and T2-high asthma (both 0.74). Across phenotypes, increasing age was associated with higher odds of good adherence (OR 1.25, p <0.001). Among male patients, those with T2-high (OR 0.13, p = 0.022) and possible T2-high (OR 0.14, p = 0.023) phenotypes had lower odds of good adherence than those with T2-low phenotype.</p><p><strong>Conclusion: </strong>In patients with asthma, adherence to ICS did not differ significantly across inflammatory phenotypes, although patients with T2-low asthma tended to show lower adherence. Among males, adherence varied by phenotype, with T2-high and possible T2-high asthma associated with lower odds of good adherence.</p>","PeriodicalId":15079,"journal":{"name":"Journal of Asthma and Allergy","volume":"19 ","pages":"609810"},"PeriodicalIF":3.3,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13633673/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110112","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Comparative Effectiveness of Mepolizumab versus Benralizumab in an Older Population with Asthma: A US Medicare Fee-for-Service Analysis.","authors":"Guillaume Germain, Emmeline Burrows, Jacob Klimek, Patrick Gravelle, Kioumars Tavakoli Tafti, François Laliberté, Arijita Deb","doi":"10.2147/JAA.S646978","DOIUrl":"https://doi.org/10.2147/JAA.S646978","url":null,"abstract":"<p><strong>Background: </strong>Biologic therapies, including mepolizumab and benralizumab, are used to treat uncontrolled asthma. However, real-world evidence comparing these treatments is limited. This study compared asthma-related hospitalizations and asthma exacerbations between mepolizumab and benralizumab among Medicare fee-for-service (FFS) beneficiaries with asthma.</p><p><strong>Methods: </strong>Data were obtained from Komodo Research Database (01/01/2018-05/31/2025). Eligible patients included Medicare FFS beneficiaries with asthma and a first claim for mepolizumab or benralizumab on or after January 1, 2019 (index date). An adherent subgroup included those who remained adherent to their index biologic for ≥6 months. Overlap weighting based on a propensity score model was used to balance cohorts. Asthma-related hospitalizations and asthma exacerbations were evaluated while on treatment. Rates were reported as the number of events per-patient-year (PPY) and compared between weighted cohorts using rate ratios (RRs) with 95% confidence intervals (CIs). Non-inferiority using a fixed-margin approach was used to compare rates of asthma-related hospitalizations between cohorts.</p><p><strong>Results: </strong>In total, 125 and 177 patients were included in the mepolizumab and benralizumab cohorts, respectively (mean age: 70.7 years, 69.1 years). After weighting, baseline characteristics were well-balanced. At 1-year post-index, mepolizumab demonstrated superiority over benralizumab for asthma-related hospitalizations, showing a 77% rate reduction (0.036 PPY vs 0.155 PPY; RR: 0.23, 95% CI: 0.07, 0.74; p=0.013) and was associated with comparable rates of asthma exacerbations (1.056 PPY vs 1.302 PPY; RR: 0.81, 95% CI: 0.52, 1.26; p=0.348). In the adherent subgroup, mepolizumab remained superior to benralizumab for asthma-related hospitalizations (0.040 PPY vs 0.167 PPY; RR: 0.24, 95% CI: 0.07, 0.79; p=0.019) and remained associated with comparable rates of asthma exacerbations (0.927 PPY vs 1.249 PPY; RR: 0.74, 95% CI: 0.44, 1.25; p=0.265). Consistent results were observed at 2-years post-index.</p><p><strong>Conclusion: </strong>Mepolizumab was superior to benralizumab for asthma-related hospitalizations, while asthma exacerbation rates were comparable between the two therapies.</p>","PeriodicalId":15079,"journal":{"name":"Journal of Asthma and Allergy","volume":"19 ","pages":"646978"},"PeriodicalIF":3.3,"publicationDate":"2026-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13625837/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110107","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Unique Associations Between Complement Split Products and Pollen Species in Adults with Respiratory Allergic Disease: A Pilot Study.","authors":"Sairaman Nagarajan, Tamar Smith-Norowitz, Martin H Bluth, Andrew Eng, Yosif Pak, Stephan Kohlhoff, Rauno Joks","doi":"10.2147/JAA.S632374","DOIUrl":"https://doi.org/10.2147/JAA.S632374","url":null,"abstract":"<p><strong>Background: </strong>Complement split product (CSP) anaphylatoxins, C3a and C5a, are important mediators of innate immune responses and have been implicated in the pathogenesis of asthma. Environmental pollen exposure is a trigger of asthma symptoms, leading to generation of CSP, which amplify allergic responses. The relationship between seasonal pollen levels, complement activation and clinical outcomes of asthma control remain unknown. This exploratory pilot study evaluated the association between concurrent tree, grass, and weed pollen exposure, CSP levels, and measures of asthma control in adults with asthma.</p><p><strong>Methods: </strong>In this prospective study, which included 11 allergic adults, blood samples were drawn monthly for measurement of plasma C5a desArg and C3a desArg levels (ELISA). Concurrent local tree, grass, and weed pollen exposure, as well as clinical measures of asthma control (ACT) were determined. Spearman correlation matrices were computed.</p><p><strong>Results: </strong>Tree pollen counts were positively associated with C3a desArg expression (r=0.562, p<0.0001). Weed pollen counts were negatively associated with C3a desArg expression (r=-0.419, p<0.0001). Increasing weed pollen counts decreased FeNO (β=0.956, p<0.001). Higher C5a desArg levels over time correlated with increased ACT scores (p=0.02), improved AQLQ and RQLQ (P=0.03, 0.03, respectively).</p><p><strong>Conclusion: </strong>Seasonal pollen exposure is associated with distinct patterns of complement activation in asthma. Larger studies are required to elucidate the relation of these patterns of complement activation to immune mechanisms in asthma pathogenesis and clinical disease.</p>","PeriodicalId":15079,"journal":{"name":"Journal of Asthma and Allergy","volume":"19 ","pages":"632374"},"PeriodicalIF":3.3,"publicationDate":"2026-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13625834/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110055","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Defining Treatment Response in Pediatric Asthma Pharmacogenomics: Comments on \"Gene Polymorphisms Associated with Treatment Response of Asthma in Chinese Children\" [Letter].","authors":"Ercan Yılmaz","doi":"10.2147/JAA.S654536","DOIUrl":"10.2147/JAA.S654536","url":null,"abstract":"","PeriodicalId":15079,"journal":{"name":"Journal of Asthma and Allergy","volume":"19 ","pages":"654536"},"PeriodicalIF":3.3,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13616172/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149069636","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Potential Determinants of Progression from Cough-Variant Asthma to Classic Asthma in Children: Evidence, Mechanisms, and Clinical Research Gaps.","authors":"Kaiwen Zheng, Ran Ma, Yingqian Zhang","doi":"10.2147/JAA.S644110","DOIUrl":"10.2147/JAA.S644110","url":null,"abstract":"<p><strong>Objective: </strong>To synthesize current evidence on host and environmental factors potentially associated with progression of cough variant asthma (CVA) to classic asthma in children, with explicit distinction between direct evidence from pediatric CVA cohorts and indirect evidence extrapolated from general asthma or adult studies, and to identify research gaps for future investigation.</p><p><strong>Data sources: </strong>PubMed, EMBASE, and Web of Science were searched for studies examining CVA progression, risk factors, and mechanisms in pediatric populations.</p><p><strong>Study selections: </strong>Original research articles, meta-analyses, and systematic reviews investigating genetic susceptibility, atopy, airway hyperresponsiveness, medication adherence, diet, psychological stress, respiratory infections, allergen exposure, and indoor air pollution in relation to CVA-to-classic asthma progression in children aged <18 years were included.</p><p><strong>Results: </strong>Atopy and airway hyperresponsiveness carry the most consistent evidence. Poor medication adherence is the most readily modifiable risk factor. Environmental triggers include respiratory viral infections (particularly rhinovirus), allergen exposure, and indoor air pollution. These factors converge on Th2-biased immunity, epithelial barrier dysfunction, neuroimmune interactions, and epigenetic reprogramming. A nomogram integrating clinical variables and biomarkers achieved AUCs of 0.929 and 0.914 in training and validation cohorts, respectively, but validated prediction tools for CVA progression remain unavailable.</p><p><strong>Conclusion: </strong>Early identification of high-risk children through integrated clinical and biomarker assessment, combined with comprehensive management targeting modifiable risk factors, remains the most rational approach to symptom control, exacerbation prevention, and preservation of lung function; whether this delays progression awaits validation in pediatric interventional trials.</p>","PeriodicalId":15079,"journal":{"name":"Journal of Asthma and Allergy","volume":"19 ","pages":"644110"},"PeriodicalIF":3.3,"publicationDate":"2026-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13599799/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149038694","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical and Cost-Effectiveness of Omalizumab in Concomitant Asthma and Chronic Rhinosinusitis with Nasal Polyps: A Real-World Exploratory Study.","authors":"Xiaohan Xu, Duo Mou, Peng Men, Jingwen Wang, Mingnuo Zheng, Rongsheng Zhao, Lifeng Xie, Chun Chang","doi":"10.2147/JAA.S626890","DOIUrl":"10.2147/JAA.S626890","url":null,"abstract":"<p><strong>Purpose: </strong>Severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) frequently coexist, representing the severe \"United Airway Disease\" (UAD) phenotype. Although omalizumab is approved for both conditions individually, real-world evaluations of its clinical and economic viability for this concomitant phenotype remain limited. We evaluated the cost-effectiveness of omalizumab add-on therapy in Chinese adults with UAD.</p><p><strong>Methods: </strong>This 52-week exploratory study compared omalizumab add-on therapy (n=23) with standard care (n=17) in patients with concomitant asthma and CRSwNP. Clinical outcomes included acute exacerbations (AEs), endoscopic sinus surgery (ESS) requirements, asthma control test (ACT) scores, sinus CT Lund-Mackay (LM) scores, corticosteroid and antibiotic exposure. Cost-effectiveness was analyzed from a healthcare provider perspective using 2024 constant prices, with decision uncertainty assessed via 1000-iteration bootstrapping. Scenario analyses evaluated the economic impact of recently approved domestic biosimilars.</p><p><strong>Results: </strong>At week 52, compared with standard care, the omalizumab add-on group achieved significant reductions in annual AEs (median 0 [IQR 1.00] vs 1.0 [IQR 2.00]; <i>P</i> = 0.037) and ESS rates (8.70% vs 41.18%; <i>P</i> = 0.016). Although cross-sectional ACT scores at week 52 were comparable, omalizumab demonstrated superior peak efficacy with higher best ACT scores (median 25.0 [IQR 1.00] vs 24.0 [IQR 3.00]; <i>P</i> = 0.029) and greater maximum improvement from baseline (mean 7.52 [SD 4.90] vs 4.47 [SD 2.83]; <i>P</i> = 0.018). Omalizumab also produced significantly lower LM scores (median 12.92 [IQR 2.50] vs 18.00 [IQR 0]; <i>P</i> < 0.001) and a profound antibiotic-sparing effect (median duration 0.0 [IQR 8.5] vs 23.0 [IQR 24.0] days; <i>P</i> < 0.001). Total direct medical costs were approximately 7-fold higher (¥44,681.09 [IQR 47,780.91] vs ¥6282.25 [IQR 16,179.90]; <i>P</i> < 0.0001), primarily driven by biologic acquisition costs. Baseline incremental cost-effectiveness ratios (ICERs) for the reference originator were ¥64,223.84 per AE avoided and ¥114,398.72 per ESS avoided, with 0% probability of cost-effectiveness at strict willingness-to-pay thresholds. Substituting the originator with the lowest-priced domestic biosimilar substantially reduced the ICERs to ¥42,943.60 and ¥76,493.28, respectively.</p><p><strong>Conclusion: </strong>Omalizumab provides superior multi-domain clinical control and profound antibiotic-sparing effects. While the reference originator is not cost-effective over a 52-week horizon at its baseline price in China, stepwise price reductions through centralized procurement and the emergence of affordable biosimilars provides a highly viable economic pathway. Future optimization requires dynamic value-based pricing and targeting high-burden UAD phenotypes.</p>","PeriodicalId":15079,"journal":{"name":"Journal of Asthma and Allergy","volume":"19 ","pages":"626890"},"PeriodicalIF":3.3,"publicationDate":"2026-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13601823/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149038620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dupilumab Improves Lung Function and Reduces Severe Exacerbations in Patients from China with Type 2 Asthma: A Subgroup Analysis of a Phase 3 Randomized Trial.","authors":"Qingling Zhang, Xiuhua Fu, Haohui Fang, Jie Lin, Arman Altincatal, Yvonne Huang, Jason H Kwah, Olivier Ledanois, Nanshan Zhong","doi":"10.2147/JAA.S597499","DOIUrl":"10.2147/JAA.S597499","url":null,"abstract":"<p><strong>Purpose: </strong>Asthma affects approximately 46 million adults in China. The safety and efficacy of dupilumab, a monoclonal antibody which blocks the shared receptor component for interleukin (IL)-4 and IL-13, were evaluated in a phase 3 study in patients with moderate-to-severe asthma in the Asia-Pacific region (NCT03782532). This is a pre-specified subgroup analysis of patients in China derived from the Asia-Pacific trial.</p><p><strong>Patients and methods: </strong>Patients (≥12 years) with inadequately controlled asthma despite medium/high-dose inhaled corticosteroids and ≥1 additional controller were included. Patients with type 2 inflammation (eosinophil counts ≥150 cells/µL or fractional exhaled nitric oxide ≥25 parts per billion) without maintenance oral corticosteroids (OCS) (type 2 non-OCS group, for primary efficacy analysis) were randomized 1:1 to receive 200-mg dupilumab every 2 weeks or placebo for 24 weeks. In this pre-specified subgroup analysis, primary efficacy endpoints examined included change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV₁) to week 12. Additional outcomes assessed included asthma control measures, annualized severe exacerbation rates, and safety.</p><p><strong>Results: </strong>In a total of 412 patients randomized from China (206 per treatment group) 347 (84.2%) were included in the primary efficacy analysis. Changes from baseline to week 12 in FEV₁ were significantly greater for dupilumab vs placebo (least squares [LS] mean difference: 0.34 L [95% confidence interval (CI): 0.25, 0.43]), as were improvements in 5-Item Asthma Control Questionnaire scores at week 24 (LS mean difference: -0.19 [95% CI: -0.35, -0.03]). Severe exacerbation risk was significantly reduced by 74.2% (risk ratio: 0.258 [95% CI: 0.127, 0.521], P = 0.0002) vs placebo. Treatment-emergent adverse event rates were similar across groups.</p><p><strong>Conclusion: </strong>In this 24-week subgroup analysis, dupilumab improved lung function, asthma control, and exacerbations, and was well tolerated in patients from China with type 2 asthma without maintenance OCS.</p>","PeriodicalId":15079,"journal":{"name":"Journal of Asthma and Allergy","volume":"19 ","pages":"597499"},"PeriodicalIF":3.3,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13589984/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149012394","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}