International Archives of Allergy and Immunology最新文献

{"title":"Efficacy and Safety of Yiqi Tongqiao Pill for Allergic Rhinitis With Lung-Spleen Qi Deficiency: A Multicenter Randomized Double-Blind Phase III Trial.","authors":"Yu Zhang, Jing Liu, Fengying Qiao, Xiaoning Chen, Zhenhua Zhu, Bo Tao, Zhaoye Zheng, Daxin Liu","doi":"10.1159/000553598","DOIUrl":"https://doi.org/10.1159/000553598","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the clinical efficacy and safety of Yiqi Tongqiao Pill (YQTP) in treating allergic rhinitis (AR) with a Traditional Chinese Medicine (TCM) pattern of Lung-Spleen Qi Deficiency.</p><p><strong>Methods: </strong>A multicenter, randomized, double-blind, parallel-controlled, phase III clinical trial was conducted. A total of 480 patients with allergic rhinitis were randomly assigned in a 3:1 ratio to a treatment group (oral YQTP, n=360) and a control group (oral low-dose mimic agent, n=119) for a 2-week course. The primary efficacy endpoint was the change from baseline in the Total Nasal Symptom Score (TNSS) after 2 weeks of treatment.</p><p><strong>Results: </strong>The Full Analysis Set (FAS) included 479 patients. After 2 weeks of treatment, the reduction in TNSS score in the treatment group (5.79±2.23) was significantly greater than that in the control group (0.84±1.82) (P<0.0001). The treatment group also demonstrated significant superiority over the control group in terms of overall response rate (92.78% vs 10.92%), improvement in TCM syndrome score, quality of life, and speed of symptom relief (all P<0.0001). There was no statistically significant difference in the incidence of adverse events between the two groups, indicating a good safety profile.</p><p><strong>Conclusion: </strong>YQTP significantly improved nasal symptoms and quality of life over 2 weeks in patients with SAR with the TCM pattern of lung-spleen qi deficiency, with a safety profile comparable to the mimic control.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry (ChiCTR-TRC-13003137); http://www.chictr.org.cn.</p>","PeriodicalId":13652,"journal":{"name":"International Archives of Allergy and Immunology","volume":" ","pages":"1-16"},"PeriodicalIF":2.3,"publicationDate":"2026-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149038423","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"From Allergy to Tumor Immunology: The Dual Role of Antigen-Specific IgE-Mechanisms, Challenges, and Prospects for Clinical Translation.","authors":"Yaojun Wang, Tong Yu, JunTao Li, Zhongcheng Liu","doi":"10.1159/iaa/adfag029","DOIUrl":"https://doi.org/10.1159/iaa/adfag029","url":null,"abstract":"<p><p>This review aims to systematically explore the dual role of antigen-specific IgE (AS-IgE) in allergic reactions and tumor immunity, focusing on the possibility, mechanism and current obstacles of its clinical transformation. Recent studies have revealed that AS-IgE is not only a single function of promoting allergies. It can activate antibody-dependent cytotoxicity (ADCC) and phagocytosis (ADCP) by binding to FcεRI receptors on the surface of immune cells (common in monocytes and macrophages), thereby reshaping the surrounding environment of tumors (TME) and enhancing the anticancer activity of CD8+ T cells. However, this duality also carries risks. For example, AS-IgE may induce the shift of Th2 immune response, causing immunosuppression and thus contributing to tumors. At the same time, the potential for it to activate allergic reactions remains a significant barrier to clinical application. It is worth noting that some experiments have tried to optimize AS-IgE through engineering modification. For example, sialic acid modification has been observed to reduce its sensitivity to allergic stimuli, providing ideas for safe applications. These findings suggest that AS-IgE is expected to become a new tool for tumor immunotherapy. However, in order to achieve transformation, it is necessary to first solve the key issues: how to balance its anti-cancer effect with allergies and tumor-promoting risks? At present, optimizing safety (especially reducing the risk of allergy) is the primary task, and exploring the combination with immune checkpoint inhibitors may improve the efficacy. Future research should be closer to the individual differences of patients, based on the characteristics of tumor environment in different people, and accurately regulate the dual role of AS-IgE. Only in this way can this molecule truly move from the laboratory to the clinic.</p>","PeriodicalId":13652,"journal":{"name":"International Archives of Allergy and Immunology","volume":" ","pages":"1"},"PeriodicalIF":2.3,"publicationDate":"2026-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149024712","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Erratum.","authors":"","doi":"10.1159/iaa/adfag022","DOIUrl":"https://doi.org/10.1159/iaa/adfag022","url":null,"abstract":"<p><p>In the article \"Safety and Efficacy of Remibrutinib for Chronic Spontaneous Urticaria: A Systematic Review and Meta-Analysis\" [Int Arch Allergy Immunol. 2026;187(6):635-646. https://doi.org/10.1159/000548302] by Muhammad Burhan et al., online supplementary Figure 11 has been corrected.Following publication, the authors reviewed their data and found that an error occurred during the compilation of their forest plot of online supplementary Figure 11. This error arose from an internal data entry oversight during the analysis phase.The corrected online supplementary Figure 11 has been provided here. In addition, the corrected Results sentence in the manuscript text is as follows:\"Three studies examined nasopharyngitis cases in both groups. The pooled analysis, as depicted in online supplementary Figure 11, demonstrated a statistically significant increase in the risk of nasopharyngitis in the remibrutinib group compared with placebo (RR: 1.88, 95% CI: 1.11-3.19, I² = 0%, p = 0.02).\"</p>","PeriodicalId":13652,"journal":{"name":"International Archives of Allergy and Immunology","volume":" ","pages":"1"},"PeriodicalIF":2.3,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149074522","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comprehensive 17-Allergen Panel for Inhalant Specific IgE: Reliability and Validation of Optimized Quantitative Assays.","authors":"Andrea Ianniello, David Osamwonuyi Amadsun, Elisabetta Bencini, Nicole Peli, Helena Cerutti, Alessandra Cartocci, Tommaso Bandini, Giulia Tesi, Tiziana Scacchetti, Alessandra Brogi","doi":"10.1159/iaa/adfag015","DOIUrl":"10.1159/iaa/adfag015","url":null,"abstract":"<p><strong>Introduction: </strong>Atopic diseases, such as asthma and allergic rhinitis, are chronic inflammatory disorders mediated by immunoglobulin E (IgE) responses to environmental allergens. Detecting allergen-specific IgE is essential for diagnosing sensitization and guiding clinical management. Allergen-specific IgE assays have, thus, become indispensable in clinical diagnostics and allergy research. The CHORUS Specific IgE Capture assays are automated immunoassays designed to quantify up to 17 allergen-specific IgE antibodies in human serum. In this study, optimized versions of the assays have been evaluated to determine their analytical performance in terms of sensitivity, specificity, precision, and overall reliability.</p><p><strong>Methods: </strong>Each assay was tested using human serum from patients with suspected IgE-mediated sensitization. Limits of detection (LoD) and quantitation were determined according to current guidelines. Precision and repeatability were assessed across intra-run, inter-run, intra-batch, and inter-batch conditions, with coefficients of variation (CVs) ≤15% considered acceptable. Method comparison with ImmunoCAP was performed using Spearman's correlation, Passing-Bablok regression, and Bland-Altman analysis.</p><p><strong>Results: </strong>Across 72 replicate measurements per lot, the LoD was 0.08 kU/L, with a quantifiable range of 0.10-50.0 kU/L. Sensitivity ranged from 90.2% (Phleum pratense) to 97.0% (meadow grass), while specificity ranged from 90.2% (Dermatophagoides pteronyssinus) to 100% (Alternaria alternata, Betula verrucosa, rye grass, meadow grass). All assays demonstrated high precision (CV <15%) and strong correlation with ImmunoCAP (Spearman's r > 0.700). Outliers were rare and mostly observed above 10 kU/L.</p><p><strong>Conclusion: </strong>CHORUS Specific IgE Capture assays exhibit high analytical accuracy and reproducibility, supporting their reliability for routine clinical determination of allergen-specific IgE.</p>","PeriodicalId":13652,"journal":{"name":"International Archives of Allergy and Immunology","volume":" ","pages":"1"},"PeriodicalIF":2.3,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149016715","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Characteristics and Factors Associated with Reaction Severity among Children Experiencing Reactions during Oral Food Challenges.","authors":"Onur Uğurlu, Bahri Can Duran, Ezgi Ulusoy Severcan, Seda Şirin","doi":"10.1159/iaa/adfag026","DOIUrl":"10.1159/iaa/adfag026","url":null,"abstract":"<p><strong>Introduction: </strong>Oral food challenges (OFCs) may provoke reactions ranging from mild symptoms to anaphylaxis. Identifying factors associated with severe reactions is important for patient safety.</p><p><strong>Methods: </strong>We retrospectively evaluated 150 children with IgE-mediated food allergy who experienced reactions during open OFCs for tolerance assessment between October 2022 and March 2026. Clinical and laboratory characteristics were analyzed. Multivariable logistic regression identified factors independently associated with challenge-related anaphylaxis. A sensitivity analysis additionally adjusted for age, sex, total IgE, and reaction step. Receiver operating characteristic (ROC) analysis assessed laboratory markers.</p><p><strong>Results: </strong>Anaphylaxis occurred in 29 (19.3%) patients. In univariate analyses, a history of anaphylaxis at presentation and concomitant allergic diseases were associated with challenge-related anaphylaxis. In multivariable analysis, milk sIgE/total IgE ratio and concomitant allergic diseases remained independently associated with anaphylaxis. Each 1% increase in the ratio increased the odds of anaphylaxis by 5.5% (OR 1.055, 95% CI: 1.010-1.103; p = 0.013), while concomitant allergic diseases were associated with higher odds (OR 5.75, 95% CI: 1.04-31.48; p = 0.039). The ratio remained associated with anaphylaxis in sensitivity analysis (OR 1.057, 95% CI: 1.010-1.106; p = 0.018). ROC analysis showed moderate discrimination for milk sIgE (AUC 0.70), casein sIgE (AUC 0.72), and the ratio (AUC 0.66), with sensitivities of approximately 50%.</p><p><strong>Conclusions: </strong>Among children who experienced reactions during OFCs, the milk sIgE/total IgE ratio and concomitant allergic diseases were independently associated with challenge-related anaphylaxis. Milk and casein sIgE provided modest discriminatory information with limited sensitivity and should not be considered standalone markers. Larger prospective studies are needed for validation.</p>","PeriodicalId":13652,"journal":{"name":"International Archives of Allergy and Immunology","volume":" ","pages":"1"},"PeriodicalIF":2.3,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148976886","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Challenge-verified shrimp allergy in a Danish patient cohort throughout 23 years.","authors":"Sebastian Vigand Svendsen, Carsten Bindslev-Jensen, Charlotte Gotthard Mortz","doi":"10.1159/iaa/adfag027","DOIUrl":"https://doi.org/10.1159/iaa/adfag027","url":null,"abstract":"<p><p>Background Shrimp allergy is a prevalent, although data from Northern Europe are limited. This study evaluated oral food challenge (OFC)-verified shrimp allergy and the relationship between shrimp and house dust mite (HDM)-sensitizations in patients suspected of shrimp allergy. Methods Patients undergoing OFC to shrimp between 2002 and 2024 were retrospectively included (n=324). Clinical OFC data, skin prick-prick tests (SPT), serum-specific immunoglobulin E (s-IgE) to shrimp and HDM (Dermatophagoides pteronyssinus, Dermatophagoides farinae), and demographics were analyzed. Risk factors for positive OFC were evaluated using multivariate logistic regression. Results Shrimp allergy (all shrimp-types) was confirmed by OFC in 12.3% (n=40), with a higher prevalence in children/adolescents (≤17 years) than in adults (22.8% vs 8.2%, p<0.001). The median cumulative eliciting dose was 18.8 grams (interquartile range: 8.8-48.8). Reactions were predominantly cutaneous, mucosal, and gastrointestinal; 10% developed anaphylaxis. Patients allergic to Northern Shrimp (positive OFC) more frequently had positive SPT to shrimp (23.7% vs 4.7%, p<0.001) and trended toward higher shrimp-specific s-IgE. Sensitization to HDM was more frequent in shrimp-allergic than tolerant patients (68.6% vs 46.6%, p=0.013). A stronger response to shrimp than HDM (difference in SPT >1 mm or s-IgE >1 kUA/L) was associated with positive OFC. Mono-sensitization to shrimp (odds ratio (OR)=6.41), concomitant shrimp and HDM sensitization (OR=8.89), and age ≤17 years (OR=0.27) were independent risk factors for a positive OFC. Conclusion Shrimp allergy was confirmed by OFC in 12% of suspected cases evaluated at a tertiary allergy centre. Cross-reactivity with HDM may impair the diagnostic accuracy of conventional allergy tests, highlighting the need for improved in vitro-diagnostics.</p>","PeriodicalId":13652,"journal":{"name":"International Archives of Allergy and Immunology","volume":" ","pages":"1"},"PeriodicalIF":2.3,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148944823","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative Safety and Treatment Persistence of Aeroallergen and Venom Immunotherapy: A Real-World Patient- and Injection-Level Analysis.","authors":"Emrah Harman, Mehmet Emin Gerek, Ferhat Sağun, Seçim Kolak, Şükran Aslan Savaş, İsmail Yiğitdöl, Ümmügülsüm Yılmaz Ergün, Fatih Çölkesen, Şevket Arslan","doi":"10.1159/iaa/adfag021","DOIUrl":"10.1159/iaa/adfag021","url":null,"abstract":"<p><strong>Introduction: </strong>Subcutaneous aeroallergen immunotherapy (SCIT) and venom immunotherapy (VIT) are established disease-modifying treatments, but treatment-related adverse reactions remain an important safety concern. Direct real-world comparisons of these modalities, particularly using injection-level analyses that account for repeated injections within patients, remain limited. This study aimed to compare adverse reactions and documented treatment discontinuation between SCIT and VIT at both the patient and injection levels.</p><p><strong>Methods: </strong>This retrospective single-center study included 172 adults receiving SCIT (n = 144) or VIT (n = 28) between January 2023 and December 2025. Adverse reactions were evaluated at the patient level and across 2,251 administered injections. Injection-level local and systemic reactions were compared using generalized estimating equation models accounting for repeated injections within patients.</p><p><strong>Results: </strong>At the patient level, local reactions (28.6% vs. 10.4%; p = 0.016) and systemic reactions (21.4% vs. 2.1%; p < 0.001) were more frequent with VIT than with SCIT. Four of the 6 VIT patients who experienced systemic reactions had a maximum severity grade of 3-4. At the injection level, local reaction frequencies were 95 versus 15 per 1,000 VIT and SCIT injections, respectively (odds ratio [OR] 4.33, 95% CI 1.36-13.76; p = 0.013), while systemic reaction frequencies were 95 versus 3 per 1,000 injections (OR 31.47, 95% CI 7.00-141.50; p < 0.001). Documented treatment discontinuation was numerically less frequent with VIT than with SCIT (3.6% vs. 13.9%), although the difference was not statistically significant (p = 0.205). Sensitization pattern was not associated with adverse reactions, and no exploratory biomarker association remained statistically significant after correction for multiple comparisons.</p><p><strong>Conclusion: </strong>VIT was associated with more frequent local and systemic reactions than SCIT, and higher-grade systemic reactions were observed among VIT recipients. Treatment persistence was numerically higher with VIT, although documented discontinuation did not differ significantly between modalities. Injection-level analyses complemented patient-level reporting by capturing repeated reaction episodes relative to treatment exposure.</p>","PeriodicalId":13652,"journal":{"name":"International Archives of Allergy and Immunology","volume":" ","pages":"1"},"PeriodicalIF":2.3,"publicationDate":"2026-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148906143","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"PENFAST-A: A Modified Clinical Decision Rule for β-Lactam Allergy Risk Stratification in a Tertiary Allergy Center.","authors":"Patricia Rojas-Perez-Ezquerra, Patricia Letón-Cabanillas, Alejandra Jover-Walsh, Marta Blanco-López, Gabriela Aray-Moran, Lucia Noguerales-Fuertes, Cristina Cuevas-Bravo, Blanca Noguerado-Mellado","doi":"10.1159/iaa/adfag020","DOIUrl":"10.1159/iaa/adfag020","url":null,"abstract":"<p><strong>Introduction: </strong>Penicillin allergy labels are common and frequently inaccurate, leading to suboptimal antibiotic use. The PENFAST clinical decision rule has been validated to identify patients at low risk of true penicillin allergy; however, its performance may be limited in allergist-led settings, where specific low-risk clinical phenotypes are prevalent. To develop and evaluate PENFAST-A, a modified version of the PENFAST score incorporating common allergy phenotypes observed in specialist practice, and to assess its diagnostic performance in a real-world cohort.</p><p><strong>Methods: </strong>We conducted a retrospective study in a tertiary Allergy Unit including patients with a reported β-lactam allergy who underwent a standardized diagnostic workup. PENFAST and PENFAST-A scores were calculated retrospectively. Diagnostic performance metrics, including sensitivity, specificity, and predictive values, were compared between the two models.</p><p><strong>Results: </strong>In our cohort, PENFAST-A demonstrated higher sensitivity than the original PENFAST score (94.9% vs. 81.8%), with a corresponding increase in negative predictive value (97.4% vs. 93.5%). PENFAST-A reclassified a larger proportion of patients into higher risk categories, resulting in lower specificity (44.2%). Importantly, no patients with a PENFAST-A score <2 had a confirmed β-lactam allergy, supporting its safety for identifying low-risk patients suitable for delabeling without further testing.</p><p><strong>Conclusion: </strong>PENFAST-A improves the identification of low-risk patients with reported β-lactam allergy in allergist-led settings by incorporating clinically relevant phenotypes. This modified score may serve as a practical screening tool to guide safe delabeling and direct oral challenge in specialized clinical practice.</p>","PeriodicalId":13652,"journal":{"name":"International Archives of Allergy and Immunology","volume":" ","pages":"1"},"PeriodicalIF":2.3,"publicationDate":"2026-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148897128","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety of Low-Dose Wheat Oral Food Challenges in Cases with Low ω-5 Gliadin-Specific Immunoglobulin E Levels.","authors":"Takanobu Yoshida, Jun Kido, Mika Ogata, Daisuke Katayama, Suguru Watanabe, Sachiko Shimomura, Natsuko Nishi, Masaaki Yanai, Kimitoshi Nakamura","doi":"10.1159/iaa/adfag014","DOIUrl":"10.1159/iaa/adfag014","url":null,"abstract":"<p><strong>Introduction: </strong>Oral food challenge (OFC) test is essential for the diagnosis and management of wheat allergy. In individuals considered to be at low risk, OFCs may be performed even in general clinical settings. Although ω-5 gliadin-specific IgE (sIgE) is associated with immediate allergic reactions to wheat, the safety of OFCs in cases with low ω-5 gliadin-sIgE levels has not been well investigated. We evaluated the safety of wheat OFCs in cases with ω-5 gliadin-sIgE levels <3.5 kU/L.</p><p><strong>Methods: </strong>We retrospectively analyzed wheat OFCs performed at two hospitals between 2017 and 2021. 337 cases with ω-5 gliadin-sIgE levels <3.5 kU/L were included. These cases were further classified according to wheat-sIgE levels: wheat-sIgE <3.5 kU/L (low wheat-sIgE [LW-sIgE] group; 115 cases) vs. ≥3.5 kU/L (high wheat-sIgE [HW-sIgE] group; 222 cases). The OFC-positive rate and its association with the challenge dose were evaluated.</p><p><strong>Results: </strong>A total of 337 cases with ω-5 gliadin-sIgE levels (<3.5 kU/L) were included. The OFC-positive rate was comparable between the LW-sIgE group (22.6%) and the HW-sIgE group (23.0%). Anaphylaxis occurred in six cases (1.8%); however, none required intramuscular adrenaline administration. In low-dose OFC (≤2 g of udon; ≤52 mg of wheat protein), more than 90% of cases in both groups were negative. Cases with positive low-dose OFC results had higher ω-5 gliadin-sIgE levels and a higher rate of complete wheat elimination.</p><p><strong>Conclusion: </strong>Wheat OFCs can be performed relatively safely in cases with low ω-5 gliadin-sIgE levels. Initiating OFCs at a low dose may improve their safety.</p>","PeriodicalId":13652,"journal":{"name":"International Archives of Allergy and Immunology","volume":" ","pages":"1"},"PeriodicalIF":2.3,"publicationDate":"2026-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148864863","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Performance of a Standardized Two-Step Drug Provocation Test Protocol after Retrospective Application of the EAACI/ENDA 2024 Risk Stratification: A Real-World Cohort Study.","authors":"Johanna Ramirez-Villamizar, Diana L Espinosa-Silva, Manuela Olaya Hernández, Luis F Ramírez Zuluaga, Carlos D Serrano-Reyes","doi":"10.1159/iaa/adfag011","DOIUrl":"10.1159/iaa/adfag011","url":null,"abstract":"<p><strong>Introduction: </strong>Drug provocation testing (DPT) is the gold standard for diagnosing drug hypersensitivity, but its implementation remains limited by heterogeneous protocols and concerns regarding safety. The clinical performance of simplified DPT protocols across the recently proposed European Academy of Allergy and Clinical Immunology/European Network on Drug Allergy (EAACI/ENDA) 2024 risk categories is unknown. We aimed to evaluate the clinical performance of a standardized placebo-free two-step equal-dose DPT protocol after retrospective application of the EAACI/ENDA 2024 risk stratification in a historical real-world cohort.</p><p><strong>Methods: </strong>We conducted a retrospective descriptive study including consecutive patients with suspected hypersensitivity to antibiotics or selective nonsteroidal anti-inflammatory drugs who underwent culprit-drug DPT between January 2017 and November 2023 at a tertiary allergy center. All patients had originally been managed using the same placebo-free two-step equal-dose DPT protocol before publication of the EAACI/ENDA 2024 recommendations. After data collection, index reactions were retrospectively classified according to the EAACI/ENDA 2024 framework. The primary outcome was DPT positivity overall and according to retrospectively assigned risk categories.</p><p><strong>Results: </strong>A total of 161 patients were included. Overall, 17 DPTs were positive (10.6%; 95% CI, 6.7-16.3%). Positivity differed significantly across retrospectively assigned risk categories (p < 0.0001): 5.4% in the low-risk group, 9.1% in the low-to-intermediate-risk group, 6.0% in the intermediate-risk group, and 61.5% in the high-risk group. Among patients reclassified as high risk because of isolated early urticaria and/or angioedema, 7 of 8 (87.5%) had a positive DPT. Two patients (1.2%) developed anaphylaxis, both after the first dose; one had been retrospectively classified as high risk and the other as intermediate risk.</p><p><strong>Conclusion: </strong>In this historical cohort, retrospective application of the EAACI/ENDA 2024 framework identified marked differences in DPT positivity, despite all patients undergoing the same standardized placebo-free two-step equal-dose protocol. These findings support the feasibility of this protocol in routine clinical practice while highlighting the clinical relevance of early urticaria and/or angioedema within the current EAACI/ENDA risk stratification and the need for prospective validation.</p>","PeriodicalId":13652,"journal":{"name":"International Archives of Allergy and Immunology","volume":" ","pages":"1"},"PeriodicalIF":2.3,"publicationDate":"2026-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148864855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}