Background: The optimal oral immunotherapy (OIT) protocol following low-dose desensitization remains unclear.
Objective: We compared the efficacy and safety of fixed low-dose versus escalation to medium-dose for severe cow's milk allergy.
Methods: This study included children who had a positive oral food challenge (OFC) to 3 mL of milk before initiating OIT, had continued low-dose OIT targeting 3 mL for ≥1 year, and subsequently failed OFC with 25 mL. They were randomized (32 children each) into "fixed-dose group; 3 mL target (99-mg protein)" or "dose-escalation group; 25 mL target (825-mg protein)". Short-term unresponsiveness (STU) to 25 mL was assessed using the OFC at 1 and 2 years after the 2-week avoidance.
Results: The fixed-dose group vs. dose-escalation group had the following characteristics, respectively: median age (9.2 vs. 9.1 years), history of anaphylaxis (94% vs. 100%), milk-specific IgE level (19.9 vs. 27.0 kUA/L), and period from OIT initiation (2.0 vs. 1.8 years). The rates of achieving 25 mL STU were 31% and 28% at 1 year and 47% and 44% at 2 years, respectively (p > 0.99). The total symptom frequency per OIT dose was 0.9% vs. 3.8% in the first year, and 0.8% vs. 2.0% in the second year (p < 0.001), and anaphylaxis was 0.01% vs. 0.06% in the first year. Milk-, casein-, α-lactalbumin-, and β-lactoglobulin-specific IgE levels decreased from baseline at 2 years in both groups (p < 0.001).
Conclusion: The fixed low-dose OIT protocol following low-dose desensitization provides comparable efficacy and improved safety compared to dose-escalation.
背景:低剂量脱敏后的最佳口服免疫疗法(OIT)方案尚不清楚。目的:比较固定低剂量与递增至中剂量治疗严重牛奶过敏的疗效和安全性。方法:本研究纳入了在开始OIT前对3ml牛奶口服食物刺激(OFC)呈阳性,持续低剂量OIT (3ml)≥1年,随后口服食物刺激(25ml)失败的儿童。他们随机分为“固定剂量组”(每组32名儿童);3 mL靶(99 mg蛋白)”或“剂量递增组”;25ml靶蛋白(825mg蛋白)”。在回避2周后的1年和2年,使用OFC评估对25 mL的短期无反应性(STU)。结果:固定剂量组与剂量增加组分别具有以下特征:中位年龄(9.2 vs 9.1岁)、过敏史(94% vs 100%)、牛奶特异性IgE水平(19.9 vs 27.0 kUA/L)和从OIT开始的时间(2.0 vs 1.8年)。1年和2年达到25 mL STU的比率分别为31%和28%和47%和44% (p < 0.05)。第一年每次OIT剂量的总症状频率为0.9%对3.8%,第二年为0.8%对2.0% (p < 0.001),第一年过敏反应为0.01%对0.06%。两组2年时,乳蛋白、酪蛋白、α-乳蛋白和β-乳球蛋白特异性IgE水平均较基线下降(p < 0.001)。结论:与剂量递增相比,低剂量脱敏后的固定低剂量OIT方案具有相当的疗效和更高的安全性。
{"title":"Randomized Trial of Milk Oral Immunotherapy: Fixed Low-Dose vs Escalation to Medium-Dose.","authors":"Ken-Ichi Nagakura, Kyohei Takahashi, Yoko Miura, Kaito Goto, Akira Kawai, Naoko Fusayasu, Kiyotake Ogura, Sakura Sato, Motohiro Ebisawa, Noriyuki Yanagida","doi":"10.1016/j.jaip.2026.01.025","DOIUrl":"https://doi.org/10.1016/j.jaip.2026.01.025","url":null,"abstract":"<p><strong>Background: </strong>The optimal oral immunotherapy (OIT) protocol following low-dose desensitization remains unclear.</p><p><strong>Objective: </strong>We compared the efficacy and safety of fixed low-dose versus escalation to medium-dose for severe cow's milk allergy.</p><p><strong>Methods: </strong>This study included children who had a positive oral food challenge (OFC) to 3 mL of milk before initiating OIT, had continued low-dose OIT targeting 3 mL for ≥1 year, and subsequently failed OFC with 25 mL. They were randomized (32 children each) into \"fixed-dose group; 3 mL target (99-mg protein)\" or \"dose-escalation group; 25 mL target (825-mg protein)\". Short-term unresponsiveness (STU) to 25 mL was assessed using the OFC at 1 and 2 years after the 2-week avoidance.</p><p><strong>Results: </strong>The fixed-dose group vs. dose-escalation group had the following characteristics, respectively: median age (9.2 vs. 9.1 years), history of anaphylaxis (94% vs. 100%), milk-specific IgE level (19.9 vs. 27.0 kU<sub>A</sub>/L), and period from OIT initiation (2.0 vs. 1.8 years). The rates of achieving 25 mL STU were 31% and 28% at 1 year and 47% and 44% at 2 years, respectively (p > 0.99). The total symptom frequency per OIT dose was 0.9% vs. 3.8% in the first year, and 0.8% vs. 2.0% in the second year (p < 0.001), and anaphylaxis was 0.01% vs. 0.06% in the first year. Milk-, casein-, α-lactalbumin-, and β-lactoglobulin-specific IgE levels decreased from baseline at 2 years in both groups (p < 0.001).</p><p><strong>Conclusion: </strong>The fixed low-dose OIT protocol following low-dose desensitization provides comparable efficacy and improved safety compared to dose-escalation.</p>","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":" ","pages":""},"PeriodicalIF":6.6,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146114871","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01DOI: 10.1016/j.jaip.2025.11.005
Laurence E. Ruane BSc , Paul Leong FRACP, PhD , Garun S. Hamilton FRACP, PhD , Emil S. Walsted MD, PhD , Joy Lee FRACP, PhD , Eve Denton FRACP, PhD , Elaine Yap MBChB, FRACP , Åse J. Rogde MD , Alice Crawford MBBS, FRACP , Paul A. Finlay DipAs , Martin I. MacDonald FRACP, PhD , John D. Brannan PhD , Kathryn Prior BSc, MBBS , Andrej A. Petrov MD , James H. Hull FRACP, PhD , Sally E. Wenzel MD , Peter G. Gibson FRACP, PhD , Philip G. Bardin FRACP, PhD
{"title":"Poor diagnostic performance of flow volume loops for detection of inducible laryngeal obstruction/vocal cord dysfunction","authors":"Laurence E. Ruane BSc , Paul Leong FRACP, PhD , Garun S. Hamilton FRACP, PhD , Emil S. Walsted MD, PhD , Joy Lee FRACP, PhD , Eve Denton FRACP, PhD , Elaine Yap MBChB, FRACP , Åse J. Rogde MD , Alice Crawford MBBS, FRACP , Paul A. Finlay DipAs , Martin I. MacDonald FRACP, PhD , John D. Brannan PhD , Kathryn Prior BSc, MBBS , Andrej A. Petrov MD , James H. Hull FRACP, PhD , Sally E. Wenzel MD , Peter G. Gibson FRACP, PhD , Philip G. Bardin FRACP, PhD","doi":"10.1016/j.jaip.2025.11.005","DOIUrl":"10.1016/j.jaip.2025.11.005","url":null,"abstract":"","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":"14 2","pages":"Pages 531-533.e1"},"PeriodicalIF":6.6,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145534840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01DOI: 10.1016/j.jaip.2025.10.032
Eugenio De Corso PhD , Claudio Montuori MD , Ernesto Pasquini MD , Ignazio La Mantia PhD , Angelo Ghidini PhD , Carlotta Pipolo PhD , Massimiliano Garzaro MD , Giancarlo Ottaviano PhD , Veronica Seccia MD , Andrea Ciofalo MD , Sara Torretta MD , Elena Cantone PhD , Giulia Danè MD , Fabio Pagella MD , Daniela Lucidi MD , Gian Luca Fadda MD , Alice Mannocci PhD , Carlo Cavaliere PhD , Giulio Pagliuca PhD , Frank Rikki Mauritz Canevari MD , Riccardo Bernardi e Sonny Zampollo
Background
Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) treated with dupilumab may experience an increase in blood absolute eosinophil count (AEC). However, the onset and temporal pattern of dupilumab-induced blood eosinophilia (DIBE) have not been thoroughly investigated in real life.
Objective
To evaluate DIBE prevalence and temporal pattern in patients with CRSwNP, and to determine associations between DIBE and adverse events (AEs), patients’ clinical characteristics, and treatment outcomes.
Methods
This is a multicentric historical prospective observational study conducted across 14 Italian centers of the DUPIREAL network. DIBE onset and temporal pattern, clinical characteristics, CRSwNP outcomes, and AEs were analyzed. DIBE was defined as an AEC increased by 50% from baseline and at least >500 cells/mm3, or AEC >1500 cells/mm3.
Results
A total of 564 patients with CRSwNP were enrolled. Mean AEC peaked at 3 months and declined by 12 months. Among patients developing DIBE (48.2%), 3 distinct temporal patterns were identified based on onset and duration: early-onset temporary (group 1, 30.7% patients), early-onset persistent (group 2, 14.4% patients), and late-onset (group 3, 3.2% patients). Asthma prevalence (P < .001), use of asthma inhalers (P < .001), and previous oral corticosteroid use (P < .045) were greater in patients with DIBE (group 1-3) than in patients without DIBE (group 0). DIBE >1500 cells/mm3 was associated with a higher risk of developing mild AEs (P < 0.001). DIBE occurrence did not influence dupilumab outcomes in patients with CRSwNP.
Conclusions
Distinct DIBE patterns have been identified in patients with CRSwNP based on eosinophilia temporal trends. DIBE was mainly observed in patients with comorbid asthma and previous use of systemic steroids. The findings confirm that DIBE is a mostly transient and harmless phenomenon associated only with mild AEs.
{"title":"Dupilumab-Induced Blood Eosinophilia in Patients With Chronic Rhinosinusitis With Nasal Polyps: Temporal Trends and Correlation With Adverse Events","authors":"Eugenio De Corso PhD , Claudio Montuori MD , Ernesto Pasquini MD , Ignazio La Mantia PhD , Angelo Ghidini PhD , Carlotta Pipolo PhD , Massimiliano Garzaro MD , Giancarlo Ottaviano PhD , Veronica Seccia MD , Andrea Ciofalo MD , Sara Torretta MD , Elena Cantone PhD , Giulia Danè MD , Fabio Pagella MD , Daniela Lucidi MD , Gian Luca Fadda MD , Alice Mannocci PhD , Carlo Cavaliere PhD , Giulio Pagliuca PhD , Frank Rikki Mauritz Canevari MD , Riccardo Bernardi e Sonny Zampollo","doi":"10.1016/j.jaip.2025.10.032","DOIUrl":"10.1016/j.jaip.2025.10.032","url":null,"abstract":"<div><h3>Background</h3><div>Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) treated with dupilumab may experience an increase in blood absolute eosinophil count (AEC). However, the onset and temporal pattern of dupilumab-induced blood eosinophilia (DIBE) have not been thoroughly investigated in real life.</div></div><div><h3>Objective</h3><div>To evaluate DIBE prevalence and temporal pattern in patients with CRSwNP, and to determine associations between DIBE and adverse events (AEs), patients’ clinical characteristics, and treatment outcomes.</div></div><div><h3>Methods</h3><div>This is a multicentric historical prospective observational study conducted across 14 Italian centers of the DUPIREAL network. DIBE onset and temporal pattern, clinical characteristics, CRSwNP outcomes, and AEs were analyzed. DIBE was defined as an AEC increased by 50% from baseline and at least >500 cells/mm<sup>3</sup>, or AEC >1500 cells/mm<sup>3</sup>.</div></div><div><h3>Results</h3><div>A total of 564 patients with CRSwNP were enrolled. Mean AEC peaked at 3 months and declined by 12 months. Among patients developing DIBE (48.2%), 3 distinct temporal patterns were identified based on onset and duration: early-onset temporary (group 1, 30.7% patients), early-onset persistent (group 2, 14.4% patients), and late-onset (group 3, 3.2% patients). Asthma prevalence (<em>P <</em> .001), use of asthma inhalers (<em>P <</em> .001), and previous oral corticosteroid use (<em>P <</em> .045) were greater in patients with DIBE (group 1-3) than in patients without DIBE (group 0). DIBE >1500 cells/mm<sup>3</sup> was associated with a higher risk of developing mild AEs (<em>P <</em> 0.001). DIBE occurrence did not influence dupilumab outcomes in patients with CRSwNP.</div></div><div><h3>Conclusions</h3><div>Distinct DIBE patterns have been identified in patients with CRSwNP based on eosinophilia temporal trends. DIBE was mainly observed in patients with comorbid asthma and previous use of systemic steroids. The findings confirm that DIBE is a mostly transient and harmless phenomenon associated only with mild AEs.</div></div>","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":"14 2","pages":"Pages 482-494.e13"},"PeriodicalIF":6.6,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145433149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01DOI: 10.1016/j.jaip.2025.10.040
Joao Pedro Lopes MD , George N. Konstantinou MD, PhD, MSc, MC , Jennifer Roeder , Mary Jo Strobel , Juliet M. Ross PsyD , Wendy M. Book MD , Talaya McCright-Gill MS , Mirna Chehade MD, MPH
{"title":"Patient and caregiver perspectives on the use of elemental formula in eosinophilic gastrointestinal disease","authors":"Joao Pedro Lopes MD , George N. Konstantinou MD, PhD, MSc, MC , Jennifer Roeder , Mary Jo Strobel , Juliet M. Ross PsyD , Wendy M. Book MD , Talaya McCright-Gill MS , Mirna Chehade MD, MPH","doi":"10.1016/j.jaip.2025.10.040","DOIUrl":"10.1016/j.jaip.2025.10.040","url":null,"abstract":"","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":"14 2","pages":"Pages 521-523"},"PeriodicalIF":6.6,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145482481","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01DOI: 10.1016/j.jaip.2025.11.008
Oluwatobi Olayiwola MD , Lauren Mudd PhD , Lars Dunaway PhD , Tanya M. Laidlaw MD , Stacie M. Jones MD , Patricia C. Fulkerson MD, PhD , Srinath Sanda MD , Michelle F. Huffaker MD
Background
Peanut oral immunotherapy (pOIT) is a recognized treatment for patients with peanut allergy, though not all patients who undergo this therapy achieve desensitization or remission.
Objective
To determine whether missed doses or dosing reactions predict clinical outcomes with pOIT.
Methods
Data from IMPACT (Oral Immunotherapy for Induction of Tolerance in Peanut Allergic Children trial), a randomized, double-blind, placebo-controlled trial of pOIT in children aged 1 to 4 years with peanut allergy, were analyzed to determine whether treatment-emergent variables influence desensitization (ability to consume 5000 mg of peanut protein without reaction during a blinded oral food challenge after 134 weeks of pOIT) and remission (6 months after discontinuation of pOIT). Logistic regression models, controlling for age and Ara h2–specific IgE, were performed to assess the relationship between dosing reactions, missed doses, and outcomes.
Results
Consecutive missed doses during build-up significantly correlated with reduced likelihood of desensitization (P = .03; odds ratio [OR], 0.69; 95% CI, 0.49-0.96), whereas consecutive missed doses during maintenance did not (P = .10; OR, 0.79; 95% CI, 0.59-1.05). Furthermore, the total individual missed doses did not significantly correlate with desensitization or remission in either phase of pOIT. Conversely, dosing reactions during maintenance did significantly correlate with reduced likelihood of desensitization (P = .01; OR, 0.71; 95% CI, 0.54-0.93), whereas dosing reactions during build-up did not significantly correlate with desensitization (P = .57; OR, 0.95; 95% CI, 0.79-1.14). Fewer than 10% of missed doses were attributed to dosing reactions.
Conclusions
Missed doses during therapy and dosing reactions during maintenance associated with poorer pOIT outcomes. Clinicians should support adherence during build-up and consider dose adjustments for patients having dosing reactions during maintenance therapy.
背景:花生口服免疫疗法(pOIT)是公认的花生过敏患者的治疗方法,尽管并非所有接受这种治疗的患者都能脱敏或缓解。目的:确定漏给剂量或给药反应是否能预测pOIT的临床预后。方法:IMPACT试验是一项随机、双盲、安慰剂对照的试验,对1至4岁花生过敏儿童进行pOIT治疗,分析该试验的数据,以确定治疗产生的变量是否会影响脱敏(pOIT治疗134周后,在盲法口服食物挑战中摄入5000mg花生蛋白而无反应的能力)和缓解(停止pOIT治疗6个月后)。采用Logistic回归模型,控制年龄和Ara h2特异性IgE,评估给药反应、漏给剂量和结局之间的关系。结果:在建立期间连续错过剂量与降低脱敏可能性显著相关(p = 0.03, OR 0.69(0.49, 0.96)),而在维持期间连续错过剂量则没有(p = 0.10, OR 0.79(0.59, 1.05))。此外,在pOIT的任何阶段,个体总遗漏剂量与脱敏或缓解没有显著相关。相反,维持期间的给药反应与脱敏可能性降低显著相关(p = 0.01, OR 0.71(0.54, 0.93)),而建立期间的给药反应与脱敏不显著相关(p = 0.57, OR 0.95(0.79, 1.14))。不到10%的漏给剂量归因于给药反应。结论:治疗期间遗漏的剂量和维持期间的剂量反应与较差的pOIT结果相关。临床医生应在治疗过程中支持依从性,并考虑在维持治疗期间对出现剂量反应的患者进行剂量调整。
{"title":"Dosing Reactions and Missed Doses Affect Peanut Oral Immunotherapy Outcomes","authors":"Oluwatobi Olayiwola MD , Lauren Mudd PhD , Lars Dunaway PhD , Tanya M. Laidlaw MD , Stacie M. Jones MD , Patricia C. Fulkerson MD, PhD , Srinath Sanda MD , Michelle F. Huffaker MD","doi":"10.1016/j.jaip.2025.11.008","DOIUrl":"10.1016/j.jaip.2025.11.008","url":null,"abstract":"<div><h3>Background</h3><div>Peanut oral immunotherapy (pOIT) is a recognized treatment for patients with peanut allergy, though not all patients who undergo this therapy achieve desensitization or remission.</div></div><div><h3>Objective</h3><div>To determine whether missed doses or dosing reactions predict clinical outcomes with pOIT.</div></div><div><h3>Methods</h3><div>Data from IMPACT (Oral Immunotherapy for Induction of Tolerance in Peanut Allergic Children trial), a randomized, double-blind, placebo-controlled trial of pOIT in children aged 1 to 4 years with peanut allergy, were analyzed to determine whether treatment-emergent variables influence desensitization (ability to consume 5000 mg of peanut protein without reaction during a blinded oral food challenge after 134 weeks of pOIT) and remission (6 months after discontinuation of pOIT). Logistic regression models, controlling for age and Ara h2–specific IgE, were performed to assess the relationship between dosing reactions, missed doses, and outcomes.</div></div><div><h3>Results</h3><div>Consecutive missed doses during build-up significantly correlated with reduced likelihood of desensitization (<em>P</em> = .03; odds ratio [OR], 0.69; 95% CI, 0.49-0.96), whereas consecutive missed doses during maintenance did not (<em>P</em> = .10; OR, 0.79; 95% CI, 0.59-1.05). Furthermore, the total individual missed doses did not significantly correlate with desensitization or remission in either phase of pOIT. Conversely, dosing reactions during maintenance did significantly correlate with reduced likelihood of desensitization (<em>P</em> = .01; OR, 0.71; 95% CI, 0.54-0.93), whereas dosing reactions during build-up did not significantly correlate with desensitization (<em>P</em> = .57; OR, 0.95; 95% CI, 0.79-1.14). Fewer than 10% of missed doses were attributed to dosing reactions.</div></div><div><h3>Conclusions</h3><div>Missed doses during therapy and dosing reactions during maintenance associated with poorer pOIT outcomes. Clinicians should support adherence during build-up and consider dose adjustments for patients having dosing reactions during maintenance therapy.</div></div>","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":"14 2","pages":"Pages 453-463.e3"},"PeriodicalIF":6.6,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145574980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01DOI: 10.1016/j.jaip.2025.11.029
Megan Le MD, Tara McCaffrey BA, Li Gao MD, PhD, Sarbjit Saini MD
Background
Proposed negative biopredictors of omalizumab response in patients with chronic spontaneous urticaria are low baseline IgE (≤40 IU/mL), positive CU Index (CUI) test result, and basopenia defined by blood histamine content (BHC) (≤8 ng/mL).
Objective
To test the hypothesis that patients with these negative biopredictors will have a poorer response to omalizumab.
Methods
We performed a retrospective analysis of 3 phase III studies of antihistamine-refractory subjects with chronic spontaneous urticaria who received omalizumab 300 mg every 4 weeks for 12 weeks. The relationship between baseline biopredictors and subjects with excellent symptom control measured by Urticaria Activity Score over 7 days (UAS7 ≤ 6) or poor symptom control (UAS7 > 6) after 12 weeks was examined. We performed χ2, logistic regression, and receiver-operating characteristic analysis.
Results
In 363 subjects, data were available for IgE and CUI; 266 had BHC measures. Subjects with UAS7 higher than 6 at 12 weeks significantly more often expressed a baseline negative biopredictor: IgE level less than or equal to 40 IU/mL (n = 109 [50%]) versus IgE level more than 40 IU/mL (n = 239 [33%]); CUI positive (n = 98 [55%]) versus negative (n = 263 [32%]); BHC less than 8 ng/mL (n = 64 [55%]) versus BHC more than 8 ng/mL (n = 202 [33%]). CUI positivity significantly predicted a UAS7 higher than 6 at 12 weeks (P = .0002; odds ratio, 2.54; 95% CI, 1.55-4.15). According to receiver-operating characteristic curve analysis, a BHC of 6.4 ng/mL was distinguishing nonresponders from responders. Among subjects with low baseline IgE, the presence of low BHC was predictive for nonresponsiveness to omalizumab (χ2 = 4.215; P = .040).
Conclusions
Subjects with positive CUI, low BHC, or both low IgE and BHC have an increased likelihood of poorer response to omalizumab at 12 weeks.
{"title":"Biopredictors for Omalizumab Response in Patients With Chronic Spontaneous Urticaria","authors":"Megan Le MD, Tara McCaffrey BA, Li Gao MD, PhD, Sarbjit Saini MD","doi":"10.1016/j.jaip.2025.11.029","DOIUrl":"10.1016/j.jaip.2025.11.029","url":null,"abstract":"<div><h3>Background</h3><div>Proposed negative biopredictors of omalizumab response in patients with chronic spontaneous urticaria are low baseline IgE (≤40 IU/mL), positive CU Index (CUI) test result, and basopenia defined by blood histamine content (BHC) (≤8 ng/mL).</div></div><div><h3>Objective</h3><div>To test the hypothesis that patients with these negative biopredictors will have a poorer response to omalizumab.</div></div><div><h3>Methods</h3><div>We performed a retrospective analysis of 3 phase III studies of antihistamine-refractory subjects with chronic spontaneous urticaria who received omalizumab 300 mg every 4 weeks for 12 weeks. The relationship between baseline biopredictors and subjects with excellent symptom control measured by Urticaria Activity Score over 7 days (UAS7 ≤ 6) or poor symptom control (UAS7 > 6) after 12 weeks was examined. We performed χ<sup>2</sup>, logistic regression, and receiver-operating characteristic analysis.</div></div><div><h3>Results</h3><div>In 363 subjects, data were available for IgE and CUI; 266 had BHC measures. Subjects with UAS7 higher than 6 at 12 weeks significantly more often expressed a baseline negative biopredictor: IgE level less than or equal to 40 IU/mL (n = 109 [50%]) versus IgE level more than 40 IU/mL (n = 239 [33%]); CUI positive (n = 98 [55%]) versus negative (n = 263 [32%]); BHC less than 8 ng/mL (n = 64 [55%]) versus BHC more than 8 ng/mL (n = 202 [33%]). CUI positivity significantly predicted a UAS7 higher than 6 at 12 weeks (<em>P</em> = .0002; odds ratio, 2.54; 95% CI, 1.55-4.15). According to receiver-operating characteristic curve analysis, a BHC of 6.4 ng/mL was distinguishing nonresponders from responders. Among subjects with low baseline IgE, the presence of low BHC was predictive for nonresponsiveness to omalizumab (χ<sup>2</sup> = 4.215; <em>P</em> = .040).</div></div><div><h3>Conclusions</h3><div>Subjects with positive CUI, low BHC, or both low IgE and BHC have an increased likelihood of poorer response to omalizumab at 12 weeks.</div></div>","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":"14 2","pages":"Pages 495-502.e1"},"PeriodicalIF":6.6,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145650076","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01DOI: 10.1016/j.jaip.2025.11.013
G.U. Machado MD , V. Bourdenet MD , G. Devouassoux MD, PhD , A. Beurnier MD, PhD , C. Bernier MD , O. Carpentier MD , C. Chenivesse MD, PhD , A. Du Thanh MD, PhD , S. Fry MD, PhD , Y. Gadiolet MD , A.S. Gamez MD, PhD , E. Kelkel MD , M. Larrousse MD , A. Soria MD, PhD , D. Staumont-Sallé MD, PhD , A. Streker MD , A. Valois MD , X. Blanc MD, PhD , N. Freymond MD , J.F. Nicolas MD, PhD , A. Nosbaum MD, PhD
{"title":"Eczema following IL-5 inhibitors for the treatment of severe asthma with improvement after switching to an IL-4Rα mAb","authors":"G.U. Machado MD , V. Bourdenet MD , G. Devouassoux MD, PhD , A. Beurnier MD, PhD , C. Bernier MD , O. Carpentier MD , C. Chenivesse MD, PhD , A. Du Thanh MD, PhD , S. Fry MD, PhD , Y. Gadiolet MD , A.S. Gamez MD, PhD , E. Kelkel MD , M. Larrousse MD , A. Soria MD, PhD , D. Staumont-Sallé MD, PhD , A. Streker MD , A. Valois MD , X. Blanc MD, PhD , N. Freymond MD , J.F. Nicolas MD, PhD , A. Nosbaum MD, PhD","doi":"10.1016/j.jaip.2025.11.013","DOIUrl":"10.1016/j.jaip.2025.11.013","url":null,"abstract":"","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":"14 2","pages":"Pages 510-512.e1"},"PeriodicalIF":6.6,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145641805","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01DOI: 10.1016/j.jaip.2025.10.013
Thanai Pongdee MD , James Moriarty MSc , Mansi Kanuga MD , Adela Taylor MD , Dayne Voelker MD , John Wheeler MD , Richard Crockett MD , Gavin Schaeferle MS , Hojjat Salehinejad PhD , Sergio E. Chiarella MD , Bijan Borah PhD
{"title":"Rural health disparities in the utilization of biologics for the treatment of allergic diseases","authors":"Thanai Pongdee MD , James Moriarty MSc , Mansi Kanuga MD , Adela Taylor MD , Dayne Voelker MD , John Wheeler MD , Richard Crockett MD , Gavin Schaeferle MS , Hojjat Salehinejad PhD , Sergio E. Chiarella MD , Bijan Borah PhD","doi":"10.1016/j.jaip.2025.10.013","DOIUrl":"10.1016/j.jaip.2025.10.013","url":null,"abstract":"","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":"14 2","pages":"Pages 507-509.e1"},"PeriodicalIF":6.6,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145656125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}