Annals of Allergy Asthma & Immunology最新文献

{"title":"Long-term safety and efficacy of once-daily berotralstat in patients with hereditary angioedema: APeX-S final results.","authors":"Henriette Farkas, Jonny G Peter, Marcin Stobiecki, John Anderson, Emel Aygören-Pürsün, David Hagin, Miloš Jeseňák, Aharon Kessel, Sorena Kiani-Alikhan, Tamar Kinaciyan, Michael Manning, Avner Reshef, Adrian Wu, Heather A Iocca, Douglas T Johnston, Lindsey Noble, Dianne Tomita, Aleena Banerji","doi":"10.1016/j.anai.2025.06.004","DOIUrl":"10.1016/j.anai.2025.06.004","url":null,"abstract":"<p><strong>Background: </strong>Berotralstat is a once-daily oral medication for the prophylaxis of hereditary angioedema (HAE) attacks in patients aged 12 years and older.</p><p><strong>Objective: </strong>To assess the long-term safety and efficacy of berotralstat in patients with HAE caused by C1 inhibitor deficiency.</p><p><strong>Methods: </strong>APeX-S was a global, open-label phase 2 study (NCT03472040) assessing berotralstat 150 and 110 mg for up to 96 weeks in the United States and 240 weeks elsewhere. The primary objective was long-term safety and tolerability; secondary objectives included efficacy and impact on quality of life (QoL) of berotralstat. Safety was evaluated by means of treatment-emergent adverse events and laboratory analyses. Efficacy was assessed using the number and rate of HAE attacks, durability of response, and number and proportion of days with angioedema symptoms. QoL was evaluated using the Angioedema Quality of Life Questionnaire.</p><p><strong>Results: </strong>In APeX-S, 387 patients were enrolled and received berotralstat 150 mg (n = 287) or 110 mg (n = 100) from day 1. A total of 70 patients on berotralstat 110 mg crossed over to berotralstat 150 mg after a median (range) of 48 (46-71) weeks. Treatment-emergent adverse events up to 240 weeks were reported by 334 patients (86.3%); the most common being nasopharyngitis (23.8%), headache (14.7%), diarrhea (14.5%), upper respiratory tract infection (12.9%), and abdominal pain (11.1%). Treatment with berotralstat led to improvements in HAE attack rates and Angioedema Quality of Life Questionnaire scores up to week 96, with greater improvements observed in patients who received berotralstat 150 mg from day 1.</p><p><strong>Conclusion: </strong>This study supports the long-term safety of berotralstat and its efficacy in preventing HAE attacks and improving QoL.</p><p><strong>Clinical trial registration: </strong>This trial was registered at ClinicalTrials.gov as NCT03472040 (https://clinicaltrials.gov/study/NCT03472040).</p>","PeriodicalId":50773,"journal":{"name":"Annals of Allergy Asthma & Immunology","volume":" ","pages":""},"PeriodicalIF":5.8,"publicationDate":"2025-06-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144259294","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Aspirin-exacerbated respiratory disease in the era of biologics.","authors":"Tanya M Laidlaw","doi":"10.1016/j.anai.2025.06.001","DOIUrl":"10.1016/j.anai.2025.06.001","url":null,"abstract":"<p><p>Aspirin-exacerbated respiratory disease (AERD) is a chronic, inflammatory syndrome defined by asthma, nasal polyposis, and respiratory sensitivity to cyclooxygenase-1-inhibiting nonsteroidal anti-inflammatory drugs. Patients with AERD often experience severe nasal polyps, frequent sinus surgeries, impaired sense of smell, and persistent asthma. Traditional therapies, including corticosteroids, endoscopic sinus surgery, and aspirin desensitization, have offered symptomatic relief but are often limited by adverse effects or short-lived efficacy. In recent years, the emergence of targeted biologics-including anti-interleukin-5/5Rα (mepolizumab and benralizumab), anti-IgE (omalizumab), anti-interleukin-4Rα (dupilumab), and anti-thymic stromal lymphopoietin (tezepelumab)-has significantly expanded the treatment landscape for AERD, providing nonsurgical options that directly modulate type 2 inflammation and improve both upper and lower airway symptoms. This review synthesizes available data on the efficacy and applicability of each available biologic in AERD, highlighting benefits such as restoration of smell, reduced corticosteroid use, fewer surgical interventions, and potentially diminished nonsteroidal anti-inflammatory drug sensitivity. However, challenges remain. Biologics are costly and not universally accessible, long-term safety data are limited, and no reliable biomarkers currently exist to guide therapeutic selection. Not all patients respond to every agent, underscoring the need for personalized medicine approaches. Future directions include developing predictive biomarkers, conducting head-to-head biologic trials, and exploring earlier biologic interventions to modify disease progression. Although not curative, biologics offer meaningful improvements in the quality of life for many patients with AERD. Ongoing research and innovation are essential to realize a future in which treatment decisions are guided by precision, accessibility, and sustained disease control.</p>","PeriodicalId":50773,"journal":{"name":"Annals of Allergy Asthma & Immunology","volume":" ","pages":""},"PeriodicalIF":5.8,"publicationDate":"2025-06-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144259293","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sex differences in urinary mast cell mediators: Implications for diagnosing atopic and mast cell disorders.","authors":"Valerie Jaroenpuntaruk, Sarah M Jenkins, Carin Y Smith, Alexei Gonzalez-Estrada, Lyda Cuervo-Pardo, Miguel A Park, Elina Jerschow, Rohit Divekar, Avni Y Joshi, Thanai Pongdee, Dayne H Voelker, Joseph H Butterfield, Sergio E Chiarella","doi":"10.1016/j.anai.2025.05.028","DOIUrl":"10.1016/j.anai.2025.05.028","url":null,"abstract":"<p><strong>Background: </strong>Urinary mast cell mediators aid in diagnosing atopic and mast cell disorders, yet sex differences in these mediators remain unreported despite known sex-specific variations in eicosanoid pathways.</p><p><strong>Objective: </strong>To characterize sex differences in urinary mast cell mediators 2,3-dinor-11β-prostaglandin F2α (2,3-BPG), N-methylhistamine, and leukotriene E4 (LTE4).</p><p><strong>Methods: </strong>This retrospective chart review of 4033 patients of all ages at Mayo Clinic from June 1, 2019 to May 31, 2024 including demographic and clinical data. Urine mast cell mediators 2,3-BPG, N-methylhistamine, and LTE4 were quantified using liquid chromatography-tandem mass spectrometry and normalized to creatinine levels. Statistical analyses were performed using R software (R Core Team, Vienna, Austria).</p><p><strong>Results: </strong>Among patients tested for urinary mast cell mediators, 78.8% were female sex. Compared with females, males were older at testing (mean 48.0 vs 40.1 years), more likely to report ever smoking (33.5% vs 22.7%), had higher body mass index (mean 28.6 vs 27.7), more often had an atopic condition (82.6% vs 71.0%) or comorbidity (46.1% vs 30.3%), and had higher median LTE4 levels (102.5 vs 90.0 pg/mg creatinine) (P < .001 for all). Males also more typically had elevated 2,3-BPG (8.0% vs 3.7%) and eosinophil counts (17.0% vs 5.9%) and higher median tryptase levels (5.1 vs 4.3 pg/mL) (P < .001 for all). Multivariable analysis revealed a sex-by-atopy interaction for LTE4, with higher levels in atopic males (male/female ratio 1.15 [95% CI: 1.07-1.25], P < .001) and higher levels in nonatopic females (male/female ratio 0.86 [95% CI: 0.76-0.97], P = .02).</p><p><strong>Conclusion: </strong>Sex differences in testing rates and urinary mediator levels highlight the need to consider sex in optimizing the diagnostic utility of these mediators.</p>","PeriodicalId":50773,"journal":{"name":"Annals of Allergy Asthma & Immunology","volume":" ","pages":""},"PeriodicalIF":5.8,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144250595","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Body mass index not associated with clinical severity in chronic rhinosinusitis.","authors":"Aaron D Smith, Catherine E Lyons, Maria Amelia Perozo, Aaron J Stein, Larry Borish","doi":"10.1016/j.anai.2025.05.032","DOIUrl":"10.1016/j.anai.2025.05.032","url":null,"abstract":"","PeriodicalId":50773,"journal":{"name":"Annals of Allergy Asthma & Immunology","volume":" ","pages":""},"PeriodicalIF":5.8,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144235842","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"When life gets complicated: Food allergy, food insecurity, mental health, and substance use disorder.","authors":"Elena Gupta, Alexandra E Conway, Navya Kartha, Marylee Verdi, Juliette Madan, Aikaterini Anagnostou, Elissa M Abrams, Matthew Greenhawt, Andrew White, S Shahzad Mustafa, Alastair P Huntley, Jakobi A Johnson, Marcus Shaker","doi":"10.1016/j.anai.2025.05.030","DOIUrl":"10.1016/j.anai.2025.05.030","url":null,"abstract":"<p><p>Patients seen in allergy-immunology clinics may experience a myriad of socioeconomic problems that intersect with both social determinants of health and allergic and immunologic disease. Although not a primary focus of allergist-immunologist management, all clinicians must be ready and able to express compassion and understanding for patients who struggle with conditions that affect their adherence to recommended therapies. Food allergy in particular can have complex interactions with food insecurity, mental health, and substance use disorder because each of these comorbidities affects allergen avoidance and risk of anaphylaxis. This review outlines key considerations and provides resources to connect patients with needed assistance. Approaching patients who have challenging psychosocial and socioeconomic comorbidities with a willingness to help connect them with needed resources-from primary care providers, counselors, and allergen-aware food banks-can have a positive impact on health and well-being.</p>","PeriodicalId":50773,"journal":{"name":"Annals of Allergy Asthma & Immunology","volume":" ","pages":""},"PeriodicalIF":5.8,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144227483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Where to challenge?","authors":"Lisa M. Bartnikas MD ,&nbsp;Theresa A. Bingemann MD","doi":"10.1016/j.anai.2025.02.015","DOIUrl":"10.1016/j.anai.2025.02.015","url":null,"abstract":"","PeriodicalId":50773,"journal":{"name":"Annals of Allergy Asthma & Immunology","volume":"134 6","pages":"Pages 626-627"},"PeriodicalIF":5.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144195691","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Can central registries adequately track severe adverse reactions to allergen immunotherapy?","authors":"David I. Bernstein MD","doi":"10.1016/j.anai.2025.03.023","DOIUrl":"10.1016/j.anai.2025.03.023","url":null,"abstract":"","PeriodicalId":50773,"journal":{"name":"Annals of Allergy Asthma & Immunology","volume":"134 6","pages":"Pages 628-629"},"PeriodicalIF":5.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144195692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Allergen immunotherapy-induced anaphylaxis","authors":"Meslina Almaci MD ,&nbsp;Regina Treudler MD ,&nbsp;Maria Breiding MD ,&nbsp;Alice Köhli MD ,&nbsp;Lars Lange MD ,&nbsp;Claudia Pföhler MD ,&nbsp;Christian Vogelberg MD ,&nbsp;Margitta Worm MD","doi":"10.1016/j.anai.2025.02.012","DOIUrl":"10.1016/j.anai.2025.02.012","url":null,"abstract":"<div><h3>Background</h3><div>Data on anaphylaxis due to allergen immunotherapy (AIT) are limited. This study assessed AIT-induced anaphylaxis using data from the European Anaphylaxis Registry.</div></div><div><h3>Objective</h3><div>To analyze the characteristics, symptoms, severity, and emergency management of AIT-induced anaphylactic reactions across age groups and the administered allergenic source.</div></div><div><h3>Methods</h3><div>Data were obtained from 54 allergy centers across 10 European countries from 2007 to 2023. Anaphylactic reactions involving at least 2 organ systems were analyzed for symptoms, severity, associated diseases, administration routes, and emergency treatment. Statistical methods included χ² and Fisher's exact tests.</div></div><div><h3>Results</h3><div>AIT accounted for 1.1% of the cases in the anaphylaxis registry (173/15,748), of which 1.8% were pediatric and 0.7% were adults. Respiratory symptoms were more frequent in children/adolescents (92%) than in adults (66%) among AIT-related anaphylaxis, whereas cardiovascular and gastrointestinal symptoms were more common in adults (40% vs 78% and 20% vs 42%, respectively). Only a few sublingual immunotherapy-related cases were documented, including 2 grade III reactions, with no fatalities (sublingual immunotherapy [n = 8] vs subcutaneous immunotherapy (SCIT) [n = 153]). One fatality due to SCIT was reported (grass pollen). Delayed reactions (&gt;30 minutes) were reported in 22 cases, predominantly after SCIT. All delayed grade III reactions that occurred more than 120 minutes were reported in children. Adrenaline was underused in emergency management and administered in 30% of grade II and 50% of grade III reactions.</div></div><div><h3>Conclusion</h3><div>Our study highlights the importance of age-specific monitoring and appropriate emergency treatment to enhance patient safety during AIT.</div></div>","PeriodicalId":50773,"journal":{"name":"Annals of Allergy Asthma & Immunology","volume":"134 6","pages":"Pages 724-730"},"PeriodicalIF":5.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494446","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Can exclusive breastfeeding in the first 4 months reduce food allergy?","authors":"Nadira Musallam MD,&nbsp;Meital Almog MD,&nbsp;Roni Wagner RD,&nbsp;Larisa Epov MD,&nbsp;Vika Dor MD,&nbsp;Aharon Kessel MD","doi":"10.1016/j.anai.2025.02.011","DOIUrl":"10.1016/j.anai.2025.02.011","url":null,"abstract":"<div><h3>Background</h3><div>IgE-mediated food allergy (FA) is a major global health concern. Although the early introduction of allergenic foods and breastfeeding are potential preventive strategies, the role of breast milk in reducing the incidence of FAs remains inconclusive.</div></div><div><h3>Objective</h3><div>To investigate the impact of exclusive breastfeeding for the first 4 months compared with partial breastfeeding or cow's milk formula (CMF) on the development of IgE-mediated FAs in an Israeli cohort.</div></div><div><h3>Methods</h3><div>A cross-sectional online survey in 3030 mothers with infants aged 6 to 24 months collected data on early feeding practices, allergen introduction, atopic conditions, and family history. It documented suspected allergic reactions, symptoms, and diagnostic procedures.</div></div><div><h3>Results</h3><div>Of the 3030 mothers surveyed, 2920 provided complete feeding data for the first 4 months. Among them, 39.0% exclusively breastfed, 12.1% used CMF, and 48.9% partially breastfed. There were 392 infants with FAs, totaling 480 cases involving cow's milk, sesame, egg, or peanut. Of these cases, 122 (25.4%) were in the breastfeeding group, and 358 (74.6%) were in the other groups. Exclusively breastfed infants had lower odds of egg (odds ratio [OR] = 0.53), sesame (OR = 0.58), and peanut (OR = 0.53) allergies than others. The interaction between feeding patterns and atopic dermatitis (AD) related to these FAs was not significant. Exposure to CMF in the nursery, exclusively breastfed, was associated with higher odds of developing a cow's milk allergy. Delayed exposure to sesame in infants with AD has been linked to increased odds of developing a sesame allergy.</div></div><div><h3>Conclusion</h3><div>Exclusive breastfeeding may reduce the risk of IgE-mediated FA development, regardless of AD status.</div></div>","PeriodicalId":50773,"journal":{"name":"Annals of Allergy Asthma & Immunology","volume":"134 6","pages":"Pages 713-718.e10"},"PeriodicalIF":5.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494461","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of asthma severity on surgical outcomes in patients with chronic rhinosinusitis comorbid with asthma","authors":"Bo Zhang MD ,&nbsp;Min Yan MD ,&nbsp;Cong Li MD ,&nbsp;Jiashu Zhao MD ,&nbsp;Yang Liu MD ,&nbsp;Xiaomei Yang MD ,&nbsp;Xuelan Zeng MD ,&nbsp;Zhiying Nie MD ,&nbsp;Zhaoyang Ke MD ,&nbsp;Wei Zhang MD ,&nbsp;Yuanyuan Guo MD ,&nbsp;Jianbo Shi MD, PhD ,&nbsp;Fenghong Chen MD","doi":"10.1016/j.anai.2024.11.022","DOIUrl":"10.1016/j.anai.2024.11.022","url":null,"abstract":"<div><h3>Background</h3><div>Patients with chronic rhinosinusitis with nasal polyps comorbid with asthma often experience poor outcomes after endoscopic sinus surgery.</div></div><div><h3>Objective</h3><div>To evaluate the impact of asthma severity on the long-term outcomes after surgery in these patients.</div></div><div><h3>Methods</h3><div>A total of 83 patients with chronic rhinosinusitis with nasal polyps comorbid with asthma who underwent endoscopic sinus surgery were prospectively enrolled in this study. Patients were classified into mild, moderate, and severe asthma groups based on their preoperative asthma severity. Clinical symptom scores, nasal endoscopy scores, and asthma control test results were recorded preoperatively and at 1 year and 12 years postoperatively.</div></div><div><h3>Results</h3><div>A total of 71 patients completed the 12-year follow-up. All patients had significant improvement in nasal symptom scores and nasal endoscopy scores. However, 48 of 71 patients (67.6%) experienced nasal polyp recurrence, and 22 of them (31.0%) underwent revision surgery. Patients in the severe asthma group had the highest rate of nasal polyp recurrence (<em>P</em> = .02) and revision surgery (<em>P</em> = .01) and the least improvement in smell disturbance (<em>P</em> = .04) and general symptom (<em>P</em> = .02) compared with the other asthma groups.</div></div><div><h3>Conclusion</h3><div>Preoperative asthma severity significantly influenced the outcome of endoscopic sinus surgery in patients with chronic rhinosinusitis with nasal polyps comorbid with asthma, in whom endoscopic sinus surgery had a long-term beneficial effect.</div></div><div><h3>Trial Registration</h3><div><span><span>https://www.chictr.org.cn/</span><svg><path></path></svg></span>: ChiCTR2100050583.</div></div>","PeriodicalId":50773,"journal":{"name":"Annals of Allergy Asthma & Immunology","volume":"134 6","pages":"Pages 676-684.e1"},"PeriodicalIF":5.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142774573","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}