Annals of Allergy Asthma & Immunology最新文献_第8页

STABILITY OF EPINEPHRINE NASAL SPRAY UNDER FREEZE, THAW AND EXTREME TEMPERATURES 肾上腺素鼻喷雾剂在冰冻、解冻和极端温度下的稳定性

IF 4.7 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology

Pub Date : 2025-11-01 DOI: 10.1016/j.anai.2025.08.055

D. Golden , S. Silvers , P. Bansal , R. Lowenthal , B. Dorsey , B. Burrell , S. Tanimoto

Introduction

Severe allergic reactions typically occur outside healthcare settings and require patients/caregivers to respond quickly to avoid serious complications. To be rapidly accessible in any location, it is vital that epinephrine delivery devices be able to withstand a wide range of environmental conditions, including extreme temperatures. The stability of an epinephrine nasal spray was evaluated during freeze/thaw cycles and following extended exposure to extreme heat.

Methods

Intranasal epinephrine samples were subjected to five consecutive 24- to 72-hour freeze/thaw cycles ranging from freezing (-20°C/-4°F) to extreme heat (40°C/104°F). Heat stability was also assessed relative to other epinephrine products. Products were kept at 50°C/122°F for 3 months or 40°C/104°F for 6 months, with a reference condition of 25°C/77°F.

Results

Following the five freeze/thaw cycles, intranasal epinephrine potency ranged from 103.6% (Day 2) to 103.3% (Day 14) of labeled potency. After 3 months at 50°C/122°F, potency decreased by 56.6% for pre-filled syringes, 41.6% for autoinjectors, and 8.6% for intranasal epinephrine. After 6 months at 40°C/104°F, potency decreased by 27.5% for autoinjectors, 17.2% for pre-filled syringes, and 13.9% for intranasal.

Conclusions

Intranasal epinephrine potency was not affected by extreme temperature fluctuations (-20/-4 to 40°C/104°F) or by multiple freeze/thaw cycles and remained within specifications for potency under extreme temperature conditions after 3-months at 50°C/122°F or 6-months at 40°C/104°F. While intranasal epinephrine is unlikely to have reduced efficacy following exposure to extreme high or low temperatures that mimic real world exposures and boosting confidence in use throughout its 24 to 30-month shelf-life, patients/caregivers should always carry devices with them.

严重的过敏反应通常发生在医疗机构之外，需要患者/护理人员迅速反应以避免严重的并发症。为了能够在任何地点快速到达，肾上腺素输送装置能够承受各种环境条件，包括极端温度，这一点至关重要。在冷冻/解冻周期和长时间暴露于极端高温下，评估肾上腺素鼻喷雾剂的稳定性。方法将经鼻肾上腺素样品在冷冻（-20°C/-4°F）至极热（40°C/104°F）期间连续5次进行24至72小时的冻融循环。还评估了相对于其他肾上腺素产品的热稳定性。产品在50°C/122°F保存3个月或40°C/104°F保存6个月，参考条件为25°C/77°F。结果经5次冻融循环后，鼻内肾上腺素效价为标记效价的103.6%（第2天）至103.3%（第14天）。在50°C/122°F下放置3个月后，预充注射器的效价下降了56.6%，自体注射器的效价下降了41.6%，鼻内肾上腺素的效价下降了8.6%。在40°C/104°F下放置6个月后，自动注射器的效力下降了27.5%，预充注射器的效力下降了17.2%，鼻内注射器的效力下降了13.9%。结论经鼻肾上腺素的效价不受极端温度波动（-20/-4至40°C/104°F）或多次冻融循环的影响，在极端温度条件下50°C/122°F下3个月或40°C/104°F下6个月仍保持在效价标准内。虽然鼻内肾上腺素不太可能在暴露于模拟真实世界的极端高温或低温下并在其24至30个月的保质期内增强使用信心后降低疗效，但患者/护理人员应始终随身携带设备。

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引用次数: 0

SUSTAINED THERAPEUTIC EXPOSURE WITH ONCE-DAILY ORAL DEUCRICTIBANT EXTENDED-RELEASE TABLET FOR PROPHYLAXIS OF HEREDITARY ANGIOEDEMA ATTACKS 持续治疗暴露于每日一次口服减氧剂缓释片预防遗传性血管性水肿发作

IF 4.7 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology

Pub Date : 2025-11-01 DOI: 10.1016/j.anai.2025.08.105

Z. Zhang , P. Lu , K. Groen , R. Crabbe

Introduction

Deucrictibant is a selective, orally administered bradykinin B2 receptor antagonist. Deucrictibant extended-release (XR) tablet is under development for prophylaxis and deucrictibant immediate-release (IR) capsule for on-demand treatment of bradykinin-mediated angioedema attacks.

Methods

PHA022121-C020 and PHA022121-C017 were phase 1, open-label, studies in healthy volunteers. PHA022121-C020 objectives were to characterize single-dose pharmacokinetics of deucrictibant XR tablet (40mg) and IR capsule (2 × 20mg), and assess relative bioavailability, safety and tolerability. PHA022121-C017 objectives included characterizing multiple-dose pharmacokinetics of deucrictibant XR (40mg).

Results

PHA022121-C020: Mean (SD) maximum plasma concentration (Cmax) was 87 (26) and 547 (193) ng/mL for deucrictibant XR (40mg) and IR (2 × 20mg), respectively. Mean (SD) plasma concentration at 24 hours post-dose (C24h) was 52 (30) and 7 (7) ng/mL, respectively. Mean C24h for deucrictibant XR was ∼4-fold higher than the anticipated therapeutic exposure threshold concentration estimated to provide 85% maximal response (EC85; 13.8 ng/mL). Median tmax was longer for deucrictibant XR vs IR (5.0 vs 1.0 hours). Half-lives were comparable for both formulations (5.7 vs. 5.1 hours). Area under the curve (AUC) data showed comparable relative bioavailability and overall exposure between the two formulations. PHA022121-C017 showed unaltered exposure with repeated deucrictibant XR dosing with limited accumulation. Daily deucrictibant XR (40 mg) dosing demonstrated sustained exposure, with mean C24h (predose) at concentrations ∼3-fold higher than EC85.

Conclusions

A single oral deucrictibant XR tablet resulted in sustained exposure for at least 24 hours, which was not altered by repeat dosing, supporting once-daily dosing of deucrictibant XR tablet in phase 3 trials.

deucrictibant是一种选择性口服缓激肽B2受体拮抗剂。deucrichant缓释（XR）片剂用于预防和deucrichant速释（IR）胶囊用于按需治疗缓激肽介导的血管性水肿发作。方法spha022121 - c020和PHA022121-C017是在健康志愿者中进行的开放标签一期研究。PHA022121-C020目的：表征除湿剂XR片（40mg）和IR胶囊（2 × 20mg）的单剂量药代动力学，并评价其相对生物利用度、安全性和耐受性。PHA022121-C017目的包括表征除湿剂XR （40mg）的多剂量药代动力学。结果spha022121 - c020：去氧剂XR （40mg）和IR（2 × 20mg）的平均（SD）最大血药浓度（Cmax）分别为87（26）和547 (193)ng/mL。给药后24小时（C24h）平均（SD）血药浓度分别为52（30）和7 (7)ng/mL。脱水剂XR的平均C24h比预期的治疗暴露阈值浓度高4倍，估计可提供85%的最大反应（EC85; 13.8 ng/mL）。去氧剂XR比IR的中位tmax更长（5.0比1.0小时）。两种制剂的半衰期相当（5.7小时对5.1小时）。曲线下面积（AUC）数据显示两种制剂的相对生物利用度和总暴露量相当。PHA022121-C017在反复给药的情况下暴露不变，积累有限。每日除湿剂XR （40mg）剂量显示持续暴露，平均c24小时（剂量前）浓度比EC85高约3倍。结论单次口服减氧剂XR片可导致持续暴露至少24小时，重复给药不会改变暴露时间，在3期试验中支持每日一次的减氧剂XR片给药。

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引用次数: 0

LONG-TERM SAFETY AND EFFICACY OF ORAL DEUCRICTIBANT FOR PROPHYLAXIS IN HEREDITARY ANGIOEDEMA: CHAPTER-1 OPEN-LABEL EXTENSION 口服减湿剂预防遗传性血管性水肿的长期安全性和有效性：第一章开放标签扩展

IF 4.7 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology

Pub Date : 2025-11-01 DOI: 10.1016/j.anai.2025.08.034

M. Riedl , J. Anderson , M. Cancian , S. Kiani-Alikhan , M. Magerl , M. Manning , R. Crabbé , J. Levy , U. Katbeh , E. Aygoren-Pursun

Introduction

Deucrictibant is an orally administered bradykinin B2 receptor antagonist under development for prophylactic and on-demand treatment of hereditary angioedema (HAE) attacks. CHAPTER-1 (NCT05047185; two-part Phase 2 study) evaluates the efficacy and safety of deucrictibant for long-term prophylaxis of HAE attacks. The open-label extension (OLE; part 2) is nearing completion and final results will be presented.

Methods

CHAPTER-1 enrolled 34 participants (≥18 and ≤75 years) diagnosed with HAE-1/2. Thirty participants completed part-1, during which they received deucrictibant 20mg/day (n=11), 40mg/day (n=10), or placebo (n=9) for 12 weeks, and continued into the OLE and received deucrictibant 40mg/day.

Results

A data snapshot (cutoff: 10 June 2024) are reported and includes 30 participants. Mean (maximum) treatment duration in the OLE: 12.8 (20.8) months and maximum deucrictibant exposure during entire study: 23.7 months. Deucrictibant was generally well tolerated with no treatment-related serious treatment emergent adverse events (TEAEs). Mean (standard deviation) attack rate was 2.18 (1.35) at study baseline and least squares mean (LSM) attack rate was 0.15 (standard error [SE] 0.05) in the OLE. Attack rate in the OLE was low irrespective of participants’ attack rate at study baseline. During the OLE, LSM (SE) monthly rate of attacks using on-demand medication was 0.07 (0.02). Relative to study baseline, 93.1%/93.1%/79.3% of participants had ≥50%/≥70%/≥90% reduction in attack rate, respectively; 55.2% were attack free in the OLE.

Conclusions

CHAPTER-1 OLE results provide additional evidence on the long-term safety and efficacy of deucrictibant for prophylaxis of HAE attacks. Final OLE data will be presented.

deucrictibant是一种口服缓激肽B2受体拮抗剂，正在开发中，用于遗传性血管性水肿（HAE）发作的预防和按需治疗。第1章（NCT05047185；两部分2期研究）评估了脱硝剂长期预防HAE发作的有效性和安全性。开放标签扩展（OLE；第2部分）即将完成，并将给出最终结果。方法schapter -1纳入34名确诊为HAE-1/2患者（≥18岁，≤75岁）。30名参与者完成了第一部分，在此期间，他们接受了20mg/天（n=11）， 40mg/天（n=10）或安慰剂（n=9），持续12周，并继续进入OLE并接受40mg/天的去氧剂。结果报告了30名参与者的数据快照（截止日期：2024年6月10日）。OLE的平均（最长）治疗时间：12.8（20.8）个月，整个研究期间的最大除湿剂暴露时间：23.7个月。Deucrictibant总体耐受性良好，无与治疗相关的严重治疗突发不良事件（teae）。研究基线的平均（标准差）攻击率为2.18 (1.35)，OLE的最小二乘平均（LSM）攻击率为0.15（标准误差[SE] 0.05）。无论受试者在研究基线时的发作率如何，OLE中的发作率都很低。在OLE期间，LSM （SE）每月使用按需药物的发作率为0.07（0.02）。与研究基线相比，93.1%/93.1%/79.3%的受试者发作率分别降低≥50%/≥70%/≥90%；55.2%的OLE无发作。结论：chapter -1 OLE结果为减氧剂预防HAE发作的长期安全性和有效性提供了额外的证据。最后的OLE数据将会公布。

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引用次数: 0

BIOLOGIC USE FOR ATOPIC DISORDERS AND PREGNANCY: VARIABILITY IN REAL-WORLD TREATMENT PATTERNS 特应性疾病和妊娠的生物应用：现实世界治疗模式的可变性

IF 4.7 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology

Pub Date : 2025-11-01 DOI: 10.1016/j.anai.2025.08.086

S. Chiarella , W. McCann , I. Novoa-Caicedo , I. McEwen , T. Pongdee

Introduction

Biologic use during pregnancy is not well characterized in real-world settings. We assessed treatment patterns around pregnancy to understand biologic continuation, interruption, and return to therapy.

Methods

This retrospective, observational study utilized data in a large U.S. network of allergy and asthma specialty clinics. Biologic use was identified through procedures, prescriptions, or clinical notes. Pregnancies were identified using two definitions: clinician notes (CN) documenting treatment changes due to pregnancy, and ICD10/procedure codes (IPC) indicating pregnancy. Manual data review was conducted to evaluate biologic use timing, treatment changes, and return to therapy. Patients with multiple pregnancies or appearing in both sources were de-duplicated.

Results

A total of 154 pregnancy-biologic pairs were identified, with 5 patients overlapping across definitions and 2 patients experiencing two separate pregnancy and biologic instances. Of 95 discontinuations due to pregnancy according to CN, 53 (56%) returned to biologic therapy, of which 45 (85%) returned to the same biologic. From IPC, 63 pregnancies had biologic exposure within ±9 months of the IPC date. Manual review of these pregnancies determined that 12 were false positives for exposure, 39 were exposed to a biologic during pregnancy (omalizumab: 31, dupilumab: 5, benralizumab: 2, mepolizumab: 1), 10 patients discontinued the biologic while pregnant, returning to the same following pregnancy, and 2 had unclear exposure timing.

Conclusion

Findings highlight the need for clearer clinical guidance on biologic use during pregnancy. Real-world patterns of biologic continuation, interruption, and return to therapy underscore the importance of individualized decision-making and improved evidence to support treatment planning in reproductive-age patients.

在现实世界中，怀孕期间生物制剂的使用并没有很好地表征。我们评估了怀孕前后的治疗模式，以了解生物学上的继续、中断和恢复治疗。方法：这项回顾性观察性研究利用了美国大型过敏和哮喘专科诊所网络的数据。生物用途是通过程序、处方或临床记录确定的。使用两种定义确定妊娠：记录妊娠引起的治疗变化的临床医生笔记（CN）和指示妊娠的ICD10/程序代码（IPC）。进行人工数据回顾，以评估生物制剂的使用时间、治疗变化和恢复治疗。多胎妊娠或出现在两个来源的患者被去重复。结果共发现154例妊娠-生物学对，其中5例患者定义重叠，2例患者出现两个独立的妊娠和生物学实例。根据CN，在95例因妊娠停止治疗的患者中，53例（56%）恢复生物治疗，其中45例（85%）恢复相同的生物治疗。从IPC来看，63例妊娠在IPC日期±9个月内发生生物暴露。对这些孕妇进行人工检查，确定12例为假阳性，39例在怀孕期间暴露于生物制剂（奥玛单抗：31例，杜匹单抗：5例，贝那利单抗：2例，美宝单抗：1例），10例在怀孕期间停止使用生物制剂，在怀孕后又恢复使用，2例暴露时间不明确。结论研究结果表明，需要对妊娠期生物制剂的临床应用给予更明确的指导。现实世界的生物延续、中断和恢复治疗模式强调了个体化决策和改进证据的重要性，以支持育龄患者的治疗计划。

{"title":"BIOLOGIC USE FOR ATOPIC DISORDERS AND PREGNANCY: VARIABILITY IN REAL-WORLD TREATMENT PATTERNS","authors":"S. Chiarella , W. McCann , I. Novoa-Caicedo , I. McEwen , T. Pongdee","doi":"10.1016/j.anai.2025.08.086","DOIUrl":"10.1016/j.anai.2025.08.086","url":null,"abstract":"<div><h3>Introduction</h3><div>Biologic use during pregnancy is not well characterized in real-world settings. We assessed treatment patterns around pregnancy to understand biologic continuation, interruption, and return to therapy.</div></div><div><h3>Methods</h3><div>This retrospective, observational study utilized data in a large U.S. network of allergy and asthma specialty clinics. Biologic use was identified through procedures, prescriptions, or clinical notes. Pregnancies were identified using two definitions: clinician notes (CN) documenting treatment changes due to pregnancy, and ICD10/procedure codes (IPC) indicating pregnancy. Manual data review was conducted to evaluate biologic use timing, treatment changes, and return to therapy. Patients with multiple pregnancies or appearing in both sources were de-duplicated.</div></div><div><h3>Results</h3><div>A total of 154 pregnancy-biologic pairs were identified, with 5 patients overlapping across definitions and 2 patients experiencing two separate pregnancy and biologic instances. Of 95 discontinuations due to pregnancy according to CN, 53 (56%) returned to biologic therapy, of which 45 (85%) returned to the same biologic. From IPC, 63 pregnancies had biologic exposure within ±9 months of the IPC date. Manual review of these pregnancies determined that 12 were false positives for exposure, 39 were exposed to a biologic during pregnancy (omalizumab: 31, dupilumab: 5, benralizumab: 2, mepolizumab: 1), 10 patients discontinued the biologic while pregnant, returning to the same following pregnancy, and 2 had unclear exposure timing.</div></div><div><h3>Conclusion</h3><div>Findings highlight the need for clearer clinical guidance on biologic use during pregnancy. Real-world patterns of biologic continuation, interruption, and return to therapy underscore the importance of individualized decision-making and improved evidence to support treatment planning in reproductive-age patients.</div></div>","PeriodicalId":50773,"journal":{"name":"Annals of Allergy Asthma & Immunology","volume":"135 5","pages":"Pages S24-S25"},"PeriodicalIF":4.7,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145442649","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}

引用次数: 0

THUNDERSTORM-ASSOCIATED INCREASES IN ASTHMA ED VISITS IN A MIDWESTERN US CITY: A FIVE-YEAR REVIEW 雷暴导致美国中西部城市哮喘病就诊人数增加：五年回顾

IF 4.7 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology

Pub Date : 2025-11-01 DOI: 10.1016/j.anai.2025.08.022

D. Merheb , T. Nguyen , S. Gierer , H. Chang

Introduction

Thunderstorm asthma is an environmental phenomenon marked by surges in asthma exacerbations during or shortly after storms. While documented internationally, few studies have evaluated this effect in U.S. regions with high allergen burdens. This study assesses whether thunderstorms are associated with increased asthma-related emergency department (ED) visits in Wichita, Kansas, and explores demographics.

Methods

This study was approved by the Ascension Health Institutional Review Board. We conducted a retrospective analysis of 4,439 asthma-related ED visits from January 1, 2020, to December 31, 2024, across three hospitals in Wichita. Thunderstorm days (n = 38) were identified using meteorologic records from the National Centers for Environmental Information. Each ED visit was classified as occurring on a storm or non-storm day. Daily asthma admissions were compared using a Mann-Whitney U test. Multivariable logistic regression assessed the relationship between storm-day admissions and age, gender, zip code, and ED disposition.

Results

Of 4,439 asthma-related ED visits, 627 (14.1%) occurred on 38 thunderstorm days. The mean number of admissions on storm days (17.91) was significantly higher than on non-storm days (3.09) (Mann-Whitney U = 41,787.5; p < 5.55 × 10?²²). Storm days accounted for only 2% of calendar days but over 14% of asthma visits. Regression identified older age as a significant predictor of storm-day presentation (β = 0.0071, p = 0.002). Gender, zip code, and disposition were not significant.

Conclusion

Asthma-related ED visits rose significantly on thunderstorm days in Wichita. Findings support storm-specific public health preparedness, including education and modifications to asthma action plans to ease healthcare burden.

雷暴哮喘是一种环境现象，其特征是在暴风雨期间或之后不久哮喘发作激增。虽然在国际上有记录，但很少有研究评估美国过敏原负担高的地区的这种影响。本研究评估了雷暴是否与堪萨斯州威奇托市哮喘相关急诊科（ED）就诊增加有关，并探讨了人口统计学。方法本研究经阿森松健康机构审查委员会批准。我们对威奇托三家医院2020年1月1日至2024年12月31日期间的4439例哮喘相关急诊科就诊进行了回顾性分析。雷暴日（n = 38）是根据国家环境信息中心的气象记录确定的。每次急诊科就诊都被分为暴风雨日和非暴风雨日。使用曼-惠特尼U测试比较每日哮喘入院人数。多变量logistic回归评估了暴风雨日入院与年龄、性别、邮政编码和ED处置之间的关系。结果4439例哮喘相关急诊科就诊中，有627例（14.1%）发生在38个雷雨天。暴雨日平均入场人数（17.91）显著高于非暴雨日（3.09）（Mann-Whitney U = 41,787.5;p < 5.55 × 10?²²）。风暴日仅占日历日的2%，但哮喘就诊人数超过14%。回归发现年龄较大是风暴日出现的重要预测因子（β = 0.0071,p = 0.002）。性别、邮政编码和性格不显著。结论威奇托市雷雨天气哮喘相关急诊科就诊人数显著增加。研究结果支持针对风暴的公共卫生准备，包括教育和修改哮喘行动计划，以减轻医疗负担。

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引用次数: 0

PRESCRIBING PATTERNS IN PEDIATRIC CELLULITIS: A MULTI-STATE ANALYSIS STRATIFIED BY PENICILLIN ALLERGY STATUS 儿科蜂窝织炎的处方模式：青霉素过敏状态分层的多状态分析

IF 4.7 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology

Pub Date : 2025-11-01 DOI: 10.1016/j.anai.2025.08.051

J. Keelin , C. Chang

Introduction

Pediatric cellulitis is a common skin and soft tissue infection, typically treated empirically with antibiotics. Although guidelines recommend narrow-spectrum agents, real-world prescribing varies. Antibiotic selection in patients with documented drug allergies may impact both prescribing patterns and cost.

Methods

We conducted a retrospective cross-sectional study of pediatric patients (<18 years) diagnosed with cellulitis between April 2020 and April 2025 using Epic Cosmos, a de-identified nationwide electronic health record database. Encounters with ICD-10 codes containing “cellulitis” were included. Demographics, encounter type, and the top 10 prescribed antibiotics were analyzed. Prescription-level costs were estimated for both the overall cohort and penicillin-allergic subgroup using GoodRx Walmart retail pricing.

Results

Among 1,051,086 pediatric cellulitis patients, cephalexin was the most prescribed antibiotic (n=398,547; 37.92%), followed by mupirocin and amoxicillin/clavulanate. Of 28,871 patients with documented penicillin allergy, cephalexin (n=8,682; 30.07%) remained most prescribed, followed by TMP-SMX, clindamycin, and cefdinir. The average drug cost per prescription was $20.00 in the overall cohort and $19.54 in the penicillin-allergic group. This unexpected cost pattern may reflect continued cephalexin use in allergy-labeled patients. Beta-lactams were prescribed in some allergy-labeled cases, suggesting inaccurate documentation or post-treatment allergy coding.

Conclusions

Despite allergy labels, lower-cost β-lactams like cephalexin were still frequently prescribed, resulting in slightly lower average drug costs in the penicillin-allergic group. These findings support the need for improved allergy documentation, de-labeling strategies, and adherence to evidence-based guidelines to optimize both care quality and cost-effectiveness.

儿科蜂窝织炎是一种常见的皮肤和软组织感染，通常经验性地使用抗生素治疗。尽管指南建议使用窄谱药物，但现实世界的处方各不相同。有记录的药物过敏患者的抗生素选择可能会影响处方模式和成本。方法：我们对2020年4月至2025年4月期间诊断为蜂窝织炎的儿科患者（18岁）进行了回顾性横断面研究，使用Epic Cosmos（一个去识别的全国电子健康记录数据库）。包含“蜂窝织炎”的ICD-10代码被纳入。分析人口统计学、就诊类型和前10名处方抗生素。使用GoodRx沃尔玛零售定价对整个队列和青霉素过敏亚组的处方水平成本进行估计。结果1051086例小儿蜂窝组织炎患者中，头孢氨苄是处方最多的抗生素（n= 398547; 37.92%），其次是莫匹罗星和阿莫西林/克拉维酸。在28,871例有青霉素过敏记录的患者中，头孢氨苄（n=8,682; 30.07%）仍然是处方最多的，其次是TMP-SMX、克林霉素和头孢地尼。在整个队列中，每个处方的平均药物成本为20.00美元，青霉素过敏组为19.54美元。这种意想不到的成本模式可能反映了过敏标签患者继续使用头孢氨苄。在一些过敏标签的病例中开了β -内酰胺类药物，这表明记录不准确或治疗后过敏编码不准确。结论尽管有过敏标签，但较低成本的β-内酰胺类药物如头孢氨苄仍被频繁使用，导致青霉素过敏组的平均药物成本略低。这些发现支持改进过敏记录、去除标签策略和遵守循证指南的必要性，以优化护理质量和成本效益。

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引用次数: 0

RETROSPECTIVE REVIEW OF PENICILLIN ALLERGY EVALUATIONS AND SUBSEQUENT DE-LABELING: A SINGLE PEDIATRIC TERTIARY CENTER EXPERIENCE 青霉素过敏评价和随后去标签的回顾性回顾：一个儿科三级中心的经验

IF 4.7 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology

Pub Date : 2025-11-01 DOI: 10.1016/j.anai.2025.08.052

A. Mason, F. Khan, R. Scherzer, A. La Mantia

Introduction

Approximately 10% of patients are labeled with a penicillin (PCN) allergy. However, up to 95% of those patients do not have an IgE-mediated or T-cell mediated hypersensitivity to PCN. Mislabeling PCN allergy has significant medical and financial consequences for both patients and the medical systems at-large.

Methods

We conducted a retrospective chart review of patients evaluated for PCN allergy at our outpatient Allergy clinic between November 1, 2022, and August 31, 2023. Data collected included reactions to penicillin containing antibiotics, prevalence of skin testing, completed oral drug challenges (DC), whether subsequent visit drug challenges were performed, and rates of penicillin allergy de-labeling.

Results

We identified 222 patients referred for drug allergy, of which 196 had a documented PCN allergy. From the cohort of 196 patients, 23 patients (11.7%) were de-labeled based on historical information alone. 66 patients (33.6%) completed a graded dose oral penicillin challenge with a 98.5% success of de-labeling the PCN allergy based on challenge outcomes. However, 93 patients (47.4%) did not follow-up for the recommended oral drug challenge at the time of our chart review. Of the cohort evaluated, only 13 patients (6.6%) remained labeled after assessment due to serum sickness like reactions (n=9), positive PCN skin testing (n=2), and having been relabeled as PCN allergic at an outside facility (n=2).

Conclusion

Our study provides further evidence that oral drug challenges are safe and effective at de-labeling Penicillin allergy. Next steps in the project include developing opportunities to overcome barriers preventing the completion of oral drug challenges at subsequent visits.

大约10%的患者被标记为青霉素（PCN）过敏。然而，高达95%的患者没有ige介导或t细胞介导的PCN超敏反应。错误标记PCN过敏对患者和整个医疗系统都有重大的医疗和经济后果。方法我们对2022年11月1日至2023年8月31日期间在我们的过敏门诊就诊的被评估为PCN过敏的患者进行回顾性图表回顾。收集的数据包括对含青霉素抗生素的反应，皮肤试验的流行率，完成口服药物挑战（DC），是否进行后续访问药物挑战，以及青霉素过敏脱标率。结果222例药物过敏患者，其中196例有PCN过敏记录。在196例患者中，23例患者（11.7%）仅根据历史信息去标签。66例患者（33.6%）完成了分级剂量口服青霉素刺激，根据刺激结果，98.5%的患者成功地去除了PCN过敏的标签。然而，在我们的图表回顾时，93名患者（47.4%）没有对推荐的口服药物挑战进行随访。在评估的队列中，由于血清疾病反应（n=9）， PCN皮肤试验阳性（n=2）以及在外部设施被重新标记为PCN过敏（n=2），只有13名患者（6.6%）在评估后仍被标记。结论本研究进一步证明口服药物刺激治疗青霉素过敏是安全有效的。该项目的下一步工作包括开发机会，以克服在后续访问中阻碍完成口服药物挑战的障碍。

{"title":"RETROSPECTIVE REVIEW OF PENICILLIN ALLERGY EVALUATIONS AND SUBSEQUENT DE-LABELING: A SINGLE PEDIATRIC TERTIARY CENTER EXPERIENCE","authors":"A. Mason, F. Khan, R. Scherzer, A. La Mantia","doi":"10.1016/j.anai.2025.08.052","DOIUrl":"10.1016/j.anai.2025.08.052","url":null,"abstract":"<div><h3>Introduction</h3><div>Approximately 10% of patients are labeled with a penicillin (PCN) allergy. However, up to 95% of those patients do not have an IgE-mediated or T-cell mediated hypersensitivity to PCN. Mislabeling PCN allergy has significant medical and financial consequences for both patients and the medical systems at-large.</div></div><div><h3>Methods</h3><div>We conducted a retrospective chart review of patients evaluated for PCN allergy at our outpatient Allergy clinic between November 1, 2022, and August 31, 2023. Data collected included reactions to penicillin containing antibiotics, prevalence of skin testing, completed oral drug challenges (DC), whether subsequent visit drug challenges were performed, and rates of penicillin allergy de-labeling.</div></div><div><h3>Results</h3><div>We identified 222 patients referred for drug allergy, of which 196 had a documented PCN allergy. From the cohort of 196 patients, 23 patients (11.7%) were de-labeled based on historical information alone. 66 patients (33.6%) completed a graded dose oral penicillin challenge with a 98.5% success of de-labeling the PCN allergy based on challenge outcomes. However, 93 patients (47.4%) did not follow-up for the recommended oral drug challenge at the time of our chart review. Of the cohort evaluated, only 13 patients (6.6%) remained labeled after assessment due to serum sickness like reactions (n=9), positive PCN skin testing (n=2), and having been relabeled as PCN allergic at an outside facility (n=2).</div></div><div><h3>Conclusion</h3><div>Our study provides further evidence that oral drug challenges are safe and effective at de-labeling Penicillin allergy. Next steps in the project include developing opportunities to overcome barriers preventing the completion of oral drug challenges at subsequent visits.</div></div>","PeriodicalId":50773,"journal":{"name":"Annals of Allergy Asthma & Immunology","volume":"135 5","pages":"Page S14"},"PeriodicalIF":4.7,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145442360","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}

引用次数: 0

BENRALIZUMAB FOR PATIENTS WITH HYPEREOSINOPHILIC SYNDROME: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 TRIAL (NATRON) Benralizumab用于嗜酸性粒细胞增多综合征患者：一项随机、双盲、安慰剂对照的3期试验（natron）

IF 4.7 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology

Pub Date : 2025-11-01 DOI: 10.1016/j.anai.2025.10.019

P. Ogbogu , F. Roufosse , P. Akuthota , P. Lacwik , M. Groh , A. Reiter , A. Yokota , S. Siddiqui , P. Mutsaers , B. Li , L. Bahadori , A. Bednarczyk , G. Bouma , L. Brooks , J. Ferreira , H. Grindebacke , C. Ho , P. Jain , R. Palmer , C. Walton , A. Klion

Introduction

Benralizumab, an anti-IL-5Rα antibody causing near-complete depletion of eosinophils, has demonstrated efficacy in severe asthma and EGPA. Phase 2 results in hypereosinophilic syndrome (HES) were promising

Methods

NATRON (NCT04191304) was a phase 3, randomized, double-blind, placebo-controlled study. Patients were ≥12 years, FIP1L1::PDGFRA-negative, with HES flare signs/symptoms at screening or ≥2 flares within the past year, and corticosteroid-responsive. Patients received benralizumab (30mg) or placebo (1:1) Q4W, plus background therapy, for 24 weeks. Primary endpoint was time to first HES flare. Key secondary endpoints were proportion of patients with flares, annualized flare rate, time to first hematologic relapse (AEC≥1 × 10⁹/L), and change from baseline to Week 24 in PROMIS Fatigue SF7a.

Results

133 patients (median/range age was 51/14–87 years, 61.7% female) were randomized (n=67 benralizumab, n=66 placebo). Benralizumab significantly reduced risk of flare (HR: 0.35; 95% CI: 0.18, 0.69; P=0.0024; Figure), proportion of patients with flares (22.4% versus 45.5%; OR: 0.31; 95% CI: 0.14, 0.69; P=0.0033), annualized flare rate (0.41 versus 1.23 flares/year; RR: 0.34; 95% CI: 0.18, 0.63; P=0.0008), and risk of hematologic relapse (HR: 0.08; 95% CI: 0.03, 0.20; P<0.0001) versus placebo. PROMIS Fatigue scores significantly improved with benralizumab versus placebo (LS means difference: –4.72; 95% CI: –7.64, –1.80; P=0.0017). Similar proportions of benralizumab- and placebo-treated patients experienced adverse events (AEs; 64.2%, 66.7%) and serious AEs (7.5%, 7.6%).

Conclusion

Add-on benralizumab demonstrated clinical benefit in HES by reducing flare and hematologic relapse risk and improving fatigue. Benralizumab tolerability was consistent with its known safety profile.

benralizumab是一种抗il - 5r α抗体，可导致嗜酸性粒细胞几乎完全耗尽，已证明对严重哮喘和EGPA有效。方法：snatron （NCT04191304）是一项随机、双盲、安慰剂对照的3期研究。患者年龄≥12岁，FIP1L1:: pdgfr阴性，筛查时有HES发作体征/症状或过去一年内≥2次发作，皮质类固醇反应。患者接受benralizumab （30mg）或安慰剂（1:1）Q4W，加上背景治疗，为期24周。主要终点为首次HES发作的时间。关键的次要终点是耀斑患者的比例，年化耀斑率，到首次血液学复发的时间（AEC≥1 × 109/L），以及PROMIS疲劳SF7a从基线到第24周的变化。结果133例患者（年龄中位数/范围为51/14-87岁，61.7%为女性）被随机分配（n=67例贝纳利珠单抗，n=66例安慰剂）。与安慰剂相比，贝纳利珠单抗显著降低了耀斑风险（HR: 0.35; 95% CI: 0.18, 0.69； P=0.0024；图）、耀斑患者比例（22.4% vs 45.5%; OR: 0.31; 95% CI: 0.14, 0.69； P=0.0033）、年化耀斑率（0.41 vs 1.23次耀斑/年；RR: 0.34; 95% CI: 0.18, 0.63； P=0.0008）和血肿复发风险（HR: 0.08; 95% CI: 0.03, 0.20; P<0.0001）。与安慰剂相比，benralizumab显著改善了PROMIS疲劳评分（LS均值差异：-4.72;95% CI: -7.64, -1.80； P=0.0017）。贝纳利珠单抗和安慰剂治疗的患者出现不良事件（ae; 64.2%, 66.7%）和严重ae（7.5%, 7.6%）的比例相似。结论加用贝那利珠单抗可降低血液学复发风险，改善疲劳，对HES有临床益处。Benralizumab耐受性与其已知的安全性一致。

{"title":"BENRALIZUMAB FOR PATIENTS WITH HYPEREOSINOPHILIC SYNDROME: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 TRIAL (NATRON)","authors":"P. Ogbogu , F. Roufosse , P. Akuthota , P. Lacwik , M. Groh , A. Reiter , A. Yokota , S. Siddiqui , P. Mutsaers , B. Li , L. Bahadori , A. Bednarczyk , G. Bouma , L. Brooks , J. Ferreira , H. Grindebacke , C. Ho , P. Jain , R. Palmer , C. Walton , A. Klion","doi":"10.1016/j.anai.2025.10.019","DOIUrl":"10.1016/j.anai.2025.10.019","url":null,"abstract":"<div><h3>Introduction</h3><div>Benralizumab, an anti-IL-5Rα antibody causing near-complete depletion of eosinophils, has demonstrated efficacy in severe asthma and EGPA. Phase 2 results in hypereosinophilic syndrome (HES) were promising</div></div><div><h3>Methods</h3><div>NATRON (NCT04191304) was a phase 3, randomized, double-blind, placebo-controlled study. Patients were ≥12 years, FIP1L1::PDGFRA-negative, with HES flare signs/symptoms at screening or ≥2 flares within the past year, and corticosteroid-responsive. Patients received benralizumab (30mg) or placebo (1:1) Q4W, plus background therapy, for 24 weeks. Primary endpoint was time to first HES flare. Key secondary endpoints were proportion of patients with flares, annualized flare rate, time to first hematologic relapse (AEC≥1 × 10<sup>9</sup>/L), and change from baseline to Week 24 in PROMIS Fatigue SF7a.</div></div><div><h3>Results</h3><div>133 patients (median/range age was 51/14–87 years, 61.7% female) were randomized (n=67 benralizumab, n=66 placebo). Benralizumab significantly reduced risk of flare (HR: 0.35; 95% CI: 0.18, 0.69; P=0.0024; Figure), proportion of patients with flares (22.4% versus 45.5%; OR: 0.31; 95% CI: 0.14, 0.69; P=0.0033), annualized flare rate (0.41 versus 1.23 flares/year; RR: 0.34; 95% CI: 0.18, 0.63; P=0.0008), and risk of hematologic relapse (HR: 0.08; 95% CI: 0.03, 0.20; P<0.0001) versus placebo. PROMIS Fatigue scores significantly improved with benralizumab versus placebo (LS means difference: –4.72; 95% CI: –7.64, –1.80; P=0.0017). Similar proportions of benralizumab- and placebo-treated patients experienced adverse events (AEs; 64.2%, 66.7%) and serious AEs (7.5%, 7.6%).</div></div><div><h3>Conclusion</h3><div>Add-on benralizumab demonstrated clinical benefit in HES by reducing flare and hematologic relapse risk and improving fatigue. Benralizumab tolerability was consistent with its known safety profile.</div></div>","PeriodicalId":50773,"journal":{"name":"Annals of Allergy Asthma & Immunology","volume":"135 5","pages":"Pages S2-S3"},"PeriodicalIF":4.7,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145442372","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}

引用次数: 0

Disclosures 披露的信息

IF 4.7 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology

Pub Date : 2025-11-01 DOI: 10.1016/S1081-1206(25)01296-7

引用次数: 0

HOME EGG LADDER INITIATION IN CHILDREN WITH ISOLATED CUTANEOUS SYMPTOMS FOLLOWING EGG EXPOSURE 接触鸡蛋后出现孤立皮肤症状的儿童的家庭鸡蛋阶梯启动

IF 4.7 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology

Pub Date : 2025-11-01 DOI: 10.1016/j.anai.2025.08.029

S. Pawer , N. Yu , S. Jeimy , S. Erdle , T. Wong , V. Cook

Introduction

Referrals for cutaneous symptoms following egg exposure are commonly received by pediatric allergists. At our community allergy clinic, 47% of food allergy referrals for 0–2-year-olds involve egg. Rather than traditional egg avoidance, the Canadian Egg Ladder facilitates reintroduction. We describe home egg ladder initiation in patients with cutaneous symptoms, to assess safety and potential to decrease allergist assessments.

Methods

From 2018–2025, 0–2-year-olds with isolated cutaneous symptoms began the egg ladder at home, without in-person allergist assessment. Caregivers were educated on initiation, and epinephrine autoinjectors were prescribed. Patients were reviewed every 3–6 months. Demographics, adverse reactions, and ladder progress were recorded. Descriptive statistics were analyzed in Excel. As quality improvement, this study was exempted from IRB approval.

Results

Of 116 patients who began the egg ladder, 84% (n=97) completed it. Median initiation age was 12 months (IQR 9–16); average completion time was 6 months (IQR 2–9). Twenty-five patients (22%) experienced adverse reactions, predominantly contact rashes (18/25; 72%). Six experienced grade 1 CoFAR reactions, two experienced grade 2 CoFAR reactions. No patients required epinephrine. Attrition rate was 8%; 7% transitioned to oral immunotherapy (5 ladder failure, 2 parental anxiety, 1 logistical burden). Based on egg tolerance by time of allergy assessment, ladder initiation by referring providers could have prevented 63% of allergy referrals.

Conclusion

This study supports safe, effective home initiation of the egg ladder for pediatric patients with isolated cutaneous symptoms after egg exposure. Implementing ladders in primary care may reduce unnecessary allergist referrals, shortening wait times and improving access for those requiring specialist care.

介绍：儿童过敏专科医生通常会收到接触鸡蛋后皮肤症状的转诊。在我们的社区过敏诊所，0 - 2岁儿童的食物过敏转诊中有47%涉及鸡蛋。而不是传统的鸡蛋避免，加拿大鸡蛋梯子促进重新引入。我们描述了家庭鸡蛋阶梯在皮肤症状患者中的启动，以评估安全性和减少过敏医师评估的潜力。方法2018-2025年，0 - 2岁的儿童在没有过敏专家评估的情况下，在家中开始鸡蛋阶梯治疗。护理人员接受了启蒙教育，并开了肾上腺素自身注射器。每3-6个月复查一次。记录人口统计、不良反应和阶梯进展。在Excel中进行描述性统计分析。作为质量改进，本研究免IRB审批。结果116例开始卵梯的患者中，84% （n=97）完成了卵梯。起始年龄中位数为12个月（IQR 9-16）；平均完成时间为6个月（IQR 2-9）。25例患者（22%）出现不良反应，主要是接触性皮疹（18/25;72%）。6例发生1级CoFAR反应，2例发生2级CoFAR反应。没有病人需要肾上腺素。流失率为8%；7%转为口服免疫治疗（阶梯失败5例，父母焦虑2例，后勤负担1例）。根据过敏评估时间的鸡蛋耐受性，转诊提供者的阶梯启动可以阻止63%的过敏转诊。结论：本研究支持对暴露于鸡蛋后出现孤立皮肤症状的儿科患者进行安全有效的家庭鸡蛋阶梯治疗。在初级保健中实施阶梯可减少不必要的过敏症专家转诊，缩短等待时间，并改善需要专科护理的患者的可及性。

{"title":"HOME EGG LADDER INITIATION IN CHILDREN WITH ISOLATED CUTANEOUS SYMPTOMS FOLLOWING EGG EXPOSURE","authors":"S. Pawer , N. Yu , S. Jeimy , S. Erdle , T. Wong , V. Cook","doi":"10.1016/j.anai.2025.08.029","DOIUrl":"10.1016/j.anai.2025.08.029","url":null,"abstract":"<div><h3>Introduction</h3><div>Referrals for cutaneous symptoms following egg exposure are commonly received by pediatric allergists. At our community allergy clinic, 47% of food allergy referrals for 0–2-year-olds involve egg. Rather than traditional egg avoidance, the Canadian Egg Ladder facilitates reintroduction. We describe home egg ladder initiation in patients with cutaneous symptoms, to assess safety and potential to decrease allergist assessments.</div></div><div><h3>Methods</h3><div>From 2018–2025, 0–2-year-olds with isolated cutaneous symptoms began the egg ladder at home, without in-person allergist assessment. Caregivers were educated on initiation, and epinephrine autoinjectors were prescribed. Patients were reviewed every 3–6 months. Demographics, adverse reactions, and ladder progress were recorded. Descriptive statistics were analyzed in Excel. As quality improvement, this study was exempted from IRB approval.</div></div><div><h3>Results</h3><div>Of 116 patients who began the egg ladder, 84% (n=97) completed it. Median initiation age was 12 months (IQR 9–16); average completion time was 6 months (IQR 2–9). Twenty-five patients (22%) experienced adverse reactions, predominantly contact rashes (18/25; 72%). Six experienced grade 1 CoFAR reactions, two experienced grade 2 CoFAR reactions. No patients required epinephrine. Attrition rate was 8%; 7% transitioned to oral immunotherapy (5 ladder failure, 2 parental anxiety, 1 logistical burden). Based on egg tolerance by time of allergy assessment, ladder initiation by referring providers could have prevented 63% of allergy referrals.</div></div><div><h3>Conclusion</h3><div>This study supports safe, effective home initiation of the egg ladder for pediatric patients with isolated cutaneous symptoms after egg exposure. Implementing ladders in primary care may reduce unnecessary allergist referrals, shortening wait times and improving access for those requiring specialist care.</div></div>","PeriodicalId":50773,"journal":{"name":"Annals of Allergy Asthma & Immunology","volume":"135 5","pages":"Page S7"},"PeriodicalIF":4.7,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145442406","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}

引用次数: 0