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

CT-P39 COMPARED TO REFERENCE OMALIZUMAB IN PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA; 40-WEEK RESULTS 在慢性自发性荨麻疹患者中，ct-p39 与参考药物奥马珠单抗的比较；40 周结果

IF 5.8 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology

Pub Date : 2024-10-25 DOI: 10.1016/j.anai.2024.08.050

S. Saini , M. Maurer , Y. Dytyatkovska , E. Springer , M. Ratkova , S. Lee , J. Ka , C. Grattan

Introduction

CT-P39 is the first biosimilar to reference omalizumab (ref-OMA) approved in the European Union. Therapeutic equivalence and comparable safety, pharmacokinetics, and pharmacodynamics of CT-P39 to ref-OMA have been shown in patients with chronic spontaneous urticaria through 24-week results. Here, additional efficacy and safety data up to 40 weeks are presented.

Methods

Patients were randomized to receive 300 mg of CT-P39 (N=204) or ref-OMA (N=205) every 4 weeks. From Week 12, patients who received CT-P39 were continued on CT-P39 (N=187), and patients who received ref-OMA were re-randomized in a 1:1 ratio to switch to CT-P39 (N=96) or to continue ref-OMA (N=97). From Week 24, patients were followed up until Week 40 without dosing.

Results

The mean weekly itch-severity-scores and urticaria-activity-scores gradually decreased from the baseline during the treatment period, with similar levels among the treatment groups, and increased towards baseline during the off-dose follow-up period (Figure). The number of patients experiencing ≥1 treatment-emergent-adverse-events (TEAEs) up to Week 40 was similar across the treatment groups (84 [44.9%] in CT-P39 maintenance group, 48 [50.0%] in switched to CT-P39 from ref-OMA group, and 47 [49.0%] in ref-OMA maintenance group). Most TEAEs were grade 1 or 2 in intensity. The proportion of patients with positive anti-drug antibody results at each visit in each group was below 8%, and no clinical impact was observed.

Conclusion

CT-P39 showed comparable efficacy and safety to ref-OMA during both treatment and off-dose periods. A switch from ref-OMA to CT-P39 from Week 12 showed comparable efficacy and safety to continuing treatment with ref-OMA.

简介：CT-P39 是欧盟批准的首个参考药物奥马珠单抗（ref-OMA）的生物类似药。在慢性自发性荨麻疹患者中，CT-P39与ref-OMA的治疗等效性和可比安全性、药代动力学和药效学已通过24周的结果得到证实。方法患者被随机分配到每 4 周接受 300 毫克 CT-P39（204 人）或 ref-OMA（205 人）。从第12周开始，接受CT-P39治疗的患者继续接受CT-P39治疗（187人），接受ref-OMA治疗的患者按1:1的比例重新随机分配，转为接受CT-P39治疗（96人）或继续接受ref-OMA治疗（97人）。结果在治疗期间，每周平均瘙痒严重程度评分和荨麻疹活动评分从基线逐渐降低，各治疗组的评分水平相似，在停药随访期间，评分向基线升高（图）。截至第 40 周，各治疗组出现≥1 次治疗诱发不良事件（TEAEs）的患者人数相似（CT-P39 维持治疗组 84 [44.9%]，从 ref-OMA 转为 CT-P39 治疗组 48 [50.0%]，ref-OMA 维持治疗组 47 [49.0%]）。大多数 TEAEs 的强度为 1 级或 2 级。结论 CT-P39 在治疗和停药期间显示出与 ref-OMA 相当的疗效和安全性。从第12周开始从ref-OMA转用CT-P39，其疗效和安全性与继续使用ref-OMA相当。

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引用次数: 0

DISCREPANCIES IN ANAPHYLAXIS PROTOCOLS ACROSS EMERGENCY MEDICAL SERVICES IN THE UNITED STATES – OPPORTUNITIES FOR IMPROVEMENT 美国紧急医疗服务中过敏性休克治疗方案的差异 - 改进的机会

IF 5.8 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology

Pub Date : 2024-10-25 DOI: 10.1016/j.anai.2024.08.034

C. Gunderson , S. Lopez , K. Lukose , N. Akar-Ghibril

Introduction

Across the United States, there are significant inconsistencies in the protocols used by Emergency Medical Services (EMS) in the prehospital treatment of anaphylaxis. These discrepancies include variations in the definition of anaphylaxis as well as treatment recommendations. This study performed an analysis of statewide anaphylaxis protocols to identify gaps in the recognition of anaphylaxis and to provide areas for improvement in prehospital management.

Methods

States with mandatory or model state-wide ACLS protocols were included (total of 30). Each allergic reaction and/or anaphylaxis protocol was reviewed – emphasis was placed on the definitions used to identify reactions and treatment algorithms.

Results

Of the 30 states, only 50% (15) included gastrointestinal symptoms in the definition of anaphylaxis, and only 40% (12) included neurologic manifestations. 47% (14) used a two-organ system definition. For anaphylactic reactions, 100% (30) of protocols recommended diphenhydramine and epinephrine. 90% (27) recommended albuterol if respiratory symptoms were present, 73% (22) recommended intravenous fluids, and 60% (18) recommended steroids. Epinephrine was the first line recommendation for anaphylaxis in 97% (29) of protocols. 25 states (83%) allowed epinephrine autoinjectors and 17 (57%) provided autoinjectors.

Conclusion

Many EMS anaphylaxis protocols are incomplete and/or outdated. Surprisingly, many protocols do not consider gastrointestinal or neurologic manifestations. Additionally, many contain outdated recommendations, including the use of steroids and first-generation antihistamines. Despite the convenience of epinephrine autoinjectors, many protocols do not permit or provide them. Given the frequency of EMS activation for allergic reactions, our communities would benefit from standardized protocols using current evidence-based guidelines for the management of anaphylaxis.

导言在美国各地，急救医疗服务机构（EMS）在过敏性休克的院前治疗中使用的方案存在很大的不一致。这些差异包括过敏性休克定义和治疗建议的不同。本研究对全州范围内的过敏性休克协议进行了分析，以找出在识别过敏性休克方面存在的差距，并提供院前管理方面需要改进的地方。对每个过敏反应和/或过敏性休克协议都进行了审查--重点放在用于识别反应和治疗算法的定义上。结果在 30 个州中，只有 50% （15 个州）将胃肠道症状纳入过敏性休克的定义，只有 40% （12 个州）将神经系统表现纳入过敏性休克的定义。47%（14 个州）使用了双器官系统的定义。对于过敏性反应，100%（30 份）的方案建议使用苯海拉明和肾上腺素。如果出现呼吸道症状，90%（27 份）的方案建议使用沙丁胺醇，73%（22 份）的方案建议静脉输液，60%（18 份）的方案建议使用类固醇。在 97%（29 份）的方案中，肾上腺素是治疗过敏性休克的一线推荐药物。25 个州（83%）允许使用肾上腺素自动注射器，17 个州（57%）提供自动注射器。令人惊讶的是，许多方案并未考虑胃肠道或神经系统表现。此外，许多方案包含过时的建议，包括使用类固醇和第一代抗组胺药。尽管肾上腺素自动注射器非常方便，但许多方案都不允许或不提供肾上腺素自动注射器。鉴于因过敏反应而启动急救服务的频率很高，我们的社区将受益于使用当前循证指南管理过敏性休克的标准化规程。

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引用次数: 0

CHARACTERIZATION OF INJECTION SITE-RELATED ADVERSE EVENTS WITH GARADACIMAB IN PATIENTS WITH HEREDITARY ANGIOEDEMA 遗传性血管性水肿患者使用加拉达西单抗发生的注射部位相关不良事件的特征描述

IF 5.8 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology

Pub Date : 2024-10-25 DOI: 10.1016/j.anai.2024.08.121

J. Jacobs , M. Manning , A. Reshef , K. Yamagami , H. Shetty , J. Lawo , M. Pollen , F. Hsu

Introduction

Hereditary angioedema (HAE) is characterized by unpredictable, recurrent, and potentially life-threatening attacks. Garadacimab, a subcutaneous, once-monthly, fully human anti-activated factor XII monoclonal antibody in development for long-term prophylaxis (LTP), has demonstrated early and durable efficacy and favorable safety profile, and allowed most patients to achieve the HAE treatment goal of total disease control in clinical studies. Approved LTPs have demonstrated treatment-related injection-site reactions (e.g., pain, erythema, bruising). Patients have indicated a preference for new LTPs that reduce treatment burden. We characterize injection-site adverse events from the garadacimab Phase 3 clinical program.

Methods

Treatment-related injection-site reaction (ISR) data were analyzed from the pivotal Phase 3 (VANGUARD) and Phase 3 open-label extension (OLE) studies. Patient proportions, event numbers (E), and annualized rate (RY) data for ISRs were reported by study treatment group and preferred term within those groups.

Results

In the pivotal Phase 3 (VANGUARD) study (median garadacimab exposure: 5.98 months), 2/39 of garadacimab-treated patients (5.1%; E=3, RY=0.154) and 2/25 placebo-receiving patients (8.0%; E=2, RY=0.177) reported ISRs. Garadacimab-related ISRs were erythema, bruising, and pruritus (2.6% each; E=1, RY=0.051). Both placebo-related ISRs were erythema. In the Phase 3 OLE study (median garadacimab exposure: 13.8 months), 14/159 garadacimab-treated patients (8.8%; E=36, RY=0.195) reported ISRs – erythema (6.8%; E=14, RY=0.075), pruritus (2.5%; E=12, RY=0.065) and irritation (0.6%; E=1, RY=0.005; moderate, discontinuation at Month 6 upon patient decision).

Conclusion

In garadacimab Phase 3 studies, incidence of ISRs such as erythema, bruising and pruritus was low. The favorable injection-site tolerability with garadacimab may help reduce treatment burden during HAE LTP treatment.

导言遗传性血管性水肿（HAE）的特点是发作难以预测、反复发作并可能危及生命。加拉地单抗是一种皮下注射、每月一次的全人源抗活化因子 XII 单克隆抗体，目前正在开发用于长期预防（LTP），已证明具有早期、持久的疗效和良好的安全性，并使大多数患者在临床研究中实现了完全控制疾病的 HAE 治疗目标。已获批准的 LTPs 出现了与治疗相关的注射部位反应（如疼痛、红斑、瘀伤）。患者表示更青睐能减轻治疗负担的新型 LTP。我们分析了加拉达西单抗 3 期临床项目中注射部位不良事件的特征。方法分析了关键性 3 期（VANGUARD）和 3 期开放标签扩展（OLE）研究中与治疗相关的注射部位反应（ISR）数据。结果在关键的3期（VANGUARD）研究中（中位加拉达西单抗暴露期：5.98个月），2/39的加拉达西单抗治疗患者（5.1%；E=3，RY=0.154）和2/25的安慰剂接受患者（8.0%；E=2，RY=0.177）报告了ISR。加拉地单抗相关的 ISR 为红斑、瘀伤和瘙痒（各占 2.6%；E=1，RY=0.051）。安慰剂相关的 ISR 均为红斑。在 3 期 OLE 研究中（中位加拉达西单抗暴露时间：13.8 个月），14/159 名加拉达西单抗治疗患者（8.8%；E=36，RY=0.195）报告了 ISRs--红斑（6.8%；E=14，RY=0.075）、瘙痒（2.5%；E=12，RY=0.结论在加拉地单抗 3 期研究中，红斑、瘀斑和瘙痒等 ISR 的发生率较低。加拉单抗良好的注射部位耐受性可能有助于减轻HAE LTP治疗期间的治疗负担。

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引用次数: 0

SHIFTING PERSPECTIVES: DIPHENHYDRAMINE USAGE IN ANAPHYLAXIS AND URTICARIA ACROSS UNITED STATES EMERGENCY DEPARTMENTS 转变视角：美国急诊科在过敏性休克和荨麻疹中使用苯海拉明的情况

IF 5.8 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology

Pub Date : 2024-10-25 DOI: 10.1016/j.anai.2024.08.061

J. Ifikhar, D. Sparks, A. Hendrix-Dicken, M. Hartwell, M. Condren

Introduction

In recent years, there has been a notable shift in the medical community's perspective regarding the use of diphenhydramine for allergic reactions, specifically for urticaria and anaphylaxis, stemming from its side effect profile and superior efficacy of second-generation antihistamines. Notably, the AAAAI's updated 2020 anaphylaxis guidelines recommended against use of first-generation antihistamines in the acute phase or to prevent biphasic reactions. Our study aimed to assess diphenhydramine utilization in US emergency departments (EDs) for anaphylaxis and urticaria from 2019 to 2021.

Methods

We conducted a cross-sectional study using data from the 2019-2021 National Hospital Ambulatory Medical Care Survey (NHAMCS) for patient visits to emergency departments. We analyzed individuals with ICD-10 codes for anaphylaxis (T78) and/or urticaria (L50) who received at least one medication. The NHAMCS is conducted by the CDC and includes demographics, reasons for visits, diagnoses, treatments, and outcomes. Significance was determined using design-based Pearson chi-square with P<0.050.

Results

Of 450 anaphylaxis and/or urticaria cases, 276 involved diphenhydramine use which after sampling weights were applied represented 62.0% of cases. Diphenhydramine administration rates were 58.0% for anaphylaxis alone, 69.5% for urticaria alone, and 73.4% for individuals presenting with both conditions. No significant change in diphenhydramine use was observed from 2019 to 2021 (P=0.9421).

Conclusion

Despite emerging evidence and evolving clinical guidelines regarding diphenhydramine use, our findings suggest no discernible changes in ED practices post-AAAAI updates. Moving forward, bridging this gap between evidence-based guidelines and clinical practice is imperative for enhancing patient care and ensuring adherence of evolving standards in urticaria and anaphylaxis management.

导言近年来，由于苯海拉明的副作用和第二代抗组胺药的卓越疗效，医学界对使用苯海拉明治疗过敏反应（尤其是荨麻疹和过敏性休克）的观点发生了明显转变。值得注意的是，美国过敏性休克协会（AAAAI）更新的2020年过敏性休克指南建议在急性期或预防双相反应时不要使用第一代抗组胺药。我们的研究旨在评估2019年至2021年美国急诊科（ED）对过敏性休克和荨麻疹使用苯海拉明的情况。方法我们利用2019年至2021年全国医院非住院医疗护理调查（NHAMCS）中急诊科就诊患者的数据进行了一项横断面研究。我们分析了ICD-10编码为过敏性休克（T78）和/或荨麻疹（L50）且至少接受过一次药物治疗的患者。NHAMCS 由美国疾病预防控制中心（CDC）实施，包括人口统计学、就诊原因、诊断、治疗和结果。结果在 450 例过敏性休克和/或荨麻疹病例中，有 276 例使用了苯海拉明，在应用抽样权重后，占病例总数的 62.0%。仅过敏性休克患者使用苯海拉明的比例为 58.0%，仅荨麻疹患者使用苯海拉明的比例为 69.5%，同时出现两种情况的患者使用苯海拉明的比例为 73.4%。从 2019 年到 2021 年，苯海拉明的使用没有发生明显变化（P=0.9421）。结论尽管有关苯海拉明使用的证据不断涌现，临床指南也在不断发展，但我们的研究结果表明，AAAAI 更新后，急诊室的做法没有发生明显变化。展望未来，缩小循证指南与临床实践之间的差距对于加强患者护理、确保遵守荨麻疹和过敏性休克管理方面不断发展的标准至关重要。

{"title":"SHIFTING PERSPECTIVES: DIPHENHYDRAMINE USAGE IN ANAPHYLAXIS AND URTICARIA ACROSS UNITED STATES EMERGENCY DEPARTMENTS","authors":"J. Ifikhar, D. Sparks, A. Hendrix-Dicken, M. Hartwell, M. Condren","doi":"10.1016/j.anai.2024.08.061","DOIUrl":"10.1016/j.anai.2024.08.061","url":null,"abstract":"<div><h3>Introduction</h3><div>In recent years, there has been a notable shift in the medical community's perspective regarding the use of diphenhydramine for allergic reactions, specifically for urticaria and anaphylaxis, stemming from its side effect profile and superior efficacy of second-generation antihistamines. Notably, the AAAAI's updated 2020 anaphylaxis guidelines recommended against use of first-generation antihistamines in the acute phase or to prevent biphasic reactions. Our study aimed to assess diphenhydramine utilization in US emergency departments (EDs) for anaphylaxis and urticaria from 2019 to 2021.</div></div><div><h3>Methods</h3><div>We conducted a cross-sectional study using data from the 2019-2021 National Hospital Ambulatory Medical Care Survey (NHAMCS) for patient visits to emergency departments. We analyzed individuals with ICD-10 codes for anaphylaxis (T78) and/or urticaria (L50) who received at least one medication. The NHAMCS is conducted by the CDC and includes demographics, reasons for visits, diagnoses, treatments, and outcomes. Significance was determined using design-based Pearson chi-square with P<0.050.</div></div><div><h3>Results</h3><div>Of 450 anaphylaxis and/or urticaria cases, 276 involved diphenhydramine use which after sampling weights were applied represented 62.0% of cases. Diphenhydramine administration rates were 58.0% for anaphylaxis alone, 69.5% for urticaria alone, and 73.4% for individuals presenting with both conditions. No significant change in diphenhydramine use was observed from 2019 to 2021 (P=0.9421).</div></div><div><h3>Conclusion</h3><div>Despite emerging evidence and evolving clinical guidelines regarding diphenhydramine use, our findings suggest no discernible changes in ED practices post-AAAAI updates. Moving forward, bridging this gap between evidence-based guidelines and clinical practice is imperative for enhancing patient care and ensuring adherence of evolving standards in urticaria and anaphylaxis management.</div></div>","PeriodicalId":50773,"journal":{"name":"Annals of Allergy Asthma & Immunology","volume":"133 6","pages":"Page S11"},"PeriodicalIF":5.8,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142529378","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

DERMATOGRAPHISM MAY BE AN UNRECOGNIZED FEATURE OF SERUM SICKNESS-LIKE REACTION 皮纹症可能是血清病样反应的一个未被发现的特征

IF 5.8 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology

Pub Date : 2024-10-25 DOI: 10.1016/j.anai.2024.08.062

A. Suara-Istanbouli, E. Fernandez, C. Stone, A. Norton

Introduction

Serum sickness-like reaction (SSLR) is a syndrome characterized by urticarial-like rash with arthralgia/arthritis. Oral drug challenge is recommended in patients with a history of SSLR to antibiotics. Some studies have reported immediate reactions upon challenge. Previous studies stated that the presence of dermatographism excludes the diagnosis of SSLR. Identifying dermatographism in SSLR patients at time of oral challenge is vital to avoid mislabeling dermatographic urticaria as an immediate drug reaction.

Methods

We reviewed patients with SSLR history who presented to clinic between February 2022 to January 2024. Data collected included age, sex, the antibiotic implicated, and the presence of dermatographism on physical exam.

Results

Of the 24 patients identified with a history of SSLR, 71% were male, with a median age of 2. The implicated antibiotics included amoxicillin (54%), amoxicillin-clavulanic acid (8%), and cefdinir (38%). 100% of patients tolerated graded oral challenge. On physical exam, 17 of the 24 patients with SSLR had dermatographism, accounting for 71% of the cases. The previously published rate of dermatographism in the general-pediatric population is reported to be 24%. Using a two-sided test of proportion, we found the rate of dermatographism in our cohort was significantly higher compared to the previously published rate in the general-pediatric population (p<0.001).

Conclusion

We identified that dermatographism at time of oral challenge is an exam feature associated with SSLR. If reproduced in future studies, this association may redefine SSLR criteria, suggest underlying pathophysiology, or serve as important information to avoid misclassifying minor cutaneous symptoms as drug allergy after oral challenge.

导言皮肤病样反应（SSLR）是一种以荨麻疹样皮疹伴关节痛/关节炎为特征的综合征。建议对有抗生素血清病样反应病史的患者进行口服药物挑战。一些研究报告称，挑战后会立即出现反应。以前的研究指出，出现皮疹可排除 SSLR 的诊断。我们回顾了 2022 年 2 月至 2024 年 1 月期间就诊的有 SSLR 病史的患者。结果在24名有SSLR病史的患者中，71%为男性，中位年龄为2岁，涉及的抗生素包括阿莫西林（54%）、阿莫西林-克拉维酸（8%）和头孢地尼（38%）。100%的患者都能耐受分级口服挑战。体格检查结果显示，24 名 SSLR 患者中有 17 人患有皮炎，占病例总数的 71%。据报道，此前公布的普通儿科人群皮纹增多率为 24%。通过双侧比例检验，我们发现与之前公布的普通儿科人群皮纹增多率相比，我们的队列中皮纹增多率明显更高（p<0.001）。如果这种关联在今后的研究中得以重现，则可能重新定义 SSLR 标准，提示潜在的病理生理学，或作为重要的信息，避免在口服药物后将轻微的皮肤症状误诊为药物过敏。

{"title":"DERMATOGRAPHISM MAY BE AN UNRECOGNIZED FEATURE OF SERUM SICKNESS-LIKE REACTION","authors":"A. Suara-Istanbouli, E. Fernandez, C. Stone, A. Norton","doi":"10.1016/j.anai.2024.08.062","DOIUrl":"10.1016/j.anai.2024.08.062","url":null,"abstract":"<div><h3>Introduction</h3><div>Serum sickness-like reaction (SSLR) is a syndrome characterized by urticarial-like rash with arthralgia/arthritis. Oral drug challenge is recommended in patients with a history of SSLR to antibiotics. Some studies have reported immediate reactions upon challenge. Previous studies stated that the presence of dermatographism excludes the diagnosis of SSLR. Identifying dermatographism in SSLR patients at time of oral challenge is vital to avoid mislabeling dermatographic urticaria as an immediate drug reaction.</div></div><div><h3>Methods</h3><div>We reviewed patients with SSLR history who presented to clinic between February 2022 to January 2024. Data collected included age, sex, the antibiotic implicated, and the presence of dermatographism on physical exam.</div></div><div><h3>Results</h3><div>Of the 24 patients identified with a history of SSLR, 71% were male, with a median age of 2. The implicated antibiotics included amoxicillin (54%), amoxicillin-clavulanic acid (8%), and cefdinir (38%). 100% of patients tolerated graded oral challenge. On physical exam, 17 of the 24 patients with SSLR had dermatographism, accounting for 71% of the cases. The previously published rate of dermatographism in the general-pediatric population is reported to be 24%. Using a two-sided test of proportion, we found the rate of dermatographism in our cohort was significantly higher compared to the previously published rate in the general-pediatric population (p<0.001).</div></div><div><h3>Conclusion</h3><div>We identified that dermatographism at time of oral challenge is an exam feature associated with SSLR. If reproduced in future studies, this association may redefine SSLR criteria, suggest underlying pathophysiology, or serve as important information to avoid misclassifying minor cutaneous symptoms as drug allergy after oral challenge.</div></div>","PeriodicalId":50773,"journal":{"name":"Annals of Allergy Asthma & Immunology","volume":"133 6","pages":"Pages S11-S12"},"PeriodicalIF":5.8,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142529379","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

CLINICAL VALIDATION OF THE SPECIALIZED PARTICULATE CONTROL ENVIRONMENTAL EXPOSURE UNIT (SPAC-EEU) FOR CAT DANDER EXPOSURE 专用微粒控制环境暴露单元（SPAC-EEU）对猫皮屑暴露的临床验证

IF 5.8 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology

Pub Date : 2024-10-25 DOI: 10.1016/j.anai.2024.08.079

L. Hossenbaccus, S. Garvey, T. Walker, H. Botting, L. Steacy, A. Ellis

Introduction

The Specialized Particulate Control Environmental Exposure Unit (SPaC-EEU) is a controlled allergen challenge facility that has recently undergone a successful technical validation for cat dander exposure, specifically Felis domesticus 1 (Fel d 1). We subsequently performed a clinical validation with cat-allergic and non-allergic participants.

Methods

Recruited participants attended a screening visit where eligibility was assessed. Successfully screened cat-allergic and non-allergic participants subsequently attended one of two 3-hour cat dander exposure sessions in the SPaC-EEU. Fel d 1 concentrations were determined using a Fel d 1-specific ELISA. Participants recorded symptom scores at 18 timepoints, between baseline and 24 hours post-onset of allergen exposure.

Results

Forty-five participants completed this study, 31 cat-allergics and 15 non-allergics. Twenty-five participants attended first session (median Fel d 1=36.1 ng/m³) and 21 participants attended second session (median Fel d 1=102.0 ng/m³). Total nasal symptom scores (TNSS) for allergic participants in both sessions were not significantly different (p<0.05) at any timepoint, hence results were combined. Allergic participants had significantly increased (p<0.01) TNSS at all timepoints, from 15 minutes to 24 hours post-exposure, compared to non-allergics. Peak nasal inspiratory flow as percent change from baseline was significantly decreased (p<0.05) for allergics compared to non-allergics from 1.0 to 2.5 hours. No clinically significant safety outcomes were reported in either session.

Conclusion

The SPaC-EEU can safely produce clinically relevant and meaningful nasal symptoms in only cat-allergic participants. We have proven that this facility is an effective and reliable clinical model for cat allergen-induced allergic rhinitis.

导言专用微粒控制环境暴露装置（SPaC-EEU）是一种受控过敏原挑战设施，最近成功通过了猫皮屑（特别是家猫皮屑 1（Fel d 1））暴露的技术验证。我们随后对对猫过敏和不过敏的参与者进行了临床验证。通过筛查的猫过敏者和非过敏者随后参加了在 SPaC-EEU 进行的两个 3 小时猫皮屑暴露疗程中的一个疗程。使用 Fel d 1 特异性酶联免疫吸附法测定 Fel d 1 的浓度。参与者在 18 个时间点（从基线到接触过敏原后 24 小时）记录症状评分。结果45 名参与者完成了这项研究，其中 31 名猫过敏者，15 名非过敏者。25 名参与者参加了第一次治疗（中位数 Fel d 1=36.1 纳克/立方米），21 名参与者参加了第二次治疗（中位数 Fel d 1=102.0 纳克/立方米）。在两个疗程中，过敏性参与者的鼻部症状总分（TNSS）在任何时间点都没有显著差异（p<0.05），因此结果合并计算。与非过敏者相比，过敏者在暴露后 15 分钟至 24 小时的所有时间点上的 TNSS 都明显增加（p<0.01）。从 1.0 小时到 2.5 小时，与非过敏者相比，过敏者的峰值鼻吸气流量（与基线相比的百分比变化）明显下降（p<0.05）。结论 SPaC-EEU 可以安全地在对猫过敏的参与者中产生临床相关和有意义的鼻部症状。我们已经证明，该设备是猫过敏原诱发过敏性鼻炎的有效、可靠的临床模型。

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引用次数: 0

ADHERENCE AND PERSISTENCE AMONG HEREDITARY ANGIOEDEMA PATIENTS TREATED WITH BEROTRALSTAT, LANADELUMAB, AND SUBCUTANEOUS PLASMA-DERIVED C1-INHIBITOR 遗传性血管性水肿患者接受 berotralstat、lanadelumab 和皮下血浆源性 c1 抑制剂治疗的依从性和持续性

IF 5.8 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology

Pub Date : 2024-10-25 DOI: 10.1016/j.anai.2024.08.103

B. Zuraw , L. Lopez-Gonzalez , I. Winer , A. Dean , J. Manjelievskaia , S. Nestler-Parr , P. Gillard , S. Christiansen

Introduction

Berotralstat is a novel, targeted oral long-term prophylactic (LTP) treatment for hereditary angioedema (HAE). Real-world evidence comparing WAO/EAACI recommended first-line HAE LTP therapies is limited. We investigated adherence and persistence following initiation of berotralstat, lanadelumab, and subcutaneous plasma-derived C1-inhibitor (SC-pdC1-INH).

Methods

Veradigm Health Network EHR linked to claims data was utilized to select mutually exclusive cohorts of patients ≥12 years initiating one of the three LTPs between 06/22/2017-09/12/2023. Inclusion criteria also included ≥12 months continuous enrollment before and following date of initiation of LTP. Analysis: demographics, clinical characteristics, LTP adherence and persistence. Adherence was defined as the mean proportion of days covered (PDC). Persistence was defined as having no gap in treatment ≥ 45 days after the index LTP. Sensitivity analyses were conducted requiring at least 2 claims for the index LTP.

Results

Included subjects: 90 berotralstat, 189 lanadelumab, and 78 SC-pdC1-INH. Berotralstat patients were older (mean age 44) than lanadelumab (39) and SC-pdC1-INH (36) cohorts (p-value <0.025). >90% had an HAE diagnosis in the baseline period and 46-51% were LTP treatment experienced. Mean PDC was similar between treatments at 0.73, 0.78, and 0.74 for berotralstat, lanadelumab, and SC-pdC1-INH, respectively (p-value=NS). Proportion of patients persistent on index LTP at 12-months follow-up was also similar across LTPs: 61% for berotralstat compared to 58% for lanadelumab (58%) and 53% for SC-pdC1-INH (p-value=NS).

Conclusions

HAE patient adherence and persistence rates for all three LTP treatments are uniformly high. Berotralstat adherence and persistence were comparable to those observed following lanadelumab or SC-pdC1-INH initiation.

简介：Berotralstat 是治疗遗传性血管性水肿 (HAE) 的一种新型、有针对性的口服长期预防 (LTP) 疗法。比较WAO/EAACI推荐的一线HAE LTP疗法的真实世界证据非常有限。我们调查了贝罗曲司他(berotralstat)、拉那度单抗(lanadelumab)和皮下血浆源性C1抑制剂(SC-pdC1-INH)开始治疗后的依从性和持续性。方法利用与理赔数据相连的Veradigm Health Network EHR，选择在6/22/2017-09/12/2023期间开始接受三种LTP之一治疗的≥12岁患者组成相互排斥的队列。纳入标准还包括在开始 LTP 日期之前和之后连续注册≥12 个月。分析：人口统计学、临床特征、LTP依从性和持续性。依从性定义为平均覆盖天数比例（PDC）。持续性的定义是在开始 LTP 后的 45 天内没有中断治疗。进行敏感性分析时，要求指数 LTP 至少有 2 次索赔：结果包括 90 名 Berotralstat 患者、189 名 lanadelumab 患者和 78 名 SC-pdC1-INH 患者。贝罗曲星患者的年龄（平均 44 岁）高于 lanadelumab（39 岁）和 SC-pdC1-INH（36 岁）（P 值为 0.025）。>90% 的患者在基线期诊断为 HAE，46-51% 的患者有 LTP 治疗经验。berotralstat、lanadelumab和SC-pdC1-INH三种治疗方法的平均PDC相似，分别为0.73、0.78和0.74（p值=NS）。在随访12个月时，坚持指数LTP的患者比例在各种LTP中也很相似：berotralstat为61%，而lanadelumab为58%（58%），SC-pdC1-INH为53%（p值=NS）。Berotralstat 的依从性和持续率与开始使用 lanadelumab 或 SC-pdC1-INH 后观察到的情况相当。

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引用次数: 0

QUALITY OF LIFE AND BURDEN OF DISEASE IN PATIENTS WITH HEREDITARY ANGIOEDEMA AND THEIR CAREGIVERS 遗传性血管性水肿患者及其护理人员的生活质量和疾病负担

IF 5.8 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology

Pub Date : 2024-10-25 DOI: 10.1016/j.anai.2024.08.108

D. Levy , F. Nagase , A. Cheung , M. Manning

Introduction

Hereditary angioedema (HAE) is characterized by recurrent and unpredictable episodes of angioedema. This targeted literature review assessed the burden of disease experienced in HAE patients and their caregivers.

Methods

In January 2024, a search strategy was implemented in Medline and Embase with additional conference abstract screening, using key terms for HAE and burden. Studies describing burden of disease among adults with HAE Type 1 and 2 were included, prioritizing North American and European studies.

Results

A total of 1,975 abstracts were screened for relevance, of which 48 studies met eligibility criteria and were included for analysis. HAE patients had lower quality of life (QoL) than the general population, associated with increased attack frequency, attack severity, depression and anxiety. Anxiety and depression were largely driven by societal perceptions and disease burden, with constant fear of laryngeal attacks. Consistent long-term prophylaxis (LTP) has been shown to alleviate anxiety and depression and improve QoL, compared to no treatment or only on-demand treatment. Uncontrolled attacks and adverse effects were common reasons for treatment discontinuation. Caregiver burden was profoundly influenced by the severity and unpredictability of HAE symptoms, diagnosis delays and negative healthcare provider interactions.

Conclusions

HAE patients and caregivers bear a heavy disease burden, driven by the severity, frequency, location, and unpredictability of attacks. Because of their symptoms, patients experience poor QoL and high psychological distress, the latter of which could also trigger HAE attacks. To improve QoL patients seek LTP that provide less frequent dosing, fewer attacks and less side effects.

导言遗传性血管性水肿（HAE）的特点是反复发作且无法预测。本篇有针对性的文献综述评估了 HAE 患者及其护理人员的疾病负担。方法 2024 年 1 月，我们在 Medline 和 Embase 中使用 HAE 和负担这两个关键词实施了检索策略，并对会议摘要进行了额外筛选。结果共筛选出 1,975 篇相关摘要，其中 48 篇符合资格标准并纳入分析。HAE患者的生活质量（QoL）低于普通人群，与发作频率、发作严重程度、抑郁和焦虑增加有关。焦虑和抑郁在很大程度上是由社会观念和疾病负担以及对喉部疾病发作的持续恐惧造成的。与不治疗或仅按需治疗相比，坚持长期预防（LTP）已被证明可减轻焦虑和抑郁，改善 QoL。无法控制的发作和不良反应是中断治疗的常见原因。HAE症状的严重性和不可预测性、诊断延迟和医疗服务提供者的负面互动对照顾者的负担产生了深远影响。由于其症状，患者的生活质量差，心理压力大，后者也可能诱发 HAE 发作。为了改善患者的生活质量，他们寻求用药次数少、发作次数少、副作用小的 LTP。

{"title":"QUALITY OF LIFE AND BURDEN OF DISEASE IN PATIENTS WITH HEREDITARY ANGIOEDEMA AND THEIR CAREGIVERS","authors":"D. Levy , F. Nagase , A. Cheung , M. Manning","doi":"10.1016/j.anai.2024.08.108","DOIUrl":"10.1016/j.anai.2024.08.108","url":null,"abstract":"<div><h3>Introduction</h3><div>Hereditary angioedema (HAE) is characterized by recurrent and unpredictable episodes of angioedema. This targeted literature review assessed the burden of disease experienced in HAE patients and their caregivers.</div></div><div><h3>Methods</h3><div>In January 2024, a search strategy was implemented in Medline and Embase with additional conference abstract screening, using key terms for HAE and burden. Studies describing burden of disease among adults with HAE Type 1 and 2 were included, prioritizing North American and European studies.</div></div><div><h3>Results</h3><div>A total of 1,975 abstracts were screened for relevance, of which 48 studies met eligibility criteria and were included for analysis. HAE patients had lower quality of life (QoL) than the general population, associated with increased attack frequency, attack severity, depression and anxiety. Anxiety and depression were largely driven by societal perceptions and disease burden, with constant fear of laryngeal attacks. Consistent long-term prophylaxis (LTP) has been shown to alleviate anxiety and depression and improve QoL, compared to no treatment or only on-demand treatment. Uncontrolled attacks and adverse effects were common reasons for treatment discontinuation. Caregiver burden was profoundly influenced by the severity and unpredictability of HAE symptoms, diagnosis delays and negative healthcare provider interactions.</div></div><div><h3>Conclusions</h3><div>HAE patients and caregivers bear a heavy disease burden, driven by the severity, frequency, location, and unpredictability of attacks. Because of their symptoms, patients experience poor QoL and high psychological distress, the latter of which could also trigger HAE attacks. To improve QoL patients seek LTP that provide less frequent dosing, fewer attacks and less side effects.</div></div>","PeriodicalId":50773,"journal":{"name":"Annals of Allergy Asthma & Immunology","volume":"133 6","pages":"Page S26"},"PeriodicalIF":5.8,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142529627","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

DEVELOPMENT OF A NOVEL KININ BIOMARKER ASSAY FOR CHARACTERISATION OF BRADYKININ-MEDIATED DISORDERS 开发一种新型激肽生物标志物测定法，以确定缓激肽介导的疾病的特征

IF 5.8 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology

Pub Date : 2024-10-25 DOI: 10.1016/j.anai.2024.08.119

E. Pardali , O. Domenig , D. Sexton , G. Zahn , A. Lessage

Introduction

Bradykinin (BK) is involved in various physiological and pathological processes, including angioedema (AE). AE is a predominant manifestation in multiple medical conditions and is generally mediated by BK and/or by histamine. Differentiating BK-mediated from histamine-mediated AE and assessing the role of bradykinin in the pathogenesis of other conditions by measuring kinins remains a challenge. Establishment of a method to accurately measure kinins could aid in identifying, studying, and managing BK-mediated disorders.

Methods

To inhibit ex vivo activation of kallikrein-kinin system (KKS) proteases and degradation of kinins, a protease inhibitor cocktail was developed. An ultra-high performance liquid chromatography-mass spectrometry (UPLC)-MS/MS protocol was optimized to measure BK1-9, BK1-8, BK1-7, BK1-5, and kallidin. Qualification of the UPLC-MS/MS was performed using plasma from healthy volunteers (HV) collected using PI or ethylenediaminetetraacetic acid (EDTA).

Results

The UPLC-MS/MS assay underwent qualification to assess the efficacy of the protease inhibitor cocktail. The range of quantification was 5 to 10,240 pg/mL for BK1-9, BK1-8, BK1-7 and BK1-5 and 20 to 10,240 pg/mL for kallidin. Analysis of the results revealed that kallidin levels were below limit of quantification in HV plasma. BK peptide levels were significantly lower in HV plasma collected using protease inhibitor cocktail vs EDTA. Protease inhibitor cocktail cocktail efficiently inhibited KKS activation and stabilized kinin peptides following 2 freeze and thaw cycles.

Conclusions

The developed BK assay can be used to reliably measure kinin peptides and could become a key tool for identifying, studying, and managing BK-mediated pathologies, including AE.

导言缓激肽（BK）参与各种生理和病理过程，包括血管性水肿（AE）。血管性水肿是多种疾病的主要表现，通常由缓激肽和/或组胺介导。通过测量激肽来区分缓激肽介导的血管性水肿和组胺介导的血管性水肿，以及评估缓激肽在其他疾病发病机制中的作用，仍然是一项挑战。为了抑制体内外激肽-激肽系统（KKS）蛋白酶的激活和激肽的降解，我们开发了一种蛋白酶抑制剂鸡尾酒。优化了超高效液相色谱-质谱（UPLC）-MS/MS 方案，以测量 BK1-9、BK1-8、BK1-7、BK1-5 和 kallidin。使用 PI 或乙二胺四乙酸（EDTA）收集的健康志愿者（HV）血浆对 UPLC-MS/MS 进行了鉴定。BK1-9、BK1-8、BK1-7 和 BK1-5 的定量范围为 5 至 10,240 pg/mL，Kallidin 的定量范围为 20 至 10,240 pg/mL。分析结果显示，HV 血浆中的凯利丁水平低于定量限。在使用蛋白酶抑制剂鸡尾酒和 EDTA 收集的 HV 血浆中，BK 肽水平明显低于 EDTA。结论：所开发的 BK 检测方法可用于可靠地检测激肽，并可成为识别、研究和管理 BK 介导的病症（包括 AE）的重要工具。

{"title":"DEVELOPMENT OF A NOVEL KININ BIOMARKER ASSAY FOR CHARACTERISATION OF BRADYKININ-MEDIATED DISORDERS","authors":"E. Pardali , O. Domenig , D. Sexton , G. Zahn , A. Lessage","doi":"10.1016/j.anai.2024.08.119","DOIUrl":"10.1016/j.anai.2024.08.119","url":null,"abstract":"<div><h3>Introduction</h3><div>Bradykinin (BK) is involved in various physiological and pathological processes, including angioedema (AE). AE is a predominant manifestation in multiple medical conditions and is generally mediated by BK and/or by histamine. Differentiating BK-mediated from histamine-mediated AE and assessing the role of bradykinin in the pathogenesis of other conditions by measuring kinins remains a challenge. Establishment of a method to accurately measure kinins could aid in identifying, studying, and managing BK-mediated disorders.</div></div><div><h3>Methods</h3><div>To inhibit ex vivo activation of kallikrein-kinin system (KKS) proteases and degradation of kinins, a protease inhibitor cocktail was developed. An ultra-high performance liquid chromatography-mass spectrometry (UPLC)-MS/MS protocol was optimized to measure BK1-9, BK1-8, BK1-7, BK1-5, and kallidin. Qualification of the UPLC-MS/MS was performed using plasma from healthy volunteers (HV) collected using PI or ethylenediaminetetraacetic acid (EDTA).</div></div><div><h3>Results</h3><div>The UPLC-MS/MS assay underwent qualification to assess the efficacy of the protease inhibitor cocktail. The range of quantification was 5 to 10,240 pg/mL for BK1-9, BK1-8, BK1-7 and BK1-5 and 20 to 10,240 pg/mL for kallidin. Analysis of the results revealed that kallidin levels were below limit of quantification in HV plasma. BK peptide levels were significantly lower in HV plasma collected using protease inhibitor cocktail vs EDTA. Protease inhibitor cocktail cocktail efficiently inhibited KKS activation and stabilized kinin peptides following 2 freeze and thaw cycles.</div></div><div><h3>Conclusions</h3><div>The developed BK assay can be used to reliably measure kinin peptides and could become a key tool for identifying, studying, and managing BK-mediated pathologies, including AE.</div></div>","PeriodicalId":50773,"journal":{"name":"Annals of Allergy Asthma & Immunology","volume":"133 6","pages":"Page S30"},"PeriodicalIF":5.8,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142529570","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

IMPROVING THE QUALITY OF CARE FOR PATIENTS WITH CSU: STUDY DESIGN AND PATIENT BASELINE CHARACTERISTICS 提高对 CU 患者的护理质量：研究设计和患者基线特征

IF 5.8 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology

Pub Date : 2024-10-25 DOI: 10.1016/j.anai.2024.08.110

G. Mosnaim , J. Bernstein , M. Holden , D. Lang , S. Mehlis , S. Saini , E. Schafer , M. Maurer

Introduction

Management and care of patients with chronic spontaneous urticaria (CSU) is not always optimal, with diagnostic delays, dissatisfaction with care, and lack of adherence to international guidelines all impacting CSU management. Here, we propose a real-world study design to develop a greater understanding of factors affecting the management of CSU, with the goal of improving the quality of care for patients.

Methods

In Part 1 of the study, retrospective analysis will be conducted on longitudinal patient data (2012 to 2022) from the Endeavor Health System electronic medical record (EMR) to identify patient risk factors for CSU severity, duration, and relapse, as well as predictors of treatment response for CSU. In Part 2, physicians will be interviewed to assess their knowledge and perceptions of CSU guidelines and management and use of patient-reported outcomes. In Part 3, quality improvement initiatives will be developed, including education for physicians and new clinical workflows and decision tools for CSU management.

Results

For Part 1 of the study, baseline characteristics of patients with CSU from the Endeavor Health System EMR are presented in the Table. Over two-thirds of patients were female with a mean age of 35 years. The most common comorbidities were allergic rhinitis and asthma. About 40% of patients visited a physician with an allergy/immunology primary specialty.

Conclusions

A greater understanding of patient characteristics, physician perspectives, and avenues to improve quality of care will assist physicians in providing better care for patients with CSU and will ultimately improve clinical outcomes and quality of life for patients.

导言慢性自发性荨麻疹（CSU）患者的管理和护理并不总是尽如人意，诊断延误、对护理不满意以及不遵守国际指南都会影响 CSU 的管理。方法在研究的第一部分，我们将对奋进医疗系统电子病历（EMR）中的患者纵向数据（2012 年至 2022 年）进行回顾性分析，以确定 CSU 严重程度、持续时间和复发的患者风险因素，以及 CSU 治疗反应的预测因素。在第 2 部分中，将对医生进行访谈，以评估他们对 CSU 指南和管理的了解和看法，以及患者报告结果的使用情况。在第 3 部分中，将制定质量改进措施，包括对医生的教育、新的临床工作流程和 CSU 管理决策工具。结果在研究的第 1 部分中，表中列出了 Endeavor Health System EMR 中 CSU 患者的基线特征。超过三分之二的患者为女性，平均年龄为 35 岁。最常见的合并症是过敏性鼻炎和哮喘。结论更深入地了解患者特征、医生观点和提高护理质量的途径将有助于医生为 CSU 患者提供更好的护理，并最终改善临床疗效和患者的生活质量。

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引用次数: 0