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Evaluation of a disease-state education program in asthma: Application of the Knowledge-to-Action Framework.
IF 2.6 3区 医学 Q2 ALLERGY Pub Date : 2025-01-27 DOI: 10.2500/aap.2025.46.240112
Nazrin Yusufova, Ileen A Gilbert, Frank Trudo, Theodore Barlows, Scott Salvato, Omar Motawakel, James M Eudicone, Kevin R Murphy

Background: In patients with asthma, bronchoconstriction and airway inflammation both contribute to airway narrowing and airflow limitations, which lead to symptoms and exacerbations. Short-acting beta 2-agonist (SABA)-only rescue therapy addresses only bronchoconstriction and is associated with increased morbidity and mortality. Current asthma management guidelines recommend concomitant treatment of symptoms and inflammation with a fast-acting bronchodilator and inhaled corticosteroid (ICS) as rescue therapy for patients 12 years of age. However, there is an education and outreach gap for the wider adoption of anti-inflammatory rescue therapy in clinical practice.

Objective: AstraZeneca has developed an education program for health-care practitioners (HCPs) based on a Knowledge-to-Action Framework, with the aim of increasing HCPs' understanding of key disease-state concepts related to evidence-basedmanagement of asthma.

Methods: A multichannel, evidence-based education program was presented at medical conferences across the United States between December 2022 and December 2023. Before and after each event, attendees were asked to complete a survey that rated their agreement with six disease-state concepts on a five-point Likert scale. These concepts related to the role of airway inflammation, fluctuations in inflammation, SABA and ICS therapy, and the risk of exacerbations.Postevent responses to the survey were assessed relative to pre-event responses and longitudinally over 12 months by using calculated odds ratios and 95% confidence intervals. Acceptance and/or understanding of a concept was defined as a rating of "agree" or "strongly agree" from at least 80% of respondents.

Results: The proportion of respondents who agreed or strongly agreed with each concept was significantly higher postevent versus pre-event (p < 0.001). The 80% acceptance and/or understanding threshold was surpassed for all concepts after the event.

Conclusion: The medical education program improved understanding and/or acceptance of key disease-state concepts related to asthma management among participating HCPs. Effective communication of disease management concepts may lead to improved patient health outcomes through more rapid acceptance of guideline-recommended medical therapies.

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引用次数: 0
Perioperative anaphylaxis manifesting as cardiac arrest during cardiac surgery. 围手术期过敏反应表现为心脏手术期间心脏骤停。
IF 2.6 3区 医学 Q2 ALLERGY Pub Date : 2025-01-01 DOI: 10.2500/aap.2025.46.240082
Valerie Jaroenpuntaruk, Gerald W Volcheck

Perioperative anaphylaxis is a serious entity with high morbidity and mortality. Perioperative anaphylaxis can be caused by any of the multitude of medications and substances used in anesthesia and surgery, and the most common causes include neuromuscular blocking agents, antibiotics, antiseptics, latex, and dyes. The differential diagnosis of perioperative anaphylaxis is wide from both an immunologic and a nonimmunologic standpoint. The majority of the intraoperative anaphylaxis reactions are thought to be immunoglobulin E (IgE) mediated; however, other primary non-IgE-mediated mechanisms can also be present. Clinical manifestations can vary from mild cutaneous exanthema to cardiac arrest. Tryptase can be helpful in identifying perioperative anaphylaxis. In this article, we present the case of a 75-year-old man who had a cardiac arrest without skin symptoms perioperatively during coronary artery bypass surgery. We describe the presentation, strategic evaluation, and subsequent management with recommendations for future surgery based on his evaluation and the identified culprit. Subsequent surgery was later completed. Understanding the clinical presentation, key components of testing, and recommendations for future management of perioperative anaphylaxis are invaluable skills that the allergist can provide for the patient and the anesthesia and surgery teams.

围手术期过敏反应是一种严重的疾病,发病率和死亡率都很高。围手术期过敏反应可由麻醉和手术中使用的多种药物和物质引起,最常见的原因包括神经肌肉阻滞剂、抗生素、防腐剂、乳胶和染料。围手术期过敏反应的鉴别诊断从免疫学和非免疫学的角度来看都很广泛。大多数术中过敏反应被认为是免疫球蛋白E (IgE)介导的;然而,其他非ige介导的主要机制也可能存在。临床表现从轻微的皮肤小疹到心脏骤停不等。胰蛋白酶可以帮助识别围手术期过敏反应。在这篇文章中,我们报告了一例75岁的男性在冠状动脉搭桥手术期间心脏骤停而无皮肤症状的病例。我们描述的表现,战略评估,和后续的管理建议,未来的手术基于他的评估和确定的罪魁祸首。随后的手术完成。了解临床表现,测试的关键组成部分,以及对围手术期过敏反应的未来管理的建议是过敏症专科医生可以为患者和麻醉和手术团队提供的宝贵技能。
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引用次数: 0
Management of hereditary angioedema attacks by patients on long-term prophylaxis versus on-demand therapy only. 遗传性血管性水肿发作患者长期预防治疗与按需治疗的对比。
IF 2.6 3区 医学 Q2 ALLERGY Pub Date : 2025-01-01 Epub Date: 2024-11-25 DOI: 10.2500/aap.2025.46.240096
William R Lumry, Anete S Grumach, Stephen D Betschel, Cristine Radojicic, Sally van Kooten, Markus Heckmann, Sherry Danese, Neil Malloy, Ledia Goga, Mar Guilarte

Background: Despite the use of long-term prophylaxis (LTP) for hereditary angioedema (HAE), the risk of having an attack remains and patients with HAE and on LTP may still experience attacks that can be life threatening. However, the behavioral patterns and perspectives surrounding HAE attack management by patients on LTP are not fully understood. Objective: This survey aimed to better understand and compare the behavioral patterns and perspectives, including attitudes and perceptions associated with on-demand treatment among patients on LTP versus those using on-demand therapy only. Methods: People living with HAE were recruited by the US Hereditary Angioedema Association to complete a 20-minute online survey between September 6 and October 19, 2022. Participants were stratified by treatment (50% using LTP [+on-demand therapy], 50% on-demand therapy only). Results: Respondents included 107 patients with HAE (mean age, 41 years [range, 16-83 years]). Patients using LTP reported treating a mean ± standard deviation 84.8% ± 23.8% of their HAE attacks compared with a mean ± standard deviation 75.6% ± 27.5% for patients with on-demand only treatment. Similar percentages of patients on LTP versus patients on-demand only reported always carrying on-demand treatment when away from home (35% versus 38%) and modifying their daily lives to minimize the occurrence of HAE attacks, which included avoiding potential triggers (42.9% versus 45.5%). Conclusion: Although patients on LTP treat a higher percentage of their attacks compared with patients with on-demand only treatment, both groups reported similar behaviors in terms of carrying on-demand treatment when away from home and modifying their daily lives to minimize the occurrence of HAE attacks. These findings highlight the importance of understanding patient perspectives and behaviors in the management of HAE.

背景:尽管对遗传性血管性水肿(HAE)采用了长期预防疗法(LTP),但发作的风险依然存在,接受 LTP 治疗的 HAE 患者仍有可能发作,危及生命。然而,人们对接受 LTP 治疗的 HAE 患者在处理 HAE 发作时的行为模式和观点尚未完全了解:本调查旨在更好地了解和比较接受 LTP 治疗的患者与仅接受按需治疗的患者的行为模式和观点,包括与按需治疗相关的态度和认知:美国遗传性血管性水肿协会招募了 HAE 患者,让他们在 2022 年 9 月 6 日至 10 月 19 日期间完成一项 20 分钟的在线调查。参与者按治疗方法进行分层(50%使用LTP[+按需治疗],50%仅使用按需治疗):受访者包括 107 名 HAE 患者(平均年龄 41 岁 [范围 16-83 岁])。使用 LTP 治疗的患者平均+/-标准差为 84.8% +/- 23.8%,而仅按需治疗的患者平均+/-标准差为 75.6% +/- 27.5%。与按需治疗的患者相比,接受LTP治疗的患者表示离家时始终携带按需治疗药物(35%对38%),并表示会调整日常生活以尽量减少HAE发作,包括避免潜在的诱发因素(42.9%对45.5%):尽管接受 LTP 治疗的患者与仅接受按需治疗的患者相比,其发作比例更高,但两组患者在外出时按需治疗和调整日常生活以尽量减少 HAE 发作方面的行为相似。这些发现凸显了了解患者在治疗 HAE 过程中的观点和行为的重要性。
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引用次数: 0
Atopic dermatitis: Best of guidelines and yardstick. 特应性皮炎:最好的指南和标准。
IF 2.6 3区 医学 Q2 ALLERGY Pub Date : 2025-01-01 DOI: 10.2500/aap.2025.46.240087
Mark Boguniewicz

Background: Atopic dermatitis (AD), a common chronic inflammatory skin disorder is characterized by a complex pathology with skin-barrier abnormalities, immune dysregulation, and microbial dysbiosis. Patients' quality of life is often negatively impacted by persistent pruritus, sleep disturbance, and recurrent skin infections. In addition, patients may have comorbid atopic as well as nonatopic diseases. Objective: The objective was to help clinicians better manage AD by using new therapies and new indications, including a topical (Janus kinase [JAK]) inhibitor as well as monoclonal antibodies and oral JAK inhibitors, have been approved for AD. Methods: This review presents highlights from the American College of Allergy, Asthma and Immunology AD Yardstick Update, which incorporates Expert Commentary, and from the Joint Task Force (JTF) AD 2023 Guidelines that use Grading of Recommendations, Assessment, Development, and Evaluation methodology. Results: Practical pearls from the AD Yardstick Update Expert Commentary are presented, along with results from systematic reviews and meta-analyses that addressed specific recommendations on the role of (1) dilute bleach baths, (2) dietary avoidance and/or elimination diets, (3) allergen immunotherapy, (4) topical treatments, and (5) systemic treatments, informing the JTF 2023 AD Guidelines. These guidelines are noteworthy for addressing patient values and preferences. Conclusion: The AD Yardstick Update Expert Commentary and JTF 2023 AD Guidelines provide timely, practical, and trustworthy information to help clinicians manage patients with AD.

背景:特应性皮炎(AD)是一种常见的慢性炎症性皮肤病,其病理复杂,包括皮肤屏障异常、免疫失调和微生物生态失调。患者的生活质量经常受到持续瘙痒、睡眠障碍和反复皮肤感染的负面影响。此外,患者可能同时患有特应性和非特应性疾病。目的:目的是通过使用新疗法和新适应症帮助临床医生更好地管理AD,包括外用(Janus激酶[JAK])抑制剂以及单克隆抗体和口服JAK抑制剂,已被批准用于AD。方法:本综述介绍了美国过敏、哮喘和免疫学学院AD标准更新的亮点,其中包括专家评论,以及联合工作组(JTF) AD 2023指南,该指南使用分级推荐、评估、开发和评估方法。结果:本文提出了AD标准更新专家评论中的实用要点,以及系统综述和荟萃分析的结果,这些结果涉及(1)稀释漂白剂浴、(2)饮食避免和/或消除饮食、(3)过敏原免疫疗法、(4)局部治疗和(5)全身治疗的具体建议,为JTF 2023 AD指南提供了信息。这些指南对于解决患者的价值和偏好是值得注意的。结论:AD标准更新专家评论和JTF 2023 AD指南为临床医生管理AD患者提供了及时、实用和可信的信息。
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引用次数: 0
Appraisal of the evidence linking hereditary α-tryptasemia with mast cell disorders, hypermobility and dysautonomia. 遗传性α-胰蛋白酶血症与肥大细胞疾病、运动亢进和自主神经异常相关证据的评估。
IF 2.6 3区 医学 Q2 ALLERGY Pub Date : 2025-01-01 DOI: 10.2500/aap.2025.46.240088
Jonathan J Lyons

Since its first description more than a decade ago, our understanding of the clinical impact of hereditary alpha-tryptasemia has continued to evolve. First considered to be a genetic disorder with a subset of patients having a syndromic presentation composed of connective tissue abnormalities, symptoms of autonomic dysfunction, and findings of mast cell activation, we now know that hereditary alpha-tryptasemia is a common genetic trait and modifier of mast cell-mediated reactions. More recent studies have shown some previously held associations with congenital hypermobility and postural orthostatic tachycardia syndrome (POTS) to be lacking, and illuminated previously unappreciated associations with clonal and nonclonal mast cell disorders. With the discovery of heterotetrameric tryptases and demonstration of their unique functional activities, the importance of tryptase gene composition in general has begun to take focus. Hereditary alpha-tryptasemia exists at the end of a spectrum of alpha-tryptase expression and as a natural overexpression model of this protein, brought to the fore the potential of tryptase genotyping as a genetic biomarker for anaphylaxis severity. These data and future studies hold the promise of enhancing our understanding of the role that tryptases play in health and disease.

自十多年前首次描述以来,我们对遗传性α -胰蛋白酶血症临床影响的理解不断发展。最初被认为是一种遗传性疾病,有一部分患者具有结缔组织异常、自主神经功能障碍症状和肥大细胞激活的综合征表现,我们现在知道遗传性α -胰蛋白酶血症是一种常见的遗传性状和肥大细胞介导反应的修饰因子。最近的研究表明,一些先前认为的与先天性运动过度和体位性心动过速综合征(POTS)的关联是缺乏的,并阐明了以前未被认识到的与克隆和非克隆肥大细胞疾病的关联。随着异四聚体胰蛋白酶的发现和其独特功能活性的证明,胰蛋白酶基因组成的重要性开始受到关注。遗传性α -胰蛋白酶血症存在于α -胰蛋白酶表达谱的末端,并作为该蛋白的自然过表达模型,将胰蛋白酶基因分型作为过敏反应严重程度的遗传生物标志物的潜力摆在了前面。这些数据和未来的研究有望增强我们对胰蛋白酶在健康和疾病中所起作用的理解。
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引用次数: 0
Allergen immunotherapy: How to stay current with USP 797 and practice guidelines. 过敏原免疫治疗:如何跟上USP 797和实践指南。
IF 2.6 3区 医学 Q2 ALLERGY Pub Date : 2025-01-01 DOI: 10.2500/aap.2025.46.240078
Maureen M Petersen

Background: The United States Pharmacopeia (USP) Chapter 797 provides critical standards for compounding sterile preparations to ensure patient safety and medication efficacy. The latest revision, effective November 1, 2023, introduces updates particularly relevant to the compounding of allergenic extracts, which emphasizes stringent compliance measures. Objective: This article aims to review the key updates to USP Chapter 797, outline the compliance requirements for personnel and facilities, and offer strategies for staying current with these practice guidelines, leveraging resources from professional organizations such as American College of Allergy, Asthma, and Immunology and American Academy of Allergy, Asthma, and Immunology. Methods: An extensive review of the updated USP Chapter 797 guidelines was conducted, along with supplementary research from professional resources and literature to provide a comprehensive overview of the new standards and best practices for compliance. Results: The updated USP Chapter 797 mandates comprehensive training and competency testing for compounding personnel, facility maintenance and documentation standards, and robust quality assurance protocols to minimize contamination and ensure the efficacy of compounded allergenic extracts. Key requirements include enhanced personnel hygiene and garbing requirements, facility maintenance protocols, and detailed documentation practices. Conclusion: Staying current with USP Chapter 797 and practice guidelines is crucial for allergists and immunotherapy practitioners to ensure high standards of patient care and safety. By understanding the key updates, complying with personnel and facility requirements, leveraging professional resources, and adopting standardized practices, health-care providers can effectively navigate the evolving regulatory landscape. Continuous education and adherence to quality assurance protocols will further support compliance and enhance patient outcomes in allergen immunotherapy.

背景:美国药典(USP)第797章提供了配制无菌制剂的关键标准,以确保患者安全和药物疗效。最新修订于2023年11月1日生效,引入了特别与致敏提取物合成相关的更新,强调了严格的合规措施。目的:本文旨在回顾美国药典第797章的关键更新,概述人员和设施的合规性要求,并提供保持这些实践指南最新的策略,利用专业组织的资源,如美国过敏、哮喘和免疫学学院和美国过敏、哮喘和免疫学学会。方法:对更新的USP第797章指南进行了广泛的审查,并从专业资源和文献中进行了补充研究,以提供对新标准和合规最佳实践的全面概述。结果:更新后的USP第797章要求对配药人员进行全面的培训和能力测试,设备维护和文件标准,以及强有力的质量保证协议,以尽量减少污染并确保配药致敏提取物的有效性。主要要求包括加强人员卫生和着装要求,设施维护协议和详细的文件实践。结论:紧跟USP第797章和实践指南对于过敏症专家和免疫治疗从业者来说是至关重要的,以确保高标准的患者护理和安全。通过了解关键更新、遵守人员和设施要求、利用专业资源并采用标准化实践,医疗保健提供者可以有效地驾驭不断变化的监管环境。持续的教育和对质量保证协议的遵守将进一步支持依从性,并提高患者对过敏原免疫治疗的疗效。
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引用次数: 0
Health disparities investigated in a primary care penicillin allergy removal pathway. 初级保健青霉素过敏清除途径中健康差异的调查。
IF 2.6 3区 医学 Q2 ALLERGY Pub Date : 2025-01-01 DOI: 10.2500/aap.2025.46.240079
David Mari, Kelley Henson, William Day, Andrea Mcglynn, Taylor Banks

Background: Unconfirmed penicillin allergies over time lead to poor health outcomes and increased health-care cost. Health disparities (HD) can create barriers in optimizing penicillin allergy care. Objective: The objective was to characterize HDs in our primary care-led amoxicillin challenge (PLAC) delabeling pathway within a universal coverage health care system. Methods: In three outpatient clinic sites, 41,104 patients were screened, and 1,749 patients were discovered to have penicillin allergies. Of the 1,749 patients with penicillin allergy, 336 (ages 4 months to 76 years) were determined to be candidates for PLAC. A retrospective chart review was completed after 1 year of PLAC implementation to compare demographic characteristics and HD core categories (neighborhood living type, economic stability, background education status, and access to care) between those who completed and those who did not complete their PLAC appointment. All candidates underwent the same PLAC protocol and had universal health coverage that reduced health cost. Results: Of 336 PLAC candidates (45.8%), 154 presented for their PLAC appointment and had their penicillin allergy removed without adverse outcomes. One hundred and eighty-two candidates (54.2%) did not complete a PLAC appointment and retained their penicillin allergy label. Candidates who did not complete their PLAC appointment were older (p = 0.001) and white (p = 0.006), and did not identify as officers (p = 0.04). There was no significant difference in neighborhood type or gender between the groups. In candidates ages ≥ 19 years, those without proactively scheduled appointments more commonly (p < 0.001) did not complete their PLAC appointment; whereas proactive scheduling increased delabeling from 5.8% to 91.3% in candidates ages ≥ 19 years. Of the 199 candidates with proactively scheduled PLAC appointments, those with less perceived economic stability and background education status (enlisted members) were more likely not to attend their PLAC appointment (p < 0.001). Conclusion: Results of our study suggest that our PLAC protocol provides a foundation of decreased HDs to successfully delabel patients at low risk of penicillin allergy when scheduling appointments for all and controlling for health-care cost.

背景:未经证实的青霉素过敏随着时间的推移会导致不良的健康结果和医疗保健费用的增加。健康差异(HD)可能在优化青霉素过敏护理方面造成障碍。目的:目的是表征我们的初级保健主导的阿莫西林挑战(placc)去标签途径在全民覆盖的卫生保健系统中的hd。方法:在3个门诊点对41104例患者进行筛查,发现青霉素过敏患者1749例。在1749例青霉素过敏患者中,336例(年龄4个月至76岁)被确定为PLAC的候选患者。在PLAC实施一年后完成了回顾性图表审查,以比较完成和未完成PLAC预约的人群的人口特征和HD核心类别(社区生活类型、经济稳定性、背景教育状况和获得护理的机会)。所有候选人都接受了相同的placc方案,并享有全民健康保险,从而降低了医疗成本。结果:在336名placc候选人(45.8%)中,154人接受了placc预约,并在没有不良后果的情况下消除了青霉素过敏。182名患者(54.2%)未完成placc预约并保留青霉素过敏标签。未完成placc任命的候选人年龄较大(p = 0.001),白人(p = 0.006),并且不认为自己是官员(p = 0.04)。两组间邻里类型和性别无显著差异。在年龄≥19岁的候选人中,那些没有预先安排预约的人更常见(p < 0.001)没有完成他们的placc预约;而在年龄≥19岁的患者中,主动计划使去标签率从5.8%增加到91.3%。在199名预先安排了placc预约的候选人中,那些认为经济稳定性和背景教育状况较差的人(入伍成员)更有可能不参加他们的placc预约(p < 0.001)。结论:我们的研究结果表明,我们的PLAC方案为降低HDs提供了基础,在安排所有人的预约和控制医疗保健成本时,可以成功地为低风险的青霉素过敏患者去标签。
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引用次数: 0
Idiopathic non-mast cell angioedema: Treatment insights from global experts. 特发性非肥大细胞血管性水肿:全球专家的治疗见解。
IF 2.6 3区 医学 Q2 ALLERGY Pub Date : 2025-01-01 DOI: 10.2500/aap.2025.46.240091
Sandra C Christiansen, Bruce L Zuraw

Background: Idiopathic non-mast cell angioedema (INMA) is a rare disease typified by recurrent attacks of cutaneous and subcutaneous swelling. Every attack carries the potential for severe morbidity and, in the case of laryngeal involvement, mortality. Whereas therapies approved for hereditary angioedema (HAE) have been used in the care of patients with INMA, little is known with regard to their efficacy for the treatment of this disease. Objective: The objective was to gather evidence from global experts, ranking their assessment of on-demand therapy (ODT) and long-term prophylactic (LTP) treatment efficacy for INMA. Methods: A survey was developed and distributed to international experts invited to attend a 2023 symposium. INMA was diagnosed by standardized criteria. Linkert scales were used to rate the efficacy for ODT and LTP therapy. Enrollment was closed after 1 month and the data were analyzed. Results: Surveys were distributed to 31 experts from 16 countries with a 77% response rate (n = 24) reporting on 300 patients with INMA. Efficacy rankings of ODT were the following: icatibant (14 experts with 93 treated patients), 46.2% high and 38.7% moderate; and plasma-derived C1 inhibitor (C1INH) (13 experts with 31 treated patients), 32.3% moderate and 45.2% mild. Efficacy rankings of LTP were the following: antifibrinolytics (11 experts with 52 treated patients), 23.1% high and 38.5% moderate; lanadelumab (5 experts with 19 treated patients), 21% high and 79% moderate; and subcutaneous C1INH (3 experts with 19 treated patients), 21.1% moderate and 79.0% mild. LTP efficacy was also recorded for berotralstat and progestin. Conclusion: Icatibant (ODT) and either antifibrinolytics or lanadelumab (LTP) were ranked as the most efficacious treatments for the patients with INMA (among medications with at least five treated patients) by the expert physicians. Progestins, berotralstat, and plasma derived C1INH each demonstrated a favorable prophylactic effect; however, broader experience will be required to formulate overall recommendations.

背景:特发性非肥大细胞血管性水肿(INMA)是一种罕见的疾病,以反复发作的皮肤和皮下肿胀为特征。每次发作都有可能导致严重的发病率,在喉部受累的情况下,可能导致死亡。尽管已批准用于遗传性血管性水肿(HAE)的治疗方法已用于INMA患者的护理,但对其治疗该病的疗效知之甚少。目的:目的是收集来自全球专家的证据,对他们对INMA的按需治疗(ODT)和长期预防(LTP)治疗效果的评估进行排名。方法:对受邀参加2023年研讨会的国际专家进行问卷调查。通过标准化标准诊断INMA。采用Linkert量表评价ODT和LTP治疗的疗效。1个月后停止入组,并对数据进行分析。结果:来自16个国家的31位专家对300例INMA患者进行了问卷调查,应答率为77% (n = 24)。ODT疗效排名:伊卡止咳(14名专家93例),高46.2%,中38.7%;血浆源性C1抑制剂(C1INH)(13位专家,31例治疗患者),中度32.3%,轻度45.2%。LTP疗效排名如下:抗纤溶药物(11名专家,52例患者),高效23.1%,中效38.5%;Lanadelumab(5名专家,19名接受治疗的患者),21%高,79%中;皮下C1INH(专家3人,治疗患者19例),中度21.1%,轻度79.0%。贝曲司他和黄体酮的LTP疗效也被记录。结论:依卡替班特(ODT)和抗纤溶药物或lanadelumab (LTP)被专家医师评为治疗INMA患者最有效的治疗方法(至少有5例患者接受治疗的药物)。黄体酮、贝曲司他和血浆源性C1INH均显示出良好的预防作用;但是,需要更广泛的经验来拟订通盘建议。
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引用次数: 0
Real-world surveillance of standardized quality (SQ) house dust mite sublingual immunotherapy tablets for 3 years in Japan. 在日本对标准化质量(SQ)屋尘螨舌下免疫治疗片进行了3年的实际监测。
IF 2.6 3区 医学 Q2 ALLERGY Pub Date : 2025-01-01 DOI: 10.2500/aap.2025.46.240092
Minoru Gotoh, Yuriko Maekawa, Shiori Saito, Noboru Kato, Eiji Horikawa, Noriaki Nishino

Background: Standardized quality (SQ) house-dust mite (HDM) sublingual immunotherapy tablets (10,000 Japanese allergy units [JAU], equivalent to 6 SQ-HDM in Europe and the United States) are licensed for the treatment of HDM-induced allergic rhinitis (AR) without age restriction, based on 52-week administration clinical trials. There are no large-scale data on the administration of 10,000 JAU for > 1 year in actual clinical practice. Objective: To examine the safety and effectiveness of 10,000 JAU during use for up to 3 years at real-world clinical sites in Japan. Methods: This survey was a multicenter, observational, prospective study. We assessed the safety and effectiveness of the long-term administration of 10,000 JAU as well as effectiveness after its discontinuation in patients with HDM AR with an observation period of 3 years. Results: The safety analysis included 815 patients, and the effectiveness analysis included 768 patients. Adverse reactions that occurred in 144 patients (17.67%) were mainly site-related events that occurred early in the dosing period. Serious adverse reactions were dyspnea and anaphylactic reaction in one patient each, and both patients recovered. With regard to effectiveness, compared with scores before the administration of SQ-HDM, nasal symptom scores decreased, depending on the administration period, from 6 months to 3 years. Overall, 67.34% of the patients had improved quality of life after 6 months, and this improvement continued after 12 months. The proportion of patients with "improved and slightly improved" of overall improvement exceeded 90% after 2 years. Treatment discontinuation because "symptoms disappeared" occurred in 24.42% of the patients at 3 years. Patients who discontinued 10,000 JAU (n = 39) had a sustained improvement in nasal symptom scores compared with baseline, even 1 year after discontinuing treatment. Conclusion: The real-world safety and effectiveness of 10,000 JAU SQ-HDM sublingual immunotherapy tablets were confirmed in Japanese patients with HDM AR. No new safety and effectiveness precautions were required.

背景:基于52周给药临床试验,标准化质量(SQ)屋尘螨(HDM)舌下免疫治疗片(10,000日本过敏单位[JAU],相当于欧洲和美国的6 SQ-HDM)获准用于治疗HDM诱导的变应性鼻炎(AR),不受年龄限制。在实际的临床实践中,并没有10000 JAU长达100年的大规模数据。目的:在日本真实世界的临床试验中,研究10000 JAU在长达3年的使用期间的安全性和有效性。方法:本研究为多中心、观察性、前瞻性研究。我们评估了长期服用10,000 JAU的安全性和有效性,以及HDM AR患者停药后的有效性,观察期为3年。结果:安全性分析纳入815例,有效性分析纳入768例。144例(17.67%)患者的不良反应主要发生在给药期早期的部位相关事件。严重不良反应为呼吸困难、过敏反应各1例,均痊愈。在疗效方面,与给予SQ-HDM前的评分相比,根据给药时间的不同,鼻症状评分从6个月到3年不等。总体而言,67.34%的患者在6个月后生活质量得到改善,这种改善在12个月后仍在继续。2年后总体改善“改善和略改善”的患者比例超过90%。3年时,因“症状消失”而停止治疗的患者占24.42%。停止10000 JAU治疗的患者(n = 39)在停止治疗1年后,与基线相比,鼻症状评分持续改善。结论:10000 JAU SQ-HDM舌下免疫治疗片在日本HDM AR患者的实际安全性和有效性得到证实,无需新的安全性和有效性注意事项。
{"title":"Real-world surveillance of standardized quality (SQ) house dust mite sublingual immunotherapy tablets for 3 years in Japan.","authors":"Minoru Gotoh, Yuriko Maekawa, Shiori Saito, Noboru Kato, Eiji Horikawa, Noriaki Nishino","doi":"10.2500/aap.2025.46.240092","DOIUrl":"10.2500/aap.2025.46.240092","url":null,"abstract":"<p><p><b>Background:</b> Standardized quality (SQ) house-dust mite (HDM) sublingual immunotherapy tablets (10,000 Japanese allergy units [JAU], equivalent to 6 SQ-HDM in Europe and the United States) are licensed for the treatment of HDM-induced allergic rhinitis (AR) without age restriction, based on 52-week administration clinical trials. There are no large-scale data on the administration of 10,000 JAU for > 1 year in actual clinical practice. <b>Objective:</b> To examine the safety and effectiveness of 10,000 JAU during use for up to 3 years at real-world clinical sites in Japan. <b>Methods:</b> This survey was a multicenter, observational, prospective study. We assessed the safety and effectiveness of the long-term administration of 10,000 JAU as well as effectiveness after its discontinuation in patients with HDM AR with an observation period of 3 years. <b>Results:</b> The safety analysis included 815 patients, and the effectiveness analysis included 768 patients. Adverse reactions that occurred in 144 patients (17.67%) were mainly site-related events that occurred early in the dosing period. Serious adverse reactions were dyspnea and anaphylactic reaction in one patient each, and both patients recovered. With regard to effectiveness, compared with scores before the administration of SQ-HDM, nasal symptom scores decreased, depending on the administration period, from 6 months to 3 years. Overall, 67.34% of the patients had improved quality of life after 6 months, and this improvement continued after 12 months. The proportion of patients with \"improved and slightly improved\" of overall improvement exceeded 90% after 2 years. Treatment discontinuation because \"symptoms disappeared\" occurred in 24.42% of the patients at 3 years. Patients who discontinued 10,000 JAU (<i>n</i> = 39) had a sustained improvement in nasal symptom scores compared with baseline, even 1 year after discontinuing treatment. <b>Conclusion:</b> The real-world safety and effectiveness of 10,000 JAU SQ-HDM sublingual immunotherapy tablets were confirmed in Japanese patients with HDM AR. No new safety and effectiveness precautions were required.</p>","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"46 1","pages":"59-69"},"PeriodicalIF":2.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142908989","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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 remission in patients with severe eosinophilic asthma treated with mepolizumab: A post-hoc analysis of RELIght study. mepolizumab治疗严重嗜酸性哮喘患者的临床缓解:一项RELIght研究的事后分析
IF 2.6 3区 医学 Q2 ALLERGY Pub Date : 2025-01-01 DOI: 10.2500/aap.2025.46.240084
Andriana I Papaioannou, Maria Kallieri, Eleftherios Zervas, Evangelia Fouka, Konstantinos Porpodis, Marija Hadji Mitrova, Eleni Tzortzaki, Michael Makris, Maria Ntakoula, Panagiotis Lyberopoulos, Katerina Dimakou, Sofia Koukidou, Sevasti Ampelioti, Anastasia Papaporfyriou, Konstantinos Katsoulis, Maria Kipourou, Nikoletta Rovina, Katerina Antoniou, Stylianos Vittorakis, Petros Bakakos, Paschalis Steiropoulos, Katerina Markopoulou, Panteleimon Avarlis, Ιlias C Papanikolaou, Miltiadis Markatos, Eleni Gaki, Konstantinos Samitas, Konstantinos Glynos, Spyros A Papiris, Despoina Papakosta, Nikolaos Tzanakis, Mina Gaga, Konstantinos Kostikas, Stelios Loukides

Background: Remission of asthma can occur as part of the natural history of the disease; however, the use of biologics can result in disease remission in some patients. Objective: In this post hoc analysis of the RELIght study, we aimed to evaluate clinical remission in real life among patients treated with mepolizumab, to detect possible differences between "remitters" and "nonremitters," and to evaluate possible predictors of remission. Methods: Clinical remission was defined as the absence of asthma exacerbations, discontinuation of oral corticosteroids (OCS), achievement of asthma control (Asthma Control Test [ACT] ≥ 20), and stable or improved lung function. Results: A total of 146 patients were evaluated; remission was achieved in 40 (27.4%) and 29 (22%) after 12 and 24 months, respectively. At 12 months, the patients in remission had a better baseline ACT score (17.0 [14.0-19.0] versus 15.0 [12.0-17.0]; p = 0.027), were more rarely using OCS (35% versus 62.2%; p = 0.004), and required a lower baseline dose of OCS (5.0 mg/day [5.0-10.0 mg/day] versus 10.0 mg/day [5.0-15.0 mg/day]; p = 0.042) at baseline, whereas, at 24 months, they less frequently carried a baseline diagnosis of gastroesophageal reflux disease (GERD) (10.3% versus 32%; p = 0.031) and used lower doses of OCS at baseline (5.0 [1.0-5.0] versus 10.0 [5.0-15.0]; p = ≤0.001) versus nonremitters; 52.5% of patients had sustained remission, whereas 42.5% experienced relapse. These patients more frequently had GERD versus patients with sustained remission (52.9% versus 4.8%; p = 0.002). Finally, regression analysis has shown that GERD was the only predictor of relapse. Conclusion: Remitters had better asthma control and needed lower doses or no maintenance OCS at baseline, whereas GERD seems to be an important factor that affects remission and relapse.Clinical trial NCT04084613, www.clinical trials.gov.

背景:哮喘缓解可以作为疾病自然病程的一部分发生;然而,在一些患者中,使用生物制剂可以导致疾病缓解。目的:在这项RELIght研究的事后分析中,我们旨在评估接受mepolizumab治疗的患者在现实生活中的临床缓解,检测“缓解者”和“非缓解者”之间可能的差异,并评估缓解的可能预测因素。方法:临床缓解定义为没有哮喘加重,停止口服皮质类固醇(OCS),实现哮喘控制(哮喘控制试验[ACT]≥20),肺功能稳定或改善。结果:共评估146例患者;12个月后缓解40例(27.4%),24个月后缓解29例(22%)。12个月时,缓解期患者的基线ACT评分更高(17.0 [14.0-19.0]vs . 15.0 [12.0-17.0];p = 0.027),很少使用OCS(35%对62.2%;p = 0.004),并且需要较低的OCS基线剂量(5.0 mg/天[5.0-10.0 mg/天]vs . 10.0 mg/天[5.0-15.0 mg/天];p = 0.042),而在24个月时,他们较少进行胃食管反流病(GERD)的基线诊断(10.3%对32%;p = 0.031),并在基线时使用较低剂量的OCS(5.0[1.0-5.0]对10.0 [5.0-15.0];P =≤0.001)与非汇款者;52.5%的患者持续缓解,而42.5%的患者复发。与持续缓解的患者相比,这些患者更频繁地发生胃食管反流(52.9% vs 4.8%;p = 0.002)。最后,回归分析显示GERD是复发的唯一预测因子。结论:缓解者有较好的哮喘控制,需要较低的剂量或在基线时不需要维持OCS,而GERD似乎是影响缓解和复发的重要因素。临床试验NCT04084613, www.clinical trials.gov。
{"title":"Clinical remission in patients with severe eosinophilic asthma treated with mepolizumab: A <i>post-hoc</i> analysis of RELIght study.","authors":"Andriana I Papaioannou, Maria Kallieri, Eleftherios Zervas, Evangelia Fouka, Konstantinos Porpodis, Marija Hadji Mitrova, Eleni Tzortzaki, Michael Makris, Maria Ntakoula, Panagiotis Lyberopoulos, Katerina Dimakou, Sofia Koukidou, Sevasti Ampelioti, Anastasia Papaporfyriou, Konstantinos Katsoulis, Maria Kipourou, Nikoletta Rovina, Katerina Antoniou, Stylianos Vittorakis, Petros Bakakos, Paschalis Steiropoulos, Katerina Markopoulou, Panteleimon Avarlis, Ιlias C Papanikolaou, Miltiadis Markatos, Eleni Gaki, Konstantinos Samitas, Konstantinos Glynos, Spyros A Papiris, Despoina Papakosta, Nikolaos Tzanakis, Mina Gaga, Konstantinos Kostikas, Stelios Loukides","doi":"10.2500/aap.2025.46.240084","DOIUrl":"https://doi.org/10.2500/aap.2025.46.240084","url":null,"abstract":"<p><p><b>Background:</b> Remission of asthma can occur as part of the natural history of the disease; however, the use of biologics can result in disease remission in some patients. <b>Objective:</b> In this post hoc analysis of the RELIght study, we aimed to evaluate clinical remission in real life among patients treated with mepolizumab, to detect possible differences between \"remitters\" and \"nonremitters,\" and to evaluate possible predictors of remission. <b>Methods:</b> Clinical remission was defined as the absence of asthma exacerbations, discontinuation of oral corticosteroids (OCS), achievement of asthma control (Asthma Control Test [ACT] ≥ 20), and stable or improved lung function. <b>Results:</b> A total of 146 patients were evaluated; remission was achieved in 40 (27.4%) and 29 (22%) after 12 and 24 months, respectively. At 12 months, the patients in remission had a better baseline ACT score (17.0 [14.0-19.0] versus 15.0 [12.0-17.0]; p = 0.027), were more rarely using OCS (35% versus 62.2%; p = 0.004), and required a lower baseline dose of OCS (5.0 mg/day [5.0-10.0 mg/day] versus 10.0 mg/day [5.0-15.0 mg/day]; p = 0.042) at baseline, whereas, at 24 months, they less frequently carried a baseline diagnosis of gastroesophageal reflux disease (GERD) (10.3% versus 32%; p = 0.031) and used lower doses of OCS at baseline (5.0 [1.0-5.0] versus 10.0 [5.0-15.0]; p = ≤0.001) versus nonremitters; 52.5% of patients had sustained remission, whereas 42.5% experienced relapse. These patients more frequently had GERD versus patients with sustained remission (52.9% versus 4.8%; p = 0.002). Finally, regression analysis has shown that GERD was the only predictor of relapse. <b>Conclusion:</b> Remitters had better asthma control and needed lower doses or no maintenance OCS at baseline, whereas GERD seems to be an important factor that affects remission and relapse.Clinical trial NCT04084613, <ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"uri\" xlink:href=\"http://www.clinical trials.gov\">www.clinical trials.gov</ext-link>.</p>","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"46 1","pages":"45-51"},"PeriodicalIF":2.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142908837","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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Allergy and asthma proceedings
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