Pub Date : 2024-08-22DOI: 10.1016/j.jaip.2024.08.030
Mark Kosinski, Linda M Nelson, Richard H Stanford, Julie D Flom, Michael Schatz
A comprehensive definition of health includes the assessment of the patient's experience of a disease and its treatment. These patient experiences are best captured by standardized patient-reported outcome (PRO) instruments. A PRO is reported directly by the patient (or caregiver) and provides the patient's perspective into how a disease and its treatment impacts their lives. PRO instruments are typically standardized, validated questionnaires with items that are scaled and can be combined to represent an underlying health-related construct such as physical, social and role functioning, psychological well-being, symptoms, pain, and quality of life. Over the past few decades PROs have become increasingly used in clinical trials as endpoints to better understand treatment benefits from the patient's perspective and in clinical practice to identify unmet needs of patients, health risk surveillance, and monitor outcomes of care. In this paper, we describe the process for developing standardized PRO instruments, from conceptual model development through instrument validation.
对健康的全面定义包括评估患者对疾病及其治疗的体验。标准化的患者报告结果(PRO)工具最能反映患者的这些体验。患者报告结果由患者(或护理人员)直接报告,提供了患者对疾病及其治疗如何影响其生活的看法。患者报告结果工具通常是标准化的、经过验证的调查问卷,其中的项目可以按比例进行组合,以代表与健康相关的基本结构,如身体、社会和角色功能、心理健康、症状、疼痛和生活质量。在过去的几十年中,PROs 已越来越多地应用于临床试验中,作为从患者角度更好地了解治疗效果的终点,以及在临床实践中用于确定患者未满足的需求、监控健康风险和监测护理效果。在本文中,我们介绍了从概念模型开发到工具验证的标准化 PRO 工具的开发过程。
{"title":"Patient-Reported Outcome Measure Development and Validation: A Primer for Clinicians.","authors":"Mark Kosinski, Linda M Nelson, Richard H Stanford, Julie D Flom, Michael Schatz","doi":"10.1016/j.jaip.2024.08.030","DOIUrl":"https://doi.org/10.1016/j.jaip.2024.08.030","url":null,"abstract":"<p><p>A comprehensive definition of health includes the assessment of the patient's experience of a disease and its treatment. These patient experiences are best captured by standardized patient-reported outcome (PRO) instruments. A PRO is reported directly by the patient (or caregiver) and provides the patient's perspective into how a disease and its treatment impacts their lives. PRO instruments are typically standardized, validated questionnaires with items that are scaled and can be combined to represent an underlying health-related construct such as physical, social and role functioning, psychological well-being, symptoms, pain, and quality of life. Over the past few decades PROs have become increasingly used in clinical trials as endpoints to better understand treatment benefits from the patient's perspective and in clinical practice to identify unmet needs of patients, health risk surveillance, and monitor outcomes of care. In this paper, we describe the process for developing standardized PRO instruments, from conceptual model development through instrument validation.</p>","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":null,"pages":null},"PeriodicalIF":8.2,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142057287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Understanding the risk factors leading to severe systemic sting reactions (SSR) is crucial for initiating venom immunotherapy (VIT) and for educating affected individuals and their families. Some of these risk factors are well-established, some are no longer considered risk factors, and some remain controversial. Well-established risk factors for severe SSR include clonal mast cell disease, high baseline serum tryptase, and advanced age. The absence of skin symptoms and the rapid onset of symptoms are indicators of severe SSR. Recent publications indicate that antihypertensive treatment and stings in the head and neck area are not risk factors for severe SSR. VIT is the only available treatment that can potentially prevent further anaphylactic reactions. Although rare and generally manageable, individuals undergoing VIT may experience systemic adverse events (sAE). More sAE are expected in patients undergoing bee VIT compared to vespid VIT. The role of elevated baseline serum tryptase as a risk factor for sAE remains debated, but if it is a factor, the risk is increased by only about 1.5-fold. Rapid up-dosing protocols, depending on the specific regimen, can also be associated with more sAE. Severe initial SSR, antihypertensive medication, high skin test reactivity, and high specific IgE levels are not risk factors for sAE.
了解导致严重全身性蛰伤反应(SSR)的风险因素对于启动毒液免疫疗法(VIT)和教育受影响的个人及其家人至关重要。这些风险因素中,有些已经得到公认,有些不再被认为是风险因素,有些仍存在争议。严重 SSR 的公认风险因素包括克隆肥大细胞病、高基线血清胰蛋白酶和高龄。无皮肤症状和发病迅速是严重 SSR 的指标。最近的出版物表明,抗高血压治疗和头颈部蛰伤不是严重 SSR 的风险因素。VIT 是唯一可以预防进一步过敏反应的治疗方法。接受 VIT 治疗的患者可能会出现全身性不良反应 (sAE),但这种情况很少见,而且通常可以控制。与无病毒 VIT 相比,接受蜜蜂 VIT 的患者预计会出现更多的 sAE。基线血清色氨酸酶升高作为 sAE 风险因素的作用仍有争议,但如果它是一个因素,则风险仅增加约 1.5 倍。根据具体的治疗方案,快速加量方案也可能与更多的 sAE 有关。严重的初始 SSR、抗高血压药物、高皮试反应性和高特异性 IgE 水平并非 sAE 的风险因素。
{"title":"Risk factors for severe sting reactions and side effects during venom immunotherapy.","authors":"Gunter J Sturm, Eva Schadelbauer, Giorgia Marta, Patrizia Bonadonna, Mitja Kosnik","doi":"10.1016/j.jaip.2024.08.025","DOIUrl":"https://doi.org/10.1016/j.jaip.2024.08.025","url":null,"abstract":"<p><p>Understanding the risk factors leading to severe systemic sting reactions (SSR) is crucial for initiating venom immunotherapy (VIT) and for educating affected individuals and their families. Some of these risk factors are well-established, some are no longer considered risk factors, and some remain controversial. Well-established risk factors for severe SSR include clonal mast cell disease, high baseline serum tryptase, and advanced age. The absence of skin symptoms and the rapid onset of symptoms are indicators of severe SSR. Recent publications indicate that antihypertensive treatment and stings in the head and neck area are not risk factors for severe SSR. VIT is the only available treatment that can potentially prevent further anaphylactic reactions. Although rare and generally manageable, individuals undergoing VIT may experience systemic adverse events (sAE). More sAE are expected in patients undergoing bee VIT compared to vespid VIT. The role of elevated baseline serum tryptase as a risk factor for sAE remains debated, but if it is a factor, the risk is increased by only about 1.5-fold. Rapid up-dosing protocols, depending on the specific regimen, can also be associated with more sAE. Severe initial SSR, antihypertensive medication, high skin test reactivity, and high specific IgE levels are not risk factors for sAE.</p>","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":null,"pages":null},"PeriodicalIF":8.2,"publicationDate":"2024-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142037659","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-20DOI: 10.1016/j.jaip.2024.08.022
Maya Gibson, Sarah Suppes, Jared T Lovins, Emma M Tillman, Keith Feldman, Jennifer Goldman
{"title":"Clinical Presentation and Management of Children with Suspected Serum Sickness-like Reaction.","authors":"Maya Gibson, Sarah Suppes, Jared T Lovins, Emma M Tillman, Keith Feldman, Jennifer Goldman","doi":"10.1016/j.jaip.2024.08.022","DOIUrl":"https://doi.org/10.1016/j.jaip.2024.08.022","url":null,"abstract":"","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":null,"pages":null},"PeriodicalIF":8.2,"publicationDate":"2024-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142037656","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-20DOI: 10.1016/j.jaip.2024.08.023
Michaela Lucas, Britta S von Ungern-Sternberg, Annabelle Arnold, Michelle Trevenen, Susan Herrmann, Laure Braconnier, Syed Ali, Catherine Jepp, David Sommerfield, Kevin Murray, Kristina Rueter
Background: There is a scarcity of prospective studies investigating the relative roles of skin prick and intradermal testing, serum-specific Immunoglobulin E, and extended oral challenges in diagnosing children with reported beta-lactam allergies.
Objective: To determine the sensitivity and specificity of skin testing and serum-specific Immunoglobulin E in children with beta-lactam allergies, with immediate and non-immediate historic reactions.
Methods: Four hundred children with parent-reported beta-lactam allergies were recruited into an open-label prospective study. Detailed allergy histories were collected. Those with medically observed and documented histories of anaphylaxis, requiring epinephrine, or SCARs were excluded. In total, 380 children underwent all testing modalities and a direct provocation test. Each child was followed up for a minimum of three years.
Results: True allergy in children was uncommon, 8·3% reacted to the direct provocation challenge or the 5-day extended oral provocation challenge. Children reporting cephalosporin allergy or a reaction within one year were more likely to react to direct provocation testing. The sensitivity, specificity, and positive predictive value of skin testing was 12·5%, 98·8% and 20·0% for direct challenge outcomes, 4·76%, 99·0% and 25·0% for extended challenge outcomes, and 6·9%, 99·0% and 40·0% for both challenges combined. Follow-up investigations revealed that 5·7% of children had a mild repeat reaction and 2·7% continued to avoid the culprit despite successful delabeling. The relabeling rate for children readmitted to hospital was 15% with the relabeing being unfounded.
Conclusion: Genuine beta-lactam allergies were rare, with over 90% of children effectively delabeled. Skin and serum-specific Immunoglobulin E testing did not aid the diagnosis of beta-lactam antibiotic allergy in children, regardless of medical history. Extended oral challenges proved valuable in confirming allergies and boosted parental confidence.
背景:很少有前瞻性研究调查皮肤点刺和皮内试验、血清特异性免疫球蛋白 E 和扩展口服挑战在诊断报告的β-内酰胺过敏儿童中的相对作用:目的:确定皮肤测试和血清特异性免疫球蛋白 E 在β-内酰胺过敏儿童中的敏感性和特异性:一项开放标签的前瞻性研究招募了四百名由家长报告的β-内酰胺过敏儿童。研究人员收集了详细的过敏史资料。经医学观察并记录有过敏性休克病史、需要肾上腺素或 SCAR 的儿童被排除在外。共有 380 名儿童接受了所有测试方式和直接激发试验。每个儿童都接受了至少三年的随访:结果:儿童真正的过敏并不常见,8%-3% 的儿童对直接激发试验或 5 天延长口服激发试验有反应。对头孢菌素过敏或一年内出现过过敏反应的儿童更有可能对直接激发试验产生反应。皮试的敏感性、特异性和阳性预测值分别为:直接激发试验结果的 12-5%、98-8% 和 20-0%;延长激发试验结果的 4-76%、99-0% 和 25-0%;两种激发试验结果的 6-9%、99-0% 和 40-0%。后续调查显示,5%-7% 的儿童有轻微的重复反应,2%-7% 的儿童在成功脱标后仍继续回避罪魁祸首。再次入院治疗的儿童中,再次标签率为 15%,且再次标签没有依据:结论:真正的β-内酰胺过敏很少见,90% 以上的儿童能有效解除标签。无论病史如何,皮肤和血清特异性免疫球蛋白 E 测试都不能帮助诊断儿童对β-内酰胺类抗生素过敏。事实证明,扩展口服挑战对确认过敏和增强家长的信心很有价值。
{"title":"Comparing skin and serum testing to direct challenge outcomes in children with beta-lactam allergies.","authors":"Michaela Lucas, Britta S von Ungern-Sternberg, Annabelle Arnold, Michelle Trevenen, Susan Herrmann, Laure Braconnier, Syed Ali, Catherine Jepp, David Sommerfield, Kevin Murray, Kristina Rueter","doi":"10.1016/j.jaip.2024.08.023","DOIUrl":"https://doi.org/10.1016/j.jaip.2024.08.023","url":null,"abstract":"<p><strong>Background: </strong>There is a scarcity of prospective studies investigating the relative roles of skin prick and intradermal testing, serum-specific Immunoglobulin E, and extended oral challenges in diagnosing children with reported beta-lactam allergies.</p><p><strong>Objective: </strong>To determine the sensitivity and specificity of skin testing and serum-specific Immunoglobulin E in children with beta-lactam allergies, with immediate and non-immediate historic reactions.</p><p><strong>Methods: </strong>Four hundred children with parent-reported beta-lactam allergies were recruited into an open-label prospective study. Detailed allergy histories were collected. Those with medically observed and documented histories of anaphylaxis, requiring epinephrine, or SCARs were excluded. In total, 380 children underwent all testing modalities and a direct provocation test. Each child was followed up for a minimum of three years.</p><p><strong>Results: </strong>True allergy in children was uncommon, 8·3% reacted to the direct provocation challenge or the 5-day extended oral provocation challenge. Children reporting cephalosporin allergy or a reaction within one year were more likely to react to direct provocation testing. The sensitivity, specificity, and positive predictive value of skin testing was 12·5%, 98·8% and 20·0% for direct challenge outcomes, 4·76%, 99·0% and 25·0% for extended challenge outcomes, and 6·9%, 99·0% and 40·0% for both challenges combined. Follow-up investigations revealed that 5·7% of children had a mild repeat reaction and 2·7% continued to avoid the culprit despite successful delabeling. The relabeling rate for children readmitted to hospital was 15% with the relabeing being unfounded.</p><p><strong>Conclusion: </strong>Genuine beta-lactam allergies were rare, with over 90% of children effectively delabeled. Skin and serum-specific Immunoglobulin E testing did not aid the diagnosis of beta-lactam antibiotic allergy in children, regardless of medical history. Extended oral challenges proved valuable in confirming allergies and boosted parental confidence.</p>","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":null,"pages":null},"PeriodicalIF":8.2,"publicationDate":"2024-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142037657","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-20DOI: 10.1016/j.jaip.2024.08.027
Donald Day Stevenson, Ronald Alan Simon
{"title":"History of Aspirin Exacerbated Respiratory Disease: Discovery, Clinical Features, and Treatment.","authors":"Donald Day Stevenson, Ronald Alan Simon","doi":"10.1016/j.jaip.2024.08.027","DOIUrl":"https://doi.org/10.1016/j.jaip.2024.08.027","url":null,"abstract":"","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":null,"pages":null},"PeriodicalIF":8.2,"publicationDate":"2024-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142037658","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-19DOI: 10.1016/j.jaip.2024.08.026
Piotr Lacwik, Dominika Ochab-Krupnik, Anna Mościcka, Marzena Wielanek, Marta Wojciechowska, Maria Sklodowska, Maciej Kupczyk, Adam J Bialas, Youssef Sleiman, Beata Kręcisz, Małgorzata Czarny- Działak, Cezary Pałczyński
{"title":"Real-life degradation of epinephrine in adrenaline autoinjectors. A single-center, 12-month prospective observation.","authors":"Piotr Lacwik, Dominika Ochab-Krupnik, Anna Mościcka, Marzena Wielanek, Marta Wojciechowska, Maria Sklodowska, Maciej Kupczyk, Adam J Bialas, Youssef Sleiman, Beata Kręcisz, Małgorzata Czarny- Działak, Cezary Pałczyński","doi":"10.1016/j.jaip.2024.08.026","DOIUrl":"https://doi.org/10.1016/j.jaip.2024.08.026","url":null,"abstract":"","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":null,"pages":null},"PeriodicalIF":8.2,"publicationDate":"2024-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142019491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-19DOI: 10.1016/j.jaip.2024.08.021
Jonathan A Bernstein, Chistian Apfelbacher, Derek K Chu, Lynda Schneider, Sarbjit S Saini, Moshe Ben Shoshan
Reducing the burden of disease for patients and families requires being able to measure health status changes related to disease severity, control, and response to treatment over time. Patient-reported outcomes are patient perceptions of their health status. Such perceptions are critical to decision making. Some patient-reported outcome measures (PROMs) are extensive and often intended to be used only for detailed research assessments. Many PROMs, however, form critical components of valid, reliable, and responsive assessments in clinical research and routine clinical practice. The smallest score change in a PROM that would lead to different decision making by patients is called the minimally important difference. Using PROMs may also offer advantages over general questions or unvalidated tools. With the innovation of technology, the ability to chronicle disease symptoms using communication technology (mobile phone applications) has become increasingly available. Collection of real-world data in this capacity will be very useful for identifying more precise phenotypes/endotypes necessary for investigation of tailored therapies for chronic spontaneous and inducible urticaria, angioedema, and atopic dermatitis. Here, we provide an overview of PROMs that have been developed for the assessment of disease severity, control, and quality of life and that have been validated for the use of adults and children with these skin disorders.
{"title":"Patient-Reported Outcome Measures in Chronic Spontaneous Urticaria, Angioedema, and Atopic Dermatitis.","authors":"Jonathan A Bernstein, Chistian Apfelbacher, Derek K Chu, Lynda Schneider, Sarbjit S Saini, Moshe Ben Shoshan","doi":"10.1016/j.jaip.2024.08.021","DOIUrl":"10.1016/j.jaip.2024.08.021","url":null,"abstract":"<p><p>Reducing the burden of disease for patients and families requires being able to measure health status changes related to disease severity, control, and response to treatment over time. Patient-reported outcomes are patient perceptions of their health status. Such perceptions are critical to decision making. Some patient-reported outcome measures (PROMs) are extensive and often intended to be used only for detailed research assessments. Many PROMs, however, form critical components of valid, reliable, and responsive assessments in clinical research and routine clinical practice. The smallest score change in a PROM that would lead to different decision making by patients is called the minimally important difference. Using PROMs may also offer advantages over general questions or unvalidated tools. With the innovation of technology, the ability to chronicle disease symptoms using communication technology (mobile phone applications) has become increasingly available. Collection of real-world data in this capacity will be very useful for identifying more precise phenotypes/endotypes necessary for investigation of tailored therapies for chronic spontaneous and inducible urticaria, angioedema, and atopic dermatitis. Here, we provide an overview of PROMs that have been developed for the assessment of disease severity, control, and quality of life and that have been validated for the use of adults and children with these skin disorders.</p>","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":null,"pages":null},"PeriodicalIF":8.2,"publicationDate":"2024-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142019490","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-19DOI: 10.1016/j.jaip.2024.07.035
Justin H Turner, Atsushi Kato
{"title":"Understanding Inflammatory Heterogeneity in NSAID-exacerbated Respiratory Disease.","authors":"Justin H Turner, Atsushi Kato","doi":"10.1016/j.jaip.2024.07.035","DOIUrl":"https://doi.org/10.1016/j.jaip.2024.07.035","url":null,"abstract":"","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":null,"pages":null},"PeriodicalIF":8.2,"publicationDate":"2024-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142019492","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-15DOI: 10.1016/j.jaip.2024.07.002
Vivian E Saper, Lu Tian, Ruud H J Verstegen, Carol K Conrad, Michal Cidon, Rachel K Hopper, Christin S Kuo, Kazutoyo Osoegawa, Kevin Baszis, Catherine A Bingham, Ian Ferguson, Timothy Hahn, Annacarin Horne, Eugenia A Isupova, Jordan T Jones, Özgür Kasapcopur, Marisa S Klein-Gitelman, Mikhail M Kostik, Seza Ozen, Omkar Phadke, Sampath Prahalad, Rachel L Randell, Seher Sener, Cory Stingl, Rabheh Abdul-Aziz, Shoghik Akoghlanian, Dalila Al Julandani, Marcela B Alvarez, Brigitte Bader-Meunier, Erin E Balay-Dustrude, Imelda Balboni, Sarah K Baxter, Roberta A Berard, Sagar Bhattad, Roxana Bolaria, Alexis Boneparth, Elaine A Cassidy, Dominic O Co, Kathleen P Collins, Paul Dancey, Aileen M Dickinson, Barbara S Edelheit, Graciela Espada, Elaine R Flanagan, Lisa F Imundo, Ankur K Jindal, Hyoun-Ah Kim, Günter Klaus, Carol Lake, W Blaine Lapin, Erica F Lawson, Itay Marmor, Joy Mombourquette, Benson Ogunjimi, Rebecca Olveda, Michael J Ombrello, Karen Onel, Catherine Poholek, Athimalaipet V Ramanan, Angelo Ravelli, Adam Reinhardt, Amanda D Robinson, Kelly Rouster-Stevens, Nadine Saad, Rayfel Schneider, Velma Selmanovic, Irmina Sefic Pasic, Susan Shenoi, Natalie R Shilo, Jennifer B Soep, Angeli Sura, Sarah F Taber, Melissa Tesher, Jessica Tibaldi, Kathryn S Torok, Cathy Mei Tsin, Natalia Vasquez-Canizares, Diana S Villacis Nunez, Emily E Way, Benjamin Whitehead, Lawrence S Zemel, Surbhi Sharma, Marcelo A Fernández-Viña, Elizabeth D Mellins
Background: After introducing IL-1/IL-6 inhibitors, some patients with Still and Still-like disease developed unusual, often fatal, pulmonary disease. This complication was associated with scoring as DReSS (drug reaction with eosinophilia and systemic symptoms) implicating these inhibitors, although DReSS can be difficult to recognize in the setting of systemic inflammatory disease.
Objective: To facilitate recognition of IL-1/IL-6 inhibitor-DReSS in systemic inflammatory illnesses (Still/Still-like) by looking at timing and reaction-associated features. We evaluated outcomes of stopping or not stopping IL-1/IL-6 inhibitors after DReSS reaction began.
Methods: In an international study collaborating primarily with pediatric specialists, we characterized features of 89 drug-reaction cases versus 773 drug-exposed controls and compared outcomes of 52 cases stopping IL-1/IL-6 inhibitors with 37 cases not stopping these drugs.
Results: Before the reaction began, drug-reaction cases and controls were clinically comparable, except for younger disease-onset age for reaction cases with preexisting cardiothoracic comorbidities. After the reaction began, increased rates of pulmonary complications and macrophage activation syndrome differentiated drug-reaction cases from drug-tolerant controls (P = 4.7 × 10-35 and P = 1.1 × 10-24, respectively). The initial DReSS feature was typically reported 2 to 8 weeks after initiating IL-1/IL-6 inhibition. In drug-reaction cases stopping versus not stopping IL-1/IL-6-inhibitor treatment, reaction-related features were indistinguishable, including pulmonary complication rates (75% [39 of 52] vs 76% [28 of 37]). Those stopping subsequently required fewer medications for treatment of systemic inflammation, had decreased rates of macrophage activation syndrome, and improved survival (P = .005, multivariate regression). Resolution of pulmonary complications occurred in 67% (26 of 39) of drug-reaction cases who stopped and in none who continued inhibitors.
Conclusions: In systemic inflammatory illnesses, recognition of IL-1/IL-6-inhibitor-associated reactions followed by avoidance of IL-1/IL-6 inhibitors significantly improved outcomes.
{"title":"Interleukin (IL)-1/IL-6-Inhibitor-Associated Drug Reaction With Eosinophilia and Systemic Symptoms (DReSS) in Systemic Inflammatory Illnesses.","authors":"Vivian E Saper, Lu Tian, Ruud H J Verstegen, Carol K Conrad, Michal Cidon, Rachel K Hopper, Christin S Kuo, Kazutoyo Osoegawa, Kevin Baszis, Catherine A Bingham, Ian Ferguson, Timothy Hahn, Annacarin Horne, Eugenia A Isupova, Jordan T Jones, Özgür Kasapcopur, Marisa S Klein-Gitelman, Mikhail M Kostik, Seza Ozen, Omkar Phadke, Sampath Prahalad, Rachel L Randell, Seher Sener, Cory Stingl, Rabheh Abdul-Aziz, Shoghik Akoghlanian, Dalila Al Julandani, Marcela B Alvarez, Brigitte Bader-Meunier, Erin E Balay-Dustrude, Imelda Balboni, Sarah K Baxter, Roberta A Berard, Sagar Bhattad, Roxana Bolaria, Alexis Boneparth, Elaine A Cassidy, Dominic O Co, Kathleen P Collins, Paul Dancey, Aileen M Dickinson, Barbara S Edelheit, Graciela Espada, Elaine R Flanagan, Lisa F Imundo, Ankur K Jindal, Hyoun-Ah Kim, Günter Klaus, Carol Lake, W Blaine Lapin, Erica F Lawson, Itay Marmor, Joy Mombourquette, Benson Ogunjimi, Rebecca Olveda, Michael J Ombrello, Karen Onel, Catherine Poholek, Athimalaipet V Ramanan, Angelo Ravelli, Adam Reinhardt, Amanda D Robinson, Kelly Rouster-Stevens, Nadine Saad, Rayfel Schneider, Velma Selmanovic, Irmina Sefic Pasic, Susan Shenoi, Natalie R Shilo, Jennifer B Soep, Angeli Sura, Sarah F Taber, Melissa Tesher, Jessica Tibaldi, Kathryn S Torok, Cathy Mei Tsin, Natalia Vasquez-Canizares, Diana S Villacis Nunez, Emily E Way, Benjamin Whitehead, Lawrence S Zemel, Surbhi Sharma, Marcelo A Fernández-Viña, Elizabeth D Mellins","doi":"10.1016/j.jaip.2024.07.002","DOIUrl":"10.1016/j.jaip.2024.07.002","url":null,"abstract":"<p><strong>Background: </strong>After introducing IL-1/IL-6 inhibitors, some patients with Still and Still-like disease developed unusual, often fatal, pulmonary disease. This complication was associated with scoring as DReSS (drug reaction with eosinophilia and systemic symptoms) implicating these inhibitors, although DReSS can be difficult to recognize in the setting of systemic inflammatory disease.</p><p><strong>Objective: </strong>To facilitate recognition of IL-1/IL-6 inhibitor-DReSS in systemic inflammatory illnesses (Still/Still-like) by looking at timing and reaction-associated features. We evaluated outcomes of stopping or not stopping IL-1/IL-6 inhibitors after DReSS reaction began.</p><p><strong>Methods: </strong>In an international study collaborating primarily with pediatric specialists, we characterized features of 89 drug-reaction cases versus 773 drug-exposed controls and compared outcomes of 52 cases stopping IL-1/IL-6 inhibitors with 37 cases not stopping these drugs.</p><p><strong>Results: </strong>Before the reaction began, drug-reaction cases and controls were clinically comparable, except for younger disease-onset age for reaction cases with preexisting cardiothoracic comorbidities. After the reaction began, increased rates of pulmonary complications and macrophage activation syndrome differentiated drug-reaction cases from drug-tolerant controls (P = 4.7 × 10<sup>-35</sup> and P = 1.1 × 10<sup>-24</sup>, respectively). The initial DReSS feature was typically reported 2 to 8 weeks after initiating IL-1/IL-6 inhibition. In drug-reaction cases stopping versus not stopping IL-1/IL-6-inhibitor treatment, reaction-related features were indistinguishable, including pulmonary complication rates (75% [39 of 52] vs 76% [28 of 37]). Those stopping subsequently required fewer medications for treatment of systemic inflammation, had decreased rates of macrophage activation syndrome, and improved survival (P = .005, multivariate regression). Resolution of pulmonary complications occurred in 67% (26 of 39) of drug-reaction cases who stopped and in none who continued inhibitors.</p><p><strong>Conclusions: </strong>In systemic inflammatory illnesses, recognition of IL-1/IL-6-inhibitor-associated reactions followed by avoidance of IL-1/IL-6 inhibitors significantly improved outcomes.</p>","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":null,"pages":null},"PeriodicalIF":8.2,"publicationDate":"2024-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141604465","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-14DOI: 10.1016/j.jaip.2024.08.019
Catherine Haber, Taha Al-Shaikhly, Pooja Jhaveri
{"title":"Milk or Egg Allergy Diagnosis Increases the Risk of Eosinophilic Esophagitis Diagnosis.","authors":"Catherine Haber, Taha Al-Shaikhly, Pooja Jhaveri","doi":"10.1016/j.jaip.2024.08.019","DOIUrl":"10.1016/j.jaip.2024.08.019","url":null,"abstract":"","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":null,"pages":null},"PeriodicalIF":8.2,"publicationDate":"2024-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141996922","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}