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Patient reported outcomes on food immunotherapy differ between countries and foods: results from COFAITH
Rodríguez Del Río, Pablo; Riggioni, Carmen; Deschildre, Antoine; Greenhawt, Matthew; Schnadt, Sabine; Arasi, Stefania; Nowak-Wegrzyn, Anna; Wasserman, Richard L; Begin, Philippe; Waserman, Susan; Patel, Nandinee; Lins de Holanda Coelho, Gabriel; Alvaro, Pedro Cuesta; Mori, Francesca; Caminiti, Lucia; Mack, Douglas P; Wexler, Michael; Bernaola, Marta; Ruano Perez, Francisco Javier; Jimenez, Antonio Ramirez; El Abd, Kamal; Wanin, Stephanie; Yassin, Mohamed; Guenard-Bilbaut, Lydie; Metz-Favre, Carine; Badina, Laura; Schreiber, Rachel; Amorós, Silvia Molo; Fox, Adam T; Vazquez-Cortés, Sonia; Garriga-Baraut, Teresa; Cros, Pierrick; Bazire, Raphaëlle; Fitzhugh, David; Muraro, Antonella; Perea, Alberto Alvarez; Turner, Paul J; Alvaro-Lozano, Montse; Fernandez-Rivas, Montserrat; Galvin, Audrey Dunn
BACKGROUND:Food allergen immunotherapy (FAIT) is a consolidated treatment included in clinical guidelines that has shown efficacy in terms of researcher-defined variables, but little work has been done yet to evaluate patient´s perspectives. OBJECTIVE:We aimed to understand and explore the relevance of different patient-reported outcomes (PROs) METHODS: An EAACI Taskforce designed a questionnaire to prospectively collect information from parents or caregivers of patients below 18 years on FAIT. Participants from North America and several European countries were invited to provide data regarding socioeconomic aspects, allergic background, FAIT modality, burden, safety and food allergy quality of life (FAQoL). As primary outcome, 19 proposed PROs were ranked according to their relevance (5-point Likert scale). A descriptive and cluster analysis of the data was performed. RESULTS:84 FAIT prescribers recruited 857 patients suitable for analysis, 41.5%, 39.7% and 18.8% were on milk, peanut, and egg AIT, respectively. Patients were grouped into regions, South Europe (46.2%), North America (24.3%), Western Europe (20.7%) and United Kingdom (8.9%). Total FAQoL questionnaire score was 4.1 (±SD1.4), significantly higher among South Europeans [4.7 (±SD1.3), p<0.0001]. Worse FAQoL scores were found for milk and egg FAIT vs peanut. Cluster analysis identified 5 different phenotypes of patients considering similar replies to the proposed PROs, labeled: "High expectations", "Beyond protection", "Social Functioning", "Aiming at normalization" and "Low motivations". CONCLUSIONS:The data-driven analysis provided novel information on the level of complexity and personalization that patient´s desires display and opens the field to future research lines to improve FAIT patient-perceived value.
PMID: 40345331
ISSN: 2213-2201
CID: 5839602
10 ways to improve your management of food allergy
Anagnostou, Aikaterini; Lieberman, Jay; Bingemann, Theresa; Buckey, Tim; Cianferoni, Antonella; Cosper, Arjola; Kim, Edwin; Love, Marissa; Mallapaty, Anu; Moore, Lindsey; Wasserman, Richard; Nowak-Wegrzyn, Anna; Somani, Shaan; Yu, Joyce; Greenhawt, Matthew
PMID: 40345717
ISSN: 1534-4436
CID: 5839652
Food allergy endotypes revisited
Baker, Mary Grace; Wong, Lydia Su Yin; Konstantinou, George N; Nowak-Wegrzyn, Anna
PMID: 40306493
ISSN: 1097-6825
CID: 5833802
Effectiveness and safety of the four-step versus six-step milk ladder in children with IgE-mediated cow's milk protein allergy: protocol for an open-label randomised controlled trial
Wiszniewska, Daria; Horvath, Andrea; Stróżyk, Agata; Nowak-Wegrzyn, Anna; Grzela, Katarzyna; Szajewska, Hanna
INTRODUCTION/BACKGROUND:Introducing baked milk into the diet of children with cow's milk protein allergy (CMPA) has been shown to potentially accelerate the development of tolerance to non-heated milk. However, there is no standardised milk ladder (ML) protocol, and different scientific societies across countries recommend varying versions. This study aims to assess the effectiveness and safety of the four-step ML (4-ML) compared with the six-step ML (6-ML) in children with IgE-mediated CMPA. METHODS AND ANALYSIS/METHODS:We will perform an open-label randomised trial with two parallel arms in two departments of the same academic hospital. A total of 92 children with IgE-mediated CMPA will be allocated in a 1:1 ratio to introduce cow's milk into their diet according to either 4-ML or 6-ML with a 4-week break period between subsequent steps. Oral food challenge (OFC) with tested products at each subsequent step of the ML will be conducted in hospital settings. The primary outcome will be the percentage of children with tolerance to non-heated cow's milk proteins defined as no allergic reaction to raw cow's milk (120-240 mL depending on the age of the patient) during the last OFC; measured at the end of the 12-week observation period for the 4-ML and 20-week observation period for the 6-ML. Secondary outcomes will include the percentage of children with a negative OFC to each ML step; the percentage of children with anaphylaxis (both those who were treated and those who were not treated with epinephrine); the percentage of children with exacerbation of atopic dermatitis; growth; compliance; and quality of life of the caregivers and parents' anxiety about adverse events during their child's OFC. ETHICS AND DISSEMINATION/BACKGROUND:The bioethics committee of the Medical University of Warsaw, Poland, approved this protocol (KB/107/2024). The findings will be published in a peer-reviewed journal and submitted to relevant conferences no later than 1 year after data collection. TRIAL REGISTRATION NUMBER/BACKGROUND:NCT06664918.
PMCID:11997811
PMID: 40228856
ISSN: 2044-6055
CID: 5827582
Assessing Protocol Variability for Food Protein-Induced Enterocolitis Syndrome Oral Food Challenges
Anvari, Sara; Banerjee, Ankona; Leonard, Stephanie; Gonzalez-Delgado, Purificacion; Nguyen, Duc T; Nowak-Wegrzyn, Anna
PMID: 39542210
ISSN: 2213-2201
CID: 5753602
Management of children with food allergies by allergists in the United States
Anagnostou, Aikaterini; Greenhawt, Matthew; Lieberman, Jay A; Ciaccio, Christina E; Sindher, Sayantani B; Creasy, Blaine; Baran, Katherine; Gupta, Sachin; Nowak-Wegrzyn, Anna
BACKGROUND/UNASSIGNED:Management of patients with food allergies is complex, especially in cases of patients with multiple and potentially severe food allergies. Although international guidelines exist for food allergy management, the role of the allergist in the decision-making process is key. OBJECTIVE/UNASSIGNED:Our aim was to investigate the management patterns and educational needs of practicing allergists treating patients with food allergies. METHODS/UNASSIGNED:An online survey was e-mailed to United States-based practicing allergists (N = 2833) in November-December 2021. The allergists were screened for managing 1 or more patients (including ≥25% pediatric patients) with food allergies per month. The allergists responded to questions regarding food allergy management in response to 2 hypothetical pediatric case studies, their familiarity with available guidelines and emerging treatments, and their future educational preferences. A descriptive analysis of outcomes was conducted. RESULTS/UNASSIGNED:A total of 125 responding allergists (4.4%) met the eligibility criteria and completed the survey. The allergists prioritized written exposure action plans, patient-caregiver communication, prevention of serious reactions, and consideration of both food allergy severity and allergic comorbidities in the management of patients with food allergies. With regard to recommending biologics in the future, the allergists identified patient history of anaphylaxis and hospitalizations, food allergy severity, and allergic comorbidities as all being important factors to consider when deciding on appropriate treatment options. The allergists noted their ongoing educational needs, especially for current and emerging treatments for food allergies. CONCLUSION/UNASSIGNED:With the treatment landscape for food allergies evolving rapidly, the decision-making priorities and continuing educational needs of allergists will be important in optimizing the management of patients with food allergies.
PMCID:11750536
PMID: 39844911
ISSN: 2772-8293
CID: 5802402
Current status and future directions in Food Protein-Induced Enterocolitis Syndrome (FPIES): An NIAID Workshop Report
Nowak-Wegrzyn, Anna; Sicherer, Scott H; Akin, Cem; Anvari, Sara; Bartnikas, Lisa M; Berin, M Cecilia; Bingemann, Theresa A; Boyd, Scott; Brown-Whitehorn, Terri; Bunyavanich, Supinda; Cianferoni, Antonella; du Toit, George; Fortunato, John E; Goldsmith, Jeffrey D; Groetch, Marion; Leonard, Stephanie A; Rao, Meenakshi; Schultz, Fallon; Schwaninger, Julie M; Venter, Carina; Westcott-Chavez, Amity; Wood, Robert A; Togias, Alkis
Food Protein-Induced Enterocolitis (FPIES) is a non-IgE mediated GI food allergy characterized by delayed, protracted vomiting, accompanied by lethargy and pallor, usually 1-4 hours following ingestion of the food allergen. The pathophysiology of FPIES remains unknown and currently there are no diagnostic biomarkers available to assess disease activity or its resolution. Over the last two decades, FPIES has become increasingly recognized in both pediatric and adult patients. Forty years later after the initial FPIES description, the first international classification of diseases (ICD-10) code for FPIES was established and the first international consensus guidelines for diagnosis and management of FPIES was published. On June 22, 2022, the National Institute of Allergy and Infectious Diseases (NIAID) held its first virtual multidisciplinary workshop on FPIES. Various clinical and translational aspects of FPIES, as well as the important areas of unmet needs were discussed as priorities for future research during this 2-day virtual workshop. The following report provides a summary of content of the workshop, including updated literature on the topic areas, as well as providing a critical commentary on the state of FPIES.
PMID: 39521282
ISSN: 1097-6825
CID: 5752372
The use and implementation of omalizumab as food allergy treatment: Consensus-based guidance and Work Group Report of the Adverse Reactions to Foods Committee of the American Academy of Allergy, Asthma & Immunology
Anagnostou, Aikaterini; Bird, J Andrew; Chinthrajah, Sharon; Dribin, Timothy E; Fleischer, David M; Kim, Edwin; Nowak-Wegrzyn, Anna; Rachid, Rima; Shaker, Marcus S; Shreffler, Wayne; Sicherer, Scott; Tam, Jonathan; Vickery, Brian P; Virkud, Yamini V; Wang, Julie; Young, Michael; Greenhawt, Matthew
Omalizumab was recently approved by the US Food and Drug Administration for treatment of any single food allergy or multiple food allergies in children aged 1 year and older and adults. There is currently no formal guidance regarding recommended best practices for omalizumab use in food allergy, including patient selection, anticipated goals and outcomes of therapy, procedure for monitoring patients who elect to start omalizumab therapy, and ways in which omalizumab can be incorporated into the landscape of food allergy management and daily clinical practice. This work group report was developed by the food allergy therapies subcommittee of the Adverse Reactions to Foods Committee within the American Academy of Allergy, Asthma & Immunology. Consensus, evidence-based guidance regarding experts' recommendations for using omalizumab to treat children and adults with food allergy was developed by using modified Delphi methodology. In iterative fashion, a total of 8 statements regarding how to use omalizumab to treat patients with food allergy were developed by 16 clinical experts. This guidance provides the clinician with a suggested approach to patient selection, initiation of therapy, monitoring of efficacy, and long-term follow-up care. The role of preference-sensitive care is emphasized, with most statements offering care recommendations relevant to the culture and values of a particular practice setting.
PMID: 39580718
ISSN: 1097-6825
CID: 5775212
An Algorithm for the Diagnosis and Treatment of Food Protein-Induced Enterocolitis Syndrome (FPIES), 2024 Update
Beaudoin, Michele; Mehra, Ashna; Wong, Lydia Su Yin; Vazquez-Ortiz, Marta; González-Delgado, Purificación; Nowak-Wegrzyn, Anna
PMID: 39655844
ISSN: 1398-9995
CID: 5762522
Understanding Experiences, Barriers, and Facilitators of Safe Airline Travel: A Global Survey of Food Allergy Patients and Caregivers
Warren, Christopher; Herbert, Linda; Mandelbaum, Lianne; Nowak-Wegrzyn, Anna; Sicherer, Scott; Sampson, Hugh; Moassessi, Caroline; Gupta, Ruchi
BACKGROUND:The global prevalence of food allergy (FA) has increased markedly across recent decades, with millions of patients engaging in airline travel each year. However, air travel can pose specific challenges to FA management. OBJECTIVE:To collect global data about patients' and families' FA-related airline travel experiences, attitudes, and behaviors. METHODS:An electronic survey was developed and refined by global FA stakeholders, which was administered between October 2022 and January 2023 to patients with FA and caregivers recruited via 45 FA patient advocacy organizations and research institutions. RESULTS:Most of the 4704 survey respondents self-reported as female (88.4%), aged between 40 and 59 years (67.7%), and non-Hispanic White race (75.8%), and resided in the United States (79.6%). A history of 1 or more in-flight food-allergic reaction was reported by 8.5% of participants, with peanut (3.9%), tree nuts (2.4%), and milk (0.6%) the most reported triggers. Epinephrine was administered in 15.1% of reactions and was most often self-carried (91.7% of events). Only 57.4% of in-flight reactions were reported to either the flight crew in the air or the airline on landing. Many preventive measures were reportedly taken by respondents to avoid adverse FA outcomes during air travel, including specific requests for accommodation, which were often not provided as assured. Respondents generally reported high levels of anxiety managing FA during air travel and that FA-related policies and other related factors were primary drivers of travel-related decision making. CONCLUSIONS:Air travel presents numerous challenges to optimal FA management, many of which can be at least partially mitigated though consistent implementation of appropriate FA-related policies.
PMID: 39645358
ISSN: 2213-2201
CID: 5763862