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2. Peanut Can Be Used as a Reference Allergen for Hazard Characterization in Food Allergen Risk Management: A Rapid Evidence Assessment and Meta-Analysis

Author

Turner, Paul J., Patel, Nandinee, Ballmer-Weber, Barbara K., Baumert, Joe L., Blom, W. Marty, Brooke-Taylor, Simon, Brough, Helen, Campbell, Dianne E., Chen, Hongbing, Chinthrajah, R. Sharon, Crevel, René W.R., Dubois, Anthony E.J., Ebisawa, Motohiro, Elizur, Arnon, Gerdts, Jennifer D., Gowland, M. Hazel, Houben, Geert F., Hourihane, Jonathan O.B., Knulst, André C., La Vieille, Sébastien, López, María Cristina, Mills, E.N. Clare, Polenta, Gustavo A., Purington, Natasha, Said, Maria, Sampson, Hugh A., Schnadt, Sabine, Södergren, Eva, Taylor, Stephen L., and Remington, Benjamin C.

Published
2022
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5. Deriving individual threshold doses from clinical food challenge data for population risk assessment of food allergens

Author

Westerhout, Joost, Baumert, Joseph L., Blom, W. Marty, Allen, Katrina J., Ballmer-Weber, Barbara, Crevel, René W.R., Dubois, Anthony E.J., Fernández-Rivas, Montserrat, Greenhawt, Matthew J., Hourihane, Jonathan O'B., Koplin, Jennifer J., Kruizinga, Astrid G., Le, Thuy-My, Sampson, Hugh A., Shreffler, Wayne G., Turner, Paul J., Taylor, Steve L., Houben, Geert F., and Remington, Benjamin C.

Published
2019
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23. Health-related quality of life in food-allergic adults from eight European countries

Author

Goossens, Nicole J., Flokstra-de Blok, Bertine M.J., van der Meulen, Gerbrich N., Arnlind, Marianne H., Asero, Ricardo, Barreales, Laura, Burney, Peter, Cerecedo, Imnaculada, Clausen, Michael, Fernandéz-Rivas, Monteserrat, Frewer, Lynn, de la Hoz Caballer, Belén, Jansson, Sven-Arne, Jedrzejczak-Czechowicz, Monica, Knulst, André C., Kowalski, Marek L., Papadopoulos, Nikos G., Purohit, Ashok, Rokicka, Ewa, Starosta, Pawel, Vásquez-Cortés, Sonia, Duiverman, Eric J., and Dubois, Anthony E.J.

Published
2014
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25. Genome-wide association study and meta-analysis in multiple populations identifies new loci for peanut allergy and establishes C11orf30/EMSY as a genetic risk factor for food allergy

Author

Asai, Yuka, Eslami, Aida, van Ginkel, Dorien C., Akhabir, Loubna, Wan, Ming, Ellis, George, Ben-Shoshan, Moshe, Martino, David, Ferreira, Manuel A., Allen, Katrina, Mazer, Bruce, de Groot, Hans, de Jong, Nicolette W., Gerth van Wijk, Roy N., Dubois, Anthony E.J., Chin, Rick, Cheuk, Stephen, Hoffman, Joshua, Jorgensen, Eric, Witte, John S., Melles, Ronald B., Hong, Xiumei, Wang, Xiaobin, Hui, Jennie, Musk, Arthur W. (Bill), Hunter, Michael, James, Alan L., Koppelman, Gerard H., Sandford, Andrew J., Clarke, Ann E., and Daley, Denise

Published
2018
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26. Peanut Can Be Used as a Reference Allergen for Hazard Characterization in Food Allergen Risk Management: A Rapid Evidence Assessment and Meta-Analysis

Author

MS Dermatologie/Allergologie, Infection & Immunity, Turner, Paul J., Patel, Nandinee, Ballmer-Weber, Barbara K., Baumert, Joe L., Blom, W. Marty, Brooke-Taylor, Simon, Brough, Helen, Campbell, Dianne E., Chen, Hongbing, Chinthrajah, R. Sharon, Crevel, René W.R., Dubois, Anthony E.J., Ebisawa, Motohiro, Elizur, Arnon, Gerdts, Jennifer D., Gowland, M. Hazel, Houben, Geert F., Hourihane, Jonathan O.B., Knulst, André C., La Vieille, Sébastien, López, María Cristina, Mills, E. N.Clare, Polenta, Gustavo A., Purington, Natasha, Said, Maria, Sampson, Hugh A., Schnadt, Sabine, Södergren, Eva, Taylor, Stephen L., Remington, Benjamin C., MS Dermatologie/Allergologie, Infection & Immunity, Turner, Paul J., Patel, Nandinee, Ballmer-Weber, Barbara K., Baumert, Joe L., Blom, W. Marty, Brooke-Taylor, Simon, Brough, Helen, Campbell, Dianne E., Chen, Hongbing, Chinthrajah, R. Sharon, Crevel, René W.R., Dubois, Anthony E.J., Ebisawa, Motohiro, Elizur, Arnon, Gerdts, Jennifer D., Gowland, M. Hazel, Houben, Geert F., Hourihane, Jonathan O.B., Knulst, André C., La Vieille, Sébastien, López, María Cristina, Mills, E. N.Clare, Polenta, Gustavo A., Purington, Natasha, Said, Maria, Sampson, Hugh A., Schnadt, Sabine, Södergren, Eva, Taylor, Stephen L., and Remington, Benjamin C.

Published
2022

34. The direct and indirect costs associated with food hypersensitivity in households: A study in the Netherlands, Poland, and Spain

Author

Jantine Voordouw, Gerrit Antonides, Margaret Fox, Inma Cerecedo, Javier Zamora, Belen de la Hoz Caballer, Ewa Rokicka, Judith R. Cornelisse-Vermaat, Maciej Jewczak, Pawel Starosta, Marek Kowalski, Monika Jędrzejczak-Czechowicz, Sonia Vázquez-Cortes, Sara Cano-Escudero, Bertine M.J. Flokstra-De Blok, Anthony E.J. Dubois, Miranda Mugford, and Lynn J. Frewer

Subjects
food hypersensitivity, households, the Netherlands, Poland, Spain, Agriculture, Regional planning, HT390-395
Abstract

Background: Recent studies show that food hypersensitivity, such as food allergy or food intolerance, has the potential to affect direct, indirect and intangible economic costs experienced by individuals and their families. This research assesses the direct and indirect economic costs of food hypersensitivity at the household level in the Netherlands, Poland, and Spain. Methods: A self-administered postal survey was conducted (n=1558). Respondents with food hypersensitivity were clinically diagnosed cases recruited through clinical centres in Poland and Spain. In the Netherlands, food hypersensitivity cases were recruited through hospitals, patient organisations and advertisements. The controls formed the baseline sample and were obtained from households in which none of the members had food hypersensitivity. The monetary value of indirect costs, forgone time, was calculated using the opportunity cost method. The indirect and direct costs were expressed in purchasing power parity. Analysis of co-variance on the cost items was used to test the within-country differences between respondents with food hypersensitivity and respondents without food hypersensitivity, as well as across the three countries. Results: The average total direct and indirect costs across all countries for families with food hypersensitive family members are not higher than for households without food hypersensitive members. However, the intangible costs for food hypersensitive individuals appear to be higher than for individuals in the control group. Conclusions: These results do not support the hypothesis that all food allergies incur high costs to the individual. However, being hypersensitive to foods may have a negative impact on quality of life compared to people who are not food hypersensitive.

Published
2016
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35. Peanut Can Be Used as a Reference Allergen for Hazard Characterization in Food Allergen Risk Management: A Rapid Evidence Assessment and Meta-Analysis

Author

M. Hazel Gowland, Natasha Purington, Nandinee Patel, Dianne E. Campbell, Arnon Elizur, María Cristina López, Sebastien La Vieille, Hugh A. Sampson, Anthony E.J. Dubois, Eva Södergren, Motohiro Ebisawa, Benjamin C. Remington, Sabine Schnadt, E. N. Clare Mills, Barbara Ballmer-Weber, Helen A. Brough, R. Sharon Chinthrajah, Geert F. Houben, André C. Knulst, W. Marty Blom, Gustavo Alberto Polenta, Paul Turner, Jonathan Hourihane, Stephen L Taylor, Simon Brooke-Taylor, Jennifer Gerdts, Maria Said, René W.R. Crevel, Joseph L. Baumert, Hongbing Chen, Groningen Research Institute for Asthma and COPD (GRIAC), Medical Research Council (MRC), National Institute for Health Research, University of Zurich, and Turner, Paul J

Subjects
ORAL TOLERANCE INDUCTION, CLINICAL REACTIVITY, Arachis, IGE ANTIBODIES, PFAS, Pollen food allergy syndrome, WHEAT ALLERGY, medicine.disease_cause, DOUBLE-BLIND, Allergen, Dosis de Referencia, Food Labeling, immune system diseases, Alérgenos, COWS MILK ALLERGY, Immunology and Allergy, Risk management, Randomized Controlled Trials as Topic, ED, Eliciting dose, Threshold, 10177 Dermatology Clinic, Hazard, humanities, Eliciting Dose, Dosis Provocadora, Meta-analysis, CROSS-REACTIVITY, ED01, Amount of allergen expected to cause objective symptoms in 1% of the population with that allergy, 2723 Immunology and Allergy, ED05, Amount of allergen expected to cause objective symptoms in 5% of the population with that allergy, Alergia Alimentaria, THRESHOLD DOSE DISTRIBUTIONS, Eliciting dose, Food Hypersensitivity, Precautionary allergen labeling, Food Allergies, 610 Medicine & health, Legislation, Cacahuete, Maní, PAL, Precautionary allergen labeling, Risk Assessment, WHO, World Health Organization, Reference Dose, Food allergy, Environmental health, FC, Food challenge, medicine, Humans, Precautionary Allergen Labeling, Review and Feature Article, Reacciones Anafilácticas, Anaphylaxis, HENS EGG, EIA, Exercise-induced anaphylaxis, Reference dose, CI, Confidence interval, business.industry, CHALLENGE-PROVEN, Evidence-based medicine, Allergens, medicine.disease, Etiquetado Preventivo de Alérgenos, Umbral, Groundnuts, Metanálisis, respiratory tract diseases, Peanut, FAO, Food and Agriculture Organization, business, DBPCFC, Double-blind, placebo-controlled food challenge, Anaphylactic Reactions, Meta-Analysis
Abstract

Regional and national legislation mandates the disclosure of “priority” allergens when present as an ingredient in foods, but this does not extend to the unintended presence of allergens due to shared production facilities. This has resulted in a proliferation of precautionary allergen (“may contain”) labels (PAL) that are frequently ignored by food-allergic consumers. Attempts have been made to improve allergen risk management to better inform the use of PAL, but a lack of consensus has led to variety of regulatory approaches and nonuniformity in the use of PAL by food businesses. One potential solution would be to establish internationally agreed “reference doses,” below which no PAL would be needed. However, if reference doses are to be used to inform the need for PAL, then it is essential to characterize the hazard associated with these low-level exposures. For peanut, there are now published data relating to over 3000 double-blind, placebo-controlled challenges in allergic individuals, but a similar level of evidence is lacking for other priority allergens. We present the results of a rapid evidence assessment and meta-analysis for the risk of anaphylaxis to a low-level allergen exposure for priority allergens. On the basis of this analysis, we propose that peanut can and should be considered an exemplar allergen for the hazard characterization at a low-level allergen exposure. Resumen: La legislación regional y nacional exige la divulgación de alérgenos "prioritarios" cuando están presentes como ingrediente en los alimentos, pero esto no se extiende a la presencia involuntaria de alérgenos debido a instalaciones de producción compartidas. Esto ha dado lugar a una proliferación de etiquetas de precaución para alérgenos ("pueden contener") (PAL) que los consumidores alérgicos a los alimentos suelen ignorar. Se han hecho intentos para mejorar la gestión del riesgo de alérgenos para informar mejor el uso de PAL, pero la falta de consenso ha llevado a una variedad de enfoques regulatorios y a la falta de uniformidad en el uso de PAL por parte de las empresas alimentarias. Una posible solución sería establecer “dosis de referencia” acordadas internacionalmente, por debajo de las cuales no se necesitaría PAL. Sin embargo, si se van a utilizar dosis de referencia para informar la necesidad de PAL, entonces es esencial caracterizar el peligro asociado con estas exposiciones de bajo nivel. Para el maní, ahora hay datos publicados relacionados con más de 3000 desafíos doble ciego controlados por placebo en individuos alérgicos, pero falta un nivel similar de evidencia para otros alérgenos prioritarios. Presentamos los resultados de una evaluación rápida de la evidencia y un metanálisis del riesgo deanafilaxia a una exposición a alérgenos de bajo nivel para alérgenos prioritarios. Sobre la base de este análisis, proponemos que el cacahuete puede y debe considerarse un alérgeno ejemplar para la caracterización del peligro en una exposición a un alérgeno de bajo nivel. Instituto de Investigación de Tecnología de Alimentos Fil: Turner, Paul J. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Patel, Nandinee. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Ballmer-Weber, Barbara K. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Ballmer-Weber, Barbara K. Clínica de Dermatología y Alergología. Kantonsspital; Suiza. Fil: Baumert, Joe L. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Blom, W. Marty. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Brooke-Taylor, Simon. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Brough, Helen. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Brough, Helen. King's College London. Departamento de Alergia Pediátrica; Reino Unido. Fil: Campbell, Dianne E. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Campbell, Dianne E. Tecnologías DBV. Montrouge; Francia. Fil: Chen, Hongbing. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Chinthrajah, R. Sharon. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Crevel, René W.R. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Dubois, Anthony E.J. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Ebisawa, Motohiro. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Elizur, Arnon. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Elizur, Arnon. Universidad de Tel Aviv. Facultad de Medicina Sackler. Departamento de Pediatría; Israel. Fil: Gerdts, Jennifer D. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Gowland, M. Hazel. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Houben, Geert F. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Hourihane, Jonathan O.B. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Knulst, André C. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: La Vieille, Sébastien. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: López, María Cristina. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Mills, E.N. Clare. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Polenta, Gustavo Alberto. Instituto Nacional de Tecnología Agropecuaria (INTA). Instituto de Investigación Tecnología de Alimentos; Argentina. Fil: Polenta, Gustavo Alberto. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Purington, Natasha. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Said, María. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Sampson, Hugh A. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Sampson, Hugh A. Escuela de Medicina Icahn. División de Alergia e Inmunología Pediátricasen. Nueva York. Estados Unidos de América. Fil: Schnadt, Sabine. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Södergren, Eva. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Södergren, Eva. ThermoFisher Scientific; Suecia. Fil: Taylor, Stephen L. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Remington, Benjamin C. Imperial College London. Instituto Nacional del Corazón y los Pulmones; Reino Unido. Fil: Remington, Benjamin C. Grupo BV. Consultoría Remington; Holanda.

Published
2022

36. Deriving individual threshold doses from clinical food challenge data for population risk assessment of food allergens

Author

Benjamin C. Remington, Joost Westerhout, Jennifer J. Koplin, Thuy My Le, Hugh A. Sampson, W. Marty Blom, Wayne G. Shreffler, Matthew Greenhawt, René W.R. Crevel, Geert F. Houben, Montserrat Fernandez-Rivas, Jonathan O'b Hourihane, Katrina J. Allen, Anthony E.J. Dubois, Joseph L. Baumert, Barbara Ballmer-Weber, Astrid G. Kruizinga, Steve L. Taylor, Paul Turner, University of Zurich, Blom, W Marty, and Groningen Research Institute for Asthma and COPD (GRIAC)

Subjects
Male, no observed adverse effect level-lowest observed adverse effect level derivation, double-blind, placebo-controlled food challenge, Administration, Oral, CHILDREN, food challenge, placebo-controlled food challenge, DOUBLE-BLIND, threshold, eliciting dose, Immunology and Allergy, Decision-making, Risk management, education.field_of_study, Biological Variation, Individual, 10177 Dermatology Clinic, risk assessment, Child, Preschool, no observed adverse effect level–lowest observed adverse effect level derivation, 2723 Immunology and Allergy, Female, Risk assessment, Food Hypersensitivity, medicine.medical_specialty, Resource (biology), EUROPE, Maximum Tolerated Dose, Clinical Decision-Making, Population, Immunology, 610 Medicine & health, PEANUT, DIAGNOSIS, risk management, Double-Blind Method, Population Groups, Food allergy, Environmental health, medicine, Journal Article, Humans, education, No-Observed-Adverse-Effect Level, 2403 Immunology, decision-making process, business.industry, Public health, Infant, Allergens, Placebo Effect, medicine.disease, Food, Immunization, Population Risk, business
Abstract

Background: Food allergies are a significant public health issue, and the only effective management option currently available is strict avoidance of all foods containing the allergen. In view of the practical impossibility of limiting risks to zero, quantitative allergen risk assessment and management strategies are needed. Objective: We sought to develop appropriate methods for informing population-based risk assessments and risk management programs to benefit all stakeholders but particularly patients with food allergy. Methods: Individual thresholds for food allergens (maximum tolerable doses and minimum eliciting doses) can ideally be established through double-blind, placebo-controlled food challenges. If double-blind, placebo-controlled food challenge data are not available, data from widely used open food challenges using predefined objective criteria can also provide useful data regarding minimum eliciting doses. For more than 20 years, the Netherlands Organisation for Applied Scientific Research and the Food Allergy Research and Resource Program at the University of Nebraska-Lincoln have been collecting individual maximum tolerable doses and minimum eliciting doses that produce objective symptoms from published and unpublished clinical data to better refine knowledge regarding the sensitivity of the population to food allergens. Results: In this article we provide in-depth insights into the methodology applied by the Netherlands Organisation for Applied Scientific Research and Food Allergy Research and Resource Program to derive individual maximum tolerable doses and minimum eliciting doses for objective symptoms from clinical food challenge data. More than 90 examples for determining individual allergic thresholds are presented. Conclusion: With the methodology presented in this article, we aim to stimulate harmonization and transparency in quantitative food allergen risk assessment and risk management programs, encouraging their wider adoption. © 2019 American Academy of Allergy, Asthma & Immunology

Published
2019

42. List of contributors

Author

Abad, A., primary, Abanades, J.C., additional, Adánez, J., additional, Alonso, M., additional, Anthony, E.J., additional, Arai, Y., additional, Arias, B., additional, Bidwe, A.R., additional, Blamey, J., additional, Boot-Handford, M., additional, Broda, M., additional, Butler, J.W., additional, Chen, X., additional, Diego, M.E., additional, Dieter, H., additional, Fennell, P., additional, Florin, N., additional, Grace, J.R., additional, Kierzkowska, A.M., additional, Lara, Y., additional, Linderholm, C., additional, Lisbona, P., additional, Lyngfelt, A., additional, Martínez, I., additional, Martínez, A., additional, Müller, C.R., additional, Pröll, T., additional, Romeo, L.M., additional, Rydén, M., additional, Scheffknecht, G., additional, Yao, J.G., additional, Zhao, Changsui, additional, and Zhao, Chuanwen, additional

Published
2015
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43. List of contributors

Author

Acha, E., primary, Agrafiotis, C., additional, Allakhverdiev, S.I., additional, Anthony, E.J., additional, Basile, A., additional, Bensmann, B., additional, Bernardo, P., additional, Bonura, G., additional, Cambra, J.F., additional, Charpentier, P.A., additional, Dodds, P.E., additional, Fierro, J.L.G., additional, Frusteri, F., additional, García, L., additional, Guil, R., additional, Hanke-Rauschenbach, R., additional, Hossain, M.Z., additional, Idriss, H., additional, Inoue, K., additional, Iulianelli, A., additional, Jansen, J.C., additional, Koirala, A.R., additional, Lee, D.H., additional, Masukawa, H., additional, Millet, P., additional, Mougin, J., additional, Muradov, N., additional, Najafpour, M.M., additional, Navarro, R.M., additional, Poudyal, R.S., additional, Requies, J.M., additional, Roeb, M., additional, Sattler, C., additional, Scott, M., additional, Subramani, V., additional, Tiwari, I., additional, Tomo, T., additional, Tong, J., additional, and Veziroğlu, T.N., additional

Published
2015
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44. Food allergy: Stakeholder perspectives on acceptable risk

Author

Madsen, Charlotte B., Crevel, René, Chan, Chun-Han, Dubois, Anthony E.J., DunnGalvin, Audrey, Flokstra-de Blok, Bertine M.J., Gowland, M. Hazel, Hattersley, Sue, Hourihane, Jonathan O’B, Nørhede, Pia, Pfaff, Sylvia, Rowe, Gene, Schnadt, Sabine, and Vlieg-Boerstra, Berber J.

Published
2010
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48. Development and construct validation of a parent-proxy quality of life instrument in children with bronchopulmonary dysplasia aged 4-8 years old

Author

Bertine M. J. Flokstra-de Blok, Boudewijn J. Kollen, Lysbert Meijer-Schaap, Anthony E.J. Dubois, Elianne J.L.E. Vrijlandt, Jet Tijmens‑van der Hulst, Groningen Research Institute for Asthma and COPD (GRIAC), and Life Course Epidemiology (LCE)

Subjects
Male, Psychometrics, Health-related quality of life, Population, behavioral disciplines and activities, Article, 03 medical and health sciences, 0302 clinical medicine, Quality of life (healthcare), Cronbach's alpha, Surveys and Questionnaires, medicine, Humans, Child, education, Child Behavior Checklist, Children, Reliability (statistics), education.field_of_study, Item analysis, business.industry, 030503 health policy & services, Public Health, Environmental and Occupational Health, Reproducibility of Results, Construct validity, medicine.disease, Bronchopulmonary dysplasia, Instrument development, Child, Preschool, 030220 oncology & carcinogenesis, Quality of Life, Female, 0305 other medical science, business, Clinical psychology
Abstract

Purpose Children with bronchopulmonary dysplasia often develop complications that affect them well into adult life. Very little is known about how this affects their quality of life, since no sensitive instrument is available to measure health-related quality of life in this population. In this study, a Dutch parent-proxy instrument was developed for this purpose. Methods A list of items was generated after literature search and interviews with both parents of patients and clinical experts. Clinically relevant items were selected with the clinical impact method and item analysis. Results of clinical tests to measure complications in children with bronchopulmonary dysplasia were correlated with these items to select the items that show construct validity. Cronbach’s alpha was calculated to estimate internal consistency of the items in the final questionnaire. Results In total, 92 children and their parents and 7 clinicians participated. Of 130 identified items, 47 showed clinical relevance. Spirometry, the Child Behavior Checklist, mean arterial pressure, and body mass index were used to determine construct validity of 33 items. These items were structured within five domains: pulmonary complaints, school functioning, growth and nutrition, exercise and locomotion, emotional functioning and health care concerns. The questionnaire showed excellent internal consistency with Cronbach’s alpha of 0.919. Conclusion This study developed a disease-specific parent-proxy instrument to measure health-related quality of life in children with bronchopulmonary dysplasia aged 4–8 years old, the BPD-QoL. All included items show construct validity and internal consistency reliability. Future research should focus on further validation and analysis of responsiveness and reliability. Electronic supplementary material The online version of this article (10.1007/s11136-018-2029-7) contains supplementary material, which is available to authorized users.

Published
2019

50. AR101 Oral Immunotherapy for Peanut Allergy

Author

Hey Chong, Antonella Muraro, Caroline Nilsson, Julie Wang, Jonathan Matz, Tara F. Carr, Andrea Vereda, Stephanie A. Leonard, Douglas T Johnston, Katharina Blumchen, Moshe Ben-Shoshan, Stanley Fineman, Frank C Hampel, Montserrat Fernandez-Rivas, Michael J Welch, José Manuel Zubeldia, Jay M. Portnoy, Carsten Bindslev-Jensen, Rima Rachid, Leon Greos, Vibha Sharma, Brian P. Vickery, Marina Tsoumani, Dareen Siri, Edwin H. Kim, Lyndon E Mansfield, A. Wesley Burks, J. Andrew Bird, Daniel C. Adelman, Ellen Sher, Robert A. Wood, Thomas B. Casale, Stephen A. Tilles, Annette Marcantonio, Hugh H Windom, Hanneke N G Oude Elberink, Stefan Zielen, Hemant P Sharma, Wayne G. Shreffler, Bruce J. Lanser, Amarjit Cheema, Ned Rupp, Stephen B Fritz, Stacie M. Jones, Allan Stillerman, Gordon Sussman, Frederick E Leickly, Stephen G Dilly, W. Carr, Jay A. Lieberman, Pooja Varshney, David Fleischer, Kirsten Beyer, William H. Yang, Jacqueline A. Pongracic, Morna J. Dorsey, George Du Toit, Jason A. Ohayon, Aikaterini Anagnostou, M Dolores Ibáñez, David K Jeong, Amal Assa'ad, Jonathan O'b Hourihane, Rita Kachru, Anthony E.J. Dubois, Christina E. Ciaccio, Rezi Zawadzki, Sharon Chinthrajah, Lawrence Sher, Georgiana M Sanders, Jonathan M. Spergel, and Groningen Research Institute for Asthma and COPD (GRIAC)

Subjects
Male, 0301 basic medicine, Arachis, Gastrointestinal Diseases, Peanut allergy, Administration, Oral, CHILDREN, GUIDELINES, FOOD ALLERGY, law.invention, DOUBLE-BLIND, 0302 clinical medicine, Randomized controlled trial, law, Young adult, Child, Plant Proteins, Age Factors, food and beverages, General Medicine, Middle Aged, PREVALENCE, Child, Preschool, SAFETY, Female, Adult, medicine.medical_specialty, Adolescent, Dose-Response Relationship, Immunologic, Placebo, DIAGNOSIS, Young Adult, 03 medical and health sciences, Double-Blind Method, Food allergy, Internal medicine, medicine, Humans, Peanut Hypersensitivity, Adverse effect, Biological Products, business.industry, NATURAL-HISTORY, Allergens, medicine.disease, Clinical trial, Regimen, 030104 developmental biology, 030228 respiratory system, Desensitization, Immunologic, business
Abstract

BACKGROUND: Peanut allergy, for which there are no approved treatment options, affects patients who are at risk for unpredictable and occasionally life-threatening allergic reactions.METHODS: In a phase 3 trial, we screened participants 4 to 55 years of age with peanut allergy for allergic dose-limiting symptoms at a challenge dose of 100 mg or less of peanut protein (approximately one third of a peanut kernel) in a double-blind, placebo-controlled food challenge. Participants with an allergic response were randomly assigned, in a 3:1 ratio, to receive AR101 (a peanut-derived investigational biologic oral immunotherapy drug) or placebo in an escalating-dose program. Participants who completed the regimen (i.e., received 300 mg per day of the maintenance regimen for approximately 24 weeks) underwent a double-blind, placebo-controlled food challenge at trial exit. The primary efficacy end point was the proportion of participants 4 to 17 years of age who could ingest a challenge dose of 600 mg or more, without dose-limiting symptoms.RESULTS: Of the 551 participants who received AR101 or placebo, 496 were 4 to 17 years of age; of these, 250 of 372 participants (67.2%) who received active treatment, as compared with 5 of 124 participants (4.0%) who received placebo, were able to ingest a dose of 600 mg or more of peanut protein, without dose-limiting symptoms, at the exit food challenge (difference, 63.2 percentage points; 95% confidence interval, 53.0 to 73.3; PCONCLUSIONS: In this phase 3 trial of oral immunotherapy in children and adolescents who were highly allergic to peanut, treatment with AR101 resulted in higher doses of peanut protein that could be ingested without dose-limiting symptoms and in lower symptom severity during peanut exposure at the exit food challenge than placebo. (Funded by Aimmune Therapeutics; PALISADE ClinicalTrials.gov number, NCT02635776 .).

Published
2018

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