@article{73fe7d3f075949e8b4cfdf242d3c8730,
title = "Emollients for prevention of atopic dermatitis: 5-year findings from the BEEP randomized trial",
abstract = "Background: The effectiveness of emollients for preventing atopic dermatitis/eczema is controversial. The Barrier Enhancement for Eczema Prevention trial evaluated the effects of daily emollients during the first year of life on atopic dermatitis and atopic conditions to age 5 years. Methods: 1394 term infants with a family history of atopic disease were randomized (1:1) to daily emollient plus standard skin-care advice (693 emollient group) or standard skin-care advice alone (701 controls). Long-term follow-up at ages 3, 4 and 5 years was via parental questionnaires. Main outcomes were parental report of a clinical diagnosis of atopic dermatitis and food allergy. Results: Parents reported more frequent moisturizer application in the emollient group through to 5 years. A clinical diagnosis of atopic dermatitis between 12 and 60 months was reported for 188/608 (31%) in the emollient group and 178/631 (28%) in the control group (adjusted relative risk 1.10, 95% confidence interval 0.93 to 1.30). Although more parents in the emollient group reported food reactions in the previous year at 3 and 4 years, cumulative incidence of doctor-diagnosed food allergy by 5 years was similar between groups (92/609 [15%] emollients and 87/632 [14%] controls, adjusted relative risk 1.11, 95% confidence interval 0.84 to 1.45). Findings were similar for cumulative incidence of asthma and hay fever. Conclusions: Daily emollient application during the first year of life does not prevent atopic dermatitis, food allergy, asthma or hay fever.",
keywords = "asthma, atopic dermatitis, food allergy, prevention, rhinitis",
author = "Bradshaw, {Lucy E.} and Wyatt, {Laura A.} and Brown, {Sara J.} and Haines, {Rachel H.} and Montgomery, {Alan A.} and Perkin, {Michael R.} and Sandra Lawton and Sach, {Tracey H.} and Chalmers, {Joanne R.} and Ridd, {Matthew J.} and Carsten Flohr and Joanne Brooks and Richard Swinden and Mitchell, {Eleanor J.} and Stella Tarr and Nicola Jay and Kim S Thomas and Hilary Allen and Cork, {Michael J.} and Kelleher, {Maeve M.} and Eric L Simpson and Lartey, {Stella T.} and Susan Davies-Jones and Boyle, {Robert J.} and Williams, {Hywel C.}",
note = "Funding Information: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (project number 12/67/12). The funder had no role in the study design, collection, analysis and interpretation of data; in the writing or the report; and in the decision to submit the article for publication. Funding Information: Research nurse support was provided by the NIHR Clinical Research Networks. The trial was developed with and supported by the UK Dermatology Clinical Trials Network (UK DCTN) and designed in collaboration with and managed by the Nottingham Clinical Trials Unit (NCTU). Grace Holt (NCTU) independently validated the analysis for the UKWP AD tertiary outcome. The majority of the genetic analysis work was undertaken by SJB whilst at the Skin Research Group, School of Medicine, University of Dundee. During this time SJB also worked clinically at the Ninewells Hospital and Medical School, Dundee. UKDCTN is grateful to the British Association of Dermatologists and the University of Nottingham for financial support of the Network. We would like to thank the parents and infants who took time to participate in this trial, and the patients who contributed to trial design by providing helpful feedback at different stages of trial development. We would like to thank the independent members of the Trial Steering Committee: Sarah Meredith, (Chair, Medical Research Council Clinical Trials Unit), Angela Crook (Statistician, Medical Research Council Clinical Trials Unit), Paula Beattie (Dermatologist, Royal Hospital for Sick Children, Glasgow), Kirsty Logan (Paediatric Epidemiologist, King's College London) and Emma Thomas (patient representative). Michael Perkin (St. George's, London) was previously an independent member of the TSC prior to bec'mIng part of the team involved in the food allergy assessment. Funding Information: Research nurse support was provided by the NIHR Clinical Research Networks. The trial was developed with and supported by the UK Dermatology Clinical Trials Network (UK DCTN) and designed in collaboration with and managed by the Nottingham Clinical Trials Unit (NCTU). Grace Holt (NCTU) independently validated the analysis for the UKWP AD tertiary outcome. The majority of the genetic analysis work was undertaken by SJB whilst at the Skin Research Group, School of Medicine, University of Dundee. During this time SJB also worked clinically at the Ninewells Hospital and Medical School, Dundee. UKDCTN is grateful to the British Association of Dermatologists and the University of Nottingham for financial support of the Network. We would like to thank the parents and infants who took time to participate in this trial, and the patients who contributed to trial design by providing helpful feedback at different stages of trial development. We would like to thank the independent members of the Trial Steering Committee: Sarah Meredith, (Chair, Medical Research Council Clinical Trials Unit), Angela Crook (Statistician, Medical Research Council Clinical Trials Unit), Paula Beattie (Dermatologist, Royal Hospital for Sick Children, Glasgow), Kirsty Logan (Paediatric Epidemiologist, King's College London) and Emma Thomas (patient representative). Michael Perkin (St. George's, London) was previously an independent member of the TSC prior to bec'mIng part of the team involved in the food allergy assessment. Funding Information: Robert Boyle received personal fees from Cochrane, Wiley, British Society of Allergy and Clinical Immunology for editorial work and from medicolegal firms for expert witness work, outside of the submitted work. Robert's employing institution Imperial College London has a formal research and innovation partnership with Nestl{\'e}, who manufacture and market nutritional products for managing food allergy and sponsor infant nutrition research related to eczema and food allergy. Matthew Ridd is Chief Investigator on UK National Institute for Health Research‐funded Best Emollients for Eczema ( ISRCTN84540529 ). Carsten Flohr is Chief Investigator of the UK National Institute for Health Research‐funded TREAT (ISRCTN15837754) and SOFTER ( Clinicaltrials.gov : NCT03270566) trials as well as the UK‐Irish Atopic eczema Systemic Therapy Register (A‐STAR; ISRCTN11210918) and a Principal Investigator in the European Union (EU) Horizon 2020‐funded BIOMAP Consortium ( http://www.biomap‐imi.eu/ ). He also leads the EU Joint Program Initiative Trans‐Foods and the UK Medical Research Foundation‐funded Mind & Skin consortia. His department has received investigator‐led funding from Sanofi‐Genzyme and Pfizer for skin microbiome work. Carsten Flohr is also Editor of the British Journal of Dermatology Evidence‐Based Dermatology Section. Eric Simpson reports personal fees from AbbVie, Amgen, Arena Pharmaceuticals, Aslan Pharma, Boston Consulting Group, Collective Acumen, LLC (CA), Dermira, Eli Lilly, Evidera, ExcerptaMedica, Forte Bio RX, Galderma, GlaxoSmithKline, Incyte, Janssen, Kyowa Kirin Pharmaceutical Development, Leo Pharm, Medscape LLC, Merck, Pfizer, Physicians World LLC, Regeneron, Roivant, Sanofi‐Genzyme, Trevi therapeutics, Valeant, WebMD. Eric Simpson also reports grants (or Principal investigator role) from AbbVie, Amgen, Arcutis, Aslan, CorEvitas, Dermavant, Dermira, Eli Lilly, Incyte, Kymab, Kyowa Hakko Kirin, Leo Pharmaceuticals, Pfizer, Regeneron, Sanofi, and TARGET‐DERM. These potential conflicts of interest have been reviewed and managed by OHSU. Hywel Williams was director of the NIHR Health Technology Assessment Programme from 2015 to 2020, Tracey Sach was a member of the NIHR Health Technology Assessment Programme Themed calls/general funding/commissioning committees from 2013–2019. Alan Montgomery was a member of NIHR HTA Clinical Trials and Evaluations Funding Committee 2015–2021. HW, TS and AM had no part in the decision making for funding this study. Sara Brown is a Wellcome Trust Senior Research Fellow (106865/A/15/Z and 220875/Z/20/Z); she has also received research funding (but no personal payments) from the British Skin Foundation, Pfizer, Sosei‐Heptares and the European Union (EU) Horizon 2020‐funded BIOMAP Consortium, outside of the submitted work. Sara receives personal fees from Wiley for editorial work, outside of the submitted work. MK received funding from National Institute of Health (NIHR) for Transitional Research Fellowship for the systematic review of skincare interventions for preventing eczema and food allergy. All other authors declare no competing interests. Publisher Copyright: {\textcopyright} 2022 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.",
year = "2023",
month = apr,
doi = "10.1111/all.15555",
language = "English",
volume = "78",
pages = "995--1006",
journal = "Allergy: European Journal of Allergy and Clinical Immunology",
issn = "0105-4538",
publisher = "John Wiley and sons",
number = "4",
}