Impact case study database

Every year more than 15,000 babies in the UK will develop peanut allergy; King’s research has shown that at least 12,000 of these cases can be prevented. This fundamental shift in our understanding of childhood allergy has reversed infant weaning policy worldwide, and has directly led to new national and international guidelines recommending early peanut consumption for the prevention of peanut allergy. This impact case follows on from a REF2014 case covering the early impact of this research that led to a shift in the guidelines to withdraw the recommendation to actively avoid food allergens in the infants’ diet. Since 2014, King’s research has subsequently led international guidelines to be rewritten to recommend active introduction of allergenic foods, namely peanut and egg, in infants’ diet during weaning; a fundamental shift in the understanding of food allergy, and associated change in clinical practice; and direct benefit to children and families around the world

King’s trial results immediately reversed the global consensus on allergenic foods in infant diets. The LEAP findings were deemed so convincing that a statement was immediately published simultaneously (from August 2015) in eight journals recommending that the LEAP strategy should be put into practice, based on consensus among the 10 major international allergy specialist organisations: American Academy of Allergy, Asthma & Immunology (AAAAI), American Academy of Pediatrics (AAP), American College of Allergy, Asthma & Immunology (ACAAI), Australasian Society of Clinical Immunology and Allergy (ASCIA), Canadian Society of Allergy and Clinical Immunology (CSACI), European Academy of Allergy and Clinical Immunology (EAACI), Israel Association of Allergy and Clinical Immunology (ISACI), Japanese Society for Allergology (JSA), Society for Pediatric Dermatology (SPD), and World Allergy Organization (WAO). This was considered interim guidance whilst national and international guidelines were formalised [A].

New national clinical guidelines for the prevention of childhood peanut allergy are being developed around the world. In January 2017, the National Institute of Allergy and Infectious Diseases (USA) published new clinical practice guidelines for the prevention of peanut allergy which were endorsed by 26 federal agencies, professional societies, foundations, and advocacy groups [B]. In March 2019, the American Academy of Paediatrics updated its guidelines on how to prevent food allergies in children, saying there was not enough evidence to prove that delaying the exposure of children as young as four to six months old to allergenic foods helps keep them from developing food allergies. On the contrary, based on strong evidence from the LEAP study they endorsed the evidence showing that purposeful early introduction of peanuts may prevent peanut allergies in high-risk infants, resulting in the recommendation to introduce peanut protein as early as between four and six months [B]. Independently, scientific societies such as the Australasian Society of Clinical Immunology and Allergy have also produced their own guidelines [B]. As a result of these findings, the European Guidelines (from the European Academy of Allergy and Clinical Immunology, EAACI) have been re-written and are under submission for publication; these are followed by clinicians in the UK [B].

New clinical guidelines are already leading to a significant change in clinical practice. Implementation of the ASCIA guidelines in Australia has resulted in a dramatic shift in infant feeding, documented very rigorously: prior to 2011 fewer than 30% of 12-month-old infants were eating peanuts, whereas after the guidelines were introduced in 2017, almost 90% of infants were eating peanuts (of more than 6000 infants surveyed) [C].

Clinical programs are now being set up nationally and internationally to implement the findings of the LEAP study:

• The first NHS food allergy prevention clinic has been established. The research findings resulted in the first NHS food allergy prevention clinics being established at Guy’s & St. Thomas’ NHS Trust in 2018, with community liaison using Skype video consultations to promote early intervention in the first 12 months of life. In the last two years, more than 500 infants at risk of peanut allergy have been seen in this clinic and peanut has been introduced successfully in their diet in the vast majority, either at home or in hospital [D].

• Harvard clinicians Wayne Shreffler and colleagues at Massachussets General Hospital have instituted a similar programme in the Boston area. This focuses on identifying infants at risk of developing food allergies and facilitating early introduction of peanut and other allergenic foods, under medical supervision if needed. Since the establishment of the prevention programme in 2017, 862 new patient visits for evaluation of eczema or egg allergy in infants under one year of life have taken place. Over 616 food challenges have been conducted to a variety of foods, including 100 peanut challenges on patients under 18 months of life, where the allergenic food is introduced under medical supervision to assess for possible allergic reaction. 68 children did not react, allowing the incorporation of peanut in the diet [E].

King’s research has improved the lives of children at risk of food allergy, and their families. This patient-focused research has improved the lives of children worldwide by providing clear guidance on the age of dietary introduction of peanut to reduce allergies via simple, low-cost, safe, and practical means. Looking locally within our prevention clinic at who has been assessed and established on peanut consumption, this will have prevented more than 80 new cases in our community in the last couple of years [D]. This practice is now expanding to our Institutions in the four UK nations. The testimonials from parents of children identified as being at risk of peanut allergy who had the opportunity to attend our clinic and have medically supervised introduction of peanut into the diet have expressed how much difference it has made to their lives. For instance: “I am and will be forever grateful for the care you bestowed on baby (child’s name) when she was driven to madness by her eczema and the subsequent improvement in her health once she was found to be allergic to breast milk, eggs and wheat by your excellent team. Knowing now how lucky she is to hopefully be peanut tolerant for the rest of her life (she loved her Bamba) I feel so very grateful *.*” [F.1]. King’s has also improved the lives of children with allergies and their families through charities. The Anaphylaxis Campaign, for example, widely disseminated King’s papers on the LEAP and EAT studies. After that, they received feedback, via their helpline, from “parents who have changed their strategy for introducing solid food in order to ensure early introduction of allergenic foods that they would otherwise have avoided based on outdated advice” [F.2]. Additionally, the Head of Clinical Services at another organisation - Allergy UK - has said: “This is such important research and I have no doubt has given much more structure to our advice as a charity and helping parents make informed decisions.” [F.3]

The paradigm shift resulting from King’s RCTs is being transmitted to the medical community and trainees through teaching and professional development, transforming clinical practice and approach to treating and preventing childhood food allergy [G]:

• Medical students: Textbooks have been rewritten to include the new evidence and recommendations. Locally, at Kings the Paediatric Allergy Service has two medical students allocated per year who often focus their case study reports on early food introduction; and other groups of medical students covering paediatric specialties in their rotations (approximately eight students per week) who learn about food allergy prevention during their clinic placements.

• Paediatricians: There have been articles in general paediatrics journals about early introduction of allergenic foods in infants, which target a large and broad readership within the medical community. As part of the training in Paediatrics, the UK national curriculum now includes illustrations such that general paediatric trainees need to provide evidence of understanding of the principles of allergy prevention.

• GPs and other health professionals: In the UK this work is being communicated to the medical community beyond the Allergy specialty through courses about prevention of food allergy run by the KCL Allergy Academy. This was set up by King’s researchers and is directed at GPs, general paediatricians, nurses and dietitians. The Children’s Allergy Service at the Evelina London also hosts international courses and two visiting professionals per year from around the world who come to learn about food allergy prevention, among other aspects of Paediatric Allergy. An allergy trainee from Portugal said: “I have had a wonderful experience at St Thomas’. I have learnt so much that I can take back into my own practice back home *.*” A visiting paediatrician commented: “I have gained so much from my year here and was exposed to so much, from so many different areas of allergy. I now feel confident to develop a service when I return to Greece” and a Clinical fellow from the Children's Hospital of Fudan University, China said: “The learning experience in St Thomas Hospital was very helpful for my professional career. I plan to do the skin prick test, food challenge and sublingual immunotherapy in our hospital in the future, which we do not do now. I think this work will benefit patients. ”

King’s raised public awareness on how to prevent childhood peanut allergy [H]. This work has been widely disseminated to the public through multiple national and international media outlets such as BBC, ITV, Sky, Channel 4, CNN, NHK, Al Jazeera, Canadian Broadcasting Corportation, ABC News, CBS, The Wall Street Journal, The New York Times, The Guardian, Daily Mail, The Times, and many more.