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Promising results as Viaskin Peanut trial in peanut-allergic toddlers concludes

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A recent trial by DBV Technologies has produced promising results for very young children with peanut allergies and their families.

The trial assessed whether Viaskin Peanut – an immunotherapy skin patch – was safe, and if it worked for children between one and three years old. Most peanut-allergic children are diagnosed between these ages, but there are currently no approved therapies for this age group.

For a successful result, toddlers intolerant to tiny amounts (10 mg or less) of peanut protein, needed to be able to tolerate 300 mg or more after 12 months. Toddlers who could already manage more than 10 mg had to be tolerant of 1,000 mg of peanut protein after 12 months.

Results:

  • Did it work? Viaskin Peanut met the trial’s criteria for 67% of toddlers on the trial, compared to 33.5% in a placebo trial.
  • Was it safe? 8.6% of toddlers had adverse reactions – this was most commonly mild to moderate skin reactions – compared to 2.5% in the placebo trial.

The findings matched results from other trials DBV Technologies has carried out with children aged four and over. Many of the families (88%) have opted for the toddlers to continue to benefit from the treatment by signing up for a further long-term trial.

Simon Williams, Chief Executive of the Anaphylaxis Campaign, says, “It’s easy for parents of small children to get disheartened about peanut allergy when there is such a lack of treatments. But the truth is, research and development is evolving all the time. This latest trial from DBV Technologies gives us further hope for a much brighter future for families living with peanut allergy.”

Dr Pharis Mohideen, Chief Medical Officer of DBV Technologies, said, “We are thrilled by the topline results of EPITOPE, our second Phase 3 clinical trial to evaluate the safety and efficacy of Viaskin Peanut.

“We are grateful to the toddlers and their parents, caregivers and allergists who are contributing to a brighter future by having participated in this first-of-its kind trial.”

Aimmune study shows the practical and emotional impact of living with peanut allergy

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Aimmune Announces Publication of UK and Ireland Findings from the APPEAL Study Highlighting the Practical and Emotional Impact of Living with Peanut Allergy

– Largest study to date to probe the impact of peanut allergy on allergic individuals and their caregivers in the UK and Ireland –
– Study reveals the impact of peanut allergy across all aspects of daily life, including its effect on relationships, experiences of bullying, persistent stress, and anxiety –
– Peanut allergy affects between 0.5-2.5% of children in the UK[1] –

 London, UK — February 8, 2022 — Aimmune Therapeutics UK Ltd. today announced the publication of UK and Ireland country data from the APPEAL (Allergy to Peanuts ImPacting Emotions And Life) study which have been published in PLOS ONE. APPEAL is the largest European study to date, focused on the emotional and psychosocial impact of peanut allergy, and was created through a collaboration of allergy specialists and representatives of patient advocacy groups from eight European countries.[2],[3] It was conducted in two phases (APPEAL-1 and APPEAL-2) with over 300 individuals in the UK and Ireland taking part.[4]

The APPEAL study examined the influence and psychosocial burden of living with peanut allergy experienced by allergic individuals and their caregivers. The results demonstrate the wide-ranging practical and emotional impact of peanut allergy on the lives of children, teenagers, adults, and their caregivers, and highlight a significant need to improve education, care, and management for these individuals.

“Our research shows that most people in the studies with peanut allergy face an overwhelming feeling of uncertainty, stress and anxiety in their day-to-day lives, even in daily activities that are meant to be relaxing and fun, with only a third feeling that they cope “extremely well” managing their allergy. Most shockingly, children are reluctant to tell other people about their peanut allergy in fear of being bullied or to avoid embarrassment,” said Marina Tsoumani, School of Biological Sciences, University of Manchester, and lead author of the publication. “These data indicate an urgent need for greater support and education to ensure those with peanut allergy feel confident their condition is managed, and both their risk of anaphylaxis and fear of bullying is minimised, if not eliminated.”

“We know all too well that peanut allergy is incredibly challenging and fearful for most children and teenagers. Now, we’re also learning about the detrimental impact on parents and caregivers in the UK and Ireland, with over half in this study reporting feeling constant stress because of their child’s peanut allergy, as well as experiencing damaging effects on their relationship with their partner,” said Amena Warner, Allergy UK, and one of the authors of the publication. “The new data provides invaluable insights into both the peanut allergic individual and caregiver experience and presents a clear signpost for clinicians and policymakers to address the impact of peanut allergy.

Key findings include:

  • Due to living with peanut allergy, the majority of patients and caregivers experience levels of uncertainty (79%), stress (71%) and feeling anxious (75%). More than a third even reported feeling worried in situations that don’t involve food (35%).
  • Among children and teenagers, just over half reported experiencing bullying or teasing because of their peanut allergy (52% of survey participants).
  • Over a fifth of patients and caregivers reported feelings of isolation (22%) and 28% have been made to feel different because of their or their child’s peanut allergy.
  • All adult, teenage and caregiver respondents, and over half of the children interviewed reported a negative impact of peanut allergy on their social activities. Restricted choices were reported in various situations, including choosing where to eat out (82%), special occasions (76%), and when choosing a holiday destination (68%).
  • More than half of the caregivers reported an adverse impact on their relationship with their partner, mainly due to the stress around paying enough attention to avoiding peanuts.

The study also uncovers that despite the majority of those with a peanut allergy adopting various coping strategies and had been prescribed an adrenaline auto-injector for emergency use, only 37% reported that they cope “extremely well” with their peanut allergy. Respondents’ coping strategies to avoid accidental exposure to peanuts in their everyday lives include checking ingredients, constantly paying attention to what others are eating, staying away from other people if they are eating peanuts, and asking other people to wash their hands after eating peanuts.

“Peanut allergy is often lifelong and, as these data from the UK and Ireland show, can be very difficult for children, their parents or caregivers,” said Simon Williams, Chief Executive Officer, Anaphylaxis Campaign, a UK-wide charity for people at risk of severe allergies. “This study clearly indicates that the whole family is impacted, not only from the stress and anxiety of peanut allergy itself, but also from restrictions on social activities and even the potential for bullying and harassment. These findings reinforce our understanding of the substantial burden that peanut allergy has on young people and their families and highlight the importance of having new treatment options and ongoing advice and support available for those living with this condition.”

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About the APPEAL-1 and APPEAL-2 Studies

The APPEAL (Allergy to Peanuts ImPacting Emotions And Life) studies are the first pan-European quantitative and qualitative, cross-sectional surveys to explore the burden and psychosocial impact of living with peanut allergy. The results from the UK and Ireland include findings from a total of 284 adults (187 caregivers and 97 adults with peanut allergy) who participated in APPEAL-1 and 42 individuals (11 adults, 11 teenagers and 8 children with peanut allergy and 12 caregivers of a child with peanut allergy) participated in APPEAL-2.

About Peanut Allergy

In the UK, peanut allergy affects between 0.5-2.5% of children.1 Unlike other common food allergies, peanut allergy can be lifelong.[5] Reactions to peanut are potentially life-threatening, accounting for the majority of deaths related to food allergy.[6] The standard of care has been a strict elimination diet and the timely administration of rescue medications in case of an allergic reaction from accidental exposure.[7] Despite vigilance, accidental exposures may occur and cause reactions of unpredictable severity, leading to a lifelong risk of severe reactions.4 Beyond the physical impact of peanut allergy, this condition also has a significant psychosocial impact on children, their families and caregivers. Those living with peanut allergy face many uncertainties and restrictions, in addition to constant feelings of fear, frustration, anxiety and stress in their daily lives.2

Contacts:

 

UK Media:

Jemini Sedani

+44 7940 594788
jsedani@realchemistry.com

 

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References:

 

[1] Stiefel, G., Anagnostou, K., Boyle, R.J., et al. 2017. BSACI Guideline for the Diagnosis and Management of Peanut and Tree Nut Allergy. Clinical and Experimental Allergy. 47, pp. 719-739.

[2] DunnGalvin, A., et al. APPEAL-1: A multiple-country European survey assessing the psychosocial impact of peanut allergy. Allergy. 2020 Nov;75(11):2899-2908. DOI: 10.1111/all.14363. Epub 2020 Jul 9.PMID: 32400915

[3] Blumchen, K, et al. APPEAL-1: A pan-European survey of patient/caregiver perceptions of peanut allergy management. Allergy. 2020 May; 75(11):2920-2935. DOI: 10.1111/all.14414. Epub 2020 Jun 24.. PMID: 32438514

[4] Tsoumani M, et al. (2022) Allergy to Peanuts imPacting Emotions And Life (APPEAL): The impact of peanut allergy on children, teenagers, adults and caregivers in the UK and Ireland. PLoS ONE 17(2): e0262851. https://doi.org/10.1371/journal.pone.0262851.

[5] Du Toit G, Katz Y, Sasieni P, Mesher D, Maleki SJ, Fisher HR, Fox AT, Turcanu V, Amir T, Zadik-Mnuhin G, Cohen A, Livne I, Lack G. Early consumption of peanuts in infancy is associated with a low prevalence of peanut allergy. J Allergy Clin Immunol. 2008 Nov;122(5):984-91. doi: 10.1016/j.jaci.2008.08.039. PMID: 19000582.

6 Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reaction to foods. J Allergy Clin Immunol. 2001;107:191-

7 Lanser, Bruce J., et al. “Current options for the treatment of food allergy.” Pediatric Clinics 62.6 (2015): 1531-1549.

New research reveals challenges facing young people with food allergies and intolerances

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Survey shows over half of young people with a food allergy or intolerance have avoided eating out in the last six months due to their condition.

The results are from a bespoke survey, released by the Food Standards Agency (FSA), in partnership with Allergy UK and the Anaphylaxis Campaign, on the views of young people living with food allergies and intolerances. The survey also revealed that while 67% of respondents reported being aware of the legal requirement of food businesses to provide information on the top 14 allergens, only 14% felt extremely confident asking for allergen information when dining out and 14% reported feeling not at all confident.

The FSA, working with Allergy UK (AUK) and Anaphylaxis Campaign (AC), has launched easy to ASK, a campaign designed to empower young people to ask food businesses about allergens when eating out, so that they can make safe choices. The campaign follows several allergy-related deaths among young people – data shows that children and young adults are disproportionately more prone to die from an allergic reaction than adults.

‘We are delighted to be working with the Food Standards Agency on the Ask the Question project. It is unfortunate that most serious allergy related instances and even deaths happen when young people are eating out, or buying takeaway food. We have communicated extensively with young allergy sufferers to make sure they take responsibility for their condition when eating out, but it is also vital that foodservice establishments take the initiative to help prevent tragic accidents. Ask the Question is a timely development which will provide important materials for foodservice staff and will give allergic consumers more confidence when they go out to eat. We are happy to provide access to our extensive range of information resources to any food business that needs further help and advice.’ Chief Executive, Lynne Regent.

Easy to ASK is also a reminder to businesses to be up front about the provision of accurate allergen information, particularly with this vulnerable group. Asking a customer if they have food allergies could save a life. The campaign includes the simple mnemonic:

  • Always ask about allergies
  • Speak up
  • Keep safe

Research reveals worrying challenges

When meeting new people, 5% of respondents with a food allergy and 11% with a food intolerance reported not telling anyone about their condition at all, potentially risking allergic reactions or fatal consequences. When asked why, some respondents said they felt embarrassed and some said that their condition was too complicated to explain.

Other findings include:

  • 59% reported they tend to visit the same places when eating out
  • 55% reported always researched the menu online before going to a new or unfamiliar place
  • only 9% reported always contacting a restaurant in advance to check they provide allergen information

Food businesses step up

Commenting on the easy to ASK campaign, FSA Chairman Heather Hancock, said:
“We’ve seen real progress in how food businesses approach customers with allergies. However, 60% of the young people surveyed tell us they’ve avoided eating out in the past six months because of their condition.

“Living with a food allergy or intolerance is not easy and can have fatal consequences. Many in this age group will be students starting out at university or college, in new surroundings and with new friends. It’s crucial that they feel confident to speak up and ask for allergen information, and that the people around them make that easier.

“Food businesses have an important part to play in making this age group feel more at ease. They are required always to provide accurate allergen information. Through our easy to ASK campaign, we’re raising awareness and understanding to boost the confidence of young people, and we’re encouraging food businesses to make it easier for everyone to ask the question, speak up and help keep those at risk safe.”

Speaking for the Anaphylaxis Campaign, Lynne Regent, CEO, commented:
“We are delighted to be working with the Food Standards Agency on the easy to ASK campaign. It is unfortunate that most serious allergy related instances and even deaths happen when young people are eating out, or buying takeaway food.

“We have communicated extensively with young people with an allergy to make sure they take responsibility for their condition when eating out, but it is also vital that foodservice establishments take the initiative to help prevent tragic accidents.

“The easy to ASK campaign is a timely development which will provide important materials for foodservice staff and will give allergic consumers more confidence when they go out to eat. We are happy to provide access to our extensive range of information resources to any food business that needs further help and advice.”

Survey report

Young people and food allergies/intolerances was conducted by the Food Standards Agency in partnership with Allergy UK and Anaphylaxis Campaign. The survey is based on responses from 2599 young people aged 16-24 in the UK.

Many respondents skipped some of the questions. Therefore, tables are based on the respondents to the relevant question, rather than all 2599 respondents.

Statement regarding the death of Sadie Bristow

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The Anaphylaxis Campaign is saddened to learn of the death of talented young tennis player Sadie Bristow, a 9-year-old from Canterbury, following a tragic accident in August this year as a result of a severe allergic reaction. Sadie Bristow was known to have a milk allergy and nut allergy and have asthma and eczema.

Our general advice on managing a severe allergy is:

Carrying your medication

If you have been prescribed treatments for your allergy — such as injectable adrenaline — the golden rule is, carry it everywhere at all times, with no exceptions. It’s important to make sure others are aware of what to do when a reaction occurs, such as relatives and close friends.

Asthma control

If you have asthma as well as allergies, your asthma should be well controlled. Poorly-controlled asthma will raise the chances of any allergic reaction being severe. If your asthma needs more treatment than usual, you should take extreme care to avoid those foods or substances that might cause a reaction. You will also need to discuss your asthma with your GP.

If you suspect a reaction is serious or becoming serious, use your injector immediately, any delay could be extremely serious. Dial 999 or get someone else to do it. Immediately after your adrenaline has been administered, you will need to get to hospital because the symptoms can return and you may need further treatment.

Symptoms to look out for:

Children may appear weak and ‘floppy’. Swollen lips and/or eyes, itchy skin or a rash like hives, wheezing and finding it hard to breathe or speak, feeling faint, dizzy or confused, vomiting or having diarrhoea are just some of the symptoms of severe allergy and need immediate action. This is by no means a full list of symptoms, so always speak to your doctor about what you should watch out for.

Sometimes there are other factors that on the day can increase the severity of your reaction. These are called co-factors and these can include exercise, feeling unwell with a viral illness, alcohol and tablets, such as some painkillers.

For some people with allergies, more serious reactions such as anaphylaxis may only occur if they have eaten a specific food, or taken the medication to which they are allergic, then they exercise. People with asthma and allergies are known to be more at risk of severe reactions than those without.

Lynne Regent, Chief Executive of the Anaphylaxis Campaign, said:

“We are deeply saddened to learn about the death of Sadie Bristow as a result of this tragic incident. Our heartfelt condolences go out to Sadie’s family and friends at this difficult time. Sadly, we also know teenagers and young people are a particular at risk group.

“We continue to highlight our advice for all people living with allergies or intolerances to always carry two adrenaline auto-injectors if prescribed, ensure that you have well managed asthma and for people with food allergies, they must read the ingredient list every time they buy a product, even if they have bought it before.

“We would welcome anyone with an interest in managing allergies to become a member of the Anaphylaxis Campaign to receive information, advice as well as our personalised alerts, factsheets and our online courses.”

 

If you have any concerns or questions, please contact our helpline team at info@anaphylaxis.org.uk or call 01252 542 029.

For further information, please contact our press office via press@anaphylaxis.org.uk or call 01252 893 862.