Integrated approaches to food allergen and allergy risk management - ifaam

Transcription

1 Manchester Institute of Biotechnology Integrated approaches to food allergen and allergy risk management - ifaam Clare Mills, Kirsten Beyer, Lars Poulsen, Steve Taylor, Sabine Baumgartner, Rene Crevel, Sabine Schnadt, Ronald van Ree

2 Declaration of interests Current Funding: UK Food Standards Agency UK Biological and Biotechnological Sciences Research Council UK Medical Research Council European Union European Food Safety Authority NW Lung Centre Charity Reacta Biotech Ltd In-kind sponsorship of students and collaborations Waters Corporation, Romer Laboratories Ltd, Fera, LGC, Marks and Spencer, PeptiGel Design, Unilever Spin-out company ReactaBiotech Ltd

3 Mandatory labelling of ingredients has helped allergic consumers.but what about all the precautionary labelling..and freefrom foods allergic consumers can trust? As well as managing allergenic ingredients in recipes, what about managing the use of common utensils in fast-food outlets?

4 Managing food allergies needs data which have been lacking. How many people suffer from food allergy in Europe? Which are the major foods? What is the relationship with severity/minimum eliciting doses? What are the risk factors/causes? What is the impact of quality of life? How much does food allergy cost society?

5 The Prevalence, Cost and Basis of Food Allergy Across Europe (IP, 4 years 7months; 14.3M) Investigating environmental, dietary & genetic influences on food allergy. Delivering information (patterns & prevalence, socioeconomic cost) & new tools to improve management 63 Partners from 23 countries including Europe (UK, NL, D, B, S, F, I, IRL, E, GR, PL, CZ, HU, lt CH, A, DK, IS, BG, RU)Africa (Ghana) and Asia (India, China) with collaborating centres from USA, Canada, NZ and Australia

6 Integrated Approaches to Food Allergen and Allergy Management (IP, 4 years, 9M) Developing evidence-based approaches and tools for MANAGEMENT of ALLERGENS in FOOD Integrating knowledge derived from their application into FOOD ALLERGY MANAGEMENT plans and dietary advice. Reducing the burden of food allergies in Europe and enabling the European food industry to compete in the global market place. 43 Partners from 16 countries including Europe (UK, AU, BE, DK, CH, CR, DE, FR, IE, IS,IT, ES, GR, LT, NL,PL,), Turkey, USA and Australia.

7 Objective 1: Nutrition and allergy throughout life (Module 1) Objective 2: Risk factors and severity (Module 2) Objective 3: Validated Risk Models (Module 3) Objective 4: Tools for Allergen Management (Module 4) Early life nutrition and allergy Dietary interventions for allergy prevention Biomarkers for severe reactions to food Intrinsic and extrinsic risk factors Modelling allergenic risk Clinical evidence and validation of models Multi-analyte allergen analysis Clinically-relevant analysis Objective 5: Delivery of evidence-based integrated tools for food allergen and allergy management across the food chain to key stakeholders groups (Module 5) INNOVATION, INDUSTRIAL COMPETITIVENESS AND SMEs

8 Early Life Nutrition and Allergy (Kirsten Beyer with Thomas Keil and Gideon Lack) Currently advice is that Women with a family history of allergy are encouraged to feed their babies only on breast milk for the first 6 months Introduction of allergenic foods, like milk, eggs, wheat, nuts, peanuts, seeds, fish and shellfish should be phased after 6 months of age However, we lack the evidence on which to base such guidance!

9 EuroPrevall Birth cohort (Kirsten Beyer, Thomas Keil, Linus Grabenheinrich, Berlin) final size ~ 12,000 National funding Follow-up 2.5 years Study planning Ethical approval Recruitment Mo 12,200 newborns (8,625 target) Follow-up until 2.5 years old

10 The cohort data shows geographic differences in incidence of food allergy Incidence is highest (~1.25%) in UK, The Netherlands and Lithuania There is v little allergy to cow s milk in Athens and NO reported allergy to peanut

11 What underlies these differences? And how do they change as the children grow up? The ifaam follow-up of the EuroPrevall cohort sought to provide data on how early life nutrition affects allergy outcomes It will also provide further challenge data in an unselected population and information on how patterns and prevalence of food allergies change Data were also consolidated from randomised controlled trials of early instruction of allergenic foods in the UK [EAT, LEAP], Germany [PEAAD, HEAP] and Australia [STEP, STAR, BEAT]

12 Risk Factors and Severity (Ronald van Ree with Montserrat Fernandez-Rivas and Lars Poulsen) Currently we cannot predict which individuals might experience a severe allergic reaction. There are three factors that appear to be involved in driving more severe reactions, Food and food allergens themselves, Patient-associated intrinsic factors Patient-associated extrinsic factors

13 Certain foods seem to elicit more severe reactions than others patterns of anaphylaxis in EuroPrevall outpatient clinic study A key activity in ifaam is to mine these data sets to identify risk factors associated with severity of reaction peanut hazelnut walnut shrimp milk fish celery sesame seed egg apple kiwi sunflower pine nut peach banana soybean lentil tomato wheat corn cabbage Anaphylaxis to foods in the EuroPrevall Outpatient Clinic Survey (Montserrat Fernandez-Rivas, Madrid)~ 2,200 patients recruited)

14 FOOD MATRIX: Does food structure affect the release of allergens during digestion and hence severity of reactions? Cookies and the EuroPrevall chocolate dessert? Challenges being undertaken with peanut and hazelnut in UK, CH and DK M r (kda) S Stomach Gastric secretion S 11S Mousse Placebo Active 12 m 24 m 36 m 48 m 60 m 72 m 2S 84 m Pepsin Spinal column Alan Mackie and Paul Malcolm (N&N Radiology)

15 ALLERGEN STRUCTURE: Do proton pump inhibitors (PPIs) affect the susceptibility of Bet v 1 homologues to digestion and hence clinical reactivity to foods? Bet v 1 homologues are susceptible to gastric digestion if modified with PPIs this may affect clinical reactivity of foods In contrast 2S albumins (e.g. Ara h 2/6) would be unlikely to modify allergic reactions driven by

16 PATIENT-ASSOCIATED RISK FACTORS Is severity linked to threshold? It might be but we do not know. Host-related factors may play a role The ifaam team are assessing the impact of antacids and infections. The impact of exercise and stress (sleep deprivation) were explored in TRACE (Andy Clark, Addenbrooks, Bob Boyle, Imperial, Clare Mills, UNIMAN)

17 Module 3: Risk Models (Steve Taylor with Astrid Kruizinga, Jonathan Hourihane, Rene Crevel) Developing tools for allergen tracking and managing contamination UAP Identification As an ingredient in ALL recipes Ensure appropriate contains labeling is applied How does the allergen enter the facility? As an ingredient in some recipes UAP in an ingredient Consistent? Concentration? Dilution in Recipe? Done Process vulnerability assessment Supplier Issues Linked to clinical validation through single dose challenges contamination and community studies

18 Voluntary Incidental Trace Allergen Labelling (VITAL) Scientific Expert Panel Proposed Action Levels Allergen Reference dose (mg Protein) Action Level (ppm) per serving size 5 g 50g 250g Peanut Milk Egg Hazelnut Soy Wheat Tree nuts Mustard Lupine Sesame Shrimp No VITAL reference dose has been identified for fish and celery due to lack of data

19 Allergic reactions in the community (AlleRiC) Audrey Dunn Galvin, Aida Semic-Jusufagic, Angela Simpson, Chris Munro The AlleRiC web-based interface has been developed in collaboration with the UK Anaphylaxis Campaign and Anaphylaxis Ireland The tool is being evaluated and refined It will be used to collect data on reactions in 100 foodallergic individuals regarding allergic reactions they experience in daily living

20 Probabilistic risk assessment for management of allergenic risks Tool is QUANTITATIVE requires expert input and interpretation Data Surveys Consumption Analyses Levels Clinical studies Distributions Allergen intake Thresholds Probabilistic model OUTCOME Probability of an allergic reaction Spanjersberg et al Food Chem Tox (2007) 45: 49-54; Madsen et al Food Chem Tox (2009)

21 Module 4: Tools for Allergen Management (Sabine Baumgartner [AT] with Karine Adel-Patient [FR]) This aspect is focussed on the Development of effective multianalyte analysis tools potentially suitable for infactory testing or confirmatory in-laboratory analysis Defining how the performance of these tools relates to the nature of the allergenic hazard they are attempting to quantify. Focussed on egg, milk, peanut, hazelnut and walnut

22 Helping to inform industry when to use PAL Helping patients to understand what PAL means for them How much is too much? [informing what to measure and how low do we need to go] Measuring how much [making sure we are measuring what is important and at a relevant level]

23 What next?

24 Manchester Institute of Biotechnology Detection and quantification of allergens in foods and minimum eliciting doses in food allergic individuals (ThRAll) GP/EFSA/AFSC, 2017/03 Clare Mills, Chiara Nitride, Rosa Pilloli, Christoff van Pouke, Marc de Loose, Nathalie Gillard, Ann Catherine Huet, Olivier Tranquet, Karine Adel-Patient, Linda Monaci Development of Quality Control Materials for Food Allergen Analysis FS Michael Walker, Gill Holcombe, Clare Mills, Chiara Nitride AFSCA-FAVV

25 All only possible through the 63 EuroPrevall partners and collaborating centres AND those individuals who have participated in the studies!