11 to 26 million people suffer from food allergy in Europe while at the global level, the estimate is 220 to 500 million people (source: White Paper allergy, WAO, 2011). 3 to 5% of Americans suffer from food allergies and the prevalence of peanut allergy in children has almost quadrupled from 1997 to 2008. (source : Sicherer et al JACI 2010 ;125 :1322-6).
As has been said, food allergies can cause extremely dangerous reactions and can lead to anaphylactic shock. Food allergies (mainly groundnut) are responsible for 150-200 deaths each year in the United States (source: Keet CA, Wood RA. Immunol Allergy Clin N Am 2007, 27 :193-212) and more than 125 000 emergency admissions (source: Sicherer et al. Immunol.2001 Ann Allergy Asthma).
For this reason, there is no treatment in clinical use for these daily food allergies that may be life threatening. The existing methods of desensitization, whether injections or oral, do not treat them because of the systemic reactions that it can lead to and so far, the eviction of the offending food was the only solution.
The list of foods implicated in anaphylactic reactions is long, but few foods are responsible for the vast majority of severe anaphylactic reactions. In Western countries, peanuts and tree nuts, egg, fish (eg: cod and whitefish) and crustaceans (shrimp, lobster, crab, scallops, oysters) are the foods more often involved in fatal or serious reactions. It should be noted that these foods also tend to induce "persistent sensitivity" in the vast majority of patients, unlike other foods such as milk, eggs and soybeans that are just as dangerous but whose allergic effects often disappear with time.
Food anaphylaxis reactions account for more than one third of anaphylactic reactions treated in emergency departments and are most often due to peanuts. In children, the food polyallergies are frequent and heavily impact everyday life.
As regards more particularly peanut allergy, a national survey in the United States indicated that approximately 1.1% of the general population in this country, more than 3 million people are allergic to peanut and / or nuts (source: Sicherer et al. 1999a). Two recent studies in the U.S. and the UK have shown that peanut allergy has doubled in five years among children under 5 years of age (source: Grundy et al., 2002, Sicherer and al., 2003). It is therefore very likely that peanut allergy gradually increases in the general population as it ages. The prevalence of peanut allergy in other Western countries (Canada, France, Spain) was studied by many authors and is between 0.9 and 1.5% (source: Crespo et al. 1995; Kanny et al. 2001; Kagan et al., 2003). In Sweden, the peanut sensitization determined by IgE tests was estimated at 3.3% of the population (Van Odijk et al., 1998).
This allergy affects children: it is estimated that peanut allergy affects 1.8% of young children in the United Kingdom (Hourihane et al., 2007, Du Toit et al., 2008). Peanut allergy is a major cause of fatal food reactions or threatening death, making it a major health concern worldwide, especially in developed countries where prevalence has increased over the last ten years. Peanut allergy is usually considered a persisting indoor allergy, in fact, many studies indicate that less than 20% of children are likely to have their peanut allergy disappear.
Allergy to cow's milk is the most common food allergy in infants and young children, affecting 2-3% of the general population. Sensitization to milk at the age of one year is a predictor of increased sensitization of peanut at the age of 3 years. The resolution rates were 19% at the age of 4 years, 42% at the age of 8 years, 64% at the age of 12 years and 79% at the age of 16. The rate of specific IgE to cow's milk during the first year is a good predictor of disease progression: the more, the higher the child is likely to remain allergic to cow's milk all his life (Skripack, JACI 2007).
The Following table summarizes the major food allergens in children for which first allergies could disappear and in adults, with the predominance of peanuts (and nuts) and crustaceans.
Worldwide, the incidence of food anaphylaxis appears to vary depending on eating habits in different regions. An international study conducted finds that 1 to 3 persons out of 10 000 are victims of anaphylactic shock.
Five U.S. studies using medical and administrative databases were used to estimate the incidence of food anaphylaxis (source: Boyce et al., NIAID guidelines - 2010). The rate of hospitalization or visits to emergency departments due to anaphylaxis varies with the study and the methods used and the population studied: it is between 1/100 000 et 70/100 000, the proportion of anaphylaxis due to food is between 13% and 65%. This rate depends on the criteria used for the diagnosis of anaphylaxis.
Although there are differences in methods in such studies, all show an increase in hospitalizations over the past 10 years due to food anaphylaxis. Thus, a recent American study shows an increase of 350% of hospitalizations of children under 18 due to a food allergy diagnosis: 2600 between 1998 and 2000 against 9500 between 2004 and 2006 (source: Branum AM, et al. Food Allergy Among Children in the United States. Pediatrics 2009; 124:1549-1555). This increase may be due to both increased prevalence and increased general awareness of the problems of allergy.
The majority (50-65%) of fatal anaphylaxis patients are caused by peanut allergy (source: Keet CA, Wood RA. Food allergy and anaphylaxis. Immunol Allergy Clin N Am 2007; 27:193-212).
While food anaphylaxis represents between one third and half of anaphylaxis treated in emergency departments in North America, Europe and Australia, it appears to be uncommon in countries whose inhabitants do not have a diet "Western", as in China, for example.
Today, the only option for patients with food allergy, especially for the most serious cases, is to strictly avoid the foods they are allergic to and learn how to recognize and treat allergic reactions caused by accidental exposure. However, allergens can be hidden in foods that are not suspected, labeling is often misleading and contamination by food not supposed to contain food allergens occur regularly. Therefore, a strict foreclosure is difficult to obtain. For example, the accidental ingestion of peanuts by a patient allergic to peanut is relatively common and causes severe reactions or death. Accidental exposure to peanut occurs every three to five years for the same patient, the annual incidence of accidental ingestion was 14% (Source: Yu et al., 2006).
Thus, a general treatment and safe food allergy has always been a goal for allergists.
Among the potential allergen immunotherapy (ITS) specialists available to food allergies, subcutaneous immunotherapy (SCIT) has raised serious security concerns. Similarly, sublingual immunotherapy (SLIT) and oral immunotherapy (ITO) have been studied in humans. However, despite encouraging results with different types of food allergies (egg, nuts, milk, peanuts), these methods require deeper clinical research and its safety concerns - including a high proportion of severe systemic reactions - limit their development in standard treatment for food allergies.
Taking into account all these factors, there is a clear and important unmet medical need for safe and effective treatment of food allergies, and among the possibilities of ITS as a cure for food allergies, EPIT (Epicutaneous Immunotherapy) as it is developed by DBV Technologies is able to combine clinical benefits and good safety profile, enabling it to consider releasing in the long run an innovative therapeutics to the market.
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