DBV Technologies, the firm that received the Food and Drug Administration’s (FDA) Breakthrough Therapy Designation for their peanut patch in April, issued a press release stating that the board overseeing their milk patch Phase I trial found no safety concerns and is recommending the therapy progress on to Phase II.
Phase I studies focus on the safety of a new therapy while Phase II studies focus on a therapy’s efficacy. Pending a review of the Phase I data by the FDA and approval of the proposed Phase II protocol, the firm expects to continue on to the Phase II study in the second half of 2015.
DBV describes Viaskin® as “an electrostatic patch, based on Epicutaneous Immunotherapy, or EPIT®, which administers an allergen directly onto the superficial layers of the skin to activate the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the bloodstream.” In other words, the patch therapy introduces increasing quantities of an allergen through the skin and by doing so desensitizes the individual to that allergen.
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A team from the University of Pennsylvania identified 233 quick-service restaurants in the Center City District of Philadelphia and conducted a study of the 187 that agreed to participate. Staff were asked to respond to a tablet-based survey that assessed their knowledge, attitudes, and practices related to food allergy.
The results were both heartening and disturbing: “Despite their high motivation to help food allergic patrons, respondents knew little about how to prevent or respond to adverse events,” as quoted in the summary on the American Public Health Association (APHA) website.
In a study of discharge data collected over 5 years from over 200 hospitals in Illinois, it was determined that emergency room visits and hospitalizations of children with severe food allergies rose an average of 30% each year between 2008 and 2012.
The study, led by Dr. Ruchi Gupta, professor of pediatrics at Northwestern University Feinberg School of Medicine and attending physician at Ann & Robert H. Lurie Children’s Hospital of Chicago, focused on children that suffered anaphylaxis, a potentially fatal allergic reaction.
Previously, white children and those from higher-income families were affected most by food allergies, but the study shows that the rates of Hispanic, African American and lower-income children are skyrocketing as well.
“This study shows that severe food allergies are beginning to impact children of all races and income. This is no longer primarily a disease of children who are white and/or from middle-to-high income families. Nobody is immune to it,” said Dr Gupta.
In a study to be presented at the ongoing American Thoracic Conference (ATS) 2015, it was determined that many children suffering from asthma have a sensitivity to peanuts but their families are unaware.
“Many of the respiratory symptoms of peanut allergy can mirror those of an asthma attack, and vice versa. Examples of those symptoms include shortness of breath, wheezing and coughing,” said study lead author Robert Cohn, MD, MBA. “This study aimed to evaluate the proportion of asthmatic children who also demonstrated a sensitivity to peanuts.”
The study researched the charts of 1517 children diagnosed with asthma at Mercy Children’s Hospital in Toledo, Ohio. Of the charts reviewed, 665 (43.8%) had IgE testing for peanuts, and of this group 148 (22.3%) had positive results.
Of the children with positive IgE tests, more than half (53%) of the children and their families did not suspect there was any sensitivity to peanut.
A study of the accidental exposure of children with physician-confirmed peanut allergy was published in the Journal of Clinical and Translational Allergy earlier this month.
The parents of 1941 children were recruited from Canadian allergy clinics and allergy advocacy organizations over a ten year period beginning in 2004, who completed questionnaires regarding the accidental exposure to peanuts of their children over the preceding year and the results were correlated.
Food challenge: where the patient consumes a food they may be allergic to while the medical staff hovers nearby, ready to inject epinephrine if the symptoms of a severe allergic reaction appear. Low-tech, dangerous, and the only reliable way to test how severely someone may react to an allergen. Until now.
A blood test resulting from a study led by researchers from The Mindich Child Health and Development Institute and the Jaffe Food Allergy Institute promises to predict which people will have severe allergic reactions to specific foods. The study was published yesterday in The Annals of Allergy, Asthma & Immunology accompanied by a press release by Mount Sinai.
Current testing relies on skin pricks and blood tests that detect proteins called allergen-specific IgE produced by the immune system, though these cannot accurately predict the severity of reactions. The study reports that measuring another immune system component, the basophil, can accurately predict how a person will react to specific allergens. The basophil activation test (BAT) requires only a small amount of blood and provides quick results.
“While providing crucial information about their potential for a severe allergic reaction to a food, having blood drawn for BAT testing is a much more comfortable procedure than food challenges.” says first author Ying Song, MD. “Although food challenges are widely practiced, they carry the risk of severe allergic reactions, and we believe BAT testing will provide accurate information in a safer manner.”
Note that BAT testing is currently only approved for research study.
There’s a good reason why we refer to Erin Brockovich as “The Robyn O’Brien of Environmental Issues”.
Ms O’Brien – author, TED speaker, founder of AllergyKids Foundation, and leading advocate for clean, safe, affordable food – hits yet another ball out of the park with her editorial on the recent LEAP (Learning Early about Peanut Allergy) Study. In it, she excoriates the media, study’s authors, and quoted physicians for a lack of disclosure regarding the funding and selection of subjects for the study.
Here’s a sample from the article:
That’s like conducting a diabetes study on sugar and throwing out the diabetics before you start. It skews the results to suggest a false positive when if the food had been given to the entire population, without pre-screening, the results would have been entirely different.
On February 23rd at this year’s annual meeting of the American Academy of Allergy Asthma and Immunology (AAAAI) in Houston, a study was presented regarding incidence of anaphylaxis in schools during the 2013-2014 school year, confirming the need for stock epinephrine.
Of 5683 schools that responded to the study survey, a total of 919 anaphylactic events were reported by 11% of the schools. Here’s a quick breakdown:
Live Attenuated Influenza Vaccine (LAIV) is an intranasal flu vaccine in widespread use. Since the vaccine contains egg protein, it has been contraindicated for use by children with egg allergy, and North American guidelines also recommend against its use in asthmatic children.
In a British study funded by the Department of Health UK and published in the Journal of Allergy and Clinical Immunology (JACI), 433 doses of LAIV were administered to 282 children with egg allergy, 41% of which had experienced prior anaphylaxis to egg and 67% had a physician’s diagnosis of asthma or recurring wheeze with 51% receiving regular preventer therapy.
A study by researchers of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), may shed light on why women suffer more frequent and more severe instances of anaphylaxis than men.
Anaphylaxis – a life threatening allergic reaction triggered by foods, medication, and animal stings and bites – occurs when immune cells release enzymes that cause tissues to swell and blood vessels to widen. Clinical studies have shown that women experience anaphylaxis more often than men, though the mechanism for this has not been clearly understood.
NIAID researchers found that female mice experienced more severe and longer lasting anaphylactic reactions than males. They discovered that Estradiol – a type of estrogen – enhances the effect of endothelial nitric oxide synthase (eNOS), an enzyme that causes a number of symptoms of anaphylaxis.
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