Pediatric & Adult
55 Walls Dr., Fairfield, (203) 259-7070
500 Monroe Tpk, Monroe, (203) 445-1960
Dr. Kenneth Backman, Dr. Katherine Bloom, Suzanne Hines, APRN, and Jill Ross, APRN
Posted on January 22, 2015 | Permalink
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We are often asked about oral immunotherapy to foods such as peanut. These treatments are still considered experimental and are as yet unapproved by the FDA. However, studies have been ongoing, and FDA approval may occur within the next year. Please see this article from the American Academy of Allergy, Asthma, and Immunology for the latest information about immunotherapy to foods. https://www.aaaai.org/conditions-and-treatments/library/allergy-library/oit
Due to the snowstorm and forecast of dangerous driving conditions throughout the day, Allergy & Asthma Care of Fairfield County will be closed today, Tuesday, February 12. We sincerely apologize for any inconvenience this may cause. Please call our office tomorrow, Wednesday, to reschedule any appointments.
An FDA-approved treatment for food allergy is closer to reality after Aimmune Therapeutics announced that its large, Phase 3 trial for AR101, an oral immunotherapy treatment, met all the endpoints set out by the Food and Drug Administration. “For the first time in the history of food allergy, a large-scale, late-stage clinical trial has shown that oral immunotherapy, done with our investigational medicine, AR101, significantly increased the amount of peanut protein that a patient could consume with no more than mild symptoms,” CEO Stephen Dilly said on a call to investors on Feb. 20.
At the end of the one-year study, about two-thirds of peanut-allergic patients were able to eat 600 milligrams, or approximately two peanuts, which was considerably more than the placebo group. An impressive number were able to tolerate even more at one sitting. The company plans to file for approval with the FDA at the end of 2018 and, if approved, begin rolling out the treatment midway through 2019.
With AR101, patients eat a carefully processed and measured amount of peanut powder (held in a capsule, then opened and sprinkled in food) on a daily basis. The amount of protein powder in the capsule starts out minuscule, and gradually increases until it reaches a maintenance dose amount of 300 mg, or approximately a peanut.
In the Phase 3 trial, dubbed PALISADE, patients worked up to the maintenance dose of 300 mg for about six months, and then stayed on that dose for another six months. At that point they were evaluated with an oral food challenge by a clinician who had not been involved in their treatment thus far, to minimize any chance of bias. Out of the 496 patients treated in the study, 372 were in the active treatment arm, while the other 124 were given a placebo. Of the 372 patients on AR101, 67 percent tolerated a single dose of 600 mg at the end of the study, or about two peanuts. Only 4 percent of the placebo arm tolerated 600 mg.
“The intent of our drug is not to necessarily allow patients free range on peanuts, but rather to protect them from accidental and inadvertent exposures that are part and parcel to everyday life,” Dr. Daniel Adelman, chief medical officer for Aimmune, told investors on the call.
The patients chosen for the study were considered highly sensitive – almost three-quarters had a history of anaphylaxis, more than half had asthma, and two-thirds had multiple food allergies. None of the patients were able to tolerate more than 30 mg, or one-tenth of a peanut, at the beginning of the study. Over the course of the treatment, about 20 percent of patients on AR101 dropped out, a rate that’s consistent with other oral immunotherapy trials. Twelve percent left the study due to adverse events, with the most common reason being gastrointestinal symptoms. Ten patients (2.7 percent) experienced systemic reactions, including one case of severe anaphylaxis requiring epinephrine and an overnight hospital stay. The other 8 percent left for non-study-related reasons, including moving out of the area, study fatigue or school commitments.
On the patients who experienced reactions, Dilly emphasized: “This is a drug to be used by allergists who know who to manage the spectrum of allergic reactions as part of their routine practice of desensitization therapy.”
When you look only at the patients who completed the treatment, the therapy looks more successful. A full 96 percent were able to tolerate the equivalent of one peanut, 85 percent were able to tolerate the equivalent of two peanuts, and 63 percent were able to tolerate the equivalent of three peanuts. The company believes that the number of patients who will tolerate higher amounts of peanut will go up the longer they are on the maintenance dose.
Data from two other ongoing Phase 3 trials, one an extension of PALISADE and the other looking at AR101 in real-world clinical settings, is required for AR101’s submission to the FDA. The company is also looking at a much younger study population, as well as adults, where they are so far also seeing favorable results.
“Many patients rely on self-injectable epinephrine products, such as EpiPen, to reverse life-threatening reactions to bee stings or other allergens for either themselves or for their children. We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season. We’ve completed the necessary reviews of the data to extend the expiration date by four months for specific lots of EpiPen that are expired or close to expiring. We’re hopeful this action will ensure patients have access to this important medication and provide additional peace-of-mind to parents as the agency works with the manufacturer to increase supply,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA remains committed to using all of the tools available to help prevent and mitigate drug shortages of medically necessary products used to prevent or treat a serious or life-threatening disease or medical condition.”
The U.S. Food and Drug Administration today took additional action to mitigate shortages of EpiPen (epinephrine) auto-injector by extending the expiration date of specific lots of 0.3 milligram products marketed by Mylan by four months beyond the labeled expiration date. This change beyond the approved 20-month shelf life is based on stability data provided by Mylan and reviewed by the FDA. To help ensure patient safety, these products, which already have been dispensed to patients, should have been — and should continue to be — stored as labeled.
While product is currently available, multiple factors, including regional supply disruptions and manufacturer issues, have contributed to EpiPen’s limited availability in certain areas in the U.S. The FDA continues to work closely with Mylan on EpiPen production and supply, and also has been in contact with the other manufacturers of epinephrine auto-injectors, including Adrenaclick and Auvi-Q, regarding their supply as the school year begins since this is historically accompanied by increased product demand. The agency also recently approved the first generic version of EpiPen.
The FDA has granted Breakthrough Therapy designation to omalizumab (Xolair, Genentech), a subcutaneous injection therapy indicated for atopic conditions which could become the first treatment approved for the prevention of severe food allergy reactions.
Omalizumab was granted the designation to expedite its regulatory development and review as a potential therapy for serious or life-threatening conditions. The designation was based on data from 7 clinical trials over the past decade, which assessed omalizumab’s efficacy and safety versus various food allergens, such as peanut, milk, and egg.
The trials, which assessed omalizumab as both a monotherapy or in combination with oral immunotherapy, were supported by both Genentech and individual sponsors, such as the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). Genentech and Novartis Pharmaceuticals are currently working with the NIAID and the Consortium of Food Allergy Research to launch a potentially pivotal study assessing the efficacy and safety of omalizumab in multiple food allergies, with details coming at a later date.
Omalizumab was previously approved by the FDA to treat moderate to severe persistent asthma in patients aged 6 years or older whose asthma symptoms are not controlled by inhaled corticosteroids, as well as chronic idiopathic urticaria in patients 12 years and older who continue to have hives that are not controlled by H1 antihistamine treatment.
To read the full article, visit MdMag.com.
Dr. Kenneth Backman of Allergy and Asthma Care of Fairfield County comments: "This is incredibly exciting news for food allergy sufferers. Up until now, avoidance has been the only treatment proven safe and effective for preventing allergic reactions to food. While oral immunotherapy is being studied, it is still considered experimental and not recommended by food allergy researchers or allergy societies. Xolair offers the ability to reduce the likelihood of severe allergic reactions to foods without the risk associated with ingesting the food allergen daily, as is done in oral immunotherapy, which often triggers reactions including anaphylaxis, and carries the risk of complications such as eosinophilic esophagitis. We are hopeful that Xolair will obtain rapid approval for use in food allergies, and look forward to the protection and relief it will provide to countless patients."
Posted on August 21, 2018 | Permalink
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Asthma and respiratory viruses don't go well together. Weakened by the common cold or the flu, a person suffering an asthma attack often responds poorly to emergency treatment; some must be hospitalized. This is especially true for preschoolers. But what if there were a simple solution to help ward off the double whammy of an asthma attack and a respiratory virus? Well, there is one: to prevent getting sick, asthmatics can get an annual flu shot. Unfortunately, however, only about 60% do, but that might change.
In a new study in the journal Pediatrics, researchers at the Université de Montréal-affiliated CHU Sainte-Justine children's hospital and a master's student in epidemiology at McGill University make a strong case for vaccinating asthmatic kids against flu. Just over 1 in 10 Canadian children have asthma, about 600,000 under the age of 12. The chronic disease often starts in early childhood—before age six years, in the preschool years. "These kids should get their flu shot and they should get it systematically—it's worth it," said study coauthor Francine Ducharme, a pediatrician and clinical epidemiologist at CHU Sainte-Justine who's a professor of pediatrics at UdeM.
"We now know that if these kids get the flu the risks are very high that emergency treatment for an asthma attack will fail," said Ducharme. "Instead of having an overall 17% risk of treatment failure, with flu their risk rises to almost 40%." The study is based on the national DOORWAY (Determinants Of Oral Corticosteroid Responsiveness in Wheezing Asthmatic Youth) study that Ducharme and colleagues conducted between 2011 and 2013, with funding from the Canadian Institutes of Health Research. That study looked at close to 1,000 children treated for moderate or severe asthma attacks in emergency rooms at Sainte-Justine, the Montreal Children's Hospital, and three other Canadian hospitals. Nose swabs were taken and analyzed to see if the children also had the flu or other respiratory viruses when they came to the ER.
It turned out almost two-thirds did. Yet when the kids with respiratory viruses were given the standard treatments for their asthma attack—oral corticosteroids and inhaled bronchodilators—20% didn't respond and in most cases needed to be hospitalized. Those with influenza or parainfluenza turned out to have a 37% or more chance of not responding to treatment, compared to 13% for children without a virus. Failure was also high in kids with respiratory syncytial virus (RSV).
By contrast, kids with strains of human rhinoviruses (HRVs)—the usual cause of the common cold—did respond well to treatment for their asthma. To the researchers, this was very reassuring, as HRVs are the most frequent trigger of asthma attacks necessitating a visit to the ER.
"This is the first time we've been able to disentangle the risk of non-response to asthma treatment with the presence of specific viruses—specifically, influenza and rhinovirus," said coauthor Caroline Quach, an associate professor of microbiology and infectious diseases at UdeM, chair of the Quebec Immunization Committee, and chair of the National Advisory Committee on Immunization of the Public Health Agency of Canada. "The more than 20% higher absolute risk of treatment failure in flu cases is very significant."
There's also a simple solution, but with hurdles, she added. "Influenza is the only respiratory virus that is vaccine-preventable. Granted, it's at best only 50% efficacious, but that's no reason for kids with asthma not to get vaccinated yearly, in the fall, before flu season starts. We can start as young as age 6 months. Asthma is not usually diagnosed that early, but in Quebec every child who is diagnosed with asthma is eligible for influenza vaccination. The problem is that not many parents are prevailing themselves of the opportunity."
A major reason is access. Getting a flu shot often means an extra trip to a physician's office clinic, and not all parents can or want to take the time to get it done. "It's an additional step, so what we're trying to promote is that kids get vaccinated where they get care—at Sainte-Justine, for example, where children can be vaccinated onsite at our asthma, respiratory, or general pediatric clinics."
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "We have long known of the link between viral infections and asthma exacerbations. This study is unique in that it quantifies the relation between treatment response and specific infections. This study once again emphasizes the importance of influenza vaccination in all asthma patients. Our office offers influenza vaccination to all of our patients."
Babies who are given antacids or antibiotics during their first 6 months of life may have a sharply higher risk for allergies or asthma, a large new study warns. The finding is based on an analysis of health records of more than 792,000 children born between 2001 and 2013. While the study does not prove that the medications cause allergy, lead author Dr. Edward Mitre said the links appear to be strong. "I did find it striking that we found positive associations between the use of antacid medications and virtually every class of allergy we evaluated," he said. That associated risk "appears substantial and clinically significant," Mitre added.
Infant antacid exposure was linked to a doubling of the risk for developing food allergies, and a 50 percent increase in the risk for developing drug allergies and a hypersensitive immune reaction to foreign toxins, such as a bee sting (anaphylaxis). Exposure to antibiotics appeared to double children's future asthma risk, while prompting a 50 percent increase in risk for allergies to dust, dander and pollen (allergic rhinitis); eye allergies (allergic conjunctivitis); and anaphylaxis, Mitre said.
Mitre suspects "biological reasons" are at play. "Both antibiotics and antacid medications can disturb the normal microbiome," he said, referring to the complex environment of microbes that is critical to a well-functioning immune system. Evidence is mounting that changes in the microbiome can increase allergy risk. Antacids can reduce protein digestion in the stomach, Mitre explained, which may lead to food allergies.
Mitre is an associate professor of microbiology and immunology at the Uniformed Services University (USU) of the Health Sciences' School of Medicine in Bethesda, Md. Mitre and his colleagues published their report online April 2 in JAMA Pediatrics. Co-author Dr. Cade Nylund said that while babies are prone to acid reflux, it's typically not a cause for concern or drug treatment.
"One reason that infants are prone to reflux is the immature anatomy of the infant," he noted. "Another is they have to eat so many calories per body weight. If an adult were to have to take in the same volume as an infant, it would be like drinking roughly two quarts every four hours. If I did that, I would be spitting up, too."
Nyland said that, in most cases, feeding babies smaller and more frequent meals and burping them often is preferable to giving them antacids. He is an associate professor of pediatrics at USU, and program director of the pediatric gastroenterology, hepatology and nutrition fellowship at Bethesda's National Capital Consortium.
Added Mitre: "There are certainly some infants with severe gastroesophageal reflux who warrant medical therapy, but it is probable that the vast majority do not." Still, the team found that about 8 percent of the children in their analysis had been prescribed an antacid during their first six months of life. All were enrolled in the military health system within 35 days of birth and stayed enrolled for at least a year. Investigators looked at their early medication exposure and the onset of allergies and asthma over an average period of 4.6 years.
The study findings underscore well-known risks of antibiotics and counter the belief that acid-suppressives are harmless, Mitre said. "Given the association we and others have found between acid-suppressive medications and allergy, and given that they are not generally beneficial for infants, this study suggests that antibiotics and acid-suppressive medications should only be used in situations of clear clinical benefit," Mitre concluded.
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "The incidence of allergic diseases continues to rise, and this study suggests two possible contributors. While there are many infants who require these medications, and where the risk of not treating is far greater than the risk of treating, it is important that we consider potential adverse effects of medications, and weigh the risk vs. benefit, before prescribing medications to children."
Posted on April 13, 2018 | Permalink
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Women using short-acting asthma inhalers took longer to become pregnant than women using long-acting inhaled asthma medications and those without asthma, researchers from the University of Adelaide in Australia, have found. The study, published in the European Respiratory Journal, used data from the Screening for Pregnancy Endpoints (SCOPE) study, which included 5600 woman from Australia, New Zealand, the UK and Ireland. The women were all in the early stages of pregnancy with their first child.
Around 10 percent of participants in the study reported that they had asthma. Women treating their asthma with short-acting beta-agonists took on average 20 percent longer to conceive than women without asthma, or those using long-acting inhaled corticosteroids. Short-acting medication takers were also 30 percent more likely to take more than a year to conceive. 'Several studies have identified a link between asthma and female infertility, but the impact of asthma treatments on fertility has been unclear,' said Dr Luke Grzeskowiak from University of Adelaide who led the study.
Asthma is one of the most common conditions affecting women of reproductive age. Today, an estimated 5.4 million people in the UK are receiving asthma treatment, according to Asthma UK. The relationship between asthma and fertility is not well understood. Both women and healthcare professionals have expressed concerns in the past about the safety of using medication to control asthma during pregnancy.
'This large study provides reassurance that using preventers, which include inhaled corticosteroids and long-acting bronchodilators, to prevent asthma symptoms helps asthmatic women be as fertile as non-asthmatic women, while intermittent treatment with short acting relievers is associated with reduced fertility,' said Professor Mina Gaga, president of the European Respiratory Society and medical director of the respiratory department of Athens Chest Hospital.
However, researchers have expressed concern about the interpretation of the results. Professor Kevin McConway, a statistician at the Open University who was not involved in the study, said in a statement: 'Though the researchers found that the women taking only short-term relievers were more likely to take over a year to get pregnant, this effect was not big enough to rule out the possibility that it was simply due to chance.'
Professor Tony Fox, a pharmaceutical medicine researcher at King's College London added: 'The investigators should consider whether patients using symptomatic short-acting bronchodilators are actually treating their asthma less well than those patients using inhaled corticosteroids to prevent asthma attacks from happening in the first place.'
Further studies are planned for women undergoing fertility treatments to see if improving asthma control is able to improve fertility outcomes.
Dr. Katherine Bloom of Allergy & Asthma Care comments: "While the possible effects of quick relief asthma inhalers on fertility need to be confirmed with future studies, this study is reassuring in that asthma control medications did not impact fertility. Women with asthma who are planning pregnancy should continue their asthma control medications and speak with their physicians."
Posted on April 08, 2018 | Permalink
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A review published in Pediatrics summarizes the current safety and efficacy data regarding the use of subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT) in pediatric allergic asthma.
For this study, researchers searched several databases (PubMed, Embase, Cochrane Central Register of Controlled Trials between January 1, 2005 to May 8, 201), ClinicalTrials.gov, and the Food and Drug Administration (FDA) Adverse Event Reporting System for data pertaining to pediatric usage of aeroallergen SCIT or SLIT. They also reexamined the trials included in a 2013 systematic review.
Randomized controlled trials of pediatric patients aged ≤18 years reporting on pre-specified outcomes with an intervention arm were included for efficacy. Both non-randomized and randomized controlled trials were examined for safety outcomes.
Forty studies were included in total: 17 SCIT trials, 11 SLIT trials, 8 non-randomized controlled trials for SCIT safety, and 4 non-randomized controlled trials for SLIT safety. Results showed that SCIT decreased long-term asthma medication use (moderate strength evidence) and improved asthma-related quality of life and FEV1(low strength evidence); SLIT also improved medication use and FEV1 (low strength evidence). Regarding safety, the authors observed that local and systemic allergic reactions were common, however anaphylaxis was rarely reported.
The authors concluded that "in children with allergic asthma, SCIT may reduce long-term asthma medication use."
For more information visit aappublications.org.
Taking fish oil during pregnancy cuts the risk of some child allergies by nearly a third, a UK government study suggests. A daily fish oil capsule taken after the 20th week of pregnancy and for the first three or four months of breastfeeding cut the chances of a child developing an egg allergy by 30 per cent, the research showed.
Eczema risk was reduced by 22 per cent in children whose mothers took a probiotic supplement between 36 and 38 weeks of pregnancy. Adding beneficial bacteria to the diet during the first three to six months of breastfeeding had the same effect. The findings come from one of the biggest investigations of maternal diet and childhood allergy ever undertaken.
Commissioned by the Food Standards Agency of the UK, scientists at Imperial College London pooled data from more than 400 studies involving 1.5 million mothers and their children. While clear benefits were seen from fish oil and probiotics, there was no evidence that avoiding potentially allergy-triggering foods such as nuts, dairy produce and eggs during pregnancy had any effect. Lead researcher Dr Robert Boyle, from Imperial College London, said: "Food allergies and eczema in children are a growing problem across the world.
"Although there has been a suggestion that what a woman eats during pregnancy may affect her baby's risk of developing allergies or eczema, until now there has never been such a comprehensive analysis of the data. "Our research suggests probiotic and fish oil supplements may reduce a child's risk of developing an allergic condition, and these findings need to be considered when guidelines for pregnant women are updated."
Allergies to foods such as nuts, egg, milk or wheat affect around one in 20 children. They are the result of the immune system overreacting to harmless substances, leading to symptoms such as rashes, swelling, vomiting and wheezing. Eczema, also thought to involve an overactive immune response, affects around one in five children and causes dry, cracked and itchy skin. People who suffer from eczema are also more likely to have allergies.
More work is needed to understand how fish oils and probiotics may protect against allergies and eczema, according to study co-author Dr Vanessa Garcia-Larsen, also from Imperial College. She said: "Despite allergies and eczema being on the rise, and affecting millions of children, we are still hunting for the root causes of these conditions, and how to prevent them. "This study has provided clues, which we now need to follow with further research."
The new findings appear in the latest issue of the online journal Public Library of Science Medicine. Previous studies have suggested that omega-3 fatty acids in fish oil may help to dampen down an overactive immune system. Probiotics, taken in the form of capsules, a powder or a health drink, contain live bacteria that may influence the natural balance of microbes in the gut. Scientists have linked the disruption of naturally occurring gut "flora" to allergy risk.
Commenting on the research, Seif Shaheen, professor of respiratory epidemiology at Queen Mary University of London, said: "More definitive answers on the possible role of maternal probiotic and fish oil supplementation in the prevention of childhood allergic disease can only come from further large trials, which follow up the children to school age. "If such trials are big enough they may be able to identify particular subgroups of mothers and children who would benefit most from these interventions."
Dr. Katherine Bloom of Allergy & Asthma Care comments: "Studies of dietary interventions in pregnancy and breastfeeding have often yielded conflicting results, but this study, a "meta-analysis" of multiple prior studies, provides evidence that fish oil and probiotics may be of benefit. As always, discuss these and any other interventions with your obstetrician and pediatrician prior to implementing changes."
An experimental treatment aimed at helping people with severe peanut allergy recently scored a clinical win, putting it in line to possibly become the first drug to provide meaningful protection against accidental exposure.
Based on the positive results, Aimmune Therapeutics expects to seek U.S. approval for its preventative peanut allergy therapy by the end of the year, with a European filing in 2019, the company said. The company’s lead product, AR101, is a capsule filled with a precise, measured quantity of peanut flour. The capsules are opened and mixed into food. The idea is simple: Expose people to small, escalating doses of ingestible peanut protein over time with the goal of desensitizing them enough to prevent severe reactions.
Aimmune is trying to standardize a peanut allergy protection method already tried on an ad hoc basis. AR101 proved highly effective in a phase 3 clinical trial known as PALISADE. The results: 67 percent of patients ages 4 to 17 tolerated at least a 600-mg dose of peanut protein at the end of the study, compared with 4 percent of placebo patients.
Six hundred milligrams of peanut protein is roughly the equivalent of two peanuts or a child-sized bite from a peanut butter sandwich. The patients entered the study not being able to tolerate exposure to 10 percent of a single peanut. To meet the FDA requirements for approval, AR101 had to beat placebo by a biostatistical cushion of at least 15 percent. Aimmune cleared this statistical hurdle easily with a 53 percent difference.
There were some safety concerns in the study. Twenty percent of the AR101 patients and 6.5 percent of the placebo patients discontinued from the trial. Among AR101 patients, 12 percent discontinued due to adverse events, including gastrointestinal side effects. Ten AR101 patients, or just under 3 percent, left the study because of systemic allergic hypersensitivity reactions. Of these, seven patients were deemed by their doctors to have experienced potentially serious allergic reactions known as anaphylaxis, including one severe case.
Anyone with school age children knows peanut allergy is a serious and prevalent health problem. It’s estimated that between 1.5 million to 2 million people under 18 in the U.S. have peanut allergy. Apart from scrupulous peanut avoidance, there are no approved treatments for people at risk for severe allergic reaction if exposed to even trace amounts of peanut protein.
There is no cure for peanut allergy. A “peace of mind” treatment would still be beneficial, however, and offers the possibility of reassurance to parents and patients that accidental reactions would be less likely to occur.
Dr. Kenneth Backman of Allergy & Asthma Care comments: "Oral immunotherapy, or desensitization, to foods has been studied for some time and remains experimental. There are many different protocols and doses in use among different investigators, and some centers have offered the treatment in unapproved, off-label protocols that remain unproven in safety and efficacy. They often use nonstandard doses of peanut protein, such as peanut M&Ms, which due to marked variability of peanut content can cause unexpected severe reactions. While there is the potential for adverse reactions, this study is promising and offers hope that we will be able to offer an FDA approved, carefully controlled, safe and effective treatment to help reduce the risk of accidental food reactions. We look forward to further studies and FDA action."
Although only one percent of the population are affected by celiac disease, gluten-free diets have become a major food trend in recent years. Non-celiac gluten sensitivity is a controversial topic among many researchers, with up to 13 percent of people claiming to suffer from the condition. A new study is now suggesting that fructans, and not gluten, could be the source of many people's gastrointestinal upset.
With recent research pointing to a relationship between low-gluten diets and a higher risk of Type 2 diabetes, the modern gluten-free trend is increasingly looking like a dangerous dietary fad, potentially doing more harm than good. Yet the anecdotal weight of non-celiac people claiming to feel better when avoiding gluten cannot be denied. A great deal of this can surely be associated with a psychological, or placebo, effect, but what if there was another culprit responsible?
Fructan is a type of carbohydrate found in wheat, and many scientists are beginning to suspect it could be the dietary villain behind many people's acute gastrointestinal upsets rather than gluten. Fructan is also found in onions, garlic, asparagus, cabbage and artichokes. A new study from an international team of researchers took 59 individuals who were on a self-imposed gluten-free diet, yet had also been cleared of suffering from celiac disease. Each person spent seven days eating muesli bars containing either gluten, fructan or neither. With a week to clear their systems between each challenge, every subject cycled through all three groups while rating their gastrointestinal symptoms.
The results were fascinating, with the fructan muesli bar inducing the most symptoms overall. On average, the study also found no difference in reported symptoms between the gluten and placebo groups. While earlier studies have found a link between fructans and irritable bowel syndrome symptoms, this is the first to closely examine the connection in those claiming a non-celiac gluten sensitivity.
"Gluten was originally assumed to be the culprit because of celiac disease, and the fact that people felt better when they stopped eating wheat," says one of the authors of the study, Peter Gibson, in New Scientist. "Now it seems like that initial assumption was wrong." Non-celiac gluten sensitivity may certainly be a real condition, but it is becoming increasingly possible that those who feel bloated and uncomfortable after certain meals are actually reacting to fructans and mistaking this for a gluten intolerance.
ATLANTA, GA (November 7, 2014) – Many people have been told, incorrectly, that they’re allergic to penicillin, but have not had allergy testing. These people are often given alternative antibiotics prior to surgery to ward off infection. But when antibiotic choices are limited due to resistance, treatment alternatives may be more toxic, more expensive and less effective.
According to two studies presented at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting, people who believe they have a penicillin allergy would benefit from consultation from an allergist and penicillin allergy skin testing. Once they know if they are allergic, they can be given appropriate – and not more resistant – treatment prior to surgery. Of the 384 people in the first study who believed they were allergic to penicillin, 94 percent tested negative for penicillin allergy.
“A large number of people in our study who had a history of penicillin allergy were actually not allergic,” said allergist and ACAAI member Thanai Pongdee, MD, lead study author. “They may have had an unfavorable response to penicillin at some point in the past, such as hives or swelling, but they did not demonstrate any evidence of penicillin allergy at the current time. With that in mind, their doctors prescribed different medications prior to surgery.”
In the second study, 38 people who believed they were allergic to penicillin were given penicillin skin testing to see if it was possible to help reduce the use of high-cost antibiotics. Of the 38 people tested, all of them tested negative to an allergy for penicillin. Once it was known they weren’t allergic to penicillin, the medical center was able to change the medications of 29 of the patients, thereby significantly lowering prescription costs.
“When you are told you have an allergy to something, it’s important to be seen and tested by an allergist, who has the specialized training needed for accurate diagnosis and treatment,” said allergist James Sublett, ACAAI president-elect. “If you’re truly allergic to a medication, your allergist will counsel you on an appropriate substitute.”
Dr. Katherine Bloom of Allergy & Asthma Care of Fairfield County comments: "With increasing resistance to antibiotics, and the importance of saving broad spectrum antibiotics for infections where they're absolutely necessary, the CDC recommends that all patients who believe they have a penicillin allergy be tested to confirm or, in most cases, rule out the allergy. Please call our office to schedule testing."
"As the science governing allergies and diets continues to evolve, so do expert recommendations around how best to safely introduce babies and children to various foods. Perhaps one of the most challenging decisions for parents of my generation is when and how to introduce foods that pose a potential for a significant allergic reaction. These decisions are made more difficult as the prevalence of certain food allergies appear to be on the rise. Peanut allergy is one of the most common food allergies. It’s also one of the most dangerous. Peanut allergy is the leading cause of death related to food-induced anaphylaxis in the United States. For these reasons, it’s rightly a cause of significant concern among new parents. The majority of individuals who are allergic to peanuts developed the allergy early in life and never outgrew it. You would be hard pressed to find a parent who doesn’t know a child who suffers from a serious peanut allergy. Even if our own children don’t have a peanut allergy, most of us have friends or relatives whose children do. That’s not surprising, given that the prevalence of peanut allergy has more than doubled in children from 1997 to 2008 alone. Today, about two percent of American children are allergic to peanuts.
As the incidence of peanut allergy grew, along with an awareness of the consequences, doctors began advising parents not to introduce peanut-containing foods to children under the age of three who were at high risk for peanut allergy. While this advice was well intended, new evidence-based guidelines recommend that the medical community consider a different approach. A recent landmark clinical trial funded by the National Institutes of Health found that introducing foods containing smooth peanut butter to babies as early as 4 months of age who are at high risk of developing a peanut allergy -- due to severe eczema or egg allergy or both -- reduces their risk of developing peanut allergy later in childhood by about 80 percent. That finding led the NIH to issue new guidelines in January, recommending that parents of infants with severe eczema, egg allergy, or both introduce peanut-containing foods into a child’s diet as early as 4 to 6 months of age. The guidelines advise parents to check with their infant’s healthcare provider before feeding their baby peanut-containing foods in order to determine whether an allergy test is needed first and whether feeding should be done under a doctor’s supervision.
Along with the information that you currently see on food labels, which disclose when a food contains peanuts or peanut residue, the new advice about the early introduction to peanuts and reduced risk of developing peanut allergy will soon be found on the labels of some foods containing ground peanuts that are suitable for infant consumption. Whole peanuts, on the other hand, are a choking hazard for young children and should not be consumed. Recognizing the importance of science-based food decisions, the FDA has responded to a petition for a new qualified health claim that states “for most infants with severe eczema and/or egg allergy who are already eating solid foods, introducing foods containing ground peanuts between 4 and 10 months of age and continuing consumption may reduce the risk of developing peanut allergy by 5 years of age.” This is the first time the FDA has recognized a qualified health claim to prevent a food allergy. Our goal is to make sure parents are abreast of the latest science and can make informed decisions about how they choose to approach these challenging issues.
The new claim on food labels will recommend that parents check with their infant’s healthcare provider before introducing foods containing ground peanuts. It will also note that the claim is based on one study. The FDA will continue to monitor the research related to peanut allergy. If new scientific information further informs what we know about peanut allergy, the FDA will evaluate whether the claim should be updated.
We know that there’s more to learn about food allergies. The more we learn, the better we can consider how best to introduce allergenic foods, as well as prevent and treat food allergies. We need to continue to invest in the science related to our diets. The FDA remains committed to advancing and supporting research and innovations that help lower the rate of food allergies and better protect the public health."
Delaying the introduction of potentially allergenic foods until after a baby's first year may increase the likelihood of a food allergy later on, according to new findings from the Canadian Healthy Infant Longitudinal Development (CHILD) Study. The research, published in Pediatric Allergy and Immunology, found that infants who avoided cow's milk products, egg and peanut during the first year of life were more likely to be sensitized to these foods at age one.
"Food sensitization early in life is associated with an increased risk of wheeze, asthma, eczema and allergic rhinitis in later childhood," said Dr. Malcolm Sears, co-director of the CHILD Study and a professor of medicine at McMaster University. "While not all food-sensitized infants become food allergic, sensitization is an important step on the pathway," he added. Sears is also a researcher at the Firestone Institute for Respiratory Health at St. Joseph's Healthcare Hamilton.
Using data from more than 2,100 Canadian children, the researchers found that infants who avoided cow's milk products in their first year were nearly four times as likely to be sensitized to cow's milk compared to infants who consumed cow's milk products before 12 months of age. Similarly, infants who avoided egg or peanut in their first year were nearly twice as likely to be sensitized to those foods compared to infants who consumed them before 12 months of age.
"Early introduction of eggs before one year of age seemed to be especially beneficial, as it significantly reduced the odds of developing sensitization to any of the three food allergens," says the study's first author, Maxwell Tran, a BHSc graduate from McMaster University and an AllerGen trainee. "To our knowledge, this is the first observational study in a general population of infants to report on how the timing of introduction of multiple foods affects the risk of developing a food allergy."
The study also revealed that most Canadian parents delay the introduction of potentially allergenic foods, particularly egg and peanut: only three per cent of parents introduced egg before six months of age, while just one per cent of parents introduced peanut to their infants before six months of age and 63% of parents avoided feeding peanut entirely during the first year of life. "Our findings support infant feeding guidelines that promote the introduction of foods such as cow's milk products, egg and peanut between four to six months of age," says Mr. Tran. "This is an important shift in thinking away from avoidance of potentially allergenic foods, toward their early introduction to reduce the risk of food allergy later on."
The study was funded by the Canadian Institutes of Health Research and the Allergy, Genes and Environment (AllerGen) Network.
Dr. Kenneth Backman of Allergy & Asthma Care comments: "This study supports other recent studies suggesting that early introduction of foods can help prevent food allergies. It is becoming increasingly clear that withholding foods beyond 6 months of age does not prevent, and likely increases the risk of, food allergies. Further studies are under way."
Dear patients of Allergy and Asthma Care,
It has been a great privilege to be your doctor for the past 12 years. As many of you know, I am moving to Israel this summer. Allergy and Asthma Care has been a wonderful place to work. We have great doctors, nurse practitioners and staff who go out of their way to make you feel welcome and at ease, while providing top quality care.
I am grateful that you trusted me with your health and the health of your families. It has been amazing to see your kids grow and overcome so many small and large obstacles related to their health. It has been humbling to watch how you handle the most difficult news and your strength and resilience in living with allergies and asthma every day.
Irena Veksler, MD
Researchers have shown that a wearable patch that delivers small amounts of peanut protein through the skin has yielded promising results for treating children and young adults with peanut allergy, with greater benefits for younger children, according to one-year results from an ongoing clinical trial, published online on October 26 in the Journal of Allergy and Clinical Immunology.
The treatment, called epicutaneous immunotherapy or EPIT, was found to be safe and well-tolerated, and nearly all participants used the skin patch daily as directed. The ongoing trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and conducted by the NIAID-funded Consortium of Food Allergy Research (CoFAR), which is led by Hugh Sampson, MD, of Icahn School of Medicine at Mount Sinai in New York. Stacie Jones, MD, of the University of Arkansas for Medical Sciences and Arkansas Children’s Hospital, chairs the study.
“To avoid potentially life-threatening allergic reactions, people with peanut allergy must be vigilant about the foods they eat and the environments they enter, which can be very stressful,” said NIAID Director Anthony S. Fauci, MD. “One goal of experimental approaches such as epicutaneous immunotherapy is to reduce this burden by training the immune system to tolerate enough peanut to protect against accidental ingestion or exposure.”
CoFAR researchers at five study sites randomly assigned 74 peanut-allergic volunteers aged 4 to 25 years to treatment with either a high-dose (250 micrograms peanut protein), low-dose (100 micrograms peanut protein), or placebo patch. The investigators assessed peanut allergy at the beginning of the study with a supervised, oral food challenge with peanut-containing food. The patches were developed and provided by the biopharmaceutical company DBV Technologies under the trade name Viaskin. Each day, study participants applied a new patch to their arm or between their shoulder blades.
After one year, researchers assessed each participant’s ability to consume at least 10 times more peanut protein than he or she was able to consume before starting EPIT. The low-dose and high-dose regimens were found to offer similar benefits, with 46% of the low-dose group and 48% of the high-dose group achieving treatment success, compared with 12% of the placebo group. In addition, the peanut patches induced immune responses similar to those seen with other investigational forms of immunotherapy for food allergy. Investigators observed greater treatment effects among children aged 4 to 11 years, with significantly less effect in participants aged 12 years and older.
“The clinical benefit seen in younger children highlights the promise of this innovative approach to treating peanut allergy,” said Daniel Rotrosen, MD, director of NIAID’s Division of Allergy, Immunology and Transplantation (DAIT). “Epicutaneous immunotherapy aims to engage the immune system in the skin to train the body to tolerate small amounts of allergen, whereas other recent advances have relied on an oral route that appears difficult for approximately 10% to 15% of children and adults to tolerate.”
According to the report, nearly all of the study participants followed the EPIT regimen as directed. None reported serious reactions to the patch, although most experienced mild skin reactions, such as itching or rash, at the site of patch application. “The high adherence to the daily peanut patch regimen suggests that the patch is easy-to-use, convenient, and safe,” said Marshall Plaut, chief of DAIT’s Food Allergy, Atopic Dermatitis and Allergic Mechanisms Section. “The results of this study support further investigation of epicutaneous immunotherapy as a novel approach for peanut allergy treatment.”
Additional studies in larger groups of children are needed before the therapy could be approved for wider use. The CoFAR study continues to assess the long-term safety and effectiveness of peanut EPIT. After the first year, all participants began receiving high-dose daily patches, and they will continue in the study for a total of two and a half years of EPIT.
The work was funded by NIAID, NIH, under award numbers U19AI066738 and U01AI066560. Additional support was provided by NIH’s National Center for Advancing Translational Sciences. The ClinicalTrials.gov identifier for the study Epicutaneous Immunotherapy for Peanut Allergy (CoFAR6) is NCT01904604. The CoFAR clinical sites involved in the trial are Arkansas Children's Hospital in Little Rock, National Jewish Health in Denver, The Johns Hopkins University in Baltimore, Icahn School of Medicine at Mount Sinai in New York and the University of North Carolina at Chapel Hill School of Medicine.
A new University of Alberta study showed that babies from families with pets -- 70 per cent of which were dogs -- showed higher levels of two types of microbes associated with lower risks of allergic disease and obesity.
But don't rush out to adopt a furry friend just yet.
"There's definitely a critical window of time when gut immunity and microbes co-develop, and when disruptions to the process result in changes to gut immunity," said Anita Kozyrskyj, a U of A pediatric epidemiologist and one of the world's leading researchers on gut microbes -- microorganisms or bacteria that live in the digestive tracts of humans and animals.
The latest findings from Kozyrskyj and her team's work on fecal samples collected from infants registered in the Canadian Healthy Infant Longitudinal Development study build on two decades of research that show children who grow up with dogs have lower rates of asthma.
The theory is that exposure to dirt and bacteria early in life -- for example, in a dog's fur and on its paws -- can create early immunity, though researchers aren't sure whether the effect occurs from bacteria on the furry friends or from human transfer by touching the pets, said Kozyrskyj.
Her team of 12, including study co-author and U of A post-doctoral fellow Hein Min Tun, take the science one step closer to understanding the connection by identifying that exposure to pets in the womb or up to three months after birth increases the abundance of two bacteria, Ruminococcus and Oscillospira, which have been linked with reduced childhood allergies and obesity, respectively.
"The abundance of these two bacteria were increased twofold when there was a pet in the house," said Kozyrskyj, adding that the pet exposure was shown to affect the gut microbiome indirectly -- from dog to mother to unborn baby -- during pregnancy as well as during the first three months of the baby's life. In other words, even if the dog had been given away for adoption just before the woman gave birth, the healthy microbiome exchange could still take place.
The study also showed that the immunity-boosting exchange occurred even in three birth scenarios known for reducing immunity, as shown in Kozyrskyj's previous work: C-section versus vaginal delivery, antibiotics during birth and lack of breastfeeding.
What's more, Kozyrskyj's study suggested that the presence of pets in the house reduced the likelihood of the transmission of vaginal GBS (group B Strep) during birth, which causes pneumonia in newborns and is prevented by giving mothers antibiotics during delivery.
It's far too early to predict how this finding will play out in the future, but Kozyrskyj doesn't rule out the concept of a "dog in a pill" as a preventive tool for allergies and obesity.
"It's not far-fetched that the pharmaceutical industry will try to create a supplement of these microbiomes, much like was done with probiotics," she said.
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "This is another in a series of studies suggesting beneficial effects of pets in the home in early childhood. The preventive effect for allergies appear to apply only in the very early months of life. There is much more to be learned, and we do not recommend bringing a pet into the home as a preventive treatment at this time. While it may reduce the chances of allergy, if your child develops a pet allergy anyway, which can definitely occur, you are then left in the very difficult situation of having a pet that is causing allergy symptoms in your child. We lo0k forward to additional studies regarding this interesting topic."
The voluntary recall of Epipen devices has been expanded to multiple lot numbers that may have been sold in the US. Here is the latest information from the manufacturer:
If you think you may be impacted by this recall, please follow these steps:
STEP 1: Check the lot number on your carton or device to see if your EpiPen® Auto-Injector is affected by the recall.
STEP 2: If your EpiPen® Auto-Injector has been recalled, contact Stericycle at 877-650-3494 to obtain a voucher code for your free replacement product. Stericycle also will provide you with a pre-paid return package to ship the product back to Stericycle.
STEP 3: Visit your pharmacy with your voucher information to redeem your free replacement.
STEP 4: Send your recalled product to Stericycle. Do not return any devices affected by the recall until you have your replacement in hand.
Stericycle’s hours of operation are Monday-Friday 8 a.m.-10 p.m. ET, and Saturday and Sunday 8 a.m.-8 p.m. ET.
(last updated April 19, 3:30 PM ET)
Yesterday, the U.S. Food and Drug Administration approved Dupixent (dupilumab), the first biologic medication for adults with moderate to severe atopic dermatitis (AD) for whom other topical treatments have not worked or are not advised.
Different from topical or oral medications, biologic drugs or “biologics” are made from proteins typically derived from human DNA and “grown” through a sophisticated manufacturing process.
Dupixent works by blocking proteins called interleukins, or ILs, from attaching to cell receptors. Interleukins contribute to a functioning immune system by helping to fight off viruses or bacteria in our bodies. When the immune system goes haywire, it can trigger certain ILs to mistakenly attack the body, resulting in chronic, inflammatory conditions such as atopic dermatitis.
Dupixent works on two interleukins thought to contribute to atopic diseases: IL-4 and IL-13. By blocking IL-4 and IL-13 from binding to its receptors, Dupixent curbs the immune system over-reaction that results in atopic dermatitis. A calmed immune system leads to fewer and/or less severe symptoms of AD.
In clinical trials, Dupixent was shown to reduce symptoms of AD such as itching, redness, lichenification (thickened skin), swelling, and scratched skin. Dupixent is given by 300 mg injection every other week after a starting dose of 600 mg. Dupixent is available by prescription only.
For more information please call 1-844-Dupixent (1-844-387-4936), visit www.dupixent.com , or call our office for an appointment.
ATLANTA -- Children and teens who participated in three separate peanut immunotherapy studies showed a high rate of anaphylaxis requiring epinephrine if they kept with the peanut challenge at home, researchers reported here. Four of 27 participants (14.8%) who continued the peanut desensitization after leaving the studies had allergic reactions, including three patients enrolled in a trial of oral immunotherapy plus omalizumab (Xolair) and one patient enrolled in trial of oral immunotherapy alone, reported Megan Ott Lewis, MSN, RN, of the Children's Hospital of Philadelphia (CHOP), and colleagues.
The analysis included 33 children and teens. Surveys were completed by study participants or their parents roughly 2 years (oral therapy plus biologic) or 1 year (oral therapy alone and EPIT) after the trials ended. All 33 reported satisfaction with having participated in the immunotherapy studies, but 17 reported that dosing during the clinical trial interfered with daily life. Post-trial peanut consumption frequency varied from monthly to daily, with most surveyed participants consuming peanut about five times a week. All participants were told to maintain 2-hour exercise restrictions after dosing, and 22 reported following this recommendation.
Among the patients introducing peanuts into their diets following the study, 74% ate peanut-containing candy, 15% ate peanut flour mixed in foods, and 11% ate peanuts. Doses were determined based on individual and study team preference. Participants in the oral immunotherapy plus omalizumab study consumed the highest post-trial dosages of peanut, with 100% achieving an average daily dosage of 300 mg or more compared with 66% of the oral immunotherapy alone group, and 75% in the EPIT group. Ott Lewis told MedPage Today that this higher post-study dosage could explain the higher peanut-induced anaphylaxis incidence in these patients. Physical exertion, which increases the risk for allergic reactions following food challenge, was not a factor in any of the episodes, she said.
"Higher maintenance doses seem to be associated with this reaction," she said, adding that most kids and teens with peanut allergies don't really like peanut-containing foods. Only six survey participants reported liking the taste of peanuts or foods containing peanut, which did not surprise co-author Jonathan Spergel, MD, PhD, also of CHOP. "The body is pretty smart. Most kids with peanut allergies have no interest in eating peanut butter sandwiches all day," he told MedPage Today.
Spergel called the four allergic reactions among the 27 participants who continued peanut ingestion "concerning," adding that the optimal dosage of peanut consumption following oral or epicutaneous immunotherapy remains to be determined. It also remains to be seen if continued ingestion will lead to permanent desensitization. "My guess is that we will see something similar to what we have seen with the rest of allergy immunotherapy," Spergel said. "Allergy shots are typically given for 3 to 5 years." But Spergel cautioned that 3 - 5 years of ingestion following peanut immunotherapy may or may not lead to permanent desensitization. "We just don't know yet," he said.
Dr. Katherine Bloom of Allergy & Asthma Care of Fairfield County comments: "Oral immunotherapy to foods remains an experimental treatment, and we need to learn much more about this approach to food allergy before it should be offered to the general population. With a risk of anaphylaxis seen here of 4 in 27 patients, a higher incidence of anaphylaxis than many peanut allergic patients not in treatment, oral immunotherapy may be most appropriate in patients with a history of frequent reactions or extreme sensitivity to small amounts of peanut protein. We look forward to more studies regarding this and the peanut patch, and hope to have a form of FDA approved food immunotherapy available within the next few years."
The US Food and Drug Administration has approved Odactra, the first allergen extract to be administered under the tongue (sublingually) to treat house dust mite (HDM)–induced nasal inflammation (allergic rhinitis), with or without eye inflammation (conjunctivitis), in people 18 through 65 years of age. “House dust mite allergic disease can negatively impact a person’s quality of life,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “The approval of Odactra provides patients an alternative treatment to allergy shots to help address their symptoms.”
House dust mite allergies are a reaction to tiny bugs that are commonly found in house dust. Dust mites, close relatives of ticks and spiders, are too small to be seen without a microscope. They are found in bedding, upholstered furniture, and carpeting. Individuals with house dust mite allergies may experience a cough, runny nose, nasal itching, nasal congestion, sneezing, and itchy and watery eyes.
Odactra exposes patients to house dust mite allergens, gradually training the immune system in order to reduce the frequency and severity of nasal and eye allergy symptoms. It is a once–daily tablet, taken year round, that rapidly dissolves after it is placed under the tongue. The first dose is taken under the supervision of a health care professional with experience in the diagnosis and treatment of allergic diseases. The patient is to be observed for at least 30 minutes for potential adverse reactions. Provided the first dose is well tolerated, patients can then take Odactra at home. It can take about eight to 14 weeks of daily dosing after initiation of Odactra for the patient to begin to experience a noticeable benefit.
The safety and efficacy of Odactra was evaluated in studies conducted in the United States, Canada, and Europe, involving approximately 2,500 people. Some participants received Odactra, while others received a placebo pill. Participants reported their symptoms and the need to use symptom–relieving allergy medications. During treatment, participants taking Odactra experienced a 16% to 18% reduction in symptoms and the need for additional medications compared with those who received a placebo.
The most commonly reported adverse reactions were nausea, itching in the ears and mouth, and swelling of the lips and tongue. The prescribing information includes a boxed warning that severe allergic reactions, some of which can be life–threatening, can occur. As with other FDA–approved allergen extracts administered sublingually, patients receiving Odactra should be prescribed auto–injectable epinephrine. Odactra also has a Medication Guide for distribution to the patient.
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "Odactra offers the first FDA approved sublingual immunotherapy for dust mite, a significant advance. This offers a convenient immunotherapy option for patients whose main allergen is dust mites, and who wish to avoid the time or expense of injections. While sublingual immunotherapy is likely less effective than injection immunotherapy, this does offer an effective option that should prove beneficial for many patients. Odactra joins grass and ragweed pollen sublingual tablets as the only FDA approved forms of sublingual immunotherapy."
A clinical trial conducted in Japan and published online in The Lancet (Dec. 8, 2016) found that the development of egg allergy in infants with eczema was dramatically reduced by aggressive eczema treatment combined with regular consumption of heated whole-egg powder. The prevalence of egg allergy was 79 percent lower among one-year-olds who had eaten egg daily for six months, compared to one-year-olds who had avoided egg.
The Prevention of Egg Allergy with Tiny Amount InTake study (PETIT) took a stepwise approach to egg introduction. Infants in the egg-consuming group ate a squash/egg mixture, starting at 50 mg egg per day from ages 6 to 9 months and increasing to 250 mg egg per day from ages 9 to 12 months. A squash-only placebo was fed to the egg-avoiding group. At age 12 months, an oral food challenge with a cumulative dose of 7000 mg egg confirmed egg allergy in 38 percent of the egg-avoiding infants. In contrast, only 8 percent of the egg-consuming infants developed egg allergy.
Since sensitization to food proteins through damaged skin may increase food allergy risk, both the egg and placebo groups received eczema treatment to prevent flare-ups and achieve remission. Blood tests measuring egg-white-specific IgE revealed that most subjects were already sensitized to egg at the time they enrolled in the study.
The initial feedings at 6 months and 9 months took place under medical supervision, but did not cause acute symptoms in either the egg or placebo groups. No infants in either group withdrew because of adverse reactions. Hospitalization rates for the two groups differed – none of the egg avoiders was admitted to hospital, compared to five hospital admissions among the egg consumers – but the hospitalizations were not attributed to allergic reaction.
Reduced rates of egg allergy in egg-eating high-risk infants are consistent with Learning Early About Peanut Allergy trial (LEAP) findings that, compared to regular peanut consumption from infancy onward, avoiding peanut until age 5 led to much higher rates of peanut allergy in children with egg allergy, eczema or both. LEAP trial results are reflected in new guidelines from the National Institute of Allergy and Infectious Diseases, which recommend early peanut introduction for children at elevated risk of peanut allergy.
Babies with a high risk of developing peanut allergy should be introduced to the food as early as 4 months according to an expert panel from the National Institute of Allergy and Infectious Disease (NIAID) consisting of representatives from 25 professional organizations, federal agencies, and patient advocacy groups. The recommendations were published in a number of medical journals today including the Annals of Allergy, Asthma and Immunology.
The panel’s recommendations come as no surprise after the findings of the LEAP study were published last year, in which the incidence of peanut allergy in high-risk children was reduced by 80% after the early introduction of the food. Infants with severe eczema and/or egg allergy are considered at high risk for developing peanut allergy. The panel recommends introducing foods containing peanuts to high-risk infants who have already started solid foods at 4-6 months, after consultation with the child’s healthcare provider or an allergist. The recommendations state that for such infants, evaluation with peanut-specific IgE test, skin prick test, or both should be “strongly considered before the introduction of peanut to determine if peanut should be introduced and, if so, the preferred method of introduction.”
“To minimize a delay in peanut introduction for children who may test negative, testing for peanut-specific IgE may be the preferred initial approach in certain healthcare settings, such as family medicine, pediatrics, or dermatology practices, in which skin prick testing is not routine. Alternatively, referral for assessment by a specialist may be an option if desired by the heathcare provider and when available in a timely manner,” the guidelines state. The panel identified three categories of infants based on their response to skin prick testing:
A wheal diameter of 2 mm or less is indicative of low risk: peanut introduction is recommended soon after testing;
Wheal diameter of 3 to 7 mm reflects medium likelihood of peanut allergy; supervised peanut feeding or an oral food challenge at a specialist’s office or specialized facility can be employed;
A wheal diameter of 8 mm or more is indicative of a high likelihood of allergy, and children in this category should be evaluated and managed by a specialist.
Pediatric allergist and panel member Hugh Sampson, MD of the Jaffe Food Allergy Institute at Mount Sinai, said parents and caregivers who introduce peanuts at home should initially give two teaspoons of peanut butter diluted in warm water or a warm puree that the baby enjoys, followed by two more such feedings over the course of a week for a total of roughly six grams of peanut protein. The schedule should be repeated weekly. “This needs to be done pretty consistently to establish tolerance, at least based on what we know from the LEAP trial,” he told MedPage Today. The guidelines for low-risk infants recommend that peanut-containing foods be introduced around 6 months of age.
Here is a summary sheet from NIAID: Peanut Allergy Prevention Guidelines
Dr. Kathy Bloom from Allergy & Asthma Care comments: "Allergists were already aware of the LEAP study results from the New England Journal of Medicine publication, but these new guidelines provide specifics on how best to implement these results. We anticipate that these changes in the age of peanut introduction, over time, will lead to dramatic decreases in the incidence of peanut allergy. This is a very exciting time in the world of food allergy, and many significant advances are expected over the next 5-10 years."
Auvi-Q, an epinephrine auto-injector considered an alternative to the EpiPen, will be reintroduced in the U.S. market in early 2017, according to its manufacturer. The auto-injectors are used to stop potentially life-threatening allergic reactions by administering a dose of the hormone epinephrine. A major U.S. recall of Auvi-Q happened in October 2015, with then-manufacturer Sanofi saying the device may not deliver enough medication to someone with a severe reaction.
The pharmaceutical company Kaleo said Wednesday it has regained the rights to Auvi-Q and will reintroduce the injectors in the first half of 2017. The company said it conducted a "thorough manufacturing assessment and invested in new technology and quality systems." "As the inventors of Auvi-Q, my brother and I have dedicated our lives to researching and developing an innovative epinephrine auto-injector that would do for severe allergy sufferers what the AEDs did for cardiac arrest," says Evan Edwards, Kaleo's vice president of product development and industrialization, in the company's statement.
Auvi-Q has a voice prompt system that guides users through the injection process, as well as a needle that automatically retracts following injection, the company says. "In emergencies such as anaphylaxis, it is often individuals without medical training who need to step in," according to the Kaleo statement. Auvi-Q does not need to seek new approval from the FDA, according to Spencer Williamson, Kaleo president and CEO.
Mylan, the company that manufacturers EpiPens, recently drew criticism from lawmakers and parents of allergic children after news that the company had increased the price by more than 480 percent since 2009. EpiPens can cost as much as $ 700 for a pack of two auto injectors before insurance. Mylan responded to the criticism by saying it would offer a savings card to cover up to $ 300 in costs for the two-pack. It also said it would expand eligibility for its patient assistance program. However, experts said such actions do little to address the problem of high drug prices. Insurance companies still pay most of the wholesale drug cost, and patients may face higher insurance costs as a result.
Kaleo did not offer information on how much Auvi-Q would cost, but said it is committed to affordability. "Our goal is that any patient, regardless of insurance coverage, should have options when it comes to epinephrine auto-injectors, including the option to access Auvi-Q at an affordable price," the company says on Auvi-Q's website. At the time of the October 2015 recall, Auvi-Q cost about $ 400 per set.
Dr. Kenneth Backman of Allergy & Asthma Care comments: "Epinephrine auto-injectors are life-saving, medically necessary devices for patients with life-threatening allergies, such as to food or insect stings. The return of Auvi-Q to the market will offer another option to our patients, and we hope that it will be reasonably priced and readily available. The design of the Auvi-Q was preferred by many patients, and we look forward to the opportunity to prescribe it again soon."