Pediatric & Adult
55 Walls Dr., Fairfield, (203) 259-7070
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Dr. Kenneth Backman, Dr. Katherine Bloom, Suzanne Hines, APRN, and Jill Ross, APRN
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."
As we have found with the recent deaths in Australia in the news from “thunderstorm asthma” it is important to remember that storms can trigger your asthma and allergies and could, in rare, severe cases, be fatal.
Asthma and thunderstorms
Thunderstorm asthma is a potentially dangerous mix of pollens, weather conditions and rain that can trigger severe asthma symptoms. People residing in metropolitan, regional and rural areas can be affected.
How does a thunderstorm cause asthma symptoms?
Thunderstorms cause a rapid increase in the number of triggers in the air such as pollens, mold and dust and changes in humidity and temperature. Breathing this air in can irritate the lining of the airway causing swelling and extra mucus to be produced. This causes the airway to narrow and triggers an asthma flare-up. These flare-ups may become severe very quickly.
Do you have to be allergic to pollens or grasses to experience thunderstorm asthma?
Thunderstorm asthma can affect anyone. In fact, during very severe storms, some people who have never been diagnosed with asthma may experience breathing difficulties.
If you have asthma, be alert to the potential dangers of thunderstorm asthma.
What do you do if a thunderstorm is in the forecast?
Always carry your rescue inhaler
Know the signs of worsening asthma and the asthma first aid steps
Reports of peanut allergies have increased more than three-fold among U.S. children in the last 20 years, Anvari and colleagues note in JAMA Pediatrics. During this time, feeding guidelines have moved away from telling parents to avoid introducing some foods that can cause allergies until kids are 2 or 3 years old, and stopped telling women to avoid peanuts when they're pregnant or nursing. But many recommendations still stop short of urging parents to give babies eggs and peanuts early in life. For the current analysis, researchers summarized research published since 2008, when the American Academy of Pediatrics (AAP) revised its guidelines for peanut introduction to note there's no evidence to suggest waiting longer than six months could reduce the risk for allergies to this food.
After these guidelines and other similar recommendations came out, a shift in thinking about peanuts came courtesy of a study of 640 babies in the U.K. who were already at high risk for nut allergies because they had eczema or an egg allergy already, researchers note. This U.K. experiment compared the effects of giving some babies a 6-gram dose of peanut each week to strict peanut avoidance in children over a five-year period. All of the kids in the study got skin tests to determine if they developed a peanut allergy. At age 5, about 14 percent of the kids who avoided nuts had a peanut allergy compared with roughly 2 percent of the children who got an early taste of this food. Based on these results, some proposed guidelines may be shifting toward early introduction of peanuts even in babies with a history of other allergies, the authors note.
But when these high risk babies get that first taste of peanuts, they should have it in a clinical setting with lab tests to check for allergic reactions before parents offer peanuts to children at home, the researchers point out. This study had some limitations, including a lack of data on how much peanuts babies could have at one time or how long they might need to continue eating nuts on a regular basis to protect against allergies. It's also unclear what risks babies might face if they got a taste of peanuts then stopped eating them.
Still, guidelines in development from the National Institute of Allergy and Infectious Diseases are expected to come out soon and recommend that all kids get their first taste of peanuts around 4 to 6 months of age as long as they have tried some other foods first, said Dr. Matthew Greenhawt, a food researcher at the University of Colorado School of Medicine who wasn't involved in the current analysis. "Guidance regarding when to introduce peanut into the diet of an infant is changing, based on new research that shows that early introduction around 4 to 6 months of life, after a few other foods have been introduced into the infant's diet, is associated with a significantly reduced risk of such infants developing peanut allergy," Greenhawt added by email. "This is an amazing opportunity to help potentially reduce the number of cases of peanut allergy."
Babies, however, should stick to nut butters and pastes, said Dr. Robert Boyle, a pediatric allergy researcher at Imperial College London who wasn't involved in the current analysis." Whole nuts are not advised for babies or children up to the age of 3, due to the risk of choking," Boyle added by email.
Source: JAMA Pediatrics, November, 2016
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments:"The past year has brought a great deal of new information about food allergy. It is now clear that infants at high risk of food allergy, such as those with severe eczema or known egg allergy, benefit from early introduction of peanut. As more studies are performed, we will learn more about when to introduce which foods. For now, it is clear that high risk infants should be tested for peanut, and if testing is negative, peanut should be introduced before age 1."
Initial trial results have shown that a wearable patch, which delivers small amounts of peanut protein, can protect children and young adults with peanut allergies from the effects of accidental ingestion or exposure. The findings come from the first year of an ongoing trial of a treatment called epicutaneous immunotherapy or EPIT, which is being conducted by the Consortium of Food Allergy Research (CoFAR).
A total of 74 peanut-allergic individuals were enrolled, aged 4 – 25 years, and assigned to either a high-dose (250mg peanut protein), low-dose (100mg peanut protein), or placebo patch. Baseline peanut tolerance was tested with a supervised oral food challenge with peanut-containing food. The study involved the patients applying a new EPIT patch each day to their arm or between their shoulder blades.
Results show that after one year, 46% of the low-dose and 48% of the high-dose group achieved treatment success, which was defined as the ability to consume at least 10 times more peanut protein than he or she was able to before starting EPIT. The placebo group had a treatment success rate of 12%. Greater treatment effects were seen among children aged 4 to 11 years, with significantly less effect in participants aged 12 years and older. No serious reactions were reported apart from mild skin reactions such as itching or rash at the site of application.
“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 percent of children and adults to tolerate,” said Daniel Rotrosen, MD, director of the National Institute of Allergy and Infectious Diseases' Division of Allergy, Immunology and Transplantation.
The plan is to keep the participants in the study for a total of two and a half years. After the first year all participants in the EPIT group have begun using the high-dose daily patches. Additional studies in larger groups of children are needed before the therapy could be approved for wider use. The patches used in the trial are developed and provided by the DBV Technologies under the trade name Viaskin.
For more information visit www.niaid.nih.gov
Dr. Kenneth Backman comments: "This provides further evidence that the peanut patch will offer a huge advance in our ability to treat food allergies and prevent severe reactions. We look forward to further studies and hope for the patch to be commercially available within the next year or two."
For many years parents were advised not to give their child eggs and peanuts before the age of one or even later, but more recently it's been suggested that earlier introduction may be better, and a recent large review of studies confirms this. The review, based on 146 studies and more than 200,000 children, was conducted for UK Food Standards Agency and published in JAMA – the Journal of the American Medical Association. They looked at data on the introduction of allergenic foods – milk, egg, fish, shellfish, tree nuts, wheat, peanuts, and soy – during an infant's first year, and the development of allergies at any age.
Although some studies have found feeding children peanut and egg may reduce allergy risk, other studies have found no effect. Overall, there was moderate-certainty evidence that, compared with later introduction of these foods, introducing egg to a child's diet at the age of four to six months was associated with reduced egg allergy later in life, and introducing peanut at age four to 11 months was associated with reduced peanut allergy.
Dr Robert Boyle, lead author of the research from the Department of Medicine at Imperial College London, said: "This new analysis pools all existing data, and suggests introducing egg and peanut at an early age may prevent the development of egg and peanut allergy, the two most common childhood food allergies. "Until now we have not been advising parents to give these foods to young babies, and have even advised parents to delay giving allergenic foods such as egg, peanut, fish and wheat to their infant."
There was weak evidence that introducing fish before the age of six to nine months could reduce allergies developing, and strong evidence that the likelihood of developing celiac disease was not affected by the timing of introducing gluten. Findings for other potentially allergenic foods were inconclusive.
The study authors note that the findings should not automatically lead to new recommendations to feed egg and peanut to all infants, and in particular warned against introducing these foods to a baby who already has a food allergy or another allergic condition such as eczema, suggesting you should talk to your pediatrician or allergist before introducing these foods.
In an accompanying editorial, pediatric allergy expert Dr Matthew Greenhawt writes, "Their conclusions highlight that the 2008 guidelines to not delay introduction were correct. Delay of introduction of these foods may be associated with some degree of potential harm, and early introduction of selected foods appears to have a well-defined benefit."
Dr. Irena Veksler of Allergy & Asthma Care of Fairfield County comments: "Several recent studies have demonstrated that early introduction of foods is likely better than delayed introduction, and this review is an excellent addition to the literature showing that early introduction of egg and peanut reduces the risk of allergy to these foods. While we can never completely prevent allergies, it is good to have means available to reduce the risk. The current data are only strong for peanut and egg, but additional studies are sure to follow."
A Cochrane Review (meta-analysis of multiple studies) suggests that patients with asthma who take vitamin D supplements can reduce the number and severity of attacks, researchers reported at the annual meeting of the European Respiratory Society. In nine trials reviewed by a team headed by Adrian R. Martineau, MD, of Queen Mary University in London, administration of vitamin D reduced the rate of exacerbations by 37% [RR 0.63 (95% CI 0.45-0.88)], and the risk of having at least one exacerbation requiring an emergency department visit was reduced 61% [OR 0.39 (95% CI 0.19-0.78)].
The trial included outcomes among 435 children in seven trials and 658 adults who were participants of two other trials. "Vitamin D is likely to prevent severe asthma exacerbation and reduce healthcare use by people with asthma," Martineau said. Subgroup analysis to determine whether the effect of vitamin D on the risk of severe exacerbation was modified by baseline vitamin D status was not performed, due to the unavailability of suitably disaggregated data, the researchers noted. Giving an oral vitamin D supplement reduced the risk of severe asthma attacks requiring hospital admission or emergency department attendance from 6% to around 3%. Vitamin D supplementation also reduced the rate of asthma attacks needing treatment with steroid tablets. The results are based largely on trials in adults, Martineau and colleagues cautioned, adding that vitamin D did not improve lung function or day-to-day asthma symptoms or increase the risk of side effects.
Low blood levels of vitamin D have been linked to an increased risk of asthma attacks in children and adults with asthma, the team noted. The study participants were ethnically diverse, reflecting the broad range of global geographic settings, involving Canada, India, Japan, Poland, the United Kingdom, and the United States. The majority of people recruited to the studies had mild to moderate asthma, and a minority had severe asthma. Most people continued to take their usual asthma medication while participating in the studies. The studies lasted for 6 to 12 months. Asked for his opinion of the study, Len Horovitz, MD, of Lenox Hill Hospital in New York City told MedPage Today: "Everyone should be on vitamin D supplementation because vitamin D deficiency is epidemic unless you are a forester or a tennis pro.
"Most of us are vitamin D deficient and need to take supplements. Vitamin D deficiency can lead to a lot of adverse consequences -- they may be involved in autoimmune disease, and some people see a link with certain cancers. So I would never say that it could not be involved in asthma as well." Martineau said that caution is required in interpreting the results of the study, however. "First, the findings relating to severe asthma attacks come from just three trials. Most of the patients enrolled in these studies were adults with mild or moderate asthma. Further vitamin D trials in children and in adults with severe asthma are needed to find out whether these patient groups will also benefit. "Second," he continued, "it is not yet clear whether vitamin D supplements can reduce the risk of severe asthma attacks in all patients, or whether this effect is seen just in those who have low vitamin D levels to start with. Further analyses to investigate this question are ongoing, and results should be available in the next few months."
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "This adds to the evidence that vitamin D may be beneficial in asthma. However, it is not clear whether the benefit would mainly be seen in those who are vitamin D deficient. We encourage patients to discuss their vitamin D status, and possible supplementation, with their primary care physician."
Nasal irrigation appears beneficial in symptom improvement for patients with chronic sinusitis, according to a study published online July 18 in CMAJ, the journal of the Canadian Medical Association.
Paul Little, M.D., professor of primary care research at the University of Southampton in the United Kingdom, and colleagues followed 871 patients in England who had a history of chronic or recurrent sinusitis. Participants were assigned one of four treatments: daily nasal irrigation with saline plus use of an instructional video; daily steam inhalation; a combination of both; or their usual treatment. Usual care was at the discretion of the patient's physician and could include the use of antibiotic medications. The team assessed Rhinosinusitis Disability Index (RSDI) scores as the primary outcome.
At three months and six months, the researchers found that patients who used nasal irrigation had improved RSDI scores. Fewer participants in the nasal irrigation group (compared to no-irrigation patients) took over-the-counter medications, had headaches, or intended to consult a doctor in future episodes. Those using steam inhalation said headaches had eased, but had no significant improvement in RSDI scores. Adverse effects were similar in both intervention groups.
"Advice to use steam inhalation for chronic or recurrent sinus symptoms in primary care was not effective," the authors write. "A similar strategy to use nasal irrigation was less effective than prior evidence suggested, but it provided some symptomatic benefit."
Source: Little P, Stuart B, Mullee M, et al. Effectiveness of steam inhalation and nasal irrigation for chronic or recurrent sinus symptoms in primary care: a pragmatic randomized controlled trial [published online July 18, 2016]. CMAJ. doi: 10.1503/cmaj.16
Dr. Katherine Bloom of Allergy & Asthma Care comments: "Saline irrigation has been found to be effective in controlling symptoms and improving outcomes in sinusitis. This study adds to the evidence that nasal saline irrigation is a worthwhile intervention."
Prenatal supplementation with omega-3 (n-3) long-chain polyunsaturated fatty acids (LCPUFA) does not reduce immunoglobulin E (IgE)-associated allergic disease in children, according to a study published online May 25 in Pediatrics.
Karen P. Best, R.N., Ph.D., from the South Australian Health and Medical Research Institute in Adelaide, and colleagues assessed 706 children with a family history of allergic disease from the Docosahexaenoic Acid to Optimize Mother Infant Outcome trial at six-year follow-up. Women enrolled in the trial were randomized to n-3 LCPUFA-rich fish oil capsules or vegetable oil capsules.
The researchers found that the percentage of children with any IgE-associated allergic disease did not differ between the n-3 LCPUFA and control groups (31.5 versus 31.5 percent; adjusted relative risk, 1.04; 95 percent confidence interval, 0.82 to 1.33). The percentage of children sensitized to house dust mite Dermatophagoides farinae was reduced in the n-3 LCPUFA group (13.4 versus 20.3 percent; adjusted relative risk, 0.67; 95 percent confidence interval, 0.44 to 1.00).
"Prenatal n-3 LCPUFA supplementation did not reduce IgE-associated allergic disease at 6 years of age," the authors write. "Secondary outcomes were suggestive of a protective effect of the intervention on the incidence of D. farinae sensitization."
Source: Pediatrics 2016
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "While some reduction in dust mite sensitization (IgE production to dust mite) was seen in children of mothers who took fish oil during pregnancy, the actual incidence of allergic disease did not appear to be reduced by fish oil. There are certainly many benefits of fish oil, but this study suggests that prenatal prevention of allergic disease does not appear to be one of them."
The safety of long-acting beta-agonists (LABAs) such as salmeterol and formoterol, in medications such as Advair, Symbicort, Dulera, and Breo, has been widely debated. Large, poorly structured trials in the past have shown increased risk of serious asthma related events in patients on LABAs, but many patients were on these without adequate asthma controller medication.
A new study published in the New England Journal of Medicine (May 12 2016) addresses this issue. A multicenter, randomized, double-blind trial of adolescent and adult patients with persistent asthma randomized patients to either fluticasone with salmeterol or fluticasone alone for 26 weeks. All patients had a history of a serious asthma exacerbation in the year before study onset, though not the previous month. Patients were excluded if they had life threatening or unstable asthma. The primary end point was the first series asthma related event (death, incubation, or hospitalization.)
Of 11,679 patients enrolled, 67 had 74 serious asthma related events, with similar numbers in both groups and no statistically significant different between them. There were no asthma related deaths, and only 2 intubations, both in the fluticasone group. The risk of asthma exacerbation was 21% lower in the fluticasone-salmeterol group vs. the fluticasone only group.
The conclusions of the study were that salmeterol in fixed dose combination with fluticasone did not lead to a significantly higher risk of serious asthma-related events, and patients on fluticasone-salmeterol combination therapy had fewer severe asthma exacerbations than the fluticasone only group.
(N Engl J Med 2016;374:1822-30)
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "There has been concern about the safety of LABAs since a couple of poorly designed studies over a decade ago. Several smaller studies have shown no danger of LABAs when combined with inhaled corticosteroid, but this large, very well designed study is the most reassuring so far that inhaled steroid-LABA combination therapy is safe and puts asthma patients at no increased risk of exacerbations or adverse effects. In fact, the combination therapy actually reduced the risk of exacerbations. There is still a need for further studies, because this study did not include children under 12, and excluded patients with very severe, life-threatening asthma."
Although anaphylaxis accounts for an increasing percentage of all pediatric emergency department (ED) visits, early use of epinephrine before ED arrival is associated with a lower likelihood of requiring multiple doses of epinephrine in the ED, Canadian researchers report.
Epinephrine use before ED arrival was the only factor associated with a reduced risk for multiple ED epinephrine doses among pediatric patients with anaphylaxis, write Elana Hochstadter, MD, from the Department of Pediatric Emergency Medicine at the University of Toronto's Hospital for Sick Children, Ontario, Canada, and colleagues. The researchers reviewed 965 anaphylaxis cases from Montreal Children's Hospital that were included in the Cross-Canada Anaphylaxis Registry (C-CARE), which tracks individuals presenting to EDs or emergency medical services with the condition.
More than 25% of moderate/severe anaphylaxis cases did not receive epinephrine inside or outside the hospital, and "[o]nly 50.7% (95% CI, 45.9-55.4) of those who had an epinephrine autoinjector used it before arrival to the ED," the authors write in a letter to the editor published online April 20 in the Journal of Allergy and Clinical Immunology. Factors associated with an increased likelihood of receiving multiple doses of epinephrine in the ED were older age, a severe reaction, and anaphylaxis cases triggered by peanuts, tree nuts, and milk .
The percentage of anaphylaxis cases among all ED visits more than doubled from April 2011 to April 2015, going from 0.20% to 0.41%, with the largest annual increase seen between 2013-2014 and 2014-2015 (0.11%). The median age of patients was 5.8 years. Almost half of patients reported a known food allergy, and asthma and eczema were reported in almost 20% of patients. Most cases (85.3%)were referred to an allergist after the ED visit or already had consulted with an allergist. Food was the most common trigger of anaphylaxis in the study, responsible for 80% of cases, with peanut responsible for 22.2%. Most reactions were moderate in severity; asthma (OR, 2.3) and eczema (OR, 2.1) were associated with severe reactions.
Although the results are from just one center, "they suggest a worrisome increase in anaphylaxis rate that is consistent with the worldwide reported increase," the authors note. "Both our study and US studies reveal that a higher percentage of pediatric ED visits are due to anaphylaxis in North America compared with European centers. This likely reflects differences in the prevalence of food allergies between North America and Europe."
From J Allergy Clin Immunol. Published online April 20, 2016.
Dr. Irena Veksler of Allergy & Asthma Care of Fairfield County comments: "This study reinforces the importance of early administration of epinephrine in all cases of anaphylaxis. While anaphylaxis is on the rise, we have an extremely effective treatment in epinephrine, and it is important that it be administered as soon as anaphylaxis is suspected."