Pediatric & Adult
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Dr. Kenneth Backman, Dr. Irena Veksler, and Dr. Katherine Bloom
A recent study by a Japanese institute found that consistently using emollients on newborn babies can prevent atopic dermatitis (eczema) and food allergies later in life. Emollient therapy with newborn babies is an inexpensive and easy way to prevent and treat the increasing global epidemic of eczema and prevent food allergies.
The National Center for Child Health and Development in Tokyo conducted a small-scale study. Researchers found that using emollients regularly during the first few weeks of life can help the immune system and keep it functioning properly. Researchers studied two groups of newborns. One group used emollients regularly on the babies. Another group had no treatment. The researchers studied 118 newborns for 32 weeks.
Results showed 19 babies developed atopic dermatitis (eczema) in the group using regular emollients. 28 babies developed atopic dermatitis (eczema) in the group using no treatment. This is the first study of it’s kind worldwide and suggests that using emollient therapy can reduce the risk of developing atopic dermatitis (eczema) by 30 percent.
The National Center for Child Health and Development stated in a recent press release that emollient therapy prevents the skin from drying out and cracking. Dry cracked skin allows irritants to enter the body exposing immune cells to these irritants. The immune system then boosts the body’s production of antibodies to combat these irritants, resulting in over-production. This over-production of antibodies causes the symptoms of allergy such as atopic dermatitis (eczema) and allergies and food allergies.
Toru Sato, the center’s spokesman, stated “It was known before that dry skin would cause eczema. One of the achievements of this study is that we came up with clear figures for the probability of developing eczema. Researchers are now looking at why some babies in the group still went on to develop eczema. Another important point is that the study suggests atopic skin problems could be linked to other allergic reactions, such as asthma and hay fever, that may appear later in life.”
How to apply this study? If you have a young baby, applying an emollient or moisturizer after their bath is a good way to keep their skin soft and supple. Keeping newborn skin healthy is easy and may prevent them from developing eczema, allergies and food allergies.
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "We've long known that moisturization is a critical component of eczema skin care, and that good skin care can help prevent eczema flares. There is now evidence that moisturization in early life can actually prevent eczema. We look forward to more studies on this topic."
Babies exposed to traces of peanut protein in house dust may have a higher risk of peanut allergy researchers say. In a new UK study, published online in the Journal of Allergy and Clinical Immunology, exposure to peanut protein in house dust doubled the chance of having a peanut allergy. In children who have eczema, the risk of having peanut allergy was even higher.
Around 2% of school children in the UK are allergic to peanuts. Researcher Helen Brough, from the department of paediatric allergy at King's College London and colleagues from the University of Manchester and the University of Dundee , note that eczema "is often cited as the first step in the allergic march." They say that exposure to peanut proteins in dust through eczema-inflamed skin can trigger a peanut allergy. How peanut allergies develop is not yet clear, says Dr Carla Davis, a specialist in children's allergies at Texas Children's Hospital in Houston in the US. There is still plenty of controversy in the field, she says. For instance, some researchers are testing a "patch" for people who already have a peanut allergy that would introduce the allergen through the skin to build tolerance. That seems to contradict the findings in this study, she says.
The researchers found out how much peanut protein infants were exposed to by measuring dust vaccuumed from the patients' living rooms. They studied 359 children who had a high risk of developing a peanut allergy because they were already allergic to cow's milk or eggs, or had moderate or severe levels of eczema and had allergies to those foods. "This study adds to the growing body of evidence that exposure to peanut via a damaged skin barrier [as in eczema] may increase the risk of peanut allergy,” Helen Brough says in a news release.
Professor Gideon Lack, senior author from the Department of Paediatric Allergy, King's College London, adds: "This is further evidence for the dual-allergen-exposure theory which suggests food allergies develop through exposure to allergens via the skin, likely through a disrupted skin barrier, whilst consumption of these food proteins early in life builds up tolerance in the body. Previous guidelines recommending that mothers should avoid peanuts during pregnancy and breastfeeding have now been withdrawn. Ongoing studies at King's aim to find if exposure to solids in early infancy might actually help to prevent allergies. It may be that the timing and balance of skin and oral exposure to a particular food early in life determines whether a child develops an allergy or tolerance to that food."
Several people involved in the study report receiving support from, or consulting for, pharmaceutical and other companies and organisations, including the US National Peanut Board.
Dr. Irena Veksler of Allergy & Asthma Care of Fairfield County comments: "It has long been known that patients with eczema are at increased risk of food allergies. This study identifies one possible cause of this increased risk, and suggests a possible cause of peanut allergy in particular. More studies are definitely needed."
Eosinophilic esophagitis (EoE) is an emerging allergic disorder predominantly triggered by food allergens. Several dietary interventions have been evaluated in adults so far. Based on amino acid-based formulas, elemental diet is the most effective, but is also impractical, whereas elimination diet based on skin testing has shown suboptimal cure rates (26%-36%). An empiric six-food group elimination diet (SFGED), prospectively evaluated in unicenter studies, has achieved remission in over 70% EoE patients. Still, the majority (65%-85%) of SFGED responders have just one or two causative foods identified after six food-group challenges and endoscopies, so some dietary restrictions and subsequent endoscopies after food challenge may be unnecessary.
Now, in a study recently published in The Journal of Allergy and Clinical Immunology, Javier Molina-Infante and colleagues present the results of the first prospective multicenter study on empiric elimination diet for EoE, evaluating a simplified four-food group elimination diet (FFGED) (dairy products, wheat, egg and legumes) for adult EoE.
The efficacy of this six week FFGED was evaluated in 52 consecutive patients from four Spanish hospitals. In those unresponsive to FFGED, a rescue SFGED was proposed. Among patients responsive to a FFGED, 78% completed the individual food reintroduction process.
The study shows 54% of adult EoE patients achieve clinicohistological remission on an empiric FFGED; in addition, almost a third of non-responders to FFGED could be effectively rescued with a SFGED, coming to an overall effectiveness of 72%. Therefore, 3 out of every 4 adult patients achieving remission on a SFGED may achieve it on a FFGED, a less restrictive dietary intervention that requires fewer endoscopies and shortens the food reintroduction process. After food reintroduction, all FFGED responders had just 1 or 2 food triggers identified. The most common food triggers were cow´s milk (50%), egg (36%) and wheat (31%), with milk being the only causative food in 27% of adult patients. Results were consistent among the four participating centers.
This study underscores the general applicability of dietary interventions for adult EoE in clinical practice. This multistage, empiric, dietary approach (FFGED followed by SFGED) may be recommended to simplify dietary management for EoE patients, since a FFGED is a simpler, cheaper and less inconvenient initial dietary intervention to screen a majority of EoE patients with one or two food triggers.
(from AAAAI.org website) For more info on eosinophilic esophagitis, click here
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "Eosinophilic esophagitis is a relatively newly identified disorder about which we continue to learn more. Food elimination diets have clearly been very effective in children, but in adults results have been mixed. This study demonstrates that food elimination diets can be quite helpful in adults, even while making them easier by reducing the number of foods avoided. Due to the difficulty in eliminating even this smaller number of foods, many adults choose to pursue swallowed "inhaled" steroids, which are highly effective."
A study in the Annals of Allergy, Asthma, and Immunology examined the effects of dairy intake during pregancy (Miyake Y. Ann Allergy Asthma Immunol. 2014;113:82-87.):
Higher maternal intake of total dairy products, cheese, yogurt and calcium during pregnancy was associated with a reduced risk for infantile eczema, asthma and atopic eczema in children, according to study results.
Researchers in Japan studied 1,354 mother-child pairs (mean maternal age, 31.5 years) to determine the association between maternal consumption of dairy foods, calcium and vitamin D during pregnancy and childhood allergic disorders in children aged 23 to 29 months. A diet history questionnaire was administered between April 2007 and March 2008 to determine maternal intake during pregnancy. International Study of Asthma and Allergies in Childhood criteria defined wheeze and eczema, while a questionnaire completed by mothers determined physician-diagnosed asthma and atopic eczema.
Reduced risk for infantile eczema was significantly associated with higher maternal intake of total dairy products (adjusted OR between extreme quartiles, 0.64; 95% CI, 0.42-0.98). A reduced risk for physician-diagnosed infantile asthma correlated with a greater maternal intake of cheese (aOR=0.44; 95% CI, 0.18-0.97).
Yogurt (aOR=0.49; 95% CI, 0.2-1.16) and calcium consumption (aOR=0.34; 95% CI, 0.12-0.84) during pregnancy showed inverse associations with physician-diagnosed infantile atopic eczema. A significant association existed between maternal vitamin D consumption during pregnancy and infantile eczema (aOR=1.63; 95% CI, 1.07-2.51).
“The current prebirth cohort study in Japan suggests that higher maternal intake of total dairy products, cheese, yogurt and calcium during pregnancy may reduce the risk of infantile eczema in the last 12 months, physician-diagnosed asthma, physician-diagnosed atopic eczema, and physician-diagnosed atopic eczema, respectively,” the researchers concluded. “Higher maternal intake of vitamin D during pregnancy may increase the risk of infantile eczema in the last 12 months.
“Further well-designed prebirth cohort studies with accurate assessment of dietary habits during pregnancy and childhood allergic disorders are required to confirm these findings.”
Dr. Katherine Bloom from Allergy & Asthma Care of Fairfield County comments:"While this study needs to be confirmed, it is encouraging that something as simple as increasing the intake of dairy products may have the potential to help prevent eczema and allergic diseases in children."
Posted on September 17, 2014 | Permalink
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The American College of Allergy, Asthma and Immunology has warned parents of children with asthma and allergies to be aware of their child’s symptoms regarding enterovirus D68.
“If your child seems to be struggling to breathe and their normal asthma medications aren’t working, get him or her to the emergency department as soon as possible,” allergist Bradley Chipps, MD, a spokesman for theACAAI, said in a press release. “The most important thing is for every child with asthma to have a personalized action plan, created with his or her allergist, [which] helps quickly identify when a child … needs immediate, emergency attention.”
Although enterovirus D68 symptoms first appear as a common cold, they can quickly move to more severe respiratory symptoms including wheezing and difficulty breathing, the release said.
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "While many children affected by enterovirus D68 may develop an illness no worse than the common cold, this virus can cause very serious and sudden respiratory complications. If your child becomes ill and develops asthma symptoms that are not quickly and easily reversed with the quick relief inhaler (albuterol or levalbuterol,) contact your physician immediately. If your child is in distress or struggling to breathe, do not hesitate to seek emergency care."
Posted on September 17, 2014 | Permalink
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Surveyed pediatric patients with food allergies, and accompanying parents and families did not always carry self-injectable epinephrine, according to recent survey results. Researchers surveyed patients or families of patients with a documented history of food allergy during a 30-day follow-up period at the Nationwide Children’s Hospital outpatient allergy clinic, Columbus, Ohio. Age, previously diagnosed food allergies, diagnostic method, symptoms associated with previous food reactions and comorbid atopic conditions were collected. Information about carrying epinephrine auto-injector also was requested.
Thirty-five surveys were returned, and 20% of respondents reported a previous allergic reaction to food requiring treatment with self-administered epinephrine. Twenty-nine percent of those respondents had self-injectable epinephrine with them during the survey. Of the patients with self-injectable epinephrine during the survey, almost 90% had the weight-appropriate dose, but almost 50% of the auto-injectors were expired. While 60% of patients endorsed always carrying self-injectable epinephrine, only 40% of patients had the product available during the survey.
Nearly 90% of respondents reported peanut allergies, but only 43% of the patients had self-injectable epinephrine available. Accidental exposure to a food allergen was reported by 30% of patients, but only one-third of them had epinephrine available during the survey. Availability in other places such as the home, car or school, expiration of previous prescription, cost, and not knowing that it should always be carried were reasons given for not having self-injectable epinephrine with them.
“It will be necessary to continue to foster relationships with patients and their families, teachers, school administrators and staff, and community leaders to provide comprehensive food allergy care,” the researchers concluded. “Moreover, we must routinely evaluate our educational methods with respect to epinephrine efficacy and access; if these methods are ineffective it will be necessary to improve them.”
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "We have long known that one of the strongest risk factors for fatality in patients with food allergy is the absence of immediately available epinephrine. While prescribing of epinephrine autoinjectors is on the rise, unfortunately many patients with food allergy do not carrry them at all times. This is an important issue that education and frequent reminders can hopefully help overcome."
MILWAUKEE, WI – Warmer weather means more time outdoors, but spending time outside brings with it the chance of coming in contact with stinging insects, which are among the most common triggers of a serious, life-threatening reaction called anaphylaxis. However, a new paper in The New England Journal of Medicine cites venom immunotherapy as the best treatment option for people who are allergic to stinging insects as it can reduce the risk of a future severe reaction to less than 5%.
Written by American Academy of Allergy, Asthma & Immunology (AAAAI) Executive Vice President Thomas B. Casale, MD, FAAAAI, and A. Wesley Burks, MD, FAAAAI, a past President, the paper follows the case of a 24-year-old woman who was stung while drinking soda at a picnic. The woman began experiencing symptoms indicative of anaphylaxis minutes after being stung, including swelling of the lips, light-headedness, difficulty swallowing and hives. She was transported to a local emergency room and treated with epinephrine. After being observed for several hours, she was discharged and given autoinjectable epinephrine.
“As far as long-term therapy for people with stinging insect allergy, avoiding exposure to these insects is key, but the only treatment option that will actually prevent life-threatening anaphylactic reactions is venom immunotherapy,” said Dr. Casale.
Patients who have experienced a severe allergic reaction to an insect sting should see an allergist/immunologist, who can provide appropriate testing and determine if venom immunotherapy is the right treatment option. Venom immunotherapy is given in the form of shots, and about 80 to 90% of patients who receive it for 3 to 5 years do not have a severe reaction to a future sting.
“The other important thing to keep in mind is that patients with venom-specific IgE who have had a severe allergic reaction are at higher risk of having another severe allergic reaction,” explained Dr. Burks. “It is imperative for these individuals to carry autoinjectable epinephrine and know how to use it in an emergency.”
Epinephrine is the first-line treatment for anaphylaxis. In fact, the AAAAI recently released a second list for the ABIM Foundation’s Choosing Wisely® initiative that included an item highlighting the importance of epinephrine because data indicate that antihistamines are overused as the first-line treatment of anaphylaxis. Overuse of antihistamines, which do not treat the cardiovascular or respiratory symptoms of anaphylaxis, can delay treatment with epinephrine. Fatalities during anaphylaxis have been associated with delayed administration of epinephrine. Anyone who believes they are having an anaphylactic reaction should use autoinjectable epinephrine and seek medical attention immediately.
More information on stinging insect allergy, anaphylaxis and immunotherapy is available at the AAAAI website, www.aaaai.org
A recently published multi-center study found that supplemental vitamin D did not help patients with low vitamin D blood levels and symptomatic asthma. The trial, funded by the National Heart Lung and Blood Institute, failed to demonstrate any benefit of vitamin D on the primary measure - time to first treatment failure – or on eight of nine secondary measures.
“These findings do not support a strategy of therapeutic Vitamin D3 supplementation in patients with symptomatic asthma,” wrote the authors, who included Richard Martin, MD, chair of medicine at National Jewish Health, and Michael Wechsler, MD, director of the asthma program at National Jewish Health.
Earlier studies had associated low vitamin D blood levels with more asthma symptoms and medication use, and with reduced response to the mainstay asthma medication, inhaled corticosteroids.
The Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma (VIDA) trial was conducted at nine academic medical centers participating in the NHLBI’s AsthmaNet clinical research network. It randomized 408 adults with low vitamin D and mild/moderate asthma to receive the inhaled corticosteroid ciclesonide supplemented with either high-dose vitamin D3 or placebo. Participants were then monitored over 28 weeks for the occurrence of worsening asthma.
Vitamin D3 supplementation did not reduce the proportion of participants who experienced at least one treatment failure (28 percent vs. 29 percent in placebo) or one exacerbation (13 percent vs. 19 percent) nor the overall exacerbation rate. More of the vitamin D treated patients were able to reduce their inhaled steroid dose by 75 percent compared to those treated with placebo (89 percent vs. 80 percent).
The findings were presented on May 18, 2014, at the American Thoracic Society annual meeting and concurrently published in the Journal of the American Medical Association.
Dr. Katherine Bloom of Allergy & Asthma Care of Fairfield County comments: "Much has been learned about the benefits of vitamin D over the past several years. There has been some preliminary evidence that vitamin D supplementation might benefit asthma patients, but this well-constructed study demonstrates minimal effect. More studies need to be performed, but at this time, we cannot recommend vitamin D supplementation in the treatment of asthma."
The FDA approved the ragweed allergy treatment Ragwitek, the third sublingual immunotherapy (SLIT) approval last month. The announcement followed that of Merck's other SLIT agent, the Timothy grass pollen allergy tablet Grastek, on Tuesday and that of Greer's multi-grass pollen immunotherapy tablet Oralair earlier in April. While under-the-tongue drops made off-label from subcutaneous allergy shot extracts have been used by some practitioners, no SLIT agents had been FDA approved before. The liquid extracts manufactured for injections have generally been too weak to have clinical effectiveness when administered sublingually, but the new sublingual tablets are high dose and are proven effective.
Ragwitek gained approval for treatment of short ragweed pollen-induced allergic rhinitis, confirmed by a positive skin test or in vitro testing for pollen-specific immunoglobulin-E antibodies, with or without conjunctivitis, in adults ages 18 through 65. That upper age limit had been the source of some dissension on the FDA advisory panel that recommended approval. The pivotal trials included no patients over age 51, so a few panel members felt the evidence wasn't sufficient for older patients.
The other two SLIT agents approved have gained an indication for pediatric use, but that wasn't sought or studied with Ragwitek. But the Ragwitek approval otherwise followed closely with that of the grass allergy SLIT agents. It was approved for once daily use starting 12 weeks before the start and continued through the offending pollen season, which typically runs from late summer to early fall. The first dose should be taken in-office and the patient observed for at least 30 minutes for potential adverse reactions.
The most common adverse reactions reported with Grastek and Ragwitek have been itching in the mouth and ears and throat irritation, but the drug carries a boxed warning of the risk of severe allergic reactions. Due to that risk, patients should be prescribed auto-injectable epinephrine and trained in its use.
Patients with severe, unstable, or uncontrolled asthma or a history of any severe systemic allergic reaction, eosinophilic esophagitis, or any severe local reaction after taking any SLIT agent shouldn't get Ragwitek.
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "This adds two more options to the new category of sublingual immunotherapy tablets, the first under-the-tongue allergen immunotherapy that has proven effectiveness to the satisfaction of the FDA. It is exciting to have this new treatment option available, and look forward to discussing this and other options with our patients."
The FDA has approved the first and only sublingual oral immunotherapy formulation, Oralair, a sublingual dissolving tablet for grass allergies in the United States.
Oralair (sweet vernal, perennial rye, Orchard, Timothy and Kentucky blue grass mixed pollens allergen extract, Greer/Stallergenes) is to be used as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin or blood testing for grass pollen-specific IgE antibodies for any of the five grass species contained in the product. It is indicated for patients aged 10 to 65 years.
“While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “The approval of Oralair provides an alternative to allergy shots that must be given in a health care provider’s office. Oralair can be taken at home after the first administration.”
The first dose would be administered at a doctor’s office. Data indicate that the drug be initiated 4 months before the expected onset of each grass pollen season and continued throughout the season. In clinical trials, Oralair was well-tolerated; the most common adverse events were oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough, and oropharyngeal pain. The drug contains a black boxed warning due to the drug’s potential for anaphylaxis and severe laryngopharyngeal edema. Oralair is contraindicated (not recommended) in patients with severe, unstable, or uncontrolled asthma, or with a history of severe systemic or local reaction to sublingual allergen immunotherapy.
Merck and Danish partner ALK Abelló also are expected to launch their rival agent, Grastek, later this year, according to a press release. Oralair was first approved in the European Union in 2008 and is marketed in Canada, Australia and Russia to treat grass pollen allergy.
Dr. Irena Veksler of Allergy & Asthma Care of Fairfield County comments: "This is exciting as it represents the first FDA approved sublingual immunotherapy in the United States. While most studies have found that subcutaneous (injected) allergen immunotherapy is more effective than sublingual, this is an option for patients whose main allergen is grass pollen, and who desire a way to build their immunity to grass pollen without injections. While some practitioners in this country have offered sublingual drop immunotherapy, this has generally been at doses far too low to have any clinical effect. These grass pollen tablets, while less effective than injections, should provide significant improvement in symptoms."
Chronic urticaria (hives) can be a miserable experience for those that are afflicted. Many patients with this condition suffer from daily, very itchy hives that are difficult to control, often requiring multiple antihistamines and other medications to control their symptoms. For many of these patients, complete control is rarely if ever achieved.
There is now a new option available for the treatment of chronic urticaria - Xolair (omalizumab.) Xolair is a biologic medication originally developed to treat asthma, and it has turned out to be highly effective for many patients suffering from chronic hives. Xolair has now received FDA approval for the treatment of chronic hives. If you or a loved one suffers from chronic hives, please contact our office and schedule an appointment to review your options.
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "We've had success treating difficult-to-control asthma with Xolair, and in our office it has been a remarkably safe and well tolerated option. Chronic hives can often be much more difficult to control, and the ability to prescribe Xolair for this condition should greatly improve the lives of many of our patients."
Oral immunotherapy (OIT) for children's peanut allergy may be a safe and effective approach, a new study has shown. Findings from the phase 2 trial, published in the Lancet in January, add to accumulating evidence that children can gradually build tolerance by ingesting increasing amounts of peanut protein.
Previous results from small studies have suggested that peanut OIT might be an effective strategy for managing children with peanut allergy. However, until now, the approach had not been thoroughly evaluated in a sizable group of children. Therefore, the investigators designed a 2-step, randomized controlled crossover trial testing OIT in 99 children aged 7 to 16 years. Children with all levels of peanut sensitivity were included in the trial.In the first step, children were randomly assigned to 1 of 2 groups. One group received 26 weeks of OIT, which consisted of gradually increasing doses of peanut protein up to 800 mg daily. The other group was advised to avoid peanuts per usual, serving as controls. At the end of the 26 weeks, both groups underwent peanut challenge.
In the second phase, children in the control group were offered the 26-week OIT treatment followed by challenge. "OIT successfully induced desensitisation in most children within the study population with peanut allergy of any severity, with a clinically meaningful increase in peanut threshold," the researchers report. "Peanut OIT raises the reactive threshold at least 25-times so that 84–91% of participants can tolerate daily ingestion of 800 mg protein."
At the end of the first trial phase, 84% (95% confidence interval [CI], 70% - 93%) of the children in the active intervention group tolerated daily ingestion of 800 mg protein compared with none in the control group. In addition, 62% (95% confidence interval [CI], 45% - 78%) of the active intervention group had become desensitized, which was defined as having no reaction to ingestion of 1400 mg peanut protein (roughly equivalent to 10 peanuts). After the second trial phase, 91% (95% CI, 79% - 98%) of children who had been assigned initially to the control group were able to tolerate ingestion of 800 mg protein daily, and 54% (95% CI, 35% - 72%) had become desensitized. The authors point out that it would be unlikely for children to accidentally encounter 1400 mg of peanut protein.
About a fifth of the patients reported adverse reactions to OIT. However most were mild, with oral itching being the most common, occurring after 6.3% of doses (76 children). Gastrointestinal symptoms were also common, with 31 children reporting nausea, 31 reporting vomiting, and 1 reporting diarrhea. In addition, 41 children developed wheeze (0.41% of doses) and 1 child required intramuscular adrenaline. In an accompanying comment, Matthew J. Greenhawt, MD, from the University of Michigan Food Allergy Center, Division of Allergy and Clinical Immunology, Ann Arbor, stressed that although the results of the study are promising, more high-quality data are needed before recommending the therapy to all child and adolescent patients with peanut allergy.
"It is important to understand that OIT research cannot be rushed, and is years away from routine clinical use," Dr. Greenhawt notes. "Investigative groups need time to refine protocols, revalidate data, understand the mechanisms of OIT, and minimise adverse effects. This must be done without added pressure or heightened expectations to quickly produce a marketable therapy," he concludes.
Dr. Katherine Bloom of Allergy & Asthma Care of Fairfield County emphasizes "while this adds to the exciting research demonstrating effectiveness of oral immunotherapy, it is still too soon for this to be offered in the community. As Dr. Greenhawt notes, more research is needed before it would be appropriate to offer this in physicians' offices outside an academic clinical trial. We look forward to more research in this area."
Source: Medscape Medical News 1/29/14
Drug regulators in the European Union (EU) have recommended approving omalizumab ( Xolair, Novartis, Genentech) as an add-on therapy for patients with chronic spontaneous urticaria (CSU), the European Medicines Agency (EMA) announced today.
Omalizumab already is approved in the EU as an add-on therapy for allergic asthma. Yesterday the EMA's Committee for Medicinal Products for Human Use (CHMP) cleared the drug for patients 12 years of age and older with CSU who have not responded adequately to H1 antihistamine treatment.
The US Food and Drug Administration (FDA) okayed omalizumab as a stand-alone therapy for allergic asthma in 2003. Four years later, the agency added a boxed warning to the drug's label about the risk for life-threatening anaphylaxis. The FDA is weighing whether to follow CHMP's lead and approve the drug for CSU.
CHMP's recommendations on omalizumab and ustekinumab await a final decision from the European Commission, the executive branch of the EU.
From Medscape Medical News
Dr Kenneth Backman from Allergy & Asthma Care of Fairfield County comments: "Studies have demonstrated that Xolair can lead to dramatic improvement in patients with difficult-to-treat hives. The FDA is expected to approve Xolair for this condition soon, and we look forward to being able to offer this to patients. There are some insurance companies that already cover this for severe hives, so patients suffering from chronic hives should contact us for additional information."
A recent study published in the Journal of Allergy and Clinical Immunology (JACI) demonstrates that toddlers who are allergic to raw egg but can safely eat foods containing baked egg seem more likely to outgrow their egg intolerance by age 2.
"The findings show us that there are in general two types (of) patients with egg allergy, those who will outgrow the allergy in a few years and those who it will take longer to outgrow it," said Dr. Wesley Burks, who chairs the department of pediatrics at the University of North Carolina in Chapel Hill and was not involved in the study."The first group can be identified with the ability to consume baked-egg products and if they put these products in their diet they may outgrow the egg allergy sooner," Dr. Burks told Reuters.
The new work, led by Dr. Katrina Allen from the Royal Children's Hospital in Parkville, Victoria, Australia, was published online December 27 in the Journal of Allergy and Clinical Immunology.
To test for allergic reactions, Dr. Allen and her team administered prick tests to more than 5,100 one-year-olds. They then performed oral food challenges on those who responded, including raw eggs and a muffin containing baked egg, and followed up with baked-egg tests again when the children were two years old. They reported results for 140 children who completed follow-up. Nearly half the children (47%) outgrew their egg allergy by age 2. Statistical analysis revealed two significant predictors of persistent egg allergy: the baseline skin-prick test (adjusted odds ratio, 3.34) and egg specific serum IgE of 95% or greater positive predictive value (aOR, 29.46).
Another predictor was tolerance to baked egg. At baseline, 20% of the infants who reacted to raw egg also reacted to baked egg, and after adjustment for confounders these children were five times as likely to remain allergic through age 2 as were those who tolerated baked eggs (aOR, 5.27). "We believe our results will help decide which children should be entered into studies of oral immunotherapy for egg allergy," Dr. Allen said.
It's possible that eating baked eggs may improve tolerance. When infants who could eat baked egg at age 1 ate foods containing baked eggs five or more times per month they were three times more likely to tolerate raw egg at age 2 (OR, 3.51)." For families with children with egg allergy, this is a well done study to help them know that for many children with egg allergy, this allergy will be outgrown early in life. It also shows us that if a child can tolerate baked egg, then it is probably good for them to incorporate this into their diet," Dr. Burks says.
Dr. Katherine Bloom of Allergy & Asthma Care of Fairfield County comments: "Previous studies have demonstrated that patients with milk allergy are more likely to outgrow the allergy if they tolerate baked milk, and that ingestion of baked milk may lead to more rapid resolution of the allergy. This study demonstrates that the same appears to be true of egg allergy. Patients with these food allergies would benefit from allergy testing and possible in-office baked food challenges to determine whether they can eat these forms of the food and accelerate resolution of the allergy."
SOURCE: http://bit.ly/19EVBdX and Reuters.
J Allergy Clin Immunol 2013.
The following summary is taken from the American Academy of Allergy, Asthma, and Immunology website, www.aaaai.org.
Patients with chronic idiopathic urticaria/chronic spontaneous urticaria (CIU/CSU) often have uncontrolled symptoms despite the use of non-sedating H1-antihistamines at up to four times the standard dose. For those patients who remain symptomatic, other treatment options include H2-antihistamines, leukotriene receptor antagonists [LTRAs], dapsone, cyclosporine and methotrexate. However, there is a lack of high-quality clinical evidence to support their use, and immunosuppressants are potentially associated with severe adverse effects. In an original article in The Journal of Allergy and Clinical Immunology (JACI), Kaplan et al. present results from a randomized, double-blind, placebo-controlled study of omalizumab, an anti-immunoglobulin E monoclonal antibody approved as add-on therapy for inadequately-controlled moderate-to-severe allergic asthma and under investigation for use in refractory CIU/CSU.
The primary objective of the study was to assess the safety of omalizumab 300 mg administered at 4-week intervals in patients with CIU/CSU refractory to H1-antihistamines (including up to 4x approved dose) plus H2-antihistamines and/or LTRAs. Efficacy assessments included weekly itch severity score (key secondary endpoint), change from baseline in weekly urticaria activity score, weekly number of hives score, weekly size of largest hive score, health-related quality-of-life (Dermatology Life Quality Index), proportion of angioedema-free days, and proportion of patients who were completely hive- and itch-free.
During 24 weeks of treatment and a subsequent 16-week follow-up period, the incidence and severity of adverse events and serious adverse events were similar between omalizumab and placebo. There were no anaphylactic reactions, malignancies or deaths, and no new safety issues were identified. At Week 12, there was a greater improvement in weekly itch score in the omalizumab group, compared with placebo (-8.6 vs. -4.0; P<.001), with sustained benefit at Week 24 (-8.6 vs. -4.0; P<.001) (see figure). There were also significant improvements with omalizumab, versus placebo, for all other efficacy endpoints.
Overall, this study showed that omalizumab is well tolerated and effective in patients with symptomatic CIU/CSU despite multiple background therapy with H1-antihistamines and H2-antihistamines and/or LTRAs.
Dr. Irena Veksler of Allergy & Asthma Care of Fairfield County comments: "The study demonstrated that omalizumab (Xolair,) currently approved for moderate to severe asthma, can help control chronic hives of unclear cause (chronic idiopathic urticaria.) We currently await FDA approval of Xolair for this condition, and then will need to see how well insurance companies cover this very expensive treatment. We are hoping to have this treatment available for this frustrating condition."
Mothers' receipt of immunotherapy during pregnancy may reduce the risk of any type of allergy in offspring, according to a study presented at the annual meeting of the American College of Allergy, Asthma & Immunology, held from Nov. 7–12 in Baltimore.
Jay Lieberman, MD, from Le Bonheur Children's Hospital in Memphis, Tenn., and colleagues performed a pilot study to examine the correlation between immunotherapy in mothers and allergic disease status in offspring. One hundred forty-three women, aged 18–48 years, with a physician diagnosis of allergic rhinitis were surveyed to assess immunotherapy history and presence of allergic disease in their 277 biological children.
The researchers found that treatment with immunotherapy while pregnant was not associated with the prevalence of allergic disease in offspring in univariate analysis. However, after controlling for breastfeeding, gender, presence of older siblings, and father's allergic status, receipt of immunotherapy while pregnant correlated with a non-significant trend toward decreasing child allergy rates for any type of allergy (odds ratio, 0.84; 95% confidence interval, 0.38–1.84).
"More research is needed to understand if mothers can truly prevent allergies in their children by receiving allergy shots during or before pregnancy," Lieberman said in a statement. "However, these study results show there is a strong association which is very encouraging as allergists explore this possibility."
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "This is provocative research that needs to be validated. We've long known that allergen immunotherapy is highly effective and is safe to receive during pregnancy. Now there is evidence that immunotherapy during pregnancy may actually benefit the unborn child. We look forward to additional research in this area."
Penicillin allergy testing can safely exclude IgE-mediated penicillin allergy.
Almost 8% of the U.S. population claims to be allergic to penicillin, but only a small proportion of these patients are truly allergic. Penicillin skin testing is the only way to identify IgE-mediated allergy (an immediate hypersensitivity reaction mediated by preformed IgE bound to the surface of mast cells and basophils). Penicilloyl-poly-lysine (Pre-Pen), the major determinant of penicillin allergy, has been available commercially since 2009, but clinicians rarely order skin testing. Some physicians are concerned that Pre-Pen testing is inadequate without also testing for minor determinants (penicilloate and penilloate), which are not readily available.
From 2010 to 2012, 500 patients with histories of penicillin allergy (based on diagnoses recorded in their records) were skin tested in a California allergy department using penicilloyl-poly-lysine and fresh penicillin G. Negative tests were followed by oral challenges with amoxicillin. Four patients reacted to one of the two skin-test agents, and another four exhibited positive objective symptoms after oral challenges. None of these reactions [were] life threatening or required epinephrine.
In this study, fewer than 1 in 50 patients with penicillin allergy histories were truly allergic. We should stop accepting penicillin allergy history as a reason for lifelong avoidance. All drug reactions should be documented carefully. Patients with severe delayed reactions such as Stevens Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), or hemolytic anemia should never be challenged or tested; those with mild delayed reactions probably can undergo oral challenges. For those with potential IgE-mediated reactions (i.e., hives, edema, or other symptoms of anaphylaxis occurring within 1–2 hours), penicillin testing followed by oral challenge is safe and effective. Penicillin is the only antibiotic for which such testing is available.
Macy E and Ngor EW. Safely diagnosing clinically significant penicillin allergy using only penicilloyl-poly-lysine, penicillin, and oral amoxicillin. J Allergy Clin Immunol Prac 2013 May; 1:258. [J Allergy Clin Immunol Prac article abstract]Dr. Irena Veksler of Allergy & Asthma Care of Fairfield County comments: "This reinforces what we have long known - most patients with a history of possible penicillin allergy turn out not to be allergic. With increasing resistance to antibiotics, and overuse of many newer antibiotics, it is important to have penicillin antibiotics available as an option in as many patients as possible. All patients with a history of possible penicillin allergy should consider penicillin testing."
Allergen-specific immunotherapy is the only treatment that alters the clinical course of allergic rhinitis (nasal allergies), reducing the risk of asthma and the development of new allergies. A recent Florida Medicaid study found that allergen-specific immunotherapy(AIT or allergy shots,) reduced costs in children with allergic rhinitis, and a further study was then performed to evaluate the cost impact of AIT in adults as well as children.
Through a review of Florida Medicaid claims from 1997 to 2009, researches identified 1319 adults and 3648 children receiving AIT for recently diagnosed allergic rhinitis. They were matched to 4815 adult and 14,463 children with recently diagnosed allergic rhinitis who were not treated with AIT. 18 months of health care costs were compared between groups.
For the total sample, 18 month health care costs $6637 for patients receiving AIT vs. $10,644 for those not receiving AIT - a 38% reduction. The cost reductions were similar for adults and children, with savings of 30% for adults and 42% for children. Analysis of the data disclosed that the savings were from both inpatient and outpatient expenses.
From the Journal of Allergy and Clinical Immunology, 2013;131:1084-1091.
Kenneth Backman, MD from Allergy & Asthma Care of Fairfield County comments: "Allergen-specific immunotherapy has long been known to effectively treat allergic rhinitis and asthma, reducing symptoms and medication usage. It's good to have another study demonstrating that allergy injections save money as well."
We are passing along this information to our patients:
NEW STUDY ON PEANUT ALLERGY OPENS: Research News from Mount Sinai Jaffe Food Allergy Institute
You are receiving this email because you signed up for our research news. We are pleased to announce the start of a new study for those with Peanut Allergy. Please read this entire email carefully to see if you/your child may be interested in participating and learn how to inform us of your interest.
The purpose of this study is to learn if daily ingestion of Peanut Oral Immunotherapy can result in long term tolerance in children with Peanut allergy.
Participants must fulfill the following (NO EXCEPTIONS)*:
· AGES 12 months-48 months
· Peanut Allergy (including a Peanut IgE level of 5kU/L or higher). If you do not know your child’s test result, it will be determined during screening for the study. However, if the result was less than 5kU/L in the past year, your child does not qualify.
· Currently does NOT have an Oat Allergy
The study includes/requires (this is a partial list of study activities):
· Skin tests, blood tests, stool/saliva test, physical examinations and medical histories.
· Feeding tests with peanut where the food is eaten very gradually under medical supervision until symptoms develop. This allows us to see how sensitive a person is to learn if treatments make an improvement.
· Multiple weekday visits to Mount Sinai over approximately 3 years.
· A daily home treatment with some form of peanut protein or placebo (oat flour).
If you/your likely child qualifies and you are interested in learning more, please reply to this email with the subject line INTERESTED IN THE PEANUT STUDY. Include your name, child’s name and date of birth, and contact information.
IMPORTANT: This is a small study and we anticipate more interested participants than we are able to include. We will be working primarily on a “first come” basis. We will reply to your email by phone or reply email to discuss the study further or to inform you that the study is filled. This may take several weeks. Please be patient.
You can always learn more about research studies by searching www.clinicaltrials.gov. Look for our future newsletters about upcoming studies.
THANK YOU FOR YOUR INTEREST IN RESEARCH AT THE JAFFE FOOD ALLERGY INSTITUTE AT MOUNT SINAI!
THE TEAM AT THE JAFFE FOOD ALLERGY INSTITUTE
We are passing along this information to our patients:
NEW STUDY ON EGG ALLERGY OPENS:
Research News from Mount Sinai Jaffe Food Allergy Institute
You are receiving this email
because you signed up for our research news. We are pleased to
announce the start of a new study for children with EGG Allergy.
Please read this entire email carefully to see if you/your child may be interested in
participating and learn how to inform us of your interest.
The purpose of this study
is, in part, to learn if treatment with daily ingestion of egg taken in two
different forms can result in an improved ability to eat egg and whether there
is a loss of egg allergy or not after the treatment is stopped.
To join the study, you must be (NO
The study includes/requires
(this is a partial list of study activities):
Skin tests, blood tests, physical examinations
and medical histories.
If your child qualifies and
you are interested in learning more, please call our Research Information
Line at (212) 241-2000.
IMPORTANT: This is a small study and we anticipate more interested
participants than we are able to include. We will be working primarily on
a “first come” basis. We will return phone calls in the order that we
receive them to discuss the study further or to inform you that the study is
filled. This may take several weeks. Please be patient.
You can always learn more about
research studies by searching www.clinicaltrials.gov. Look for our future newsletters
about upcoming studies.
THANK YOU FOR YOUR INTEREST IN
RESEARCH AT THE JAFFE FOOD ALLERGY INSTITUTE AT MOUNT SINAI!
JACI, June 2013: Outdoor air pollution is related to exacerbation of pre-existing asthma and even with the development of atopic diseases or allergic sensitization. In contrast, there are few studies to show the association between outdoor air pollution and atopic dermatitis (AD).
In a Letter to the Editor published in The Journal of Allergy & Clinical Immunology (JACI), Kim et al theorized that symptoms of AD would be affected by outdoor air pollution. They enrolled 22 patients (17 boys and 5 girls) with AD living in Seoul, Korea, and followed them for 18 months between July, 2009, and December, 2010. Symptoms, frequency of bathing, application of moisturizers, and the use of topical corticosteroids (TCS) were recorded on a daily basis. The authors obtained daily mean concentrations of particulate matters (PMs), nitric oxides (NO, NO2, NOx), volatile organic compounds (VOCs) including benzene, toluene, ethyl-benzene, xylene, and styrene, and 24 hour average temperature and relative humidity from the closest monitoring sites to each patient’s residence during the study period to estimate the patients’ exposure to outdoor air pollution and meteorological conditions. These sites were operated by Seoul Metropolitan Government Research Institute of Public Health and Environment. A generalized linear mixed model (GLMM) was used to assess the association between outdoor air quality and AD symptoms. The researchers analyzed the level of air pollutants from the same day, the previous day (lag 1), and 2 days (lag 2) before the report of AD symptoms in separate models.
From symptom records of 1,880 person-days, the authors found that AD symptoms were associated with the levels of outdoor air pollutants such as PM, toluene, and TVOC. Interestingly, this association varied according to season, and the lag effect of PM10, benzene, and TVOC on AD symptoms was found after exposure. The authors’ findings suggest that outdoor air pollution acts as an aggravating factor in AD as it does in asthma and may need to be controlled for better management of AD. Further research is required to elucidate the mechanism by which ambient pollutants influence exacerbation of skin symptoms in AD.
Dr. Kenneth Backman of Allergy and Asthma Care comments: "We've long known that there are many potential triggers of atopic dermatitis flares, both allergic and nonallergic. This data suggests that outdoor pollution is a potential nonallergic trigger, and may explain some flares that were previously unexplained."
From Journal of Allergy and Clinical Immunology, June, 2013
Allergies are very common in industrialized countries. It has been suggested that exposure to harmless bacteria during infancy may be protective against the development of allergy. However, it has been difficult to pinpoint which bacteria a baby should be exposed to, and at what time and by which route this exposure should ideally occur.Swedish researchers at the Sahlgrenska Academy, University of Gothenburg, now report that a simple habit may give significant protection against allergy development, namely, the parental sucking on the baby's pacifier.
In a group of 184 children, who were followed from birth, the researchers registered how many infants used a pacifier in the first 6 months of life and how the parents cleaned the pacifier. Most parents rinsed the pacifier in tap water before giving it to the baby, e.g., after it had fallen on the floor. However, some parents also boiled the pacifier to clean it. Yet other parents had the habit of putting the baby's pacifier into their mouth and cleaning it by sucking, before returning it to the baby.
It was found that children whose parents cleaned the pacifier with their mouths were three times less likely to suffer from eczema at 1.5 years of age, as compared with the children of parents who did not do this. When controlled for other factors that could affect the risk of developing allergy, such as allergy in the parents and delivery by Caesarean section, the beneficial effect of parental sucking on the pacifier remained. Pacifier use per se had no effect on allergy development in the child. Boiling the pacifier also did not affect allergy development in a statistically proven fashion.
Saliva is a very rich source of bacteria and viruses, and the researchers believe that oral commensal microbes are transferred from parent to infant when they suck on the same pacifier. When the composition of the bacterial flora in the mouth was compared between infants whose parents sucked on their pacifiers and those whose parent did not, it was found to differ, supporting this hypothesis. According to "the hygiene hypothesis," the development of allergy can be attributed in part to a paucity of microbial stimulation during early infancy. "Early establishment of a complex oral microflora might promote healthy maturation of the immune system, thereby counteracting allergy development," says professor Agnes Wold who led the study.
Source: B. Hesselmar, F. Sjoberg, R. Saalman, N. Aberg, I. Adlerberth, A. E. Wold. Pacifier Cleaning Practices and Risk of Allergy Development. PEDIATRICS, 2013
The Journal of the American Medical Association published a review of the effectiveness of sublingual immunotherapy (allergy drops) in the March 27, 2013 issue. The review analyzed several databases of medical literature through December 2012. They found 63 studies that could be analyzed, and found moderate grade evidence the sublingual immunotherapy decreases nasal and ocular symptoms by more than 40%. Efficacy in asthma was found as well. The conclusion was that the studies analyzed do support the effectiveness of sublingual immunotherapy, but that high quality studies are needed to answer questions regarding optimal dosing.
An important point made is that there are no sublingual forms of immunotherapy extracts approved for use in the United States. Because of this, sublingual immunotherapy performed in this country is NOT FDA APPROVED. Extracts used in Europe for sublingual immunotherapy are higher dose than those used for injection immunotherapy, other studies have found that the doses required for sublingual immunotherapy are 50-300 times higher than those given by injection. The studies analyzed in this summary used these higher doses, and lower doses have been found in other studies to be ineffective.
Since there are no extracts approved for sublingual immunotherapy, providers offering this in the US use the injectable extracts that are far weaker than required for sublingual immunotherapy. The resulting doses have been shown to have minimal or no effectiveness, far less effective than the doses used in Europe. Unfortunately, some practitioners continue to offer this form of therapy with inadequate doses, which as unnapproved therapy is not covered by insurance and can cost upwards of $1500/year.
High dose sublingual immunotherapy is likely effective, though some studies have shown it is not as effective as injection immunotherapy. When adequate strength extracts are approved and available in the United States, Allergy & Asthma Care will be happy to offer this therapy to our patients. Until then, we will not offer unproven therapy with inadequate doses simply because some other, less scrupulous practitioners do so. The only extracts currently available in the United States are not adequate for effective sublingual immunotherapy. We continue to offer injection immunotherapy for appropriate patients. There are also many other options for controlling allergy symptoms. Our office can be reached at (203)259-7070.