Pediatric & Adult
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Dr. Kenneth Backman, Dr. Irena Veksler, and Dr. Katherine Bloom
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."
As another potentially bad pollen season approaches, clinicians can help patients with allergies manage their symptoms with recommendations from the American College of Allergy, Asthma, and Immunology (ACAAI).
“Unfortunately, it's true that in the past few years, the amount of pollen in the air during spring allergy season seems to have gotten worse,” says allergist Bryan Martin, DO, president of the ACAAI. “One of the reasons is the effects of climate change. Increased carbon dioxide from longer growing seasons as a result of warmer weather has a positive effect on pollen production. That means a negative effect on those suffering from pollen allergens.”
To help patients with allergies combat their symptoms, the ACAAI has released a number of tips.
The most effective treatment for allergies is immunotherapy (also known as allergy shots), though treatment is gradual with a therapy duration of 3 to 5 years, according to the ACAAI. The organization rates it as a good option for patients seeking a natural treatment for their allergies, though immunotherapy is usually only recommended for patients who are selectively sensitive to several allergens.
Although many patients with allergies self-medicate using over-the-counter options, clinicians are advised to suggest prescription medications. A recent study found that prescription medications were more effective than over-the-counter options for alleviating allergy symptoms. To make these medications even more effective, the ACAAI recommends encouraging patients to start taking their prescription allergy medication 2 to 3 weeks before their symptoms usually manifest. This can help reduce overall symptom severity.
If patients are looking for small, easy changes that can help manage their symptoms, clinicians can recommend the following:
Source: www.clinicaladvisor.com, March 23, 2016
Infants who are fed peanuts within the first 11 months of life are less likely to develop peanut allergies, even if they take a break from eating the nuts when they're older, according to a new study.
Called the LEAP-on study, it followed a study called LEAP (Learning Early About Peanut Allergy) in which approximately 600 high risk children were examined for peanut allergies. In the LEAP study, about half of the children avoided peanuts and the other half were advised to eat peanuts during their first year of life. Researchers found out that among the children who avoided peanuts, 35 percent tested positive for a peanut allergy with a skin prick test, whereas among the children fed peanuts regularly, just 11 percent tested positive for the allergy.
For the LEAP-on study, which was published today in the New England Journal of Medicine, researchers examined 556 children involved in the LEAP study to see if there were effects of avoiding peanuts for a year later in life. Researchers had both groups -- those who ate peanuts early in life and those who did not -- stop eating any peanut products for a year starting at age 5. About 18.6 percent in the peanut-avoidance group and 4.8 percent of the peanut-consuming group showed an allergy to peanuts at the beginning of the second study. "The aim of our study was to find out whether infants who had consumed peanut in the LEAP study would remain protected against peanut allergy after they stopped eating peanut for 12 months," Professor Gideon Lack, lead author of the study and head of pediatric allergy at King's College London and head of the Children's Allergy Service at Guy's and St. Thomas' National Health Service Foundation Trust, said today. "LEAP-on clearly demonstrates that the majority of infants did in fact remain protected and that the protection was long-lasting," he said.
The study authors found that there was no statistically significant increase in the number of children who developed a new peanut allergy after avoiding peanuts for a year. Three children from each group developed a peanut allergy by the end of the year. The study authors said more work is needed to be done to understand how the amount of peanuts consumed affects allergy risk. "We need more research to better understand the mechanisms behind the development and prevention of allergic responses to peanut, and how this might translate to other food allergies," Dr. George Du Toit, co-investigator of the study and consultant in pediatric allergy at Guy's and St. Thomas' NHS Foundation Trust, said in a statement. "However, it is reassuring that the highly protective intervention demonstrated in LEAP was not only safe, nutritionally favorable and acceptable to participant families but also sustained even with cessation of peanut consumption for 12 months," he said. Peanut allergy has been a growing problem in the U.S., according to the American College of Allergy Asthma and Immunology.
Dr. Lolita McDavid, a pediatrician at University Hospitals Rainbow Babies and Children’s Hospital, said the study reaches some important findings. "Why these studies are important is the global allergy to peanuts has been growing," McDavid said. "This was not seen in the past. There are a lot of cultures where peanut is a staple in the diet." Parents who want to desensitize high-risk children to peanuts should talk to a doctor so that children don't have a dangerous reaction to eating peanuts, she said. "Talk to a pediatric allergist and they can do a skin prick test and you can find out whether they’re allergic or not," McDavid said. Exposure to peanuts in high risk children or those with signs of peanut allergies needs "to be done under a doctor’s supervision. You have to have an epipen available."
Dr. Katherine Bloom of Allergy & Asthma Care comments: "This study builds on the original LEAP study, which demonstrated that peanut allergy can be prevented in high risk children through early introduction. It is exciting news that this beneficial preventive effect persists even if peanut is subsequently removed from the diet. While these studies only included children with moderate to severe eczema or egg allergy, it is suspected that early introduction may be beneficial for all infants. More research is needed in this exciting area."
Posted on March 05, 2016 | Permalink
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Children whose mothers took certain asthma drugs during pregnancy may have an increased risk of autism, a new study suggests. The study, published online Jan. 6 in Pediatrics, found a connection between autism risk and prenatal exposure to drugs called beta-agonists. They are most often used to control asthma, and include inhaled medications such as albuterol, salmeterol (Serevent) and formoterol (Foradil). Researchers said the findings do not prove cause and effect, and stressed that women with asthma should not simply abandon their medication during pregnancy.
"Uncontrolled asthma in pregnancy has been associated with poor birth outcomes, such as preterm birth, low birth weight and admission to the neonatal intensive care unit," said lead researcher Nicole Gidaya, of Drexel University, in Philadelphia. What's more, preterm delivery and low birth weight have been tied to an increased autism risk. Geraldine Dawson, director of the Duke Center for Autism and Brain Development at Duke University, in Durham, N.C., made the same point. Taking beta-agonists during pregnancy has both potential benefits and potential risks for the developing fetus, said Dawson, who wrote an editorial published with the study. "It's important for a woman taking these drugs to talk with her physician and make an individual decision based on her unique circumstances," Dawson said.
Beta-agonists come in both short-acting forms -- which are used to treat asthma attacks -- and long-acting forms, which are taken regularly to help prevent attacks. Gidaya said her study did not differentiate between the two. Scientists generally agree, though, that autism arises from a combination of genetic vulnerability and certain environmental exposures. Many genes have been linked to autism risk, and the list of environmental suspects is growing. Birth complications -- especially ones that cause oxygen deprivation -- are among them, according to the advocacy group Autism Speaks. So are prenatal exposures to certain infections, air pollution and some medications, such as the anti-seizure drug valproic acid, the group said. According to Gidaya, it's plausible that beta-agonists could affect fetal brain development in a way that raises the risk of autism. Given to pregnant lab rats, the drugs can affect fetal nerve cell development.
For the new study, Gidaya's team combed through Denmark's system of national databases to find information on 5,200 children diagnosed with an autism spectrum disorder. The researchers compared them with 52,000 children of the same age without autism. Overall, just under 4 percent of children with autism had been exposed to a beta-agonist, versus just under 3 percent of other kids. When the researchers controlled for other factors -- including mothers' asthma, parents' age and birth complications -- children exposed to beta-agonists in the womb were still 30 percent more likely to develop autism. But while that number might sound big, it is actually a "modest" increase in autism risk, Dawson said.
Plus, there are other factors the researchers could not account for, such as exposure to pollutants, Gidaya said. According to Dawson, more research is needed to confirm the link between beta-agonists and autism. If the drugs are a risk factor, Gidaya said, studying the biology behind it could help researchers gain a better understanding of how autism arises.
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "While this study is concerning, it does not imply causation but merely found an association between beta-agonist use and the risk of autism. Control of asthma is very important in pregnancy to protect both the mother and the developing child. This study emphasizes the importance of asthma control to avoid the need for quick relief, bronchodilator medications. We encourage any concerned patients to speak with their physician before making any medication changes."
People who experience occasional migraine headaches may be at greater risk of developing chronic migraine headaches if they also have asthma, according to a study published online in November in the journal Headache, a publication of the American Headache Society.
“Migraine and asthma are disorders that involve inflammation and the activation of smooth muscle, either in blood vessels or in the airways,” says Richard Lipton, MD, director of the Montefiore Headache Center and the Edwin S. Lowe Chair in Neurology at the Albert Einstein College of Medicine, New York City. “Therefore, asthma-related inflammation may lead to migraine progression.” The study, led by Vincent Martin, MD, co-director of the Headache and Facial Pain Program at the University of Cincinnati Neuroscience Institute, involved 4,500 individuals.
Researchers found that those diagnosed with asthma were more than twice as likely to progress to chronic migraine compared to those without asthma. Further, the risk of worsening migraine increases with the severity of asthma symptoms, Dr. Lipton says. Migraine headaches are chronic when they occur in an individual 15 or more days per month. About 12 percent of the U.S. population experiences migraine headaches, according to the American Migraine Prevalence and Prevention Study (AMPP), which was directed by Dr. Lipton. Migraines are three times more common among women than men.
According to Dr. Lipton, people with asthma who experience migraine headaches should do the following: 1) Manage each condition by learning to identify and avoid triggers for asthma flares and migraine headaches. “Migraine is often triggered by hormonal changes, stress, not enough sleep and a range of dietary factors,” he says. 2) Talk with your primary care doctor about preventive medications that can reduce the frequency of migraine headaches, especially if they increase to more than three or four per month. 3) Review all prescription and over-the-counter medications, as well as vitamins and supplements, with your healthcare team, as some might conflict. For instance, people with asthma should avoid certain migraine medications, including beta blockers (such as propranolol), which can impact lung function.
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "This confirms a trend others have reported about a connection between migraines and allergies and asthma. It is not clear whether better control of asthma will lead to improvement in migraines, but it is always important to keep asthma under good control. Speak with your doctor if you are using your rescue inhaler for symptom relief more than twice a week."
Posted on December 16, 2015 | Permalink
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Food allergy is common, especially in early childhood, and eczema, another allergic condition, often co-exists in children with food allergy. Food allergy has previously been associated with lower height and weight in cross-sectional studies in children. However, no previous studies have investigated the combined effect of food allergy and eczema on growth in early childhood. In addition, the effect of resolved and persistent food allergy and eczema on height and weight throughout early childhood has not been reported.
Beck et al report in The Journal of Allergy and Clinical Immunology: In Practice the analysis of growth parameters in children with persistent and resolved food allergy and eczema at ages 1 and 4 years. The Healthnuts study, a population based cohort of over 5,000 children from Melbourne, Australia, recruited infants at age 1 and followed them up at 4 years of age. All infants underwent skin prick testing at 1 year of age to peanut, egg, and sesame, and those sensitized went on to oral food challenges. Food challenges repeated at age 4 determined resolution or persistence of food allergy. Eczema status, as well as height and weight were collected at both ages.
Children with both food allergy and eczema at age 1 had lower weight and height at age 1 compared to those with neither condition. However, for children with only food allergy or only eczema there was no difference in growth parameters. By age 4, children who had grown out of their food allergy had caught up and had no differences in height or weight. Those who had persistent food allergy at age 4 were still shorter and lighter, irrespective of their eczema status.
This study indicates that children with both food allergy and eczema in infancy should be closely followed up. This is the case for children with any food allergy, not just those with allergies to nutritionally important foods. These children and their families should receive good dietary guidance and eczema management to ensure optimum growth. Parents should speak with their pediatricians about nutritional counseling.
From AAAAI and JACI-In Practice
Sanofi US, the manufacturer of Auvi-Q, has recalled all Auvi-Q devices from the market due to reports of malfunctions and inaccurate doses being administered. If you or your child has a life-threatening allergy and you have Auvi-Q devices, please call your doctor's office as soon as possible for a prescription for an alternative epinephrine auto injector. Patients of Allergy & Asthma Care of Fairfield County should contact our office, or your pharmacy (who will contact us,) as soon as possible.
Researchers in Dresden, Germany, have demonstrated that allergy immunotherapy can effectively prevent asthma in patients with allergic rhinitis in a realistic setting.
Doctors reviewed routine healthcare data from German National Health Insurance beneficiaries which helped them identify a cohort of about 118,754 patients who chronically suffered from allergy symptoms but did not have asthma. This means they had not been previously diagnosed with asthma, did not have documented physician contacts due to asthma symptoms and did not have prescriptions filled for corticosteroids. They used this information to track new appearances of asthma between 2007-2012 and compared patients who had been treated with immunotherapy against those who had never been exposed to immunotherapy.
“Counts and percentages were calculated for each confounding, outcome and exposure variable,” Jochen Schmitt, MD, MPH, said. “We discovered that allergy immunotherapy being used in routine clinical care effectively prevents the onset of asthma. Most pronounced preventive effects were observed for subcutaneous immunotherapy, immunotherapy containing native allergens, and immunotherapy administered for at least three years.”
Patients with allergic rhinitis are at increased risk for the development of asthma. Allergy immunotherapy is one method of treating allergic rhinitis and it’s recognized in the U.S. by the Food and Drug Administration in two forms. The first is subcutaneous immunotherapy or allergy shots. The second is sublingual immunotherapy or allergy tablets. Both are forms of long-term treatment that decrease symptoms for many people with allergic rhinitis, allergic asthma, conjunctivitis (eye allergy) or stinging insect allergy. They work to decrease sensitivity to allergens and often lead to lasting relief of allergy symptoms, even after treatment has ended.
In total, 2,431 patients had been exposed to allergy immunotherapy (2% of the cohort). The risk of incident asthma was significantly lower in these patients – only 33 out of 1,646 patients who had a new diagnosis of asthma were exposed to immunotherapy. Patients with asthma also received, on average, higher doses of antihistamines and had more physician contact due to allergic rhinitis or allergy symptoms.
“In patients with allergic rhinitis, allergy immunotherapy should be considered to prevent asthma. By reducing the primary risks for developing asthma, we can directly address and improve the burden of the disease for the patients and present significant cost savings for the healthcare system,” Schmitt concluded.
More information on asthma and immunotherapy is available at the AAAAI website. This study was accepted in September and currently appears as an article in press in The Journal of Allergy and Clinical Immunology.
Posted on October 01, 2015 | Permalink
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Seasonal allergic rhinitis (AR) is just one of many conditions that can cause nasal congestion, and the impact on sufferers and society is substantial, including lost work productivity and impairments in sleep and quality of life. Of the four main symptoms of AR (itchiness, sneezing, runny nose, and nasal congestion), nasal congestion occurs most often and is considered by people with AR to be more bothersome than the other symptoms. With limitations placed on the over-the-counter sale of pseudoephedrine (a decongestant shown to be effective) since 2006, Phenylephrine HCL (PE) has increasingly entered the marketplace and is widely used by consumers for the treatment of nasal congestion. Based on IMS Health Incorporated state-level data it is possible that the annual cost to American society of using PE for nasal congestion is upwards of half a billion dollars. Yet despite decades of widespread use and a Food and Drug Administration (FDA) indication of 10 mg every 4 hours for the temporary relief of nasal congestion, the most effective dose of PE and duration of action for nasal congestion are unknown. In fact, there have been no large-scale, well-conducted, peer-reviewed clinical studies published supporting the effectiveness of PE for the relief of nasal congestion.
In a recently published article in The Journal of Allergy and Clinical Immunology: In Practice, Meltzer and colleagues reported results from a clinical trial that randomly assigned 539 adults with seasonal AR who were suffering from nasal congestion but were otherwise healthy to receive one of four doses of PE (10 mg, 20 mg, 30 mg, or 40 mg) or placebo tablets that looked similar to the PE tablets. Participants took the study medication for 7 days, approximately every 4 hours, and recorded in a diary, using a 4-point scale, how congested they felt. These assessments included self-evaluation of symptom severity over the preceding 12 hours and at the moment of assessment prior to the next dose.
The results showed that even though PE was well tolerated at doses up to 30 mg, none of the doses (10–40 mg) showed any statistically significant difference in nasal congestion scores compared with placebo. It is likely that similar results would be seen in patients suffering from nasal congestion due to other causes such as nasal membrane swelling from irritants and the common cold.
The study was conducted in response to calls by the FDA upon the pharmaceutical industry to conduct large, well-designed, dose-ranging studies to assess the effectiveness of PE for the relief of nasal congestion. The authors conclude that consumers and healthcare practitioners should be warned about the ineffectiveness of PE to relieve nasal congestion, and the FDA should revise their labeling for PE accordingly.
Dr. Katherine Bloom of Allergy & Asthma Care of Fairfield County comments: "For many years, pseudoephedrine was the main oral decongestant used in over-the-counter allergy and cold medications. When this was moved behind the counter (due to its use in the manufacture of "crystal meth") many pharmaceutical companies substituted phenylephrine into their products to allow them to remain OTC. Unfortunately, many patients have found these products to be less effective, and this study confirms that phenylephrine is not as effective as pseudoephedrine."
DBV Technologies recently announced it has received the green light from the Food and Drug Administration (FDA) to begin a global Phase III trial using Viaskin® Peanut (also known as the “peanut patch”). This is the first time that a drug for food allergy has reached Phase III – a step in the clinical trial process during which a drug or treatment is given to a larger group of people to confirm its effectiveness and collect information that will allow it to be used safely.
The anticipated Phase III trial, Peanut EPIT Efficacy and Safety Study (PEPITES), which will enroll children ages 4 to 11, is expected to begin later this year following submission of the final clinical trial protocol and review by the FDA. PEPITES is planned as a randomized, double-blind, placebo-controlled trial with about 260 patients from 35 sites in North America, Australia and Europe.
DBV Technologies’ primary goal is to show that its therapy significantly reduces an individual’s sensitivity to peanut; this would help them avoid a life-threatening allergic reaction from accidental ingestion. This endpoint could potentially increase the study’s clinical relevance by better showing that the therapy increases safety for people with peanut allergy. This is the first specific therapy for food allergy to be approved to enter a Phase III trial, which is the final phase before consideration by the FDA for approval in the market.
The company also plans to conduct additional separate clinical trials in younger and older patients.
Earlier this year, DBV Technologies presented clinical data on the company’s Phase 2b trial, the results of which continue to support the effectiveness and safety of the peanut patch. This data showed that 50 percent of children were able to tolerate an oral challenge of at least 300 mg of peanut protein after 12 months of treatment versus 12.9 percent in the placebo arm. The study’s authors say this threshold dose of 300 mg peanut protein is clinically relevant, as reaching this level significantly reduces the risk of allergic reactions to potential peanut traces in foods.
(Source: FARE newsletter)
Dr. Kenneth Backman of Allergy & Asthma Care comments: "This product represents an exciting advance in the potential treatment of food allergies. It offers the possibility of reducing a patient's sensitivity to peanut without the potential risks of oral desensitization. We are hopeful that phase III trials will be successful and that the patch will be available within the next few years."
The AAAAI recently commented on the safety of asthma inhalers in patients allergic to soy and peanuts despite some concern based on misperceptions regarding ingredients in the inhalers. A similar concern has been raised regarding possible food allergens in intravenous medications used for anesthesia. Propofol is an intravenous medication used for anesthesia prior to some surgical and other medical procedures and for some people on ventilators. The propofol is mixed in a liquid containing soybean oil and a substance called egg lecithin. Lecithin is a fatty substance found in some plant and animal tissues.
Patients who are allergic to foods, including soy and egg, are allergic to proteins in the foods and are not allergic to the oils or fats in the foods. Soybean oil and egg lecithin may contain trace amounts of residual protein, however no allergic reactions have been demonstrated to be caused by this. Although peanuts and soybeans are both in the legume family, the overwhelming majority of peanut-allergic patients are not clinically allergic to soy, and even if they were, would not be expected to react to soybean oil.
There are reports of reactions to propofol involving hives or other symptoms of systemic allergic reactions (anaphylaxis). However, most reports of anaphylaxis to propofol have occurred in patients without egg allergy and the vast majority of patients with egg allergy receive propofol without reaction. Some patients may be allergic to the propofol itself. Also, most patients who react after receiving propofol have received other drugs at the same time that can cause or worsen anaphylaxis, including antibiotics, muscle relaxants and narcotic pain medications. Thus, although it is clear that propofol can cause anaphylactic reactions, the cause of these reactions is unclear and appears not to be related to soy or egg allergy.
The bottom line: Patients with soy allergy or egg allergy can receive propofol without any special precautions. Any patient, whether soy or egg-allergic or not, who has an apparent allergic reaction to propofol should be evaluated by an allergist.
Additional information on food allergies.
Dr. Irena Veksler of Allergy & Asthma Care of Fairfield County comments: "Anesthesiologists have generally denied propofol to patients with a history of soy or egg allergy. It is reassuring to know that this useful anesthetic is safe in these patients."