Allergies: Overview and More
Australia Launches Landmark Peanut Allergy Treatment For Babies
Australian children with potentially deadly peanut allergies will be offered life-saving treatment in a nationwide program touted as a world first.
Eligible babies will receive daily doses of peanut powder for two years to build up their tolerance, said officials announcing the initiative on Wednesday.
Over time, the infants will be given increasing doses in the hope of reducing their sensitivity to peanuts, under the supervision of doctors at 10 pediatric hospitals around the country.
It is the first national peanut allergy treatment program offered in hospitals outside of a clinical trial setting, said Kirsten Perrett, head of oral immunotherapy at the National Allergy Centre of Excellence.
At the end of the two years, a food allergy test will determine if the treatment has led to a remission.
"Ultimately we want to change the trajectory of allergic disease in Australia so that more children can go to school without the risk of a life-threatening peanut reaction," Perrett said.
Previously, families have been told to ensure their children strictly avoid foods with peanuts.
Australian children have some of the highest rates of food allergies in the world.
Peanut allergies affect three percent of Australian children by the time they are 12 months old, government data shows.
Of those, only 20 percent will outgrow their allergy by the time they are teenagers.
Nine-month-old Hunter Chatwin, who is among those in the free treatment program, started developing hives after eating peanut butter.
"We are taking part in the program to try and improve his chance of being able to safely eat peanut in the future," Hunter's mother Kirsten said.
"Many families are desperate to protect their children from allergic reactions and anaphylaxis," she said.
"To have this program available and free at public hospitals is a game-changer."
If successful, the program will be rolled out more broadly, including in regional and remote areas.
Deaths from peanut allergies are rare in Australia, but almost 20 percent of the population has an allergic disease, data from Australia's leading allergy institute found.
This figure is estimated to grow by 70 percent by 2050, impacting 7.7 million Australians.
© 2024 AFP
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FDA Approves U.S. Pediatric Indication Extension For Palforzia® Oral Immunotherapy For The Treatment Of Peanut Allergy
BAAR, Switzerland, July 30, 2024--(BUSINESS WIRE)--Stallergenes Greer, a leading global healthcare company specialising in allergen immunotherapy, today announced that the U.S Food and Drug Administration (FDA) has approved Palforzia®[Peanut (Arachis hypogaea) Allergen Powder-dnfp], for the treatment of toddlers (ages 1-3 years) with a confirmed diagnosis of a peanut allergy. This approval expands the January 2020 FDA approval for patients ages 4-17 years. Palforzia® is to date the first and only approved oral immunotherapy treatment (OIT) for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut.
Peanut allergy currently affects approximately 2% of the general population of Western nations1, and the prevalence of peanut allergy doubled among children between 2005 and 20152. Compared with other food allergies, peanut allergy is associated with higher rates of accidental exposure, severe reactions and potentially fatal anaphylaxis1. The difficulty in avoiding peanuts, combined with the severity of allergic reactions, shows the need for effective treatment3.
"We are delighted that Palforzia® has received regulatory approval in the U.S. For toddlers as there is a high unmet medical need for this age group and we are confident that this indication extension will alleviate the burden of peanut allergy for younger patients and their families," says Elena Rizova, MD, PHD, Chief Medical Officer of Stallergenes Greer.
The FDA approval in toddlers is based on data from the Phase 3 POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization) study that was published in the New England Journal of Medicine Evidence in 2023. The study evaluated the efficacy and safety of Palforzia® in peanut-allergic children aged 1 to 3 years old, meeting all its primary and secondary efficacy endpoints and demonstrating a favourable safety profile.
Stallergenes Greer acquired the rights to Palforzia® in September 2023. As part of our ongoing commitment to delivering innovative solutions in allergen immunotherapy, our focus in the U.S has been on establishing a specialised Food Allergy business unit and transitioning the product into our AIT portfolio.
ABOUT PALFORZIA®
Palforzia® is in the U.S an oral immunotherapy treatment indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut for patients. The treatment is approved for use in patients with a confirmed diagnosis of peanut allergy and in conjunction with a peanut-avoidant diet. Limitation of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
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Palforzia® is approved by the U.S. Food and Drug Administration (FDA) for ages 1-17 years and for ages 4-17 years by the European Medicine Agency (EMA), by the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K., and by Swissmedic in Switzerland. Pediatric indication extension submissions are currently under review by the EMA and Swissmedic.
ABOUT POSEIDON PHASE 3 STUDY
POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization, clinicaltrials.Gov number NCT03736447) is an international, randomized (2:1), double-blind, placebo-controlled Phase 3 study that evaluated the efficacy and safety of Palforzia® in peanut-allergic children aged 1 to 3 years of age in North America and Europe.
The POSEIDON study was completed by Aimmune Therapeutics, part of Nestlé Health Science before Nestlé divested Palforzia® to Stallergenes Greer in September 2023.
Enrollment was based on several entry criteria, including a documented clinical history of peanut allergy, positive skin prick tests and/or elevated blood levels of peanut antibodies, and dose-limiting symptoms after consuming single doses of peanut protein >3 to ≤300 mg in a positive double-blind, placebo-controlled food challenge.
In POSEIDON, patients underwent a dose-escalation period of approximately 22 weeks to reach a dose of 300 mg per day of Palforzia® or placebo, then continued that dose for approximately six months. At the end of the trial, patients underwent an exit double-blind, placebo-controlled food challenge (DBPCFC).
ABOUT STALLERGENES GREER INTERNATIONAL AG
Headquartered in Baar (Switzerland), Stallergenes Greer International AG is a global healthcare company specialising in the diagnosis and treatment of respiratory, food and venom allergies through the development and commercialisation of allergen immunotherapy products and services. Stallergenes Greer International AG is the parent company of Greer Laboratories, Inc. (whose registered office is in the United States) and Stallergenes SAS (whose registered office is in France). For more information, visit www.Stallergenesgreer.Com.
1 The global burden of illness of peanut allergy: A comprehensive literature review. Jay A. Lieberman, Ruchi S Gupta, Rebecca C. Knibb, Tmirah Haselkorn, Stephen Tilles, Douglas P. Mack, and Guillaume Pouessel. Online: https://www.Ncbi.Nlm.Nih.Gov/pmc/articles/PMC8247890/ Accessed August 31, 20232 Du Toit G, et al. Randomized Trial of Peanut Consumption in Infants at Risk for Peanut Allergy. N Engl J Med 2015; 372: 803-13. Accessed August 31, 2023.3 Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol. 2001;107:191-3. Accessed August 31, 2023.
Palforzia®: © 2023, Société des Produits Nestlé S.A. Or its affiliates
View source version on businesswire.Com: https://www.Businesswire.Com/news/home/20240730211334/en/
Contacts
Stallergenes GreerCommunicationsCatherine KressTel: +33 (0)1 55 50 26 05Email: catherine.Kress@stallergenesgreer.Com
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Eating Peanuts For Peanut Allergy Protection: A New Study
Can you prevent a peanut allergy? Scientists found that introducing peanuts into the diet during infancy protected from allergic reactions well into adolescence.
By Vaishnavi Sridhar
Many foods are labeled as "made in a peanut-free facility" or "nut-free." This is especially common in Western countries and in products being exported to these countries. Why are these labels important? Foods with these labels are deemed safe for those with peanut allergies.
A peanut allergy is one of the most common food allergies and its prevalence has grown 3.5 fold in the past twenty years. In individuals allergic to peanuts, a chance exposure to peanuts can cause a severe allergic reaction ending in the emergency room.
"Prevention is better than cure" is the commonly followed strategy in case of allergies. However, scientists now have clear evidence that directly facing the challenge early on might help prevent allergies to peanuts. A team of scientists across the US and UK, led by Dr. Gideon Lack of King's College London, found that introducing peanuts during infancy in high-risk infants provides long-lasting peanut tolerance well into adolescence.
Peanut allergy: What do we know so far?People may have different kinds of allergies. An allergic reaction occurs on exposure to an allergen. Some common allergens include milk, eggs, wheat, soy, peanuts, tree nuts, fish, seafood, pollen, and dust. Exposure to allergens can occur either through inhaling them, coming in contact with them, or eating anything with the allergen in it. Studies suggest that peanuts and tree nuts cause more severe reactions than other allergens.
At the molecular level, most allergic reactions are a case of a specific key fitting a specific lock. In this case, this fit or binding is between two proteins—the allergen and its specific antibody. An allergen is a protein found in the product that causes an allergic reaction. An antibody is also a protein, which is present in our bodies. Our bodies contain specific classes of antibodies. The specific class of antibodies involved in certain kinds of allergic reactions are IgE. IgE is present in immune cells. When an allergen interacts with its specific IgE molecule in the immune cells, these cells release chemicals that trigger an allergic reaction.
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Most plant-based allergens are proteins that are required for either storage, plant defense, or another role in the plant. There are 12 identified allergens in peanuts that could trigger an allergic response. The most common are Ara h1, h3, h2, and h6.
Typically, the diagnosis for a specific allergy begins with a medical history analysis and physical examination. This is primarily through testing for allergen-specific IgE antibodies, through a blood test or skin prick test, and also an oral food test to confirm the allergy. The current solutions to prevent a peanut allergy are to avoid peanuts in the diet and to have peanut allergen–specific immunotherapy. It is also important to recognize signs of allergy, use an EpiPen in case of a reaction, and take antihistamines to relieve the symptoms of allergies.
Origins of a multiyear peanut allergy studyResearchers have observed that in countries where peanuts are introduced early into the diet, there is reduced prevalence of peanut allergy. Following this observation, Dr. Lack's research team set up the LEAP (Learning Early About Peanut allergy) study in 2006, in which high-risk infants were either introduced to peanuts early in their diet or peanuts were completely avoided from their diet. The researchers then compared the incidence of peanut allergy in both groups. This study showed that introducing peanuts in the diet of high-risk infants from infancy reduced the prevalence of peanut allergy.
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The LEAP-On study was a follow-on study to LEAP and showed that children whose diet included peanuts in the LEAP study continued to be protected against developing peanut allergy a year after avoiding peanuts in their diet.
The current study, called the LEAP-Trio cohort study, is an extension of the previous LEAP and LEAP-On studies. Here, researchers followed the impact of introducing peanuts from an early age up to age 12, when consumed in the amount and frequency chosen by the participant. They found that early introduction to peanuts protects participants against peanut allergy up to adolescence.
Updated findings on peanut allergic reactionsThe three cohorts in LEAP-Trio included participants of the original LEAP study, their siblings, and their parents. Starting in 2018, data collection continued until 2022. The participants completed general medical, dietary, allergy, and other assessments. These included a blood test and skin prick test. The original LEAP study had 640 participants, of which 508 enrolled in this study.
The researchers found that those participants who were introduced to peanuts during infancy (LEAP study) were able to avoid peanut allergy at age 12 as compared to those who avoided peanuts during the LEAP study. However, participants in both the peanut-exposure and peanut-avoidance groups reported avoiding peanuts for prolonged periods of time between age 6 and 12 years.
Higher levels of peanut-specific, Ara h2–specific IgE were found in the peanut-avoidance group as compared to the peanut-exposed group. In contrast, these participants had lower levels of the peanut-specific IgG4, another kind of antibody produced by our body that competes with IgE to bind to immune cells and might prevent allergic reactions.
This implies that introducing peanuts in the diet of high-risk infants early provides prolonged tolerance to peanut allergy. Moreover, avoiding peanuts for prolonged periods after this initial introduction of peanuts did not appear to impact the acquired tolerance. This study shows that prolonged tolerance to peanut allergy can be built by introducing peanuts into the diet during infancy.
This research article was published in the peer-reviewed journal NEJM Evidence.
The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.
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Du Toit, G., Huffaker, M. F., Radulovic, S., Feeney, M., Fisher, H. R., Byron, M., … & Lack, G. (2024). Follow-up to adolescence after early peanut introduction for allergy prevention. NEJM Evidence, 3(6), EVIDoa2300311. Https://doi.Org/10.1056/EVIDoa2300311
Du Toit, G., Roberts, G., Sayre, P. H., Bahnson, H. T., Radulovic, S., Santos, A. F., … & Lack, G. (2015). Randomized trial of peanut consumption in infants at risk for peanut allergy. New England Journal of Medicine, 372(9), 803–813. Https://doi.Org/10.1056/NEJMoa1414850
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Maslinska, M., Dmowska-Chalaba, J., & Jakubaszek, M. (2022). The role of IgG4 in autoimmunity and rheumatic diseases. Frontiers in Immunology, 12, 787422. Https://doi.Org/10.3389/fimmu.2021.787422
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Mueller, G. A., Maleki, S. J., & Pedersen, L. C. (2014). The molecular basis of peanut allergy. Current Allergy and Asthma Reports, 14, 429. Https://doi.Org/10.1007/s11882-014-0429-5Tirumalasetty, J., Barshow, S., Kost, L., Morales, L., Sharma, R., Lazarte, C., & Nadeau, K. C. (2023). Peanut allergy: risk factors, immune mechanisms, and best practices for oral immunotherapy success. Expert Review of Clinical Immunology, 19(7), 785–795. Https://doi.Org/10.1080/1744666X.2023.2209318
Featured image "a granel" by ruurmo, licensed under CC BY-SA 2.0.
Vaishnavi Sridhar completed a PhD in Cell and Developmental Biology from the University of British Columbia, Canada. Currently she works as Manager, Academic Collaborations and Events at the National Centre for Biological Sciences, Canada. She loves discussing science, taking nature walks, and cooking in her free time. Follow Vaishnavi on LinkedIn or X (formerly Twitter) @VaishnaviSrid10.
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