FDA Advisory Panel Reviews New Peanut Allergy Treatment
Rising Incidence of Peanut Allergy
Peanut allergy ranks among the most prevalent food allergies affecting children in the United States. The prevalence of this condition has been on the rise, as evidenced by a 2017 study indicating a 21 percent increase in peanut allergies among children since 2010. Approximately 2.5 percent of children in the U.S. are now believed to be affected. Symptoms associated with peanut allergies can range from digestive issues, such as indigestion, vomiting, and diarrhea, to respiratory difficulties, including cough, throat tightness, wheezing, and shortness of breath. The most severe reaction, known as anaphylaxis, poses a life-threatening risk, leading to impaired breathing, throat swelling, and a sudden drop in blood pressure. Anaphylaxis constitutes a medical emergency and requires immediate treatment with epinephrine, typically administered via an auto-injector that individuals with known allergies carry.
Oral Immunotherapy: A New Approach
In addition to advising patients to avoid peanut-containing foods and prescribing epinephrine auto-injectors for accidental exposure, allergy specialists may offer treatments to modify allergic responses. Oral immunotherapy involves administering gradually increasing doses of peanut protein to help the immune system build tolerance. While this method has been utilized for other allergies, such as those related to pollen and pet dander, it is a relatively new application for food allergies. A groundbreaking treatment named AR101 uses capsules containing controlled doses of peanut products to gradually expose individuals to peanuts, aiming to lessen allergic reactions. Although children undergoing AR101 must still avoid peanut-containing foods, this treatment strives to provide a safeguard against accidental peanut exposure, which is often a source of distress for both children and their parents.
Clinical Trial Findings for AR101
In clinical trials, participants began with doses as small as one-500th of a peanut and worked up to a maintenance dose of approximately one peanut. Among 294 highly allergic youths who completed a year-long study, 84 percent were able to tolerate two peanuts with only mild allergic symptoms, and 63 percent could tolerate three peanuts after treatment. Approval for AR101 is being sought for children aged 4 to 17, but ongoing therapy may be necessary to maintain protective effects, a subject that requires further research.
Potential Side Effects of Oral Immunotherapy
Oral immunotherapy, while promising, does carry potential side effects primarily related to allergic reactions. A combined analysis of multiple trials indicated that the likelihood of needing epinephrine was three times higher for those undergoing treatment compared to those not receiving it. Notably, 20 percent of participants in the AR101 phase III clinical trial withdrew due to side effects. Factors such as exercise, hot showers, illness, or fatigue were found to increase the risk of allergic reactions. Long-term data on AR101’s efficacy is still lacking, leaving uncertainties about the duration of protection and the length of treatment necessary. Nevertheless, many children with peanut allergies and their families are willing to accept these risks, given the significant anxiety surrounding accidental exposure.
Next Steps for FDA Approval
After reviewing the evidence, the expert advisory panel determined that AR101 could effectively reduce allergic reactions from accidental peanut exposure. The panel supported a proposed safety plan for administering the product to children and teenagers, recommending that the initial and subsequent doses of AR101 be provided under supervision in a certified facility. The FDA will review the panel’s recommendations before making a final decision on the treatment’s approval.
Source Information
Written by Julie McShane, MA MB BS
Reference: Couzin-Frankel J. Science, September 13, 2019. “First peanut allergy treatment gains backing from FDA advisory panel” (Posted in: Science and Policy Section, doi:10.1126/science.aaz5008)
Link: https://www.sciencemag.org/news/2019/09/first-peanut-allergy-treatment-gains-backing-fda-advisory-panel?utm_campaign=news_daily_2019-09-13&et_rid=605481053&et_cid=2987101
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