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Does currently available data support the use of oral immunotherapy treatments
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Does currently available data support the use of oral immunotherapy treatments?
The general belief is that there is no treatment for food allergies. Food allergies affect more than 15 million Americans and many more worldwide. According to the CDC, the prevalence of food allergy has increased by 50% between 1997 and 2011, and triples for peanut and tree nut allergies. Food allergies are serious and can be life threating. More than 200,000 people require emergency medical care each year due to a reaction to food allergies. From 2005 through 2014 children from 5 to 7 years of age had an increase of 285% in food-related anaphylaxis and children from 0 to 4 years had a 479% increase.
Children who have been diagnosed with food allergies have significant increase in stress, anxiety, depression, and symptoms of ADHD. Food avoidance can lead to poor nutrition, social isolation and further anxiety. Quality-of-life scores in a child with a peanut allergy is lower than those of a child with type one diabetes.
Food allergy has reached epidemic proportions. Waiting for a cure all for allergies is not an option, because our limited knowledge of the immune system and limited technology most likely will keep this possibility out of our grasp for our lifetime. Customized food allergy treatment is possible and well-studied. OIT is ready for use as a treatment modality for food allergy.
Desensitization has been used for more than 100 years in patients with environmental allergies, drug allergies and food allergies. OIT has a long history of study dating back to the first publication of a child treated for an anaphylactic egg allergy in 1908, and more than 250 articles have been published since then. Most studies have shown OIT to be safe and the success rate of completing the protocol for treating various food allergies with OIT to be approximately 80% to 85%. Outside of studies, where the treatment can be modified as needed due to physical and psychological barriers, the completion rate is more than 90%. Studies have shown a significant rise in quality of life during and after treatment with OIT. Patients who have a moderate quality of life before OIT may have some worsening during the therapy but ultimately see a significant improvement by the time therapy has been completed.
The FDA does not approve treatments (for example widely accepted treatment protocols for penicillin and aspirin are not FDA approved), they approve drugs. Most physicians currently offering OIT use off-the-shelf foods.
The only viable therapy currently undergoing FDA trials is for peanuts only, using a capsule filled with peanut flour and using an OIT protocol. Due to the inability to adjust doses, they have a 20% dropout rate, compared with a less than 10% dropout rate seen in other current studies.
This also does not factor in all the patients who could not tolerate the first dose (and subsequently could not participate in the study), which is generally 500 times higher than the first dose currently being used in OIT. The CEO of AImmune stated in February 2018 the company expects the therapy to cost $5,000 to $10,000 for the first 6 months and then $300 to $400 monthly. This cost for the buildup is two to four times as much as it would be without a pharmaceutically developed peanut. At a cost of approximately 50 cents a month for peanuts (OIT with off-the-shelf peanuts), the monthly cost will be approximately 800 times as high.
I have treated 500 patients for more than a dozen different food allergies over the last 8 years and collaborate with numerous doctors from around the world, who have together treated thousands of patients. My experience has shown that OIT is safe and highly successful. OIT does need close supervision of a board-certified allergist who is well-versed in food allergy and highly experienced in oral challenges.
Chad W. Mayer, DO, FAAAAI, FAAP, Allergy & Asthma Institute of SE Michigan Comprehensive Food Allergy Clinic.
Disclosure:Mayer reports no relevant financial disclosures.
Current guidelines regard OIT as experimental, and there is a phase 3 clinical trial in progress for the treatment of peanut allergy that appears to be on track for filing to the FDA for consideration of approval.
Over the past several years, there has been a growing number of practitioners who have offered OIT. Many of these programs have ancillary research objectives, but they are billing for treatment and/or accepting philanthropic donations to offset costs and are widely perceived by and embraced by patients effectively as treatment.
Because of the unmet need for options beyond vigilant allergen avoidance and preparedness for accidents, patients — and particularly parents of young patients — have expressed strong desire for access to such treatment. And although there are numerous and substantive benefits of an FDA-approved therapy, including both the standardization of protocol and a GMP-produced product, because the active ingredients are the allergens which are present in foodstuffs, there is no inherent barrier to treatment as there is with most pharmaceuticals. Foods can essentially be used as drugs for OIT.
I believe that we must recognize this unmet medical need and be realistic about the feasibility of the traditional pharma/FDA approval process to approve multiple individual food allergens. I believe there is a strong case for selective use of OIT at well-qualified facilities to address this unmet need.
However, it cannot be overemphasized that OIT has yet to be shown to reduce severe reactions in the real world and that many families seek out OIT because of anxiety about real-world situations that pose very low risk and may not justify such intensive and burdensome therapy.
A physician’s obligation to their patient is to offer the best therapy available. The high- level evidence base for OIT, even in the face of the growing anecdotal experience, remains extremely limited, and we should proceed with great caution lest we look back on this as another example of the medicine getting way out in front of the research.
Wayne Shreffler, MD, PhD, is an Associate professor of pediatrics, Harvard Medical School, Chief, Pediatric Allergy & Immunology, Principal investigator, Center for Immunology and Inflammatory Diseases, Massachusetts General Hospital and MassGeneral Hospital for Children.
Disclosure:Shreffler reports serving on the scientific advisory board for Aimmune and as a site investigator of Aimmune and DBV trials of immunotherapy for food allergy.