OIT: The Proven Treatment

proven“In our world of instant access to countless internet resources and social media groups, I believe it is more important than ever to rely on evidence-based information when making decisions about one’s health.” – Dr. David Stukus, board-certified allergist in a guest post on an allergy blog.

When you look at the evidence-based information on oral immunotherapy to treat food allergies (well over 250 published journal articles and news clips in the last decade), it is reported over and over that OIT works for vast majority of treated patients. It’s staggering. Different scientists, different institutions, different allergens, different protocols, different countries, different private practice doctors….all converge on the success of this treatment for a life-threatening condition for which there is no cure. And there is no other food allergy treatment that frees people from their allergies like OIT. Note: there are other desensitization methods being researched, namely the Viaskin patch and SLIT (sublingual immunotherapt) which also show great promise going forward.

We will review a few key articles and studies that support OIT as a valid scientific therapy. Long-term epigenetic /DNA results, high effectiveness, good safety profile and a life-saving treatment resulting in improved quality of life.

To date, OIT is the ONLY food allergy treatment with “walls of graduates”: thousands of patients freely eating their allergens and eating all food without fear, and over 125 published studies on human subjects.  OIT works for the majority: between 85-95% of patients.

2016: ANNUAL REVIEW OF MEDICINE

OIT getting recommended as a viable treatment in a major mainstream reference source.  From the 2016 Annual Review of Medicine:

“Results from studies of oral immunotherapy show high efficacy rates, improvement in quality of life, and a good safety profile. Treatment may result in sustained unresponsiveness in a proportion of patients, whereas others require ongoing treatment.”

“Sustained unresponsiveness” means not responding/reacting to the allergen when daily or regular ingestion is stopped. In other words, moving toward true tolerance instead of just desensitized. Studies have shown OIT has lasting benefits for many, even when treatment is stopped many retain some desensitization as long as a month. Desensitization is maintained and proven by regularly eating the allergen for life.

http://www.annualreviews.org/doi/abs/10.1146/annurev-med-061014-094943?journalCode=med

image5-YEAR BRITISH PEANUT STUDY

The prestigious British Lancet journal (started in 1823) published the largest OIT study done to date in 2014.  “We’ve shown fantastic results, with 80 to 90 percent of children being able to tolerate eating peanuts regularly after treatment,” says Andrew Clark of Addenbrooke’s Hospital in Cambridge, UK, who co-led the team that developed the treatment.”  Their protocol went to 5 peanuts, considered to be safe from an accidental bite of peanut, called “bite-proof.” 84% of the group passed the 5-peanut challenge, and 62% actually went on to pass a 10-peanut challenge.

Then they took the former “placebo” or control group, followed the same OIT protocol, then tested them. “Of those, 91 per cent were able at the end to eat the equivalent of five peanuts a day, validating the original result in the process. “It’s almost like we got two trial results for the price of one,” says Ewan.”

“Before the treatment, children and their parents had to check every food label, but now they can go out anywhere without fear of accidentally swallowing and reacting to traces of peanuts,” he says.”

“After the trial, I felt as though a huge burden had been lifted off my shoulders,” says one recipient of the treatment, 14-year-old Chris Poll of Perth, Australia. “I don’t have to worry about going to parties any more, don’t have to stress about going to school camps, and don’t have to worry about eating in restaurants.”

Other findings of this landmark study included long-term effectiveness, data that is often incorrectly cited as missing with OIT:  “…some children receiving the Addenbrooke’s regimen have remained tolerant for five years, provided they regularly take small doses of peanut protein.”

Lastly, the Lancet study revealed “Quality of life improved after intervention and there was a good safety profile.”  We have seen in multiple studies about the improvement in quality of life for the entire family, this was again validated in this large study.

“This treatment allowed children with all severities of peanut allergy to eat large quantities of peanuts — well above the levels found in contaminated snacks and meals — freeing them and their parents from the fear of a potentially life-threatening allergic reaction,” Clark said in a journal news release. “The families involved in this study say it has changed their lives dramatically.”

https://www.newscientist.com/article/dn24968-peanut-allergy-cured-in-children-using-immunotherapy#.UxFIrPldVWh
http://www.webmd.com/allergies/news/20140130/gradual-exposure-to-peanuts-may-help-some-allergic-kids
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)62301-6/abstract

5-YEAR U.S. PEANUT STUDY AT UNC

In this 5-year study at the University of North Carolina (UNC), the first long-term formal study in the U.S., researchers had all patients who completed the study stop their peanut dosing for a full month. “50 percent achieved what is known as “sustained unresponsiveness” – or the ability to consume peanut without reacting – even three or four years after stopping OIT.

Notably, the other half who did not reach “sustained unresponsiveness” were still able to consume a much larger amount of peanut, with less severe reactions, than they could at the study’s outset.”

Note that the half that “failed” being able to eat unlimited peanuts after being off therapy for a month were still able to eat 10-12 peanuts with the majority being able to eat 12! Not one child in the study ate less than 10 peanuts safely after totally discontinuing peanut ingestion dosing for a month. Oddly, they were classified as TF: Treatment Failures since they didn’t get as high as the researchers wanted.  These 50% that were “Treatment Failures” simply resumed regular OIT maintenance dosing since they were already eating 10-12 peanuts. We would not consider them “failures” in the real world!

So half of the children started losing desensitization after being off OIT for a month but STILL safely ate 10-12 peanuts. This is certainly more protection than cross-contamination or an accidental bite of allergen (“bite-proof”). 100% were able to eat 10-12 peanuts!

“Our findings suggest for the first time that in peanut-allergic patients, long-term treatment with oral immunotherapy may produce sustained benefits allowing introduction of peanut back into the diet,” said study author Dr. Brian Vickery, Assistant Professor of Pediatrics at the University of North Carolina.”

http://allergicliving.com/2014/02/05/first-long-term-study-of-peanut-therapy-shows-lasting-protection/
http://www.jacionline.org/article/S0091-6749%2813%2901750-8/abstract

THE UNC PEANUT STUDY CONTINUES: 3 MONTHS WITHOUT DOSING

The study continued, and after 3 months of not eating peanut, 25% passed a food challenge. Still an amazing accomplishment after 3 months without peanut! The remaining 75% had their skin prick tests (SPT) return to baseline levels and did not pass the food challenge. This is the reason why we assume peanut dosing is for life, yet are hopeful that some patients, like the 25% in this study, have a longer-lasting or permanent immunological changes that approach tolerance.

Even when food allergy children outgrow an allergy, allergists recommend that they regularly ingest the allergen, because we just don’t have a true test for tolerance. If you stop ingesting the allergen you run the risk of losing all desensitization and regaining the allergy—becoming sensitized.

Definitions:
“SENSITIZED” is the state of reacting to the allergen when exposed.
“DESENSITIZATION” is the state of not reacting to a substance while regularly being exposed to the allergen.
“TOLERANCE” is the state of not reacting to the allergen when regular exposure is discontinued.

https://aaaai.confex.com/aaaai/2014/webprogram/Paper11940.html
http://www.jacionline.org/article/S0091-6749(13)02464-0/fulltext

image10-YEAR STANFORD STUDY
2014: “For everyone who has stayed in the study, the treatment has been 100 percent successful,” says Nadeau. “It turns out that everyone’s immune system is capable of adapting — and surprisingly, it is as true of adults as children.” She and her team now have an eight-year study of OIT — the longest record in the United States — in which they found that everyone who was compliant with the treatment and continued to eat the foods has kept their allergies from returning.”

Here’s the latest on OIT research from Stanford, including an 8 year (now 10-year)  OIT study. Gives a good history too.
http://stanmed.stanford.edu/2014fall/i-can-eat-it.html

4-YEAR EGG STUDY
The  Consortium of Food Allergy Research (CoFAR) ran a long-term egg OIT study. “Long-term treatment with egg oral immunotherapy enhances sustained unresponsiveness that persists after cessation of therapy.”  Remember that “sustained unresponsivess” means “not reacting” to the allergen after stopping OIT therapy.

In this study,  27.5% had sustained unresponsiveness after 2 years, and 50% after 4 years.  Longer treatment time  increases the success rate and the likelihood of tolerating unbaked egg in the diet.

http://www.jacionline.org/article/S0091-6749(16)00117-2/abstract

WALNUT OIT HELPS WITH DESENSITIZATION TO OTHER TREE NUT ALLERGIES

In this small but exciting study, it shows how walnut OIT, in particular, affects other tree nut allergies.  Children with food allergy to walnut and another test tree nut (pecan, cashew, hazelnut, pistachio) received walnut OI  for 38 weeks. Results were that they showed significant increases in successfully consumed doses of both walnut and the other tree nut!  While we have seen this anecdotally in our Facebook OIT groups, where OIT for one allergen results in improvement in other allergens, having this confirming study is a step toward more research in this area.

https://aaaai.confex.com/aaaai/2016/webprogram/Paper25418.html

imagePOSITIVE DNA / EPIGENETIC CHANGES FROM ORAL IMMUNOTHERAPY

Stanford is doing exciting research on desensitization  creating change at the DNA level and that it could alter how  DNA reacts as described in this article titled “Peanut Allergy Oral Immunotherapy Changes DNA: Alteration In Gene Expression Possible Way To Monitor Treatment’s Long-Term Effectiveness.”

“It’s interesting that the change we saw is at the epigenetic level,” Nadeau said in a news release. “This might help us tell people if they can safely go off of immunotherapy, or if they need to continue to eat the food every day.”

In a NY Times article: “Research in Nadeau’s lab has found that treating allergies actually changes the genes by epigenetics (a chemical modification of the genes that does not affect the actual DNA sequence), so desensitizing children may reduce the likelihood that they will pass on the disease to their children. One day, perhaps, fatal anaphylaxis may become a sorrow associated with an earlier age, like dying of appendicitis or polio.”

The  Stanford scientists, led by Dr. Kari Nadeau, explain that this type of DNA alteration is an epigenetic change, from the Latin word epi, which means above. An “epigenetic” change literally means an alteration that is “above” the genes that a person is born with.“ They further discovered that these methyl groups “fall off” when treated with oral immunotherapy:

”For the patients who never received immunotherapy (the control group), a large number of chemical tags called methyl groups were now affixed to their DNA. These methyl groups controlled how certain genes actively expressed themselves in the body. The large clump found on the control group’s genes had locked, or silenced, the genes that were supposed to help them fight off the allergic reactions.

In contrast, the researchers found that the seven patients who could now tolerate peanuts showed a very sparse number of methyl groups on their DNA, meaning that the genes that help them control their allergic reactions were free to actively work within their body.”

What is so promising is the test that Dr. Nadeau and Stanford are working on to determine WHO might not have to take lifetime dosing of their allergen.  This test would determine if the patient’s body has released these methyl groups, and therefore could stop regular dosing.  “The differences could be detected in small blood samples with commonly-available lab equipment, pointing the way to a possible clinical test. FDA approval is needed before the test could be clinically used for this purpose.”  It apparently is an inexpensive test and would let patients know to keep maintenance dosing for longer periods in the hope of eventual tolerance showed through a repeat test.

Articles about epigenetic / DNA changes:
http://www.medicaldaily.com/peanut-allergy-oral-immunotherapy-changes-dna-alteration-gene-expression-possible-way-monitor-268328
http://scopeblog.stanford.edu/2014/01/31/new-dna-based-test-could-keep-peanut-allergy-at-bay/
http://www.jacionline.org/article/S0091-6749%2813%2902957-6/fulltext
http://mobile.nytimes.com/2013/03/10/magazine/can-a-radical-new-treatment-save-children-with-severe-allergies.html?pagewanted=all&_r=1&

Dr. Nadeau herself explains in a 1-minute PBS video how this works: “What we’ve found in a small number of people and now we’re doing it in a larger number of people, is that it looks like DNA that is so important as we pass on to our children and their children’s children. This DNA seems to have a “coat” over it and when you put this coat over the DNA, the DNA doesn’t work very well for certain genes. And what we’ve found was that there is one gene in particular that had this “coating”over it that was changed in allergy. But then once we started the immunotherapy that coat got taken off. So, their DNA started to look like people that were not allergic and not allergic to food. That was a huge “aha” moment.

We were so excited to see that this chemical change had occurred in the DNA and that it was helpful to the people that had successful therapy. And what’s really cool for me to know as a scientist is whether or not that change in their DNA, that helpful change, will actually be passed onto their children; and whether or not their children will have less allergies because of the therapy they took as children.”

Watch the 1 minute PBS video clip:

IMMUNOTHERAPY AND THE QUEST TO TREAT AND CURE FOOD ALLERGY

Dr. Kari Nadeau of Stanford, an OIT Pioneer, talks about immunotherapy and the quest to treat and possibly cure food allergies. Sean Parker, of Napster fame, donated $24 million for a research foundation she heads.

Because OIT, as Dr Nadeau says about immunotherapy  in her new video “It’s only known way, at the current time, to cure someone of their allergies.”

She goes on to explain what she means by that, “So, I’m always careful about saying the word ‘cure’ because patients talk about the word ‘cure’, and to them it means, “I can eat whatever I want every day.” But to me, as a scientist and as a physician, when we say ‘cure’, we mean cured for life. It took me 9 years to get where we are today to be able to get a recipe that’s helping out patients for therapy. And it’s a lot of building blocks, so I understand that the road may not be easy. But importantly, is that what we’re looking forward to is to really making a deep impact in the field of allergy research and through understanding the immune system. And Sean’s foundation is going to be key to that.”

Watch the 2-minute video:

imageFROM CLINICAL TRIALS TO THE PRIVATE PRACTICE OFFICE:
85% SUCCESS RATE

“Clinical trials are really important and we depend on them to provide us with more rigorous information. But children are suffering now. I don’t think every ‘i’ must be dotted and every ‘t’ crossed before you help people.”
Dr. Richard Wasserman, pediatric allergist
http://res.dallasnews.com/interactives/2014_January/foodallergies/

While there are over 125 oral immunotherapy published journal articles, there wasn’t much information available on how OIT fared when practiced by board-certified allergists in an office (private practice) setting.  Several allergists collected statistics from  their practices and published them in the leading allergy journal titled “Oral Immunotherapy for Peanut Allergy: Multipractice Experience With Epinephrine-treated Reactions”.

Their results showed that peanut OIT has an 85% success rate in private practice. That’s better than the success rate of allergy shots for environmental allergies. The research covered 352 treated patients who received 240,351 doses (yes 240,000!) of peanut, peanut butter, or peanut flour. Interestingly, as noted in the accompanying tables, 84% of the reactions that used Epi Pens occurred in 1 of the 5 practices, and further digging shows that those patients were instructed to use Epi rather aggressively versus  other practices.

The study also showed that not all reasons for withdrawal included reasons related to OIT: “Reasons for withdrawal included gastrointestinal symptoms (abdominal pain or vomiting hours after dosing), taste aversion, mild (urticarial) reactions, ETRs, anxiety, uncontrolled asthma (symptoms not temporally related to peanut dosing), poor adherence and/or inconvenience, and lost to follow up.”
http://www.jaci-inpractice.org/article/S2213-2198(13)00391-7/fulltext
http://www.sciencedirect.com/science/article/pii/S2213219813003917

For even more research and articles, make sure to review our Research & Learn Center!

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