Roller Coaster Ride, a.k.a., Peanut Clinical Trial

It's been quite an emotional roller coaster ride this spring.  At our last visit to Duke in January, we discussed the details of Abigail's pending peanut food challenge.  At that time, we were all set for this summer.  In March, we received an e-mail from our doctor stating that the protocol had changed.  They've decided to extend the study from 3 years to 5 years.  My heart sank.

Earlier in the year, they selected 10 participants, those that have been in the study for 3 years, and who had passed their original food challenge at the year mark, to do the 3 year challenge.  This challenge consists of eating the equivalent of 16 - 17 peanuts.  Less than half of those 10 passed the desensitization challenge and were able to go onto the tolerance challenge.  The thinking is that SLIT (Sublingual Immunotherapy Treatment) takes longer, much like traditional allergy shots, and the additional 2 years will allow for more changes in the immune system.

At this point in the e-mail, I'm almost in panic mode.  We've been saying to Abigail for months now, "You're almost there.", "You can do this.", "It's countdown time." and "You can make it till July."  Obviously, we're operating on the thought that she's going to pass her challenge.  Now, I'm not so sure, and what I'm going to tell her?

I was relieved to read further in the e-mail that there is a provision in the study protocol that allows for a food challenge sooner than 5 years if the IgE is 15 or less and the skin test is 5mm or less.  Whew!!!  Those numbers were based on their experience with the peanut flour studies, and the fact that the kids from the SLIT group of 10 who did pass both food challenges had lower IgE numbers.  Abigail's number was 7.54, and her skin prick test was almost non-existent.  We're back on for July!!

Fast forward to May.  I call the now transferred staff at UNC Chapel Hill to see about scheduling her food challenge in July.  In talking with the nurse that's been there from day one and more or less coordinates all of the peanut clinical trials, I find out that they are re-thinking the 3 year challenge provision.  There goes the heart sink again.  She explained that the additional 2 years may mean the difference between being desensitized and being tolerant.  Obviously, as disappointed as we may be, we choose the cure over the band-aid.  On that call, I did find out that we could skin test for tree nuts, and if the test backs up Abigail's negative blood test results, we could introduce tree nuts.  That's a big deal, and helped ease the blow of potentially staying on the SLIT drops for another 2 years.  We'd know for sure after the staff met and made a final decision.

I got a call last week.  We're back on!  Told you it was a roller coaster ride.  Here's how it will work.  At the 36 month mark which we've actually passed (it was mid-May, but over the years, we've pushed our annual visits to June to get past end-of-school commitments), Abigail will do the desensitization challenge.  Looks like this year it'll actually be July due to summer camp and their schedule.  On challenge day, she'll consume doses of peanut flour up to the equivalent of 16 to 17 peanuts.  If she can finish the challenge, then she's considered desensitized.  We go home, and stop the drops for a period of 1 month.  In August, we go back for her tolerance challenge which is the same dosages up to 16+ peanuts.  If she doesn't tolerate the full amount, they look at the dose where she started showing symptoms and step back one.  That amount will be her tolerance level.

We're excited and scared at the same time.  I'm praying that she passes both challenges with no issues.  Having her be tolerant to peanuts would be so much more than what we were asking for when we started this trial.  My hope then was that she could consume products processed in a facility that manufacturers peanuts, and that I would no longer have to worry about accidental exposure.  Being in a position where she needs to eat peanuts would be amazing!

Let's hope there are no more changes!

Interview with Dr. Wesley Burks

In all of our trips to the Duke Clinical Research Unit, we've never actually met or even seen Dr. Wesley Burks (Chief of the Division of Pediatric Allergy and Immunology at Duke University Medical Center in Durham, NC). This picture is as close as we've come. I've joked before that I feel like if we do, we should ask for his autograph given the amount of publicity he and his department get regarding their research of food allergies.  All joking aside, we are very grateful to Dr Burks and his staff at Duke for allowing Abigail the opportunity to participate in the peanut sublingual immunotherapy trial, and for giving her the chance to become peanut allergy free!

A fellow mom/blogger of food allergic children recently had the opportunity to interview Dr. Burks.  She has an informative website, www.allergymoms.com and a blog at http://www.allergymoms.com/modules/wordpress/index.php.  Here is the link to her interview with Dr. Burks.  It gives a great overview of the immunotherapy clinical trials, some results they've seen, next steps, etc.  There's more information on the oral immunotherapy trials (peanut flour) than the sublingual (drops that Abigail takes) because that was the original trial, and they have 5 plus years of data.  Our doctor for the sublinugal trial has submitted a paper and hopes that it will be published soon.  We're looking forward to reading about the current successes of the sublingual study.  It's neat to know that Abigail's data is a part of those results.

Food Allergies in the News

Last week was a very busy week for food allergy news.  The Journal of the American Medical Association (JAMA) released a new study in their May 12th issue that was picked up by a ton of major news outlets including my own local paper. The objective of the study as written in the article, "Diagnosing and Managing Common Food Allergies", was to review all available evidence regarding the prevalence, diagnosis, management and prevention of food allergies.  Using 72 pre-qualified studies indexed between 1988 and 2009, the conclusion was made that "the evidence for the prevalence and management of food allergy is greatly limited by the lack of uniformity of criteria for making a food allergy diagnosis, severely limiting conclusions about best practices for management and prevention." Wow....tell me something I didn't know!  Sorry, just a little sarcasm there.

Here are a few of my thoughts from combing through the various news articles related to the JAMA study.  The study concludes that 1 to 2 percent of the population have a food allergy, but not more than 10%.  The JAMA abstract states that "it is unclear if the prevalence of food allergies is increasing."  Ever ask yourself why it is that you didn't know anyone with a food allergy growing up, nor do you or your spouse have a food allergy...so why is it your child does?  Not very scientific, but I'd conclude that food allergies have increased over the last 10 years!

Another study conclusion was that food challenges, skin prick tests and blood tests for IgE are all valuable in diagnosing a food allergy, however there is not just one test that can be solely recommended to use by itself or even over the other.  Again, there's no surprise there.  Our poor kids are being pricked and poked, and yet we still don't know the true severity of their reaction....unless of course they've actually had one that's rushed us to the hospital! 

Here's another finding, "immunotherapy is promising but data are insufficient to recommend use."  Speaking as a mother with a daughter participating in a sublingual immunotherapy clinical trial, how can a study recommend not using a "promising" therapy simply because data is insufficient.  If it looks promising, then wouldn't you think that the recommendation would be for more people to participate in these types of trials so that a more conclusive finding can be published??

And my last comment, it turns out they found there to be no universally accepted definition for "food allergy" leaving the public in a state of confusion regarding the difference between food intolerances, food allergies, and life-threatening food allergies.  I think we'd all have to agree that there is a general lack of appreciation for the risk that our children live with on a daily basis doing something as routine as eating a meal.

The upside of the study is that The National Institute of Allergy and Infectious Diseases, which funded it, is working on guidelines for the diagnosis and management of food allergies to be released this fall. If the average, non-allergic reader took the time to read the articles, then all of the press that circulated last week did a good job of raising food allergy awareness.  I thought CNN Health wrote a particularly good article.  Regardless of how good the article is though, with headlines like "Doubt is Cast on Many Reports of Food Allergies" from The New York Times, or "Are Your Food Allergies for Real?  Many Mistakenly Think They are Allergic" by abc NEWS  there is a downside if a reader stops there.

I can truly appreciate how wonderful it would be to find out that your mild food allergy doesn't require a strict elimination of that food from your diet, or that after all this time, you don't have a food allergy at all.  But...please, please...don't muddy the water for those that do have a severe, life threatening allergy!!