Sunday, May 27, 2012

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!


Lisa said...

What do you mean by the tolerance dose if she doesn't pass the second one? Would she go back on drops equivalent to that amount or would she consume a food product equivalent? Also, would that happen to keep her trying for tolerance?

I know this is nervewracking, but it will be worth it. Also, the work that she is doing is helping SO many other kids...let her know we all appreciate and thank her for her hard work! They have learned SO much from her participation already!

Mom with a Mission said...

Hi Lisa. Thanks for all of your kind comments!

Regarding your questions, assuming she's passed the desensitization challenge, and after being off drops for a month, she then has the tolerance challenge. Let's say, for example, after the equivalent of 9 peanuts, she has a reaction, even a mild one, then she would "fail" the challenge; however, her tolerance limit would be recorded at 8 peanuts. She wouldn't go back on drops. She'd consume peanut products at home, but we wouldn't exceed the 8 peanut level.

There is so much not known. They'll continue to track her, and I think we'd even challenge again at the 4th and 5th year. It may be that consuming peanut products (not to exceed that tolerant level) will continue to train her immune system and her tolerance level would continue to climb.

Thanks again Lisa.

Lisa said...

Okay! That is what I thought you meant and seems to be what they are doing for some kids. It does seem that the drops seem to be taking longer than the flour, but they are, which do you go with and which one works best.
In our trial, they are trying to figure out which size dose works the best...the 300mg or the 3000mg. There is still so much they don't know for sure, but they are learning more each year and hopefully can get it out there.
We head back in June and I will be anxious to hear how she does this summer! Wishing you all the best of luck!

mom with SPECIAL [needs] kids said...

So happy for Abigail...and all of you! Know it has been up and down. You deserve all ups from here on out. Tell sweet Abigail we are proud of her!!

Anonymous said...

I had reviewed the Peanut Clinical trial literature at length and decided to pursue another path first (NAET): check out my blog and others in our same situation:

Anonymous said...

Here are some other interesting videos:

Bugs said...

Thank you for this blog! I just happened upon it researching some peanut free products. Three of my 5 kids have severe peanut and/or tree nut allergies. I am so grateful to read that your daughter is in a clinical trial that could potentially help my boys! I hope everything goes as planned and soon will be available for all kids with life-threatening allergies! Do I understand that after 2 more years the SLIT method might be available? If so, we can hang in there! THANK YOU! Mom of 5, with a 10,7,4 year old with severe

master bedroom ideas said...

Peanut Allergy Free....Here We Come!!
This article has pointed out some wonderful details. Cheers for the author for raising such a topic!

Mom with a Mission said...

Bugs, I just realized I never responded to your comment. Sorry about that and that you and your family are also dealing with severe peanut allergies. To be honest, I don't really know when SLIT will be available mainstream. There are some allergist that are doing a version of it at their offices. My understanding though is that they're doing it faster and with higher doses. Meanwhile, the doctors on our study are saying it takes more time than they original thought to train the body using SLIT. Makes me think that those doing it through their local allergist should do so with caution. I'll ask tomorrow when we go for our challenge for an update.