We're in!
Two nights ago, I was a wreck, comfort eating (schnitzel, cake, you name it) to try to assuage my anxiety about the big screening appointment at Stanford we had the next morning. We were told that the appointment, where the boys would undergo blood tests, scratch (skin prick) tests, physicals and finally blind food challenges, was going to be difficult, long, and critical in Dr. Nadeau’s determination of whether they would be included in one of her coveted and cutting edge desensitization studies. No pressure. It’s 48 hours later, and I am still recovering from the exhausting and amazing (in that order) day we had yesterday. (If you don’t want to read all the details, feel free to jump to the end of this post - or the title of it - for the bottom line.)
We were on the road to Stanford yesterday, weighted down with bags of toys, books and an iPad filled with movies (we would have a lot of time to kill there), extra clothes (in case there was vomiting), food, and lots of jitters, before the clock turned 7am. Once at the hospital, Ari and Aviv were in the hands of a lovely team of medical professionals who work with Dr. Nadeau, who gave them physicals, drew blood, and administered skin tests to get some baseline information. Ari was quite calm during the tests, but Aviv was agitated (and he has a heck of a set of lungs on him, when he starts yelling); a role reversal from their usual reaction to blood/skin tests that started things out with some excitement. Based on those test results and ranking likelihood of exposure to certain nuts, we decided on a ‘top 3’ list of nuts for each kid that would likely be the three that they would be desensitized to in the study. But before that could occur, those 3 nuts – plus a placebo – would be given to the boys as part of a double blind challenge to confirm the allergy. What that means is that, on each of four ‘dosing’ days (yesterday being the first one), each kid would be given microscopic amounts of one of the nuts, increasing dosage throughout the day, to confirm that the child is (1) allergic to the nut, and (2) at what dosage (i.e. what is the baseline from which to begin desensitizing). Double blind means that we wouldn’t know which nut they’re getting (or if they’re getting the placebo instead), and neither would the Dr. or her staff; the only person who would know is the nutritionist who mixes the pure nut flour into little cups of chocolate pudding or apple sauce for the kids to eat.
So around 11:30am, with our kids hooked up to oxygen and blood pressure monitors, watching Star Wars for the first time (big day for them on many levels!), the dosing began. This was the part we were dreading. Blood and skin tests aren’t fun, but our kids have done them dozens of times and we knew what to expect; intentionally giving our kids the allergens that are so dangerous to them was a first, and I was terrified inside (while presenting as calm externally). First they were given .1mg of the allergen, and I watched like a hawk for any change in their demeanor or vitals. Every 15 minutes, the staff asked them a series of questions (do they feel itchy in their eyes/throat/anywhere, how is their breathing, do they feel they need to vomit, etc.) and checked their vitals. After observing no reaction for designated periods of time (15 minutes after the first dose, 30 minutes after the second dose, up to one hour intervals between dosings), the kids were given their next dose (1.6mg). Just to put the volume in perspective, a typical square of chocolate is 10,000mg. No reaction from either kid at the 1.6 dose, or the next one (6mg). At the 25mg dose, however, as soon as Aviv got the bite of pudding into his mouth, he began to freak out. His demeanor immediately changed, he became red and welt-y, and he began crying and yelling that his mouth “felt spicy” (which was his interpretation of the tingly/stinging feeling of his mouth reacting and starting to close up). To go back to the chocolate analogy, if you took a typical square and divided it into 400 pieces, one of those 400 pieces is what 25mg looks like. That’s the miniscule amount that caused Aviv to start reacting. The medical team was great – staying calm and medicating him immediately, but his welting continued to get worse for the next hour. A second dose of medication and topical cream helped to stop the welting, and he was done with dosing for the day. The challenge/dosing protocol says that the child continues escalating the dosage until the first of either 100mg is reached, or a reaction occurs; the child then needs to stay put there for two hours of observation after the final dose. (Interesting fact we learned: 74% of reactions occur within 20 minutes of ingestion, but another 22% take longer to react and can occur up to 2 hours after ingestion.) Ari, however, had no reactions during the day, and continued on until the final 100mg dose (and the 2 hours of observation after, which made for a VERY long day there). Having no reaction could mean that Ari received the placebo yesterday, or that he has a very low reaction trigger to one of his nuts, such that 100mg wouldn’t trigger it. (We think it’s more likely that it was the placebo, but we’ll know for sure at the end of the 4th dosing appointment.)
While Aviv’s reaction was scary to watch, there was a great lesson in it for us. We got to see exactly how he reacts when he ingests nuts (not sure yet which nut), which is very helpful when educating others on what to look for with Aviv, as every kid reacts differently. We know how he reacted 2.5 years ago, but he hasn’t had an ingestion reaction since then (thankfully!), and it was an important learning.
Dr. Nadeau finally arrived as we were wrapping up around 4:30pm. It was interesting to see Aviv’s connection with her. They had bonded at the pre-screening appointment a few months ago, and he asked for her specifically all day yesterday. When she arrived at the end of our day, although he was zombie-like from the draining experience and the medication, he still wanted to hug her and spend time with her. She was amazing with both kids, before turning to us to talk. She told us more about the different trials she has opening up in the next few months, including that the one we want – the common auto-immunotherapy/desensitization protocol with the ‘accelerator’ drug, Xolair – has received FDA approval, and is now pending before the Stanford Internal Review Board (IRB); they expect to receive IRB approval within 3 weeks, and then move forward with opening the trial. We shared with her about our day, and how Aviv articulated what was happening with his body during the reaction, and she was very pleased as that’s a big deal from a 4 year old. She reviewed all of their test results, heard from us about the research we’ve been doing to feel comfortable with the Xolair study (many discussions with experts and reviewing data), and then told us that she had planned to have 15 kids in the Xolair study, but based on what she saw, she could add us to the study as numbers 16 and 17. I almost fell over. It seemed so surreal that I had to ask her for confirmation that she was saying Ari and Aviv would be included in the study. She was. She even drew me a picture of the time line of the study, gave us numbers of who to talk to for various needs, etc. I asked about how to handle the other nuts that Aviv is allergic to (that couldn’t be included in the 3-nut limit of the trial), and she assured us that she would work with us to figure it out, whether through periodic testing to see if we’re benefiting from a ‘bystander affect’ (where other nut allergies that aren’t being treated for directly essentially get treated by association) or by treating the other nuts ‘off protocol’. I don’t even know exactly what that means, but she made clear that she wouldn’t let us go through this whole journey only to still have nut allergies to worry about. (With one caveat – one of the nuts Aviv is allergic to can’t, at this time, be treated for, as the FDA hasn’t approved a source of the pure nut flour for it.)
Assuming the IRB approves the study, it will begin in December 2011 or January 2012. Ari and Aviv can enter it once they’ve finished their dosing appointments (one yesterday; 2 scheduled for November; 1 more to follow), and then will begin 15 weeks of receiving a Xolair injection (once every 2 weeks). They won’t begin taking the allergens (in carefully measured/monitored daily doses) until week 9, and will ‘up-dose’ the amounts through week 24. After that, they’ll go through another 4 days of double blind challenges to validate that it worked. And then we all sigh. Or cry. Or both.
As we headed home, our bodies exhausted and our heads swimming with information, excitement and hope (and in Aviv’s case, antihistamines), we tried to make sense of it all. We all slept a lot more soundly last night than the night before, that’s for sure. In a testament to the hopefulness of children, while I’m still having trouble believing all that Dr. Nadeau said (even as I type this), Ari announced this morning, as he boarded his school bus to Kindergarten, that ‘he went to Stanford and they’re going to do treatment, so that by the time he starts First grade next year, he won’t have nut allergies anymore.’ As the saying goes: from his mouth, to G-d’s ears.
