FAHF-2: The Holy Grail?

So my son had his second peanut challenge yesterday.

It has been a LONG quest. As I mentioned in last week's post, he took somewhere around 4600 pills over the last 6 months. During that time, we had no idea whether what he was taking was placebo or the real medication.

Yesterday, we girded our loins and got in the car before sunrise, knowing that this time it was no rehearsal. Since he had no issues with the applesauce on Thursday, we knew the poisoned apple (sauce) was waiting.

As with previous challenges, there were 11 little applesauce containers lined up on the counter of the exam room. After placing an I.V. line and doing some preliminary vitals, the clinical manager handed him the first container.

For the next two hours, I did my best to either read or pretend to read while other people asked him how he felt. Any change? No change from last time? Do you feel o.k. to go on to the next dose?

He did.

Around Dose 4, everyone started visiting a little more. Dose 4 was where he had started noticing the sensation of throat closing last time around. Dose 5 was where it escalated a little; Dose 6 was where they had called it off. 490mg total peanut protein.

Dose 5 came and went uneventfully. Dose 6. Dose 7.

Around Dose 8, my son finally said "I can tell it has peanut it in. I'm starting to feel something in my throat." When asked what the sensation was on a scale from 1 to 10, he answered "1".

Things moved more slowly then. After Dose 9, the sensation in his throat moved up to a "2". After Dose 10, it became a "6". By this time, he was also a little itchy in his throat and the sensation of constriction was getting more and more pronounced. Finally, he coughed a little and the research staff called it off and gave him an antihistamine.

Unfortunately, the feeling of constriction in his throat continued to climb in intensity, despite the antihistamine. My son was starting to feel a little anxious, although nowhere near as anxious as during the initial fail back in April. However, they pulled out the Epi-Pen. In LESS THAN TWO MINUTES (no kidding!), he went from an "8" to a "2" with regard to throat constriction. Thank God for the wonder drug.

All in all, it was less stressful than the first challenge, even though he got a good bit further. While the clinical director said she couldn't tell me exactly how much peanut he consumed until we complete the next set of challenges in January, she did tell me that the total amount for the trial is 5000 mg of peanut flour, somewhere around 16-17 peanuts. My son completed all but the last dose, so that probably put him in the 4000 mg area.

That's almost eight times the amount of peanut he consumed in April.

13 peanuts.

Think about that. He achieved a better result than most of the oral tolerance trials...without any actual peanut consumption. Best of all, the medication has been reformulated so kids can hopefully achieve the same result without needing to take 30 pills each day.

So...here we are. What I thought might come to pass has come to pass, thanks to the hard work of a lot of good researchers and some really brave kids.

A therapy that mitigates the severity of food allergies has been discovered and tested.

I asked it back in May and I will ask it again now: How much risk are you willing to take? How much discomfort will you tolerate? Can your kid take 10 pills a day? 5 pills? Will you be willing to undergo a food challenge at the end of the therapy to see if it worked? Will you be the first to step up...or the last?

For us, the real excitement is all ahead. While it's very nice to have a larger buffer with regard to peanut, what we really want to know is whether our son can now tolerate more MILK. A tablespoon of peanut butter is great, but a tablespoon of milk would be even better. Unfortunately, we are still supposed to avoid all baked milk introduction or additional food challenges until the study completes in January. However, that's not long to wait to see if perhaps everything is better for him.

All his food allergies getting better — that's the real Holy Grail. Here's hoping I can clink chalices with you sometime next year when we confirm we're already there.

A heartfelt thank you to all the wonderful people at Lurie's Children's Hospital who made this both possible and easy. 

Halfway There...But The Second Half Is All Uphill

Yesterday was our first of two food allergy challenges for FAHF-2.

This is going to be a very quick update because the challenge was completely uneventful. My son had a full work-up in the morning, including cardiac, spirometry and many, many Vacutainer® tubes of blood. I asked if they could share anything about RAST levels, since we've had a blood draw every 6 weeks, but this info is apparently being consolidated at Mt. Sinai and will only be shared after the study completes.

After the work-up, he started on the applesauce. (If you haven't read about the FAHF-2 clinical trial before, here's a link that describes the process in excruciating detail.) By Dose 6 or 7, we were all chatting, reading, working...it was obvious nothing was going to be happening. Placebo.

Early on in the morning, I had asked our study manager what type of results they had seen to date. She said that, of the three kids who had completed the second set of challenges, two were able to achieve a four-fold increase in tolerance. (The third probably had placebo, since it's a 2-to-1 ratio of real medication to placebo in the study.)

She also confirmed that I was close on my estimation of the peanut my son had tolerated at the last set of challenges — 490 mg in all, about 1-1/2 to 1-3/4 peanuts. I asked if that was typical for the study and she said he actually reacted sooner than most of the kids — for many of the kids, it took slightly more to set off the reaction. However, my son was a "slow reactor" according to the clinicians, so the time between his doses was increased to half an hour during the first challenges to help ensure he didn't suddenly reach a critical point and have a really bad reaction. Two of the other kids did have bad reactions and her theory was that it may have been related to the dose hitting them all at once.

Here's the bad news: my son's skin tests are actually more reactive now than they were when we started the trial. Does this matter? The trial director shrugged it off, saying that skin tests are notoriously unreliable to start with. However, it made us nervous. Over the last month or so, my son has also noticed a reduced tolerance to "may contain" milk foods that he had previously been eating (with doctor approval) without problem.

Did the medicine actually reduce his tolerance? Has he spent 6 months and taken 4600 pills, only to discover it's actually worsened his allergies?

It's also possible the medicine needs more time to kick in. (And, if we want to be irrationally hopeful, it's possible the applesauce he had yesterday was not placebo and that he's cured. Sure.)

I guess we'll know more after next week. Even if you disagree with me, please think good thoughts for him. He's just a kid and a very courageous one.