Monday, January 14, 2013

FAHF-2 Clinical Trial Summary

As promised, here's the update on the last round of clinical food challenges. I've seen both sunrise and sunset today, but I want to do it while it's all fresh in my mind.

I generally do not like to give specific details about my son's situation, but I know a lot of you are invested in the stats so in this case, I'll make an exception.

1.71 (class 2)
3.5 mm
~3.0 mm?
(not sure about this one)
No reaction
Peanut consumed
496 mg
~9 peanuts
1746 mg (almost 6 peanuts)

Please keep in mind this is just one kid, and there's no guarantee the other kids will have patterns at all like this. However, it's interesting that a) the RAST number went up pretty significantly, and b) the amount of peanut tolerated after 3 months off the medication went down slightly.

I'm going to do the rest of this in a Q&A format, since I basically spent the whole morning asking questions of the clinical trial manager and on-call physician. Again, keep in mind these are only their opinions. Actual mileage may vary.

Q. Will the tolerance we saw with peanut extend to his other allergens?

A. No reason to think it will not. The formula has been used in Eastern medicine for all allergens. (We will work with our own physician to pursue new RAST testing and challenges if appropriate.)

Q. Once the trial ends and the medication is available again to trial participants, is there a recommendation for how it should be taken? 

A. This is an open question at this point. However, in Chinese medicine, the tradition has been for people to take the medicine for nine months and then take three months off. This was probably because two of the ingredients in the original FAHF formulation had some liver toxicity associated with them. Those two ingredients were dropped from the second (FAHF-2) formulation for that reason. As a result, the thought is that patients may need to stay on the medication life-long.

On the other hand, the tolerance may last. No one really knows.

Q. What route will be taken for commercialization? What's the timeline?

A. Right now, it does look like the researchers are pursuing an FDA approval (vs. going to market with a "dietary supplement"). This will ensure the widest availability. However, it also takes a little longer.

Q. So what happens next?

A. The medication has been reformulated in a more concentrated form. That form will need to be tested for efficacy in Phase 3 clinical trials just starting in Dallas. (Heads up, Texas residents!) Participants will take 10 pills a day, 5 in the morning and 5 at night. This should significantly reduce the issues with compliance. (One of the issues they had with the Phase 2 trial was the difficulty for kids of getting in three doses, with food, without dosing as school since that's difficult for many schools to manage.) If the current trial shows positive results and the Phase 3 trial also succeeds, the researchers will pursue commercialization. That's probably still a couple years away.

Q. So was the trial successful?

A. Obviously this is what we'd all like to know! However, even if she could have shared it with me (which she can't at this point), our clinical manager indicated that she really doesn't know. 1 in 3 kids in the trial were receiving placebo, so it's impossible to tell the difference between a child who didn't respond to the medication and one who didn't receive the medication.

Q. What does success even look like?

A. There are two separate outcomes that will need to be evaluated to determine whether the trial was successful. First, did children show an increase in threshold? My son's experience was a definite yes: depending on which food challenge you look at, he showed an increase between 3X and 5X in the amount of peanut he could consume before a reaction occurred.

The second measure of success is severity of reaction. This one is trickier to measure because, while this trial attempted to use objective symptoms before calling a food challenge, subjective symptoms were used if they were persistent. There's obviously some anxiety for these kids going into a food challenge, so they are going to be more aware of all their bodily sensations. Since the amount of peanut is often tied to severity of reaction, it will be hard to evaluate whether the reactions were milder because of the medication, or whether the kids just got anxious and bailed.

Important to note: this is more my interpretation of what may have happened, not the researchers' opinion. Unfortunately, the researchers could not share specifics about the other kids at this point, other than to say there was a range of response with regard to both threshold and reaction severity.

Q. Was the change in RAST what they expected?

A. Well...sort of. Our trial manager said my son's RAST probably went up due to the known peanut exposures, even though tolerance increased. I was under the impression that they expected RAST to go up, then come back down, so it will be interesting to see what happens with the rest of the kids in the trial.

Q. When will the information from the trial be made available?

A. Probably end of summer, 2013. The last participant is finishing the main part of the trial in June.

Q. Is there any thought that kids should be taking a daily dose of peanut to help maintain tolerance?

A. No. That's outside the scope of this trial, there's no continuing supervision to make that happen, and there's no guarantee at all of how long any increased tolerance will last. (The tolerance was achieved without any peanut consumption at all, so maintaining it would have more to do with the medication than with actually eating peanut.)

Q. What changes can the kids in the study make to their diet, now that the study has completed?

A. Really, none. In our particular case, the researchers were pretty secure telling my son that cross-contamination was not a real concern. However, I clarified today that that's primarily because his starting threshold was already so high. All the kids in the study are definitely not being told this. In general, the advice is to continue to strictly avoid peanut and always carry epinephrine. (In addition, they reiterated that reactions are unpredictable -- the mild ones we experienced as part of the study are no guarantee of future mild reactions.)

Q. Is there any thought that my son's milder reactions/slow response time perhaps are because he's really allergic to pea and just cross-reacting to peanut?

A. According to the researchers, very unlikely. A peanut allergy seems to be most often be what it appears to be: a true peanut allergy. Different people just respond differently.

Q. Are we still "just five years away from a cure"?

A. This is a little inside joke among my food-allergy friends. I've been told "just 5 years" for almost 18 years now.

However...our clinical trial manager's opinion on this is that one of the trials they're working on will definitely pan out into a usable treatment. The hard part for me to hear was that she's not necessarily betting on FAHF-2. She spoke with a great deal of enthusiasm about both the oral immunotherapy (OIT) with omalizumab (Xolair) and the peanut patch trial currently underway. However, that may just be because those trials are the new kids on the block. We'll see when the data is correlated from all the reporting sites whether FAHF-2 is a go.

I think that was everything I thought of to ask. If you do have a specific question I didn't answer here, post it in the comments. It's possible I've already asked it and just didn't note it here -- if that's the case, I'll add it in.

Also, if you're just finding my blog, here are the other posts specifically about FAHF-2 in order:

FAHF-2 Trials In Chicago!

We're In

BTDT, Got the FAHF-2 Food Allergy Clinical Trial T-Shirt

Brief FAHF-2 Update

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

FAHF-2: The Holy Grail?

Waiting in the Wings for the Show to Begin

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  1. Thank you for sharing. This is interesting the rise in IgE while experiencing a rise in tolerance. My son is 7 and allergic to multiple foods. We have been working with an herbalist and have seen our IgE numbers go up and down and up again - but we've gotten a new food recently - avocado. I wonder if that is because of the herbs and whether or not he truly "tolerates" the avocado or if that is the herbs inducing their own form of "tolerance."

  2. Thanks so much for sharing and kudos to your son (and his supportive parents :) for doing the study! The measured IgE (RAST) values are really intriguing to me. I've been trying to wrap my head around this for some time to no avail (how IgE can still be present, yet a reaction does not occur). You would think that IgE values would go down if/when tolerance is achieved. Yet, this clearly is not always the case since a person can have quite measurable IgE, yet nothing happens when eating the food. The only thing that I can conclude is that IgE is not the whole story with allergies, and thus why allergy testing (which relies on measuring IgE) in general sucks. If indeed your son had the FAFH-2, it makes me wonder what it actually is doing? Although you can't say for sure that he had the FAFH-2, this looks really promising! Thanks again :)

  3. O.K. I'm posting a comment for the first time in my life (to any article!). Your question about whether we might have a cure within 5 years cracked me up!! Don't even get me started! I also just read your post from Christmas and laughed out loud at you going through the trash. I can't tell you how many times I've done that at my mom's house while wearing my festive holiday attire! In regards to the FAFH-2 study, I'm bummed they've decided to go through the FDA approval process before making it widely available as a supplement. I've got an "exquisitely sensitive" (as her doctor calls it) daughter with a severe tree nut allergy, and I'd love to cut down the risk of cross-contamination as she's entering her teen years and going out to restaurants has become very fashionable with her friends. It's a challenge to keep her safe yet to also allow her to participate in social activities without so many restrictions. Anyway, THANK YOU for your blog, for making me laugh and giving me both information and perspective.

  4. Thanks for the nice feedback, guys!

    I don't know an FA mother who *hasn't* waded through garbage at one point or another. Just comes with the territory. :)

    Denise and FAS, one thing I didn't put in the description was my son's drop in total IgE. When we did the benchmark study (probably 5 years ago at this point), my son's total IgE was in the 3000s. This time, it was in the 800s.

    I don't have the starting point for IgE so I don't know when the change occurred, but it does seem like multiple allergy kids gain foods as their "touchiness" improves. It may be the herbs or it may just be the natural progression of allergies, especially with boys. (My son's allergist says boys grow out of their allergies and girls grow into them.)

  5. Love your blog! Just wondering if you have gotten any update to this trial since this post? I tried searching and didn't see any (but that doesn't mean much). Did you find out if you were placebo?

  6. Hi Carrie:

    We have not received info about the study results/placebo yet; we were told it would be wrapped up and issued in June, so hopefully soon!

  7. Hey Fab, thanks! I also received a similar reply from Lurie (I asked about other studies they have going on and if they would be doing anymore FAHF studies in the future). They indicated it would wrap up this month. Can't wait to read your update!

  8. I did run across this one the other day:

    (Scroll down to the section on FAHF-2.)

    They are already speculating about Phase 3 trial sites - hopefully that will be the case. I also saw recently that they opened a new clinical trial to evaluate the drug for other bowel diseases.

  9. Hey! That was a great little find! (sorry, I don't get any notification when you respond, so it's only when I remember to check your blog (because I love it so!) that I see you posted.

    That seems really encouraging on FAHF-2.

  10. Is there any data on how it effects (for better or for worse) eczema? We have atopic dermatitis, food, environmental allergies and asthma, all equally difficult and somewhat related.

  11. I haven't done much research in that area, but here's an interesting one for you from 2011:

    Looks like the answer is that it helps.

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