Within the last few days, mainstream media has been writing about the one year results of the peanut patch phase III trial. I think it's important to read this information with a grain of salt. There are several reasons that I didn't read these articles. However, I was asked for my opinion on the results, so I read a few to gain some insight. I think that these articles miss the mark. There are many important factors that were left out, which I feel was a huge oversight.
- The media needs to create headlines that sensationalize the topic. If there is no interesting headline, there are fewer readers. The media wants people to read their stories.
- This study and these results are only 1/3 of the way through. The peanut patch is a 3 year treatment, not a 1 year treatment. Analyzing results and promoting them as conclusions is like explaining the whole plot of a movie that you’ve watched only a third of. Could we have predicted the end of Titanic after the first hour?
- This is not a vaccine. Obviously the journalist who wrote this didn't even understand that simple fact. This is an Epicutaneous Immunotherapy (EPIT) treatment.
- The articles never mentions what a "responder” is, just the percentage of children who are considered responders.
- A responder for this study can eat 10x the amount of peanut protein after 3 years of treatment compared to day 1. Some patients may be half way to that goal or - gasp - 1/3 of the way to that goal after 1/3 of the treatment length.
- An important thing to note: some children don’t need to get to 10x for this treatment to change their lives.
- For example, a child who was able to eat 100mg on day 1 and is able to eat 600mg after 1 year isn't considered a responder and yet can eat just over 2 peanuts worth of protein, whereas initially they reacted at approx 1/3 of a peanut. That’s HUGE for them. Imagine what could happen after 3 years of treatment.
- It’s not a hard and fast statement to say they “didn’t respond” when no additional information is provided by the writer explaining factors such as treatment length.
For those who may be thinking this means that Oral Immunotherapy (OIT) is a better option: many children cannot do OIT, including my son. OIT is a great option for some, but just like other treatments, it's not one-size-fits-all. We are super excited at the opportunity to “treat” his allergy without having him go into anaphylaxis after one dose of OIT. It’s different for everyone of course.
My son needs to reach only 100mg (not even 1 peanut) after 3 years to be considered a responder, which really wouldn't change our lives much. However, he could reach more than that - the patch doesn't have a mechanism in it that automatically stops at 10x. Some children will surpass the 10x and some won’t. This slight increase in tolerance could make OIT an option for some whom it wasn't before.
The data they don’t provide this early is the huge difference in skin prick tests after only 3 or 6 months. We've seen our son's skin prick test decrease considerably. We recently visited our regular allergist (not the study allergist) for some paperwork and he did a skin prick test on our son. He said with the results he saw that day, without knowing the history and the fact that he was on the peanut patch (which are important to note), he would consider doing a food challenge to see if he had outgrown his allergy. Obviously he was wearing a peanut patch, which could affect the skin prick test results (I don't know the science on how that works), and his reaction history is also an important factor to consider, so that's non-conclusive as the allergist pointed out, but it’s hopeful.
I understand that medical trials need to have checks and balances to be approved by the FDA and Health Canada. However, early results don't always translate to the final results after the full study period.
The children who have had their lives forever changed by the patch treatment in this trial and previous phases of this trial don't care if they are considered responders or not. They care that they can eat at a restaurant without having to worry about cross contamination, their parents care that they can send their child to school without worrying every second that the school will call with horrific news, they care that they can live their life more safely than before. That's the hope that drives our family.