Just Imagine: the PEOPLE trial - Blog Post #3

For those of you who have been following my son's year long journey in the peanut patch trial - PEPITES, we have now moved into the rollover study referred to as PEOPLE. This study is quite similar; the major difference being that Hunter is guaranteed to be on the actual peanut patch for the next 2-3 years (two years if he was on the peanut patch during PEPITES; three years if he was on the placebo during PEPITES). This ensures that he will get three full years of treatment on the patch.

Hunter had reactions to the patch during the first year. At first it was nothing, so we were disappointed that he may have been on the placebo. After a couple weeks, his back started to react and we were sure he was on the real thing. It wasn't a huge reaction and he wasn't itchy but we were hopeful that it was the peanut patch. Our hopes were dashed when his year one food challenge results were far from ideal. He was actually not able to tolerate as much peanut as he was prior to wearing the patch for a full year. We had so many questions and no answers. We took him for his second day of his year end food challenge on January 23 and he ate all of the doses no problem - of course we knew it was placebo day after the reaction he had the previous week.

After the food challenge, his first PEOPLE patch was applied. Just like the beginning of PEPITES, Hunter would wear the patch for 6 hours a day the first week, 12 hours a day the second week and 24 hours a day starting on day 15. After the patch was applied, we were required to wait in the doctor's office for three hours for monitoring. Within minutes, his back was itchy. He got increasingly more itchy as time went on. He was never that itchy during the entire year in the PEPITES trial. Photos of the patch were required every hour until we left - the first photo was very red. The second was even worse and by the time we were ready the leave the doctor told us if it got worse than what he was seeing that I should remove it regardless if the 6 hours were up. The redness had gone past the edges of the patch and was encompassing a larger area - and oh the itching.

During the first week, Hunter had trouble leaving the patch alone. He said it was super itchy and for a day or two he scratched it so badly that it came off. Luckily we were able to leave the patch on for about 5 hours (the trial allows for +/- of 1 hour during the first week). The reactions were quite large. With the patch on it appeared red all the way around about one inch away from the patch. When the patch was removed, we could see why it was so itchy - his back was splotchy, lobster red and puffy. I began applying the hydrocortisone ointment we were given along with a topical Bendryl cream.

We are currently in week two and the patch is supposed to remain on for 12 hours (+/- 2 hours). The first two days, I was able to distract him enough to leave it on for ten hours each time. The reactions were even worse, and he looked like he had a giant goose egg on his back after removal. I received a follow up email from the doctor's office asking how things were going. I explained how bad his reactions were and included a couple photos. The researcher showed the photos to the doctor and emailed back quickly that the doctor said to take it off much sooner. The reactions were too large and we should try and work up slowly to the 24 hours, which could take much longer than two weeks for Hunter. We were also to continue applying the hydrocortisone ointment to reduce the reaction after the patch was removed each day. Slowly, we will work up to it, and I feel much better knowing that the doctor has recommended that as well.

At first, I was devastated that it is so obvious that he was on the placebo for the first year (although we still won't have confirmation of that until late spring). This means that he will be wearing the patch a year longer than we had hoped, which means that many more blood tests and prick tests. Now there is also an extra anxiety-ridden and scary, food challenge. Had he been on the peanut patch for the first year, there would have been a total of three food challenges but now there will be four.

As much as those extra tests are upsetting, I am reminded that over a one year period, Hunter's tolerance went from 44mg of peanut protein down to only 14mg. One peanut is ~250mg. The amount of peanut protein on each patch is 250mcg, which is the equivalent of 1/1000th of a peanut. If his back looks this terrible with only that small amount of peanut protein, I can't even fathom what his reaction would look like if he were to come in contact with a full peanut.

Although we have "wasted" a year on a placebo, that year went toward helping other children with life-threatening allergies. For Hunter and our family, his treatment started just under two weeks ago - this means HOPE - this means that there is still a chance that this patch will help his tolerance. During the last food challenge, we met two wonderful boys who were enrolled in the milk patch trial. They had both been on the milk patch for one year, having been on placebo during their first year as well, and were also completing food challenges. The amount of milk that they were able to tolerate was huge in comparison to their dose just one year prior - enough so that it brought one mother to tears. Just imagine what that could do for their family's quality of life! Just imagine what it could do...

Read about the first year in this journey in blog posts #1and #2.