Peanut Patch Trial Ups and Downs - Blog Post #2

This past Monday, we learned that our son was the first person globally to complete the PEPITES peanut patch phase 3 trial, as well as the first person globally who will begin the rollover study, PEOPLE. This rollover study guarantees my son the peanut patch for an additional two or three years. If he was on the peanut patch for the first blinded year of PEPITES, he will get another two years of patches. If he was on the placebo during PEPITES, then he will receive three years of the peanut patch. You can read about the first food challenge at the onset of the trial as well as what the first year was like here.

The peanut patch trial has had its ups and downs for our family and it is a part of our daily lives. The biggest ups were finding out he was accepted into the trial and “guessing” that he had the peanut patch and not the placebo when his back looked like giant circles of redness and hives. Until last Monday, the biggest down was the first food challenge, which I describe in the first blog post linked above. That down was emotionally hard as it hurt so badly to see my son in tears from a needle that was necessary to save his life. However, the down we experienced this week was mentally, emotionally and physically draining.

Both my husband and I were up most of the night prior, so when we woke up at 4:30am to head to Toronto, we were already tired. However, I figured we knew what to expect and that if it was placebo day or peanut day, we would all be ok. After the last skin prick test, my son’s reaction seemed to be smaller. This time, it again started out smaller but after about 10 minutes his arm was puffy and red all the way up his arm. The researcher said that this test kit seemed to do that to everyone so we were still hopeful. After his blood test, he had his first dose of “pudding”, which was 1mg of either peanut protein or placebo. He didn’t start scratching his neck right away and we were thinking that was a good sign, I was kind of excited. He mentioned an itchy lip so we figured it was peanut day. After dose two (3mg), he mentioned an itchy mouth but there was no scratching, sneezing or coughing like the previous year. I was quite hopeful that his tolerance must have gone up if he only had one symptom. The researcher was fantastic and kept monitoring his vitals and checking on him consistently. The third dose (10mg), was given and at first everything seemed ok. Then he mentioned a sore tummy - he has never mentioned a sore tummy during a previous reaction so I wasn’t sure if he was maybe just hungry. He also kept playing his game, which is always a good sign. However, he started to get hot; he started to get red; he started to get hives. The doctor came to take a look and just like the previous year, he said no epinephrine was needed. The doctor did say that it was an observed reaction so the challenge was over. He was telling the researcher to dispense Reactine when Hunter started to seem uncomfortable. The look on my husband’s face was the same as mine - give the epi please since we know he’s had peanuts - although we didn’t say anything out loud at that point. We would have used an epi-pen. The doctor looked at Hunter again and asked for the epinephrine. This all took place over the course of a couple of minutes. After the epi was given and some Reactine as well, I relaxed.

As a mom, I know when something isn’t right. I sat down with Hunter so I could monitor him because he didn’t look like his symptoms were improving. He was fidgeting, mopey and still pretty red, so I mentioned that he seemed to be getting worse. The researcher took his vitals again and then checked his oxygen levels, which were decreasing. The doctor was called in and he checked him over and said Hunter was stable. Hunter’s heart rate wasn’t what it should be and he was scratching everywhere - his legs, his head, his arms - his hives were turning into all over redness and a lacy rash. Then the wheezing and sneezing started and Hunter said it was harder to breath. The doctor asked for another syringe of epinephrine. This upset Hunter, because he thought one needle was what happened when he was having a reaction. The doctor ordered another Reactine and prednisone. Almost immediately, we could see his symptoms improving. He was happy, his oxygen was back up to 99 and his itching was gone although the redness and hives took a bit longer to resolve. The doctor also decided not to give the prednisone since the second epi worked so well, but he did ask us if we had epi-pens for our drive home just in case.

None of his previous reactions ever required 2 doses of epi. This again proves why we never get complacent; why we always check labels, call companies, always carry 2 epi-pens, ask for accommodations, and advocate at school, recreation centres and with family and friends. His tolerance went from about 1/15th of a peanut to about 1/50th of a peanut.

Although Hunter didn’t grasp what this meant. I was deflated. What did this mean? We were sure he was on the peanut patch. My husband and I bounced so many different scenarios back and forth while we waited for Hunter to be discharged. Was he on the placebo and his tolerance got worse? Was he on the peanut patch and it didn’t work? Was he on the peanut patch and the combined amount of peanut protein between the patch and the amount he ingested was actually higher than last time? I asked if we would find out which patch he was on after our next challenge day, as this was what we were told initially. Some more bad news: because he was the first to complete the trial, we may not know for quite a while as they can wait to unblind everyone until the last person completes the trial. This means we may not know for another six months or more. Until that time, we have the hope that the next couple years on the peanut patch will help. Unfortunately, the rollover study involves more skin prick tests and blood tests than the first year and another one or two more food challenges.

Part of me hopes he was on the placebo and even though that means two more rounds of food challenges over the next three years, he will get those three years on the peanut patch. Another part of me hopes that he was on the peanut patch for this past year so that he only has to go through one more food challenge at the end of the PEOPLE study. Yet, in hoping that, I also must believe that his tolerance did go up because the ingested amount and the patch amount combined in his system, but if that’s not the case then what will two more years on the peanut patch do?

Hunter wants to help other kids like him, which he’s said since the start, so we continue, even though we are deflated and emotionally drained that this food challenge went so badly. There is still a tiny chance that the patch will work and help increase his tolerance. Even a tiny chance means we don’t give up. Although it’s not fun for Hunter and he doesn’t like getting his skin pricked and prodded, he’s a resilient little boy. He’s also excited that he gets safe donuts after each appointment, which are far better then Tim Hortons anyway.

Read more about this journey in blog post #3.