I hope your school year is off to a good start. I waited to write this e-mail until after the first few days because I knew it would be long, and I can only imagine how chaotic and busy the first few days of school are.
As you all know, our daughter, Susan, has a life threatening peanut allergy. She has had airborne and contact reactions to peanut protein in a number of settings, including on an airplane, in a movie theater and while in a gymnastics class with a child who had eaten a peanut butter sandwich on the way to the program.
As I think you all know, Susan is in a clinical trial at Lurie Children's Hospital (downtown Chicago). Because we were frightened by the risks Susan faces every time she leaves our house, we actively and aggressively pursued treatment options once we understood the seriousness of her allergy.
We were thrilled when Susan was enrolled as the second of nine subjects in the PRROTECT Clinical Trial in February of this year. This is a double-blind study of Xolair, a medication believed to inhibit the body's autoimmune response to allergens. The goal is that all study subjects (including the two control subjects who will receive placebo at the outset of the clinical trial) be able to consume 2000 mg (or eight peanuts) by the end of the clinical trial (which -- if all goes perfectly -- takes 26 weeks).
I am e-mailing you because we feel it is very important that Susan's teachers (and other staff at Northwood) understand what her experiences in the clinical trial have been like thus far -- and so that they can have some sense of what to expect in the future.
Susan's experience in the clinical trial thus far has been quite difficult. She had a delayed, multiphasic anaphylactic reaction to the peanut she consumed during the intake evaluation (all subjects had to react to a low dose of peanut in order to be enrolled in the clinical trial). After a three-month period in which Susan underwent clinic visits every two weeks to receive three injections of either Xolair or the placebo, she had an anaphylactic reaction during the initial rapid desensitization visit (in late May) and experienced another anaphylactic reaction the following day. Despite the addition of multiple medications and decreasing the rate of desensitization to peanut, Susan was never able to tolerate a clinically significant peanut dose. When school ended in June, Susan was barely tolerating a 45 mg dose of peanut. Shortly after school ended, her dose was increased to 60 mg, which she could not tolerate. She experienced hives, nausea, extreme fatigue and bouts of intense vomiting.
The timing of the rapid desensitization was far from ideal, as the school year was drawing to a close when Susan was feeling her worst. Fortunately, the 6th grade team at Northwood supported her, ensuring that she knew what she would be missing when she was absent, providing assignments and sending supportive and encouraging e-mails and text messages.
In late June (after an extremely difficult month), the Principle Investigator of the clinical trial determined that Susan had likely received the placebo and petitioned the Clinical Trial Coordinator for permission to move Susan to what is called the "Open Label Injection" arm of the clinical trial. In July, Susan essentially started the clinical trial over, beginning the build-up phase of Xolair. Even during the absolute worst of it all, Susan was steadfast in her commitment to the clinical trial -- hoping that she will not only help herself but also countless others.
Susan gave the opening remarks at the Food Allergy Research and Education Luncheon in May. I am including a link to the YouTube video. The quality of the first 30 seconds or so of the video is quite poor, but I think it captures well both why she is so committed to the clinical trial and who she is as a person. I know I am her mother, but I believe it is well-worth watching: 
Unfortunately, the most intense part of the clinical trial will begin in mid-September. And while I know the timing is far from ideal, we are hoping that Susan's 7th grade teachers can provide the same type of support that her 6th grade teachers did. (We are also hoping the rapid desensitization to peanut will not be as difficult now that Susan has definitely been receiving Xolair injections).
At this point, Susan is on a daily "maintenance dose" of 30 mg of peanut (that's 12% of a peanut). This is the highest dose Susan was able to reasonably tolerate and it is believed to be very important that she continue consuming peanut on a daily basis, or her allergy might worsen. There are many requirements regarding the daily peanut dose, including the timing of the dose (as close to 24-hour dose intervals as possible), the restriction of any and all physical activity and (once she begins updosing in mid-September) parental supervision for two-hours post dose.
Throughout the clinical trial, Susan will continue to carry Benadryl and Epi-Pens in her purse, which she keeps with her at all times. She is also wearing a Medic-Alert bracelet. Emergency responders will have access to information regarding the clinical trial should they need to access her profile through Medic-Alert.
As I think you all know, we met with the Principal, Assistant Principal, Associate Principal of Student Services and the Social Worker (I used their names) before school started to discuss the impact of the clinical trial on Susan's school attendance. Susan, my husband and I were all VERY relieved after our meeting, because it felt like we developed a very workable plan with the support of the school district.
There are three main issues:
1) timing of daily dose
2) absences for clinical trial appointments (some of which will be all day)
3) management of symptoms while at school (if necessary)
We are thankful that the 7th grade schedule is what it is, with PE and the CAPE classes the first two periods of the day. And, fortunately, Susan's Spanish immersion class and Accelerated Math class are the last two periods of the day. We have spoken with the Clinical Trial Coordinator and will schedule Susan's visits as early in the day as possible in order to try to ensure that she is back for those academically rigorous courses whenever possible.
We developed the following plan:
1) Susan will take her peanut dose at 7:30 am. Between now and the updosing (which will begin in mid-September), Susan will attend school after taking her maintenance dose at 7:30 am. She will not be able to physically participate in PE. Susan's doctors have approved of this plan because the 30 mg dose is essentially a maintenance dose. Once she begins weekly (or more frequent) updoses, she will take her peanut dose with me at approximately 7:30 am, and I will supervise her until approximately 9:30 am. As long as she is feeling well, and has no concerning symptoms, I will bring her to school in time for 3rd period.
Unfortunately, Susan will miss PE and Art and Music (her next CAPE segment). I am looking forward to collaborating with those teachers who classes she will miss entirely so that I can ensure Susan learns what she needs to learn. She is a competitive figure skater who also plays travel soccer, so fortunately the missed PE classes will not result in the loss of the only opportunity for exercise in a given day. Susan also plays viola in the MYA orchestra, and I am hopeful that we can develop a workable plan for covering what she will miss in Music class.
2) We agreed that we would do our best to schedule appointments early in the morning (so that Susan can be back for as many of her academic courses as possible), and that we will schedule them on days when there is no school (if possible). I will provide Susan's teachers with as much advance notice of her absences as possible, with the understanding that given the uncertain nature of this process, the plan can change at any time. As of now, we have the following appointments scheduled:
-- Tuesday, September 2nd at 9:30 am (this should be a 1-hour appointment)
-- Monday, September 8th at 9:30 am (this should be a 1-hour appointment)
-- Monday & Tuesday, September 15th & 16th (the first is an all-day rapid-desensitization to peanut appointment; the second day could be shorter)
3) In the Spring, when Susan was not tolerating the updoses, she experienced rapid-onset nausea followed by violent vomiting. While we are hopeful that she will fare far better now that she has received the Xolair, we did discuss a plan that includes her being allowed to leave the classroom upon her announcing that she needs to leave and a pre-designated student being sent to follow her. She will attempt to make it to the nurse's office, but understands that she can use any bathroom along the way (including the one in the Staff Lounge should she need to).
I know many of you are just meeting Susan for the first time this year. Let me assure you that she is a conscientious student and a very hard worker. She will do all that she can to keep up with her work, and, if need be, we will support her efforts with outside supports.
We are thankful beyond words for the support we received in planning the first part of Susan's 7th grade year, and look forward to working with Susan's teachers and administrators to ensure that she has the best possible school year while pursuing this potentially life-changing treatment opportunity. It is incredible to go into what is likely to be a very stressful period of the clinical trial feeling like we have the support of the school district.