www.foodallergy.org #ContainsCourage
DECEMBER 2018 NEWSLETTER
A publication of FARE, Food Allergy Research & Education
Join Our CONTAINS: COURAGE ™ Campaign. Go to www.foodallergy.org to learn more.
In This Issue: Leadership Letter
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Campaign Partners
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Trailblazing a Treatment in Clinical Trial
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Research Update: Oral Immunotherapy & Prevalence
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A publication of FARE, Food Allergy Research & Education
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foodallergy.org
LEADERSHIP LETTER
Dear Friends of FARE,
Lisa Gable Chief Executive Officer
We’re excited to introduce a new direction for FARE that will carry our message to new allies and new places. Our CONTAINS: COURAGE™ Campaign is a transformative five-year fundraising and awareness campaign supporting families living with food allergies and educating ALL communities about the disease. CONTAINS: COURAGE™ will raise a historic amount of funding for research, therapies and treatments to reverse the rise of food allergies, and ultimately find a cure. We will extend our reach and service through exciting community engagement opportunities nationwide. Through our CONTAINS: COURAGE ™ Campaign, FARE will host activities in 10 cities each year, scaling up over the next five years by partnering with donors, sponsors, pediatricians, school districts, universities and non-profits.
Thank You, CONTAINS: COURAGE™ Inaugural Partners FARE extends its deepest appreciation to the 2018 Inaugural Partners of the CONTAINS: COURAGE™ Campaign. Thank you to the following partners for their commitment to supporting FARE’s mission:
• The Bunning Family • David A. Crown
We know our kids are not problems to be fixed; they are assets to be gained. The CONTAINS: COURAGE ™ Campaign will amplify the powerful voices of our children. In this newsletter, we meet one of these young storytellers. Fifteen-yearold Tessa Grosso describes her journey participating in a 2012 clinical trial to treat multiple food allergies. By taking part in early research on multiple allergen oral immunotherapy, this brave young woman has helped make many lives safer.
• DBV Technologies
We also recognize the dedication of Tessa’s mom, Kim Yates, who was honored on Dec. 3 at the Food Allergy Ball in New York City for her fundraising and community building on behalf of Stanford University’s Sean N. Parker Center for Allergy Research, and for her commitment to making specialized food allergy care more accessible. FARE is fortunate that Kim will be joining our Board of National Ambassadors as a co-chair.
• Ira and Diana Riklis Family
We are grateful as well to welcome Alan and Kim Hartman, dedicated supporters of food allergy research who will bring a wealth of healthcare industry expertise to FARE’s Board of Governors. Also joining FARE as medical advisors in support of the Contains: Courage™ Campaign are four well-known researchers in the food allergy space: Dr. Ruchi Gupta (Policy, Education and Public Health), Dr. Kari Nadeau (Innovation), Dr. Wayne Shreffler (Research) and Dr. Brian Vickery (Patient Experience). We hope you will join forces with us to advance the critical work we are doing for families across America. May your holidays be joyous and safe. Warmest regards,
Lisa Gable
• Jaffe Family Foundation • Anna-Maria and Stephen Kellen Foundation • OWYN – Only What You Need
“
I finally realized that I am
NOT ALONE in this journey.
– Shaina, age 22
TRAILBLAZING A TREATMENT IN
CLINICAL TRIAL Tessa Grosso grew up with allergies to milk, egg, wheat, nuts, shellfish, and more. Her allergens were so hard to avoid and her reactions so severe that she was assigned an aide at school to help her stay safe. Today, at age 15, Tessa eats freely at restaurants, parties, even school lunch since she has been treated for her food allergies. She still avoids some foods, reads ingredients, and will always carry epinephrine, but she no longer lives in fear as if she’s navigating a minefield. “For me it went beyond just the dietary restrictions. It really had an impact on me socially. At school, I didn’t get to hang out with friends at lunch since I had to sit with my aide who kept me safe. Sleepovers were out of the question, and birthday parties were just not that fun; they always ended with cake, and I would have to pull out my ‘special’ cupcake. Being allergic to so many foods, there was always the fear that there would be peanut butter, milk or something dangerous lurking somewhere.” The transformation from avoidance at all costs to eating allergens every day was a phase 1 clinical trial at Stanford University that combined multiple allergen oral immunotherapy with Xolair® (omalizumab), an injectable drug that targets IgE antibodies to blunt reaction symptoms. Tessa’s mother, Kim Yates, helped organize a coalition of food allergy families that raised funds for the trial, which included 35 patients. Kim, this year’s honoree at the 21st Annual Food Allergy Ball, now works to make specialized food allergy care more widely available. After food challenges for milk, egg, wheat, peanut and almond, Tessa embarked on four months of updosing, progressing from a few small grains up to more than a FARE+Well Newsletter Dec. 2018
serving of each food daily. “It was the most terrifying thing in the world,” she explains. “On the first day walking into the hospital, I looked at my mom and said ‘If I die, this is your fault.’ The first time I ate a cracker, when I got to a high enough dose to eat real food, I held the cracker in my hand for 15 minutes. My entire life I had been told that this was poison to me, so to hold it in my hand and eat it was unfathomable.” In May 2012, Tessa became the first person desensitized to five allergens simultaneously with the use of Xolair. While she was delighted with the new foods she could eat, “it was always about safety and just living a carefree life.” Her new freedom has liberated her entire family. Tessa recalls, “It was really difficult. My sisters watched me almost die multiple times, which was traumatic for me but also traumatic for them.” Lingering effects from that trauma remains a challenge, but Tessa is much less anxious than before the trial. “Looking back now,” she says, “It’s the best thing that I’ve done in my life. Seeing how many families we’ve met and become close with, I realize that the clinical trial has so much more meaning than just my own safety. I’ve been able to connect with people who understand me, and I understand them. And being able to help them, even just by talking, has been really amazing.” Flanked by her sisters Reese and Alyssa, Tessa Grosso celebrates her first bagel. Tessa was desensitized to milk, egg, wheat, peanut and almond in 2012. 3
RESEARCH UPDATE:
ORAL IMMUNOTHERAPY & PREVALENCE
Peanut oral immunotherapy (OIT) Results of a phase 3 trial of peanut OIT in children and adolescents with peanut allergy – the largest peanut OIT trial to date -- were published in the New England Journal of Medicine on Nov. 18. Known as the PALISADE trial, the study met its primary endpoint, with treatment resulting in a significant increase in the amount of peanut protein tolerated compared to placebo. AR101 is Aimmune Therapeutics’ oral immunotherapy for desensitization of patients with peanut allergy, offering protection against accidental consumption. According to the study’s findings, 67 percent of AR101 patients tolerated a single dose of at least two peanuts after 9-12 months of treatment, and half tolerated the equivalent of seven or eight peanuts total. Treatment also reduced the number and severity of allergic reactions in the exit food challenge. Study participants were primarily between 4-17 years old, though some participants were as old as 49. One-quarter were given a placebo. By the end of 2018, Aimmune plans to submit its application to the U.S. Food and Drug Administration for approval. Wheat OIT Funded by FARE and others, a multi-center clinical trial of wheat OIT has been published online in the Journal of Allergy and Clinical Immunology. Researchers treated 46 patients, ages 4 - 22, who reacted to small doses of wheat with severe symptoms. One group consumed gluten flour for two years, starting with very small amounts and escalating to a low daily dose of about 1.4 grams of wheat protein per day. The other group received placebo for one year before starting wheat OIT up to a high daily dose, about 2.7 grams. After the first year, more than half of the low-dose treatment group could tolerate about 4.4 grams of gluten, the amount of protein found in one to two slices of bread. No one taking placebo could tolerate the challenge dose. Children and FARE+Well Newsletter Dec. 2018
young adults who consumed the higher daily dose of gluten for one year were more likely to become desensitized than those who consumed a lower dose for two years. Compared to a study of egg OIT that used a similar daily dose of egg protein, the low-dose wheat OIT was less effective in allowing patients to tolerate a large challenge dose (7.4 grams), and fewer wheat OIT participants were able to discontinue daily dosing and remain desensitized. Treating wheat allergy with OIT may require higher maintenance doses and, perhaps, longer courses of treatment. The authors report that the safety of wheat OIT is comparable to the safety of OIT for other foods. Childhood food allergy prevalence New survey results for more than 38,000 children living in the U.S. indicate that food allergies affect about 5.6 million U.S. children – nearly 8 percent – of which more than onethird are allergic to multiple foods. Published in Pediatrics by researchers from Ann & Robert H. Lurie Children’s Hospital of Chicago, the study found that one in five children with food allergy required emergency room care during the past year for a life-threatening reaction to food, and 42 percent reported that their food allergy had caused at least one ER visit. Only 40 percent of children with food allergies had a current prescription for epinephrine auto-injectors. Affecting about 1.6 million children, allergy to peanut was most commonly reported, followed by allergy to milk (1.4 million), shellfish (1 million), tree nut (900,000), egg (600,000), fin fish (400,000), wheat (400,000) and soy (400,000). Sesame, the ninth most common food allergen, affects about 150,000 children, and the study’s authors recommend that U.S. allergen labeling laws be expanded to require sesame labeling. As in a previous study published in 2011, the current study found that food allergy prevalence varied among racial and ethnic groups, with black children more likely to have food allergies than white children and more likely to have multiple food allergies than children of other races and ethnicities. 4