Stanford Pioneers Breakthrough in Allergy Treatment

For more than a decade, sister and brother Samantha and Nicholas lived a life where eating or even being near foods they are allergic to could have been fatal.
Now Samantha, 13, and Nicholas, 11, and their parents are getting used to a life where they can go to restaurants and parties without worrying. They can try new foods that at one time they couldn’t even touch.
It’s the result of a clinical trial in which the siblings participated at the Sean N. Parker Center for Allergy and Asthma Research at Stanford University that is changing the lives of kids with severe food allergies. This research – one of several different trials for food allergies at the center – specifically focused on those with multiple food allergies, which is not uncommon. About 30 percent of people with food allergies are allergic to more than one food.
The trial combined oral immunotherapy – in which tiny doses of a food allergen are consumed and gradually increased – with the asthma drug omalizumab, or Xolair, which is meant to lower an allergic response. The response was positive for more than 80 percent of patients.
It’s Life Changing
Joann, mom of Samantha and Nicholas, was hesitant about signing her kids up for the clinical trial at first, but now she hopes the treatment becomes more easily available for those with food allergies. The Peninsula family asked that their last name not be published.
Samantha is allergic to dairy, peanuts, cashews and eggs; Nicholas has allergies to sesame, eggs, cashews, peanuts, walnuts and pecans.
Both kids had several emergency room visits from being exposed to their allergens, and the idea of having them purposely ingest these foods made their mother nervous. When the kids were younger, they had severe reactions to their allergens like coughing, wheezing, swelling and hives.
Samantha started showing symptoms when she was 4 months old when ingesting baby formula caused her to break out in hives and welts all over her head. Nicholas was 3 when he first had an allergic reaction to a sesame bagel.
As the kids got older, life became difficult for them socially, says Joann.
“We would go out to eat and we would say, ‘Does your food have these ingredients?’ and we would get these funny looks from our waiter. People just weren’t as familiar with allergies as they are today,” she says. “For school birthday parties and celebrations, we would coordinate with the teachers. I would sign up to bring food a lot. We always had food with us just in case there was nothing for them to eat. Food is such a social aspect of everyday interactions.”
When Joann’s friend told her about the studies, “I thought this sounded great, but was hesitant to pursue for my kids because there still seemed to be many unknown risks.”
It was after she met Dr. Kari Nadeau, a lead researcher in the clinical trials, that she changed her mind. Nadeau happened to be attending the same family camp as Joann’s family and they had a chance to talk to her about the research.
It was approximately a year-long process that involved regular trips to the clinic and missing some school, but in the end it was worth it.
“We just have more freedom when we go out to eat. We don’t have to ask questions,” Nicholas says. “We can just order something.”
Samantha adds, “It’s really fun experimenting and trying new foods. Some of them I’ve never even heard of before. But I really like eggs.”
To maintain tolerance to their allergens, Samantha and Nicholas must eat foods they are allergic to every day. Joann says they’ve enjoyed experimenting with different recipes.
“We wanted to try new ways to eat eggs,” says Joann. “We tried egg burritos for dinner and for two months that’s all they wanted.”
Sometimes, she says, it’s hard to get used to them eating these foods.
“For 10 to 12 years, they never had these foods. They never had cake. Vegan cake is okay, but it’s different from regular cake,” Joann says. “I was still on edge in the beginning because we had lived this life for over a decade. Even having these foods in the house at first was hard for me.”
How the Therapy Works
The results of the study were published in The Lancet Gastroenterology and Hepatology last December. In it, 48 children with multiple food allergies were given small but gradually increasing amounts of the food allergens along with Xolair. In addition to lowering the allergic response, the drug speeds up the desensitization process making treatment much more bearable for families with busy lives.
More than 80 percent of the cohort who received Xolair were successfully desensitized to two or more of their allergens at the level of two grams protein for each of their allergens, says Dr. Sharon Chinthrajah, director of the clinical translational research unit at the Parker Center.
With no treatment being available to those with multiple food allergies, this research was a breakthrough.
“We were able to show that it was very safe,” says Chinthrajah. “This pilot study was very successful. The common side effects were mild in severity and less in those who received Xolair.”
In August, the research at Stanford University prompted the U.S. Food and Drug Administration (FDA) to grant South San Francisco-based biotechnology company Genentech “Breakthrough Therapy Designation” for Xolair for the prevention of severe allergic reactions from accidental exposure to food allergens. Being given this designation expedites the development and review of medicines intended to treat life-threatening diseases, and to make sure people have access to them through FDA approval.
This could open the door for more people with food allergies to receive help.
“We are very excited that the FDA is so supportive of food allergy studies and are looking forward to conducting larger studies to find where Xolair might be most effective in the treatment of food allergic patients,” Chinthrajah says. 
Peninsula Clinic Offers New Treatment
Many children are still waiting to receive treatment. There are about 2,000 people on the waitlist for the clinical trials, says Chinthrajah.
That’s why Whitney Morgan Block, a lead nurse practitioner at Stanford’s allergy research center who participated in the clinical trials, decided to open a clinic in Redwood City to help more children with food allergies.
“I felt there was a very big need, so I took it out to private practice and it’s doing well,” she says. “I can teach other allergists how to administer therapy, and I’m opening other locations across the country.”
One of biggest reasons families choose to go to her clinic, she says, is that she can administer the Xolair. Oral immunotherapy has been around for decades, but it can take six to 12 months to successfully become desensitized to allergens with that alone. With Xolair, the process speeds up to two to three months, Block says.
The downside, she says, is that Xolair is not covered by insurance since it’s still in the experimental phase, and it can cost between $3,000 to $20,000 for the whole therapy. There is a loophole: If a medical professional determines that a patient needs the drug for an asthma condition, Xolair is approved by the FDA and therefore covered by most insurances, she says.
Genentech receiving breaththrough therapy designation is great news, she says, but it still could be years before it receives FDA approval. In Block’s clinic, she’s using Xolair “off-label” – meaning it’s treating patients for something that isn’t yet approved by the FDA.
Still, some parents, like Dawn Orso of Annapolis, Maryland, aren’t willing to wait. After trying to get her daughter Amelia, 9, into the clinical trials with no success, they made seven trips to the Bay Area and paid out of pocket to receive treatment at Block’s clinic.
Allergies to nuts and sesame seeds made Amelia’s social life very difficult, Orso says. “She was beginning to feel socially isolated. She wasn’t able to go to sleep-away camps. It was hard to go to birthday parties.”
Orso took a year off from work to help her daughter go through this process. When Amelia had to miss school, her teachers provided assignments to do while traveling. She received her first treatment in August 2017 and now she’s been able to eat peanuts, hazelnuts, cashews and sesame without a reaction.
While Orso says she’s probably not going to feed Amelia a peanut butter and jelly sandwich any time soon, they no longer worry about cross-contamination from food being prepared around nuts.
Amelia’s social life is already changing. Last summer, she went on a five-day sleep-away camp that they never would have considered in the past because of her allergies.
“We used to only be able to go to two restaurants in Maryland,” Orso says. “I used to have to cook all of our meals on vacations. Now she can eat anything processed in a nut facility.”
Going through therapy at Block’s clinic has also been life-changing for Haley Rome, 12, of Alameda. She was diagnosed with a peanut allergy when she was 4, her mom Kate Rome says.
Now she’s counting the days until Halloween when she’ll be able to try different candy bars.
“Halloween is going to be so much fun this year. I can’t wait to try Twix and Kit Kats,” says Haley, with her eyes lighting up.
Kate points out that most candy bars are made in factories where there are peanuts, causing holidays like Halloween, Valentine’s Day and Easter to be extra stressful. She admits it was hard watching her daughter eat peanuts for the first time at the clinic. She started with a quarter of a peanut, then half and then a whole peanut. There were no serious reactions.
“We spent eight years keeping peanuts away from her and now we were giving her peanuts,” Kate says. “It’s such a change from what our life was before.”
Teresa Mills-Faraudo is an associate editor at Bay Area Parent.
Sean N. Parker Center for Allergy and Asthma Research at Stanford University.
U.S. Food and Drug Administration (FDA).
Whitney Morgan Block Allergy Treatment Center.


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