“The study showed significant efficacy and safety improvements in multi-allergic patients treated with omalizumab and food immunotherapy,” said co-author Kari Nadeau, MD, PhD, director of the Parker Center and professor of medicine and of pediatrics. “Multi-allergic patients are at much higher risk for anaphylactic reactions since they are allergic to more foods, and omalizumab can help change the course of therapy by making it safer and faster.”

The study included 48 children ages 4-15. Thirty-six children were randomly assigned to receive omalizumab, and 12 children to receive placebo, during oral immunotherapy. The drug or placebo was given for eight weeks before oral immunotherapy began, and also for the first eight weeks of oral immunotherapy. Immunotherapy continued without the medication or placebo for the next 20 weeks. The oral immunotherapy was tailored to patients’ individual allergies, with each child being treated for two to five of their food allergens. The foods included in the study were almond, cashew, egg, hazelnut, milk, peanut, sesame, soy, walnut and wheat, all of which are common causes of food allergies.

Children taking omalizumab were desensitized significantly faster than those dosed with placebo. They also had fewer gastrointestinal side effects during therapy, such as nausea and abdominal pain, and fewer respiratory side effects, such as shortness of breath. Twenty-two percent of oral immunotherapy doses in omalizumab patients and 54 percent of doses for placebo patients caused gastrointestinal side effects, while 0 and 1 percent of doses caused respiratory side effects in the omalizumab and placebo groups, respectively. None of the patients in the study experienced serious side effects, such as anaphylactic shock.

They can broaden their food variety and participate in more social activities without fear of a bad allergic reaction.

To maintain success of treatment for their food allergies, patients continued to eat each food daily after the study was completed. The trial found that after the nine-month immunotherapy procedure, patients continued to be able to eat the foods safely. Larger and longer clinical trials are needed to understand how tolerance develops after someone stops eating the food every day and what makes the benefits of treatment last, the researchers said. The Parker Center is now engaged in such studies.

The successful therapy made a big difference for children who participated in the trial, Chinthrajah said.

That’s certainly the case for Joshua Geller and his family. During the trial, Joshua became tolerant to milk, eggs, cashew and pistachio. (Although pistachio was not administered in the trial, some individuals who are desensitized to one nut allergen, such as cashew, develop tolerance to other nuts, such as pistachio, the study found.) Joshua is now trying many foods that he couldn’t eat in the past, according to his mom. “He’s loving everything, and he seems a lot healthier,” Kristen Geller said. “It’s completely changed our lives.”

“Patients and families say they’re so grateful,” Chinthrajah said. “They can broaden their food variety and participate in more social activities without fear of a bad allergic reaction. Kids say things like ‘I no longer sit at the allergen-free table at lunch; I can sit with my usual friends.’ These tiny things that others take for granted can open their social world.”

The team’s work is an example of Stanford Medicine’s focus on precision health, the goal of which is to anticipate and prevent disease in the healthy and precisely diagnose and treat disease in the ill.

Other Stanford co-authors of the study are lead author Sandra Andorf, PhD, director of computational biology at the Parker Center; biostatistician Natasha Purington; nurse practitioner Whitney Block; staff pharmacist Andrew Long, PharmD; research data analyst Dana Tupa; Manisha Desai, PhD, professor of medicine and of biomedical data science; and Stephen Galli, MD, professor of medicine, of pathology and of microbiology and immunology.

Nadeau is also the Naddisy Foundation Professor of Pediatric Food Allergy, Immunology and Asthma, and is a member of the Stanford Child Health Research Institute, the Stanford Cardiovascular Institute and Stanford Bio-X.

The research was funded by the National Institute of Allergy and Infectious Diseases Asthma and Allergic Diseases Cooperative Research Centers (grant U19AI104209), the Sean N. Parker Center for Allergy & Asthma Research at Stanford University, the Simons Foundation, the Myra Reinhard Foundation, and the Food Allergy Research and Education Center of Excellence. Genentech provided omalizumab and placebo omalizumab for the research at no cost.

Stanford’s departments of Pediatrics and of Pathology also supported the work.