Advances in Immunotherapy for Multiple Food Allergens: Research Partnership with UCLA

May 2018

Sean N. Parker Center for Allergy and Asthma Research at Stanford University staff, Julie Bitler, Divya Kumar, and Dr. Sharon Chinthrajah, with trial participant.

About 40% of children with food allergies have multiple allergies. Recently published study results of OIT in multi-allergic patients are promising, but we continue to have important questions regarding durability of desensitization. To better answer some of these questions, we have partnered with UCLA to conduct a multi-OIT trial with omalizumab. 

In the United States, food allergy is estimated in approximately 5-8% of young children and is projected to increase. There is currently no FDA-approved therapy and management includes education, avoidance of the causative allergen, and prompt treatment on accidental exposure. The Sean N. Parker Center for Allergy and Asthma Research at Stanford University has been tirelessly working towards increasing research in this area and finding ways to prevent and treat food allergies. Our scientists and clinicians have been working towards understanding the mechanisms of underlying food allergy and to translate this knowledge into safe and effective therapies.

UCLA collaborator, Stacey Zedeck, RN, CCRC, and trial participant

Oral immunotherapy (OIT) is a novel treatment that has shown promise in clinical trials in desensitizing individuals to food allergies. Although mild and moderate allergic (and rarely, anaphylaxis) reactions occur, it has been shown to be safe and effective in clinical settings with trained personnel. One of the major drawbacks of OIT is the lengthy treatment period (months to years) and frequent clinic visits necessary for successful desensitization. In 2011, Dr. Nadeau and a collaborative team showed, for the very first time, that treatment length in patients with milk allergy could be reduced from months to weeks with the use of omalizumab in combination with OIT. Omalizumab is a drug that is FDA-approved for asthma and for chronic idiopathic urticaria (hives). It blocks activation of a key molecule (IgE) involved in food allergy.

About 40% of children with food allergies have multiple allergies. OIT in multi-allergic patients has additional concerns and drawbacks. These patients are at much higher risk for anaphylactic reactions and length of treatment could be much longer than those with single allergies. In another major advance in 2014, results of a study conducted by the Center showed that it was possible to successfully desensitize patients with multiple allergies with OIT (multi-OIT) plus omalizumab. Compared to OIT alone, the study found that treatment of multi-allergic patients with multi-OIT plus omalizumab reduced time to desensitization by about 67 weeks —  a very significant decrease. The study also indicated that multi-OIT plus omalizumab is safe and feasible for those with multiple allergies.

The Center recently published a large controlled study of multi-OIT with omalizumab funded by the NIH as a follow-up to earlier pilot studies. In this study, children with multiple allergies received either omalizumab and oral immunotherapy to 2-5 food allergens or placebo treatment (controls). At the end of the 9-month trial, 83% of children who had received omalizumab could tolerate at least 2 grams of 2 different food allergens, whereas only 33% receiving placebo reached the same level of tolerance. It also showed that the therapy was safe in patients with multiple allergies. The Center has recently completed another large controlled study of patients with multiple allergies conducted at 7 US sites to evaluate the safety, effectiveness, and the robustness of the standardized multi-OIT protocol. This was funded by the Bezos Family Foundation and other philanthropists. Results of the study are forthcoming.

An area that is still under investigation is the durability of desensitization. Earlier studies indicate that in a subset of patients continued ingestion of an allergen is necessary for sustaining desensitization. A number of questions remain. For example, what is the percentage of patients who maintain desensitization without continued ingestion of allergen after cessation of treatment? In those who require continued ingestion of allergen, what is the long-term maintenance dose needed? To answer some of these questions, our Center conducted a follow-up study of patients from the earlier 2014 multi-OIT study (for a median of 4 years) and it was found that either a 300 mg maintenance dose or a 2000 mg maintenance dose was as effective in maintaining desensitization. This is encouraging, as many children find it difficult to consume a high maintenance dose of each food allergen on a regular basis. A lower maintenance dose would likely increase compliance. Data from the recently completed multi-center study will also provide us further information to answer these questions.

One goal of our research is to cure food allergies by achieving sustained desensitization without continued ingestion of allergen after cessation of treatment. To better understand the differences between temporary desensitization and permanent desensitization, we have partnered with UCLA to conduct a multi-OIT trial with omalizumab to identify the immunological mechanisms using minimal dose maintenance therapy (MIMIX). The MIMIX clinical trial is currently being conducted at Stanford and UCLA. The research team at Stanford is very grateful for our collaboration with UCLA’s Dr. Maria Garcia and Dr. Rita Kachru, both specialists in allergy and immunology, and the assistance of clinical research coordinator Stacey Zedeck, RN, CCRC. We are very excited about this partnership and look forward to analyzing the data.

The MIMIX study was made possible by significant philanthropic support. We continue to seek funding to continue follow-up research of these patients. To learn more about this giving opportunity, please contact Lindsey Hincks.

By Vanitha Sampath

Vanitha Sampath received her PhD in Nutrition from the University of California at Davis. At the Sean N. Parker Center for Allergy and Asthma Research, as a medical writer and content manager, she enjoys being in the midst of groundbreaking research in asthma and allergy and is committed to communicating the scientific advances of the Center and spreading awareness of its mission and vision. 

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