In numerous studies, oral immunotherapy (OIT) has successfully desensitized a significant number of individuals with food allergies, with most able to ingest more of the food protein than prior to treatment. However, the desensitization process can take months, and patients can experience allergic reactions. Led by Drs. Lynda C. Schneider and Andrew Mac Ginnittie, researchers at Boston Children’s Hospital/Harvard Medical School conducted a pilot study to determine whether combining OIT with omalizumab (Xolair®), an asthma medication, might speed up the desensitization process and reduce the number and severity of allergic reactions during treatment. The study evaluated this treatment regimen in 13 children with peanut allergy who were at high risk for severe reactions.
This study, which was co-funded by FARE and featured in the December 2013 issue of the Journal of Allergy & Clinical Immunology, had encouraging results. Before treatment, all 13 children failed an oral food challenge, during which they were fed peanut flour in doses of 100mg or less. Within a median period of eight weeks of combination therapy, 12 of the children were able to reach the maintenance dose, 4000mg of peanut flour per day. They then stopped taking omalizumab and continued on the maintenance dose. A final oral food challenge showed that all 12 were able to tolerate 8,000mg of peanut flour, the equivalent of 20 peanuts. During the maintenance phase, most patients had no reactions or only mild reactions, but three required treatment with epinephrine. The researchers believe that longer treatment with omalizumab might reduce the number of reactions.
These results are promising, but larger studies that include a comparison group not treated with Xolair® must be conducted to determine the effectiveness and safety of this approach. A randomized trial of milk OIT/Xolair® with 56 participants, performed at Mount Sinai (NY, NY), Johns Hopkins (Baltimore, MD) and Stanford University (Stanford, CA) is near completion. Additionally, FARE recently approved funding for a new clinical trial, the PRROTECT study (“Peanut Reactivity Reduced by Oral Tolerance in an anti-IgE Clinical Trial”), which is recruiting 36 patients at four sites – Boston Children’s/Harvard, Children’s Hospital of Philadelphia/University of Pennsylvania, Stanford University (Stanford, CA), and Lurie Children’s Hospital/Northwestern University (Chicago). For more information, please visit this link on ClinicalTrials.gov.