Discovering New Uses for an Asthma Drug in Maryland
RCT for Treatment of Food Allergies
https://www.nejm.org/doi/full/10.1056/NEJMoa2312382
John Hopkins Institute for Clinical and Translational Research
Principal Investigator: Robert A. Wood, MD
This study sought to investigate if omalizumab, an injectable, FDA-approved medication for the treatment of asthma and other allergic conditions, could protect patients with multiple, severe food allergies from potentially life-threatening reactions. This study was groundbreaking in using an existing medication with a proven safety profile, especially when considering the prevalence and limited options for the treatment of food allergies. In fact, up to 8% of children have at least one food allergy, and up to 86% of these are allergic to more than one food.
This condition requires constant vigilance and carries significant risk as well as detrimental effects on patient and family quality of life. For decades, management of food allergies has mostly relied on avoidance and emergency treatment with epinephrine when an accidental exposure occurs.
The study compared the effects of 16-20 weeks of omalizumab injections to placebo in 180 participants down to the age of one year who had severe allergies to peanut and at least two other foods. Results showed that 67% of patients treated with omalizumab were able to tolerate 600 mg or more of peanut protein – equal to about 2.5 peanuts. The researchers also found that omalizumab increased participants’ threshold reactivity not just to peanut but to other common food allergens – milk, egg, wheat, cashew, walnut and hazelnut – to levels that would protect against reactions after accidental exposure. The study culminated in February 2024 with a New England Journal of Medicine publication and, most importantly, FDA approval of omalizumab for the treatment of food allergy.
Prior to this study, there was only one FDA-approved treatment for food allergies, an oral immunotherapy product approved only for peanut allergy that had limited effectiveness.
The study was designed, funded, and conducted as a unique collaboration between the National Institute of Allergy and Infectious Diseases, the Consortium for Food Allergy Research, and industry. It was supported by the Johns Hopkins Institute for Clinical and Translational Research.
This study was awarded a 2025 Distinguished Clinical Research Achievement Award by the Clinical Research Forum.