A recent clinical trial has revealed that omalizumab is more effective in treating multi-food allergies compared to oral immunotherapy (OIT). The study was published in The Journal of Allergy and Clinical Immunology and focused on individuals with severe allergic reactions to even trace amounts of common food allergens. While OIT remains the most common approach for desensitizing patients to food allergens in the United States, the trial results indicate that omalizumab offers a viable alternative with fewer adverse effects.
OIT involves consuming gradually increasing doses of food allergens to reduce allergic responses. However, its effectiveness is often limited due to high rates of allergic reactions and side effects, leading many patients to discontinue treatment. The trial found that 36% of participants who received an extended course of omalizumab could tolerate at least 2 grams of peanut protein (about eight peanuts) and two other food allergens by the end of the treatment period. In contrast, only 19% of those who received multi-food OIT reached this level of tolerance. The discrepancy was largely attributed to the high incidence of allergic reactions among OIT-treated participants, which led to a quarter of them discontinuing treatment. However, when analyzing only those who completed therapy, the proportion of individuals tolerating at least 2 grams of all three food allergens was similar between both groups.
Omalizumab acts by binding to immunoglobulin E (IgE), the antibody responsible for allergic reactions, preventing it from activating key immune cells. This mechanism significantly reduces the sensitivity of these cells to allergens. The study represents the second stage of a landmark clinical trial, which previously found that a 16-week course of omalizumab enabled multi-food allergic children as young as one year old to tolerate increased amounts of peanut, tree nuts, egg, milk, and wheat. The current phase of the trial directly compared omalizumab with OIT for the first time.
Conducted at 10 locations across the United States, the study enrolled 177 children and adolescents (ages 1 to 17) and three adults (ages 18 to 55), all with confirmed allergies to less than half a peanut and similarly small amounts of at least two other common foods, including milk, egg, cashew, wheat, hazelnut, or walnut. Of the original participants, 117 proceeded to the second stage of the trial.
During the second phase, all participants initially received omalizumab injections for eight weeks. Following this period, they were randomly divided into two groups. Group A received omalizumab injections along with multi-allergen OIT for eight weeks, while Group B received omalizumab injections with placebo OIT. Subsequently, Group A switched to placebo injections while continuing multi-allergen OIT for 44 weeks, whereas Group B continued omalizumab injections with placebo OIT for 44 weeks. The study was double-blinded, ensuring that neither the participants nor the investigators knew which treatment group individuals belonged to.
The previous study, titled OUtMATCH, also confirmed omalizumab’s effectiveness in increasing food tolerance in individuals with severe multi-food allergies. OUtMATCH demonstrated that omalizumab significantly improved allergen tolerance in young children when used as monotherapy or in combination with OIT. These results further support the role of omalizumab as a safer alternative to OIT for treating multi-food allergies, particularly in individuals with a high sensitivity to allergens.
Throughout the treatment period, 29 of the 59 participants in Group A discontinued therapy. Among them, 15 stopped due to severe allergic reactions or other intolerable symptoms related to OIT, while 14 left for unrelated reasons, including an aversion to the study foods or difficulty in continuing the trial. In contrast, no participants in Group B discontinued treatment due to allergic reactions or side effects, though seven withdrew for other reasons. Ultimately, 51 of the 58 participants in Group B (88%) and 30 of the 59 participants in Group A (51%) completed therapy.
After the treatment period, participants were tested to determine their ability to consume at least 2 grams of peanut protein and two other allergens without experiencing an allergic reaction. The results showed that 36% of the original Group B participants (omalizumab-only) achieved this level of tolerance, compared to just 19% of the original Group A participants (OIT-treated). However, when assessing only those who completed therapy, both groups demonstrated an equivalent ability to tolerate the allergens.
Omalizumab proves to be a more effective and well-tolerated alternative to OIT for individuals with severe multi-food allergies. While OIT remains an option, its high discontinuation rate due to allergic reactions limits its suitability. Omalizumab offers a safer choice, especially for high-risk patients, highlighting the need for further research to enhance food allergy treatments.
References
- Wood R, Jones S, Dantzer J, Sicherer S, Wang J, Shreffler W, et al. Treatment of Multi-Food Allergy with Omalizumab Compared to Omalizumab-Facilitated Multi-Allergen OIT. Journal of Allergy and Clinical Immunology. 2025 Feb 1;155(2):AB444.
- Wood RA, Chinthrajah RS, Rudman Spergel AK, Babineau DC, Sicherer SH, Kim EH, et al. Protocol design and synopsis: Omalizumab as Monotherapy and as Adjunct Therapy to Multiallergen OIT in Children and Adults with Food Allergy (OUtMATCH). J Allergy Clin Immunol Glob. 2022 Jul 21;1(4):225–32.