1. In this randomized controlled trial, omalizumab was superior to placebo in increasing the reaction threshold to food allergens among participants with multiple food allergies.
2. The most common adverse event associated with omalizumab was injection-site reaction.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Food allergy affects approximately 10% of the population, many of whom are allergic to multiple foods. Standard management involves food avoidance and emergency treatment upon accidental exposures, requiring high vigilance and impairing quality of life. Only one oral immunotherapy exists for peanut allergy, but it carries a high burden and risk of adverse events. Omalizumab, a monoclonal antibody targeting IgE, has effectively treated food allergies and atopic conditions. This phase three trial evaluated omalizumab as monotherapy for patients with multiple food allergies involving peanuts and two or more other prespecified foods. After 16 to 20 weeks of subcutaneous injections, omalizumab was superior to placebo in significantly raising the reaction threshold of single-dose challenge of peanut protein and cashew, milk, and egg. Accordingly, omalizumab also significantly increased the cumulative dose threshold. The adverse event profile was similar between omalizumab and placebo, except for injection-site reactions associated with omalizumab. The participant pool was composed mostly of children, and treatment responses were greatly variable. Nevertheless, these results demonstrated the potential of omalizumab as a monotherapy to treat patients with multiple food allergies.
Click here to read the study in NEJM
In-Depth [randomized controlled trial]: This study was a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of omalizumab in treating multiple food allergies. Patients between 1 and 55 years of age with a history of allergy to peanuts and at least two other foods in a pre-specified list were screened for eligibility. Participants were required to have a dose-limiting symptomatic reaction to an oral food challenge ≤100mg of peanut protein and ≤300mg of the two other foods. Exclusion criteria included severe asthma, severe prophylaxis to the pre-specified foods, previous immunotherapy for the pre-specified foods, or recent treatment with a monoclonal antibody. In total, 180 participants were randomized 2:1 to receive omalizumab or placebo administered subcutaneously every 2-4 weeks for 16-20 weeks, after which the food challenges were repeated. The primary outcome was the ability to ingest a single dose of peanut protein at ≥600mg without dose-limiting symptoms. Following the initial treatment period, 67% of patients in the omalizumab group were able to ingest a single dose of at least 600mg of peanut protein without dose-limiting symptoms, compared to 7% of those in the placebo group (difference of 60 percentage points; 95% Confidence Interval [CI], 47 to 70; p<0.001). Similarly, omalizumab also significantly raised the reaction thresholds to milk (66% versus 10%; difference 56 percentage points; 95% CI 30 to 74), egg (67% versus 0%; difference 67 percentage points; 95% CI, 46 to 79), and cashew (41% versus 3%; difference 38 percentage points; 95% CI, 19 to 52) compared to placebo (p<0.001). The first 60 participants who completed the initial treatment stage were enrolled in the extended 24-week open-label study. Omalizumab was associated with similar adverse event profile as placebo, except for injection-site reactions, which occurred more frequently with omalizumab. These results showed that omalizumab significantly increased reaction thresholds to peanuts and other foods to levels protective against accidental exposures.
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