Omalizumab: A Novel Treatment for Multiple Food Allergies

Research Article| June 01 2024 Omalizumab: A Novel Treatment for Multiple Food Allergies AAP Grand Rounds (2024) 51 (6): 66. https://doi.org/10.1542/gr.51-6-66 Views Icon Views Article contents Figures & tables Video Audio Supplementary Data Peer Review Share Icon Share Facebook Twitter LinkedIn Email Tools Icon Tools Get Permissions Cite Icon Cite Search Site Citation Omalizumab: A Novel Treatment for Multiple Food Allergies. AAP Grand Rounds June 2024; 51 (6): 66. https://doi.org/10.1542/gr.51-6-66 Download citation file: Ris (Zotero) Reference Manager EasyBib Bookends Mendeley Papers EndNote RefWorks BibTex toolbar search toolbar search search input Search input auto suggest filter your search All PublicationsAll JournalsAAP Grand RoundsPediatricsHospital PediatricsPediatrics In ReviewNeoReviewsAAP NewsAll AAP Sites Search Advanced Search Topics: food allergy, omalizumab Source: Wood RA, Togias A, Sicherer SH, et al. Omalizumab for the treatment of multiple food allergies. N Engl J Med. 2024;390:889-899; doi: https://doi.org/10.1056/NEJMoa2312382.Google Scholar Investigators from multiple institutions conducted a randomized controlled trial to assess the effectiveness of omalizumab, a monoclonal anti-IgE antibody, in treating patients with multiple food allergies. Participants were 1–55 years old with a history of allergy to peanuts and at least 2 other foods, including cashew, milk, egg, walnut, wheat, and hazelnut. Eligibility was confirmed in all participants by skin-prick tests and by oral food challenges. For each food challenge, gradually increasing doses were given to the participant at 15–30-minute intervals and specific symptoms assessed. Only those with dose-limiting symptoms, as defined by the Consortium of Food Allergy grading scale, after a dose of ≤100 mg of peanut protein and ≤300 mg of the other allergens were continued in the trial and were randomized 2:1 to receive omalizumab or placebo subcutaneously every 2 to 4 weeks. The dose and frequency of administration of the study drugs were based on body weight and baseline IgE level. Following treatment for 16–20 weeks, the food challenges were repeated. The primary outcome was consuming a single dose of ≥600 mg of peanut protein without dose-limiting symptoms. Key secondary outcomes included consuming a single dose of ≥1,000 mg of cashew, milk, or egg protein without dose-limiting symptoms. Differences in outcomes between participants in the 2 treatment groups were compared with Fisher exact tests. Adverse events also were assessed. It was planned to enroll 225 individuals in the trial. However, enrollment was slowed by the COVID-19 pandemic, and the study was stopped after an interim analysis was conducted. Overall, 180 participants were enrolled, including 177 children and adolescents and 3 adults. The main analyses were limited to pediatric participants. The median age of these children was 7.0 years, and the median baseline IgE level was 700 IU/mL. Among 118 children who received omalizumab, 79 (67%) were able to consume a single dose of ≥600 mg of peanut protein without dose-limiting symptoms, compared to 4 of 59 (7%) of those randomized to placebo (P <0.001). Similarly, among 99 participants with cashew allergy, 28/61 (41%) of those randomized to omalizumab and 1/31 (3%) of placebo recipients consumed ≥1,000 mg without dose-limiting symptoms (P <0.001); 34/51 (67%) and 0/20, respectively, consumed ≥1,000 mg of egg protein (P <0.001), and 27/41 (66%) and 2/21 (10%), respectively, consumed ≥1,000 mg of milk protein without dose-limiting symptoms (P <0.001). Injection-site reactions occurred in 17.8% of those administered omalizumab vs 10.2% of participants randomized to placebo. One child in the omalizumab treatment group had elevated liver enzymes and was withdrawn from the study. The authors conclude that omalizumab was superior to placebo in treating food allergies in children. Dr Rosenthal has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative... You do not currently have access to this content.