2026-07-27 スタンフォード大学
＜関連情報＞
- https://news.stanford.edu/stories/2026/07/trial-shows-food-allergy-treatments-let-kids-eat-safely
- https://jamanetwork.com/journals/jamapediatrics/fullarticle/2851912
- https://www.nejm.org/doi/full/10.1056/NEJMoa2312382
オマリズマブまたは多アレルゲン経口免疫療法による多食物アレルギーの治療 無作為化臨床試験 Treatment of Multifood Allergy With Omalizumab or Multiallergen Oral Immunotherapy A Randomized Clinical Trial
Robert A. Wood, MD; Alkis Togias, MD; Caitlin M. Burk, MD;et al
JAMA Pediatrics Published:July 27, 2026
DOI:10.1001/jamapediatrics.2026.2910
Key Points
Question How do omalizumab and oral immunotherapy (OIT) compare in the treatment of patients with multifood allergy?
Findings In this randomized clinical trial comparing omalizumab with multiallergen OIT (MOIT) in 117 participants with multifood allergy, omalizumab was superior in terms of both efficacy and safety.
Meaning Although the intention-to-treat analysis found a higher rate of treatment success in those receiving omalizumab, there was no difference in efficacy after accounting for the high rate of study withdrawals in the group of participants treated with omalizumab-facilitated MOIT.
Abstract
Importance Food allergy is common, affecting up to 8% to 10% of children and adults. Treatment options include oral immunotherapy (OIT) and omalizumab, an anti–immunoglobulin E (IgE) monoclonal antibody.
Objective To compare omalizumab with OIT for the treatment of patients with multifood allergy.
Design, Setting, and Participants This was a double-blind, placebo-controlled, randomized clinical trial comparing omalizumab with omalizumab-facilitated multiallergen OIT (MOIT) in participants who completed stage 1 of the Omalizumab as Monotherapy and as Adjunct Therapy to Multiallergen OIT in Children and Adults With Food Allergy (OUTMATCH) trial, which led to the approval of omalizumab. The setting comprised 10 academic centers across the US. Included in this analysis were individuals aged 1 to 55 years with an allergy to peanuts and at least 2 other foods (milk, eggs, wheat, cashews, hazelnuts, walnuts). Eligibility was based on oral food challenge thresholds, requiring dose-limiting symptoms to cumulative doses of 144 mg or less of protein for peanuts and 444 mg or less for nonpeanut allergens. Data were analyzed from October 2024 to February 2026.
Interventions Participants were randomized to receive MOIT with placebo omalizumab or omalizumab with placebo MOIT. All received 16 weeks of open-label omalizumab; at week 8, active or placebo MOIT was initiated and escalated to goal doses of 1000 mg per food. At week 16, participants transitioned to blinded omalizumab or placebo injections for 44 weeks.
Main Outcomes and Measures The primary end point was cumulative tolerated dose (CTD) of 4044 mg or greater for all 3 foods. Predefined secondary end points included CTDs of 1044, 2044, 4044, 6044, or 8044 mg for 1, 2, or all 3 foods.
Results A total of 117 participants (median [IQR] age, 7 [1-29] years; 64 male [55%]) were randomized to receive active MOIT (n = 58) or active omalizumab (n = 59). A total of 30 participants (51%) receiving active MOIT and 51 (88%) receiving active omalizumab completed the study. In the intention-to-treat (ITT) analysis, omalizumab was superior to MOIT (21 of 58 [36%] vs 11 of 59 [19%]; odds ratio, 2.6; 95% CI, 1.1-6.3; P = .03), with no differences in per-protocol analyses. Omalizumab superiority for CTDs of 4044 mg or greater was also demonstrated for 2 or more foods and for several individual foods. More participants taking active MOIT experienced adverse events (serious adverse events in 18 of 59 [31%] vs 0%; events leading to discontinuation in 13 of 59 [22%] vs 0%; events treated with epinephrine (22 of 59 [37%] vs 4 of 58 [7%]).
Conclusions and Relevance Although the ITT analysis found a higher rate of treatment success in those receiving omalizumab compared with MOIT, results suggest that the difference was largely driven by the high rate of study discontinuation in the participants treated with MOIT, mostly related to adverse events.
複数の食物アレルギーの治療薬としてのオマリズマブ Omalizumab for the Treatment of Multiple Food Allergies
Robert A. Wood, M.D., Alkis Togias, M.D., Scott H. Sicherer, M.D., Wayne G. Shreffler, M.D., Ph.D. , Edwin H. Kim, M.D., Stacie M. Jones, M.D., Donald Y.M. Leung, M.D., Ph.D., +31 , and R. Sharon Chinthrajah, M.D.
New England Journal of Medicine Published: February 25, 2024
DOI: 10.1056/NEJMoa2312382
Abstract
Background
Food allergies are common and are associated with substantial morbidity; the only approved treatment is oral immunotherapy for peanut allergy.
Methods
In this trial, we assessed whether omalizumab, a monoclonal anti-IgE antibody, would be effective and safe as monotherapy in patients with multiple food allergies. Persons 1 to 55 years of age who were allergic to peanuts and at least two other trial-specified foods (cashew, milk, egg, walnut, wheat, and hazelnut) were screened. Inclusion required a reaction to a food challenge of 100 mg or less of peanut protein and 300 mg or less of the two other foods. Participants were randomly assigned, in a 2:1 ratio, to receive omalizumab or placebo administered subcutaneously (with the dose based on weight and IgE levels) every 2 to 4 weeks for 16 to 20 weeks, after which the challenges were repeated. The primary end point was ingestion of peanut protein in a single dose of 600 mg or more without dose-limiting symptoms. The three key secondary end points were the consumption of cashew, of milk, and of egg in single doses of at least 1000 mg each without dose-limiting symptoms. The first 60 participants (59 of whom were children or adolescents) who completed this first stage were enrolled in a 24-week open-label extension.
Results
Of the 462 persons who were screened, 180 underwent randomization. The analysis population consisted of the 177 children and adolescents (1 to 17 years of age). A total of 79 of the 118 participants (67%) receiving omalizumab met the primary end-point criteria, as compared with 4 of the 59 participants (7%) receiving placebo (P<0.001). Results for the key secondary end points were consistent with those of the primary end point (cashew, 41% vs. 3%; milk, 66% vs. 10%; egg, 67% vs. 0%; P<0.001 for all comparisons). Safety end points did not differ between the groups, aside from more injection-site reactions in the omalizumab group.
Conclusions
In persons as young as 1 year of age with multiple food allergies, omalizumab treatment for 16 weeks was superior to placebo in increasing the reaction threshold for peanut and other common food allergens. (Funded by the National Institute of Allergy and Infectious Diseases and others; ClinicalTrials.gov number, NCT03881696.)
