2025-03-03 アメリカ国立衛生研究所 (NIH)
Participants in the OUtMATCH trial are allergic to peanuts and at least two other foods among milk, eggs, wheat, cashews, walnuts and hazelnuts. NIAID
<関連情報>
- https://www.nih.gov/news-events/news-releases/omalizumab-treats-multi-food-allergy-better-oral-immunotherapy
- https://www.jacionline.org/article/S0091-6749(24)02309-1/fulltext
オマリズマブによる多食品アレルギーの治療とオマリズマブによる多アレルゲン起立耐性失調の比較 Treatment of Multi-Food Allergy with Omalizumab Compared to Omalizumab-Facilitated Multi-Allergen OI
Robert Wood, MD∙ Stacie Jones, MD, FAAAAI∙ Jennifer Dantzer, MD, FAAAAI, MHS∙ … ∙ Lisa Wheatley, MD∙ Alkis Togias, MD∙ R. Sharon Chinthrajah
The Journal of Allergy and Clinical Immunology Published:February 2025
DOI:https://doi.org/10.1016/j.jaci.2024.12.1022
Rationale
Both omalizumab and oral immunotherapy (OIT) are used to treat multi-food allergy, but the two treatments have never been directly compared.
Methods
In OUtMATCH Stage 2, participants were randomized to receive either double-blind multi-allergen OIT and placebo omalizumab OR omalizumab/placebo OIT. Initially, all participants received 16 weeks of open-label omalizumab; at Week 9 OIT/placebo-OIT was initiated and was escalated to a maintenance goal of 1000mg for each participant’s study-specific foods. At week 16 participants transitioned to blinded injection therapy (omalizumab or placebo) for 44 weeks before being re-challenged (cumulative 8044mg protein/food). The protocol-defined primary endpoint was tolerance of ≥2000 mg (cumulative 4044mg) for all 3 foods.
Results
117 participants were included (55% male, median age 7 years). 51/58 (88%) in the omalizumab group and 30/59 (51%) in the OIT group completed Stage 2. In the intent-to-treat analysis of the primary endpoint, omalizumab was superior to OIT (success 36% versus 19%, OR 2.6, P=0.031). Superiority was also demonstrated for success for ≥2 foods (P=0.004) and numerous other secondary endpoints. There were no differences in the per-protocol analysis, which excluded dropouts (primary endpoint P=0.66). Serious adverse events (0% vs. 30.5%), AEs leading to treatment discontinuation (0% versus 22.0%), and AEs treated with epinephrine (6.9% versus 37.3%) were all more common in the OIT group.
Conclusions
Omalizumab was superior to multi-allergen OIT in the treatment of multi-food allergy. These differences were largely driven by the high rate of AEs leading to study discontinuation in the OIT-treated participants, despite receiving omalizumab treatment at the initiation of therapy.
