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Double-blind, placebo-controlled study of E-B-FAHF-2 in combination with omalizumab-facilitated multi-allergen oral immunotherapy.
Journal of Allergy and Clinical Immunology in Practice 2023 April 21
BACKGROUND: Oral immunotherapy (OIT) is limited by adverse events, and most patients require continued treatment to maintain their increased threshold. Adjunctive treatments have been explored to increase the safety and efficacy of OIT.
OBJECTIVE: This study aimed to determine the safety and efficacy of E-B-FAHF-2 for inducing remission in subjects undergoing omalizumab-facilitated multi-allergen OIT.
METHODS: In this double-blind, placebo-controlled clinical trial, subjects were randomized 1:1 to receive either E-B-FAHF-2 or placebo, starting 2 months before OIT and continuing throughout OIT. All subjects received a 4-month course of omalizumab, starting 2 months before OIT through the 2-month OIT build-up phase. Following 24 months of multi-OIT (maintenance dose of 1000 mg of each allergen), desensitization and remission were assessed. The primary objective was to determine if subjects in the E-B-FAHF-2 group (EOIT) were more likely than the placebo group (OIT) to develop remission to all 3 allergens treated with multi-OIT, as defined by the absence of dose-limiting symptoms to a cumulative dose of 4,444 mg protein after discontinuing treatment for 3 months.
RESULTS: Thirty-three subjects were randomized. 63.6% were desensitized to 4444mg protein for each allergen at 26 months, and 24.2% met the primary outcome of remission at 29 months, with no difference between treatment groups. There was good adherence (>85%) with study medications, with no difference between treatment groups. There was no difference in reported overall adverse events between treatment groups.
CONCLUSION: Omalizumab facilitated multi-food OIT was safe and effective, and remission was achieved in about a quarter of subjects. However, outcomes were not improved by addition of E-B-FAHF-2.
OBJECTIVE: This study aimed to determine the safety and efficacy of E-B-FAHF-2 for inducing remission in subjects undergoing omalizumab-facilitated multi-allergen OIT.
METHODS: In this double-blind, placebo-controlled clinical trial, subjects were randomized 1:1 to receive either E-B-FAHF-2 or placebo, starting 2 months before OIT and continuing throughout OIT. All subjects received a 4-month course of omalizumab, starting 2 months before OIT through the 2-month OIT build-up phase. Following 24 months of multi-OIT (maintenance dose of 1000 mg of each allergen), desensitization and remission were assessed. The primary objective was to determine if subjects in the E-B-FAHF-2 group (EOIT) were more likely than the placebo group (OIT) to develop remission to all 3 allergens treated with multi-OIT, as defined by the absence of dose-limiting symptoms to a cumulative dose of 4,444 mg protein after discontinuing treatment for 3 months.
RESULTS: Thirty-three subjects were randomized. 63.6% were desensitized to 4444mg protein for each allergen at 26 months, and 24.2% met the primary outcome of remission at 29 months, with no difference between treatment groups. There was good adherence (>85%) with study medications, with no difference between treatment groups. There was no difference in reported overall adverse events between treatment groups.
CONCLUSION: Omalizumab facilitated multi-food OIT was safe and effective, and remission was achieved in about a quarter of subjects. However, outcomes were not improved by addition of E-B-FAHF-2.
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