Double-Blind, Placebo-Controlled Study of E-B-FAHF-2 in Combination With Omalizumab-Facilitated Multiallergen Oral Immunotherapy

Authors

Julie Wang, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: julie.wang@mssm.edu.
Robert A. Wood, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Md.
Samantha Raymond, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.
Mayte Suárez-Fariñas, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY; Department of Genetics and Genomics Science, Icahn School of Medicine at Mount Sinai, New York, NY.
Nan Yang, General Nutraceutical Technology, Elmsford, NY; Department of Pathology, Microbiology and Immunology, New York Medical College, Valhalla, NY.
Scott H. Sicherer, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
Hugh A. Sampson, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
Xiu-Min Li, Department of Pathology, Microbiology and Immunology, New York Medical College, Valhalla, NY; Department of Otolaryngology, New York Medical College, Valhalla, NY.

Author Type(s)

Faculty

Journal Title

The Journal of Allergy and Clinical Immunology. In Practice

First Page

2208

Last Page

2216.e1

Document Type

Article

Publication Date

7-1-2023

Department

Pathology, Microbiology and Immunology

Abstract

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 enhanced, butanol purified Food Allergy Herbal Formula-2 (E-B-FAHF-2) for inducing remission in subjects undergoing omalizumab-facilitated multiallergen OIT (multi-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. After 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 4444 mg of protein after discontinuing treatment for 3 months. RESULTS: Thirty-three subjects were randomized. A total of 63.6% were desensitized to 4444 mg of protein for each allergen at 26 months, and 24.2% met the primary outcome of remission at 29 months, with no difference between the treatment groups. There was good adherence (>85%) with study medications, with no difference between the treatment groups. There was no difference in reported overall adverse events between the treatment groups. CONCLUSION: Omalizumab-facilitated multifood OIT was safe and effective, and remission was achieved in about a quarter of subjects. However, outcomes were not improved by the addition of E-B-FAHF-2.

Recommended Citation

Wang, J., Wood, R. A., Raymond, S., Suárez-Fariñas, M., Yang, N., Sicherer, S. H., Sampson, H. A., & Li, X. (2023). Double-Blind, Placebo-Controlled Study of E-B-FAHF-2 in Combination With Omalizumab-Facilitated Multiallergen Oral Immunotherapy. The Journal of Allergy and Clinical Immunology. In Practice, 11 (7), 2208-2216.e1. https://doi.org/10.1016/j.jaip.2023.03.051