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

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.

Next-Generation Approaches for the Treatment of Food Allergy.

PURPOSE OF REVIEW: IgE-mediated food allergies are an increasing health concern, and current management includes food avoidance and use of emergency medications. Effective treatment of food allergy is highly desirable. Next generation approaches for the treatment of food allergy aim to improve both safety and efficacy, potentially including long-term tolerance. RECENT FINDINGS: Oral immunotherapy (OIT) and epicutaneous immunotherapy (EPIT) will likely be integrated into clinical practice as part of food allergy management in the near future. Newer approaches, such as sublingual immunotherapy (SLIT), modified proteins, lysosomal-associated membrane protein DNA (LAMP DNA) vaccines, and the use of immunomodulatory agents, are early in development and depending on results, could also become important treatment options. This is a review of novel approaches to the treatment of food allergy that are currently under investigation, including the use of SLIT, modified proteins, probiotics, Chinese herbal supplements, biologic therapies, and DNA vaccines, as well as a summary of the current status of OIT and EPIT.

Classification of Food Allergens and Cross-Reactivity.

Patients with specific food allergies are commonly sensitized to related foods, for example, shrimp with other shellfish and peanut with other legumes. In some instances, this represents a true allergy to the related food, defined as cross-reactivity, while in other instances, it represents a positive skin or IgE test only, in a patient who can eat the related food without difficulty. This is defined as cross-sensitization. It is extremely important that the clinician recognize these patterns of cross-sensitization and cross-reactivity, both to counsel patients on foods that should be avoided and to make sure that foods are not unnecessarily restricted from the diet. In fact, it is very common for patients to be instructed to avoid entire food groups based just on positive tests, which leads to unnecessary dietary restrictions with effects on food choices, nutrition, and quality of life.

Emerging therapies for food allergy.

Food allergy is a common condition for which there are currently no approved treatments except avoidance of the allergenic food and treatment of accidental reactions. There are several potential treatments that are under active investigation in animal and human studies, but it is not yet clear what the best approach may be. Here, we review approaches that are currently in clinical trials, including oral, sublingual, and epicutaneous immunotherapy, immunotherapy combined with anti-IgE, and Chinese herbal medicine as well as approaches that are in preclinical or early clinical investigation, including modified protein immunotherapy, adjuvants, DNA vaccines, and helminth administration. We discuss the importance of fully exploring the risks and benefits of any treatment before it is taken to general clinical practice and the need for clarity about the goals of treatment.