Oral immunotherapy has been used for over 20 years worldwide with a great safety profile. The most common side effect from oral or sublingual immunotherapy is itchiness in the mouth. Occasionally there might be mild mouth swelling, stomach discomfort, and rashes but extremely rare to have anaphylaxis which would require an epinephrine auto-injector. Each patient is unique. The treatment with OLLEREG will be tailored specifically to each patient’s allergic sensitivity and other medical conditions.
There are several known and still undefined mechanisms of allergic development. Even with allergy shots, only around 35% of people will achieve a prolonged relief, 35% will have significant benefit but still require periodic medications, and 30% will experience no improvement in their symptoms. With OLLEREG, the effectiveness is similar to allergy shots, but without the pain, inconvenience and side effects.
EoE Food Desensitization: https://clinicaltrials.gov/ct2/show/NCT02881372
This is a single-center, prospective, pilot clinical trial in which children ages 3-17 years with eosinophilic esophagitis (EoE) who have a known food that triggers EoE flares receive oral desensitization with that specific food antigen, followed by reintroduction of that food into the diet. The purpose of this study is to investigate the safety and feasibility of oral desensitization in children with EoE so that, if determined to be safe, can be repeated on a larger scale to determine efficacy.
Q1: Has there been a clinical trial for OLLEREG on food allergy?
A1: We plan to have a clinical trial in the near future. We are currently seeking funding.
Q2: What is your protocol for food allergy treatment?
A2: Phase 1 is with OLLEREG over a 6 month period. A new dose is increased every 2 weeks. Phase 2 is with the actual food ingestion starting with 1/128th the age appropriate serving size. The patient will ingest a specific amount twice daily. This amount is doubled weekly. On the 8th week, the patient will reach the full serving size.
Q3: Can OLLEREG be done at home without a doctor’s supervision for food allergy?
A3: It will depend on the type of reaction. If the reaction is strictly hives and eczema, OLLEREG can be performed at home with monitoring by an allergist. If the reaction is anaphylaxis or if there is any concern for anaphylaxis, the first dose of each bottle needs to be performed at an allergist’s office with the ability to treat anaphylaxis. All patients are required to have an epinephrine auto-injector with demonstration of proper usage.
Q4: Is there safety and efficacy data on OLLEREG for food allergy?
A4: We are currently accumulating these data. We have many patients at different stages of Phase 1. So far, only one patient with severe shellfish allergy developed rhinitis and conjunctivitis that resolved after 30 minutes. The patient developed this brief reaction on the first spray of a new bottle during the 4th month of Phase 1.