Abstract
BackgroundA number of clinical studies focused on treating a single food allergy through oral immunotherapy (OIT) with adjunctive omalizumab treatment have been published. We previously demonstrated safety and tolerability of a rapid OIT protocol using omalizumab in a phase 1 study to achieve desensitization to multiple (up to 5) food allergens in parallel, rapidly (7–36 weeks; median = 18 weeks). In the current long-term, observational study, we followed 34 food allergic participants for over 5 years, who had originally undergone the phase 1 rapid OIT protocol.MethodsAfter reaching the maintenance dose of 2 g protein for each of their respective food allergens as a part of the phase 1 study, the long-term maintenance dose was reduced for some participants based on a pragmatic team-based decision. Participants were followed up to 62 months through standard oral food challenges (OFCs), skin prick tests, and blood tests.ResultsEach participant passed the 2 g OFC to each of their offending food allergens (up to 5 food allergens in total) at the end of the long-term follow-up (LTFU) study.ConclusionOur data demonstrate the feasibility of long-term maintenance dosing of a food allergen without compromising the desensitized status conferred through rapid-OIT.Trial registration Registry: Clinicaltrials.gov. Registration numbers: NCT01510626 (original study), NCT03234764 (LTFU study). Date of registration: November 29, 2011 (original study); July 26, 2017 (LTFU study, retrospectively registered)
Highlights
A number of clinical studies focused on treating a single food allergy through oral immunotherapy (OIT) with adjunctive omalizumab treatment have been published
There is no FDA approved therapy for food allergies, but oral immunotherapy (OIT), a treatment in which the patient eats small but slowly increasing doses of their allergen until they can tolerate a specified dose, was shown in research settings to be successful in children and adults for single foods as well as up to five foods in parallel [10,11,12,13,14]
Participants of the long-term follow-up (LTFU) study returned to the clinic on average every 6–12 months for questionnaires, skin tests, blood tests, and oral food challenges (OFCs)
Summary
A number of clinical studies focused on treating a single food allergy through oral immunotherapy (OIT) with adjunctive omalizumab treatment have been published. Food allergy is a burden for both the individual and the family, decreasing quality of life due to anxiety of potential reactions [8]. It can be associated with increased anxiety in the child [9]. There is no FDA approved therapy for food allergies, but oral immunotherapy (OIT), a treatment in which the patient eats small but slowly increasing doses of their allergen until they can tolerate a specified dose, was shown in research settings to be successful in children and adults for single foods as well as up to five foods in parallel [10,11,12,13,14]. Studies following the participants after OIT long-term were focusing on single food OIT trials and without omalizumab as adjunct therapy [15,16,17]
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