The online version of this article (https://doi.org/10.1186/s13223-017-0223-8) contains supplementary material, which is available to authorized users.
Sandra Andorf and Monali Manohar contributed equally to this work
R. Sharon Chinthrajah and Kari C. Nadeau contributed equally to this work
A 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.
After 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.
Each 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.
Our 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)
Additional file 1: Figure S1. Allergen-specific IgG4/IgE ratios for various time points during the dose escalation and after 2 g maintenance dose was reached. Each line represents one participant. The dots are colored by the dose at the specific time point.
Additional file 2: Figure S2. Wheal diameter of SPTs for various time points during the dose escalation and after 2 g maintenance dose was reached. Each line represents one participant. The dots are colored by the dose at the specific time point.
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- Observational long-term follow-up study of rapid food oral immunotherapy with omalizumab
Rohun A. Kshirsagar
R. Sharon Chinthrajah
Kari C. Nadeau
- BioMed Central
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