The online version of this article (https://doi.org/10.1186/s13223-017-0224-7) 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
Clinical trials using oral immunotherapy (OIT) for the treatment of food allergies have shown promising results. We previously demonstrated the feasibility of desensitization for up to 5 food allergens simultaneously through OIT. In this observational study, we report the findings of long-term follow-up (LTFU) of the participants treated through a single site OIT phase 1 trial.
The participants (n = 46) were followed up to 72 months since the time they reached 2 g maintenance dose per food in the initial phase 1 trial. During the long-term maintenance dosing, participants continued or reduced the initial maintenance dose of food allergen protein to high (median 2 g protein) vs. low (median 300 mg protein). Participant follow-up included clinical monitoring, standardized OFCs, and in some cases, skin prick tests and measurement of allergen-specific IgE and IgG4.
Irrespective of the high vs. low long-term maintenance dose during LTFU, all participants were able to ingest 2 g protein of each food allergen protein during OFCs performed at the end of our LTFU.
Our LTFU cohort of food OIT participants from a single site, phase 1 OIT study, supports the feasibility of sustained desensitization through long-term maintenance dosing.
Trial registration Registry: Clinicaltrial.gov. Registration numbers: NCT01490177 (original study); NCT03234764 (LTFU study). Date of registration: November 29, 2011 (original study); July 26, 2017 (LTFU study, registered)
Additional file 1: Figure S1. Coexistence of food allergies in LTFU cohort. The boxes on diagonal indicate the number of participants on maintenance dose of the respective food. The numbers in the rest of the boxes indicate the number of participants with the two foods-one from vertical and the other from horizontal axis in their OIT. The data imply coexistence of certain food allergies.
Additional file 2: Table S1. Summary of allergic reactions as adverse events in LTFU study.
US Department of Health and Human Services. Common terminology criteria for adverse events (CTCAE) version 4.0. 2009. http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. Accessed 6 July 2017.
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- Feasibility of sustained response through long-term dosing in food allergy immunotherapy
Rohun A. Kshirsagar
R. Sharon Chinthrajah
Kari C. Nadeau
- BioMed Central
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