Observational long-term follow-up study of rapid food oral immunotherapy with omalizumab

Sandra Andorf, Monali Manohar, Tina Dominguez, Whitney Block, Dana Tupa, Rohun A Kshirsagar, Vanitha Sampath, R Sharon Chinthrajah, Kari C Nadeau, Sandra Andorf, Monali Manohar, Tina Dominguez, Whitney Block, Dana Tupa, Rohun A Kshirsagar, Vanitha Sampath, R Sharon Chinthrajah, Kari C Nadeau

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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).

Keywords: Follow-up; Food allergy; Maintenance dosing; Omalizumab; Oral immunotherapy.

Figures

Fig. 1
Fig. 1
Timeline of original phase 1 trial and long-term follow-up study. Zero depicts the time at which the participant reached their 2 g maintenance dose during the original phase 1 trial
Fig. 2
Fig. 2
Number of foods in participant’s OIT. The diagonal shows the number of participants, who ingest maintenance doses of the named food. The other numbers show the number of participants with the two foods on the vertical and horizontal axis in their OIT. This is independent of other possible additional foods in the OIT. A greater number is also reflected by a darker color and a greater circle
Fig. 3
Fig. 3
Long-term maintenance doses at the end of the LTFU study. Each row shows one of the 34 participants. The red squares and the blue triangles depict that the food allergen in that column is ingested at a low long-term or a high long-term maintenance dose, respectively. The last row shows the percentage of participants that were desensitized to that food and ingesting it at a low maintenance dose at the conclusion of the LTFU. The last column shows the percentage of the food allergens per participant that the participant ingests at a low long-term maintenance dose
Fig. 4
Fig. 4
Kaplan-Meier curves of participants on a high maintenance dose over time stratified by allergen. The percentage of participants per allergen continuing on a high long-term maintenance dose is shown over time. Black lines show the latest visits of participants continuing on a high long-term maintenance dose per allergen at the end of our follow-up

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Source: PubMed

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