As there is limited data on the sustainability of desensitization of multifood-oral immunotherapy (multifood-OIT), we conducted a multisite multifood-OIT study to compare the efficacy of successful desensitization with sustained dosing vs discontinued dosing after multifood-OIT.We enrolled 70 participants, aged 5-22?years with multiple food allergies confirmed by double-blind placebo-controlled food challenges (DBPCFCs). In the open-label phase of the study, all participants received omalizumab (weeks 1-16) and multi-OIT (2-5 allergens; weeks 8-30) and eligible participants (on maintenance dose of each allergen by weeks 28-29) were randomized 1:1:1 to 1?g, 300?mg, or 0?mg arms (blinded, weeks 30-36) and then tested by food challenge at week 36. Success was defined as passing 2?g food challenge to at least 2 foods in week 36.Most participants were able to reach a dose of 2?g or higher of each of 2, 3, 4, and 5 food allergens (as applicable to the participant's food allergens in OIT) in week 36 food challenges. Using an intent-to-treat analysis, we did not find evidence that a 300?mg dose was effectively different than a 1?g dose in maintaining desensitization, and both together were more effective than OIT discontinuation (0?mg dose) (85% vs 55%, P?=?0.03). Fifty-five percent of the intent-to-treat participants and 69% of per protocol participants randomized to the 0?mg arm showed no objective reactivity after 6?weeks of discontinuation. Cross-desensitization was found between cashew/pistachio and walnut/pecan when only one of the foods was part of OIT. No statistically significant safety differences were found between the three arms.These results suggest that sustained desensitization after omalizumab-facilitated multi-OIT best occurs through continued maintenance OIT dosing of either 300?mg or 1?g of each food allergen as opposed to discontinuation of multi-OIT.Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Jeff and MacKenzie Bezos, NIAID AADCRC U19AI104209.ClinicalTrials.gov number, NCT02626611.
View details for DOI 10.1016/j.eclinm.2018.12.006
View details for PubMedID 31193674
View details for PubMedCentralID PMC6537534