Methods: A total of 73 participants completed two single-center phase 1 trials evaluating the safety of OIT for multiple food allergens using a mOIT protocol (n=43) or a rapid mOIT protocol with omalizimab (n=30). In both trials, subjects were instructed to maintain daily dosing and if skin test for the allergen became negative, dosing was decreased. Participants returned yearly for follow-up food challenges.
Results: Long-term follow up data was available for 70 of 73 participants. The long-term follow-up period for participants who completed the mOIT protocol ranged from 18 to 73 months; 22 (56%) chose to consume 2g protein doses of each allergen, while 13 (33%) chose to consume between 300mg and 2g per allergen. In the rapid mOIT protocol, follow-up ranged from 11 to 46 months; 9 (30%) participants chose to consume 2g doses and 18 (60%) participants chose to consume doses between 300mg and 2g. All subjects in both groups remained desensitized to at least 2g protein of each of their food allergens on repeat food challenge, even those who chose to consume home doses as low as 300mg of their allergens three times per week.
Conclusions: Subjects who completed a mOIT protocol continue to consume regular doses that maintain desensitization to 2g of each allergen.