title: Phase 1 results of safety and tolerability in a rush oral immunotherapy protocol to multiple foods using Omalizumab.
abstract: BACKGROUND
  Up to 30% of patients with food allergies have clinical reactivity to more than one food allergen. Although there is currently no cure, oral immunotherapy (OIT) is under investigation. Pilot data have shown that omalizumab may hasten the ability to tolerate over 4 g of food allergen protein.
  
  
  OBJECTIVE
  To evaluate the safety and dose tolerability of a Phase 1 Single Site OIT protocol using omalizumab to allow for a faster and safe desensitization to multiple foods simultaneously.
  
  
  METHODS
  Participants with multiple food allergies received OIT for up to 5 allergens simultaneously with omalizumab (rush mOIT). Omalizumab was administered for 8 weeks prior to and 8 weeks following the initiation of a rush mOIT schedule. Home reactions were recorded with diaries.
  
  
  RESULTS
  Twenty-five (25) participants were enrolled in the protocol (median age 7 years). For each included food, participants had failed an initial double-blind placebo-controlled food challenge at a protein dose of 100 mg or less. After pre-treatment with omalizumab, 19 participants tolerated all 6 steps of the initial escalation day (up to 1250 mg of combined food proteins), requiring minimal or no rescue therapy. The remaining 6 were started on their highest tolerated dose as their initial daily home doses. Participants reported 401 reactions per 7,530 home doses (5.3%) with a median of 3.2 reactions per 100 doses. Ninety-four percent (94%) of reactions were mild. There was one severe reaction. Participants reached their maintenance dose of 4,000 mg protein per allergen at a median of 18 weeks.
  
  
  CONCLUSIONS
  These phase 1 data demonstrate that rush OIT to multiple foods with 16 weeks of treatment with omalizumab could allow for a fast desensitization in subjects with multiple food allergies. Phase 2 randomized controlled trials are needed to better define safety and efficacy parameters of multi OIT experimental treatments with and without omalizumab.
authors.forename: Philippe
authors.initials: P
authors.lastname: Bégin
authors.forename: Tina
authors.initials: T
authors.lastname: Dominguez
authors.forename: Shruti P
authors.initials: SP
authors.lastname: Wilson
authors.forename: Liane
authors.initials: L
authors.lastname: Bacal
authors.forename: Anjuli
authors.initials: A
authors.lastname: Mehrotra
authors.forename: Bethany
authors.initials: B
authors.lastname: Kausch
authors.forename: Anthony
authors.initials: A
authors.lastname: Trela
authors.forename: Morvarid
authors.initials: M
authors.lastname: Tavassoli
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Hoyte
authors.forename: Gerri
authors.initials: G
authors.lastname: O'Riordan
authors.forename: Alanna
authors.initials: A
authors.lastname: Blakemore
authors.forename: Scott
authors.initials: S
authors.lastname: Seki
authors.forename: Robert G
authors.initials: RG
authors.lastname: Hamilton
authors.affiliation: Allergy, Immunology, and Rheumatology Division, Stanford University, 269 Campus Drive, CCSR3215c, Stanford, CA 94305, USA. knadeau@stanford.edu.
authors.forename: Kari C
authors.initials: KC
authors.lastname: Nadeau