To compare the treatment success rates of omalizumab and omalizumab-facilitated multiallergen oral immunotherapy (MOIT) among patients with multifood allergies.
Approach:
Study Design: A multicenter, double-blind, placebo-controlled trial (OUTMATCH) conducted at 10 US academic centers.
Participants: 117 participants aged 1 to 55 years with peanut allergy and at least 2 additional food allergies were enrolled.
Treatment Protocol: Participants received 16 weeks of open-label omalizumab followed by either omalizumab-facilitated MOIT or omalizumab with placebo MOIT for 44 weeks.
Endpoints: The primary endpoint was a cumulative-tolerated dose of at least 4,044 mg for each of 3 foods without dose-limiting symptoms.
Key Findings:
36% of participants receiving omalizumab met the primary endpoint compared to 19% receiving MOIT.
88% of participants receiving omalizumab completed the study versus 51% in the MOIT group.
Serious adverse events occurred in 31% of those receiving MOIT compared to 0% in the omalizumab group.
72% of participants receiving omalizumab tolerated at least 444 mg of all 3 allergens compared to 39% in the MOIT group.
Limitations:
Smaller-than-planned sample size after early stage 1 enrollment.
Selection of the primary endpoint may have been overly optimistic.
Participants may not represent the broader population with food allergies.
