OUtMATCH
Trial question
What is the role of omalizumab in patients with multiple food allergies?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 177
177 patients (77 female, 100 male).
Inclusion criteria: patients, aged 1-55 years, with a history of allergy to peanuts and at least two other trial-specified foods.
Key exclusion criteria: poorly controlled or severe asthma; history of severe anaphylaxis to patient-specific foods; previous immunotherapy for any of the protocol-specified foods; or monoclonal antibody therapy within 6 months before screening.
Interventions
N=118 omalizumab (subcutaneous dose based on weight and total IgE levels every 2-4 weeks for a total of 16-20 weeks).
N=59 placebo (subcutaneous matching placebo every 2-4 weeks for a total of 16-20 weeks).
Primary outcome
Successful consumption of peanut protein (a single dose of 600 mg) without dose-limiting symptoms at week 16
67%
7%
67.0 %
50.3 %
33.5 %
16.8 %
0.0 %
Omalizumab
Placebo
Significant
increase ▲
NNT = 1
Significant increase in successful consumption of peanut protein (a single dose of 600 mg) without dose-limiting symptoms at week 16 (67% vs. 7%; AD 60%, 95% CI 47 to 70).
Secondary outcomes
Significant increase in successful consumption of cashew protein (a single dose of 1,000 mg) without dose-limiting symptoms at week 16 (41% vs. 3%; AD 38%, 95% CI 19 to 52).
Significant increase in successful consumption of egg protein (a single dose of 1,000 mg) without dose-limiting symptoms at week 16 (67% vs. 0%; AD 67%, 95% CI 46 to 79).
Significant increase in successful consumption of milk protein (a single dose of 1,000 mg) without dose-limiting symptoms at week 16 (66% vs. 10%; AD 56%, 95% CI 30 to 74).
Safety outcomes
No significant differences in adverse events, treatment-related adverse events.
Conclusion
In patients, aged 1-55 years, with a history of allergy to peanuts and at least two other trial-specified foods, omalizumab was superior to placebo with respect to successful consumption of peanut protein (a single dose of 600 mg) without dose-limiting symptoms at week 16.
Reference
Robert A Wood, Alkis Togias, Scott H Sicherer et al. Omalizumab for the Treatment of Multiple Food Allergies. N Engl J Med. 2024 Mar 7;390(10):889-899.
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