Xolair Approved for Adults and Pediatric Patients With IgE-Mediated Food Allergy

The Food and Drug Administration (FDA) has approved Xolair (omalizumab) for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to 1 or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy. 

Xolair is an anti-immunoglobulin E (IgE) antibody. The approval was based on data from the phase 3, double-blind, placebo-controlled OUtMATCH trial (ClinicalTrials.gov Identifier: NCT03881696), which evaluated the safety and efficacy of Xolair in patients 1 to 55 years of age who are allergic to peanuts and at least 2 other common foods. 

The multi-stage study included patients who had experienced dose-limiting symptoms (eg, moderate to severe skin, respiratory or gastrointestinal symptoms) to a single dose of ≤100mg of peanut protein and ≤300mg protein for each of the other 2 foods (milk, egg, wheat, cashew, hazelnut, or walnut) during the screening double-blind, placebo-controlled, food challenge (DBPCFC). In the first stage, patients were randomly assigned 2:1 to receive Xolair subcutaneously or placebo for 16 to 20 weeks.

After 16 to 20 weeks of treatment, patients completed a DBPCFC. The efficacy analysis included 165 pediatric patients. The primary endpoint was the percentage of patients who were able to consume a single dose of ≥600mg of peanut protein without dose-limiting symptoms. 

Results showed the following response rates (defined as consumption of a single dose of the specified amount of food without dose-limiting symptoms) for each food challenge for Xolair-treated patients vs placebo:

• Peanut ≥600mg: 68% vs 5% (treatment difference, 63% [95% CI, 50-73]; P <.0001).
• Peanut ≥1000mg: 65% vs 0% (treatment difference, 65% [95% CI, 56-74] P <.0001).
• Cashew ≥1000mg: 42% vs 3% (treatment difference, 39% [95% CI, 20-53]; P <.0001).
• Milk ≥1000mg: 66% vs 11% (treatment difference, 55% [95% CI, 29-73]; P <.0001).
• Egg ≥1000mg: 67% vs 0% (treatment difference, 67% [95% CI, 49-80]; P <.0001).

Findings also demonstrated that 17% of Xolair-treated patients were not able to consume >100mg of peanut protein without moderate to severe dose-limiting symptoms. Additionally, in the Xolair group 18%, 22%, and 41% of patients were not able to consume >300mg of milk, egg, or cashew protein, respectively, without moderate to severe dose-limiting symptoms.

The most common adverse reactions reported were injection site reactions and pyrexia.

The effectiveness of Xolair in adults is supported by data from pediatric patients and pharmacokinetic similarity. 

Xolair should be used in conjunction with food allergen avoidance. The dose and frequency should be determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).