Real-World Study Supports Omalizumab for Food Allergy Management

Key Clinical Takeaways: 

• Most patients treated with omalizumab successfully tolerated clinically meaningful amounts of allergenic foods during oral food challenges.
• Dietary introduction of the challenged food was permitted after 92% of oral food challenges.
• Higher baseline total immunoglobulin E levels and more intensive dosing were associated with better treatment response.

Real-world data suggest that omalizumab can substantially improve food tolerance in patients with immunoglobulin E-mediated food allergy, enabling most patients to introduce previously allergenic foods into their diets following successful oral food challenges.

The retrospective study evaluated outcomes among patients treated with omalizumab before undergoing oral food challenges in routine clinical practice. Omalizumab is marketed as Xolair and has biosimilar products available, including Omalizumab-igec (Omlyclo).

Most Patients Successfully Completed Food Challenges

Investigators reviewed records from 51 patients who underwent 73 oral food challenges after initiating omalizumab therapy.

Patients had a median age of 9 years (range, 1-23 years), and 45% were female. Median baseline total immunoglobulin E concentration was 512 IU/mL.
Milk (27 challenges), egg (23 challenges), and wheat (9 challenges) accounted for 81% of all oral food challenges.

Nearly all patients (95%) had a documented history of allergic reactions to the challenged food, and every challenged food demonstrated positive allergen-specific immunoglobulin E testing before treatment.

Oral food challenges were performed after a median of 7 months of omalizumab therapy.

Among food challenges targeting at least 6000 mg of food protein, 89% of patients successfully consumed at least 1000 mg, 86% tolerated at least 2000 mg, 75% tolerated at least 4000 mg, and 66% successfully reached the full 6000 mg target dose.

Adverse Reactions Were Generally Manageable

Allergic reactions occurred during 45% of oral food challenges. Most reactions were mild and treated with antihistamines, which were administered during 21 challenges. Only 2 patients required epinephrine treatment.

Following the oral food challenge, clinicians permitted dietary introduction of allergenic food after 92% of challenges, suggesting that many patients were able to incorporate previously avoided foods into their regular diets.

Factors Associated With Better Response

Investigators identified several baseline characteristics associated with improved treatment response. Patients with higher total immunoglobulin E concentrations, lower allergen-specific immunoglobulin E–to–total immunoglobulin E ratios, and those receiving omalizumab every 2 weeks rather than every 4 weeks were more likely to achieve favorable outcomes.

Higher weight-adjusted omalizumab doses administered over a 4-week period were also associated with greater treatment success.

Implications for Managed Care

The findings provide important real-world evidence supporting omalizumab use following its approval for food allergy.

For managed care stakeholders, successful dietary introduction after treatment may reduce the burden of lifelong food avoidance, improve quality of life, and potentially decrease the risk of accidental allergic reactions. The study also suggests that patient-specific factors—including immunoglobulin E profiles and dosing strategies—may help identify individuals most likely to benefit from treatment.

Conclusion

In routine clinical practice, omalizumab enabled most patients undergoing oral food challenges to tolerate meaningful amounts of allergenic foods and subsequently introduce those foods into their diets. The authors concluded that omalizumab can be an effective treatment option for food allergies and identified several factors that may predict treatment response.

Reference

Tseng H, Wood R A, Isola J, Anania N, Dantzer J. Oral food challenges after treatment with omalizumab in the clinical setting. J Allergy Clin Immunol Pract. 2026;(14)5:1142-1152.e2. doi:10.1016/j.jaip.2026.02.033