Phase 2, randomized multi oral immunotherapy with omalizumab 'real life' study

Area of Science:

• Allergy and Immunology
• Clinical Trials
• Pharmacology

Background:

• Oral immunotherapy (OIT) is often limited by adverse events (AEs).
• Reducing OIT doses may mitigate AE severity and frequency.
• The minimum effective dose for multi-food OIT (mOIT) to induce desensitization and immune responses remains unknown.

Purpose of the Study:

• To determine the minimum effective dose of mOIT when combined with omalizumab.
• To assess immune responses and safety at different mOIT doses.
• To evaluate the impact of a lower mOIT dose on plasma markers.

Main Methods:

• Participants (2-25 years) with multi-food allergies received omalizumab pretreatment.
• Randomized 1:1 to mOIT maintenance doses of 300 mg or 1200 mg total protein.
• Primary endpoint: increase in IgG4/IgE ratio for at least 2 allergens after 18 weeks.

Main Results:

• Seventy percent of participants in both groups showed favorable changes in sIgG4/sIgE ratio.
• No significant difference in immune response changes between the 300 mg and 1200 mg groups.
• Adverse event rates were similar between the 300 mg (19%) and 1200 mg (17%) groups.

Conclusions:

• A total protein dose of 300 mg of mOIT with adjunct omalizumab can induce early plasma marker changes.
• Lower mOIT doses may be sufficient for desensitization when combined with omalizumab.
• Further research is needed to identify optimal dosing for long-term OIT success.