Alternative dosing of omalizumab as an adjunct therapy during multiallergen oral immunotherapy in food allergic patients

Adjunct therapy with omalizumab in multiallergen oral immunotherapy (mOIT) trials is typically dosed based on the FDA approved asthma dosing guidelines targeting a monthly dose of at least 0.016mg/kg/(IU/mL). However, dose-finding studies have yet to be performed to provide guidance on the minimum dose necessary for food allergy. Participants aged 7-18 years (n=41) with multiple food allergies were enrolled and received three monthly doses of 150 mg of omalizumab prior to initiating mOIT for 16 weeks. Each participant’s standardized omalizumab dose was calculated by dividing their 150 mg dose by their weight and total IgE. Participants were grouped according to this standardized dose, with those receiving less than 0.016 mg/kg/(IU/mL) categorized as low-dose (LD) and the remainder were categorized as standard-dose (SD). Rates of adverse events (AEs) and time to OIT maintenance dose (TTM) between the two groups were analyzed. Thirty-four participants were categorized as receiving LD (<0.016 mg/kg) omalizumab; seven participants received SD (≥0.016 mg/kg) of omalizumab. The median per-person AE rates for LD and SD were 0.123 and 0.0083, respectively (p=0.07). At 16 weeks, 56% and 71% of participants in the LD and SD groups, respectively, had reached maintenance (p=0.68). Our preliminary data suggest that LD and SD omalizumab dosing have a similar rate of AEs and TTM in this pilot mOIT study. Further phase 2 randomized controlled trials are needed to better define optimal dosing strategies for omalizumab in food allergy.