Eligibility for Omalizumab Dosing in Children and Young Adults Based on IgE and Body Weight

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RATIONALE: Eligibility for treatment with omalizumab, an immune-based therapy for moderate-severe allergic asthma, is guided by a dosing chart based on total serum IgE and body weight. Eligibility data based on these attributes are unavailable.

METHODS: Serum IgE, body weight, atopy measures, asthma control measures, and medication use were collected on 889 urban residents aged 6-20 years screened in the Inner-City Anti-IgE Therapy for Asthma (ICATA) Trial; all participants had evidence of persistent asthma or uncontrolled disease. Eligibility for the Xolar^® dosing chart was determined which comprised body weight 30-150 Kg and IgE 30-1300 IU/ml.

RESULTS: 33% (n = 293) of participants with available dosing parameters were ineligible for dosing. Among ineligible participants, IgE was 1300 IU/ml in 35%, and 36% had a combination of body weight and IgE unsuitable for dosing. Total number of aeroallergen positive skin tests (PST) and PST status to cat, mite, rat, cockroach, and ragweed distinguished the group excluded for IgE > 1300 IU/ml from the group excluded otherwise and the group eligible for Xolair^® (all p < 0.05). Asthma control measures and medication use were comparable.

CONCLUSIONS: A significant portion of inner city individuals who meet clinical indications for omalizumab may be ineligible due to IgE > 1300 IU/ml.

Funded by NIAID/NIH (NO1-AI-25496 and NO 1-AI-25482) and NCRR/NIH M01 RR00533.