TABLE I.
Characteristics of enrolled subjects
| Subject no. |
Age (y) | Sex | Total IgE (kU/L) |
Milk-specific IgE (kUA/L) |
Milk skin test wheal (mm)/ erythema (mm) |
Organ systems involved simultaneously in last historical reaction to milk (subjects had clinical reactivity to both cooked and uncooked milk products)* |
Omalizumab dose and frequency |
Total doses of omalizumab |
|---|---|---|---|---|---|---|---|---|
| 1 | 11 | M | 500 | 42 | 25/50 | Urticaria, angioedema, vomiting | 225 mg every 2 wk | 9 |
| 2 | 8 | M | 342 | 50 | 45/50 | Wheezing, urticaria | 225 mg every 4 wk | 5 |
| 3 | 8 | M | 148 | 73 | 20/45 | Urticaria, wheezing | 150 mg every 4 wk | 5 |
| 4 | 10 | F | 900 | 42 | 11/30 | Vomiting, congestion | 225 mg every 4 wk | 5 |
| 5 | 8 | M | 239 | 50 | 46/52 | Vomiting, generalized urticaria | 225 every 2 wk | 9 |
| 6 | 7 | F | 297 | 44 | 16/49 | Wheezing, vomiting, urticaria | 150 mg every 4 wk | 5 |
| 7 | 12 | M | 199 | 68 | 15/50 | Wheezing, urticaria, allergic rhinitis | 150 mg every 4 wk | 4 |
| 8 | 16 | M | 349 | 56 | 20/20 | Wheezing, urticaria, abdominal complaints | 225 mg every 2 wk | 12 |
| 9 | 17 | M | 364 | 43 | 16/58 | Wheezing, urticaria, conjunctivitis | 300 mg every 2 wk | 9 |
| 10 | 8 | F | 2016 | 268 | 24/46 | Wheezing, vomiting, urticaria, conjunctivitis | 300 mg every 2 wk | 8 |
| 11 | 7 | F | 2593 | 342 | 16/22 | Wheezing, urticaria, conjunctivitis | 300mg every 2 wk | 9 |
| Median | 8 | 349 | 50 | 20/50 | Not applicable | Not applicable | 8 |
Entry criteria: children 4 to 18 years of age with cow’s milk–specific IgE >25 kUA/L, total IgE <2500 kU/L; with significant clinical history of IgE mediated cow’s milk allergy, but without history of intubation, severe asthma, or previous immunotherapy or biologic therapy, and without a medical diagnosis of non–IgE-mediated eosinophilic disease.
F, Female; M, male.
None of the subjects had a diagnosis of eosinophilic esophagitis at screening and during the course of the study.