A Study About the Use of Omalizumab in the Treatment of Food Allergy and Anaphylaxis

Patients were classified as treatment responders if an oral food challenge was negative, or a decrease in severity of food allergy during an oral food challenge was determined and no anaphylactic reactions occurred during treatment. Non-responders were those who experienced repetitive food anaphylactic reactions during treatment. Partial treatment responders were patients who experienced less than 1 food anaphylactic reaction despite undergoing treatment.

Accidental reactions were those that occurred when a patient unknowingly ingested the food allergen.

Allergen threshold was measured by oral food challenge test. The change in threshold level means the increase in the food dose that the patient was able to tolerate during the food challenge test.

Change in severity of food allergy was either demonstrated by an oral food challenge or based on the clinical assessment by the investigator.

The EQ-5D is a generic multidimensional measurement tool for describing HRQoL (EuroQol, 1999). The five domains of mobility, self-care ability, daily activities, pain/discomfort and anxiety/depression are considered. For each of the dimensions, the most appropriate answer from three given possibilities is selected (1=no problem, 2=moderate problem, 3=large problem). In addition, the patient marks the current state of health on a scale from 0 (worst conceivable state of health) to 100 (best conceivable state of health). HRQoL was measured if data was available.

FAQLQs are disease-specific questionnaires used to measure the impact of food allergy on HRQoL. The forms are completed by the patients themselves or by the parents of food-allergic children and teenagers. Questions are scored on a 7-point scale from 1 (no) to 7 (maximal) impairment on quality of life. HRQoL was measured if data was available.