Anaphylaxis, Food Hypersensitivity
Conditions
Keywords
Food Allergy, IgE-mediated Food Allergy
Brief summary
This was a retrospective, multi-center observational study conducted across four allergy departments in Europe (Berlin, Leipzig, Barcelona, and Basel). The study included patients with immunoglobulin E (IgE)-mediated food allergy who were treated with omalizumab, either as monotherapy or in combination with oral immunotherapy (OIT) between 2002-2022.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A confirmed history of food allergy, either with or without prior anaphylaxis. * Treated with omalizumab, either as monotherapy or in combination with OIT.
Exclusion criteria
None identified.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients by Response to Treatment | Months 3, 6, 12, and 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Accidental Reactions | Up to approximately 7 years | Accidental reactions were those that occurred when a patient unknowingly ingested the food allergen. |
| Change From Baseline in Allergen Threshold Levels | From Baseline up to approximately 7 years | 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 From Baseline in Severity of Anaphylactic Reactions | From Baseline up to approximately 7 years | Change in severity of food allergy was either demonstrated by an oral food challenge or based on the clinical assessment by the investigator. |
| Health-related Quality of Life (HRQoL) Based on Patient Reported Data as Measured by the EuroQol-5 Dimensions (EQ-5D) Questionnaire | Months 3, 6, 12, and 24 | 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. |
| HRQoL Based on Patient Reported Data as Measured by the Food Allergy Quality of Life Questionnaire (FAQLQ) | Months 3, 6, 12, and 24 | 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. |
Countries
United States
Outcome results
None listed