Abstract
BackgroundFood allergy (FA) negatively affects quality of life in caregivers of food-allergic children, imposing a psychosocial and economic burden. Oral immunotherapy (OIT) is a promising investigational therapy for FA. However, OIT can be a source of anxiety as it carries risk for allergic reactions. The effect of OIT with multiple food allergens (mOIT) on FA-specific health-related quality of life (HRQL) has never been studied in participants with multiple, severe food allergies. This study is the first to investigate the effects of mOIT on FA-related HRQL in caregivers of pediatric subjects.MethodsCaregiver HRQL was assessed using a validated Food Allergy Quality of Life – Parental Burden (FAQL-PB) Questionnaire (J Allergy Clin Immunol 114(5):1159-1163, 2004). Parents of participants in two single-center Phase I clinical trials receiving mOIT (n = 29) or rush mOIT with anti-IgE (omalizumab) pre-treatment (n = 11) completed the FAQL-PB prior to study intervention and at 2 follow-up time-points (6 months and 18 months). Parents of subjects not receiving OIT (control group, n = 10) completed the FAQL-PB for the same time-points.ResultsHRQL improved with clinical (change < -0.5) and statistical (p < 0.05) significance in the mOIT group (baseline mean 3.9, 95% CI 3.4-4.4; 6-month follow-up mean 2.5, 95% CI 2.0-3.0; 18-month follow-up mean 1.8, 95% CI 1.4-2.1) and rush mOIT group (baseline mean 3.9, 95% CI 3.1-4.7; 6-month follow-up mean 1.7, 95% CI 0.9-2.6; 18-month follow-up mean 1.3, 95% CI 0.3-2.4). HRQL scores did not significantly change in the control group (n = 10).ConclusionMulti-allergen OIT with or without omalizumab leads to improvement in caregiver HRQL, suggesting that mOIT can help relieve the psychosocial and economic burden FA imposes on caregivers of food-allergic children.
Highlights
Food allergy (FA) is an adverse immunologic response to dietary antigen with a reported prevalence of 8% in the United States
The burden of FA on caregivers has been reported to play a predominant role in the total annual economic burden of FA, $24.8 billion [7]. Compared to those with single food allergies, those with multiple food allergies experience a greater decrease in quality of life [5,8], are more likely to suffer from dietary deficiencies [9] and are less likely to outgrow their food allergies [10]
Study intervention The intervention and medication used in the Oral immunotherapy with multiple food allergens simultaneously (mOIT) and rush mOIT groups have been described in detail previously [12,13]
Summary
Food allergy (FA) is an adverse immunologic response to dietary antigen with a reported prevalence of 8% in the United States. The burden of FA on caregivers (buying special foods, limiting social encounters, foregoing full-time employment) has been reported to play a predominant role in the total annual economic burden of FA, $24.8 billion [7] Compared to those with single food allergies, those with multiple food allergies experience a greater decrease in quality of life [5,8], are more likely to suffer from dietary deficiencies [9] and are less likely to outgrow their food allergies [10]. The effect of OIT with multiple food allergens (mOIT) on FA-specific health-related quality of life (HRQL) has never been studied in participants with multiple, severe food allergies. This study is the first to investigate the effects of mOIT on FA-related HRQL in caregivers of pediatric subjects
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