Patient-Reported Outcomes on Food Immunotherapy Differ Between Countries and Foods: Results From COFAITH

Abstract

Background: Food allergen immunotherapy (FAIT) is a consolidated treatment included in clinical guidelines that has shown efficacy in terms of researcher-defined variables, but little work has been done yet to evaluate patient perspectives.

Objective: We aimed to understand and explore the relevance of different patient-reported outcomes (PROs).

Methods: A European Academy of Allergy and Clinical Immunology task force designed a questionnaire to prospectively collect information from parents or caregivers of patients younger than 18 years on FAIT. Participants from North America and several European countries were invited to provide data regarding socioeconomic aspects, allergic background, FAIT modality, burden, safety, and food allergy quality of life (FAQoL). As a primary outcome, 19 proposed PROs were ranked according to their relevance (5-point Likert scale). A descriptive and cluster analysis of the data was performed.

Results: A total of 84 FAIT prescribers recruited 857 patients suitable for analysis; 41.5%, 39.7%, and 18.8% were on milk, peanut, and egg allergen immunotherapy, respectively. Patients were grouped into regions: South Europe (46.2%), North America (24.3%), Western Europe (20.7%), and United Kingdom (8.9%). The total FAQoL questionnaire score was 4.1 (± standard deviation 1.4), significantly higher among South Europeans (4.7 ± 1.3, P < .0001). Worse FAQoL scores were found for milk and egg FAIT versus peanut. Cluster analysis identified 5 different phenotypes of patients considering similar replies to the proposed PROs, labeled "high expectations," "beyond protection," "social functioning," "aiming at normalization," and "low motivations."

Conclusions: The data-driven analysis provided novel information on the level of complexity and personalization that a patient's desires display and opens the field to future research lines to improve FAIT patient-perceived value.

Keywords: Allergy; Children; Desensitization; Food allergy; Food allergy–related quality of life; Food immunotherapy; Patient-reported outcome; Pediatric.