Patient-perceived benefits of sublingual allergen immunotherapy: Design of the ERAPP study

Abstract

Introduction

Sublingual allergen immunotherapy (SLIT) is an aetiological treatment for allergic disorders (allergic rhinitis, rhinoconjunctivitis, and asthma). Limited data exist on the effectiveness of SLIT in the real-world treatment setting. This study was initiated to assess patient perceptions of the effectiveness of SLIT and thus inform evaluations of its risk−benefit profile in real-world practice. The present article presents the design and methodology of the study and baseline data on the patients enrolled.

Methods

This prospective cohort study was performed in patients who were delivered liquid SLIT as a named-patient product in France between September 2020 and February 2022. Participants were stratified by age (< 12 and ≥ 12 years) and by treatment duration. Data were collected through a web-based interface. In the first phase of the study, participants completed study questionnaires at baseline (study entry) and at 6 and 12 to 15 months after inclusion. Perceptions of SLIT were assessed using the Patient Needs Questionnaire and the Patient Benefit Questionnaire. In the second phase of the study, participants’ data will be linked to the French national health data system (SNDS) through their social security number. Data on comorbidities and allergy-related healthcare resource utilisation will be extracted.

Results

11,255 patients agreed to participate in the study, of whom 9,439 (83.8 %) could be analysed. 1,837 participants (19.5 %) were children aged < 12 years. 625 participants < 12 years were boys whereas 7,602 older participants were women (58.9 %). 4,974 participants (50.8 %) entered the study within six months of initiating SLIT (new users). Allergic rhinitis was the most frequent allergy presentation (N = 8,291; 87.8 %) and house mite dust the most frequently reported allergen (N = 4,262; 45.1 %).

Discussion

This large study including nearly 10,000 participants with allergic disorders should contribute important information for assessing the benefit–risk profile of SLIT.