TREATMENT SATISFACTION WITH AR101 PEANUT ALLERGY ORAL IMMUNOTHERAPY: A MIXED METHODS STUDY

Introduction This study aimed to explore treatment satisfaction and impact on quality of life (QOL) post-participation in a clinical trial of an oral immunotherapy treatment, AR101, for peanut allergy (PA). Methods Following a protocol amendment, a subset of participants and their parents, completing a phase 2 open-label extension trial of AR101 (ClinicalTrials.gov Identifier: NCT02198664) were asked to complete two treatment satisfaction questionnaires and an optional telephone interview.  The TSQM-9 (Treatment Satisfaction Questionnaire for Medication), completed by parents, was scored on a 0-100 scale.  A customized treatment-specific exit questionnaire (EXIT) assessed palatability, convenience, adherence, and treatment experience. EXIT, completed by parents and participants, was scored on 5- or 7-point Likert scales. Interview data were analyzed using thematic analysis. Results Nineteen parents and eighteen children completed EXIT; nine subjects were interviewed. Twenty parents completed the TSQM-9. The mean time in study was 3.5 years. TSQM-9 scale scores showed moderate-to-high levels of treatment satisfaction (effectiveness: 76; convenience: 58; satisfaction: 86). EXIT showed that most patients almost always/always took the drug exactly as instructed (100% parents; 86% children). All parents and 86% of children felt the advantages of therapy with AR101 outweighed the disadvantages. The qualitative analysis identified five key areas of QOL impacted by PA: emotional functioning, social and leisure activities, daily activities, relationships, and independence/supervision.  All areas improved after trial participation. Conclusions This is the first cohort of patients to be treated long-term with AR101. These results show moderate-to-high levels of treatment satisfaction and improved QOL following AR101 treatment.