Long-term longitudinal quality of life outcomes following a phase 2a open-label study of probiotic and peanut oral immunotherapy (PPOIT).

Abstract

Background: Previously, we have reported that probiotic and peanut oral immunotherapy (PPOIT) improved health-related quality eof life (HRQL), and improvement was specifically linked to acquisition of sustained unresponsiveness (SU). PPOIT-002 is a single arm open-label study which aimed to investigate long-term outcomes at 3-years post-treatment after 18-months of PPOIT treatment. Method(s): Participants (aged 1-12 years) with challenge-proven peanut allergy received PPOIT for 18-months. HRQL was evaluated at screening (T0), end-of- treatment (T2), and 12-months (T4) and 3-years (T5) post-treatment, using the Food Allergy Quality of Life Questionnaire -Parent Form (FAQLQ-PF) and Food Allergy Impact Measure (FAIM). FAQLQ-PF total score and sub-scores (emotional impact, food anxiety, and social and dietary limitations) were assessed. Difference in scores between timepoints was evaluated using paired t-tests. Result(s): Of 20 enrolled participants, 16 remained in the study at end-of- treatment (T2), and 12 achieved 8-week SU. Twenty participated in outcome assessments at T0, 16 at T2, 14 at T4, and 12 at T5. Both the FAQLQ-PF and FAIM total scores improved significantly in the 12-months following treatment completion (change in score T2 to T4: 0.44, 95% CI 0.17-0.70, p = 0.004; and 0.37, 95% CI 0.10-0.65, p = 0.01; respectively). Improvements in FAQLQ and FAIM scores were maintained at 3-years post-treatment (see Table 1). Improvement was also seen in each of the FAQLQ-PF sub-scores for emotional impact, food anxiety, and social and dietary limitations. Conclusion(s): PPOIT treatment for 18 months leads to significant and long-lasting improvement in quality of life and food allergy impact burden, as perceived by caregivers. (Table Presented).