OBJECTIVES: The eosinophilic esophagitis quality of life questionnaire (EoE-QoL) is a validated patient-reported outcome measure used to assess the impact of eosinophilic esophagitis (EoE) on health-related quality of life (HRQoL). This analysis determined the minimal important differences (MID) for EoE-QoL in patients with EoE.

METHODS: This analysis used data from a phase 3, 12-week, double-blind, randomized, placebo-controlled trial in patients with EoE and dysphagia (11–55 years old) who received budesonide oral suspension (BOS; 2.0 mg b.i.d.) or placebo (NCT02605837). Co-primary efficacy endpoints were the proportion of histologic and symptom responders at week 12. Patients completed the PedsQL-EoE (patients <18 years old) or the EoE-QoL-A (patients ≥18 years old) at baseline and end of treatment. MID, defined as the smallest change patients perceive as beneficial/harmful, was estimated for PedsQL-EoE and EoE-QoL-A composite scores. Small and moderate effect sizes were calculated for the baseline PedsQL-EoE and EoE-QoL-A scores.

RESULTS: Overall, 318 patients were randomized; co-primary efficacy endpoints of the trial were met. Mean (standard deviation, SD) PedsQL-EoE scores at baseline were 74.35 (11.13; n = 12) and 73.86 (14.46; n = 26) for placebo and BOS groups, respectively; small and moderate effect sizes were estimated as 2.681 and 6.702 for the overall population, respectively. Mean (SD) EoE-QoL-A scores at baseline were 2.46 (0.84; n = 90) and 2.66 (0.75; n = 184) for placebo- and BOS-treated patients, respectively; small and moderate effect sizes were estimated as 0.156 and 0.389 for the overall population, respectively.

CONCLUSIONS: The EoE-QoL measure is useful for assessing meaningful changes in HRQoL in patients with EoE. These results will assist clinicians and health policy-makers in their decisions regarding the management of patients with EoE.