OBJECTIVES: EuroQol-5 (EQ-5D) is a patient-reported outcome measure that quantifies health status using five domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The minimal important difference (MID) for EQ-5D has not been estimated for eosinophilic esophagitis (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. The EQ-5D-Y (patients <18 years) and EQ-5D-3L (patients ≥18 years) were completed at baseline and end of treatment. MID, defined as the smallest change patients perceive as beneficial/harmful, was estimated for EQ-5D for composite and visual analog scores (VAS). Small and moderate effect sizes were calculated for baseline EQ-5D scores.

RESULTS: Overall, 318 patients were randomized; co-primary efficacy endpoints of the trial were met. Baseline mean (standard deviation, SD) EQ-5D-Y composite scores were 0.89 (0.10; n=14) and 0.87 (0.18; n=27) for placebo and BOS groups, respectively. Small and moderate effect sizes were 0.031 and 0.077 for the overall population. Baseline mean (SD) EQ-5D-3L composite scores were 0.90 (0.12; n=89] and 0.91 (0.13; n=185) for placebo and BOS groups, respectively. Small and moderate effect sizes were 0.026 and 0.064 for the overall population. For EQ-5D-Y VAS scores, small and moderate effect sizes for the overall population were 2.631 and 6.579. Using EQ-5D-3L VAS, small and moderate effect sizes for the overall population were 3.302 and 8.256.

CONCLUSIONS: To our knowledge, this study is the largest clinical trial to date to implement the EQ-5D for EoE, and thus improves the ability to interpret the MID for health status in patients with EoE. This estimator has the potential to inform clinician and health policy-maker decisions when managing patients with EoE.