Abstract

Evaluate the relationship between health state and patient-reported health utility through a longitudinal analysis of adjusted European Quality of Life-5 dimensions-3 levels (EQ-5D-3L) health utility index (HUI) scores. Data was obtained from a Phase 3 trial conducted to evaluate the effectiveness of mogamulizumab compared to vorinostat for treatment of cutaneous T-cell lymphoma. Analysis evaluated health utility in the pre-treatment (screening assessment), pre-progression (average HUI scores from treatment initiation to discontinuation), and progression periods (derived from end of treatment assessment). A mixed model estimated the mean HUI score for each period, adjusted for covariates and baseline score. Least squares (LS) mean estimates of adjusted HUI scores were compared between treatment arms at each period (higher HUI score indicated better health). After adjustment for treatment, disease type, disease stage, and region, the adjusted LS mean HUI scores were 0.754 for vorinostat and 0.746 for mogamulizumab at baseline. After adjustment for prior covariates, in addition to baseline EQ-5D-3L HUI scores, the LS mean HUI scores increased after baseline for all subjects during progression-free survival, with higher LS mean HUI scores observed with mogamulizumab versus vorinostat (0.795 versus 0.767, respectively). HUI scores were lower after disease progression in comparison to progression-free survival, with notably higher HUI scores observed with mogamulizumab versus vorinostat (0.728 versus 0.704, respectively). A greater decline from baseline scores was reported with vorinostat versus mogamulizumab at the first post-progression visit. At progression-free survival, a notable improvement in HUI scores was observed from baseline scores with mogamulizumab. Further, at disease progression, patients on mogamulizumab experienced less of a decline from baseline in HUI compared to vorinostat.

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