OBJECTIVES: Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal tract, with increasing incidence worldwide. Treatment targets in CD have evolved from symptom control alone towards endoscopic healing, and accumulating evidence suggests that endoscopic healing improves long-term outcomes. However, health state utility values (HSUVs) for endoscopically defined health states are lacking, resulting in a disconnect between clinical decision-making and current approaches to cost-effectiveness analysis with Quality Adjusted Life Years (QALYs). Therefore, we estimated and compared utility values for CD health states as defined by endoscopy- and symptoms-based indices.

METHODS: We obtained data from VIVID-1, a Phase 3 trial comparing the efficacy of mirikizumab, ustekinumab, and placebo. Endoscopic outcomes, symptoms, and health utilities were measured using the Simple Endoscopic Score for Crohn's Disease (SES-CD), the Crohn’s Disease Activity Index (CDAI), and the EQ-5D-5L (cross-walk, UK value set), respectively. We fit linear mixed models including all time-points (baseline, weeks 12, and week 52). SES-CD and CDAI were categorized into remission (SES-CD<3; CDAI<150), mild disease (3 <=SES-CD<7 ;150<=CDAI<220), and moderate-to-severe disease (SES-CD>=7; CDAI >= 220). Least square means and 95% confidence intervals are presented.

RESULTS: In total, 1,065 individuals (mean [Standard deviation] age 36.2 [13.0]; 44.9% women) were included in the analysis. Utility values for SES-CD vs CDAI were 0.847 (0.826-0.868) vs 0.866 (0.854-0.878) for remission, 0.809 (0.792-0.825) vs 0.786 (0.770-0.802) for mild disease, and 0.697 (0.686-0.708) vs 0.649 (0.639-0.660) for moderate-to-severe disease.

CONCLUSIONS: The HSUVs for endoscopically and symptoms-defined health states were comparable, supporting the notion that endoscopic outcomes are aligned with symptoms in impacting health related quality of life in CD. The range between point estimates for remission and moderate-to-severe disease was larger for symptoms- compared to endoscopy-based health states. Whether these utility scores are driven by CD or other related causes needs to be further investigated.