B0378 - Fatigue Improvement Correlates With Reductions in Work Productivity Impairment and Related Indirect Cost in Patients With Crohn’s Disease: Post Hoc Analysis of Phase 3 Rizankizumab Induction Trials

Introduction: Patients with Crohn’s disease (CD) frequently experience fatigue,¹ which may reduce quality of life and work productivity, contributing to patient and societal costs. This analysis used Phase 3 clinical trial data in CD patients to assess this relationship.

Methods: Pooled 12-week (wk) data was used from patients with moderate to severe CD who received risankizumab (600 or 1200mg IV) or placebo in ADVANCE and MOTIVATE. Patients completed Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and Work Productivity and Activity Index (WPAI) questionnaires at Baseline (BL) and Wk 12. Risankizumab or placebo IV patients with no missing values were analyzed. Correlation between FACIT-F and WPAI was assessed by Pearson correlation. Mean change from BL to Wk 12 in WPAI assessed and stratified by quartiles of mean change from BL FACIT-F scores. Linear relationship between improvements from BL in FACIT-F and WPAI Overall Work Impairment (OWI) was assessed; results from the regression analyses were used to calculate cost savings based on corresponding WPAI scores and average hourly wages in the US and Europe. Annualized cost savings were defined in patients with clinically meaningful improvement (≥9unit increase) in FACIT-F and compared between patients who achieved or did not achieve a FACIT-F score > normative value ( >40) at Wk 12.

Results: Mean age (std dev) of patients was 38.4 (13.3) years and 53.1%were male. Moderate correlation was observed between FACIT-F and all four domains of WPAI (Pearson coefficient range ­-0.55 to -0.30, P< 0.0001) at Wk 12. Greater improvements in WPAI scores from BL were observed in patients with greater mean change from BL scores in FACIT-F at Wk 12. A ≥9unit change from BL in FACIT-F at Wk 12 corresponded to a 12% reduction in OWI, resulting in 4.8 hours of improved work productivity per wk and an annualized cost savings per person of $7,749 in US and €7,117 in Europe. Patients with normative FACIT-F score of >40 at Wk 12 had a corresponding reduction in OWI of 29%, resulting in 12 hours less work impairment per wk and an annualized cost savings per person of $18,726 in US and €17,199 in Europe.

Discussion: A significant correlation was observed between fatigue and work productivity in the induction trials of risankizumab. Early clinically meaningful improvements, and achieving fatigue normality, were associated with improvements in work productivity leading to substantial indirect cost savings.