Real-World Patterns and Economic Burden Associated with Treatment Failure with Advanced Therapies in Patients with Moderate-to-Severe Ulcerative Colitis

Abstract

Abstract Background Some patients lose response during treatment for moderate-to-severe ulcerative colitis (UC). We aimed to characterize real-world treatment failure patterns and associated economic burden during use of first-line advanced therapies for UC. Methods IBM MarketScan Commercial and Medicare Supplemental Databases were used to identify adults initiating ≥1 advanced therapy for UC (1/1/2010–9/30/2019). Treatment failure was defined as augmentation with non-advanced therapy, discontinuation, dose escalation/interval shortening, failure to taper corticosteroids, UC-related surgery, or UC-related urgent care ≤12 months after treatment initiation. The index date was the date of treatment failure (treatment failure cohort) or 12 months after treatment initiation (persistent cohort). Treatment failure rates were assessed using Kaplan-Meier analyses. All-cause and UC-related healthcare resource use (HCRU) and costs 12 months post-index were also assessed. Results Analysis of treatment failure patterns included data from 6745 patients; HCRU and cost analyses included data from 5302 patients (treatment failure cohort, n=4295; persistent cohort, n=1007). In the overall population, 75% experienced treatment failure within the first 12 months (median: 5.1 months). Augmentation with non-advanced therapy (39%) was the most common first treatment failure event. The treatment failure cohort had significantly (P<0.001) higher mean costs than the persistent cohort (all-cause, $74,995 vs $56,169; UC-related, $57,096 vs $47,347) mainly attributed to inpatient admissions and outpatient visits. Dose escalation/interval shortening accounted for the highest total costs ($101,668) across treatment failure events. Conclusions Advanced therapies for moderate-to-severe UC are associated with high rates of treatment failure and significant economic burden. More efficacious and durable treatments are needed.