P912 A Real-World Evidence Study of Dose Escalation and associated costs of advanced therapies for Ulcerative Colitis in France and United Kingdom

Abstract

Abstract Background Dose escalation to optimize advanced therapies is common practice in ulcerative colitis (UC) to avoid intra-class or inter-class drug switching and maintain clinical response. Dose escalation also has impact on healthcare resource utilization (HRU) and costs. However, there are limited data available on real-life dose-escalation. Study aim was to understand real-world dose escalation/de-escalation UC advanced therapy drugs patterns in two European countries (France, United Kingdom [UK]). Methods This retrospective study analysed data from the THIN®/CEGEDIM database to identify adult patients with moderate-to-severe UC who were naïve to advanced UC therapies or had not received any of the UC advanced therapy drugs of interest (adalimumab [ADA], golimumab [GOL], infliximab [INF], tofacitinib [TOF], ustekinumab [UST], or vedolizumab [VED]) for at least 12 months prior first prescription (and/or dispensation for France) between January 2017 and February 2022. A dose increase of ≥20% during the maintenance period compared to lowest Summary of Product Characteristics recommended dose was considered dose escalation. Proportions of patients with dose escalation after maintenance date were estimated using Kaplan-Meier (KM) survival analyses. Clinical response (defined as absence of: UC-related hospitalization or colectomy, treatment switch or addition of another UC advanced drug, systemic/rectal corticosteroids exposure), and direct (consultations, hospitalisations, diagnostic tests, UC drugs, complementary therapy) and indirect costs related to UC by treatment cohort were also analysed. Results 1663 patients fulfilled the selection criteria, of whom 619 had information on dose patterns. Overall, 89% of patients (range 33% [INF] to 100% [GOL, TOF, and UST]) had dose escalation within the first 24 months after start of maintenance, with a median % dose increase ranging from +15% [VED] to +198% [GOL] (Table). Median (95% CI) time to first dose escalation was 2.1 (1.8-2.4) months (range 0.7 [UST] to 4.6 [VED]). Clinical response ranged from 56.3% (ADA) to 77.0% (INF). Direct annual HRU costs related to UC ranged from 3,085 (INF) to 16,527 (UST) EUR in France and from 1,857 (INF) to 4,104 (VED) GBP in the UK. Mean direct HRU costs in France were 25% higher in escalated patients compared to de-escalated patients (range: +4.2% GOL to +61.9% UST). Conclusion Dose escalation of advanced therapies for UC is a common strategy to avoid treatment-switching. Despite dose escalations and their cost to the system, a proportion of patients fail to achieve clinical response, highlighting the need for more efficacious and durable treatments for patients with moderate-to-severe UC.