Journal Article

P94 Real-world evidence study of dose escalation and associated costs of advanced therapies for ulcerative colitis in France and United Kingdom

Hoque, Sami, Treuer, Tamás, Silva, Lidia, Richards, Melissa, Tan, Yubo, Can Mert, Dhesi, Endip

2024

نظرة عامة

BackgroundTo understand real-world dose escalation/de-escalation ulcerative colitis (UC) advanced therapy drugs patterns in two European countries (France, United Kingdom [UK]).MethodsThis 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.Results1663 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 1). 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).ConclusionDose 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.

• الناشر: BMJ Publishing Group LTD
• موضوع: Corticosteroids / Costs / Drug dosages / Inflammatory bowel disease / Infliximab / Monoclonal antibodies / Patients / Tumor necrosis factor-α / Ulcerative colitis