Dose Escalation of Biologic Therapies in Biologic Treatment-Naïve Adult Patients With Ulcerative Colitis: Results From the Odessa Database Study

Abstract

BACKGROUND In the real-world clinical setting, patients with moderate-to-severe ulcerative colitis (UC) may undergo dose escalation when they lose response to their prescribed biologic treatment. Such dose escalation of biologic agents has an impact on healthcare utilization and costs and may have an impact on patient outcomes. Currently, limited real-world data exist that compare rates of dose escalation between anti-tumor necrosis factor (anti-TNF) biologic therapies and vedolizumab, a gut-selective integrin antagonist, in patients with UC who have not previously been treated with biologic therapies (bio-naïve patients). METHODS ODESSA (real wOrld Dose EScalation and outcomeS with biologics in IBD pAtients) was a retrospective cohort study investigating dose escalation in bio-naïve patients with UC receiving vedolizumab or anti-TNFs (adalimumab, golimumab, and infliximab) using data from the IBM MarketScan Commercial Claims and Encounters and Medicare Supplemental Databases. Adult patients with ≥1 claim for a study drug between January 1, 2017 and December 31, 2018 were selected for inclusion, with the first claim date defined as index date 1 (Figure). Patients were eligible if they had a diagnosis of UC, identified based on UC diagnosis codes, had ≥2 claims for the study drug ≥10 days apart with ≥1 claim on or before index date 1, and had received the study drug for ≥60% of days in the first 6 months after index date 1. Patients were excluded if they had received any biologic treatment before index date 1. The maintenance period began on the date of the third (adalimumab or golimumab) or fourth (infliximab or vedolizumab) pharmacy claim. Dose escalation was defined as a ≥20% increase in mean average daily dose relative to expected daily dose based on the approved prescribing information for UC. The primary endpoint was to compare the proportions of patients experiencing dose escalation of each of the study drugs in the first 6 and 12 months after initiation of maintenance dosing and in the entire maintenance period. RESULTS The final analysis cohort included 2,628 patients (vedolizumab, n=554; infliximab, n=758; adalimumab, n=1,316). As a consequence of low patient count, patients treated with golimumab were excluded. At 12 months, the proportion of patients experiencing dose escalation was lowest in the vedolizumab group (36%) and highest in the adalimumab group (44%) (Table). CONCLUSION In this retrospective, real-world cohort of bio-naïve patients with UC receiving vedolizumab or anti-TNFs, rates of dose escalation were lowest among patients receiving vedolizumab during the maintenance period. These data seem to indicate that vedolizumab maintains efficacy with less need for dose escalation; however, additional studies are required to investigate dose-escalation requirements for all biologic treatments.