D0398 - Dose Escalation of Biologic Therapies in Biologic Treatment-Naïve Patients With Crohn’s Disease: Results From the ODESSA-CD Study

Introduction: Dose escalation is often used to recapture response in patients with Crohn’s disease (CD) who experience loss of response to biologic treatment; however, real-world data on rates of dose escalation are mostly limited to anti-tumor necrosis factor (TNF) therapies. Furthermore, outcomes after dose escalation have not been well characterized.

Methods: ODESSA-CD (real wOrld Dose EScalation and outcomeS with biologics in IBD pAtients) is a retrospective cohort study investigating dose escalation and outcomes in biologic-naïve patients with CD who received adalimumab, infliximab, ustekinumab, or vedolizumab, using data from the IBM^® MarketScan^® Research Databases. Adult patients with at least one claim for a study drug between January 1, 2017 and December 31, 2018 were included, with the first claim date defined as index date 1. Eligible patients had at least two claims for CD at least 10 days apart, identified using CD diagnosis codes, with at least one claim on or before index date 1. The maintenance period began on index date 2, defined as the date of the third (adalimumab) or fourth (infliximab or vedolizumab) claim or the first subcutaneous dose after an intravenous dose (ustekinumab) after index date 1. Dose escalation was defined as an increase of at least 20% in average daily dose relative to expected daily dose based on prescribing information for CD during the maintenance period. Drug costs after dose escalation were calculated from the paid amount captured in medical or pharmacy claims.

Results: During the entire maintenance period, the proportions of patients with CD (N = 2,664) whose dose was escalated were 45% for adalimumab, 40% for infliximab, 28% for vedolizumab, and 26% for ustekinumab (Figure 1). Mean unweighted drug costs after dose escalation ranged from $12,717.97 for vedolizumab to $36,045.07 for adalimumab (Table 1). Among patients whose dose was escalated, mean per patient per month drug costs were lowest for vedolizumab ($4,503.78) and highest for ustekinumab ($13,800.81).

Discussion: This real-world study of US claims data confirms frequent dose escalation of all biologics in biologic-naïve patients with CD. Vedolizumab and ustekinumab had less frequent dose escalation than anti-TNF therapies, and drug costs were lowest for vedolizumab. While there are multiple factors that lead to dose escalation, the findings from this study may help to inform clinicians’ choice of treatment and positioning of biologic therapies in CD.