DOP067 Treatment discontinuation, flares and hospitalisations among biologic-naïve patients with IBD over the first year of treatment: a comparative effectiveness study of vedolizumab vs. infliximab

Abstract

BackgroundCurrent inflammatory bowel disease (IBD) treatment guidelines recommend the gut-selective anti-integrin antibody vedolizumab (VDZ) for treatment of patients with moderately to severely active disease who have had an inadequate response with, lost response to, or were intolerant to a tumour necrosis factor antagonist such as infliximab (IFX). We evaluated clinical outcomes of VDZ vs. IFX over the first year of treatment to assess their effectiveness as initial therapy.MethodsBiologic-naïve patients with IBD who initiated VDZ or IFX treatment between May 2014 and April 2017 were identified from the Explorys Universe database. Patients included were aged ≥18 years and had: ≥365 days of medical history at index date (date of the first infusion); ≥188 days of follow-up; successfully completed the induction phase and moved to maintenance therapy (≥3 infusions ≤98 days from index date and a fourth infusion ≤90 days after the third). VDZ initiators were matched to IFX initiators (1:1) using propensity score matching. Kaplan–Meier estimates were used to compare median (interquartile range [IQR]) time to discontinuation of index therapy (first of the following: no receipt of biologic ≤90 days of the previous infusion, switch to or add-on of another biologic). All-cause hospitalisation, IBD surgery and flare rates (defined as use of intravenous steroids) are reported with 95% confidence intervals (CIs) and calculated as the ratio between the number of events during the 365 days of follow-up and the total number of patient-years in the cohort.ResultsBiologic-naïve VDZ initiators (n = 182: 37% UC, 63% CD) were matched to IFX initiators (n = 182: 42% UC, 58% CD). Median time since diagnosis was 2.7 years for VDZ and 2.4 years for IFX (Table 1). Median time to discontinuation was 240 days (IQR: 188–300) and 244 days (IQR: 207–292) for VDZ and IFX, respectively. All-cause hospitalisation rates (95% CI) were 1.76 (1.57–1.96) for VDZ and 1.90 (1.70–2.11) for IFX. A similar trend was observed for IBD surgery rates: 0.09 (0.05–0.15) and 0.14 (0.09–0.21) for VDZ and IFX, respectively. Flare rates were 1.30 (1.14–1.48) for VDZ and 1.13 (0.98–1.30) for IFX. Both therapies had a similar median time to discontinuation.ConclusionsA year after initiating treatment, clinical outcomes were similar for biologic-naïve patients on VDZ as for IFX, although numerically lower rates of all-cause hospitalisation and IBD surgery were seen with VDZ. Data suggest clinical benefits to using VDZ as a first-line treatment option.