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

• Published in: Journal of Crohn's and colitis 2018-01, Vol.12 (supplement_1), p.S076-S076
• Main Authors: Raluy-Callado, M, Berger, A, Khalid, J M, Patel, H
• Format: Article
• Language: English
• ISSN: 1873-9946; 1876-4479
• DOI: 10.1093/ecco-jcc/jjx180.104

Abstract Background Current 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. Methods Biologic-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. Results Biologic-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. Conclusions A 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 clinic