OBJECTIVES: Vedolizumab (VDZ), a gut-selective humanized monoclonal antibody binding to α4β7 integrin, is approved for the treatment of patients with moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD). This study aimed to characterize IBD patients initiating VDZ over time in Israel, from launch (2015).

METHODS: A retrospective cohort study was performed in Maccabi Healthcare Services, a 2-million-member health plan in Israel. Included were patients diagnosed with UC or CD with ≥1 dispensed VDZ in 2015-2017 (index date was defined as first purchase), with ≥12 months’ pre-index health plan enrolment. Baseline socio-demographic, comorbidity, pharmacy, surgery, hospitalization and laboratory data were described at VDZ initiation and compared across index calendar years using Chi-squared and Kruskal-Wallis tests.

RESULTS: The cohort included 421 patients initiating VDZ in 2015 (n=94), 2016 (n=141) and 2017 (n=186). VDZ was initiated after a median (IQR) of 7.8 (3.9-13.1) and 6.0 (2.1-13.8) years since CD (n=242) and UC (n=178) diagnosis, respectively. From 2015 to 2017, there was a trend towards initiating VDZ sooner after IBD diagnosis (median [IQR]: 9.0 [4.3-14.4] to 6.8 [2.5-13.1] years; P=0.217), increasing age of VDZ patients (mean ±SD: 36.5±15.5 to 41.4±17.8 years; P=0.050) and percentage of males (43.6% to 54.8%; P=0.148). The proportion of biologic-naïve patients initiating VDZ increased significantly (P<0.001) over time (2015, 2016, 2017) in CD (5.4%, 11.0%, 26.5%) and UC (13.2%, 33.8%, 49.3%) patients. Prior use of immunomudulators (IMM) also declined significantly from 2015 to 2017 overall (P=0.001) and among CD (96.4% to 82.3%) and UC (97.4% to 78.1%) patients. Overall baseline IBD-related surgery rates declined significantly (P=0.014) over time: 26.6% (2015); 12.8% (2016); 15.1% (2017).

CONCLUSIONS: Since launch, VDZ utilization increased in biologic-naïve and IMM-naïve IBD patients and there was a trend to use VDZ earlier in the disease course. Further analyses are planned to assess real-world outcomes in this cohort.