Characteristics of Patients Treated With Vedolizumab for Inflammatory Bowel Disease in the United States

Abstract

Introduction: Vedolizumab (VDZ), a monoclonal antibody against the α4β7 integrin, has been approved for the treatment of adults with moderately to severely active Crohn's disease (CD) and ulcerative colitis (UC) in the United States (US). Although few single-center experiences with VDZ have been described, reports from larger, nationally representative cohorts are limited. Using a large national administrative claims database, this retrospective study aims to describe the characteristics and treatment history of CD and UC patients initiating VDZ. Methods: Using the Optum Research Database, adults (≥18 years) initiating VDZ between May 2014 and February 2015, with at least 2 claims of CD or UC (based on ICD-9 criteria), ≥12 months of medical history (baseline) and ≥2 months of follow-up after the first VDZ infusion were included in the study cohort. Patients were assigned to the CD or UC cohort based on the diagnosis code on or closest to the first VDZ infusion date. Baseline demographic and clinical characteristics and treatment history at VDZ initiation are reported. Results: A total of 178 patients treated with VDZ were included in the study. The CD and UC cohorts included 122 (43% males) and 56 (59% males) patients, respectively. The mean age at VDZ initiation was 40 years (SD=14) for CD cohort and 43 years (SD=14) for UC cohort. In both cohorts, 92% patients were enrolled in a commercial health plan and 8% in Medicare Advantage plan. Most common baseline comorbid conditions were anemia (CD:48%, UC:46%), respiratory infections (CD:37%, UC:46%), skin disorders (CD:39%, UC:32%), connective tissue disease (CD:38%, UC:32%), and non-traumatic joint disorders (CD:36%, UC:29%). In the baseline period, IBD-related surgery was performed in 22% and 11% of CD and UC patients, respectively. The treatment history of patients at baseline is reported in Table 1.Table 1: Treatment History of Crohn's Disease (CD) and Ulcerative Colitis (UC) Patients at First Vedolizumab InfusionConclusion: In a large national database, more than two-thirds of patients initiating VDZ were in the CD cohort. Approximately one-third of CD and UC patients were biologic-naive in the past 12 months before VDZ initiation. A majority of the CD and UC patients initiating VDZ were exposed to biologic therapy in the previous year indicating that patients may have inadequate or suboptimal response or intolerance to their previous biologic therapy. Future studies describing real-world outcomes of VDZ in large CD and UC cohorts of both biologic-naive and biologic-exposed should be considered.