Characteristics of Patients With Crohnʼs Disease Initiating Vedolizumab Therapy in Real-World Clinical Practice

Abstract

Introduction: Vedolizumab, a monoclonal antibody to the α4β7 integrin was approved in the United States (US) in May 2014 for adults with moderately to severely active Crohn's disease (CD). While postmarketing experience has been described from single-centers, reports from larger, multi-center cohorts have been limited. This study aims to describe the characteristics and treatment history of patients with CD treated with vedolizumab in real-world clinical practice. Methods: A retrospective analysis was performed using the Explorys HIPAA-compliant database containing de-identified electronic medical records of >50 million patients from 27 large US healthcare systems. All patients initiating vedolizumab from June 2014-April 2015, with a diagnosis of CD (using International Classification of Diseases coding system [ICD]-9 criteria) and ≥12 months of medical record history were entered into the cohort at time of first vedolizumab infusion. Results: Two-hundred twenty-five patients (36% male) with CD were identified as having initiated vedolizumab. Average age at first vedolizumab treatment was 42.6 years (standard deviation [SD]: 14.9) with disease duration of 5.8 years (SD: 3.4). Median body weight was 71.4kg (interquartile range[IQR]:57.7-84.2); median C-reactive protein and mean haemoglobin concentrations were 9.0 mg/L (IQR:5.0-20.5) and 123.4 g/L (SD: ±19.1), respectively. Twenty-one percent of patients had a prior surgical procedure for CD and one-third had history of fistulizing disease. Treatment history of patients is described in Table 1.Table 1: Treatment History of Patients with Crohn's Disease (CD) at Time of First Vedolizumab InfusionConclusion: In real-world clinical practice, 16% of patients with CD who initiated treatment with vedolizumab were biologic-naive. Similar patients have been studied in the GEMINI 2 & 3 trials, with results demonstrating a more pronounced treatment effect in this group.1 Over a third of patients in this study had been previously treated with two or more different biologics, indicating these patients had refractory disease and/or had suboptimal response to prior biologic treatment. Future studies investigating real-world effectiveness in patients with CD should consider these factors when evaluating outcomes.