P387 Real-world clinical outcomes of biologic-naïve non-complicated Crohn’s disease patients treated with vedolizumab: Results from the EVOLVE study

Abstract

Background and Aim: Crohn's disease (CD) can lead to complications that affect treatment decisions and the clinical effectiveness of treatment. This analysis aimed to compare clinical effectiveness outcomes in patients with CD treated with first-line biological vedolizumab (VDZ) who did not have a complicated disease phenotype (non-complicated) with patients taking VDZ who did have complications (complex disease). Method(s): This was a retrospective, real-world, cohort study of biological therapy-naive patients with CD (>= 18 years old) in Canada, Greece, and the United States who initiated VDZ treatment between May 2014 and March 2018. Data were collected from treatment initiation to the earliest of chart abstraction date or death. Patients with non-complicated CD were defined as those who had mild or moderate disease severity and no active fistula at treatment initiation, had no prior CD-related surgeries since diagnosis, and no CD-related hospitalizations within 12 months before treatment initiation. The complex disease cohort encompassed all other patients with CD. Cumulative rates of clinical effectiveness outcomes over 24 months (treatment persistence, clinical response, and clinical remission) were estimated using the Kaplan-Meier method. Using predefined hierarchical algorithms, clinical response and clinical remission were assessed from standard disease measures reported in the medical records. Result(s): This analysis included 218 patients with CD treated with VDZ (non-complicated, 64 [29.3%]; complex, 154 [70.6%]) from 37 sites. Mean (SD) age at treatment initiation was 46.2 (15.8) years in the non-complicated group and 54.0 (16.7) years in the complex group. The proportion of male patients was 45.3% in the non-complicated group and 55.2% in the complex group. Cumulative rates of clinical response were significantly greater in the non-complicated than complex disease group over 24 months (non-complicated, 93.0% vs complex, 76.0%; P < 0.01) (Fig. 1). Treatment persistence (non-complicated, 76.7% vs complex, 66.6%; P = 0.68) (Fig. 2) and clinical remission (non-complicated, 81.9% vs complex, 73.5%; P = 0.36) (Fig. 1) were not significantly different between the two cohorts over 24 months. Fewer patients had data for mucosal healing over 24 months, and it was also not significantly different between groups at 12 months (non-complicated, 66.4% vs complex, 60.2%; P = 0.95). Conclusion(s): A high proportion of patients (70%) had complex disease when VDZ treatment was initiated, but those with a non-complicated phenotype had a higher response rate. To help guide physicians in positioning the optimal treatment for biological therapy-naive patients with CD, it is important to identify the subgroup of patients who can most benefit from VDZ treatment. The results of this real-world study suggest that biological therapy-naive patients with non-complicated CD benefit more from VDZ treatment than do those with disease complications.