S0820 Real World Comparison of Bio-Originator Infliximab vs the Biosimilar Infliximab-abda in the Treatment of Inflammatory Bowel Disease

Abstract

INTRODUCTION: Biologic therapies are indicated for the management of moderate-to-severe inflammatory bowel disease (IBD), including both Crohn’s disease (CD) and Ulcerative Colitis (UC). Biosimilars, biologic compounds that are similar but not identical to originator biologic therapies, have been developed for the management of a variety of immune mediated inflammatory disorders, including IBD, with similar efficacies and safety profiles to bio-originators. The primary aim of this study is to evaluate the efficacy and safety of biosimilars in IBD patients who were authorized for a non-medical switch from bio-originator infliximab to biosimilar infliximab-abda compared to patients who were maintained on originator therapy at the Cleveland Clinic. METHODS: This prospective observational cohort study was approved on 12/4/2019 by the institutional review board. IBD patients receiving infliximab and infliximab-abda infusions from 2018-2019 were identified. These charts were reviewed for characteristics listed in Table 1; surrogate markers of disease were used as noted in the table. Comparisons were made between cohorts using non-parametric testing for continuous variables and categorical variables (Table 1). A P-value of ≤0.05 was considered significant. RESULTS: Between Jan 2018 and Dec 2019, 359 patients were identified. 99 were switched from infliximab to infliximab-abda and 101 were continued on infliximab. Baseline demographics were similar between the two groups (Table 1). Both the infliximab-abda and infliximab groups had a higher proportion of patients with CD than UC at 63.6% and 74.3%, respectively. There was no significant difference in the use of corticosteroid taper and maintenance, fecal calprotectin, infliximab concentrations, and antibody levels. Although there was a significant difference in the CRP between patients that were switched compared to patients maintained on bio-originator, the differences are not clinically significant. Emergency department visits and inpatient admissions were similar between the two groups. Similar paired comparisons between patients pre- and post-switch showed no significant differences (Table 2). CONCLUSION: In a large cohort of patients receiving infusions at the Cleveland Clinic, our study demonstrates that a non-medical switch from bio-originator infliximab to biosimilar infliximab-abda was as safe and efficacious as continuing bio-originator therapy for IBD.Table 1.: Patients Switched to Infliximab-abda versus Patients Continued on InfliximabTable 2.: Patients Switched From Infliximab to Infliximab-abda As Self-Controls