Abstract
Abstract Background The infliximab biosimilar CT-P13 has been reported to have similar clinical effect compared with its originator. In this study, we evaluated the efficacy and safety of CT-P13 in the treatment of inpatients with severe steroid-refractory colitis. Methods Adult colitis patients (UC or isolated Crohn’s colitis; Montreal classification E2-3, or L3, respectively) admitted to the University of Chicago IBD inpatient service between January 2018 and December 2018 for management of severe colitis refractory to IV steroids who received CT-P13 were included in the study. Patients diagnosed with active small bowel Crohn’s disease were excluded. CT-P13 was given as a single or several infusions of 5 to 10 mg/kg. For all patients, demographic, clinical, laboratory, and endoscopic data were attained by a comprehensive review of their electronic medical records. The primary endpoint was colectomy-free survival. Results Twenty-one patients, 14 with ulcerative colitis and seven with Crohn’s colitis, were included. Fourteen (66%) of patients were female. The median age was 32.2 years (IQR 24.1–43.2). The median disease duration was 4.3 years (IQR 2–10.3), and the median follow-up time was 5.9 months (IQR 1.8–9.1). Patients had a median CRP of 23 (IQR 6–74). All patients had moderate to severe disease on flexible sigmoidoscopy. Three patients (14%) underwent colectomy during their index hospitalisation. Colectomy free survival was 76% at three months and 70% at six months (Figure 1). No severe adverse events were reported in this patient cohort. Conclusion A significant proportion of patients with severe colitis failing IV steroids responded to induction therapy with CT-P13. Colectomy free survival rates were similar to previous randomised trials using originator infliximab as induction therapy in severe steroid-refractory colitis. CT-P13 was effective and safe in hospitalised patients with severe steroid-refractory colitis.
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