Real-world data on the infliximab biosimilar CT-P13 (Remsima®) in inflammatory bowel disease

Abstract

BACKGROUND In recent years, biological therapies have revolutionized the management of inflammatory bowel disease (IBD); however, they are expensive. The developmentof biosimilar products has allowed us to reduce healthcare costs andimprove patients’ access to these treatments. Although various studies supportthe similarity between infliximab and its biosimilar CT-P13 in terms of efficacyand safety, there are unmet needs regarding research on these agents in thecontext of IBD.AIMTo analyze clinical response rates to CT-P13 and adverse events in IBD patients METHODSAn observational, prospective, multicenter study of IBD patients treated with CTP13in clinical practice who were naïve to biological treatments or failed torespond to other anti-tumor necrosis factor drugs or had switched from infliximaboriginator was carried out. No diagnostic or follow-up interventions wereconducted on patients outside usual clinical practice. The primary endpoints wereclinical response rates and number of adverse events. The primary efficacyvariable was the proportion of patients who were in clinical remission and/or hada clinical response at 3, 6, 9, and 12 mo.RESULTSA total of 220 IBD patients treated with CT-P13 (Remsima®) were included in thestudy: 87 (40%) with ulcerative colitis and 133 (60%) with Crohn’s disease. Meanage of the patients was 41.47 (SD 15.74) years, and 58% were female. Nineteen(9%) patients started treatment with CT-P13 after switching from infliximab. Ofthe remaining 201 patients, 142 (65%) were naïve to biologic agents. At baseline,68.6% (n = 138/201) of patients presented with active disease. After 12 mo oftreatment, 14.8% (n = 12/81) presented with active disease, and 64.2% (n = 52/81)were in clinical remission without corticosteroids. After 3 mo, 75.5% (n = 115/152)had a clinical response or achieved clinical remission, which was sustained for 12mo (85.2%; n = 69/81). There was a decrease in specific IBD indices at 3, 6, 9, and12 mo (P < 0.001). A total of 34 adverse events were reported by 27 (12.3%)patients, 9 (26.5%) of which were serious.CONCLUSIONCT-P13 is an effective and safe infliximab biosimilar for the treatment of IBD inreal-life practice and may be a valid and attractive alternative for the treatment ofIBD