Evaluation of selected serum biomarkers levels in response to the infliximab reference product (Remicade®) versus its biosimilar (Remsima®) in a sample of ulcerative colitis patients: a cross-sectional study

Abstract

Background: Biologic therapies like Remicade® (infliximab originator) and Remsima® (infliximab biosimilar) have emerged as valuable options for the management of ulcerative colitis (UC) over the years. The purpose of the present study was to provide comprehensive comparison of the efficacy of Remicade® and Remsima® in the treatment of UC by performing a comprehensive analysis of key biomarkers. Methods: The study utilized a cross-sectional observational design. It was conducted at Baghdad Teaching Hospital in Baghdad, Iraq, spanning from July 2022 to February 2023. The study population consisted of individuals aged 21 to 57 years who had previously received a diagnosis of ulcerative colitis (UC). Results: A total of 43 patients were included in the analysis. The mean infliximab trough levels in the Remicade group were 3.264 ng/mL, while in the Remsima group were 3.248 ng/mL. eight  Remicade patients developed anti-infliximab antibodies, while 9 Remsima patients tested positive. The mean serum calprotectin level was 5596 μg/ml in the Remicade group and 5795μg/ml in the Remsima group. The mean ESR value was 18.33mm/hr in the Remicade group and 16.43mm/hr in the Remsima group. The mean CRP value was 17.65mg/dl in the Remicade group and 16.19mg/dl in the Remsima group. The mean serum TNFa level measured was 159.5pg/ml in the Remicade group and 158.5pg/ml in the Remsima group. The mean serum Oncostatin M level measured was 107.3ng/ml in the Remicade group and 107.5ng/ml in the Remsima group Conclusion: These findings study suggest that Remsima, as a biosimilar to Remicade, holds promise as a cost-effective alternative in UC management