Long‐term efficacy and safety of CT‐P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study

Abstract

Background and Aim A biosimilar of infliximab, CT‐P13 (Remsima®) has the potential to reduce treatment costs and enhance access to biological therapy for inflammatory bowel disease (IBD) patients. However, long‐term clinical data on its use for IBD treatment are currently sparse. We aimed to investigate the long‐term efficacy and safety of CT‐P13 therapy in a large, real‐life IBD cohort. Methods A total of 368 IBD patients (227 with Crohn's disease [CD] and 141 with ulcerative colitis [UC]) treated with CT‐P13 at 16 referral hospitals in Korea between July 2012 and December 2017 were retrospectively analyzed. Results The cumulative retention rates at years 1, 3, and 5 were 86.1%, 68.5%, and 58.7% and 69.7%, 46.0%, and 26.7% in anti‐tumor necrosis factor (TNF)‐naïve CD and UC patients, respectively. The clinical response and remission rates at week 14 and at years 1, 3, and 5 were 94.3%, 92.7%, 76.8%, and 17.6% and 78.6%, 82.4%, 72.2%, and 17.6% in anti‐TNF‐naïve CD and 85.6%, 80.0%, 55.2%, and 6.7% and 42.6%, 59.8%, 44.2%, and 6.7% in anti‐TNF‐naïve UC patients, respectively. Among patients who switched from the biologic originator to CT‐P13, the cumulative retention rates at years 1, 3, and 5 were 88.5%, 66.1%, and 44.8% in CD, and 73.9%, 42.5%, and 42.5% in UC patients, respectively. Significant improvements in disease activity scores were accompanied by marked reductions in inflammatory marker levels, and no unexpected adverse events including death or malignancy occurred during the study period. Conclusions Long‐term treatment with CT‐P13 is effective in inducing and maintaining disease improvement and is well‐tolerated in patients with IBD. CT‐P13 may be a promising treatment option for IBD.

Effectiveness of Switching from Reference Product Infliximab to Infliximab-Dyyb in Patients with Inflammatory Bowel Disease in an Integrated Healthcare System in the United States: A Retrospective, Propensity Score-Matched, Non-Inferiority Cohort Study

“…Recently, more studies have been published regarding the experience of patients with IBD who switched to infliximab-dyyb from RP infliximab [22][23][24][25][26][27][28][29][30][31][32][33][34]. These included one meta-analysis [22], many single group observational studies [23][24][25][26][27][28][29][30][31][32], and two studies with comparison groups [33,34]. The length of follow-up ranged from 4 months [23] to 5 years [24].…”

“…These included one meta-analysis [22], many single group observational studies [23][24][25][26][27][28][29][30][31][32], and two studies with comparison groups [33,34]. The length of follow-up ranged from 4 months [23] to 5 years [24]. Patients with IBD were recruited from Europe [25][26][27][28][29][30][31][32][33][34] and Asia [23,24].…”

“…The length of follow-up ranged from 4 months [23] to 5 years [24]. Patients with IBD were recruited from Europe [25][26][27][28][29][30][31][32][33][34] and Asia [23,24]. All except one study [34] have demonstrated no differences or noninferiority in effectiveness and safety between RP infliximab and infliximab-dyyb.…”

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

“…For extrapolation to be permitted, biosimilarity must have been demonstrated in in vitro, nonclinical, and clinical studies, and the rationale for extrapolation must be scientifically justifiable [3]. Today, approval of CT-P13 in IBD is also supported by real-world evidence and clinical trial data [34,[120][121][122][123], including from the randomized, double-blind, noninferiority phase IV NOR-SWITCH study [120] and a Hungarian prospective observational cohort study [124]. To our knowledge, no published clinical trials evaluating the approved adalimumab biosimilars ABP 501, BI 695501, or SB5 in IBD, or real-world evidence for other infliximab biosimilars exist.…”

Terápiás lehetőségek kísérletes vastagbélgyulladásos patkánymodellben

“…A Remsima olyan ki-méra monoklonális IgG1 antitest, amelyet ugyanazon technológiával állítottak elő, mint az infliximabot, és az infliximabéval megegyező aminosav-szekvenciával rendelkezik, viszont olcsóbb annál. Hosszú távú alkalmazása hatékony, ígéretes kezelési lehetőség lehet az IBD-s betegek számára [116,117] .…”