Long-term Outcomes After Switching to CT-P13 in Pediatric-Onset Inflammatory Bowel Disease: A Single-Center Prospective Observational Study. Issue 3 (30th January 2018)

• Record Type: Journal Article
• Authors: Kang, Ben; Lee, Yoon; Lee, Kiwuk; Choi, Young Ok; Choe, Yon Ho
• Is Part Of: Inflammatory bowel diseases. Volume 24:Issue 3(2018)
• Page Start: 607
• Page End: 616
• Publication Date: 2018-01-30
• Subjects: biosimilar -- children -- inflammatory bowel disease -- infliximab -- switching; Inflammatory bowel diseases -- Periodicals; Colitis, Ulcerative -- Periodicals; Crohn Disease -- Periodicals; Inflammatory Bowel Diseases -- Periodicals; 616.344
• DOI: 10.1093/ibd/izx047
• Languages: English
• ISSNs: 1078-0998

Abstract

Abstract: Background: The relatively high cost and patent expiry of infliximab, an anti–tumor necrosis factor monoclonal antibody used in inflammatory bowel disease (IBD), has led to the development of biosimilar versions of the reference product (RP). This study investigated the long-term efficacy, safety, pharmacokinetics, and immunogenicity of CT-P13 after switching from infliximab RP in pediatric-onset IBD patients. Methods: In this prospective observational study, patients with pediatric-onset IBD receiving maintenance infliximab RP were followed for 1 year after continuing infliximab RP (RP maintenance group) or switching to CT-P13 (CT-P13 switch group). Primary end points were the proportion of patients continuously receiving infliximab and the proportion achieving persistent remission—corticosteroid-free sustained clinical remission without dose intensification—at 1 year. Results: Thirty-six patients were recruited to the RP maintenance group and 38 to the CT-P13 switch group. At 1 year in the RP maintenance group and CT-P13 switch group, 86.1% (31/36) and 92.1% (35/38) patients had continuously received infliximab ( P = 0.649), and 77.8% (28/36) and 78.9% (30/38) patients experienced persistent remission ( P = 1.000), respectively. There were no statistically significant differences in any measures of disease activity, pharmacokinetics, or immunogenicity between the time of switch and 1-year postswitch in the CT-P13 switch group. Twenty-seven adverse events occurred in the maintenance group and 30 in the switch group. Conclusions: Switching from maintenance infliximab RP to CT-P13 did not result in any significant differences in efficacy, pharmacokinetics, or immunogenicity in patients with pediatric-onset IBD, and no unexpected safety issues occurred, supporting findings from randomized controlled trials.