소아 청소년기 염증성 장 질환에서 인플릭시맙 바이오시밀러 CT-P13으로 교체 투여후의 장기 추적 결과에 대한 단일 기관 전향적 관찰 연구

소아 청소년기 염증성 장 질환에서 인플릭시맙 바이오시밀러 CT-P13으로 교체 투여후의 장기 추적 결과에 대한 단일 기관 전향적 관찰 연구

Long-Term Outcomes After Switching to CT-P13 in Pediatric-Onset Inflammatory Bowel Disease: a Single-Center Prospective Observational Study

(구연):
Release Date : 2017. 10. 26(목)
Ben Kang1, Yoon Lee2, Kiwuk Lee3, Young Ok Choi3 , Yon Ho Choe3
Kyungpook National University School of Medicine Department of Pediatrics1
Korea University College of Medicine Department of Pediatrics2
Sungkyunkwan University School of Medicine Department of Pediatrics3
강빈1, 이윤2, 이기욱3, 최영옥3 , 최연호3
경북대학교 의학전문대학원 소아과학교실1
고려대학교 의과대학 소아과학교실2
성균관대학교 의과대학 소아과학교실3

Abstract

Background & Aims: The relatively high cost and patent expiry of infliximab (IFX), 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). The biosimilar CT-P13 has been approved worldwide for all indications held by the infliximab RP. This study investigated the long-term efficacy, safety, pharmacokinetics, and immunogenicity of CT-P13 after switching from infliximab RP. Methods: In this prospective, observational study, patients with pediatric-onset IBD receiving maintenance IFX RP were followed for one year after continuing IFX RP (RP maintenance group) or switching to CT-P13 (CT-P13 switch group). Primary endpoints were the proportion of patients continuously receiving infliximab and the proportion achieving persistent remission – corticosteroid-free sustained clinical remission without dose intensification – at one year. Clinical activity scores, laboratory test results, IFX trough levels, and antibody to IFX levels were also compared between groups, and also between switch point and 1 year after in the CT-P13 switch group. Results: Seventy four patients (64 patients with Crohn\'s disease, 14 patients with ulcerative colitis) were included in this study. Thirty-six patients were recruited to the RP maintenance group and 38 to the CT P13 switch group. In the maintenance and switch group, 31 (86.1%) and 35 (92.1%) patients continuously received IFX for one year ( P = 0.649), and 24 (77.8%) and 28 patients (78.9%) experienced persistent remission at one year ( P =1.000), respectively. There were no statistically significant differences in any measures of disease activity, pharmacokinetics, or immunogenicity between the two groups at 1 year as well as between the time of switch and 1-year post-switch in the CT-P13 switch group. Twenty-seven adverse events occurred in the maintenance group and 30 in the switch group. No serious adverse events or infusion-related reactions leading to discontinuation of IFX were observed. Conclusions: Switching from maintenance IFX 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.

Keywords: Biosimilar, Infliximab, Switch