Clinical Experience of the Use of CT-P13, a Biosimilar to Infliximab in Patients with Inflammatory Bowel Disease: A Case Series

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• 作者：Yun-Seong Kang ; Hyoung Ho Moon ; Seung Eun Lee…
• 关键词：Biosimilar ; Infliximab ; Inflammatory bowel disease ; Anti ; tumor necrosis factor alpha
• 刊名：Digestive Diseases and Sciences
• 出版年：2015
• 出版时间：April 2015
• 年：2015
• 卷：60
• 期：4
• 页码：951-956
• 全文大小：643 KB
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• 作者单位：Yun-Seong Kang (1)
  Hyoung Ho Moon (1)
  Seung Eun Lee (1)
  Yun Jeong Lim (1)
  Hyoun Woo Kang (1)
  
  1. Department of Internal Medicine, College of Medicine, Dongguk University Ilsan Hospital, Goyang, 410-773, Republic of Korea
  
• 刊物类别：Medicine
• 刊物主题：Medicine & Public Health
  Gastroenterology
  Hepatology
  Oncology
  Transplant Surgery
  Biochemistry
  
• 出版者：Springer Netherlands
• ISSN：1573-2568

文摘

Background CT-P13 is the first biosimilar monoclonal antibody to infliximab. However, the antibody was tested only in rheumatoid arthritis and ankylosing spondylitis, which demonstrated equivalence to the originator in efficacy, safety, and pharmacokinetic profile. Extrapolation of its efficacy and safety to other pathologies is tenuous. Interchangeability with its originator is another unclear area. Aim We aimed to describe the experience of CT-P13 use in inflammatory bowel disease at a tertiary center. Methods Seventeen subjects diagnosed with Crohn’s disease (CD, n?=?8) or ulcerative colitis (UC, n?=?9) who were administered CT-P13 from November 2012 to October 2013 at Dongguk University Ilsan Hospital were retrospectively enrolled. Medical records analyzed included patients-characteristics, previous history of anti-tumor necrosis factor administration, response and remission to this biosimilar antibody, disease flare-up, and adverse drug reaction. Results Male–female ratio was 1.8. Mean age was 35.4?years (range 15-7). Mean number of CT-P13 administrations was 4.2?±?1.9. Induction treatments were done in five UC and three CD patients. Clinical response and remission at 8?weeks were achieved in seven patients (five UC and two CD). One CD patient did not respond to CT-P13. Nine patients in maintenance with the originator were interchanged with CT-P13 (four UC and five CD patients). One UC patient experienced arthralgia and CT-P13 was discontinued. One patient experienced loss of response during the study period. Conclusions CT-P13 may have biosimilarity and interchangeability with its originator in inflammatory bowel disease. A large, randomized, double-blind, prospective study is needed.