Kang Yun-Seong, Moon Hyoung Ho, Lee Seung Eun, Lim Yun Jeong, Kang Hyoun Woo
Department of Internal Medicine, College of Medicine, Dongguk University Ilsan Hospital, Goyang, 410-773, Republic of Korea.
Dig Dis Sci. 2015 Apr;60(4):951-6. doi: 10.1007/s10620-014-3392-z. Epub 2014 Oct 18.
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.
We aimed to describe the experience of CT-P13 use in inflammatory bowel disease at a tertiary center.
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.
Male-female ratio was 1.8. Mean age was 35.4 years (range 15-57). 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.
CT-P13 may have biosimilarity and interchangeability with its originator in inflammatory bowel disease. A large, randomized, double-blind, prospective study is needed.
CT-P13是首个英夫利昔单抗生物类似药单克隆抗体。然而，该抗体仅在类风湿关节炎和强直性脊柱炎中进行了测试，在疗效、安全性和药代动力学方面与原研药相当。将其疗效和安全性外推至其他病症尚无充分依据。与原研药的可互换性也是一个不明确的领域。
我们旨在描述三级医疗中心使用CT-P13治疗炎症性肠病的经验。
回顾性纳入2012年11月至2013年10月在东国大学一山医院接受CT-P13治疗的17例诊断为克罗恩病（CD，n = 8）或溃疡性结肠炎（UC，n = 9）的患者。分析的病历包括患者特征、既往抗肿瘤坏死因子治疗史、对该生物类似抗体的反应和缓解情况、疾病复发及药物不良反应。
男女比例为1.8。平均年龄为35.4岁（范围15 - 57岁）。CT-P13的平均给药次数为4.2 ± 1.9次。5例UC患者和3例CD患者进行了诱导治疗。8周时7例患者（5例UC和2例CD）实现了临床反应和缓解。1例CD患者对CT-P13无反应。9例正在使用原研药维持治疗的患者换用了CT-P13（4例UC和5例CD患者）。1例UC患者出现关节痛，停用了CT-P13。1例患者在研究期间出现反应丧失。
CT-P13在炎症性肠病中可能与原研药具有生物相似性和可互换性。需要开展一项大型、随机、双盲、前瞻性研究。
