Smits Lisa J T, Grelack Anna, Derikx Lauranne A A P, de Jong Dirk J, van Esch Aura A J, Boshuizen Ronald S, Drenth Joost P H, Hoentjen Frank
Inflammatory Bowel Disease Center, Department of Gastroenterology and Hepatology, Radboud University Medical Center, PO Box 9101, Code 455, 6500 HB, Nijmegen, The Netherlands.
Biologics Laboratory, Sanquin Diagnostic Services, Amsterdam, The Netherlands.
Dig Dis Sci. 2017 Nov;62(11):3117-3122. doi: 10.1007/s10620-017-4661-4. Epub 2017 Jun 30.
Limited data are available on long-term clinical outcomes regarding the switch from Remicade to the infliximab biosimilar CT-P13 in inflammatory bowel disease (IBD) patients.
To investigate long-term efficacy, safety, pharmacokinetic profile, and immunogenicity.
We performed a single-center prospective observational cohort study following an elective switch from Remicade to CT-P13 in IBD patients.
Eighty-three patients were included (57 Crohn's disease, 24 ulcerative colitis, and 2 IBD unclassified), and 68 patients completed one-year follow-up. Disease activity (Harvey-Bradshaw Index and Simple Clinical Colitis Activity Index) as well as inflammatory markers (CRP, fecal calprotectin) did not change significantly during the 1-year follow-up. In total, 7 out of 83 patients (8%) demonstrated detectable antidrug antibodies during follow-up, and 5 out of 7 antidrug antibody titers were already detectable at baseline prior to switching. Six patients (7%) discontinued CT-P13 due to adverse events.
Following a switch from Remicade to CT-P13, 82% of IBD patients continued treatment through 1 year. Disease activity scores and inflammatory markers remained unchanged during follow-up, and no CT-P13-related serious adverse events occurred. These 1-year data suggest that switching to CT-P13 in Remicade-treated IBD patients is safe and feasible.
关于炎症性肠病（IBD）患者从类克（Remicade）转换为英夫利昔单抗生物类似药CT-P13的长期临床结局，可用数据有限。
研究长期疗效、安全性、药代动力学特征和免疫原性。
我们对IBD患者进行了一项单中心前瞻性观察队列研究，这些患者经选择从类克转换为CT-P13。
纳入83例患者（57例克罗恩病、24例溃疡性结肠炎和2例未分类的IBD），68例患者完成了1年随访。在1年随访期间，疾病活动度（哈维-布拉德肖指数和简易临床结肠炎活动指数）以及炎症标志物（CRP、粪便钙卫蛋白）均无显著变化。在随访期间，83例患者中有7例（8%）检测到抗药抗体，7例抗药抗体滴度中有5例在转换前基线时就已可检测到。6例患者（7%）因不良事件停用CT-P13。
从类克转换为CT-P13后，82%的IBD患者持续治疗1年。随访期间疾病活动度评分和炎症标志物保持不变，且未发生与CT-P13相关的严重不良事件。这些1年的数据表明，在接受类克治疗的IBD患者中转换为CT-P13是安全可行的。
