Buer Lydia C T, Moum Bjørn A, Cvancarova Milada, Warren David J, Medhus Asle W, Høivik Marte Lie
Department of Gastroenterology, Oslo University Hospital, Oslo, Norway.
Faculty of Medicine, University of Oslo, Oslo, Norway.
J Crohns Colitis. 2017 Mar 1;11(3):297-304. doi: 10.1093/ecco-jcc/jjw166.
A biosimilar version of infliximab [CT-P13/Remsima®] recently entered the European market. The clinical data on its use in inflammatory bowel disease [IBD] are sparse, especially on switching from the originator Remicade®. In this study, we aimed to prospectively investigate the feasibility, safety and immunogenicity of switching from Remicade to Remsima in a real-life IBD population.
All adult patients who were treated with Remicade in the Department of Gastroenterology at Oslo University Hospital were switched to Remsima. The follow-up lasted for 6 months. In addition, a retrospective registration was performed with a start time of 6 months before switching drugs. The primary endpoints were [i] the proportion of patients remaining on medication 6 months after switching and [ii] adverse events during the 6 months after switching. The secondary endpoints included [i] disease activity scores [Harvey-Bradshaw Index and Partial Mayo Score], C-reactive protein, haemoglobin, faecal calprotectin, infliximab dose and interval, and p-infliximab and [ii] the development of antidrug antibodies.
In total, 143 IBD patients were switched, 99 with Crohn's disease and 44 with ulcerative colitis. The large majority [97%] remained on the medication throughout follow-up. A low number of adverse events were observed. No change in disease activity, C-reactive protein, haemoglobin, faecal calprotectin, infliximab dose and interval or p-infliximab was detected. Three patients developed new detectable antidrug antibodies.
Switching from Remicade to Remsima was feasible and with few adverse events, including very limited antidrug antibody formation and loss of response.
英夫利昔单抗的生物类似药[CT-P13/Remsima®]最近进入了欧洲市场。其用于炎症性肠病[IBD]的临床数据较少，尤其是从原研药Remicade®转换用药方面的数据。在本研究中，我们旨在前瞻性地调查在真实世界的IBD患者群体中从Remicade转换为Remsima的可行性、安全性和免疫原性。
奥斯陆大学医院胃肠病科所有接受Remicade治疗的成年患者均转换为Remsima治疗。随访持续6个月。此外，进行了一项回顾性登记，起始时间为换药前6个月。主要终点为：[i]换药后6个月仍在用药的患者比例；[ii]换药后6个月内的不良事件。次要终点包括：[i]疾病活动评分[Harvey-Bradshaw指数和部分Mayo评分]、C反应蛋白、血红蛋白、粪便钙卫蛋白、英夫利昔单抗剂量和间隔时间，以及抗英夫利昔单抗；[ii]抗药抗体的产生情况。
共有143例IBD患者进行了换药，其中99例为克罗恩病患者，44例为溃疡性结肠炎患者。绝大多数患者[97%]在整个随访期间持续用药。观察到的不良事件数量较少。未检测到疾病活动、C反应蛋白含量、血红蛋白水平、粪便钙卫蛋白含量、英夫利昔单抗剂量和间隔时间或抗英夫利昔单抗水平发生变化。3例患者产生了新的可检测到的抗药抗体。
从Remicade转换为Remsima是可行的，不良事件较少，包括抗药抗体形成非常有限以及疗效丧失。
