Implementation of CT-P13 via a Managed Switch Programme in Crohn's Disease: 12-Month Real-World Outcomes
Implementation of CT-P13 via a Managed Switch Programme in Crohn's Disease: 12-Month Real-World Outcomes
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DOI：
10.1007/s10620-018-5406-8
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发表时间：
2019-06-01
影响因子：
3.1
通讯作者：
Lees, Charlie W.
中科院分区：
文献类型：
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作者：
Plevris, Nikolas;Jones, Gareth R.;Lees, Charlie W.
背景从Remicade转换到CT-P13可以显著节省成本，并且已经被证明不逊于继续使用Remicade治疗克罗恩病。目的这项工作的目的是前瞻性地评估一组从Remicade转换到CT-P13的克罗恩病患者的临床结果。在患者最后一次Remicade输注前以及转换为CT-P13作为常规临床护理的一部分后6个月和12个月收集Harvey-Bradshaw指数、CRP、粪便钙保护素和血清英夫利昔单抗/抗体水平。结果100名和10名服用Remicade的患者改用CT-P13。在改用CT-P13前、后6个月和12个月时，Harvey-Bradshaw指数(p=0.07)、CRP(p=0.13)、粪便钙保护素(p=0.25)或英夫利昔单抗谷值(p=0.47)之间无显著差异。7名患者在从Remicade转向CT-P13后产生了新的英夫利昔单抗。大多数患者在12个月时仍在接受CT-P13检查(84.5%)，不良事件发生率为53.8%，严重不良事件发生率为13.5%/100人年。改用CT-P13治疗克罗恩病可节省约46.4%的费用。结论Remicade改用CT-P13治疗克罗恩病是安全的，对12个月后的临床结果没有负面影响。
BackgroundSwitching from Remicade to CT-P13 allows for significant cost savings and has been shown to be non-inferior to continued therapy with Remicade for the treatment of Crohn's disease.AimThe aim of this work was to prospectively evaluate clinical outcomes in a cohort of patients with Crohn's disease switching from Remicade to CT-P13.MethodsA prospective service evaluation was performed. The Harvey-Bradshaw index, CRP, faecal calprotectin and serum for infliximab/antibody levels were collected prior to patients' final Remicade infusion and at 6 and 12months after switching to CT-P13 as part of routine clinical care. All adverse events during follow-up were also recorded.ResultsOne hundredand ten patients on Remicade switched to CT-P13. No significant difference was observed between the Harvey-Bradshaw Index (p=0.07), CRP (p=0.13), faecal calprotectin (p=0.25) or trough infliximab levels (p=0.47) comparing before and at 6 and 12months after the switch to CT-P13. Seven patients developed new infliximab antibodies after switching from Remicade to CT-P13. The majority of patients remained on CT-P13 at 12months (84.5%) and the rate of adverse events and serious adverse events was 53.8 and 13.5 per 100 patient-years of follow-up, respectively. Switching to CT-P13 resulted in a cost saving of approximately 46.4%.ConclusionThe transition to CT-P13 from Remicade for the treatment of Crohn's disease is safe and has no negative effect on clinical outcomes at 12months.