从 Remicade®转换为 CT-P13 治疗炎症性肠病的有效性和安全性。
Effectiveness and Safety of the Switch from Remicade® to CT-P13 in Patients with Inflammatory Bowel Disease.
机构信息
Gastroenterology Units from Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa [IIS-IP] and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas [CIBERehd], Madrid, Spain.
Gastroenterology Units from Hospital Universitario Virgen Macarena, Sevilla, Spain.
出版信息
J Crohns Colitis. 2019 Oct 28;13(11):1380-1386. doi: 10.1093/ecco-jcc/jjz070.
BACKGROUND AND AIMS
To evaluate the clinical outcomes in patients with IBD after switching from Remicade® to CT-P13 in comparison with patients who maintain Remicade®.
METHODS
Patients under Remicade® who were in clinical remission with standard dosage at study entry were included. The 'switch cohort' [SC] comprised patients who made the switch from Remicade® to CT-P13, and the 'non-switch' cohort [NC] patients remained under Remicade®.
RESULTS
A total of 476 patients were included: 199 [42%] in the SC and 277 [58%] in the NC. The median follow-up was 18 months in the SC and 23 months in the NC [p < 0.01]. Twenty-four out of 277 patients relapsed in the NC; the incidence of relapse was 5% per patient-year. The cumulative incidence of relapse was 2% at 6 months and 10% at 24 months in this group. Thirty-eight out of 199 patients relapsed in the SC; the incidence rate of relapse was 14% per patient-year. The cumulative incidence of relapse was 5% at 6 months and 28% at 24 months. In the multivariate analysis, the switch to CT-P13 was associated with a higher risk of relapse (HR = 3.5, 95% confidence interval [CI] = 2-6). Thirteen percent of patients had adverse events in the NC, compared with 6% in the SC [p < 0.05].
CONCLUSIONS
Switching from Remicade® to CT-P13 might be associated with a higher risk of clinical relapse, although this fact was not supported in our study by an increase in objective markers of inflammation. The nocebo effect might have influenced this result. Switching from Remicade® to CT-P13 was safe.
背景与目的
评估英夫利昔单抗（Remicade®）转换为 CT-P13 后 IBD 患者的临床结局，并与继续使用英夫利昔单抗（Remicade®）的患者进行比较。
方法
纳入研究入组时正在接受标准剂量治疗且处于临床缓解期的 Remicade®患者。“转换队列”（Switch Cohort，SC）包含从 Remicade®转换为 CT-P13 的患者，“未转换队列”（Non-Switch Cohort，NC）包含继续使用 Remicade®的患者。
结果
共纳入 476 例患者：SC 组 199 例（42%），NC 组 277 例（58%）。SC 组的中位随访时间为 18 个月，NC 组为 23 个月（p < 0.01）。NC 组中有 24 例（277 例中的 8%）患者复发，复发率为 5%/患者年。该组的累积复发率在 6 个月时为 2%，24 个月时为 10%。SC 组中有 38 例（199 例中的 19%）患者复发，复发率为 14%/患者年。累积复发率在 6 个月时为 5%，24 个月时为 28%。多变量分析显示，转换为 CT-P13 与更高的复发风险相关（HR = 3.5，95%置信区间[CI] = 2-6）。NC 组有 13%的患者出现不良事件，而 SC 组为 6%（p < 0.05）。
结论
从英夫利昔单抗（Remicade®）转换为 CT-P13 可能与更高的临床复发风险相关，但本研究未发现炎症的客观标志物增加支持这一结果，可能存在安慰剂效应的影响。从英夫利昔单抗（Remicade®）转换为 CT-P13 是安全的。
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