Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
Department of Gastroenterology and Hepatology, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
J Gastroenterol Hepatol. 2021 Aug;36(8):2091-2100. doi: 10.1111/jgh.15399. Epub 2021 Jan 31.
CT-P13, an infliximab (IFX) biosimilar, was approved for treatment of inflammatory bowel disease. However, no comparison with the originator IFX in this indication has been conducted in Japan where endemic levels of tuberculosis and hepatitis virus infection are not low. We evaluated the safety and efficacy in real-world data of CT-P13 and compared with originator IFX data in Japan.
In a prospective post-marketing surveillance (PMS) study, patients who received CT-P13 in a 28-month period from January 2015 were followed up for 2 years. By conducting Japanese administrative database search (DBS) for the same period of PMS, data of the originator IFX including treatment persistence, tuberculosis incidence, and liver injury were analyzed retrospectively and compared with the corresponding PMS data of CT-P13.
CT-P13 persistence in PMS (n = 640) and IFX persistence in DBS (n = 4113) were almost similar between patients who switched from the originator and patients who continued on the originator, and also between the biologics-naïve patient groups. There were no differences in the incidences of tuberculosis and hepatic injury (Tuberculosis: 2 patients [0.31%] with CT-P13, 10 patients [0.24%] with the originator, P = 0.75; Hepatic injury: 18.5% with CT-P13, 15.4% with the originator, P = 0.22). Most of the patients with hepatic injury continued treatment in PMS and DBS at similar rates (80.8% vs 83.6%, P = 0.65).
The results of long-term PMS of CT-P13 compared with external reference data from an administrative database suggested that the biosimilar and its originator were comparably useful in real-world clinical practice.
CT-P13 是一种英夫利昔单抗（IFX）生物类似药，已被批准用于治疗炎症性肠病。然而，在日本，由于结核病和肝炎病毒感染的地方性水平不低，尚未对该适应症下的 CT-P13 与原研 IFX 进行比较。我们评估了 CT-P13 在真实世界数据中的安全性和疗效，并与日本原研 IFX 数据进行了比较。
在一项为期 28 个月的前瞻性上市后监测（PMS）研究中，随访了 2015 年 1 月至 28 个月期间接受 CT-P13 治疗的患者 2 年。通过对同期 PMS 的日本行政数据库搜索（DBS），回顾性分析了原研 IFX 的治疗持续时间、结核病发生率和肝损伤数据，并与 CT-P13 的相应 PMS 数据进行了比较。
在从原研药物转为 CT-P13 治疗的患者和继续使用原研药物的患者之间，以及在生物制剂初治患者组中，PMS 中 CT-P13 的持续性（n=640）和 DBS 中原研 IFX 的持续性几乎相似。结核病和肝损伤的发生率无差异（结核病：CT-P13 组 2 例[0.31%]，原研组 10 例[0.24%]，P=0.75；肝损伤：CT-P13 组 18.5%，原研组 15.4%，P=0.22）。在 PMS 和 DBS 中，大多数肝损伤患者继续治疗的比例相似（80.8% vs 83.6%，P=0.65）。
CT-P13 的长期 PMS 结果与来自行政数据库的外部参考数据相比，表明生物类似药及其原研药在真实临床实践中同样有用。
