目的:英夫利昔单抗生物仿制药CT-P13是首个靶向肿瘤坏死因子-α的生物仿制药。然而,其在现实临床情况下的有效性和安全性仍然不足.因此,我们旨在验证CT-P13在克罗恩病患者中的疗效和安全性。
方法:这项回顾性多中心研究比较了接受原药英夫利昔单抗或CT-P13治疗的克罗恩病患者在第54周的缓解率。评估两组的内窥镜和实验室检查结果。共分析了184例患者(156例发起人和28例CT-P13)。其中,138名发起人用户和19名生物仿制药用户完成了54周的管理。
结果:在第54周服用CT-P13原药英夫利昔单抗的患者的临床缓解率分别为92.5%和100%,分别。两组患者在第54周的内镜评分均较基线显著下降,第54周粘膜愈合率分别为53%和64%,分别。实验室数据,包括C反应蛋白,血清白蛋白,从基线至第14周和第54周,两组的血红蛋白均有显著改善.在CT-P13组中观察到的不良事件更频繁(25%vs.4.5%,p=0.0015),但严重不良事件在两组中均罕见.
结论:CT-P13的疗效和安全性与初始英夫利昔单抗的疗效和安全性相当,通过临床评估,内窥镜,和实验室发现。本研究为开发克罗恩病患者生物制剂治疗策略奠定了必要的基础。
OBJECTIVE: The infliximab biosimilar CT-P13 was the first biosimilar drug targeting tumor necrosis factor-α. However, its efficacy and safety in real-world clinical situations have remained insufficient. Therefore, we aimed to verify the efficacy and safety of CT-P13 in bio-naïve patients with Crohn\'s disease.
METHODS: This retrospective multicenter study compared the remission rate at week 54 between patients with Crohn\'s disease who were treated with originator infliximab or CT-P13. Endoscopic and laboratory findings were assessed in both groups. A total of 184 (156 originator and 28 CT-P13) patients were analyzed. Of these, 138 originator users and 19 biosimilar users completed 54-week administration.
RESULTS: The clinical remission rates in patients taking originator infliximab of CT-P13 at week 54 were 92.5 % and 100 %, respectively. The endoscopic scores of each group significantly decreased from baseline at week 54 in both groups, and the mucosal healing rate at week 54 was 53 % and 64 %, respectively. Laboratory data including C-reactive protein, serum albumin, and hemoglobin significantly improved from baseline to week 14 and 54 in both groups. Adverse events were observed more frequently in the CT-P13 group (25 % vs. 4.5 %, p = 0.0015), but severe adverse events were rare in both groups.
CONCLUSIONS: The efficacy and safety of CT-P13 were comparable with those of originator infliximab in bio-naïve patients with Crohn\'s disease evaluated by clinical, endoscopic, and laboratory findings. This study establishes the needed groundwork for the development of a strategy for treatment with biologics in patients with Crohn\'s disease.