Efficacy and safety of biosimilar infliximab in bio-naïve patients with Crohn’s disease

IF 1.1 4区 医学 Q4 GASTROENTEROLOGY & HEPATOLOGY Arab Journal of Gastroenterology Pub Date : 2024-08-01 DOI:10.1016/j.ajg.2024.03.006
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Abstract

Background and study aims

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.

Patients and 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.

Conclusion

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.

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生物仿制药英夫利西单抗在克罗恩病患者中的疗效和安全性。
背景和研究目的:英夫利昔单抗生物仿制药 CT-P13 是首个针对肿瘤坏死因子-α 的生物仿制药。然而,它在实际临床情况下的疗效和安全性仍然不足。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:这项回顾性多中心研究比较了接受原研英夫利西单抗或CT-P13治疗的克罗恩病患者在第54周时的缓解率。对两组患者的内镜和实验室检查结果进行了评估。共分析了184名患者(156名原研药使用者和28名CT-P13使用者)。其中,138名原研药使用者和19名生物仿制药使用者完成了为期54周的用药:结果:服用原研英夫利西单抗和CT-P13的患者在第54周的临床缓解率分别为92.5%和100%。第54周时,两组患者的内镜评分均较基线明显下降,第54周时的粘膜愈合率分别为53%和64%。从基线到第 14 周和第 54 周,两组的 C 反应蛋白、血清白蛋白和血红蛋白等实验室数据均有明显改善。CT-P13组出现不良反应的频率更高(25%对4.5%,P = 0.0015),但两组均很少出现严重不良反应:结论:通过临床、内镜和实验室检查结果评估,CT-P13 对生物无效的克罗恩病患者的疗效和安全性与原研药英夫利西单抗相当。这项研究为制定克罗恩病患者生物制剂治疗策略奠定了必要的基础。
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来源期刊
Arab Journal of Gastroenterology
Arab Journal of Gastroenterology Medicine-Gastroenterology
CiteScore
2.70
自引率
0.00%
发文量
52
期刊介绍: Arab Journal of Gastroenterology (AJG) publishes different studies related to the digestive system. It aims to be the foremost scientific peer reviewed journal encompassing diverse studies related to the digestive system and its disorders, and serving the Pan-Arab and wider community working on gastrointestinal disorders.
期刊最新文献
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