比较英夫利西单抗生物类似物与原研药治疗中国成人中重度活动性溃疡性结肠炎（UC）的疗效和安全性。

本研究为回顾性队列分析。纳入2017年12月至2023年12月就诊于山东中医药大学第二附属医院消化中心（来自中国17个省份）的121例接受英夫利西单抗生物类似物或英夫利西单抗原研药治疗的成人中度至重度活动性UC患者。在诱导治疗8周期间评估原研药与生物类似物治疗UC的疗效和安全性。主要观察终点为第8周临床应答率，次要观察终点为第8周临床缓解率、内镜下黏膜愈合率、C反应蛋白、大便次数及不良事件。

纳入121例UC患者中61例使用原研药，60例使用生物类似物。生物类似物组中，患者在第8周的临床应答率、临床缓解率、内镜下黏膜愈合率分别为73.3%、55.0%、53.3%。原研药组中，患者在第8周的临床应答率、临床缓解率、内镜下黏膜愈合率分别为70.5%、56.7%、57.4%。两组患者第8周的临床应答率、临床缓解率、内镜下黏膜愈合率均无明显差异（P>0.05）。两组患者C反应蛋白、大便次数与治疗前相比均明显降低（P<0.05），两组治疗后的数值则无明显差异（P>0.05）。3例（2.5%）患者出现不良事件：其中2例使用原研药，分别表现为双上肢轻微皮肤瘙痒、脱发；1例使用生物类似物，表现为轻微胸闷。

英夫利西单抗生物类似物在诱导UC患者病情缓解方面的疗效和安全性与原研药相当。

To compare the efficacy and safety of infliximab (IFX) biosimilar versus originator in Chinese adults with moderate-to-severe active ulcerative colitis (UC).

This retrospective cohort study enrolled 121 adults with moderate-to-severe active UC treated with IFX biosimilar or originator at the Gastroenterology Center of the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine (covering 17 provinces in China) between December 2017 and December 2023. Efficacy and safety were evaluated during the 8-week induction phase. The primary endpoint was clinical response rate at week 8. Secondary endpoints included clinical remission rate at week 8, endoscopic mucosal healing rate, C-reactive protein, stool frequency, and adverse events.

Among 121 patients, 61 received originator and 60 received biosimilar. In the biosimilar group, the clinical response rate, clinical remission rate, and mucosal healing rate of the patients at the 8th week were 73.3%, 55.0%, and 53.3%, respectively. In the original drug group, the clinical response rate, clinical remission rate, and endoscopic mucosal healing rate of the patients at the 8th week were 70.5%, 56.7%, and 57.4% respectively. There were no statistically significant differences (all P>0.05). Both groups showed significant reductions in CRP and stool frequency from baseline (P<0.05), with comparable post-treatment values between the two groups (P>0.05). Three patients (2.5%) experienced adverse events: two in the originator group (mild pruritus on both upper limbs, alopecia) and one in the biosimilar group (mild chest tightness).

Infliximab biosimilar demonstrates comparable efficacy and safety to the originator in inducing clinical remission in Chinese adults with moderate-to-severe UC.