Huguet Jose M, García-Lorenzo Victor, Martí Lidia, Paredes Jose María, Ramírez Jose Joaquin, Pastor Miguel, Ruiz Lucia, Sanahuja Ana, Timoneda Pilar, Sanchís Laura, Pérez Gloria Alemany, Boscá-Watts Marta Maia
Gastroenterology Department, Hospital General Universitario de Valencia, 46014 Valencia, Spain.
Gastroenterology Department, Hospital Francesc de Borja de Gandia, 46702 Valencia, Spain.
Biomedicines. 2022 Aug 30;10(9):2130. doi: 10.3390/biomedicines10092130.
Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, is characterized by chronic relapsing intestinal inflammation. There are few data on the efficacy and safety in clinical practice of infliximab (CT-P13) in subcutaneous formulation (SC) for the treatment of patients with IBD.
Multicenter, prospective study of patients with IBD in clinical remission, who had their treatment changed from intravenous (IV) infliximab to SC. Two groups of patients were evaluated according to whether they were on IV infliximab treatment at standard or intensified doses before the switch.
A total of 30 patients were on standard dosing and another 30 in intensified therapy. Treatment persistence in both groups at 6 months was greater than 95%. In both groups after the change, neither the biomarkers of inflammation nor the activity indices underwent significant changes at 3 and 6 months compared to the baseline value. Similarly, in both groups, infliximab trough levels showed a significant increase 3 and 6 months after the change to SC. No serious adverse events were registered.
The CT-P13 SC brings a new anti-TNF era. Achieving much higher drug levels that are constant over time opens new paths to explore the management of patients with IBD: less immunogenicity, better perianal disease control and higher achievement of mucosal healing.
炎症性肠病（IBD），包括克罗恩病和溃疡性结肠炎，其特征为慢性复发性肠道炎症。关于英夫利昔单抗（CT-P13）皮下制剂（SC）在临床实践中治疗IBD患者的疗效和安全性的数据较少。
对处于临床缓解期的IBD患者进行多中心前瞻性研究，这些患者的治疗从静脉注射（IV）英夫利昔单抗改为皮下注射。根据转换前患者接受标准剂量还是强化剂量的静脉注射英夫利昔单抗治疗，将患者分为两组进行评估。
共有30例患者接受标准剂量治疗，另外30例接受强化治疗。两组在6个月时的治疗持续率均超过95%。两组转换治疗后，与基线值相比，炎症生物标志物和活动指数在3个月和6个月时均未发生显著变化。同样，两组在转换为皮下注射后3个月和6个月时，英夫利昔单抗谷浓度均显著升高。未记录到严重不良事件。
CT-P13皮下制剂开启了新的抗TNF时代。实现随时间持续保持更高的药物水平为探索IBD患者的管理开辟了新途径：免疫原性更低、肛周疾病控制更好以及黏膜愈合率更高。
