CT-P13（生物类似药英夫利昔单抗）在现实生活中炎症性肠病患者6个月时的有效性和安全性。

Effectiveness and Safety of CT-P13 (Biosimilar Infliximab) in Patients with Inflammatory Bowel Disease in Real Life at 6 Months.

作者信息

Argüelles-Arias F, Guerra Veloz M F, Perea Amarillo R, Vilches-Arenas A, Castro Laria L, Maldonado Pérez B, Chaaro D, Benítez Roldán A, Merino V, Ramírez G, Caunedo Álvarez A, Romero Gómez M

机构信息

UGC Digestivo Intercentros, Hospitales Universitarios Virgen Macarena-Rocío (Sevilla), Avda Dr. Fedriani 3, 41007, Seville, Spain.

Unidad de Farmacia, Hospital Universitario Virgen Macarena (Sevilla), Avda Dr. Fedriani 3, 41007, Seville, Spain.

出版信息

Dig Dis Sci. 2017 May;62(5):1305-1312. doi: 10.1007/s10620-017-4511-4. Epub 2017 Mar 9.

BACKGROUND

CT-P13 is a biosimilar of Remicade, an agent approved in some countries for use in inflammatory bowel disease (IBD). Controlled clinical trials have demonstrated the efficacy and safety of CT-P13 in rheumatic diseases, but not in IBD.

AIMS

To assess the effectiveness and safety of CT-P13 in IBD patients in real clinical practice.

METHODS

This is a prospective observational study in patients with moderate to severe Crohn's disease or ulcerative colitis treated with CT-P13. The study was performed in one single center. Patients included were naive or switched to anti-TNF treatment from the reference infliximab (Remicade) to CT-P13. Efficacy and safety were assessed in naive and switched patients who were in remission at the time of the switch at months 3 and 6 of therapy.

RESULTS

87.5 and 83.9% of switched CD patients who were in remission at the time of the switch continued in remission, and 66.7 and 50% of naive CD patients reached remission, at months 3 and 6. In UC switched cases, 92 and 91.3% of patients in remission at the time of the switch continued in remission, at 3 and 6 months. In naive UC patients, the remission rates were 44.4 and 66.7%, at months 3 and 6. Adverse events occurred in 7.5% of patients during 6 months of study.

CONCLUSIONS

CT-P13 was efficacious and well tolerated in patients with CD or UC.

背景

CT-P13是Remicade的生物类似药，Remicade在一些国家被批准用于治疗炎症性肠病（IBD）。对照临床试验已证明CT-P13在风湿性疾病中的有效性和安全性，但在IBD中尚未得到证实。

目的

评估CT-P13在实际临床实践中对IBD患者的有效性和安全性。

方法

这是一项对接受CT-P13治疗的中度至重度克罗恩病或溃疡性结肠炎患者进行的前瞻性观察性研究。该研究在一个单一中心进行。纳入的患者为初治患者或从参比英夫利昔单抗（Remicade）转换为CT-P13进行抗TNF治疗的患者。在治疗第3个月和第6个月时，对转换时处于缓解期的初治患者和转换患者的疗效和安全性进行评估。

结果

转换时处于缓解期的克罗恩病转换患者中，分别有87.5%和83.9%在第3个月和第6个月时持续缓解，初治克罗恩病患者的缓解率分别为66.7%和50%。在溃疡性结肠炎转换病例中，转换时处于缓解期的患者分别有92%和91.3%在3个月和6个月时持续缓解。在初治溃疡性结肠炎患者中，第3个月和第6个月时的缓解率分别为44.4%和66.7%。在6个月的研究期间，7.5%的患者发生了不良事件。