Postoperative adalimumab maintenance therapy for Japanese patients with Crohn's disease: a single-center, single-arm phase II trial (CCOG-1107 study)
Postoperative adalimumab maintenance therapy for Japanese patients with Crohn's disease: a single-center, single-arm phase II trial (CCOG-1107 study)
复制标题
DOI：
10.1007/s00595-018-1634-y
复制
发表时间：
2018-06-01
期刊：
影响因子：
2.5
通讯作者：
Kodera, Yasuhiro
中科院分区：
文献类型：
--
作者：
Asada, Takahiro;Nakayama, Goro;Kodera, Yasuhiro
为研究计划术后阿达木单抗（ADA）治疗日本克罗恩病（CD）患者的疗效和安全性，本研究的受试者为26例因CD接受肠切除术的患者。所有患者均在手术时和2周后接受ADA 160/80 mg皮下注射，随后每2周一次40 mg。本研究的主要终点是术后1年内镜复发率，由Rutgeillance内镜复发量表i2定义，中位随访期41.3个月后，ADA治疗的中位次数为56次，中位至治疗失败时间为25.6个月。34.6%的患者术后1年内镜下复发。单变量分析显示，术前ADA治疗与内镜下复发显著相关。术后1年内复发率为16.7%。不需要因复发而进行二次手术。尽管15.4%的患者发生了不良事件（3级），但没有患者退出本研究。计划的术后ADA治疗降低了日本CD患者肠切除术后内镜和临床复发的发生率。本试验已在大学医院医学信息网络（UMIN 000007514）注册。
To investigate the efficacy and safety of planned postoperative adalimumab (ADA) therapy for Japanese patients with Crohn's disease (CD).The subjects of this study were 26 patients who underwent bowel resection for CD. All patients received subcutaneous injections of ADA 160/80 mg at the time of surgery and 2 weeks later, followed by 40 mg every 2 weeks thereafter. The primary endpoint of this study was the incidence of endoscopic recurrence, defined by Rutgeerts endoscopic recurrence scale i2, 1 year after surgery.After the median follow-up period of 41.3 months, the median number of treatments with ADA was 56 and the median time-to-treatment failure was 25.6 months. Endoscopic recurrence was observed in 34.6% of the patients 1 year after surgery. Univariate analyses showed that preoperative ADA therapy was significantly associated with endoscopic recurrence. Clinical recurrence developed in 16.7% of the patients within 1 year after surgery. Secondary surgery for recurrence was not required. Although adverse events (grade 3) were experienced by 15.4% of patients, none was withdrawn from this study.Planned postoperative ADA therapy reduced the incidence of endoscopic and clinical recurrence after bowel resection in Japanese patients with CD.This trial is registered with the University Hospital Medical Information Network (UMIN000007514).