Moroi Rintaro, Endo Katsuya, Yamamoto Katsutoshi, Naito Takeo, Onodera Motoyuki, Kuroha Masatake, Kanazawa Yoshitake, Kimura Tomoya, Kakuta Yoichi, Masamune Atsushi, Kinouchi Yoshitaka, Shimosegawa Tooru
Division of Gastroenterology, Department of Internal Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Division of Gastroenterology and Hepatology, Tohoku Medical and Pharmaceutical University, Sendai, Japan.
Intest Res. 2019 Jan;17(1):94-106. doi: 10.5217/ir.2018.00048. Epub 2018 Dec 3.
BACKGROUND/AIMS: Few reports have described the long-term treatment outcomes of the anti-tumor necrosis factor-α antibody for Japanese Crohn's disease (CD) patients. The aim of this study was to evaluate them and clarify the clinical factors that affect the long-term prognosis of the anti-tumor necrosis factor-α treatments.
This was a retrospective, observational, single-center cohort study. Japanese CD patients treated with either infliximab or adalimumab as a first-line therapy were analyzed. The cumulative retention rates of the biologics, relapse-free survival, and surgery-free survival were analyzed using Kaplan-Meier methods. The clinical factors associated with the long-term outcomes were estimated by both the log-rank test and Cox proportional hazard model.
The cumulative retention rate was significantly higher in the group with a concomitant elemental diet of ≥900 kcal/day, baseline C-reactive protein (CRP) levels <2.6 mg/dL, and baseline serum albumin levels ≥3.5 g/dL, respectively. The baseline serum albumin levels were also associated with both relapse-free and surgery-free survival. The lack of concomitant use of an elemental diet ≥900 kcal/day was identified as the only independent risk factor for the withdrawal of the biologics.
Baseline CRP levels and serum albumin levels could affect the long-term outcomes in CD patients. Concomitant elemental diet of ≥900 kcal/day could have a positive influence on clinical treatment course.
背景/目的:关于抗肿瘤坏死因子-α抗体对日本克罗恩病(CD)患者的长期治疗效果,鲜有报道。本研究旨在评估这些效果,并阐明影响抗肿瘤坏死因子-α治疗长期预后的临床因素。
这是一项回顾性、观察性、单中心队列研究。对接受英夫利昔单抗或阿达木单抗作为一线治疗的日本CD患者进行分析。使用Kaplan-Meier方法分析生物制剂的累积保留率、无复发生存率和无手术生存率。通过对数秩检验和Cox比例风险模型评估与长期结局相关的临床因素。
在同时接受每日≥900千卡元素饮食、基线C反应蛋白(CRP)水平<2.6毫克/分升以及基线血清白蛋白水平≥3.5克/分升的组中,累积保留率分别显著更高。基线血清白蛋白水平也与无复发和无手术生存率相关。未同时使用每日≥900千卡元素饮食被确定为停用生物制剂的唯一独立危险因素。
基线CRP水平和血清白蛋白水平可能影响CD患者的长期结局。同时接受每日≥900千卡元素饮食可能对临床治疗过程产生积极影响。