英夫利昔单抗
医学
胃肠病学
内科学
克罗恩病
不利影响
单变量分析
临床终点
炎症性肠病
置信区间
临床试验
疾病
多元分析
作者
Yasuo Suzuki,Toshiyuki Matsui,Hiroaki Ito,Toshifumi Ashida,Shirô Nakamura,Satoshi Motoya,Takayuki Matsumoto,Noriko Sato,Kokoro Ozaki,Mamoru Watanabe,Toshifumi Hibi
出处
期刊:Inflammatory Bowel Diseases
[Oxford University Press]
日期:2015-09-01
卷期号:21 (9): 2114-2122
被引量:36
标识
DOI:10.1097/mib.0000000000000475
摘要
We aimed to clarify the efficacy, safety, and factors associated with remission on dose escalation in patients with Crohn's disease showing loss of response (LOR) to infliximab treatment of 5 mg/kg at 8-week intervals in a clinical trial.Thirty-nine patients with LOR to 5 mg/kg infliximab therapy started treatment with 10 mg/kg per 8 weeks. LOR was defined as both a Crohn's Disease Activity Index of ≥175 at 8 weeks after infusion of 5 mg/kg infliximab and a Crohn's Disease Activity Index increase of ≥50 from 4 to 8 weeks after infusion.At week 8 after the first infusion of 10 mg/kg, median (95% confidence interval) reduction in Crohn's Disease Activity Index of 33 patients evaluated was 95.0 (70.0-134.0), meeting the primary endpoint. Remission rate at week 40 was 41% (16 of 39), with correlation noted between remission achievement and serum infliximab level (P = 0.036). Univariate analysis revealed that "infliximab trough level ≥1 µg/mL," "interleukin 6 level ≤2.41 pg/mL," and "albumin level ≥3.8 g/dL" before dose escalation were significantly associated with remission at week 40 (P = 0.017, P = 0.011, and P = 0.019, respectively), and these variables were correlated with each other (all: P < 0.001). The cutoff infliximab level for remission was 0.42 µg/mL in receiver operating characteristic curve analysis. No adverse events related to dose escalation were observed.Doubling the infliximab dose safely led to remission in patients with Crohn's disease with LOR to 5 mg/kg treatment. Remission was associated with pre-escalation levels of infliximab, interleukin 6, and albumin. Our findings suggest that dose escalation while maintaining a certain level of infliximab is important in achieving remission.
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