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1189 例克罗恩病患者阿达木单抗治疗的长期保留率及相关预后因素。

Long-term retention of adalimumab treatment and associated prognostic factors for 1189 patients with Crohn's disease.

机构信息

IBD Center, Sapporo Kosei General Hospital, Sapporo, Japan.

Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan.

出版信息

J Gastroenterol Hepatol. 2018 May;33(5):1031-1038. doi: 10.1111/jgh.14034. Epub 2018 Mar 15.

DOI:10.1111/jgh.14034
PMID:29087616
Abstract

BACKGROUND AND AIM

There are few studies on the long-term efficacy of adalimumab treatment for patients with Crohn's disease. We have conducted a large, multicenter, retrospective cohort study to evaluate the long-term retention rate and prognostic factors associated with the discontinuation of adalimumab treatment in patients with Crohn's disease.

METHODS

Data were collected from all patients with Crohn's disease who had received at least one induction dose of 160 mg of adalimumab between October 2010 and December 2013 at 41 institutions. The cumulative retention rates of adalimumab treatment following the first administration were estimated using the Kaplan-Meier method. Prognostic factors related to the cumulative retention rates were evaluated by log-rank tests and multivariate Cox regression analysis.

RESULTS

A total of 1189 patients were included in the study. The 1-, 2-, 3-, and 4-year cumulative retention rates of adalimumab were 81%, 72%, 65%, and 62%, respectively. The multivariate Cox regression analysis confirmed female sex, previous infliximab use, perianal disease, concomitant treatment with prednisolone at baseline, higher C-reactive protein levels, and lower albumin levels as significant independent predictors of poor retention rate of adalimumab treatment. Significantly, more female patients than male patients discontinued adalimumab because of adverse events, especially skin reactions, infections, and arthralgia.

CONCLUSIONS

Our data demonstrated a good retention rate of adalimumab in patients with Crohn's disease over a 4-year period. Female sex, perianal disease, concomitant treatment with prednisolone at baseline, previous infliximab use, higher C-reactive protein levels, and lower albumin levels were associated with poor retention of adalimumab treatment.

摘要

背景与目的

关于阿达木单抗治疗克罗恩病患者的长期疗效,研究较少。我们进行了一项大型、多中心、回顾性队列研究,以评估克罗恩病患者阿达木单抗治疗停药的长期保留率和相关预后因素。

方法

从 2010 年 10 月至 2013 年 12 月,在 41 家机构接受至少一次 160mg 阿达木单抗诱导剂量的所有克罗恩病患者中收集数据。采用 Kaplan-Meier 法估计首次给药后阿达木单抗治疗的累积保留率。通过对数秩检验和多变量 Cox 回归分析评估与累积保留率相关的预后因素。

结果

共纳入 1189 例患者。阿达木单抗的 1、2、3、4 年累积保留率分别为 81%、72%、65%和 62%。多变量 Cox 回归分析证实,女性、既往使用英夫利昔单抗、肛周疾病、基线时合用泼尼松龙、C 反应蛋白水平较高和白蛋白水平较低是阿达木单抗治疗保留率差的独立预测因素。值得注意的是,更多的女性患者因不良反应(尤其是皮肤反应、感染和关节痛)而停用阿达木单抗。

结论

我们的数据显示,在 4 年内,阿达木单抗在克罗恩病患者中的保留率良好。女性、肛周疾病、基线时合用泼尼松龙、既往使用英夫利昔单抗、C 反应蛋白水平较高和白蛋白水平较低与阿达木单抗治疗保留率差有关。

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