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接受英夫利昔单抗或阿达木单抗作为一线生物制剂的克罗恩病患者的长期结局。

Long-term outcomes of patients with Crohn's disease who received infliximab or adalimumab as the first-line biologics.

机构信息

Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.

Department of Gastroenterology, Kagawa Prefectural Central Hospital, Kagawa, Japan.

出版信息

J Gastroenterol Hepatol. 2019 Aug;34(8):1329-1336. doi: 10.1111/jgh.14624. Epub 2019 Feb 27.

Abstract

BACKGROUND AND AIM

Although previous studies compared the efficacy of infliximab (IFX) versus adalimumab (ADA) as the first-line biologics for Crohn's disease (CD), the difference in long-term prognosis based on which biologic was used first has scarcely been reported. In particular, the clinical courses after loss of response (LOR) of the first-line biologics are largely unknown.

METHODS

A multicenter, retrospective study was performed. Disease courses of biologic-naïve CD patients who were started on IFX or ADA treatment were evaluated, even after LOR of the initial biologics.

RESULTS

In total, 263 CD patients were eligible for analysis, 183 were treated with IFX first, and 80 were treated with ADA first. The median observation period was 64.2 months. The cumulative steroid-free remission rates and surgery-free rates did not differ significantly between the patients treated with IFX first and those treated with ADA first (log-rank test P = 0.42 and P = 0.74, respectively). In addition, no significant difference was observed in the rate of occurrence of events associated with ineffectiveness (modification of anti-tumor necrosis factor treatment including intensification, switch, discontinuation, or surgery) between the patient groups (log-rank test P = 0.62). The patients treated with IFX first were likely to discontinue the agent due to adverse events, whereas those treated with ADA first were likely to discontinue due to treatment failure or LOR.

CONCLUSIONS

No significant difference was observed in the long-term prognosis between biologic-naïve patients with CD who were started treatment with IFX first and ADA first.

摘要

背景与目的

虽然之前的研究比较了英夫利昔单抗(IFX)与阿达木单抗(ADA)作为克罗恩病(CD)一线生物制剂的疗效,但很少有报道基于使用哪种生物制剂的差异在长期预后方面的差异。特别是,一线生物制剂治疗应答失败(LOR)后的临床病程在很大程度上是未知的。

方法

进行了一项多中心、回顾性研究。评估了接受 IFX 或 ADA 治疗的生物制剂初治 CD 患者的疾病病程,甚至在初始生物制剂 LOR 后也是如此。

结果

共有 263 例 CD 患者符合分析条件,183 例患者首先接受 IFX 治疗,80 例患者首先接受 ADA 治疗。中位观察期为 64.2 个月。IFX 初治组和 ADA 初治组的无激素缓解率和无手术率无显著差异(log-rank 检验 P=0.42 和 P=0.74)。此外,两组患者中与治疗无效相关事件(包括强化、转换、停药或手术的抗 TNF 治疗改变)的发生率无显著差异(log-rank 检验 P=0.62)。IFX 初治组患者因不良反应而停药的可能性较大,而 ADA 初治组患者因治疗失败或 LOR 而停药的可能性较大。

结论

CD 生物制剂初治患者中,首先接受 IFX 或 ADA 治疗的患者在长期预后方面无显著差异。

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