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阿达木单抗/戈利木单抗转换为英夫利昔单抗治疗溃疡性结肠炎的结局:一项多中心回顾性研究。

Outcome in ulcerative colitis after switch from adalimumab/golimumab to infliximab: A multicenter retrospective study.

机构信息

Clinical Unit for Chronic Bowel Disorders, Dept. of Clinical and Experimental Medicine, University of Messina, Messina, Italy.

IBD-Unit Complesso Integrato Columbus, Fondazione Policlinico Gemelli, Catholic University, Rome, Italy.

出版信息

Dig Liver Dis. 2019 Apr;51(4):510-515. doi: 10.1016/j.dld.2018.10.013. Epub 2018 Oct 28.

DOI:10.1016/j.dld.2018.10.013
PMID:30472389
Abstract

BACKGROUND

Anti-TNF therapies infliximab (IFX), adalimumab (ADA), and golimumab (GOL) are approved for treating moderate to severe ulcerative colitis (UC). In UC, only the switch from IFX to ADA has been investigated, reaching no more than 10-43% remission rates at 12 months.

AIM

Of the present study was to investigate disease outcome after a switch from subcutaneous (SC) agents to the intravenous (IV) agent (IFX).

METHODS

In this retrospective multicentre study, we analysed the charts of UC patients unresponsive/intolerant or with secondary loss of response (LOR) to ADA or GOL who were switched to IFX. We evaluated clinical response and remission together with adverse events at 3, 6, and 12 months follow-up.

RESULTS

Seventy-six patients were included; 38 patients started ADA and 38 started GOL for a mean therapy duration of 6 ± 6 months. Indications for switch were adverse events in 3%, primary failure in 79%, and LOR in 18% of patients. Clinical remission was reached by 47%, 50%, and 77% of patients, respectively. Patients that switched for LOR did numerically, but not statistically, better than patients who switched for primary failure.

CONCLUSIONS

Our data show a superior remission rate in SC to IV anti-TNF switch in UC compared to the IV to SC switch reported in literature.

摘要

背景

英夫利昔单抗(IFX)、阿达木单抗(ADA)和戈利木单抗(GOL)等抗 TNF 疗法已被批准用于治疗中重度溃疡性结肠炎(UC)。在 UC 中,仅研究了从 IFX 转换为 ADA,在 12 个月时达到的缓解率不超过 10-43%。

目的

本研究旨在探讨从皮下(SC)制剂转换为静脉内(IV)制剂(IFX)后疾病结局。

方法

在这项回顾性多中心研究中,我们分析了对 ADA 或 GOL 无反应/不耐受或出现继发性失应答(LOR)的 UC 患者的病历。我们在 3、6 和 12 个月随访时评估了临床应答和缓解以及不良事件。

结果

共纳入 76 例患者;38 例患者开始使用 ADA,38 例患者开始使用 GOL,平均治疗时间为 6±6 个月。转换的指征为 3%的患者出现不良事件,79%的患者出现原发性治疗失败,18%的患者出现 LOR。分别有 47%、50%和 77%的患者达到临床缓解。LOR 患者的缓解率在数值上优于原发性治疗失败的患者,但无统计学差异。

结论

与文献报道的 IV 到 SC 转换相比,我们的数据显示 UC 中 SC 到 IV 抗 TNF 转换的缓解率更高。

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