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阿达木单抗治疗抗 TNF 初治溃疡性结肠炎患者:深度缓解和应答因素。

Adalimumab treatment of anti-TNF-naïve patients with ulcerative colitis: Deep remission and response factors.

机构信息

Department of Gastroenterology, University Hospital of Basurto, Bilbao, Spain.

Department of Gastroenterology, University Hospital of Basurto, Bilbao, Spain.

出版信息

Dig Liver Dis. 2018 Aug;50(8):812-819. doi: 10.1016/j.dld.2018.03.007. Epub 2018 Mar 14.

DOI:10.1016/j.dld.2018.03.007
PMID:29625907
Abstract

BACKGROUND

Adalimumab is the second tumour necrosis factor antagonist (anti-TNF) adopted for the treatment of ulcerative colitis. Clinical data from naïve patients are scarce.

AIM

Examine the response to adalimumab in TNF-antagonist-naïve patients.

METHODS

This multicentre, observational, prospective study was conducted using a cohort of consecutive patients with ulcerative colitis. Clinical remission, mucosal healing and deep remission were examined employing the Mayo Score and Mayo Endoscopic Score. Clinical response was assessed using the Partial Mayo Score.

RESULTS

Of 53 individuals included in this study, 49.1% of patients were in clinical remission at week 8 and 60.3%, at week 52. Clinical response was observed in 84.9% and 69.8%, respectively. Mucosal healing was found in 62.3% and 67.9% of the patients, and 43.4% and 58.4% showed deep remission at week 8 and 52, respectively. After a year, 71.7% of the patients continued the adalimumab treatment. Adverse effects were observed in 28.3% of patients. Multivariate analysis showed that the long-term factor predictive of response at week 52 was the response in week 8 (expressed as Mayo Score; OR 0.66; 95% IC 0.1-0.67, p < 0.006).

CONCLUSIONS

Adalimumab treatment of ulcerative colitis is effective; the results are better in clinical practice and in patients naïve to anti-TNF.

摘要

背景

阿达木单抗是第二种被用于治疗溃疡性结肠炎的肿瘤坏死因子拮抗剂(抗 TNF)。针对初治患者的临床数据较为匮乏。

目的

评估阿达木单抗在初治的溃疡性结肠炎患者中的应答情况。

方法

本项多中心、观察性、前瞻性研究采用了连续溃疡性结肠炎患者队列。采用 Mayo 评分和 Mayo 内镜评分评估临床缓解、黏膜愈合和深度缓解情况。采用部分 Mayo 评分评估临床应答。

结果

本研究共纳入 53 例患者,8 周时 49.1%的患者达到临床缓解,52 周时 60.3%的患者达到临床缓解。分别有 84.9%和 69.8%的患者观察到临床应答。黏膜愈合在第 8 周和第 52 周时分别为 62.3%和 67.9%,深度缓解分别为 43.4%和 58.4%。一年后,71.7%的患者继续接受阿达木单抗治疗。28.3%的患者出现不良反应。多变量分析显示,第 52 周时应答的长期预测因素是第 8 周时的应答(用 Mayo 评分表示;OR 0.66;95%CI 0.1-0.67,p<0.006)。

结论

阿达木单抗治疗溃疡性结肠炎有效;在临床实践和初治的抗 TNF 患者中疗效更好。

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