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炎症性肠病患者抗肿瘤坏死因子治疗的停用:一项前瞻性观察。

Discontinuation of anti-tumor necrosis factor therapy in inflammatory bowel disease patients: a prospective observation.

作者信息

Bortlik Martin, Duricova Dana, Machkova Nadezda, Hruba Veronika, Lukas Martin, Mitrova Katarina, Romanko Igor, Bina Vladislav, Malickova Karin, Kolar Martin, Lukas Milan

机构信息

a IBD Clinical and Research Centre, Iscare a.s. , Prague , Czech Republic .

b Department of Internal Medicine , Military Hospital, Charles University , Prague , Czech Republic .

出版信息

Scand J Gastroenterol. 2016;51(2):196-202. doi: 10.3109/00365521.2015.1079924. Epub 2015 Sep 2.

Abstract

BACKGROUND

Discontinuation of anti-TNF therapy in patients with inflammatory bowel diseases (IBD) in remission remains a controversial issue. The aims of our study were to assess the proportion of patients who relapse after cessation of biological treatment, and to identify potential risk factors of disease relapse.

METHODS

Consecutive IBD patients who discontinued anti-TNF therapy in steroid-free clinical and endoscopic remission were prospectively followed. Multiple logistic regression and Cox proportional-hazards models were used to assess the predictors of disease relapse.

RESULTS

Seventy-eight IBD patients (Crohn's disease, CD 61; ulcerative colitis, UC 17) were included and followed for a median of 30 months (range 7-47). A total of 32 (53%) CD patients and nine (53%) UC patients relapsed by the end of the follow-up with a median time to relapse of 8 months (range 1-25) in CD patients and 14 months (range 4-37) in UC patients, respectively. The cumulative probabilities of maintaining remission at 6, 12, and 24 months were 82%, 59%, and 51% in CD patients, and 77%, 77%, and 64% in UC patients, respectively. Survival of CD patients who were in deep remission (clinical and endoscopic healing; faecal calprotectin <150 mg/kg; CRP ≤5 mg/l) was not better compared with those who did not fulfill these criteria. In multivariate models, only colonic CD protected patients from disease relapse.

CONCLUSIONS

Approximately half of the IBD patients relapsed within 2 years after anti-TNF discontinuation. In CD patients, no difference between those who were or were not in deep remission was found. Colonic localization protected patients from relapse.

摘要

背景

炎症性肠病(IBD)缓解期患者停用抗TNF治疗仍是一个有争议的问题。我们研究的目的是评估生物治疗停止后复发患者的比例,并确定疾病复发的潜在危险因素。

方法

对在无类固醇临床和内镜缓解期停用抗TNF治疗的连续性IBD患者进行前瞻性随访。采用多因素logistic回归和Cox比例风险模型评估疾病复发的预测因素。

结果

纳入78例IBD患者(克罗恩病,CD 61例;溃疡性结肠炎,UC 17例),中位随访30个月(范围7 - 47个月)。随访结束时,共有32例(53%)CD患者和9例(53%)UC患者复发,CD患者复发的中位时间为8个月(范围1 - 25个月),UC患者为14个月(范围4 - 37个月)。CD患者在6个月、12个月和24个月维持缓解的累积概率分别为82%、59%和51%,UC患者分别为77%、77%和64%。深度缓解(临床和内镜愈合;粪便钙卫蛋白<150mg/kg;CRP≤5mg/l)的CD患者生存率与未达到这些标准的患者相比并无更好。在多变量模型中,只有结肠型CD可使患者免于疾病复发。

结论

约一半的IBD患者在停用抗TNF后2年内复发。在CD患者中,深度缓解和未深度缓解的患者之间未发现差异。结肠定位可使患者免于复发。

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