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Prevalence of endoscopic improvement and remission according to patient-reported outcomes in ulcerative colitis.
Alimentary Pharmacology & Therapeutics ( IF 6.6 ) Pub Date : 2019-11-22 , DOI: 10.1111/apt.15577
Parambir S Dulai 1 , Siddharth Singh 1 , Vipul Jairath 2 , Christopher Ma 3 , Neeraj Narula 4 , Niels Vande Casteele 1 , Laurent Peyrin-Biroulet 5 , Severine Vermeire 6 , Geert D'Haens 7 , Brian G Feagan 2 , William J Sandborn 1
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BACKGROUND Treatment targets for ulcerative colitis are evolving towards achievement of endoscopic improvement and remission in addition to symptom resolution. It remains to be accurately quantified what proportion of patients with symptom resolution have residual endoscopic activity that might warrant treatment modification. AIM To quantify the prevalence of endoscopic improvement and remission amongst ulcerative colitis patients with various permutations of patient-reported outcomes. METHODS Individual participant data from active intervention and placebo arms of clinical trials of infliximab, golimumab, vedolizumab and tofacitinib were pooled to estimate the prevalence of endoscopic improvement (Mayo endoscopic sub-score [MES] 0 or 1) and remission (MES 0) scores with various permutations of the rectal bleeding sub-score (RBS) and stool frequency sub-score (SFS) of the Mayo score, following induction (6-8 weeks) and maintenance (30-54 weeks) therapy. Subgroup analyses were performed by year of publication and centrally read endoscopy scoring. RESULTS Data from 2586 trial participants were analysed. Using locally scored endoscopy, the prevalence of endoscopic improvement and remission was highest among participants with a RBS 0 + SFS 0 post-induction (MES 0/1:81%, [95% CI 78-84]; MES 0:29% [26-33]) and during maintenance (MES 0/1:91% [87-93]; MES 0:57% [52-62]). Prevalence estimates were lower for more recently performed trials (P < .01). In comparison to locally scored endoscopy, when using central endoscopy scoring, the prevalence of endoscopic improvement and remission was lower post-induction (MES 0/1 57% [50-64], P < .001; MES 0 15% [11-21], P = .09) and during maintenance (MES 0/1 74% [67-81], P = .001; MES 0 31% [24-38], P = .001) for participants achieving a RBS 0 + SFS 0. CONCLUSIONS Approximately 8 of 10 patients with normalisation of rectal bleeding and stool frequency have improvement in endoscopic disease activity, whereas approximately only half of these patients have endoscopic remission.

中文翻译:

溃疡性结肠炎患者报告的结局,内镜改善和缓解的发生率。

背景技术溃疡性结肠炎的治疗目标除了症状缓解外,还朝着实现内窥镜改善和缓解的方向发展。尚有待准确量化的症状缓解患者中,有哪些内镜活动残留可能需要对治疗进行修改。目的量化在患者报告的结果有不同排列的溃疡性结肠炎患者中内镜改善和缓解的患病率。方法来自英夫利昔单抗,戈利木单抗,合并vedolizumab和tofacitinib以评估内镜改善的发生率(Mayo内镜亚评分[MES] 0或1)和缓解(MES 0)评分,以及直肠出血亚评分(RBS)和粪便频率亚的各种排列诱导(6-8周)和维持(30-54周)治疗后,对Mayo评分进行评分(SFS)。按出版年份和集中阅读内窥镜评分对亚组进行分析。结果分析了2586名试验参与者的数据。使用局部评分内窥镜检查,在诱导后RBS 0 + SFS 0的参与者中,内镜改善和缓解的发生率最高(MES 0/1:81%,[95%CI 78-84]; MES 0:29%[ 26-33])和维护期间(MES 0/1:91%[87-93]; MES 0:57%[52-62])。最近进行的试验的患病率估计值较低(P <.01)。
更新日期:2019-11-22
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