Background & Aims

We evaluated the value of post-induction fecal calprotectin (FCP) concentration as a biomarker in patients with ulcerative colitis (UC) treated with a biologic.

Methods

This post hoc analysis of the GEMINI 1/GEMINI LTS (N = 620) and VARSITY (N = 771) trials evaluated the cross-sectional accuracy of post-induction FCP in identifying endoscopic activity and histologic inflammation, and the prognostic performance of FCP in identifying patients most likely to achieve endoscopic and histologic remission or require colectomy and UC-related hospitalization.

Results

The cross-sectional accuracy of FCP in identifying endoscopic activity and histologic inflammation was modest (63%–79%). However, a post-induction FCP concentration of ≤250 μg/g vs >250 μg/g was associated with a substantially higher probability of achieving clinical remission (odds ratio [OR], 4.03; 95% confidence interval [CI], 2.78–5.85), endoscopic remission (OR, 4.26; 95% CI, 2.83–6.40), and histologic remission (Robarts Histopathology Index: OR, 5.54; 95% CI, 3.77–8.14; Geboes grade: OR, 6.42; 95% CI, 4.02–10.26) at week 52 and a lower probability of colectomy over 7 years (hazard ratio, 0.296; 95% CI, 0.130–0.677) and UC-related hospitalization (hazard ratio, 0.583; 95% CI, 0.389–0.874). The association with colectomy was significant even among patients in symptomatic remission or with endoscopic improvement post-induction, and among patients with elevated FCP at baseline.

Conclusions

Although FCP had only modest cross-sectional accuracy in identifying disease activity, an FCP concentration of ≤250 μg/g vs >250 μg/g was associated with increased probability of achieving long-term clinical, endoscopic, and histologic remission, and reduced probability of colectomy and UC-related hospitalization (ClinicalTrials.gov: NCT00783718, NCT00790933, NCT02497469).

中文翻译：

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粪便钙卫蛋白对溃疡性结肠炎治疗达标监测的预后价值

背景与目标

我们评估了诱导后粪便钙卫蛋白 (FCP) 浓度作为生物标志物在接受生物制剂治疗的溃疡性结肠炎 (UC) 患者中的价值。

方法

GEMINI 1/GEMINI LTS (N = 620) 和 VARSITY (N = 771) 试验的事后分析评估了诱导后 FCP 在识别内窥镜活动和组织学炎症方面的横截面准确性，以及 FCP 在确定最有可能实现内窥镜和组织学缓解或需要结肠切除术和 UC 相关住院治疗的患者。

结果

FCP 在识别内镜活动和组织学炎症方面的横截面准确性适中 (63%–79%)。然而，≤250 μg/g 与 >250 μg/g 的诱导后 FCP 浓度与实现临床缓解的可能性显着增加相关（比值比 [OR]，4.03；95% 置信区间 [CI]，2.78– 5.85）、内镜缓解（OR，4.26；95% CI，2.83–6.40）和组织学缓解（Robarts 组织病理学指数：OR，5.54；95% CI，3.77–8.14；Geboes 等级：OR，6.42；95% CI， 4.02–10.26) 在第 52 周和 7 年内结肠切除术（风险比，0.296；95% CI，0.130–0.677）和 UC 相关住院（风险比，0.583；95% CI，0.389–0.874）的可能性较低。即使在症状缓解或诱导后内镜改善的患者中，与结肠切除术的关联也很显着，

结论

尽管 FCP 在识别疾病活动方面只有适度的横断面准确性，但 ≤250 μg/g 与 >250 μg/g 的 FCP 浓度与实现长期临床、内窥镜和组织学缓解的可能性增加相关，并降低可能性结肠切除术和 UC 相关住院治疗（ClinicalTrials.gov：NCT00783718、NCT00790933、NCT02497469）。