Dulai Parambir S, Feagan Brian G, Sands Bruce E, Chen Jingjing, Lasch Karen, Lirio Richard A
Division of Gastroenterology and Hepatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Robarts Clinical Trials, Western University, London, Ontario, Canada.
Clin Gastroenterol Hepatol. 2023 Feb;21(2):456-466.e7. doi: 10.1016/j.cgh.2022.07.027. Epub 2022 Aug 4.
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.
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.
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.
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).
我们评估了诱导治疗后粪便钙卫蛋白（FCP）浓度作为接受生物制剂治疗的溃疡性结肠炎（UC）患者生物标志物的价值。
对GEMINI 1/GEMINI LTS（N = 620）和VARSITY（N = 771）试验进行的这项事后分析评估了诱导治疗后FCP在识别内镜活动和组织学炎症方面的横断面准确性，以及FCP在识别最有可能实现内镜和组织学缓解或需要进行结肠切除术及因UC住院的患者方面的预后性能。
FCP在识别内镜活动和组织学炎症方面的横断面准确性一般（63%-79%）。然而，诱导治疗后FCP浓度≤250 μg/g与>250 μg/g相比，在第52周时实现临床缓解（优势比[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（罗伯茨组织病理学指数：OR，5.54；95% CI，3.77-8.14；格博斯分级：OR，6.42；95% CI,；4.02-10.26）的概率显著更高，而在7年期间进行结肠切除术的概率更低（风险比，0.296；95% CI，0.130-0.677），因UC住院的概率也更低（风险比，0.583；95% CI，0.389-0.874）。即使在诱导治疗后症状缓解或内镜改善的患者以及基线时FCP升高的患者中，与结肠切除术的关联也很显著。
尽管FCP在识别疾病活动方面的横断面准确性一般，但FCP浓度≤250 μg/g与>250 μg/g相比，实现长期临床、内镜和组织学缓解的概率增加，结肠切除术和因UC住院的概率降低（ClinicalTrials.gov：NCT00783718、NCT00790933、NCT02497469）。
