Diagnostic Accuracy of Fecal Calprotectin Concentration in Evaluating Therapeutic Outcomes of Patients With Ulcerative Colitis
| Autor: | Gert De Hertogh, Jerrold R. Turner, Toer W. Stevens, David T. Rubin, Geert R. D'Haens, Krisztina B Gecse |
|---|---|
| Přispěvatelé: | Graduate School, Amsterdam Gastroenterology Endocrinology Metabolism, Gastroenterology and Hepatology |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
HISTOLOGICAL REMISSION Histology Prognostic DISEASE-ACTIVITY Gastroenterology Inflammatory bowel disease Severity of Illness Index CLINICAL RELAPSE Article 03 medical and health sciences Feces 0302 clinical medicine Interquartile range Internal medicine ENDOSCOPIC ACTIVITY Post-hoc analysis medicine Humans INDEX Science & Technology Hepatology Receiver operating characteristic Gastroenterology & Hepatology business.industry INDUCTION Inflammatory Bowel Disease Area under the curve Colonoscopy Biomarker medicine.disease Ulcerative colitis C-REACTIVE PROTEIN Treatment Outcome 030220 oncology & carcinogenesis Biomarker (medicine) 030211 gastroenterology & hepatology Colitis Ulcerative Calprotectin business Leukocyte L1 Antigen Complex Life Sciences & Biomedicine Biomarkers |
| Zdroj: | Clinical gastroenterology and hepatology, 19(11), 2333-2342. W.B. Saunders Ltd Clin Gastroenterol Hepatol |
| ISSN: | 1542-3565 |
| Popis: | BACKGROUND & AIMS: Histologic features of inflammation (histologic inflammation) are associated with clinical relapse in patients with ulcerative colitis (UC). Concentration of fecal calprotectin (FC) can be used to identify patients with mucosal inflammation. We aimed to assess the accuracy of FC measurements in identifying patients with histologic inflammation and to develop a model to predict outcomes of therapy. METHODS: We performed a post hoc analysis of data from a phase 4 trial of the efficacy of multimatrix mesalamine in patients with mild to moderate UC (the MOMENTUM trial). We obtained clinical, endoscopic, and histologic data from week 8 (n = 639) and week 52 (n = 373) of the trial. We used area under the receiver operating characteristic curves to determine the accuracy and optimal cut-off values of FC in identifying patients with different therapeutic outcomes (clinical remission, endoscopic healing, deep remission, or histologic remission) at week 8 and week 52. We performed multivariable logistic regression analyses to identify factors associated with these outcomes. RESULTS: Median FC concentrations were lower in patients who achieved outcomes of clinical remission, endoscopic healing, deep remission, or histologic remission vs patients who did not. FC concentrations identified patients with endoscopic healing and histologic remission with area under the receiver operating characteristic curve values of 0.77 and 0.76 at week 8, and 0.79 and 0.80 at week 52, respectively. The optimal FC cut-off concentrations for identification of patients with histologic remission were 75 μg/g at week 8 and 99 μg/g at week 52. In the subpopulation with an endoscopy score of 0, median FC concentrations were lower in patients with histologic remission than in patients with microscopic inflammation at week 8 (30 vs 140 μg/g; area under the receiver operating characteristic, 0.72) and week 52 (21.5 vs 134.5 μg/g; area under the receiver operating characteristic, 0.71). At both time points, the optimal FC cut-off concentration was approximately 75 μg/g. Our final prediction model for week 52 histologic remission comprised endoscopic score at week 8, FC concentration at week 8, and histologic activity at baseline and week 8. CONCLUSIONS: A post hoc analysis of data from a phase 4 trial found that, even in patients with complete endoscopic healing of UC, FC concentration can be used to discriminate patients with ongoing microscopic inflammation from patients with histologic remission. The optimal cut-off concentration of FC is between 75 and 100 μg/g. ClinicalTrials.gov no: NCT01124149. ispartof: CLINICAL GASTROENTEROLOGY AND HEPATOLOGY vol:19 issue:11 pages:2333-2342 ispartof: location:United States status: published |
| Databáze: | OpenAIRE |
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