A prospective evaluation of the predictive value of faecal calprotectin in quiescent Crohn's disease |
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| Affiliation: | 1. Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, United Kingdom;2. Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom;3. Department of Clinical Biochemistry, Glasgow Royal Infirmary, Glasgow, United Kingdom;1. Crohn-Colitis Care Unit, Hospital Universitario Vall d''Hebron, Ciberehd, Paseo Vall d''Hebron 119, 08035, Barcelona, Spain;2. Gastroenterology Department, Hospital Universitario Son Espases, Carretera de Valldemossa, 79, 07120 Palma de Mallorca, Islas Baleares, Spain;3. Gastroenterology Department, Hospital Universitario Central de Asturias, C/Celestino Villamil, s/n, 33006 Oviedo, Asturias, Spain;4. Advanced Research Techniques in Health Services (TAISS), C/Cambrils 49, 28034 Madrid, Spain;1. Department of Biomolecular Chemistry, Faculty of Medicine, Medical University of Lodz, Lodz, Poland;2. Department of Digestive Tract Diseases, Faculty of Medicine, Medical University of Lodz, Lodz, Poland;3. Department of Cytobiochemistry, Faculty of Biology and Environmental Protection, University of Lodz, Lodz, Poland;4. Department of Psychological and Brain Sciences, Gill Center for Biomolecular Science, Indiana University, Bloomington, IN, USA;5. Department of Pathology, Faculty of Medicine, Medical University of Lodz, Lodz, Poland;6. Department of Medicine, Division of Gastroenterology, Ludwig Maximilians University of Munich, Munich, Germany;1. Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA;2. Digestive Disease Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA;3. Department of Gastroenterology, University Hospitals Leuven, Leuven, Belgium;4. Hospital Clinic University of Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain;5. Departments of Radiology and Medicine, University of Calgary, Calgary, AB, Canada;6. Global Medical Affairs Gastroenterology, AbbVie, Rungis, France;7. Department of Medicine, University of Calgary, Calgary, AB, Canada;1. Department of Clinical Research, University of Bern, Murtenstrasse 35, 3010 Bern, Switzerland;2. Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois et Université de Lausanne, Lausanne, Switzerland;3. Division of Gastroenterology and Hepatology, Tiefenauspital Bern, Bern, Switzerland;1. Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chu-o-ku, Kobe, Hyogo 650-0017, Japan;2. Division of Lower Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan;3. The Integrated Center for Mass Spectrometry, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chu-o-ku, Kobe, Hyogo 650-0017, Japan;4. Division of Metabolomics Research, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chu-o-ku, Kobe, Hyogo 650-0017, Japan;1. Department of Biomedical, Experimental and Clinical Sciences, University of Florence, Viale Morgagni 50, 50134 Florence, Italy;2. Clinical Sciences, Global Biomarker, Global Discovery, Bayer Healthcare, Bayer, 10178 Berlin, Germany;3. Medicinal Chemistry, Global Drug Discovery, Bayer Healthcare, Bayer, 10178 Berlin, Germany;4. Division of Gastroenterology 2, Careggi Hospital, 50134 Florence, Italy;5. Regional Referral Center for IBD, Careggi Hospital, 50134 Florence, Italy |
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| Abstract: | BackgroundFaecal calprotectin (FC) is a non-invasive marker of gastrointestinal inflammation.AimTo determine whether higher FC levels in individuals with quiescent Crohn's disease are associated with clinical relapse over the ensuing 12 months.MethodsA single centre prospective study was undertaken in Crohn's disease patients in clinical remission. The receiver operating characteristic (ROC) curve for the primary endpoint of clinical relapse by 12 months, based on FC at baseline, was calculated. Kaplan–Meier curves of time to relapse were based on the resulting optimal FC cutoff for predicting relapse.ResultsOf 97 patients recruited, 92 were either followed up for 12 months without relapsing, or reached the primary endpoint within that period. Of these, 10 (11%) relapsed by 12 months. Median FC was lower for non-relapsers, 96 μg/g (IQR 39–237), than for relapsers, 414 μg/g (IQR 259–590), (p = 0.005). The area under the ROC curve to predict relapse using FC was 77.4%. An optimal cutoff FC value of 240 μg/g to predict relapse had sensitivity of 80.0% and specificity of 74.4%. Negative predictive value was 96.8% and positive predictive value was 27.6%, FC ≥ 240 μg/g was associated with likelihood of relapse by 12-months 12.18 (95%CI 2.55–58.2) times higher than lower values (p = 0.002).ConclusionsIn this prospective dataset, FC is a useful tool to help identify quiescent Crohn's disease patients at a low risk of relapse over the ensuing 12 months. FC of 240 μg/g was the optimal cutoff in this cohort. |
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