Serial semi-quantitative measurement of fecal calprotectin in patients with ulcerative colitis in remission

Abstract

Background: Fecal calprotectin (FC) correlates with clinical and endoscopic activity in ulcerative colitis (UC), and it is a good predictor of relapse. However, its use in clinical practice is constrained by the need for the patient to deliver stool samples, and for their handling and processing in the laboratory. The availability of hand held devices might spread the use of FC in clinical practice.

Objectives: To evaluate the usefulness of a rapid semi-quantitative test of FC in predicting relapse in patients with UC in remission.

Materials and methods: Prospective, multicenter study that included UC patients in clinical remission for ≥6 months on maintenance treatment with mesalamine. Patients were evaluated clinically and semi-quantitative FC was measured using a monoclonal immunochromatography rapid test at baseline and every three months until relapse or 12 months of follow-up.

Results: One hundred and ninety-one patients had at least one determination of FC. At the end of follow-up, 33 patients (17%) experienced clinical relapse. Endoscopic activity at baseline (p = .043) and having had at least one FC > 60 μg/g during the study period (p = .03) were associated with a higher risk of relapse during follow-up. We obtained a total of 636 semi-quantitative FC determinations matched with a three-month follow-up clinical assessment. Having undetectable FC was inversely associated with early relapse (within three months), with a negative predictive value of 98.6% and a sensitivity of 93.9%.

Conclusions: Serial, rapid semi-quantitative measurement of FC may be a useful, easy and cheap monitoring tool for patients with UC in remission.

Keywords:

• Fecal calprotectin
• semi-quantitative
• ulcerative colitis
• relapse
• remission

Disclosure statement

No potential conflict of interest was reported by the authors.

List of investigators and centers of the PRECUCAL study group

Montserrat Andreu, Parc de Mar, Barcelona; María Teresa Arroyo, Hospital Clínico Lozano Blesa, Zaragoza; Ana Bargalló, Hospital Moisès Broggi, Sant Joan Despí; Manuel Barreiro-de-Acosta, Hospital Universitario de Santiago, Santiago de Compostela; Jesús Barrio, Hospital Río Ortega, Valladolid; Belén Beltrán, Hospital Politécnico La Fe, Valencia; Fernando Bermejo, Hospital de Fuenlabrada, Madrid; Eduard Cabré, Hospital Universitari Germans Trias i Pujol, Badalona; José Cabriada, Hospital de Galdakao, Galdakao; María Chaparro, Hospital de La Princesa, Madrid; Eugeni Domènech, Hospital Universitari Germans Trias i Pujol, Badalona; Maria Esteve, Hospital Mútua Terrassa, Terrassa; Esther Garcia-Planella, Hospital Santa Creu i Sant Pau, Barcelona and Universitat Autònoma de Barcelona; Valle García-Sánchez, Hospital Reina Sofía, Córdoba; Javier P. Gisbert, Hospital de La Princesa, Madrid; Jordi Gordillo, Hospital Santa Creu i Sant Pau, Barcelona; Joaquín Hinojosa, Hospital de Manises, Manises; Míriam Mañosa, Hospital Universitari Germans Trias i Pujol, Badalona; Antonio López-Sanromán, Hospital Ramón y Cajal, Madrid; Jordina Llaó, Xarxa Hospitalària Althaia, Manresa; Marta Piqueras, Consorci Sanitari Terrassa, Terrassa; Elena Ricart, Hospital Clínic, Barcelona; Carlos Taxonera, Hospital Clínico San Carlos, Madrid; Albert Villoria, Hospital Parc Taulí, Sabadell.

Additional information

Funding

Shire Pharmaceuticals gave financial support for the monitoring of the study. Laboratorios Leti (Badalona, Spain) provided the PreventID CalDetect™ kits for the semi-quantitative measurements of FC. None of them participated in the study design, interpretation of results or elaboration of the article.