Intest Res.  2018 Oct;16(4):554-562. 10.5217/ir.2018.00027.

Usefulness of fecal calprotectin by monoclonal antibody testing in adult Japanese with inflammatory bowel diseases: a prospective multicenter study

• Nakamura S
• Imaeda H
• Nishikawa
• Iimuro M
• Matsuura M
• Oka H
• Oku J
• Miyazaki T
• Honda H
• Watanabe K
• Nakase H
• Andoh A

• KMID: 2434157
• DOI: http://doi.org/10.5217/ir.2018.00027

Abstract

BACKGROUND/AIMS
Noninvasive objective monitoring is advantageous for optimizing treatment strategies in patients inflammatory bowel disease (IBD). Fecal calprotectin (FCP) is superior to traditional biomarkers in terms of assessing the activity in patients with IBD. However, there are the differences among several FCP assays in the dynamics of FCP. In this prospective multicenter trial, we investigated the usefulness of FCP measurements in adult Japanese patients with IBD by reliable enzyme immunoassay using a monoclonal antibody.
METHODS
We assessed the relationship between FCP levels and disease or endoscopic activity in patients with ulcerative colitis (UC, n=64) or Crohn's disease (CD, n=46) compared with healthy controls (HCs, n=64).
RESULTS
FCP levels in UC patients strongly correlated with the Disease Activity Index (rs =0.676, P < 0.0001) and Mayo endoscopic subscore (MES; rs =0.677, P < 0.0001). FCP levels were significantly higher even in patients with inactive UC or CD compared with HCs (P=0.0068, P < 0.0001). The optimal cutoff value between MES 1 and 2 exhibited higher sensitivity (94.1%). FCP levels were significantly higher in active UC patients than in inactive patients (P < 0.001), except those with proctitis. The Crohn's Disease Activity Index tended to correlate with the FCP level (rs =0.283, P=0.0565).
CONCLUSIONS
Our testing method using a monoclonal antibody for FCP was well-validated and differentiated IBD patients from HCs. FCP may be a useful biomarker for objective assessment of disease activity in adult Japanese IBD patients, especially those with UC.

Keyword

Inflammatory bowel diseases; Colitis, ulcerative; Crohn disease; Fecal calprotectin; Antibodies, monoclonal

MeSH Terms

Adult*
Antibodies, Monoclonal
Asian Continental Ancestry Group*
Biomarkers
Colitis, Ulcerative
Crohn Disease
Humans
Immunoenzyme Techniques
Inflammatory Bowel Diseases*
Leukocyte L1 Antigen Complex*
Methods
Multicenter Studies as Topic
Proctitis
Prospective Studies*
Antibodies, Monoclonal
Biomarkers
Leukocyte L1 Antigen Complex