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P095. Faecal lactoferrin level is an indicator of mucosal healing in patients with ulcerative colitis: A prospective 12-month monitoring study

J. Langhorst1, A. Rueffer2, M. Baecker3, G.J. Dobos3, J. Boone4

1University Duisburg-Essen, Kliniken Essen-Mitte, Integrative Gastroenterology, Essen, Germany; 2L+S Labor, Enterosan, Bad Bocklet – Grossenbrach, Germany; 3University Duisburg-Essen, Kliniken Essen-Mitte, Internal and Integrative Medicine, Essen, Germany; 4TechLab, Blacksburg, United States

Background: Ulcerative colitis (UC) is challenging to manage. Recent studies have identified a treatment goal of mucosal healing for optimal patient outcome. Faecal lactoferrin is a validated biomarker for intestinal inflammation.

Methods: We followed patients (pts) with UC in clinical remission at baseline (CAI <5) over a 12-months period and evaluated C‑reactive protein (CRP – cut-off: 0.5 mg/dl), white blood cell count (WBC – cut-off: 8.5/nl), and faecal lactoferrin levels (FLA – cut-off: 7.25 µg/g) as biomarkers for active disease and for determining mucosal healing. UC pts were evaluated at 6 different time-points (baseline, 1; 3; 6; 9; 12 month). Stool and serum specimens were collected for quantitative FLA by immunoassay and lab parameters (CRP and WBC), respectively. Sigmoidoscopy with histology was performed at baseline, in the event of an acute flare (CAI >4) or at the end of the 12 month period. Endoscopy score (Rachmilewitz) was used for defining mucosal healing. Absence of acute immune cell infiltration, crypt abscess, mucin depletion and breaches in the surface epithelium (Riley Score) was used for defining histological healing.

Results: A total of 85 pts (male-female ratio 1:1; age range 20 to 75 years) were monitored for the complete 12-months. A total of 36 pts suffered a flare and 49 pts experienced sustained remission defined by CAI. Median FLA levels were 40 µg/g vs 5 µg/g (p < 0.0001), median CRP levels 0.6 mg/dl vs 0.1 mg/dl (p < 0.001) and median WBC levels 7.6 vs 6.0/nl (p = 0.01) for flare vs. remission, respectively.

Of the pts in sustained remission, 44 achieved mucosal healing based on Endoscopy Score 0–1. Median levels (at timepoint 12 month) of pts with mucosal healing and pts with mucosal activity were 5 µg/g vs 37 µg/g for FLA (p = 0.09), 0.2 mg/dl vs 0.1 mg/dl for CRP (p = 0.882) and 5.9 vs 6.0/nl for WBC (p = 0.787), respectively.

Of pts in sustained remission, 41 did not show any signs of acute histological activity (Riley Score). Median levels (at timepoint 12 month) of pts without signs and with signs of histological activity were 4.6 µg/g vs 14.4 µg/g for FLA (p = 0.198), 0.2 mg/dl vs 0.1 mg/dl for CRP (p = 0.948) and 6.0 vs 6.0/nl for WBC (p = 0.759), respectively.

FLA was the only biomarker to show a median level above cut-off for active disease defined by endoscopy as well as histology for pts in sustained clinical remission.

Conclusions: Our results confirm that fecal lactoferrin is a useful biomarker for identifying active UC and for determining patients that achieve mucosal healing.