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P364 The value of faecal calprotectin for assessing endoscopic activity and predicting future clinical course in patients with active ulcerative colitis treated with granulomonocytapheresis: a prospective study

T. Shimoyama*1, T. Yamamoto1, S. Umegae1, K. Matsumoto1

1Yokkaichi Hazu Medical Centre, IBD Centre, Yokkaichi, Japan

Background

Previous studies have reported that Granulomonocytapheresis (GMA) was effective in patients with mild-to-moderately active ulcerative colitis (UC) and had a favourable safety profile. Currently, GMA is widely used in Japan and is available in the European Union countries. Calprotectin is a calcium-binding protein, which can be measured in faecal samples. The faecal level of calprotectin increases during disease activity in ulcerative colitis (UC). Nonetheless, the relevance of faecal calprotectin (FC) measurement during granulomonocytapheresis (GMA) for UC has not yet been fully evaluated. This prospective study was to investigate the value of FC for assessing disease activity and predicting clinical course in UC patients undergoing GMA therapy.

Methods

One hundred and eighty-four patients with moderately active UC with endoscopic activity (Mayo endoscopic subscore [MES]=2 or 3) were investigated. Each patient received a total of 10 GMA sessions with the Adacolumn (JIMRO, Takasaki, Japan) over 5 consecutive weeks. One GMA session was about 90 min at 30 ml/min. Patients who achieved clinical remission during GMA were subsequently given maintenance medications for 12 months. Relapse was defined as worsening of the clinical symptom score with the MES of 2 or 3. FC levels were measured at entry and after treatment.

Results

After GMA, 80 of the 184 patients (43%) achieved clinical remission, and 51 (28%) achieved mucosal healing (MH; MES=0 or 1). The median FC level significantly decreased in patients who achieved MH (p = 0.02), but not in those without MH. Thirty-four patients (43%) relapsed during the 12-month follow-up. The median (IQR) FC level at the end of GMA therapy was significantly higher in patients with relapse than in those without relapse, 149.5 (96–211) µg/g vs. 45.5 (23–99) µg/g (p < 0.001). A cut-off value of 114 µg/g FC had a sensitivity of 76% (95% confidence interval [CI]: 62–91%), a specificity of 85% (95% CI: 74–95%), a positive predict value (PPV) of 79% (95% CI: 65–93%), and a negative predictive value (NPV) of 83% (95% CI: 72–94%) to predict future relapse. Relapse was observed in 26 of 33 patients (79%) with elevated FC (≥114 µg/g), but in 8 (17%) of 47 patients with low FC (<114 µg/g) (p < 0.001). Similarly, the cumulative relapse rate was significantly higher in patients with elevated FC (≥114 µg/g) compared with those with low FC (<114 µg/g).

Conclusion

FC could become a validated biomarker for the assessment of endoscopic disease activity in UC patients undergoing GMA therapy. Furthermore, FC at the end of GMA treatment course appeared to be a relevant biomarker for the prediction of clinical course in patients who had achieved remission.