P384 Gari-leo prospective study on anti-TNF therapy in ulcerative colitis relapse patients

Abstract Background Anti-TNF alpha antibody used as a medication increases the quality of life in patients with ulcerative colitis (UC). However, the appropriate length of maintenance therapy is unknown. This study was designed to determine the rate of non-relapsing cases after anti-TNF alpha antibody therapy cessation and the efficacy rate after anti-TNF alpha antibody therapy re-initiation in relapsed UC patients. Methods We conducted a prospective, single centre observational study approved by the IRB of our hospital and registered in UMIN (UMIN000011200). Thirty-one inactive UC patients treated with anti-TNF alpha antibody for >12 months were enrolled. Colonoscopic examinations and calculation of full and partial Mayo scores (PMS) were performed before admission. PMSs, serum CRP titers, faecal immunohistochemical tests (FIT) and faecal calprotectin (fCal) tests were examined every 2 months. UC relapsing patients were treated with anti-TNF alpha antibody. We defined remission, effectiveness and relapse as PMS < 3, −ΔPMS ≥ 3 or −ΔPMS ≥ 30% of baseline and +ΔPMS > 3 of baseline. Primary endpoints included the rate of UC non-relapsing cases 12 months after anti-TNF alpha antibody cessation. Secondary endpoints were the rate of remission after re-treatment with anti-TNF alpha antibody, the endoscopic Mayo scores and serum CRP, FIT and fCal values at 0, 2 and 4 months. Results We found no significant differences in patients’ background information between relapsed and non-relapsed UC patients. A majority of patients [68% (21/31)] did not have UC relapses during the first year after anti-TNF alpha antibody treatment cessation. In those cases that required re-treatment due to relapsed UC, the remission rate was 100% (10/10). fCal at 2 month was significantly higher in relapsed UC patients than in non-relapsed patients (606.6 ± 684. vs. 323.1 ± 499.6 μg/g), p = 0.006). However, we found no significant differences in FIT, serum CRP levels and endoscopic Mayo scores between relapsed and non-relapsed patients. Conclusions We evidenced a high rate of non-relapsed patients after anti-TNFalpha antibody therapy cessation. Re-initiated therapies in UC relapsed patients were effective. Our results suggest fCal level is a useful marker for the prediction of relapse in UC patients.