Abstract

BackgroundTacrolimus (TAC) is a powerful remission-inducing drug for refractory ulcerative colitis (UC). However, it is unclear whether mucosal healing (MH) influences relapse after completion of TAC.We investigated whether MH is related to relapse after TAC.Patients: Among 109 patients treated with TAC, 86 patients achieved clinical remission and 55 of them underwent colonoscopy at the end of TAC. These 55 patients were investigated.MethodsPatients with MH at the end of TAC were classified into the MH group (n = 41), while patients without MH were classified into the non-MH group (n = 14). These groups were compared with respect to 1) clinical characteristics before treatment, 2) clinical characteristics on completion of treatment, and 3) the relapse rate and adverse events rates. This is a retrospective study conducted at a single institution.Results1) There was a significant difference in baseline age between the two groups before TAC therapy, but there were no significant differences in other clinical characteristics. The NMH group was younger (MH group: 48.1 (23–79) years, NMH group: 36.3 (18–58) years, P = 0.007). Endoscopic scores showed significant differences between the 2 groups at the end of TAC. There were also significant differences in the steroid-free rate after 24 weeks (MH group: 85.3%, NMH group 50%, P = 0.012). There was no significant difference in the relapse rate between the 2 groups at 100 days after remission, but a significant difference was noted at 300 days (17% vs. 43%), 500 days (17% vs. 75%), and 1000 days (17% vs. 81%) (all P < 0.05).ConclusionsTAC is effective for refractory ulcerative colitis. However, even if clinical remission is achieved, relapse is frequent when colonoscopy shows that MH has not been achieved. It is important to evaluate the mucosal response by colonoscopy on completion of TAC.

Highlights

  • Tacrolimus (TAC) is a powerful remission-inducing drug for refractory ulcerative colitis (UC)

  • Reports have recently been published concerning the control of UC relapse by achieving mucosal healing (MH) [7], but it has not been clarified whether MH influences relapse after TAC therapy

  • Before PSL administration, there was no significant difference between the two groups in clinical activity index (CAI) MH group: 13.3 (9–19), Nonmucosal healing (NMH) group: 13.1 (10–17), P = 0.493, hemoglobin MH group: 11 (7.5–12.9), NMH group: 12.6 (7.9–15.1) g/ dL, P = 0.19, albumin MH group: 3.4 (1.9–4.4), NMH group: 3.4 (2–4.6) g/dL, P = 0.889, C-reactive protein (CRP) MH group: 3.9 (0.2–22.6), NMH group: 2.9 (0.04–11.9) mg/dL, P = 0.636, or either endoscopic score (Mayo: MH group: 2.9 (2, 3), NMH group: 3 (3), P = 0.341; Ulcerative colitis endoscopic index of severity (UCEIS) MH group: 6.6 (4– 8), NMH group: 7.4 (6–8), P = 0.236) (Table 1)

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Summary

Introduction

Tacrolimus (TAC) is a powerful remission-inducing drug for refractory ulcerative colitis (UC). It is unclear whether mucosal healing (MH) influences relapse after completion of TAC.We investigated whether MH is related to relapse after TAC. Patients: Among 109 patients treated with TAC, 86 patients achieved clinical remission and 55 of them underwent colonoscopy at the end of TAC. Surgery may be indicated for severe UC, especially refractory prednisolone-resistant or prednisolone-dependent disease, which is often difficult. Reports have recently been published concerning the control of UC relapse by achieving MH [7], but it has not been clarified whether MH influences relapse after TAC therapy. This study was performed to investigate the relationship between MH and relapse of UC after TAC

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