Abstract

Useful indices to determine whether to reduce the dose of 5-aminosalicylic acid (5-ASA) in patients with ulcerative colitis (UC) during remission remain unclear. We aimed to analyze the rate and risk factors of relapse after reducing the dose of oral 5-ASA used for maintenance therapy of UC. UC patients whose 5-ASA dose was reduced in clinical remission (partial Mayo score of ≤ 1) at our institution from 2012 to 2017 were analyzed. Various clinical variables of patients who relapsed after reducing the dose of oral 5-ASA were compared with those of patients who maintained remission. Risk factors for relapse were assessed by univariate and multivariate logistic regression analyses. Cumulative relapse-free survival rates were calculated using the Kaplan-Meier method. A total of 70 UC patients were included; 52 (74.3%) patients maintained remission and 18 (25.7%) patients relapsed during the follow-up period. Multivariate analysis indicated that a history of acute severe UC (ASUC) was an independent predictive factor for clinical relapse (p = 0.024, odds ratio: 21, 95% confidence interval: 1.50-293.2). Based on Kaplan-Meier survival analysis, the cumulative relapse-free survival rate within 52 weeks was 22.2% for patients with a history of ASUC, compared with 82.0% for those without. the log-rank test showed a significant difference in a history of ASUC (p < 0.001). Dose reduction of 5-ASA should be performed carefully in patients who have a history of ASUC.

Highlights

  • Ulcerative colitis (UC) is a chronic inflammatory disease affecting the colon, which is characterized by an unpredictable course, usually involving periods of flare-up and remission

  • Multivariate analysis indicated that a history of acute severe UC (ASUC) was an independent predictive factor for clinical relapse (p = 0.024, odds ratio: 21, 95% confidence interval: 1.50–293.2)

  • Based on Kaplan–Meier survival analysis, the cumulative relapse-free survival rate within 52 weeks was 22.2% for patients with a history of ASUC, compared with 82.0% for those without. the log-rank test showed a significant difference in a history of ASUC (p < 0.001)

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Summary

Introduction

Ulcerative colitis (UC) is a chronic inflammatory disease affecting the colon, which is characterized by an unpredictable course, usually involving periods of flare-up and remission. Giaffer et al investigated the efficacy of two doses of balsalazide for maintaining remission of UC, and found that the relapse rate at 12 months on 2 g/day balsalazide was higher (55%) than that on 4 g/day (37%) (RR: 0.66; 95% CI: 0.45–0.97) [6]. Kruis et al compared different doses of Salofalk granules (3 g/day vs 1.5 g /day) and reported that the relapse rate was lower for patients treated with 3 g/day than 1.5 g/ day (RR: 0.65; 95% CI: 0.49–0.86) [7]. Other studies showed that there was no significantly difference in the rate of relapse among patients receiving 5-ASA doses of more than 2 g/day. Green et al reported that 32% of patients treated with 6 g/day and 23% of patients treated with 3 g/day of Balsalazide experienced a relapse, demonstrating no significant difference in efficacy [9]. The decision of whether to continue a high dose of 5-ASA or reduce the dose in UC patients who are in remission is still based on the judgement of individual doctors

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