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P461 Comparison of efficacy of different oral 5-aminosalicylic acid doses for maintenance of remission in ulcerative colitis: a systematic review and meta-analysis

Choi C.H.*1, Kim Y.S.2, Moon W.3, Lee B.I.4, Kim E.S.5, Jung Y.6, Park D.I.7, Yoon Y.S.8, Lee H.9, Han D.S.10

1Chung-Ang University College of Medicine, Internal Medicine, Seoul, South Korea 2Seoul Paik Hospital, Inje University College of Medicine, Internal Medicine, Seoul, South Korea 3Kosin University College of Medicine, Internal Medicine, Busan, South Korea 4The Catholic University of Korea College of Medicine, Internal Medicine, Seoul, South Korea 5Kyungpook National University School of Medicine, Internal Medicine, Daegu, South Korea 6Soonchunhyang University College of Medicine, Internal Medicine, Cheonan, South Korea 7Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Internal Medicine, Seoul, South Korea 8Asan Medical Center, University of Ulsan College of Medicine, Surgery, Seoul, South Korea 9Seoul National University Bundang Hospital, Center for Preventive Medicine and Public Health, Seongnam, South Korea 10Hanyang University College of Medicine, Internal Medicine, Guri, South Korea 

Background

The efficacy of 5-aminosalicylic acids (5-ASAs) for maintenance of remission in quiescent ulcerative colitis (UC) has been studied previously in meta-analyses. However, there was no previous meta-analysis evaluated the effect of absolute dosage of active 5-ASA component used. We performed a systematic review and meta-analysis of all relevant randomized controlled trials (RCTs) comparing efficacy of the different dosages of 5-ASAs for maintenance of remission in patients with quiescent UC.

Methods

We searched for all relevant studies published through March 2016 using MEDLINE, EMBASE and the Cochrane Library. Review articles and conference proceedings were also searched to identify additional studies. Eligible trials recruited adults with quiescent UC, comparing different doses of 5-ASAs. Drug doses were classified according to the absolute dose of active 5-ASA component. Comparison was performed using three different dosing points of reference including 1.5 g, 2.0 g and 3.0 g: (1) <1.5 g vs. 1.5 g to 2.5 g, (2) <2.0 g vs. 2.0 g to 3.0 g, and (3) 1.5 g to 2.5 g vs. 3.0 g to 4.8 g per day. Dichotomous data were pooled to obtain relative risk (RR) of persistent remission of disease activity in quiescent UC, with a 95% confidence interval (CI) using RevMAN 5.3. Data were analyzed on an intention-to-treat basis.

Results

Ten RCTs (1865 patients) were included in the meta-analysis. Of these, 6 RCTs compared 5-ASA doses of <1.5 g with 1.5 g to 2.5 g per day, with the RR of persistent remission with dose of 1.5 g to 2.5 g of 1.16 (95% CI 1.06–1.27). There were 5 RCTs comparing 5-ASA doses of <2.0 g with 2.0 g to 3.0 g per day. Doses of 2.0 g to 3.0 g were more effective than <2.0 g for maintenance of remission (RR of persistent remission =1.74; 95% CI 1.3–2.26). There were 3 RCTs comparing 5-ASA doses of 1.5 g to 2.5 g with 3.0 g to 4.8 g per day. Doses of 3.0 g to 4.8 g appeared more effective than <2.0 g for persistent remission (RR =1.68; 95% CI 1.23–2.31). In one study that evaluated the effect of high dose 5-ASA (4.8 g/day) in UC patients with history of frequent relapses (mean of at least 3/year during the 3-year period preceding enrollment), the high dose proved to be significantly more effective than standard dose (2.4 g/day) for maintaining remission in patients with extensive disease (90.9% vs. 46.7%, p=0.0064).

Conclusion

5-ASA doses of 2.0 g to 3.0 g per day are more effective than dose of <2.0 g for preventing relapse in quiescent UC. High doses of 5-ASAs (3.0 g to 4.8 g) may be more effective than standard doses (2.0 g to 2.5 g) for maintenance of remission in UC, especially for patients with extensive colitis or with frequent relapses.