Is maintenance therapy always necessary for patients with ulcerative colitis in remission?

Background: The efficacy of sulphasalazine and mesalazine in preventing rel apse in patients with ulcerative colitis is well known. It is less clear ho w long such maintenance should be continued, and if the duration of disease remission is a factor that affects the risk of recurrence. Aim: To determine whether the duration of disease remission affects the rel apse rate, by comparing the efficacy of a delayed-release mesalazine (Asaco l, Bracco S.p.A., Milan, Italy) against placebo in patients with ulcerative colitis with short- and long-duration of disease remission. Methods: 112 patients (66 male, 46 female, mean age 35 years), with intermi ttent chronic ulcerative colitis in clinical, endoscopic and histological r emission with sulphasalazine or mesalazine for at least 1 year, were includ ed in the study. Assuming that a lower duration of remission might be assoc iated with a higher relapse rate, the patients were stratified according to the length of their disease remission, prior to randomization into Group A (Asacol 26, placebo 35) in remission from 1 to 2 years, or Group B (Asacol 28, placebo 23) in remission for over 2 years, median 4 years. Patients we re treated daily with oral Asacol 1.2 g vs, placebo, for a follow-up period of 1 year. Results: We employed an intention-to-treat analysis. In Group A, whilst no difference was found between the two treatments after 6 months, mesalazine was significantly more effective than placebo in preventing relapse at 12 m onths [Asacol 6/26 (23%), placebo 17/35 (49%), P = 0.035, 95% CI: 48-2.3%]. In contrast, in Group B no statistically significant difference was observ ed between the two treatments, either at 6 or 12 months [Asacol 5/28 (18%), placebo 6/23 (26%), P = 0.35, 95% CI: 31-14%] of follow-up, Patients in gr oup B were older, and had the disease and remission duration for longer, th an those in Group A. Conclusions: Mesalazine prophylaxis is necessary for the prevention of rela pse by patients with ulcerative colitis in remission for less than 2 pears, but this study casts doubt over whether continuous maintenance treatment i s necessary in patients with prolonged clinical, endoscopic and histologica l remission, who are at very low risk of relapse.