Background: The drug maintenance in patients with ulcerative colitis (UC) is essential. But the adherence with drug maintenance in quiescent UC is low and it is not well established how long the drug maintenance must be continued. Although discontinuation of medication may be reasonable for those with distal disease who have been in remission for 2 years and are averse to such medication according to European guideline, there were few prospective studies. We evaluated the relapse rate after discontinuation of the maintenance drug in patients with ulcerative proctosigmoiditis, prospectively.
Methods: The patients with UC who initially diagnosed and had been maintained the clinical, endoscopic, and histological remission more than 2 years were randomized two groups. Maintenance drug was continued in C group and discontinued in D group. The patients with active disease, steroid-dependency, history of biologics use, and pregnancy were excluded. Partial Mayo score and compliance were checked every 3 months for 1 year of follow-up period. Primary end point was the clinical, endoscopic, and histological relapse rate at 1 year and secondary end point was to evaluate the cumulative relapse rate over 1 year and risk factors related to relapse.
Results: Total 55 patients were enrolled and one patient in C group was dropped out because of non-adherence to drug. The age at diagnosis, gender, disease extent, frequency of relapse before enrollment, duration of remission, Mayo score at diagnosis, initial laboratory findings, and drug usage were not different in two groups. Compliance was over 90% in all patients. Nine patients (7.4%, 2/27 in C group and 25.9%, 7/27 in D group) were relapsed within 1 year but the cumulative relapse rate at 1 year was not statistically different between two groups (p=0.068). The risk factors related to relapse were initial CRP level, extent of disease, Mayo score at diagnosis and history of oral steroid use. Duration of remission and was not predictive factor for relapse.
Conclusions: Although this study was preliminary, discontinuation of maintenance drug maybe increase the relapse at 1 year, especially in patient who had abnormal initial CRP level, sigmoid involvement, or used oral steroid. Initially mild ulcerative proctitis patients who have been maintained remission more than 2 years can be withdrawn maintenance drug.