Long‐term intermittent treatment with low‐dose 5‐aminosalicylic enemas is efficacious for remission maintenance in ulcerative colitis

Abstract

Background: The standard remission maintenance treatment for ulcerative colitis (UC) is 5‐aminosalicylic acid (5‐ASA), given orally and topically and in different doses, with various frequencies and duration of administration. Both the efficacy of long‐term intermittent therapy with low‐dose 5‐ASA enemas in preventing UC relapses and its economic implications were evaluated. Methods: In accordance with a prospective case control study, 42 adult UC outpatients (29 M and 13 F) were treated with 5‐ASA tablets (1.6 g/day) and 5‐ASA enemas (2 g/50 mL) twice weekly, and 42 concurrent UC outpatients, matched for sex, age, extension and duration of disease, received only the oral therapy; the median treatment period was 6 years. Results: There was a significant reduction in the number (42%: P = 0.034) and incidence of relapses (43%: P = 0.022) in the patients receiving combined oral + topical 5‐ASA, who also had a significantly higher cumulative probability of not experiencing a first relapse (P = 0.001). There were no dropouts or side effects. Local therapy increased drug costs, but decreased the costs of relapses by 48% and completely precluded hospitalization costs. Conclusions: The scheduled oral + topical 5‐ASA treatment, at the lowest cumulative topical dosage tested over the longest known observation period, is efficacious in improving clinical outcome and decreasing overall costs in UC patients.