Sa1135 Comparative Effectiveness of Initial Therapy for Ulcerative Proctitis in Real-World Clinical Practice: A Retrospective Study

Abstract

Background: Ulcerative colitis is a common chronic inflammatory disease of the colon. In approximately 30% of patients, the disease is limited to the rectum as ulcerative proctitis (UP). While the principal medications used to treat UP have been studied extensively in randomized trials, their comparative effectiveness in real-world settings has been examined only in a few small head-to-head studies. This retrospective study examines the comparative effectiveness of oral 5-ASAs, mesalamine suppository (MS), and mesalamine enema (ME) as initial therapy for ulcerative proctitis. Methods: Using a large US integrated healthcare claims database, we identified all persons, aged ≥14 years, with evidence of newly diagnosed UP (ICD-9-CM 556.2, 556.3) between January 1, 2004 and December 31, 2008, based on: (1) ≥2 encounters with diagnoses of UP ≤90 days apart; (2) evidence of colonoscopy within 60 days of first encounter for UP (index visit); (3) evidence of receipt of either oral 5ASAs, MS, or ME as monotherapy on their index visit; and (4) no evidence of receipt of any pharmacotherapy for UP within 365 days preceding their index visit. Patients were followed for 365 days after their index visit for treatment of UP, especially evidence of treatment escalation (a proxy measure of the lack of effectiveness of initial therapy) and/or new encounters with diagnoses of more extensive disease (ICD-9-CM 556.X, excluding 556.2 and 556.3). We also examined total costs of pharmacotherapy for UP over this period. Results: We identified 548 patients with new onset UP who began monotherapy with oral 5-ASAs, MS, or ME. Mean (SD) age was 48 (16) years, and there were approximately equal numbers of men and women. Forty-five percent of patients were seen by a gastroenterologist at their index visit. At their index visit, 327 patients received MS as initial therapy; 138, an oral 5-ASA; and 83, ME. Men were more likely to have received oral 5-ASA as initial therapy than women. By day 90, 21% of patients receiving oral 5-ASAs as initial therapy had evidence of treatment escalation, compared with 9.5% of MS patients and 12% of ME patients; corresponding figures by day 365 were 34.1%, 20.8%, and 20.5%, respectively. By day 365, 9.8% of MS patients, 18.1% of ME patients, and 20.3% of oral 5-ASA patients had new encounters with evidence of more extensive disease. There were no differences in the mean numbers of emergency room visits or hospitalizations among the 3 groups. Mean total costs of pharmacotherapy for UP to day 365 in relation to initial therapy for UP were $526 for MS, $559 for ME, and $1251 for oral 5-ASAs. Summary & Conclusions: Our retrospective study confirms findings from the few existing head-to-head clinical trials that topical mesalamine (suppositories, enema) may yield better treatment outcomes than oral 5-ASAs as initial therapy for UP.