Treatment of Newly Diagnosed Ulcerative Proctitis in Community-Based Practice

Abstract

Purpose: Treatment of ulcerative proctitis (UP) is aimed at controlling inflammation and reducing symptoms. While orally administered 5-aminosalicylates (“5-ASAs”) traditionally have been the mainstay of acute and maintenance therapy for UP, 5-ASA suppositories or enemas are generally considered to be first-line therapy, due to evidence that they are more effective at inducing and maintaining remission. Little is known, however, about how UP is typically treated in community-based practice. Methods: Using a large US healthcare claims database, we identified all persons with evidence of newly diagnosed UP (ICD-9-CM 556.2, 556.3) between 1/1/2005 and 12/31/2007, based on: (1) ≥2 encounters for UP ≤90 days apart; (2) evidence of sigmoidoscopy/colonoscopy within 60 days of first visit for UP (“index date”); and (3) no evidence of receipt of any medication used to treat UP (eg, 5-ASA, glucocorticoid, etc.) in the year preceding index date. All patients were followed for 365 days from their index date. We examined pharmacotherapy for UP over post-index periods of 30 days and 365 days alternatively. Results: We identified a total of 518 patients with newly diagnosed UP. Mean (SD) age was 48 (16) years, and there were equal numbers of men and women. Forty-five percent of patients were seen by a gastroenterologist at initial visit. In the 30-day post-index period, 37% of patients had evidence of receipt of mesalamine suppository; 23%, an oral 5-ASA; 12%, mesalamine enema; 12%, rectal hydrocortisone; and 6%, oral prednisone. Antidiarrheals, antimetabolites, and TNF inhibitors were rarely used. Over the entire 365-day post-index period, the number of patients ever-prescribed 5-ASA suppositories increased to 45%; oral 5-ASAs, 38%; 5-ASA enemas, 18%; and systemic glucocorticoids, 20%. Combination and sequential treatment was frequent. Over 365 days, 24% of patients had evidence of receipt of both oral and rectal 5-ASAs; 11%, rectal 5-ASAs and rectal steroids; 2%, rectal 5-ASAs and budesonide; and 11%, rectal 5-ASAs and systemic steroids. Conclusion: While local therapy is commonly prescribed in patients with newly diagnosed UP, approximately one in four patients receive an oral 5-ASA preparation. In the year following diagnosis, one in five patients receive systemic steroids—a marker of failure of conservative therapy and/or disease progression. Our findings suggest that treatment of newly diagnosed UP by community-based physicians largely conforms to guidelines and recommendations. Support: This research was funded by Axcan Pharma Inc., which manufactures and markets a 5-ASA suppository (Canasa®). Disclosure: This research was funded by Axcan Pharma Inc., which manufactures and markets a 5-ASA suppository (Canasa®).