Long-term safety and efficacy of budesonide in the treatment of ulcerative colitis

Marisa Iborra,1 Diego Álvarez-Sotomayor,2 Pilar Nos1 1Gastroenterology Unit, Department of Digestive Disease, Centro de investigación biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), La Fe University and Polytechnic Hospital, Valencia, Spain; 2Gastroenterology Unit, Department of Digestive Disease, La Fe University and Polytechnic Hospital, Valencia, Spain Abstract: Ulcerative colitis (UC) is a chronic, relapsing, and remitting inflammatory disease involving the large intestine (colon). Treatment seeks to break recurrent inflammation episodes by inducing and maintaining remission. Historically, oral systemic corticosteroids played an important role in inducing remission of this chronic disease; however, their long-term use is limited and can lead to adverse events. Budesonide is a synthetic steroid with potent local anti-inflammatory effects and low systemic bioavailability due to high first-pass hepatic metabolism. Several studies have demonstrated oral budesonide's usefulness in treating active mild to moderate ileocecal Crohn's disease and microscopic colitis and in an enema formulation for left sided UC. However, there is limited information regarding oral budesonide's efficacy in UC. A novel oral budesonide formulation using a multimatrix system (budesonide-MMX) to extend drug release throughout the colon has been developed recently and seems to be an effective treatment in active left sided UC patients. This article summarizes budesonide's long-term safety and efficacy in treating UC. Keywords: budesonide, ulcerative colitis, Crohn's disease, safety