title: Budesonide Multi-matrix for the Treatment of Patients with Ulcerative Colitis.
abstract: Ulcerative colitis (UC) is a chronic idiopathic inflammatory disorder in which patients cycle between active disease and remission. Budesonide multi-matrix (MMX) is an oral second-generation corticosteroid designed to deliver active drug throughout the colon. In pharmacokinetic studies, the mean relative absorption of budesonide in the region between the ascending colon and the descending/sigmoid colon was 95.9 %. In 2 identically designed, phase 3 studies (CORE I and II), budesonide MMX 9 mg once daily was efficacious and well tolerated for induction of remission of mild to moderate UC. Clinical and endoscopic remission rates were 17.9 % (CORE I) and 17.4 % (CORE II) for budesonide MMX 9 mg compared with 7.4 and 4.5 %, respectively, with placebo (p < 0.05, budesonide MMX 9 mg vs. placebo in both studies), 12.1 % with mesalamine 2.4 g, and 12.6 % with budesonide controlled ileal release capsules 9 mg. A 12-month maintenance therapy study suggested that budesonide MMX 6 mg may prolong time to clinical relapse: Median time was >1 year with budesonide MMX 6 mg versus 181 days (p = 0.02) with placebo; however, further studies are needed. In the CORE studies, budesonide MMX exhibited a favorable safety profile; the majority of adverse events were mild or moderate in intensity, and serious adverse events were uncommon. Furthermore, rates of potential glucocorticoid-related adverse events were comparable across treatment groups. The long-term (12-month) safety of budesonide MMX appears to be comparable with placebo. Data support budesonide MMX in the management algorithm of UC.
authors.affiliation: Division of Gastroenterology, Department of Medicine, University of Pennsylvania Health System, GI Administration Offices, 7th Floor Perelman Center, Room 753, 3400 Civic Center Boulevard, Philadelphia, PA, 19104-4283, USA. grl@uphs.upenn.edu.
authors.forename: Gary R
authors.initials: GR
authors.lastname: Lichtenstein
mesh_terms: D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D019819:Budesonide / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004304:Dosage Forms; D006801:Humans
chemical_list: D000893:Anti-Inflammatory Agents; D003692:Delayed-Action Preparations; D004304:Dosage Forms; D019819:Budesonide
keywords: Budesonide MMX; Induction therapy; Remission; Ulcerative colitis