CORE I & II: COlonic RElease Budesonide for the Induction of Remission for Mild-Moderate Ulcerative Colitis

  • Peter R. McNally, DO, MACG, MSRF
Keywords: KEY Words, Budesonide MMX, Uceris, Ulcerative Colitis, Corticosteroids, Colitis, CORE I, CORE II, Mayo Score, UCDAI, and ACG Ulcerative Colitis Guideline.


Budesonide is a second generation corticosteroid with very high affinity for the cortisol receptor, and active first pass hepatic metabolism through the cytochrome p450-3CA4 pathway.1,2 With a 90% first pass hepatic metabolism of budesonide, systemic corticosteroid side effects are minimized, while targeted end organ release can maximize corticosteroid benefit.1,2 The use of targeted release forms of budesonide for allergic disorders of the nasopharynx, esophagus, and respiratory tract are now considered standard of care over oral corticosteroids.2,3,4,5 Budesonide MMX (multi-matrix system, Cosmo Pharmaceuticals SpA, Lainte, Italy) utilizes a unique pH dependent drug release process to deliver and release budesonide throughout the colon, see Figure 1.6 This pharmacology theoretically maximizes drug delivery to the colon and minimizes systemic corticosteroid side effects.6

In this edition of VHJOE, I will review the important findings of two Phase III pharmaceutical studies that confirm the efficacy of Budesonide MMX (Uceris* Santarus, Inc., now Salix Pharmaceuticals, Inc/Santarus Inc. all rights reserved, Raleigh, NC USA) for the treatment of mild-moderate ulcerative colitis (UC).

Author Biography

Peter R. McNally, DO, MACG, MSRF
Deputy Editor, VHJOE, Center of Human Simulation, Unversity of Colorado School of Medicine. Aurora, Colorado. Chief GI Evans Army Hospital, Colorado Springs, CO. Conflict of Interest: Advisory Boards: Salix, Gastroenterology & Endoscopy News, Roche, Astra-Zeneca, Takeda Consultant: Salix, Takeda, Astra-Zeneca Speaker’s List: Salix, Takeda, Astra-Zeneca, Wyeth, P&G, Roche, Novartis, UCB, Abbott Grants: Novartis, Astra-Zeneca, Given, Abbott, Salix, Roche Pharmaceutical Stocks: 0



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