CORE I & II: COlonic RElease Budesonide for the Induction of Remission for Mild-Moderate Ulcerative Colitis
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).
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- Sandborn WJ, Travis S, Moro L, Jones R, Gautille T, Bagin R, Huang M, Yeung P, Ballard ED. Once-daily budesonide MMX® extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: results from the CORE I study. Gastroenterology. 2012 Nov;143(5):1218-26
- Travis SPL, Danese S, Kupcinskas L, Alexeeva O, D’Haens G, Gibson PR, Moro L, Jones R, Ballard ED, Masure J, Rossini M, Sandborn WJ. Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomized CORE II study. Gut. 2014 Mar;63(3):433-41.
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- Travis, S, Danese E, Ballard D, Moro L, Jones RJ, et al. Safety analysis of budesonide MMX 6 mg used for the maintenance of remission in patients with ulcerative colitis: results from a Phase III, 12 month safety and extended use study. Gastroenterology. 2012;142(5):S566-7 (Su2080).
- Lichtenstein GA, Danese S, Ballard D, Moro L, Jones RJ, et al. Effect of budesonide MMX 6 mg on the Hypothalamic-Pituitary-Adrenal (HPA) axis in patients with ulcerative colitis: results from a phase III, 12 month safety and extended use study. Gastroenterology. 2012;142(5):S785 (Tu252).
- Travis S, Danese E, Ballard D, Moro L, Jones RJ, et al. Effect of long term Budesonide MMX use on bone mineral density in patients with ulcerative colitis: results from a phase III, 12 month safety and extended use study. Gastroenterology. 2012;142(5):S566-67 (Su2088).
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