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Review article: integrating budesonide-MMX into treatment algorithms for mild-to-moderate ulcerative colitis
S Danese1, C A Siegel, L Peyrin-Biroulet
1IBD Center, Humanitas Clinical and Research Hospital, Milan, Italy.
Background:
5-Aminosalicylates (5-ASA) are first-line treatment for mild-moderately active ulcerative colitis (UC). When 5-ASAs fail, systemic corticosteroids have been the standard next step. Due to the significant side effect profile of systemic corticosteroids, alternative options in the treatment algorithm after 5-ASA failures are needed. Budesonide-Multi-Matrix System (MMX) is a novel oral formulation of budesonide that uses colonic release MMX technology to extend release of the drug to the colon. Now that budesonide-MMX has been approved for use in some countries, and pending in others we need to understand its position in the treatment algorithm for UC.
Aim:
To review the available literature for budesonide-MMX and incorporate it into the treatment algorithm for mild-moderate UC.
Methods:
The available efficacy and safety literature regarding budesonide-MMX was reviewed, and compared to 5-ASAs and systemic corticosteroids.
Results:
In two large studies referred to as CORE (Colonic Release Budesonide trial), budesonide-MMX 9 mg daily was significantly more effective in achieving a combined end point of clinical and endoscopic remission than placebo in patients with mild-moderately active UC. Safety data are reassuring, with no clinically relevant differences between budesonide-MMX and placebo, including steroid-related side effects.
Conclusions:
Budesonide-MMX 9 mg daily is an effective and safe treatment for induction in patients with mild-moderately active UC. At the current time, it should be considered in patients after 5-ASA failure and before systemic corticosteroids. Data are still needed to understand its role and dose beyond 8 weeks, and if it should be considered first line before 5-ASAs.
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