5-Aminosalicylates (5-ASA) are first-line treatment for mild–moderately active ulcerative colitis.
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 there is a need to understand its position in the treatment algorithm for ulcerative colitis.
Dr Danese and colleagues from Italy reviewed the available literature for budesonide-MMX and incorporate it into the treatment algorithm for mild–moderate ulcerative colitis.
|Safety data are reassuring, including those for steroid-related side effects|
|Alimentary Pharmacology & Therapeutics|
The team reviewed the available efficacy and safety literature regarding budesonide-MMX, and compared to 5-ASAs and systemic corticosteroids.
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 ulcerative colitis.
The researchers report that safety data are reassuring, with no clinically relevant differences between budesonide-MMX and placebo, including steroid-related side effects.
Dr Danese's team comments, "Budesonide-MMX 9 mg daily is an effective and safe treatment for induction in patients with mild–moderately active ulcerative colitis."
"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."