Review Article

Integrating Budesonide-MMX Into Treatment Algorithms for Mild-to-Moderate Ulcerative Colitis

S. Danese; C. A. Siegel; L. Peyrin-Biroulet

Disclosures

Aliment Pharmacol Ther. 2014;39(10):1095-1103. 

In This Article

Abstract and Introduction

Abstract

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.

Introduction

5-Aminosalicylic-acids (5-ASA) remain the first-line therapy for inducing and maintaining remission of mild–moderately active ulcerative colitis (UC).[1] Systemic steroids are currently indicated for the treatment of 5-ASA failure and as a first-line therapy in moderate-to-severe UC.[1] However, systemic steroids have a poor safety profile and are only induction agents. Budesonide treatment for up to 1 year is well tolerated in Crohn's disease (CD) patients, with an adverse events (AE) profile similar to placebo.[2] In a randomised, double-blind trial, at 10 weeks, 53% of patients with ileal or ileocecal CD treated with budesonide were in remission (defined as a score ≤150 on the CD activity index), compared with 66% of those treated with prednisolone (P = 0.12).[3] In addition, budesonide is effective for reducing rates of relapse compared to placebo at 3 and 6 months.[4] Accordingly, budesonide is first-line mild-to-moderate ileal CD.[5]

Budesonide-MMX (Santarus Inc., San Diego, CA, USA) is a novel oral formulation of budesonide that uses colonic release Multi-Matrix System (MMX) technology to extend release of the drug to the colon. In two recent controlled trials, budesonide-MMX (9 mg) was shown to be well tolerated and more effective than placebo in inducing remission in patients with active, mild-to-moderate UC.[6,7] Budesonide-MMX has been approved by the US Food and Drug Administration (FDA), the Netherlands and is now awaiting approval throughout EU and the rest of the world. Hence, we need to incorporate budesonide-MMX in current treatment algorithms for mild-to-moderate UC.

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