The role of Budesonide-MMX in active ulcerative colitis

Abstract

Traditional corticosteroids represent a well-established and effective treatment for active ulcerative colitis (UC). However, the severity of their systemic side effects, led in recent years to look for new steroid molecules that could reduce them, maximizing the anti-inflammatory activity. Budesonide has been one of the most studied steroid compounds and it has been approved for the treatment of mild to moderate active Crohn's disease (CD). In order to extend the release until the distally located inflammation, budesonide has been coupled with a controlled delivery system, called Multi-Matrix system (MMX^®), already successfully tested with oral mesalazine for the treatment of distal UC. After in vitro and in vivo models, the efficacy of Budesonide-MMX has been investigated in active UC with a first small phase II study, and partially encouraging results. This article will review the evidences on the use of budesonide in inflammatory bowel diseases and will discuss the role of Budesonide-MMX in active UC nowadays.

Keywords::

• budesonide
• erative colitis
• mesalazine
• MMX
• steroids

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Although corticosteroids are an effective treatment option for active ulcerative colitis (UC), dose- and duration-dependent side effects limit their long-term use.

• Budesonide has been one of the most studied steroid compounds produced in order to reduce steroids systemic side effects and maximize the anti-inflammatory activity.

• The latest European Crohn's Colitis Guidelines recommend oral budesonide as the first-line treatment for mild-to-moderate active ileocaecal Crohn's disease.

• The oral preparations of budesonide, which are now available on the market, include controlled-ileal release and pH-modified release formulations that allow the delivery of the active drug to the small intestine and the proximal colon.

• In order to extend the delivery of budesonide to the whole colon, it has been coupled with Multi-Matrix system (MMX), a technology that was already successfully applied to mesalazine (MMX Mesalazine).

• Thus far, three multicenter studies evaluated the efficacy of Budesonide-MMX in mild-to-moderate active UC and demonstrated its significant superiority compared to placebo.

• The safety profile of Budesonide-MMX makes it a suitable option in place of traditional corticosteroids.

• According to the latest guidelines, the first-line treatment of mild-to-moderate pancolitis and active left-sided colitis remains oral and topical mesalazine.

• Further studies comparing both oral and/or topical mesalazine to Budesonide-MMX in mild-to-moderate UC are warranted.