Review article: integrating budesonide‐MMX into treatment algorithms for mild‐to‐moderate ulcerative colitis

• Published in: Alimentary pharmacology & therapeutics Vol. 39; no. 10; pp. 1095 - 1103
• Main Authors: Danese, S., Siegel, C. A., Peyrin‐Biroulet, L.
• Format: Journal Article
• Language: English
• Published: Oxford Blackwell 01.05.2014
• Subjects: Algorithms; Anti-Inflammatory Agents - administration & dosage; Anti-Inflammatory Agents - adverse effects; Anti-Inflammatory Agents - therapeutic use; Biological and medical sciences; Budesonide - administration & dosage; Budesonide - adverse effects; Budesonide - therapeutic use; Chemistry, Pharmaceutical - methods; Colitis, Ulcerative - drug therapy; Colitis, Ulcerative - physiopathology; Delayed-Action Preparations; Gastroenterology. Liver. Pancreas. Abdomen; Glucocorticoids - therapeutic use; Humans; Medical sciences; Mesalamine - therapeutic use; Other diseases. Semiology; Severity of Illness Index; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Corticosteroid; Budesonide; Treatment; Antiinflammatory agent; Digestive diseases; Intestinal disease; Review; Algorithm; Bibliographic review; Inflammatory disease; Ulcerative colitis
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1111/apt.12712

Summary 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.