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CORE II- Budesonide Multi-Matrix is the Best Possible Treatment for Remission of Ulcerative Colitis

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Budesonide Multi-Matrix is the Best Possible Treatment for Remission of Ulcerative Colitis

Background information

Ulcerative colitis (UC) is a chronic idiopathic inflammatory disorder involving the colonic mucosa and is characterized by periods of active symptomatic disease interspersed with periods of clinical remission. The 5-aminosalicylates are the first line therapy for the induction of remission in patients with mild-to-moderate UC. Corticosteroids are considered as the second option in patents who do not respond to 5-ASA formulations. But, first generation corticosteroid such as prednisone is associated with serious infections like bone disease, the development of cushingoid features, and increased risk of mortality.

Budesonide is an orally active, second generation corticosteroid. To improve the release of budesonide, it is coupled with a colonic release system (MMX Multi-Matrix System) that provides targeted drug delivery to the entire colon. These are not indicated for UC but are indicated only for the induction of remission of mild to moderate Crohn’s disease.

Objective

The objective of the CORE II (colonic release Budesonide) study is to determine the efficacy of once-daily Budesonide MMX for the induction of combined clinical and endoscopic remission in patients with active- mild-to-moderate UC compared with placebo.

Study design

The study was phase III randomized, double-blind, double-dummy, placebo-controlled trial, parallel group trial.

Sample size

A total of 509 patients, who passed inclusion and exclusion criteria were taken for the studies. In this, 129 patients were given placebo, 126 patients were given Budesonide MMX 9 mg, 128 patients were given Budesonide MMX 6 mg and nearly 126 patients were given Entocort EC.

Inclusion criteria

The inclusion criteria for the study were men and women aged 18 to 75 years with UC for more than 6 months. The UC disease activity index score should be more than 4 and less than 10. Patients should have a histological evidence of active UC identified via mucosal biopsy at baseline.

Exclusion criteria

Patients with infection or with UC limited to rectal region, or if they have used oral or rectal steroids in the last 4 weeks, immunosuppressive agents in the last 8 weeks were excluded from the study.
Patients with severe UC, UCDAI score of more than 10, severe anemia, leucopenia, or granulocytopenia were also excluded from the study.

Procedure

Patients were randomized in 1:1:1:1 ratio to receive Budesonide MMX 9 mg/day, Budesonide MMX 6 mg/day, Entocort EC 9 mg/day or placebo for 8 weeks. The patients were instructed to take Budesonide tablet once daily after breakfast, 3 capsules of active drug or placebo. The primary end point was combined clinical and endoscopic remission at week 8 and safety assessments like adverse events, potential glucocorticoid-related effects and morning plasma cortisol were determined.

Results

Primary endpoint

Combined clinical and endoscopic remission at week 8 achieved was higher in Budesonide MMX 9 mg patients when compared to the other 3 groups. The rate of combined clinical and endoscopic remission with Budesonide MMX 9 mg was also found to be significantly higher (17%) when compared to the placebo (4.5%).

Secondary endpoint

The results of clinical improvement, histological improvement, endoscopic improvement and symptom resolution from baseline to week 8 are:

Safety

The number of patients with treatment-emergent AEs was similar across all the treatment groups. The most common TEAEs observed in all the groups was UC relapse and headache.

Conclusion

From the above results, it is proved that Budesonide MMX 9 mg daily was safe and effective for the induction of remission of active, mild-to-moderate UC. Colonic-release budesonide can be an alternative to conventional corticosteroid therapy for the treatment of active, mild-to-moderate UC.

Reference

Simon P L et. al. Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study. Gut. 2014 Mar; 63(3): 433–441.

Avaliable at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3933176/

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