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Induction of clinical and colonoscopic remission of mild-to-moderate ulcerative colitis with budesonide MMX 9 mg: pooled analysis of two phase 3 studies.

ABSTRACT: BACKGROUND:Conventional oral corticosteroids are effective at reducing inflammation associated with ulcerative colitis (UC); however, systemic adverse effects limit their use. Budesonide MMX is an extended-release, second-generation corticosteroid that targets delivery of budesonide to the entire colon. AIM:To analyse efficacy and safety outcomes from two phase 3 studies of budesonide MMX in patients with mild-to-moderate active UC. METHODS:Patients were assigned to budesonide MMX 9 mg, budesonide MMX 6 mg, or placebo once daily in two randomised, double-blind, placebo-controlled, 8-week studies (CORE I and II). Pooled data were analysed for pre-defined primary (combined clinical and colonoscopic remission), secondary and exploratory endpoints. Primary endpoint data were analysed to evaluate the potential influence of demographical and baseline disease characteristics on remission. RESULTS:Modified intent-to-treat population (histological evidence of baseline inflammation) had 232, 230 and 210 patients in budesonide MMX 9 mg, budesonide MMX 6 mg and placebo groups respectively. Combined clinical and colonoscopic remission rates were significantly greater than placebo (6.2%) for the budesonide MMX 9 mg group (17.7%; P = 0.0002), but not the budesonide MMX 6 mg group (10.9%). The primary endpoint of remission with budesonide MMX 9 mg was significantly greater than placebo in most subgroups analysed. Symptom resolution and colonoscopic improvement rates were significantly greater with budesonide MMX 9 mg vs. placebo. Budesonide MMX was safe and well tolerated. CONCLUSION:This pooled analysis showed that budesonide MMX 9 mg is efficacious, safe and well tolerated for inducing remission of mild-to-moderate UC.

SUBMITTER: Sandborn WJ

PROVIDER: S-EPMC6681012 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature

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Induction of clinical and colonoscopic remission of mild-to-moderate ulcerative colitis with budesonide MMX 9 mg: pooled analysis of two phase 3 studies.

Sandborn W J WJ Danese S S D'Haens G G Moro L L Jones R R Bagin R R Huang M M David Ballard E E Masure J J Travis S S

Alimentary pharmacology & therapeutics 20150115 5

<h4>Background</h4>Conventional oral corticosteroids are effective at reducing inflammation associated with ulcerative colitis (UC); however, systemic adverse effects limit their use. Budesonide MMX is an extended-release, second-generation corticosteroid that targets delivery of budesonide to the entire colon.<h4>Aim</h4>To analyse efficacy and safety outcomes from two phase 3 studies of budesonide MMX in patients with mild-to-moderate active UC.<h4>Methods</h4>Patients were assigned to budeson ...[more]

PMID: 25588902

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Project description:IntroductionBudesonide MMX® is approved for induction of remission in mild-to-moderate active ulcerative colitis (UC) in adults in whom 5-ASA is not sufficient. There is a lack of data on its effectiveness and safety in clinical practice.Material and methodsThe CORE Practice study was a multi-centre prospective, observational study of mild-to-moderate UC-patients treated with Budesonide MMX® 9 mg for up to 8 weeks (induction). Enrolled patients had previously been prescribed Budesonide MMX® 9 mg in accordance with the SmPC within a 5-day time window. The primary endpoint was the percentage of patients achieving a decrease ≥ 3 points in the UCDAI clinical sub-score at the end of the induction treatment. Other endpoints were clinical remission (decrease ≤ 1 in UCDAI clinical sub-score), resolution of symptoms, change in Short Inflammatory Bowel Disease Questionnaire (SIBD-Q) score, treatment satisfaction, and tolerability. This report presents results from the Polish study sites.ResultsThe data from a Polish subgroup of 181 patients with mild-to-moderate UC were analysed. Clinical improvement ≥ 3 points in the UCDAI at the end of treatment induction was achieved in 63.8% patients. Clinical remission was observed in 55.9% of patients at the end of the induction treatment. Full resolution of symptoms (rectal bleeding = 0 and stool frequency = 0) at the end of the Budesonide MMX® treatment was achieved in 52.5% of patients. Significant improvement in quality of life was seen in mean SIBD-Q total score from 40 points at baseline to 56 points at last assessment (p < 0.001). A treatment satisfaction score of more than 8 out of 10 was observed in 72.9% of patients. One patient discontinued Budesonide MMX® due to an adverse event that was related to the study drug, which counted for less than 1% of patients.ConclusionsThe data from the Polish subgroup of the real-life study CORE Practice confirms the clinical efficacy of Budesonide MMX® 9 mg in the majority of patients with active mild-to-moderate UC. Budesonide MMX® was safe and well tolerated. The therapy was satisfactory for patients and showed a beneficial effect on the patients' quality of life.

Dataset Information

Induction of clinical and colonoscopic remission of mild-to-moderate ulcerative colitis with budesonide MMX 9 mg: pooled analysis of two phase 3 studies.

Publications

Induction of clinical and colonoscopic remission of mild-to-moderate ulcerative colitis with budesonide MMX 9 mg: pooled analysis of two phase 3 studies.

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