Induction of clinical and colonoscopic remission of mild-to-moderate ulcerative
colitis with budesonide MMX 9 mg: pooled analysis of two phase 3 studies.
Author(s): Sandborn WJ(1), Danese S, D'Haens G, Moro L, Jones R, Bagin R, Huang M, David
Ballard E, Masure J, Travis S.
Affiliation(s): Author information:
(1)University of California, San Diego, La Jolla, CA, USA.
Publication date & source: 2015, Aliment Pharmacol Ther. , 41(5):409-18
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.
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