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Summary   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 .

alimentary pharmacology and therapeutics

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