Abstract
BACKGROUND: Cortiment®(MMX®) (budesonide MMX®) is currently approved for the induction of remission in mild-to-moderate ulcerative colitis (UC) patients when 5-ASA treatment is not sufficient. Data in real-life settings are lacking. METHODS: This was a multicentre observational prospective cohort study conducted in Europe and Canada. Effectiveness, safety, and tolerability of Cortiment®(MMX®) in a real-life setting of patients treated for mild-to-moderate UC was investigated. Patients were prescribed Cortiment®(MMX®) in accordance with the Summary of the Product Characteristics (SmPC).The primary endpoint was the clinical benefit of Cortiment® MMX® in routine practice (improvement ≥ 3 points in the clinical sub-scores of the Ulcerative Colitis Disease Activity Index, UCDAI). RESULTS: Data from 326 patients with mild-to-moderate UC were analysed for the primary endpoint. Clinical benefit was achieved in 60.1% (196/326) of patients at the end of Cortiment®(MMX®) treatment. Clinical remission (UCDAI clinical sub-score ≤ 1), full symptoms resolution (rectal bleeding (RB) = 0 and stool frequency (SF) = 0) and symptoms resolution (RB = 0 + SF ≤ 1) at the end of the Cortiment®(MMX®) treatment were achieved in 51.8%, 45.1% and 63.2% of patients, respectively. The median time to symptoms resolution was 30 days (range 29.0-36.0 days). Fifty patients (14.3%) had to discontinue Cortiment®(MMX®) due to adverse events; 17.5% of patients (n = 61) reported at least one adverse event related to the study drug. CONCLUSIONS: This was the first time that a large cohort study was conducted with Cortiment®(MMX®) in a real-life setting. It demonstrated that Cortiment®(MMX®) is effective, safe and well tolerated in about 60% of UC patients.