Open AccessA multicentre prospective cohort study assessing the effectiveness of budesonide MMX® (Cortiment® MMX® ) for active, mild‐to‐moderate ulcerative colitis
Author(s) -
Danese Silvio,
Hart Ailsa,
Dignass Axel,
Fiorino Gionata,
Louis Edouard,
Bonovas Stefanos,
D'Haens Geert,
Dotan Iris,
Rogler Gerhard,
Paridaens Kristine,
Peyrin-Biroulet Laurent
Publication year - 2019
Publication title -
ueg journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.667
H-Index - 35
eISSN - 2050-6414
pISSN - 2050-6406
DOI - 10.1177/2050640619864848
Subject(s) - mmx , medicine , ulcerative colitis , budesonide , tolerability , clinical endpoint , adverse effect , prospective cohort study , gastroenterology , clinical trial , corticosteroid , disease , computer science , operating system
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.