IBD Centre Humanitas Clinical and Research Centre, Milan, Italy.
Department of Biomedical Sciences, Humanitas University, Milan, Italy.
United European Gastroenterol J. 2019 Nov;7(9):1171-1182. doi: 10.1177/2050640619864848. Epub 2019 Jul 17.
Cortiment® (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.
This was a multicentre observational prospective cohort study conducted in Europe and Canada. Effectiveness, safety, and tolerability of Cortiment® in a real-life setting of patients treated for mild-to-moderate UC was investigated. Patients were prescribed Cortiment® 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).
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® 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® 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® due to adverse events; 17.5% of patients ( = 61) reported at least one adverse event related to the study drug.
This was the first time that a large cohort study was conducted with Cortiment® in a real-life setting. It demonstrated that Cortiment® is effective, safe and well tolerated in about 60% of UC patients.
Cortiment®（布地奈德 MMX®）目前被批准用于治疗轻中度溃疡性结肠炎（UC）患者，当 5-ASA 治疗不足时诱导缓解。目前缺乏真实环境下的数据。
这是一项在欧洲和加拿大进行的多中心观察性前瞻性队列研究。研究了 Cortiment®在轻中度 UC 患者的真实环境中的疗效、安全性和耐受性。患者按照产品说明书（SmPC）规定使用 Cortiment®。主要终点是 Cortiment® MMX®在常规治疗中的临床获益（溃疡性结肠炎疾病活动指数（UCDAI）临床亚评分改善≥3 分）。
对 326 例轻中度 UC 患者进行了主要终点数据分析。Cortiment®治疗结束时，60.1%（196/326）的患者达到临床获益。51.8%、45.1%和 63.2%的患者在 Cortiment®治疗结束时分别达到临床缓解（UCDAI 临床亚评分≤1）、完全症状缓解（直肠出血（RB）=0 和粪便频率（SF）=0）和症状缓解（RB=0+SF≤1）。Cortiment®治疗症状缓解的中位数时间为 30 天（范围 29.0-36.0 天）。50 例（14.3%）因不良事件停止使用 Cortiment®；17.5%（61 例）的患者报告了至少 1 例与研究药物相关的不良事件。
这是首次在真实环境中使用 Cortiment®进行的大型队列研究。研究表明，Cortiment®在约 60%的 UC 患者中有效、安全且耐受良好。
