Budesonide MMX (Cortiment^® 9 mg) in the treatment of ulcerative colitis in real clinical practice

Czech version

Authors: L. Hrdlička ¹; M. Bortlík ²; T. Douda ³; P. Drastich ⁴; P. Falt ⁵; P. Matějková ⁶; J. Koželuhová ⁷; M. Liberda ⁸; L. Nedbalová ⁹; A. Novotný ¹⁰; M. Kolář ²; M. Lukáš ²
Authors‘ workplace: Gastroenterologie, Medicon a. s., Poliklinika Budějovická, Praha ¹; Klinické a výzkumné centrum pro střevní záněty, ISCARE I. V. F. a. s., Praha ²; II. interní gastroenterologická klinika LF UK a FN Hradec Králové ³; Klinika hepatogastroenterologie, Transplantcentrum, IKEM, Praha ⁴; Centrum péče o zažívací trakt, Vítkovická nemocnice a. s., Ostrava ⁵; Gastroenterologické oddělení, EGK s. r. o., Sanatorium sv. Anny, Praha ⁶; Gastroenterologie, I. interní klinika LF UK a FN Plzeň ⁷; Gastroenterologická ambulance, Nemocnice Valašské Meziříčí, a. s. ⁸; IBD centrum Turnov, Krajská nemocnice Liberec, a. s. IV. interní klinika – klinika gastroenterologie a hepatologie, 1. LF UK a VFN v Praze ⁹; IV. interní klinika – klinika gastroenterologie a hepatologie, 1. LF UK a VFN v Praze ¹⁰
Published in: Gastroent Hepatol 2016; 70(6): 509-513
Category: IDB: Original Article
doi: https://doi.org/10.14735/amgh2016509

Overview

Background:
Budesonide MMX (Cortiment^® 9 mg) is a novel local-acting glucocorticoid for the treatment of mild-to-moderate active ulcerative colitis (UC).

Aim:
To assess the efficacy and safety of this treatment in UC patients.

Methods:
In 81 patients (ten centers in the Czech Republic were involved) with mild-to-moderate UC, treatment with Cortiment^® 9 mg once daily was initiated according to routine clinical practice. These patients were included in an 8 week retrospective multicenter study. The partial Mayo score and endoscopic Mayo score were assessed at weeks 0, 4 and 8, resp. 0 and 8. Adverse events of special interest, as well as tolerability and compliance data, were collected at weeks 4 and 8.

Results:
The clinical and endoscopic activity of UC was significantly decreased; the mean partial resp. endoscopic Mayo score decreased from 5.46, resp. 2.09 at week 0 to 1.99, resp. 1.02 at week 8. Complete mucosal healing (Mayo 0) was observed in 22 (29.3%) patients at week 8. Clinical remission was achieved in 14% (week 4) and 52% (week 8) of patients. A clinical response was observed in 70% (week 4) and 84% (week 8) of patients. The safety profile was excellent: the incidence of each adverse event did not exceed 5%, an adverse event was reported by 13 patients (16%), and only four patients (4.9%) discontinued the medication because they experienced an adverse event.

Conclusion:
Our results demonstrated the very good efficacy and excellent safety profile of Cortiment^® 9 mg in the treatment of UC.

Key words:
ulcerative colitis – glucocorticoids – budesonide

The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study.

The Editorial Board declares that the manuscript met the ICMJE „uniform requirements“ for biomedical papers.

Submitted:
15. 11. 2016

Accepted:
22. 11. 2016

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