The efficacy and safety of budesonide MMX (Cortiment®) for long-term maintenance therapy of ulcerative colitis


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;  IV. interní klinika – klinika gastroenterologie a hepatologie, 1. LF UK a VFN v Praze 10;  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 FN Plzeň 7;  Gastroenterologická ambulance, Nemocnice Valašské Meziříčí, a. s. 8;  IBD centrum Turnov, Krajská nemocnice Liberec, a. s. 9
Published in: Gastroent Hepatol 2018; 72(4): 329-333
Category:
doi: 10.14735/amgh2018329

Overview

Background:

The role of budesonide-MMX (Cortiment®) in the induction of remission in mild to moderate active ulcerative colitis (UC) is already well established; however, data on maintenance treatment are limited.

Aim:

To assess the efficacy and safety of this medication as a long-term maintenance treatment.

Methods:

Forty patients, corresponding to responders in a previous 8-weeks induction study on continuing medication, were included in this multicentric (10 Czech centers were involved) retrospective 12-month study. Partial Mayo score and endoscopic Mayo score were assessed at 6 and 12 months, adverse events of special interest were recorded, and tolerability and compliance data were collected.

Results:

Significant maintenance of decreased clinical and endoscopic activity of UC were observed; the mean partial resp. endoscopic Mayo scores were 2.2 resp. 0.96 at week 8, 2.33 resp. 1.09 at 6 months, and 1.03 resp. 0.86 at 12 months. Complete mucosal healing (Mayo 0) was found in 19 (48%) patients at month 12. Clinical remission was achieved in 63% resp. (month 6) 66% (month 12) patients. A clinical response was observed even in 80% resp. 85% patients. The incidence of adverse events (AE) was very low. No patient interrupted or discontinued the maintenance medication because of the risk of experiencing AE.

Conclusion:

Our results demonstrate good efficacy and safety of Cortiment® use in the long-term maintenance treatment of mild to moderate UC.

Key words:

ulcerative colitis – maintenance therapy – glucocorticoids – budesonide-MMX

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: 4. 6. 2018

Accepted: 13. 6. 2018


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