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

Česká verzia

Authors: Luděk Hrdlička ¹; M. Bortlík ²; T. Douda ³; P. Drastich ⁴ ; Přemysl Falt ⁵ ; P. Matějková ⁶; J. Koželuhová ⁷; M. Liberda ⁸; L. Nedbalová ⁹; A. Novotný ¹⁰; M. Kolář ² ; M. Lukáš ²
Authors place of work: 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 the journal: Gastroent Hepatol 2016; 70(6): 509-513
Category: IDB: Original Article
doi: https://doi.org/10.14735/amgh2016509

Summary

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

Zdroje

1. Travis S, Danese S, Kupcinskas L et al. Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study. Gut 2014; 63(3): 433–441. doi: 10.1136/ gutjnl-2012-304258.

2. Sandborn WJ, Travis S, Moro L et al. Once-daily budesonide MMX^® extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: results from the CORE I study. Gastroenterology 2012; 143(5): 1218–1226. doi: 10.1053/ j.gastro.2012.08.003.

3. Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med 1987; 317(26): 1625–1629.

4. Rutgeerts P, Sandborn WJ, Feagan BG et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 2005; 353(23): 2462–2476.

5. Jharap B, Sandborn WJ, Reinisch W et al.Randomized clinical trial: discrepancies between patients-reported outcomes and endoscopic appearance in moderate to severe ulcerative colitis. Aliment Pharmacol Ther 2015; 42(9): 1082–1092. doi: 10.1111/ apt.13387.

6. Colombel JF, Keir ME, Scherl A et al. Discrepancies between patient-reported outcomes and endoscopic and histologic appearance in UC. Gut 2016. In press. doi: 10.1136/ gutjnl-2016-312307.

7. Sandborn WJ, Danese S, Ballard ED et al.Efficacy of budesonide MMX^® 6 mg QD for the maintenance of remission in patients with ulcerative colitis: results from a phase III, 12 month safety and extended use study. Gastroenterology 2012; 142 (5 Suppl 1): S564. Abstract Su2080.

8. Travis S, Danese S, Ballard ED et al. Safetyanalysis of budesonide MMX 6 mg used for the maintenance of remission in patients with ulcerative colitis: results from a phase III, 12 month safety and extended use study. Gastroenterology 2012; 142 (5 Suppl 1): S566–S567.

9. Lichtenstein GR, Danese S, Ballard ED et al. Effect of budesonide MMX 6 mg on the hypothalamic–pituitary–adrenal (HPA) axis in patients with ulcerative colitis: results from a phase III, 12 month safety and extended use study. Gastroenterology 2012; 142 (5 Suppl 1): S785.