Gastroenterologie
a hepatologie

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

Luděk Hrdlička ^{Orcid.org  1,2}, Martin Bortlík ^{Orcid.org  3,4,5}, Tomáš Douda ^{Orcid.org  6}, Pavel Drastich ^{Orcid.org  7}, Přemysl Falt ^{Orcid.org  8}, Petra Matějková ^{Orcid.org  9,10}, Jana Koželuhová ^{Orcid.org  11}, Martin Liberda ^{Orcid.org  12}, Lenka Nedbalová¹³, Aleš Novotný ^{Orcid.org  14}, Martin Kolář³, Milan Lukáš ^{Orcid.org  3}

+ Affiliation
¹ Gastroenterologie, Poliklinika Budějovická, Medicon a. s., Praha
² Chirurgické oddělení, NH Hospital a.s., Nemocnice Hořovice
³ IBD clinical and research centre ISCARE a.s., Prague, Czech Republic
⁴ Department of Internal Medicine, 1st Faculty of Medicine, Charles University and Military University Hospital, Prague, Czech Republic
⁵ Institute of Pharmacology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic
⁶ II. interní gastroenterologická klinika LF UK a FN Hradec Králové
⁷ Klinika hepatogastroenterologie, Transplantcentrum, IKEM, Praha
⁸ II. interní klinika – gastroenterologická a geriatrická, LF UP a FN Olomouc
⁹ Gastroenterologie, EGK, s. r. o., Sanatorium sv. Anny, Praha
¹⁰ ČSSZ, Oddělení lékařské posudkové služby, pracoviště pro Prahu a střední Čechy, Praha
¹¹ Gastroenterologie, I. interní klinika LF UK a FN Plzeň
¹² Gastroenterologická ambulance, Nemocnice Valašské Meziříčí, a. s.
¹³ Centrum pro biologickou léčbu nespecifických střevních zánětů, Gastroenterologie, Nemocnice Turnov, KN Liberec, a. s.
¹⁴ IV. interní klinika – klinika gastroenterologie a hepatologie 1. LF UK a VFN v Praze

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.

Keywords

budesonide, glukocorticoids, ulcerative colitis

 

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