Budesonide ММХ in the treatment of ulcerative colitis: real world clinical practice

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Abstract

Rationale: Mild and moderate ulcerative colitis (UC) is conventionally treated with oral and rectal 5-aminosalicylic acid (5-ASA) formulations and, if ineffective, with systemic glucocorticosteroids. A huge disadvantage of systemic steroids is that with highly efficacy they have severe side effects and the development of hormone-dependency requiring their withdrawal. The main goal of UC treatment is to achieve clinical and endoscopic remission, and possibility to stop steroids. The introduction of multimatrix (MMX) budesonide (Cortiment®), a new topical steroid for UC treatment, widens the therapeutic armamentarium and allows in some cases to refrain from systemic agents, avoiding their side effects and achieving the necessary treatment goals.

Aim: To evaluate the efficacy of topical steroid budesonide MMX for remission induction of UC in the real clinical practice.

Materials and methods: We have analyzed 122 specially designed case report forms filled in from September 2018 to March 2019 in healthcare centers of Moscow, Voronezh, Lipetsk, Krasnodar, and Krasnoyarsk Regions of Russian Federation. The case report forms included anonymized data on the UC patients treated with budesonide MMX. The results of treatment were analyzed for various severity and extension of UC and depending on budesonide MMX monotherapy or combined therapy with rectal 5-ASA formulations. Treatment was considered effective if clinical and endoscopic remission was achieved.

Results: Total efficacy in terms of improvement of clinical parameters (improvement/remission) after 4 weeks of treatment was 95% (118 patients), with clinical remission induced in 42.6% (52 patients). Positive changes over time in the endoscopic findings (improvement/remission) within the same time period were observed in 93% (60 patients), with endoscopic remission in 24.1% (21 patients).

Conclusion: Budesonide MMX allows for a rapid clinical improvement and/or clinical remission in the majority of the patients with mild and moderate UC of predominantly left-sided location.

About the authors

P. A. Makarchuk

Moscow Regional Research and Clinical Institute (MONIKI)

Author for correspondence.
Email: pashka_m79@mail.ru

Pavel A. Makarchuk – MD, PhD, Senior Research Fellow, Department of Gastroenterology

61/2-9 Shchepkina ul., Moscow, 129110

Russian Federation

O. S. Britkina

Moscow Regional Research and Clinical Institute (MONIKI)

Email: fake@neicon.ru

Ol'ga S. Britkina – Junior Research Fellow, Department of Gastroenterology

61/2-9 Shchepkina ul., Moscow, 129110

Russian Federation

E. A. Belousova

Moscow Regional Research and Clinical Institute (MONIKI)

Email: fake@neicon.ru
ORCID iD: 0000-0003-4523-3337

Elena A. Belousova – MD, PhD, Professor, Head of Department of Gastroenterology, Head of Chair of Gastroenterology

61/2-9 Shchepkina ul., Moscow, 129110

Russian Federation

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Copyright (c) 2019 Makarchuk P.A., Britkina O.S., Belousova E.A.

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