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ISSN: 1895-5770
Gastroenterology Review/Przegląd Gastroenterologiczny
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SCImago Journal & Country Rank
2/2023
vol. 18
 
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Artykuł oryginalny

Assessment of the effectiveness of Budesonide MMX® for active, mild-to-moderate ulcerative colitis in the Polish sub-group of the CORE Practice prospective multi-centre observational study

Maciej Jesionowski
1
,
Grażyna Rydzewska
2, 3
,
Silvio Danese
4
,
Kristine Paridaens
5

  1. Medical Affairs Ferring Pharmaceuticals Poland, Warsaw, Poland
  2. Department of Internal Medicine and Gastroenterology with Inflammatory Bowel Disease Unit, Central Clinical Hospital of the Ministry of the Interior and Administration, Warsaw, Poland
  3. Collegium Medicum, Jan Kochanowski University, Kielce, Poland
  4. Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milano, Italy
  5. Global Medical Affairs Ferring International Centre, St-Prex, Switzerland
Gastroenterology Rev 2023; 18 (2): 154–160
Data publikacji online: 2023/07/27
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Introduction
Budesonide MMX® is approved for induction of remission in mild-to-moderate active ulcerative colitis (UC) in adults in whom 5-ASA is not sufficient. There is a lack of data on its effectiveness and safety in clinical practice.

Material and methods
The CORE Practice study was a multi-centre prospective, observational study of mild-to-moderate UC-patients treated with Budesonide MMX® 9 mg for up to 8 weeks (induction). Enrolled patients had previously been prescribed Budesonide MMX® 9 mg in accordance with the SmPC within a 5-day time window. The primary endpoint was the percentage of patients achieving a decrease ≥ 3 points in the UCDAI clinical sub-score at the end of the induction treatment. Other endpoints were clinical remission (decrease ≤ 1 in UCDAI clinical sub-score), resolution of symptoms, change in Short Inflammatory Bowel Disease Questionnaire (SIBD-Q) score, treatment satisfaction, and tolerability. This report presents results from the Polish study sites.

Results
The data from a Polish subgroup of 181 patients with mild-to-moderate UC were analysed. Clinical improvement ≥ 3 points in the UCDAI at the end of treatment induction was achieved in 63.8% patients. Clinical remission was observed in 55.9% of patients at the end of the induction treatment. Full resolution of symptoms (rectal bleeding = 0 and stool frequency = 0) at the end of the Budesonide MMX® treatment was achieved in 52.5% of patients. Significant improvement in quality of life was seen in mean SIBD-Q total score from 40 points at baseline to 56 points at last assessment (p < 0.001). A treatment satisfaction score of more than 8 out of 10 was observed in 72.9% of patients. One patient discontinued Budesonide MMX® due to an adverse event that was related to the study drug, which counted for less than 1% of patients.

Conclusions
The data from the Polish subgroup of the real-life study CORE Practice confirms the clinical efficacy of Budesonide MMX® 9 mg in the majority of patients with active mild-to-moderate UC. Budesonide MMX® was safe and well tolerated. The therapy was satisfactory for patients and showed a beneficial effect on the patients’ quality of life.

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