Multicentre retrospective real-world evidence study evaluating the effectiveness and safety of mirikizumab in patients with moderately to severely active ulcerative colitis
Department of Gastroenterology and Internal Medicine, National Medical Institute of the Ministry of the Interior and Administration, Warsaw, Poland
Department of Gastroenterology, Dietetics, and Internal Diseases, Poznan University of Medical Sciences, Poznan, Poland
Department of Gastroenterology and Internal Medicine, Military Institute of Medicine – National Research Institute, Warsaw, Poland
Department of Gastroenterology, St. Barbara Main District Hospital, Sosnowiec, Poland
Collegium Medicum, WSB University, Dąbrowa Górnicza, Poland
Department of Gastroenterology, Pomeranian Medical University, Szczecin, Poland
Department of Gastroenterology, Hepatology, and Internal Medicine, Wroclaw Medical University, Wroclaw, Poland
Department of Gastroenterology and Hepatology, Medical University of Gdansk, Poland
Department of Gastroenterology, Faculty of Medicine, Academy of Silesia, Katowice, Poland
Endoterapia, H-T Centrum Medyczne, Tychy, Poland
Department of Gastroenterological Oncology, Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland
Department of Gastroenterology, Hepatology, and Clinical Oncology, Centre of Postgraduate Medical Education, Warsaw, Poland
Department of Gastroenterology and Hepatology with Endoscopic Unit, Medical University of Lublin, Poland
Department of Digestive Tract Diseases, Norbert Barlicki University Hospital, Lodz, Poland
Department of Gastroenterology, Medical University of Lodz, Poland
Department of Gastroenterology, Masovian Brodnowski Hospital, Warsaw, Poland
Department of Gastroenterology with IBD Unit, St. Jadwiga Queen Hospital, Rzeszow, Poland
Department of Internal Medicine, Medical College, University of Rzeszow, Poland
Department of Gastroenterology and Hepatology, Medical University of Silesia, Katowice, Poland
Department of Gastroenterology, Self-Dependent Health Care Unit of the Ministry of the Interior, Gdansk, Poland
II Gastroenterology Department, Centre of Postgraduate Medical Education, Warsaw, Poland
Department of Gastroenterology and Hepatology, Jagiellonian University Medical College, Krakow, Poland
Department of Gastroenterology and Internal Medicine, Medical University of Bialystok, Poland
Department of Internal Diseases, General Hospital, Miedzychod, Poland
Department of Gastroenterology and Nutrition Disorders, Faculty of Health Sciences, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Poland
Collegium Medicum, Jan Kochanowski University, Kielce, Poland
Introduction
Mirikizumab (MIRI), a selective IL-23 p19 inhibitor, has demonstrated efficacy in randomised trials in moderate to severe ulcerative colitis (UC), but real-world data remain limited, particularly in highly treatment-exposed populations.
Aim
To assess the real-world effectiveness and safety of MIRI in adults with moderately to severely active UC.
Material and methods
This retrospective multicentre study included 257 adults with UC initiating MIRI before 31 January 2026 across 21 Polish centres. Induction consisted of intravenous MIRI 300 mg at weeks 0, 4, and 8, with optional extension to week 24 in cases of insufficient response. Disease activity was assessed at baseline and at weeks 12 and 24 using clinical, endoscopic, and laboratory parameters. Safety was evaluated by recording adverse events (AE) and serious adverse events (SAE).
Results
Most patients had prior exposure to advanced therapy, and 54.1% underwent extended induction. Significant improvement was observed at weeks 12 and 24 across all parameters. Among evaluable patients, clinical remission was 31.7% at week 12 and 41.8% at week 24, while clinical response was 76.2% and 79.3%, respectively. Endoscopic remission was 9.5% and 18.5%, whereas endoscopic response was 67.1% and 64.8%, respectively. Corticosteroid-free clinical remission was 23.1% and 26.4%. AE occurred in 9.1% and 14.1% of patients, and SAE in 2.6% and 6.6%.
Conclusions
In this large real-world study with predominantly advanced therapy-exposed UC, MIRI was associated with significant clinical, endoscopic, and biochemical improvement through weeks 12 and 24, with a favourable safety profile.
Keywords
ulcerative colitis, real-world evidence, mirikizumab, IL-23 inhibition, advanced therapy experienced patients
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