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
Danese S, Fiocchi C. Ulcerative colitis. N Engl J Med 2011; 365: 1713-25.
Ordás I, Eckmann L, Talamini M, et al. Ulcerative colitis. Lancet 2012; 380: 1606-19.
Fumery M, Singh S, Dulai PS, et al. Natural history of adult ulcerative colitis in population-based cohorts: a systematic review. Clin Gastroenterol Hepatol 2018; 16: 343-56.e3.
Gaweł K, Dąbkowski K, Zawada I, et al. Natural history and progression risk factors of ulcerative proctitis: a retrospective study from a single tertiary centre in Poland. Gastroenterology Rev 2025; 20: 78-83.
Kim KU, Kim J, Kim WH, et al. Treatments of inflammatory bowel disease toward personalized medicine. Arch Pharm Res 2021; 44: 293-309.
Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 2005; 353: 2462-76.
Sandborn WJ, Su C, Sands BE, et al. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2017; 376: 1723-36.
Loftus EV Jr, Colombel JF, Feagan BG, et al. Long-term efficacy of vedolizumab for ulcerative colitis. J Crohns Colitis 2017; 11: 400-11.
Kamel S, Alaty W, Rashad H, et al. One-year single-center follow-up study of ustekinumab and vedolizumab use in inflammatory bowel disease Egyptian patients as second-line therapy after anti-TNF failure. Gastroenterology Rev 2025; 20: 430-8.
Sands BE, Sandborn WJ, Panaccione R, et al. Ustekinumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2019; 381: 1201-14.
Vieujean S, Jairath V, Peyrin-Biroulet L, et al. Understanding the therapeutic toolkit for inflammatory bowel disease. Nat Rev Gastroenterol Hepatol 2025; 22: 371-94.
Verstockt B, Salas A, Sands BE, et al. IL-12 and IL-23 pathway inhibition in inflammatory bowel disease. Nat Rev Gastroenterol Hepatol 2023; 20: 433-46.
Croxford AL, Mair F, Becher B. IL-23: one cytokine in control of autoimmunity. Eur J Immunol 2012; 42: 2263-73.
Louis E. Use of interleukin-23 inhibitors for the treatment of inflammatory bowel disease. Gastroenterol Hepatol 2025; 21: 180-6.
Gottlieb ZS, Sands BE. Personalised medicine with IL-23 blockers: myth or reality? J Crohns Colitis 2021; 16 (Suppl 2): ii73-82.
Steere B, Beidler C, Martin A, et al. Generation and characterization of mirikizumab, a humanized monoclonal antibody targeting the p19 subunit of IL-23. J Pharmacol Exp Ther 2023; 387: 180-7.
Keam SJ. Mirikizumab: first approval. Drugs 2023; 83: 1045-52.
D’Haens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2023; 388: 2444-55.
Abraham B, Wu J, Vermeire S, et al. Efficacy and safety of mirikizumab in moderately to severely active ulcerative colitis regardless of baseline modified Mayo score: results from the phase 3 LUCENT trials. Crohns Colitis 360 2025; 7: otaf002.
Sands BE, D’Haens G, Reinisch W, et al. Long-term efficacy and safety of mirikizumab in ulcerative colitis: extension study results. Gastroenterology 2024; 166: 1234-46.
Schreiber S, Panaccione R, Louis E, et al. Real-world effectiveness of IL-23 inhibitors in ulcerative colitis: a multicentre European cohort study. J Crohns Colitis 2025; 19: 1123-32.
Kobayashi T, Motoya S, Nakamura S, et al. Clinical outcomes of IL-23 blockade in ulcerative colitis: real-world data from a Japanese multicenter cohort. Inflamm Bowel Dis 2025; 31: 1456-65.
Shafrir A, Mathew A, Tanouye JM, et al. Guselkumab efficacy and safety in moderately to severely active ulcerative colitis: real-world data from a large tertiary center. J Crohns Colitis 2026; 20 (Suppl 1): P0732.
Levartovsky A, Lukáš M, Abitbol CM, et al. Mirikizumab in ulcerative colitis: real-world evidence from an international two-center retrospective cohort study. Therap Adv Gastroenterol 2025; 18: 17562848251392074.
Biskup L, Semeradt J, Rogowska J, et al. New interleukin-23 antagonists’ use in Crohn’s disease. Pharmaceuticals 2025; 18: 447.
Lewandowski K, Karłowicz K, Sarbinowska J, et al. RESCUE-CD – Real-world effectiveness of risankizumab in moderate-to-severe Crohn’s disease: a case series involving the most refractory and challenging patients. Gastroenterology Rev 2026; 21: 38-44.
