Mirikizumab – a new option in treatment of inflammatory bowel diseases

Jakub Olszewski; Katarzyna Kozon; Magdalena Sitnik; Katarzyna Herjan; Karolina Mikołap; Bartłomiej Gastoł; Maciej Bara; Piotr Armański; Marcin Sawczuk

doi:10.56782/pps.262

Data publikacji : 2024-09-23

Tom 22 Nr 3 (2024)

Mirikizumab – a new option in treatment of inflammatory bowel diseases

Jakub Olszewski

Katarzyna Kozon

Magdalena Sitnik

Katarzyna Herjan

Karolina Mikołap

Bartłomiej Gastoł

Maciej Bara

Piotr Armański

Marcin Sawczuk

DOI: https://doi.org/10.56782/pps.262

Abstrakt

ABSTRACT

Mirikizumab is a humanized monoclonal antibody targeting the p19 subunit of interleukin IL-23. Over the past few years, it has been the subject of clinical trials as a potential new treatment for inflammatory bowel diseases, including ulcerative colitis and Crohn's disease. Additionally, mirikizumab has been investigated in clinical trials as a potential treatment for plaque psoriasis. The results of clinical trials for mirikizumab in treating ulcerative colitis led to its approval in the European Union, the United States, Canada, and Japan for treating adult patients with moderately to severely active ulcerative colitis. Despite promising clinical trial results, mirikizumab has not yet been approved for the treatment of Crohn's disease. This review focuses on summarizing the findings from clinical trials of mirikizumab in the treatment of inflammatory bowel diseases. Information is sourced from scientific papers available on PubMed, by searching for "mirikizumab" and “IL-23” and published to march 2024, as well as from published results of clinical trials concerning mirikizumab.

KEYWORDS: mirikizumab, IL-23, ulcerative colitis

Inne teksty tego samego autora

Jakub Olszewski, Katarzyn Kozon, Andrzej Patyra, Flozins in heart failure – a new reimbursement indication , Prospects in Pharmaceutical Sciences: Tom 20 Nr 1 (2022)
Katarzyna Kozon, Małgorzata Krzyżanowska, Jakub Olszewski, Andrzej Patyra, Spinal muscular atrophy – the effectiveness of treatment and new therapeutic possibilities for selected groups of patients in Poland , Prospects in Pharmaceutical Sciences: Tom 21 Nr 2 (2023)
Adam Piasecki, Magdalena Sitnik, Jakub Olszewski, Maciej Bara, Katarzyna Herjan, Piotr Armański, The changing landscape of mineralocorticoid receptor antagonists – finerenone in cardiovascular and renal health , Prospects in Pharmaceutical Sciences: Tom 22 Nr 1 (2024)
Maciej Bara, Agata Janczak, Toxicity of anesthetic gases: exposure in operating rooms and influence on the environment. , Prospects in Pharmaceutical Sciences: Tom 21 Nr 3 (2023)
Małgorzata Krzyżanowska, Katarzyna Kozon, Jakub Olszewski, Andrzej Patyra, Efficacy of satralizumab therapy in the treatment of NMOSD , Prospects in Pharmaceutical Sciences: Tom 21 Nr 3 (2023)
Maciej Bara, Jakub Starownik, Jakub Szydło, Patryk Gryszkiewicz, Jakub Nieznański, Dapagliflozin - new solution in chronic kidney disease treatment , Prospects in Pharmaceutical Sciences: Tom 22 Nr 2 (2024)
Katarzyna Herjan, Piotr Armański, Jakub Olszewski, Magdalena Sitnik, Maciej Bara, POSITIVE IMPACT OF TRANEXAMIC ACID IN VARIOUS MEDICAL SETTINGS , Prospects in Pharmaceutical Sciences: Tom 22 Nr 3 (2024)

Szczegóły

Bibliografia

Statystyki

Autorzy

Pobierz pliki

PDF

Zasady cytowania

Olszewski, J., Kozon, K., Sitnik, M., Herjan, K., Mikołap, K., Gastoł, B., … Sawczuk, M. (2024). Mirikizumab – a new option in treatment of inflammatory bowel diseases. Prospects in Pharmaceutical Sciences, 22(3), 178–185. https://doi.org/10.56782/pps.262

Wskaźniki altmetryczne

Cited by / Share

Licencja

Utwór dostępny jest na licencji Creative Commons Uznanie autorstwa 4.0 Międzynarodowe.

Bibliografia

Tan, Z.Y.; Bealgey, K.W.; Fang, Y.; Gong, Y.M.; Bao, S. Interleukin-23: immunological roles and clinical implications. Int. J. Biochem. Cell Biol. 2009, 41(4), 733-5 DOI: 10.1016/j.biocel.2008.04.027 DOI: https://doi.org/10.1016/j.biocel.2008.04.027

Duvallet, E.; Semerano, L.; Assier, E.; Falgarone, G.; Boissier, M.C.; Interleukin-23: a key cytokine in inflammatory diseases. Ann. Med. 2011, 43(7), 503- 11, DOI:10.3109/07853890.2011.577093 DOI: https://doi.org/10.3109/07853890.2011.577093

Tian, Z.; Zhao, Q.; Teng, X. Anti-IL23/12 agents and JAK inhibitors for inflammatory bowel disease. Front. Immunol. 2024, 15, Art. No: 1393463. DOI: 10.3389/fimmu.2024.1393463 DOI: https://doi.org/10.3389/fimmu.2024.1393463

Tang, C.; Chen, S.; Qian, H.; Huang, W. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology 2012, 135(2), 112-124. DOI: 10.1111/j.1365-2567.2011.03522.x DOI: https://doi.org/10.1111/j.1365-2567.2011.03522.x

Danese, S.; Furfaro, F.; Vetrano, S. Targeting S1P in Inflammatory Bowel Disease: New Avenues for Modulating Intestinal Leukocyte Migration. J. Crohns Colitis 2017, 12(suppl_2), 678-S86. DOI:10.1093/ecco-jcc/jjx107 DOI: https://doi.org/10.1093/ecco-jcc/jjx107

Aggarwal, S.; Gurney, A.L. IL-17: prototype member of an emerging cytokine family. J. Leukoc. Biol. 2002, 71(1), 1-8. DOI: 10.1189/jlb.71.1.1 DOI: https://doi.org/10.1189/jlb.71.1.1

Aggarwal, S.; Ghilardi, N.; Xie, M.H.; de Sauvage, F.J.; Gurney, A.L. Interleukin-23 promotes a distinct CD4 T cell activation state characterized by the production of interleukin-17. J. Biol. Chem. 2003, 278(3), 1910-1914. DOI:10.1074/jbc.M207577200 DOI: https://doi.org/10.1074/jbc.M207577200

Steere, B.; Beidler, C.; Martin, A.; Bright, S.; Kikly, K.; Benschop, R.J. Generation and Characterization of Mirikizumab, a Humanized Monoclonal Antibody Targeting the p19 Subunit of IL-23. J. Pharmacol. Exp. Ther. 2023, 387(2), 180-187. DOI:10.1124/jpet.122.001512 DOI: https://doi.org/10.1124/jpet.122.001512

Lees, C.W.; Barrett, J.C.; Parkes, M.; Satsangi, J. New IBD genetics: common pathways with other diseases. Gut 2011, 60(12), 739-753 DOI:10.1136/gut.2009.199679 DOI: https://doi.org/10.1136/gut.2009.199679

Levin, A.A.; Gottlieb, A.B. Specific targeting of interleukin-23p19 as effective treatment for psoriasis. J. Am. Acad. Dermatol. 2014, 70(3), 555-561. DOI: 10.1016/j.jaad.2013.10.043 DOI: https://doi.org/10.1016/j.jaad.2013.10.043

Elson, C.O.; Cong, Y.; Weaver, C.T.; Schoeb, T.R.; McClanahan, T.K.; Fick, R.B. et al. Monoclonal anti-interleukin 23 reverses active colitis in a T cell-mediated model in mice. Gastroenterology 2007, 132(7), 2359-70. DOI:10.1053/j.gastro.2007.03.104 DOI: https://doi.org/10.1053/j.gastro.2007.03.104

Hammerhøj, A.; Boye, T.L.; Langholz, E.; Nielsen, O.H. Mirikizumab (Omvoh™) for ulcerative colitis. Trends Pharmacol. Sci. 2024, 45(3), 281-2. DOI:10.1016/j.tips.2024.01.001 DOI: https://doi.org/10.1016/j.tips.2024.01.001

Feuerstein, J.D.; Cheifetz, A.S. Ulcerative colitis: epidemiology, diagnosis, and management. Mayo Clin. Proc. 2014, 89(11), 1553-1563. DOI:10.1016/j.mayocp.2014.07.002 DOI: https://doi.org/10.1016/j.mayocp.2014.07.002

Tontini, G.E.; Vecchi, M.; Pastorelli, L.; Neurath, M.F.; Neumann, H. Differential diagnosis in inflammatory bowel disease colitis: state of the art and future perspectives. World J. Gastroenterol. 2015, 21(1), 21-46. DOI:10.3748/wjg.v21.i1.21 DOI: https://doi.org/10.3748/wjg.v21.i1.21

Rao, S.S.; Holdsworth, C.D.; Read, N.W. Symptoms and stool patterns in patients with ulcerative colitis. Gut 1988, 29(3), 342-5. DOI:10.1136/gut.29.3.342 DOI: https://doi.org/10.1136/gut.29.3.342

Raine, T.; Bonovas, S.; Burisch, J.; Kucharzik, T.; Adamina, M.; Annese, V. et al. ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment. J. Crohns Colitis 2021, 16(1), 2-17. DOI:10.1093/ecco-jcc/jjab178 DOI: https://doi.org/10.1093/ecco-jcc/jjab178

Danese, S.; Fiocchi, C. Etiopathogenesis of inflammatory bowel diseases. World J. Gastroenterol. 2006, 12(30), 4807-12. DOI:10.3748/wjg.v12.i30.4807 DOI: https://doi.org/10.3748/wjg.12.4807

Dragasevic, S.; Stankovic, B.; Sokic-Milutinovic, A.; Milosavljevic, T.; Milovanovic, T.; Lukic, S. et al. Importance of TLR9-IL23-IL17 axis in inflammatory bowel disease development: Gene expression profiling study. Clin. Immunol. 2018, 197, 86-95. DOI:10.1016/j.clim.2018.09.001 DOI: https://doi.org/10.1016/j.clim.2018.09.001

Sandborn, W.J.; Ferrante, M.; Bhandari, B.R.; Berliba, E.; Feagan, B.G.; Hibi, T. et al. Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Ulcerative Colitis. Gastroenterology 2020, 158(3), 537-549.e10. DOI: 10.1053/j.gastro.2019.08.043 DOI: https://doi.org/10.1053/j.gastro.2019.08.043

Sandborn, W.J.; Sands, B.E.; Vermeire, S.; Leung, Y.; Guo, X.; Modesto, I. et al. Modified Mayo score versus Mayo score for evaluation of treatment efficacy in patients with ulcerative colitis: data from the tofacitinib OCTAVE program. Therap. Adv. Gastroenterol. 2022, 15, Art. No: 7562848221136331. DOI: 10.1177/17562848221136331 DOI: https://doi.org/10.1177/17562848221136331

II phase clinical trial of mirikizumab in UC [accesed and cited 2024 27.07]. Available from: https://clinicaltrials.gov/study/NCT02589665.

Sandborn, W.J.; Ferrante, M.; Bhandari, B.R.; Berliba, E.; Hibi, T.; D'Haens, G.R. et al. Efficacy and Safety of Continued Treatment With Mirikizumab in a Phase 2 Trial of Patients With Ulcerative Colitis. Clin. Gastroenterol. Hepatol. 2022, 20(1), 105-115.e14. DOI: 10.1016/j.cgh.2020.09.028 DOI: https://doi.org/10.1016/j.cgh.2020.09.028

Badanie LUCENT-1 - III faza badań klinicznych mirikizumabu w leczeniu UC [accesed and cited 2024 27.07]. Available from: https://clinicaltrials.gov/study/NCT03518086.

Efficacy and Safety of Mirikizumab as Induction Therapy in Patients With Moderately to Severely Active Ulcerative Colitis: Results From the Phase 3 LUCENT-1 Study. Gastroenterol. Hepatol. 2022; 18(4 Suppl 1), 7-8.

D’Haens, G.; Kobayashi, T.; Morris, N.; Lissoos, T.; Hoover, A.; Li, X. et al. OP26 Efficacy and safety of mirikizumab as induction therapy in patients with moderately to severely active Ulcerative Colitis: Results from the Phase 3 LUCENT-1 study. J. Crohns Colitis 2022, 16(Supplement_1), i028-i029. DOI: 10.1093/ecco-jcc/jjab232.025 DOI: https://doi.org/10.1093/ecco-jcc/jjab232.025

D’Haens, G.; Dubinsky, M.; Kobayashi, T.; Irving, P.M.; Howaldt, S.; Pokrotnieks, J. et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N. Engl. J. Med. 2023, 388(26), 2444-2455. DOI:10.1056/NEJMoa2207940 DOI: https://doi.org/10.1056/NEJMoa2207940

LUCENT-2 Badanie podtrzymujące z zastosowaniem mirikizumabu u uczestników z umiarkowanie do ciężko aktywną postacią wrzodziejącego zapalenia jelita grubego. [accesed and cited 2024 27.07]. Available from: https://clinicaltrials.gov/study/NCT03524092

Kobayashi, T.; Matsuoka, K.; Watanabe, M.; Hisamatsu, T.; Hirai, F.; Milata, J. et al. Efficacy and safety of mirikizumab as induction and maintenance therapy for Japanese patients with moderately to severely active ulcerative colitis: a subgroup analysis of the global phase 3 LUCENT-1 and LUCENT-2 studies. Intest. Res. 2024, 22(2), 172-85. DOI:10.5217/ir.2023.00043 DOI: https://doi.org/10.5217/ir.2023.00043

LUCENT -3. Badanie oceniające długoterminową skuteczność i bezpieczeństwo mirikizumabu u uczestników z umiarkowanie do ciężko aktywną postacią wrzodziejącego zapalenia jelita grubego. [accesed and cited 2024 27.07]. Available from: https://clinicaltrials.gov/study/NCT03519945.

Sands, B.E.; D’Haens, G.; Clemow, D.B.; Irving, P.M.; Johns, J.T.; Hunter, T. et al. Two-Year Efficacy and Safety of Mirikizumab Following 104 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study. Inflamm. Bowel Dis. 2024, 30(6), 1044-1045. DOI: 10.1093/ibd/izae024 DOI: https://doi.org/10.1093/ibd/izae096

SHINE1 - Badanie mirikizumabu u dzieci i nastolatków z wrzodziejącym zapaleniem jelita grubego [accesed and cited 2024 27.07] Available from: https://clinicaltrials.gov/study/NCT04004611.

PK, Efficacy, and Safety of Mirikizumab as Induction Therapy in Pediatric Patients With Moderately to Severely Active Ulcerative Colitis: Results From the Phase 2 SHINE-1 Study. Gastroenterol. Hepatol. 2023, 19(7 Suppl 3), 8-9.

Informacja producenta dotycząca dopuszczenia mirikizumabu (Omvoh) na terenie USA we wskazaniu do leczenia umiarkowanej i ciężkiej postaci UC u osób dorosłych [accesed and cited 2024 27.07]. Available from: https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohtm-mirikizumab-mrkz-first-class

Informacja ze strony Europejskiej Agencji Leków (EMA) dotycząca leku Omvoh (mirikizumab) [accesed and cited 2024 27.07]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/omvoh

Decyzja o dopuszczeniu leku Omvoh(mirikizumab) na terenie Kanady do leczenia umiarkowanego i ciężkiego UC [accesed and cited 2024 27.07]. Available from: https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1695821197450.

Decyzja Japońskiej Agencji Leków o dopuszczeniu leku Omvoh (mirikizumab) do obrotu na terenie Japonii do leczenia umiarkowanej i ciężkiej postaci UC u dorosłych [accesed and cited 2024 27.07]. Available from: https://www.pmda.go.jp/PmdaSearch/iyakuDetail/GeneralList/23994A5.

Shanahan, F. Crohn's disease. The Lancet. 2002, 359(9300), 62-9. DOI: 10.1016/S0140-6736(02)07284-7 DOI: https://doi.org/10.1016/S0140-6736(02)07284-7

Baumgart, D.C.; Sandborn, W.J. Crohn's disease. The Lancet. 2012, 380(9853), 1590-605.DOI:10.1016/S0140-6736(12)60026-9 DOI: https://doi.org/10.1016/S0140-6736(12)60026-9

SERENITY - badanie skuteczności mirikizumabu u pacjentów z aktywną chorobą Crohna [accesed and cited 2024.27.07]. Available from: https://clinicaltrials.gov/study/NCT02891226.

Avedillo-Salas, A.; Corral-Cativiela, S.; Fanlo-Villacampa, A.; Vicente-Romero, J.; The Efficacy and Safety of Biologic Drugs in the Treatment of Moderate-Severe Crohn's Disease: A Systematic Review. Pharmaceuticals (Basel) 2023, 16(11), ARt. No: 1581. DOI: 10.3390/ph16111581 DOI: https://doi.org/10.3390/ph16111581

Sands, B.E.; Peyrin-Biroulet, L.; Kierkus, J.; Higgins, P.D.R.; Fischer, M.; Jairath, V. et al. Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Crohn's Disease. Gastroenterology 2022, 162(2), 495-508. DOI:10.1053/j.gastro.2021.10.050 DOI: https://doi.org/10.1053/j.gastro.2021.10.050

VIVID-1 - badanie skutecznośći mirikizumabu w leczeniu dorosłych pacjentów z umiarkowaną do ciężkiej postacią choroby Crohna [accesed and cited 2024 27.07]. Available from: https://clinicaltrials.gov/study/NCT03926130.

Aslam, M.; Ali, M.H.; Irfan, H.; Mirikizumab: A promising breakthrough in Crohn's disease treatment. Health Sci. Rep. 2024, 7(8), Art. No: e2294. DOI:10.1002/hsr2.2294 DOI: https://doi.org/10.1002/hsr2.2294

Ferrante, M.; Danese, S.; Chen, M.; D'Haens, G.; Ghosh, S.; Hisamatsu, T. et al. OP05 Primary efficacy and safety of mirikizumab in moderate to severe Crohn’s Disease: results of the treat-through VIVID 1 study. J. Crohns Colitis 2024, 18(Supplement_1), i7-i9. DOI: 10.1093/ecco-jcc/jjad212.0005 DOI: https://doi.org/10.1093/ecco-jcc/jjad212.0005

Jairath, V.; Sands, B.E.; Bossuyt, P.; Farraye, F.; Ferrante, M.; Hisamatsu, T. et al. OP35 Efficacy of mirikizumab in comparison to ustekinumab in patients with moderate to severe Crohn’s disease: Results from the phase 3 VIVID 1 study. J. Crohns Colitis 2024, 18(Supplement_1), i62-i4. DOI:10.1093/ecco-jcc/jjad212.0035 DOI: https://doi.org/10.1093/ecco-jcc/jjad212.0035

VIVID-2 - Długoterminowe badanie rozszerzone mirikizumabu u uczestników z chorobą Leśniowskiego-Crohna [accesed and cited 2024 27.07]. Available from: https://clinicaltrials.gov/study/NCT04232553.

Jakub Olszewski

olszewskij3@gmail.com

Katarzyna Kozon

Afiliacja:

Prof. W. Orłowski Memorial Hospital, 00-401 Warsaw, Poland Poland

Magdalena Sitnik

Afiliacja:

Masovian Brodnowski Hospital, 03-242 Warsaw, Poland Poland

Katarzyna Herjan

Afiliacja:

Prof. W. Orłowski Memorial Hospital, 00-401 Warsaw, Poland Poland

Karolina Mikołap

Afiliacja:

Wolski Hospital in Warsaw, 01-211 Warsaw, Poland Poland

Bartłomiej Gastoł

Afiliacja:

Masovian Specialist Hospital in Ostrołęka, 07-410 Ostrołęka, Poland Poland

Maciej Bara

Afiliacja:

Infant Jesus Clinical Hospital, Medical University of Warsaw, 02-005 Warsaw, Poland Poland

Piotr Armański

Afiliacja:

District Hospital in Sochaczew, 96-500 Sochaczew, Poland Poland

Marcin Sawczuk

Afiliacja:

Medical University of Gdansk Clinical Center, 80-952 Gdańsk, Poland Poland