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.