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    O. M. Kulchytska, N. V. Kuzminova, S. E. Lozinsky, I. I. Kniazkova, V. M. Khomenko, Yu. L. Shkarivsky, M. M. Velychkovych

    EFFICACY, SAFETY, AND FUTURE DIRECTIONS OF ADVANCED THERAPY METHODS FOR PATIENTS WITH INFLAMMATORY BOWEL DISEASES


    About the author: O. M. Kulchytska, N. V. Kuzminova, S. E. Lozinsky, I. I. Kniazkova, V. M. Khomenko, Yu. L. Shkarivsky, M. M. Velychkovych
    Heading REVIEWS
    Type of article Scentific article
    Annotation Crohn's disease and ulcerative colitis are the most common inflammatory bowel diseases. They are chronic diseases characterized by inflammation of the gastrointestinal tract that lead to poor quality of life and disability for patients around the world. The number of people with inflammatory bowel disease worldwide is approximately five million, however, the exact number is unknown, as prevalence data may vary depending on the level of health care, diagnosis, and access to treatment in different countries. The causes of these diseases are multifactorial, but one of the main ones is dysregulation of the immune system. Treatment of such patients is aimed at achieving and maintaining periods of remission. The development of newer therapies, including biologics and oral small molecules, targets different immune response mechanisms, opening up new opportunities for treatment. New therapies can significantly improve the quality of life by helping to achieve and maintain remission. However, their cost remains an important aspect that needs to be addressed in the context of treatment accessibility.
    Tags inflammatory bowel disease,Crohn's disease,ulcerative colitis,rheumatoid arthritis,advanced therapy
    Bibliography
    • Ahuja D, Murad M, Ma C. Comparative speed of early symptomatic remission with advanced therapies for moderate-to-severe ulcerative colitis: a systematic review and network meta-analysis. Am J Gastroenterol. 2023 Sep 1; 118(9): 1618-1625. doi: 10. 14309/ajg.0000000000002263.
    • Allegretti J, Peyrin-Biroulet L, Feagan B. 913b The efficacy and safety of guselkumab induction therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 QUASAR induction study. Gastroenterology 2023; 164: S-S1572.
    • Alsoud D, Sabino J, Franchimont D. Real-world efficacy and safety of risankizumab in patients with moderate to severe multirefractory Crohn's disease: a Belgian multicentric cohort study. Inflamm Bowel Dis Published online January 12, 2024. https://doi.org/10. 1093/ibd/izad315.
    • Angyal A, Bhat S. Biosimilars in IBD: what every clinician needs to know. Curr Gastroenterol Rep. 2024; 26(3): 77-85. doi:10. 1007/ s11894-023- 00913-5.
    • Armuzzi A, Cross RK, Lichtenstein GR, Hou J, Deepak P, Regueiro M, et al. Cardiovascular safety of ozanimod in patients with ulcerative colitis: True North and Open-Label extension analyses. Clin Gastroenterol Hepatol 2024; 22: 1067-1076.e3. doi: 10. 1016/j.cgh.2023.11.018.
    • Barnes E. A practical guide to the use of mirikizumab. Am J Gastroenterol 2024; 119: 400-403. doi: 10. 14309/ajg.0000000000002531.
    • Berinstein J, Karl T, Patel A. Effectiveness of upadacitinib for patients with acute severe ulcerative colitis: a multi-center experience. Am J Gastroenterol Published online March 27, 2024. https://doi.org/10.14309/ajg.0000000000002674.
    • Bruner L, White A, Proksell S. Inflammatory bowel disease. Prim Care. 2023; 50: 411-427. doi: 10. 1016/j.pop.2023.03.009.
    • Burr N, Gracie D, Black C, Ford A. Efficacy of biologic therapies and small molecules in moderate to severe ulcerative colitis: systematic review and network meta-analysis. Gut 2021: gutjnl-2021-326390. doi: 10. 1136/gutjnl-2021- 326390.
    • Chang S, Murphy M, Malter L. A review of available medical therapies to treat moderate-to-severe inflammatory bowel disease. The American Journal of Gastroenterology. 119 (1): p 55-80, January 2024. DOI: 10. 14309/ajg.0000000000002485.
    • Chugh R, Long M, Jiang Y, Weaver K, Beaulieu D, Scherl E, et al. Maternal and neonatal outcomes in vedolizumab and ustekinumab exposed pregnancies: results from the PIANO registry. Am J Gastroenterol 2024; 119: 468-476. Am J Gastroenterol. 2024 Mar 1; 119(3): 468-476.
    • Dalal R, Kallumkal G, Cabral H. One-year comparative effectiveness of upadacitinib vs tofacitinib for ulcerative colitis: a multicenter cohort study. Am J Gastroenterol Published online April 1, 2024. https://doi.org/10.14309/ajg.0000000000002746.
    • Danese S, Dignass A, Matsuoka K, Ferrante M, Long M, Redondo I, et al. Early and Sustained Symptom Control with Mirikizumab in Patients with Ulcerative Colitis in the Phase 3 LUCENT Program. J Crohns Colitis. 2024 Nov 4; 18(11): 1845-1856. doi: 10. 1093/ecco-jcc/jjae088.
    • Danese S, Panaccione R, Feagan BG, Afzali A, Rubin D, Sands B, et al. Efficacy and safety of 48 weeks of guselkumab for patients with Crohn's disease: maintenance results from the phase 2, randomized, double-blind GALAXI-1 trial. Lancet Gastroenterol Hepatol 2024; 9: 133-146. doi: 10. 1016/S2468-1253(23)00318-7.
    • Din S, Selinger CP, Black CJ, Ford A. Systematic review with network meta-analysis: risk of herpes zoster with biologic therapies and small molecules in inflammatory bowel disease. Aliment Pharmacol Ther. 2023 Mar; 57(6): 666-675. doi: 10. 1111/apt.17379.
    • D'Haens G, Panaccione R, Baert F, Bossuyt P, Colombel J, Danese S, et al. Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet 2022; 399: 2015-2030.ndoi: 10. 1016/S0140-6736(22)00467-6.
    • Dubinsky M, Charles L, Selmaj K. Pregnancy outcomes in the ozanimod clinical development program in patients with ulcerative colitis, Crohn's disease, and relapsing multiple sclerosis. Inflamm Bowel Dis Published online January 24, 2024. https://doi.org/10. 1093/ibd/izae011.
    • Ferrante M, Panaccione R, Baert F, Bossuyt P, Colombel J, Danese S, et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicenter, randomized, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet 2022; 399: 2031-2046. doi: 10. 1016/S0140-6736(22)00466-4.
    • Friedberg S, Choi D, Hunold T. Upadacitinib is effective and safe in both ulcerative colitis and Crohn's disease: prospective real-world experience. Clin Gastroenterol Hepatol. 2023 Jul; 21(7):1913-1923.e2. doi: 10. 1016/j.cgh.2023.03.001.
    • Fudman D, McConnell R, Ha C, Singh S. Modern Advanced Therapies for Inflammatory Bowel Diseases: Practical Considerations and Positioning. Clin Gastroenterol Hepatol. 2025 Feb; 23(3): 454-468. DOI: 10.1016/j.cgh.2024.06.050.
    • Greywoode R, Petralia F, Ullman T, Frederic Colombel J, Ungaro R. Racial difference in efficacy of golimumab in ulcerative colitis. Infamm Bowel Dis. 2023; 29(6): 843-849. doi:10. 1093/ibd/ izac161.
    • Jairath V, Sands BE, Bossuyt. OP35 efficacy of mirikizumab compared to ustekinumab in patients with moderate to severe Crohn's disease: results from the phase 3 VIVID 1 study. J Crohns Colitis 2024;18:i62-i64. https://doi.org/10.1093/ecco-jcc/jjad212.0035.
    • Horst S. A practical guide to the use of risankizumab. Am J Gastroenterol 2023; 118: 921-924. doi: 10. 14309/ajg.0000000000002139.
    • Loeb L, Nasir A, Picco M, Hashash J, Kinnucan J, Farraye F. Prior authorization of biologics in the management of infammatory bowel disease. Infamm Bowel Dis. 2023; 29(9): e37. doi:10. 1093/ibd/izad088.
    • Mattay S, Zamani M, Saturno D, Loftus E, Ciorba M, Yarur F, et al. Risk of major adverse cardiovascular events in immune-mediated inflammatory disorders on biologics and small molecules: network meta- analysis. Clin Gastroenterol Hepatol. 2024 May; 22(5): 961-970.e12. doi: 10. 1016/j.cgh.2023.09.033.
    • Najeeb H, Yasmin F, Surani S. Emerging role of biosimilars in the clinical care of infammatory bowel disease patients. World J Clin Cases. 2022; 10(14): 4327-4333. doi:10. 12998/wjcc.v10.i14.4327.
    • Odufalu F, Aboubakr A, Anyane-Yeboa A. Infammatory bowel disease in underserved populations: lessons for practice. Curr Opin Gastroenterol. 2022; 38(4): 321-327. doi:10. 1097/ MOG.0000000000000855.
    • Ouranos K, Saleem H, Vassilopoulos S. Risk of infection in patients with inflammatory bowel disease treated with interleukin-targeting agents: a systematic review and meta-analysis. Inflamm Bowel Dis Published online. March 1, 2024. https://doi.org/10. 1093/ibd/izae031.
    • Paik J. Ozanimod: A Review in Ulcerative Colitis. Drugs. 2022 Aug; 82(12): 1303-1313. doi: 10. 1007/s40265-022-01762-8.
    • Plevris N, Lees C. Disease monitoring in inflammatory bowel disease: Evolving principles and possibilities.Gastroenterology. 2022; 162: 1456-1475. doi: 10. 1053/j.gastro.2022.01.024.
    • Sandborn W, Feagan B, D'Haens G, Wolf D, Jovanovic I, Hanauer S, et al. Ozanimod as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2021 Sep 30; 385(14): 1280-1291. doi: 10. 1056/NEJMoa2033617.
    • Sandborn W, Vermeire S, Peyrin-Biroulet L, Dubinsky M, Panes J, Yarur A, et al. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomized, double-blind, placebo-controlled, phase 3 studies. Lancet. 2023 Apr 8; 401(10383): 1159-1171. doi: 10. 1016/S0140- 6736(23)00061-2.
    • Sands B, Irving P, Hoops T, Izanec J, Gao L, Gasink C et al. Ustekinumab versus adalimumab for induction and maintenance therapy in biologicnaive patients with moderately to severely active Crohn's disease: a multicenter, randomized, double-blind, parallel-group, phase 3b trial. Lancet. 2022 Jun 11; 399(10342): 2200-2211. doi: 10. 1016/S0140-6736(22)00688-2.
    • Taylor P, Choy, Baraliakos X, Szekanecz Z, Xavier R, Isaacs D, et al. Differential properties of Janus kinase inhibitors in the treatment of immune-mediated inflammatory diseases. Rheumatology (Oxford). 2024 Feb 1; 63(2): 298-308. doi:  10.1093/rheumatology/kead448.
    • Taxonera C, Olivares D, Alba C. Real-world efficacy and safety of tofacitinib in patients with ulcerative colitis: systematic review with meta- analysis. Inflammatory Bowel Diseases, Volume 28, Issue 1, January 2022, Pages 32-40, https: //doi.org/10.1093/ibd/izab011.
    • Turner D, Ricciuto A, Lewis A. International Organization for the Study of IBD. STRIDE-II: an update on the Selecting Therapeutic Targets in Infammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): determining therapeutic goals for treat-to-target strategies in IBD. Gastroenterology. 2021; 160(5): 1570-1583. doi:10. 1053/j. gastro.2020.12.031.
    • Whitmire N, Schlueter M, Kirkpatrick M. Advanced Therapies for Inflammatory Bowel Disease: Navigating Payer and Financial Challenges. Curr Gastroenterol Rep. 2024 Jan 20; 26(3): 68-76. doi: 10.1007/s11894-024-00916-w.
    • Yu A, Ha N, Shi B, Chang U, Mahadevan U, Beck R. Real-world experience with tofacitinib dose de-escalation in patients with moderate and severe ulcerative colitis. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3115- 3124.e3. doi: 10. 1016/j.cgh.2023.05.001.
    Publication of the article «World of Medicine and Biology» №2(92), 2025 year, 239-248 pages, index UDK 616-072.7:616.12-008.331.1:616.12-008.318.4
    DOI 10.26724/2079-8334-2025-2-92-239-248