medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/ms2024-344medsovet-8588Research ArticleЗАБОЛЕВАНИЯ КИШЕЧНИКАBOWEL DISEASESПрименение тофацитиниба в лечении язвенного колита: реальная клиническая практика и перспективыTofacitinib in the treatment of ulceral colitis: real-world clinical practice and prospectshttps://orcid.org/0000-0002-1597-1876ТруханД. И.TrukhanD. I.

Трухан Дмитрий Иванович, д.м.н., доцент, профессор кафедры поликлинической терапии и внутренних болезней

644043, Омск, ул. Ленина, д. 12

Dmitry I. Trukhan, Dr. Sci. (Med.), Associate Professor, Professor of the Department of Polyclinic Therapy and Internal Diseases

12, Lenin St., Omsk, 644043

dmitry_trukhan@mail.ruОмский государственный медицинский университетРоссияOmsk State Medical UniversityRussian Federation202417102024015200–208Copyright © Трухан Д.И., 20242024Трухан Д.И.Trukhan D.I.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.med-sovet.pro/jour/article/view/8588

Распространение в мире язвенного колита, иммуновоспалительного заболевания, характеризующегося язвенно-деструктивными процессами в слизистой оболочке толстой кишки, продолжает расти, особенно в развитых странах, приводя к инвалидности и смерти. Ключевую роль в патогенезе играют цитокины – белки, выделяемые активизированными иммунными клетками, которые влияют на активность, дифференциацию или пролиферацию других клеток. Повышение эффективности медикаментозной терапии язвенного колита в настоящее время связано с добавлением к традиционной терапии генно-инженерных биологических препаратов (ГИБП) и таргетных иммуносупрессоров ингибиторов янус-киназы (тофацитиниб). По сравнению с ГИБП тофацитиниб имеет ряд преимуществ, включая его пероральный прием, быстрое начало действия, быстрое выведение и отсутствие иммуногенности. Тофацитиниб был одобрен FDA в 2012 г. для лечения ревматоидного артрита, в 2017 г. – для лечения псориатического артрита, а в мае 2018 г. – для лечения язвенного колита. В настоящее время тофацитиниб занимает важное место в Федеральных клинических рекомендациях по язвенному колиту 2024 г. В информационных базах Pubmed и Scopus был проведен поиск статей, посвященных применению тофацитиниба при язвенном колите, опубликованных в текущем десятилетии, с акцентом на публикации последнего года и публикации, не вошедшие в ранее опубликованные отечественные обзоры. Найденные исследования подтверждают эффективность применения тофацитиниба в лечении язвенного колита среднетяжелого и тяжелого течения у пациентов в различных географических регионах. В ряде исследований отмечена фармакоэкономическая эффективнось тофацитиниба по сравнению с ГИБП. В действующих клинических рекомендациях по язвенному колиту для детского возраста тофацитиниб не представлен, однако целый ряд исследований свидетельствует о перспективах его интеграции в педиатрические протоколы.

Ulcerative colitis is an immune-inflammatory disease characterized by ulcerative-destructive processes in the colon mucosa.  Cytokines, proteins secreted by activated immune cells that affect the activity, differentiation, or proliferation of other cells, play a key role in pathogenesis. Improving the effectiveness of drug therapy for ulcerative colitis is currently associated with the addition of genetically engineered biological drugs (GEBD) and targeted immunosuppressants, Janus kinase inhibitors (tofacitinib), to traditional therapy. Compared with GEBD, tofacitinib has a number of advantages, including its oral administration, rapid onset of action, rapid elimination, and lack of immunogenicity. Tofacitinib was approved by the FDA in 2012 for the treatment of rheumatoid arthritis and in 2017 for the treatment of psoriatic arthritis, and in May 2018 for the treatment of ulcerative colitis. Currently, tofacitinib occupies an important place in the Federal Clinical Guidelines for Ulcerative Colitis of 2024. The Pubmed and Scopus databases were searched for articles on the use of tofacitinib in ulcerative colitis published in the current decade, with an emphasis on publications of the last year and publications not included in previously published domestic reviews. The studies found confirm the effectiveness of tofacitinib in the treatment of moderate to severe ulcerative colitis in patients in various geographic regions. A number of studies have noted the pharmacoeconomic effectiveness of tofacitinib compared to GEBD. Tofacitinib is not presented in the current clinical guidelines for ulcerative colitis for children, but a number of studies indicate the prospects for its integration into pediatric protocols.

ревматоидный артритлечениеингибитор янус-киназтофацитинибгенерикrheumatoid arthritistreatmentjanus kinase inhibitortofacitinibgenericReferencesТарасова ЛВ, Трухан ДИ. Болезни кишечника. Клиника, диагностика и лечение. СПб.: СпецЛит; 2022. 222 с.Тарасова ЛВ, Трухан ДИ. Болезни кишечника. Клиника, диагностика и лечение. СПб.: СпецЛит; 2022. 222 с.Абдулганиева ДИ, Алексеева ОП, Ачкасов СИ, Бакулин ИГ, Барышева ОЮ, Белоусова ЕА и др. Язвенный колит: клинические рекомендации. М.; 2024. 130 с. Режим доступа: https://cr.minzdrav.gov.ru/recomend/193_2.Абдулганиева ДИ, Алексеева ОП, Ачкасов СИ, Бакулин ИГ, Барышева ОЮ, Белоусова ЕА и др. Язвенный колит: клинические рекомендации. М.; 2024. 130 с. Режим доступа: https://cr.minzdrav.gov.ru/recomend/193_2.Гриневич ВБ, Першко АМ, Волга НВ, Иванюк ЕС, Селиверстов ПВ. Актуальные вопросы терапии пациентов с язвенным колитом. Медицинский совет. 2023;17(23):149–154. https://doi.org/10.21518/ms2023-481.Grinevich VB, Pershko AM, Volga NB, Ivanyuk ES, Seliverstov PV. Topical issues of therapy for patients with ulcerative colitis. Meditsinskiy Sovet. 2022;17(23):149–154. (In Russ.) https://doi.org/10.21518/ms2023-481.Pantavou K, Yiallourou AI, Piovani D, Evripidou D, Danese S, Peyrin-Biroulet L et al. Efficacy and safety of biologic agents and tofacitinib in moderate-to-severe ulcerative colitis: A systematic overview of meta-analyses. United European Gastroenterol J. 2019;7(10):1285–1303. https://doi.org/10.1177/2050640619883566.Pantavou K, Yiallourou AI, Piovani D, Evripidou D, Danese S, Peyrin-Biroulet L et al. Efficacy and safety of biologic agents and tofacitinib in moderate-to-severe ulcerative colitis: A systematic overview of meta-analyses. United European Gastroenterol J. 2019;7(10):1285–1303. https://doi.org/10.1177/2050640619883566.Bonovas S, Lytras T, Nikolopoulos G, Peyrin-Biroulet L, Danese S. Systematic review with network meta-analysis: comparative assessment of tofacitinib and biological therapies for moderate-to-severe ulcerative colitis. Aliment Pharmacol Ther. 2018;47(4):454–465. https://doi.org/10.1111/apt.14449.Bonovas S, Lytras T, Nikolopoulos G, Peyrin-Biroulet L, Danese S. Systematic review with network meta-analysis: comparative assessment of tofacitinib and biological therapies for moderate-to-severe ulcerative colitis. Aliment Pharmacol Ther. 2018;47(4):454–465. https://doi.org/10.1111/apt.14449.Magro F, Estevinho MM. Is tofacitinib a game-changing drug for ulcerative colitis? United European Gastroenterol J. 2020;8(7):755–763. https://doi.org/10.1177/2050640620935732.Magro F, Estevinho MM. Is tofacitinib a game-changing drug for ulcerative colitis? United European Gastroenterol J. 2020;8(7):755–763. https://doi.org/10.1177/2050640620935732.O’Shea JJ, Laurence A, McInnes IB. Back to the future: oral targeted therapy for RA and other autoimmune diseases. Nat Rev Rheumatol. 2013;9(3):173–182. https://doi.org/10.1038/nrrheum.2013.7.O’Shea JJ, Laurence A, McInnes IB. Back to the future: oral targeted therapy for RA and other autoimmune diseases. Nat Rev Rheumatol. 2013;9(3):173–182. https://doi.org/10.1038/nrrheum.2013.7.O’Shea JJ, Holland SM, Straudt LM. JAKs and STATs in immunity, immunodefficiency and cancer. N Engl J Med. 2013;368(2):161–170. https://doi.org/10.1056/NEJMra1202117.O’Shea JJ, Holland SM, Straudt LM. JAKs and STATs in immunity, immunodefficiency and cancer. N Engl J Med. 2013;368(2):161–170. https://doi.org/10.1056/NEJMra1202117.Clark JD, Flanagan ME, Telliez JB. Discovery and development of Janus kinase (JAK) inhibitors for inflammatory diseases. J Med Chem. 2014;57(12):5023–5038. https://doi.org/10.1021/jm401490p.Clark JD, Flanagan ME, Telliez JB. Discovery and development of Janus kinase (JAK) inhibitors for inflammatory diseases. J Med Chem. 2014;57(12):5023–5038. https://doi.org/10.1021/jm401490p.Roskoski RJr. Janus kinase (JAK) inhibitors in the treatment of neoplastic and inflammatory disorders. Pharmacol Res. 2022;183:106362. https://doi.org/10.1016/j.phrs.2022.106362.Roskoski RJr. Janus kinase (JAK) inhibitors in the treatment of neoplastic and inflammatory disorders. Pharmacol Res. 2022;183:106362. https://doi.org/10.1016/j.phrs.2022.106362.Насонов ЕЛ, Лила АМ. Ингибиторы янус-киназ при иммуновоспалительных ревматических заболеваниях: новые возможности и перспективы. Научно-практическая ревматология. 2019;57(1):8–16. https://doi.org/10.14412/1995-4484-2019-8-16.Nasonov EL, Lila AM. Janus kinase inhibitors in immuno-inflammatory rheumatic diseases: New opportunities and prospects. Rheumatology Science and Practice. 2019;57(1):8–16 (In Russ.) https://doi.org/10.14412/1995-4484-2019-8-16.López-Sanromán A, Esplugues JV, Domènech E. Pharmacology and safety of tofacitinib in ulcerative colitis. Gastroenterol Hepatol. 2021;44(1):39–48. https://doi.org/10.1016/j.gastrohep.2020.04.012.López-Sanromán A, Esplugues JV, Domènech E. Pharmacology and safety of tofacitinib in ulcerative colitis. Gastroenterol Hepatol. 2021;44(1):39–48. https://doi.org/10.1016/j.gastrohep.2020.04.012.Xin P, Xu X, Deng C, Liu S, Wang Y, Zhou X et al. The role of JAK/STAT signaling pathway and its inhibitors in diseases. Int Immunopharmacol. 2020;80:106210. https://doi.org/10.1016/j.intimp.2020.106210.Xin P, Xu X, Deng C, Liu S, Wang Y, Zhou X et al. The role of JAK/STAT signaling pathway and its inhibitors in diseases. Int Immunopharmacol. 2020;80:106210. https://doi.org/10.1016/j.intimp.2020.106210.Villarino AV, Kanno Y, O’Shea JJ. Mechanisms and consequences of Jak-STAT signaling in the immune system. Nat Immunol. 2017;18(4):374–384. https://doi.org/10.1038/ni.3691.Villarino AV, Kanno Y, O’Shea JJ. Mechanisms and consequences of Jak-STAT signaling in the immune system. Nat Immunol. 2017;18(4):374–384. https://doi.org/10.1038/ni.3691.Banerjee S, Biehl A, Gadina M, Hasni S, Schwartz DM. JAK-STAT Signaling as a Target for Inflammatory and Autoimmune Diseases: Current and Future Prospects. Drugs. 2017;77(5):521–546. https://doi.org/10.1007/s40265-017-0701-9.Banerjee S, Biehl A, Gadina M, Hasni S, Schwartz DM. JAK-STAT Signaling as a Target for Inflammatory and Autoimmune Diseases: Current and Future Prospects. Drugs. 2017;77(5):521–546. https://doi.org/10.1007/s40265-017-0701-9.McLornan DP, Pope JE, Gotlib J, Harrison CN. Current and future status of JAK inhibitors. Lancet. 2021;398(10302):803–816. https://doi.org/10.1016/S0140-6736(21)00438-4.McLornan DP, Pope JE, Gotlib J, Harrison CN. Current and future status of JAK inhibitors. Lancet. 2021;398(10302):803–816. https://doi.org/10.1016/S0140-6736(21)00438-4.Tanaka Y, Luo Y, O’Shea JJ, Nakayamada S. Janus kinase-targeting therapies in rheumatology: A mechanisms-based approach. Nat Rev Rheumatol. 2022;18(3):133–145. https://doi.org/10.1038/s41584-021-00726-8.Tanaka Y, Luo Y, O’Shea JJ, Nakayamada S. Janus kinase-targeting therapies in rheumatology: A mechanisms-based approach. Nat Rev Rheumatol. 2022;18(3):133–145. https://doi.org/10.1038/s41584-021- 00726-8.Fortelny N, Farlik M, Fife V, Gorki AD, Lassnig C, Maurer B et al. JAK-STAT signaling maintains homeostasis in T cells and macrophages. Nat Immunol. 2024;25(5):847–859. https://doi.org/10.1038/s41590-024-01804-1.Fortelny N, Farlik M, Fife V, Gorki AD, Lassnig C, Maurer B et al. JAK-STAT signaling maintains homeostasis in T cells and macrophages. Nat Immunol. 2024;25(5):847–859. https://doi.org/10.1038/s41590-024-01804-1.Padda IS, Bhatt R, Parmar M. Tofacitinib. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2024. Available at: https://pubmed.ncbi.nlm.nih.gov/34283514.Padda IS, Bhatt R, Parmar M. Tofacitinib. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2024. Available at: https://pubmed.ncbi.nlm.nih.gov/34283514.Насонов ЕЛ. Новые подходы к фармакотерапии ревматоидного артрита: тофацитиниб. Научно-практическая ревматология. 2014;52(2):209–221. https://doi.org/10.14412/1995-4484-2014-209-221.Nasonov EL. New approaches to pharmacotherapy of rheumatoid arthritis: tofacitinib. Rheumatology Science and Practice. 2014;52(2):209–221. (In Russ.) https://doi.org/10.14412/1995-4484-2014-209-221.Каратеев ДЕ. Ингибиторы киназ при ревматоидном артрите: реальность и перспективы. Медицинский совет. 2013;(12):90–96. https://doi.org/10.21518/2079-701X-2013-12-90-96.Karateyev DЕ. Kinase inhibitors in rheumatoid arthritis: reality and prospects. Meditsinskiy Sovet. 2013;(12):90–96. (In Russ.) https://doi.org/10.21518/2079-701X-2013-12-90-96.Spinelli FR, Meylan F, O’Shea JJ, Gadina M. JAK inhibitors: Ten years after. Eur J Immunol. 2021;51(7):1615–1627. https://doi.org/10.1002/eji.202048922.Spinelli FR, Meylan F, O’Shea JJ, Gadina M. JAK inhibitors: Ten years after. Eur J Immunol. 2021;51(7):1615–1627. https://doi.org/10.1002/eji.202048922.Liu C, Kieltyka J, Fleischmann R, Gadina M, O’Shea JJ. A decade of JAK inhibitors: What have we learned and what may be the future? Arthritis Rheumatol. 2021;73(12):2166–2178. https://doi.org/10.1002/art.41906.Liu C, Kieltyka J, Fleischmann R, Gadina M, O’Shea JJ. A decade of JAK inhibitors: What have we learned and what may be the future? Arthritis Rheumatol. 2021;73(12):2166–2178. https://doi.org/10.1002/art.41906.Насонов ЕЛ, Коротаева ТВ. Ингибиторы янус-киназ при иммуновоспалительных заболеваниях: 10 лет клинической практики в ревматологии. Научно-практическая ревматология. 2022;60(2):131–148. https://doi.org/10.47360/1995-4484-2022-131-148.Nasonov EL, Korotaeva TV. Janus kinase inhibitors in immunoinflammatory diseases: 10 years of clinical practice in rheumatology. Rheumatology Science and Practice. 2022;60(2):131–148 (In Russ.) https://doi.org/10.47360/1995-4484-2022-131-148.Lamb CA, Kennedy NA, Raine T, Hendy PA, Smith PJ, Limdi JK et al. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut. 2019;68(Suppl 3):s1–s106. https://doi.org/10.1136/gutjnl-2019-318484.Lamb CA, Kennedy NA, Raine T, Hendy PA, Smith PJ, Limdi JK et al. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut. 2019;68(Suppl 3):s1–s106. https://doi.org/10.1136/gutjnl-2019-318484.Feuerstein JD, Isaacs KL, Schneider Y, Siddique SM, Falck-Ytter Y, Singh S. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology. 2020;158(5):1450–1461. https://doi.org/10.1053/j.gastro.2020.01.006.Feuerstein JD, Isaacs KL, Schneider Y, Siddique SM, Falck-Ytter Y, Singh S. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology. 2020;158(5):1450–1461. https://doi.org/10.1053/j.gastro.2020.01.006.Nwaogu A, Bond A, Smith PJ. Guideline review: Tofacitinib for adults with moderately to severely active ulcerative colitis – NICE guidance. Frontline Gastroenterol. 2020;12(2):133–136. https://doi.org/10.1136/flgastro-2020-101502.Nwaogu A, Bond A, Smith PJ. Guideline review: Tofacitinib for adults with moderately to severely active ulcerative colitis – NICE guidance. Frontline Gastroenterol. 2020;12(2):133–136. https://doi.org/10.1136/flgastro-2020-101502.Amiot A, Bouguen G, Bonnaud G, Bouhnik Y, Hagege H, Peyrin-Biroulet L. French National Consensus Clinical guidelines for the management of IBD study group. Clinical guidelines for the management of inflammatory bowel disease: Update of a French national consensus. Dig Liver Dis. 2021;53(1):35–43. https://doi.org/10.1016/j.dld.2020.10.018.Amiot A, Bouguen G, Bonnaud G, Bouhnik Y, Hagege H, Peyrin-Biroulet L. French National Consensus Clinical guidelines for the management of IBD study group. Clinical guidelines for the management of inflammatory bowel disease: Update of a French national consensus. Dig Liver Dis. 2021;53(1):35–43. https://doi.org/10.1016/j.dld.2020.10.018.Шапина МВ, Халиф ИЛ. Эффективность и безопасность тофацитиниба при язвенном колите (обзор литературы). Колопроктология. 2018;(3):94–102. https://doi.org/10.33878/2073-7556-2018-0-3-94-102.Khalif IL, Shapina MV. Efficacy and safety of tofacitinib in ulcerative colitis (review). Koloproktologia. 2018;(3):94–102. (In Russ.) https://doi.org/10.33878/2073-7556-2018-0-3-94-102.Насонов ЕЛ, Абдулганиева ДИ, Файрушина ИФ. Место тофацитиниба в лечении воспалительных заболеваний кишечника. Терапевтический архив. 2019;91(2):8–108. https://doi.org/10.26442/00403660.2019.02.000155.Nasonov EL, Abdulganieva DI, Fairushina IF. The use of Tofacitinib in the treatment of inflammatory bowel disease. Terapevticheskii Arkhiv. 2019;91(2): 8–108. (In Russ.) https://doi.org/10.26442/00403660.2019.02.000155.Мордасова ВИ, Копылова ДВ, Добросоцких ГВ. Тактика ведения пациентов с язвенным колитом, не ответивших на лечение анти-ФНО. Эффективная фармакотерапия. 2021;17(39):80–86. https://doi.org/10.33978/2307-3586-2021-17-39-80-86.Mordasova VI, Kopylova DV, Dobrosotskih GV. Management of patients with ulcerative colitis who did not respond to anti-tnf treatment. 2021;17(39): 80–86. (In Russ.) https://doi.org/10.33978/2307-3586-2021-17-39-80-86.Белоусова ЕА, Абдулганиева ДИ, Алексеева ОП, Бакулин ИГ, Васильева ОВ, Веселов АВ и др. Опыт применения тофацитиниба в терапии язвенного колита в условиях реальной клинической практики. Колопроктология. 2019;18(4):86–99. https://doi.org/10.33878/2073-7556-2019-18-4-86-99.Belousova EA, Abdulganieva DI, Alekseeva OP, Bakulin IG, Vasilyeva OV, Veselov AV et al. Experience of tofacitinib using in therapy of ulcerative colitis in real clinical practice. Koloproktologia. 2019;18(4):86–99 (In Russ.) https://doi.org/10.33878/2073-7556-2019-18-4-86-99.Князев ОВ, Шкурко ТВ, Каграманова АВ, Лищинская АА, Бордин ДС, Парфенов АИ. Эффективность и безопасность тофацитиниба при язвенном колите средней и тяжелой степеней в реальной клинической практике: открытое наблюдательное проспективное исследование. Фарматека. 2020;27(2):38–44. https://doi.org/10.18565/pharmateca.2020.2.38-44.Knyazev OV, Shkurko TV, Kagramanova AV, Lishhinskaya AA, Bordin DS, Parfyonov AI. Efficacy and safety of tofacitinib for moderate and severe ulcerative colitis in real clinical practice: an open observational prospective study. Farmateka. 2020;27(2):38–44. (In Russ.) https://doi.org/10.18565/pharmateca.2020.2.38-44.Подольская ДВ, Шапина МВ, Баранова ТА, Тишаева ИА, Александров ТЛ, Князев ОВ, Нанаева БА. Эффективность тофацитиниба в качестве «терапии спасения» у пациентов с язвенным колитом тяжелой степени. Колопроктология. 2021;20(3):43–50. https://doi.org/10.33878/2073-7556-2021-20-3-43-50.Podolskaya DV, Shapina MV, Baranova TA, Tishaeva IA, Alexandrov AL, Knyazev OV, Nanaeva BA. Efficacy of tofacitinib as a "rescue therapy" in patients with severe ulcerative colitis. Koloproktologia. 2021;20(3):43–50. (In Russ.) https://doi.org/10.33878/2073-7556-2021-20-3-43-50.Князев ОВ, Каграманова АВ, Лищинская АА, Ли ИА, Подольская ДВ, Шкурко ТВ и др. Эффективность и безопасность тофацитиниба при язвенном колите средней и тяжелой степени в реальной клинической практике: три года наблюдения. Медицинский совет. 2021;(15):20–29. https://doi.org/10.21518/2079-701X-2021-15-20-29.Knyazev OV, Kagramanova AV, Lishchinskaya AA, Li IA, Podolskaya DV, Shkurko TV et al. Efficacy and safety of tofacitinib in moderate and severe ulcerative colitis in real clinical practice: three years of observation. Meditsinskiy Sovet. 2021;(15):20–29. (In Russ.) https://doi.org/10.21518/2079-701X-2021-15-20-29.Taxonera C, Olivares D, Alba C. Real-World Effectiveness and Safety of Tofacitinib in Patients With Ulcerative Colitis: Systematic Review With Meta-Analysis. Inflamm Bowel Dis. 2022;28(1):32–40. https://doi.org/10.1093/ibd/izab011.Taxonera C, Olivares D, Alba C. Real-World Effectiveness and Safety of Tofacitinib in Patients With Ulcerative Colitis: Systematic Review With MetaAnalysis. Inflamm Bowel Dis. 2022;28(1):32–40. https://doi.org/10.1093/ibd/izab011.Macaluso FS, Maida M, Ventimiglia M, Orlando A. Effectiveness and safety of tofacitinib for the treatment of ulcerative colitis: A single-arm meta-analysis of observational studies. Dig Liver Dis. 2022;54(2):183–191. https://doi.org/10.1016/j.dld.2021.04.018.Macaluso FS, Maida M, Ventimiglia M, Orlando A. Effectiveness and safety of tofacitinib for the treatment of ulcerative colitis: A single-arm meta-analysis of observational studies. Dig Liver Dis. 2022;54(2):183–191. https://doi.org/10.1016/j.dld.2021.04.018.Honap S, Agorogianni A, Colwill MJ, Mehta SK, Donovan F, Pollok R et al. JAK inhibitors for inflammatory bowel disease: recent advances. Frontline Gastroenterol. 2023;15(1):59–69. https://doi.org/10.1136/flgastro-2023-102400.Honap S, Agorogianni A, Colwill MJ, Mehta SK, Donovan F, Pollok R et al. JAK inhibitors for inflammatory bowel disease: recent advances. Frontline Gastroenterol. 2023;15(1):59–69. https://doi.org/10.1136/flgastro-2023-102400.Banerjee R, Sharma V, Patel R, Jena A, Pal P, Raghunathan N et al. Tofacitinib use in ulcerative colitis: An expert consensus for day-to-day clinical practice. Indian J Gastroenterol. 2024;43(1):22–35. https://doi.org/10.1007/s12664-023-01507-9.Banerjee R, Sharma V, Patel R, Jena A, Pal P, Raghunathan N et al. Tofacitinib use in ulcerative colitis: An expert consensus for day-to-day clinical practice. Indian J Gastroenterol. 2024;43(1):22–35. https://doi.org/10.1007/s12664-023-01507-9.Herfarth HH, Afzali A, Fischer M, Hudesman D, Abdalla M, McCabe R et al. Clinical Long-Term Outcomes of Patient-Reported Outcomes in the Prospective Real-World Tofacitinib Response in Ulcerative Colitis Registry. Clin Transl Gastroenterol. 2024;15(3):e00669. https://doi.org/10.14309/ctg.0000000000000669.Herfarth HH, Afzali A, Fischer M, Hudesman D, Abdalla M, McCabe R et al. Clinical Long-Term Outcomes of Patient-Reported Outcomes in the Prospective Real-World Tofacitinib Response in Ulcerative Colitis Registry. Clin Transl Gastroenterol. 2024;15(3):e00669. https://doi.org/10.14309/ctg.0000000000000669.Resál T, Bacsur P, Keresztes C, Bálint A, Bor R, Fábián A et al. Real-Life Efficacy of Tofacitinib in Various Situations in Ulcerative Colitis: A Retrospective Worldwide Multicenter Collaborative Study. Inflamm Bowel Dis. 2024;30(5):768–779. https://doi.org/10.1093/ibd/izad135.Resál T, Bacsur P, Keresztes C, Bálint A, Bor R, Fábián A et al. Real-Life Efficacy of Tofacitinib in Various Situations in Ulcerative Colitis: A Retrospective Worldwide Multicenter Collaborative Study. Inflamm Bowel Dis. 2024;30(5):768–779. https://doi.org/10.1093/ibd/izad135.Giri S, Bhrugumalla S, Kamuni A, Mishra D, Pati GK, Agrawal D et al. Upfront tofacitinib in patients with biological-naïve ulcerative colitis – An Indian multicentric experience. Indian J Gastroenterol. 2024;43(1):237–243. https://doi.org/10.1007/s12664-023-01434-9.Giri S, Bhrugumalla S, Kamuni A, Mishra D, Pati GK, Agrawal D et al. Upfront tofacitinib in patients with biological-naïve ulcerative colitis – An Indian multicentric experience. Indian J Gastroenterol. 2024;43(1):237–243. https://doi.org/10.1007/s12664-023-01434-9.Singh A, Goyal MK, Midha V, Mahajan R, Kaur K, Gupta YK et al. Tofacitinib in Acute Severe Ulcerative Colitis (TACOS): A Randomized Controlled Trial. Am J Gastroenterol. 2024;119(7):1365–1372. https://doi.org/10.14309/ajg.0000000000002635.Singh A, Goyal MK, Midha V, Mahajan R, Kaur K, Gupta YK et al. Tofacitinib in Acute Severe Ulcerative Colitis (TACOS): A Randomized Controlled Trial. Am J Gastroenterol. 2024;119(7):1365–1372. https://doi.org/10.14309/ajg.0000000000002635.Singh A, Midha V, Kaur K, Mahajan R, Singh D, Kaur R et al. Tofacitinib Versus Oral Prednisolone for Induction of Remission in Moderately Active Ulcerative Colitis: A Prospective, Open-Label, Randomized, Pilot Study. J Crohns Colitis. 2024;18(2):300–307. https://doi.org/10.1093/ecco-jcc/jjad153.Singh A, Midha V, Kaur K, Mahajan R, Singh D, Kaur R et al. Tofacitinib Versus Oral Prednisolone for Induction of Remission in Moderately Active Ulcerative Colitis: A Prospective, Open-Label, Randomized, Pilot Study. J Crohns Colitis. 2024;18(2):300–307. https://doi.org/10.1093/ecco-jcc/jjad153.Khan N, Sundararajan R, Patel M, Trivedi C, Yang YX. Effectiveness of Tofacitinib in Patients With Ulcerative Colitis: A Nationwide Veterans Administration Cohort Study. Am J Gastroenterol. 2024;119(8):1632–1635. https://doi.org/10.14309/ajg.0000000000002761.Khan N, Sundararajan R, Patel M, Trivedi C, Yang YX. Effectiveness of Tofacitinib in Patients With Ulcerative Colitis: A Nationwide Veterans Administration Cohort Study. Am J Gastroenterol. 2024;119(8):1632–1635. https://doi.org/10.14309/ajg.0000000000002761.Yu A, Ha NB, Shi B, Cheng YW, Mahadevan U, Beck KR. Real-World Experience With Tofacitinib Dose De-Escalation in Patients With Moderate and Severe Ulcerative Colitis. Clin Gastroenterol Hepatol. 2023;21(12):3115–3124.e3. https://doi.org/10.1016/j.cgh.2023.05.001.Yu A, Ha NB, Shi B, Cheng YW, Mahadevan U, Beck KR. Real-World Experience With Tofacitinib Dose De-Escalation in Patients With Moderate and Severe Ulcerative Colitis. Clin Gastroenterol Hepatol. 2023;21(12):3115–3124.e3. https://doi.org/10.1016/j.cgh.2023.05.001.Ollech JE, Eran-Banai H, Goren I, Sharar Fischler T, Avni-Biron I, Snir Y et al. Tofacitinib is an effective treatment for moderate to severe ulcerative colitis, and intestinal ultrasound can discriminate response from non-response: a pragmatic prospective real-world study. Ann Med. 2024;56(1):2358183. https://doi.org/10.1080/07853890.2024.2358183.Ollech JE, Eran-Banai H, Goren I, Sharar Fischler T, Avni-Biron I, Snir Y et al. Tofacitinib is an effective treatment for moderate to severe ulcerative colitis, and intestinal ultrasound can discriminate response from non-response: a pragmatic prospective real-world study. Ann Med. 2024;56(1):2358183. https://doi.org/10.1080/07853890.2024.2358183.Molander P, Kosunen M, Eronen H, Tillonen J, Käräjämäki A, Heikkinen M et al. Tofacitinib real-world experience in ulcerative colitis in Finland (FinTofUC): a retrospective non-interventional multicenter patient chart data study. Scand J Gastroenterol. 2024;59(4):425–432. https://doi.org/10.1080/00365521.2023.2298361.Molander P, Kosunen M, Eronen H, Tillonen J, Käräjämäki A, Heikkinen M et al. Tofacitinib real-world experience in ulcerative colitis in Finland (FinTofUC): a retrospective non-interventional multicenter patient chart data study. Scand J Gastroenterol. 2024;59(4):425–432. https://doi.org/10.1080/00365521.2023.2298361.Kojima K, Watanabe K, Kawai M, Yagi S, Kaku K, Ikenouchi M et al. Realworld efficacy and safety of tofacitinib treatment in Asian patients with ulcerative colitis. World J Gastroenterol. 2024;30(13):1871–1886. https://doi.org/10.3748/wjg.v30.i13.1871.Kojima K, Watanabe K, Kawai M, Yagi S, Kaku K, Ikenouchi M et al. Realworld efficacy and safety of tofacitinib treatment in Asian patients with ulcerative colitis. World J Gastroenterol. 2024;30(13):1871–1886. https://doi.org/10.3748/wjg.v30.i13.1871.Singh A, Mahajan R, Midha V, Kaur K, Singh D, Kaur R et al. Effectiveness of Tofacitinib in Ulcerative Proctitis Compared to Left Sided Colitis and Pancolitis. Dig Dis Sci. 2024;69(4):1389–1402. https://doi.org/10.1007/s10620-024-08276-1.Singh A, Mahajan R, Midha V, Kaur K, Singh D, Kaur R et al. Effectiveness of Tofacitinib in Ulcerative Proctitis Compared to Left Sided Colitis and Pancolitis. Dig Dis Sci. 2024;69(4):1389–1402. https://doi.org/10.1007/s10620-024-08276-1.Uzzan M, Nachury M, Nuzzo A, Amiot A, Caron B, Benezech A et al. Tofacitinib for Patients with Anti-TNF Refractory Ulcerative Proctitis: A Multicentre Cohort Study from the GETAID. J Crohns Colitis. 2024;18(3):424–430. https://doi.org/10.1093/ecco-jcc/jjad169.Uzzan M, Nachury M, Nuzzo A, Amiot A, Caron B, Benezech A et al. Tofacitinib for Patients with Anti-TNF Refractory Ulcerative Proctitis: A Multicentre Cohort Study from the GETAID. J Crohns Colitis. 2024;18(3):424–430. https://doi.org/10.1093/ecco-jcc/jjad169.Vieujean S, Laharie D, Buisson A, Roblin X, Fumery M, Nancey S et al. Histological healing induced by tofacitinib in ulcerative colitis: A multicentre study. Dig Liver Dis. 2024;56(4):613–621. https://doi.org/10.1016/j.dld.2023.11.022.Vieujean S, Laharie D, Buisson A, Roblin X, Fumery M, Nancey S et al. Histological healing induced by tofacitinib in ulcerative colitis: A multicentre study. Dig Liver Dis. 2024;56(4):613–621. https://doi.org/10.1016/j.dld.2023.11.022.Olivera PA, Lasa JS, Bonovas S, Danese S, Peyrin-Biroulet L. Safety of Janus Kinase Inhibitors in Patients With Inflammatory Bowel Diseases or Other Immune-mediated Diseases: A Systematic Review and Meta-Analysis. Gastroenterology. 2020;158(6):1554–1573.e12. https://doi.org/10.1053/j.gastro.2020.01.001.Olivera PA, Lasa JS, Bonovas S, Danese S, Peyrin-Biroulet L. Safety of Janus Kinase Inhibitors in Patients With Inflammatory Bowel Diseases or Other Immune-mediated Diseases: A Systematic Review and Meta-Analysis. Gastroenterology. 2020;158(6):1554–1573.e12. https://doi.org/10.1053/j.gastro.2020.01.001.Panés J, D’Haens GR, Sands BE, Ng SC, Lawendy N, Kulisek N et al. Analysis of tofacitinib safety in ulcerative colitis from the completed global clinical developmental program up to 9.2 years of drug exposure. United European Gastroenterol J. 2024;12(6):793–801. https://doi.org/10.1002/ueg2.12584.Panés J, D’Haens GR, Sands BE, Ng SC, Lawendy N, Kulisek N et al. Analysis of tofacitinib safety in ulcerative colitis from the completed global clinical developmental program up to 9.2 years of drug exposure. United European Gastroenterol J. 2024;12(6):793–801. https://doi.org/10.1002/ueg2.12584.Beaugerie L. Safety of tofacitinib in IBD: A tricky puzzle. United European Gastroenterol J. 2024;12(6)658–659. https://doi.org/10.1002/ueg2.12587.Beaugerie L. Safety of tofacitinib in IBD: A tricky puzzle. United European Gastroenterol J. 2024;12(6)658–659. https://doi.org/10.1002/ueg2.12587.Schreiber S, Rubin DT, Ng SC, Peyrin-Biroulet L, Danese S, Modesto I et al. Major Adverse Cardiovascular Events by Baseline Cardiovascular Risk in Patients with Ulcerative Colitis Treated with Tofacitinib: Data from the OCTAVE Clinical Programme. J Crohns Colitis. 2023;17(11):1761–1770. https://doi.org/10.1093/ecco-jcc/jjad104.Schreiber S, Rubin DT, Ng SC, Peyrin-Biroulet L, Danese S, Modesto I et al. Major Adverse Cardiovascular Events by Baseline Cardiovascular Risk in Patients with Ulcerative Colitis Treated with Tofacitinib: Data from the OCTAVE Clinical Programme. J Crohns Colitis. 2023;17(11):1761–1770. https://doi.org/10.1093/ecco-jcc/jjad104.Macaluso FS, D’Antonio E, Fries W, Viola A, Ksissa O, Cappello M et al. Safety and effectiveness of tofacitinib in ulcerative colitis: Data from TOFA-UC, a SN-IBD studу. Dig Liver Dis. 2024;56(1):15–20. https://doi.org/10.1016/j.dld.2023.08.061.Macaluso FS, D’Antonio E, Fries W, Viola A, Ksissa O, Cappello M et al. Safety and effectiveness of tofacitinib in ulcerative colitis: Data from TOFA-UC, a SN-IBD studу. Dig Liver Dis. 2024;56(1):15–20. https://doi.org/10.1016/j.dld.2023.08.061.Carvalhas Gabrielli AM, Ferretti F, Monico CM, Tombetti E, Maconi G, Romeo S et al. Effect of Tofacitinib on One-Year Colectomy Risk in Anti-TNF Refractory Ulcerative Colitis: A Prospective Multicenter Italian Study. Dig Dis Sci. 2024;69(5):1785–1792. https://doi.org/10.1007/s10620-024-08394-w.Carvalhas Gabrielli AM, Ferretti F, Monico CM, Tombetti E, Maconi G, Romeo S et al. Effect of Tofacitinib on One-Year Colectomy Risk in Anti-TNF Refractory Ulcerative Colitis: A Prospective Multicenter Italian Study. Dig Dis Sci. 2024;69(5):1785–1792. https://doi.org/10.1007/s10620-024-08394-w.Dragoni G, Innocenti T, Amiot A, Castiglione F, Melotti L, Festa S et al. Rates of Adverse Events in Patients With Ulcerative Colitis Undergoing Colectomy During Treatment With Tofacitinib vs Biologics: A Multicenter Observational Study. Am J Gastroenterol. 2024;119(8):1525–1535. https://doi.org/10.14309/ajg.0000000000002676.Dragoni G, Innocenti T, Amiot A, Castiglione F, Melotti L, Festa S et al. Rates of Adverse Events in Patients With Ulcerative Colitis Undergoing Colectomy During Treatment With Tofacitinib vs Biologics: A Multicenter Observational Study. Am J Gastroenterol. 2024;119(8):1525–1535. https://doi.org/10.14309/ajg.0000000000002676.Чичасова НВ. Тофацитиниб: эффективность и безопасность при длительном применении. Медицинский совет. 2019;(1):64–71. https://doi.org/10.21518/2079-701X-2019-1-64-71.Chichasova NV. Tofacitinib: efficiency and safety in long-term use. Meditsinskiy Sovet. 2019;(1):64–71. (In Russ.) https://doi.org/10.21518/2079-701X-2019-1-64-71.Kobayashi T, Hoshi M, Yuasa A, Arai S, Ikeda M, Matsuda H et al. Cost-Effectiveness Analysis of Tofacitinib Compared with Biologics in Biologic-Naïve Patients with Moderate-to-Severe Ulcerative Colitis in Japan. Pharmacoeconomics. 2023;41(5):589–604. https://doi.org/10.1007/s40273-023-01254-x.Kobayashi T, Hoshi M, Yuasa A, Arai S, Ikeda M, Matsuda H et al. CostEffectiveness Analysis of Tofacitinib Compared with Biologics in BiologicNaïve Patients with Moderate-to-Severe Ulcerative Colitis in Japan. Pharmacoeconomics. 2023;41(5):589–604. https://doi.org/10.1007/s40273-023-01254-x.Taxonera C, de Andrés-Nogales F, García-López S, Sánchez-Guerrero A, Menchén B, Peral C et al. Cost-effectiveness analysis of using innovative therapies for the management of moderate-to-severe ulcerative colitis in Spain. Expert Rev Pharmacoecon Outcomes Res. 2022;22(1):73–83. https://doi.org/10.1080/14737167.2021.1880324.Taxonera C, de Andrés-Nogales F, García-López S, Sánchez-Guerrero A, Menchén B, Peral C et al. Cost-effectiveness analysis of using innovative therapies for the management of moderate-to-severe ulcerative colitis in Spain. Expert Rev Pharmacoecon Outcomes Res. 2022;22(1):73–83. https://doi.org/10.1080/14737167.2021.1880324.Vellopoulou K, Stefanou G, Tzanetakos C, Boubouchairopoulou N, Nakou M, Gourzoulidis G, Kourlaba G. Cost-effectiveness of tofacitinib for the treatment of moderate to severe active ulcerative colitis in Greece. Eur J Gastroenterol Hepatol. 2021;33(3):325–333. https://doi.org/10.1097/MEG.0000000000001916.Vellopoulou K, Stefanou G, Tzanetakos C, Boubouchairopoulou N, Nakou M, Gourzoulidis G, Kourlaba G. Cost-effectiveness of tofacitinib for the treatment of moderate to severe active ulcerative colitis in Greece. Eur J Gastroenterol Hepatol. 2021;33(3):325–333. https://doi.org/10.1097/MEG.0000000000001916.Баранов АА, Намазова-Баранова ЛС, Разумовский АЮ, Хавкин АИ, Бельмер СВ, Боровик ТЭ и др. Язвенный колит: клинические рекомендации. М.; 2021. Режим доступа: https://cr.minzdrav.gov.ru/recomend/391_2.Баранов АА, Намазова-Баранова ЛС, Разумовский АЮ, Хавкин АИ, Бельмер СВ, Боровик ТЭ и др. Язвенный колит: клинические рекомендации. М.; 2021. Режим доступа: https://cr.minzdrav.gov.ru/recomend/391_2.Ledder O, Dolinger M, Dubinsky MC, Stein R, Vellanki S, Buckuk R et al. Tofacitinib in Pediatric Ulcerative Colitis: A Retrospective Multicenter Experience. Inflamm Bowel Dis. 2024:izae112. https://doi.org/10.1093/ibd/izae112.Ledder O, Dolinger M, Dubinsky MC, Stein R, Vellanki S, Buckuk R et al. Tofacitinib in Pediatric Ulcerative Colitis: A Retrospective Multicenter Experience. Inflamm Bowel Dis. 2024:izae112. https://doi.org/10.1093/ibd/izae112.Parra-Izquierdo V, Frías-Ordoñez JS, Cuadros C, Vargas M, Vera Chamorro JF, Romero Sanchez C, Flórez-Sarmiento C. Tofacitinib in the treatment of moderate to severe ulcerative colitis in Colombian pediatric patients: Real world experience. Gastroenterol Hepatol. 2024;47(6):574–581. https://doi.org/10.1016/j.gastrohep.2023.09.013.Parra-Izquierdo V, Frías-Ordoñez JS, Cuadros C, Vargas M, Vera Chamorro JF, Romero Sanchez C, Flórez-Sarmiento C. Tofacitinib in the treatment of moderate to severe ulcerative colitis in Colombian pediatric patients: Real world experience. Gastroenterol Hepatol. 2024;47(6):574–581. https://doi.org/10.1016/j.gastrohep.2023.09.013.Costaguta GA, Girard C, Groleau V, Grzywacz K, Dirks MH, Deslandres C. The Role of Tofacitinib in the Treatment of Acute Severe Colitis in Children. J Can Assoc Gastroenterol. 2023;7(2):196–203. https://doi.org/10.1093/jcag/gwad042.Costaguta GA, Girard C, Groleau V, Grzywacz K, Dirks MH, Deslandres C. The Role of Tofacitinib in the Treatment of Acute Severe Colitis in Children. J Can Assoc Gastroenterol. 2023;7(2):196–203. https://doi.org/10.1093/jcag/gwad042.Panés J, Sandborn WJ, Schreiber S, Sands BE, Vermeire S, D’Haens G et al. Tofacitinib for induction and maintenance therapy of Crohn’s disease: results of two phase IIb randomised placebo-controlled trials. Gut. 2017;66(6):1049–1059. https://doi.org/10.1136/gutjnl-2016-312735.Panés J, Sandborn WJ, Schreiber S, Sands BE, Vermeire S, D’Haens G et al. Tofacitinib for induction and maintenance therapy of Crohn’s disease: results of two phase IIb randomised placebo-controlled trials. Gut. 2017;66(6):1049–1059. https://doi.org/10.1136/gutjnl-2016-312735.Fenster M, Alayo QA, Khatiwada A, Wang W, Dimopoulos C, Gutierrez A et al. Real-World Effectiveness and Safety of Tofacitinib in Crohn’s Disease and IBD-U: A Multicenter Study From the TROPIC Consortium. Clin Gastroenterol Hepatol. 2021;19(10):2207–2209.e3. https://doi.org/10.1016/j.cgh.2020.10.025.Fenster M, Alayo QA, Khatiwada A, Wang W, Dimopoulos C, Gutierrez A et al. Real-World Effectiveness and Safety of Tofacitinib in Crohn’s Disease and IBD-U: A Multicenter Study From the TROPIC Consortium. Clin Gastroenterol Hepatol. 2021;19(10):2207–2209.e3. https://doi.org/10.1016/j.cgh.2020.10.025.Biemans VB, Verstockt B. Tofacitinib, two-faced Janus in ulcerative colitis and Crohn’s disease? United European Gastroenterol J. 2020;8(7):753–754. https://doi.org/10.1177/2050640620942641.Biemans VB, Verstockt B. Tofacitinib, two-faced Janus in ulcerative colitis and Crohn’s disease? United European Gastroenterol J. 2020;8(7):753–754. https://doi.org/10.1177/2050640620942641.Ортенберг ЭА. Ингибиторы янус-киназ и СOVID-19 – место в алгоритмах фармакотерапии. Лекарственный вестник. 2021;83(3):21–27. Режим доступа: https://www.volgmed.ru/uploads/journals/articles/1632749394-drugs-bulletin-2021-3-3968.pdf.Ortenberg EA. Janus kinase inhibitors and COVID-19 – place in pharmacotherapy algorithms. Lekarstvennyi Vestnik. 2021;83(3):21–27. (In Russ.) Available at: https://www.volgmed.ru/uploads/journals/articles/1632749394-drugs-bulletin-2021-3-3968.pdf.Patoulias D, Doumas M, Papadopoulos C, Karagiannis A. Janus kinase inhibitors and major COVID-19 outcomes: time to forget the two faces of Janus! A meta-analysis of randomized controlled trials. Clin Rheumatol. 2021;40(11):4671–4674. https://doi.org/10.1007/s10067-021-05884-4.Patoulias D, Doumas M, Papadopoulos C, Karagiannis A. Janus kinase inhibitors and major COVID-19 outcomes: time to forget the two faces of Janus! A meta-analysis of randomized controlled trials. Clin Rheumatol. 2021;40(11):4671–4674. https://doi.org/10.1007/s10067-021-05884-4.Трухан ДИ. Оригиналы и генерики: перезагрузка в свете экономического кризиса. Справочник поликлинического врача. 2012;(4):32–36. Режим доступа: https://www.indap.info/assets/files/indap2.pdf.ТTrukhan DI. Originals and generics: Rebooting in the light of the economic crisis. Spravochnik Poliklinicheskogo Vracha. 2012;(4):32–36. (In Russ.) Available at: https://www.indap.info/assets/files/indap2.pdf.Krämer I. Biosimilars. Ther Umsch. 2011;68(11):659–666. https://doi.org/10.1024/0040-5930/a000227.Krämer I. Biosimilars. Ther Umsch. 2011;68(11):659–666. https://doi.org/10.1024/0040-5930/a000227.Danese S, Fiorino G, Raine T, Ferrante М, Kemp К, Kierkus J et al. ECCO position statement on the use of biosimilars for inflammatory bowel disease-an update. J Crohns Colitis. 2017;11(1):26–34. https://doi.org/10.1093/ecco-jcc/jjw198.Danese S, Fiorino G, Raine T, Ferrante М, Kemp К, Kierkus J et al. ECCO position statement on the use of biosimilars for inflammatory bowel disease-an update. J Crohns Colitis. 2017;11(1):26–34. https://doi.org/10.1093/ecco-jcc/jjw198.Cohen H, Blauvelt A, Rifkin RM, Danese S, Gokhale SB, Woollett G. Switching reference medicines to biosimilars: a systematic literature review of clinical outcomes. Drugs. 2018;78(4):463–478. https://doi.org/10.1007/s40265-018-0881-y.Cohen H, Blauvelt A, Rifkin RM, Danese S, Gokhale SB, Woollett G. Switching reference medicines to biosimilars: a systematic literature review of clinical outcomes. Drugs. 2018;78(4):463–478. https://doi.org/10.1007/s40265-018-0881-y.Crommelin DJ, Shah VP, Klebovich I, McNeil SE, Weinstein V, Flühmann B et al. The similarity question for biologicals and non-biological complex drugs. Eur J Pharm Sci. 2015;76:10–17. https://doi.org/10.1016/j.ejps.2015.04.010.Crommelin DJ, Shah VP, Klebovich I, McNeil SE, Weinstein V, Flühmann B et al. The similarity question for biologicals and non-biological complex drugs. Eur J Pharm Sci. 2015;76:10–17. https://doi.org/10.1016/j.ejps.2015.04.010.Башкова ИБ, Мадянов ИВ. Тофацитиниб как средство оптимизации лечения ревматоидного артрита на амбулаторном этапе (клинические наблюдения). Медицинский совет. 2024;18(3):139–147. https://doi.org/10.21518/ms2024-083.Bashkova IB, Madyanov IV. Tofacitinib as a means of optimizing the treatment of rheumatoid arthritis at the outpatient stage (clinical cases). Meditsinskiy Sovet. 2024;18(3):139–147. (In Russ.) https://doi.org/10.21518/ms2024-083.

The authors declare that there are no conflicts of interest present.