Безопасность терапии ингибиторами Янус-киназ в ревматологии: современное состояние проблемы
https://doi.org/10.14412/1996-7012-2025-4-125-130
Аннотация
В обзоре представлены современные данные о безопасности применения ингибиторов Янус-киназ (иJAK) у больных с иммуновоспалительными ревматическими заболеваниями. Особый акцент сделан на риске развития инфекций, сердечно-сосудистых осложнений и злокачественных новообразований.
Ключевые слова
Об авторах
Б. С. БеловРоссия
Борис Сергеевич Белов
Россия, 115522, Москва, Каширское шоссе, 34А
Н. В. Муравьева
Россия
Россия, 115522, Москва, Каширское шоссе, 34А
М. М. Баранова
Россия
Россия, 115522, Москва, Каширское шоссе, 34А
Литература
1. Nash P, Kerschbaumer A, Dцrner T, et al. Points to Consider for the Treatment of ImmuneMediated Inflammatory Diseases with Janus kinase Inhibitors: A Consensus Statement. Ann Rheum Dis. 2021 Jan;80(1):71-87. doi: 10.1136/annrheumdis-2020-218398. Epub 2020 Nov 6.
2. Nash P, Kerschbaumer A, Konzett V, et al. Expert consensus statement on the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: 2024 update. Ann Rheum Dis. 2025 May;84(5):664-679. doi: 10.1016/j.ard.2025.01.032. Epub 2025 Mar 3.
3. Cohen SB, Tanaka Y, Mariette X, et al. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.
4. Kremer JM, Bingham CO 3rd, Cappelli LC, et al. Postapproval Comparative Safety Study of Tofacitinib and Biological Disease-Modifying Antirheumatic Drugs: 5-Year Results froma United States-Based Rheumatoid Arthritis Registry. ACR Open Rheumatol. 2021 Mar; 3(3):173-184. doi: 10.1002/acr2.11232. Epub 2021 Feb 11.
5. Winthrop KL, Harigai M, Genovese MC, et al. Infections in baricitinib clinical trials for patients with active rheumatoid arthritis. Ann Rheum Dis. 2020 Oct;79(10):1290-1297. doi: 10.1136/annrheumdis-2019-216852. Epub 2020 Aug 11.
6. Burmester GR, Cohen SB, Winthrop KL, et al. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023 Feb;9(1): e002735. doi: 10.1136/rmdopen-2022-002735.
7. https://www.who.int/ru/news-room/factsheets/detail/tuberculosis.
8. Frisell T, Bower H, Morin M, et al. ARTIS Study group. Safety of biological and targeted synthetic disease-modifying antirheumatic drugs for rheumatoid arthritis as used in clinical practice: results from the ARTIS programme. Ann Rheum Dis. 2023 May;82(5): 601-610. doi: 10.1136/ard-2022-223762. Epub 2023 Feb 14.
9. Cohen SB, van Vollenhoven RF, Winthrop KL, et al. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis. 2021 Mar;80(3):304-311. doi: 10.1136/annrheumdis-2020-218510. Epub 2020 Oct 28.
10. Лукина ГВ, Борисов СЕ. Скрининг и мониторинг туберкулезной инфекции у больных ревматическими заболеваниями, получающих генно-инженерные биологические препараты. В кн.: Насонов ЕЛ, редактор. Российские клинические рекомендации. Ревматология. Москва: ГЭОТАР-Медиа; 2017. С. 394-410.
11. https://cr.minzdrav.gov.ru/view-cr/250_3. Раздел 7.1.
12. Winthrop K, Isaacs J, Calabrese L, et al. Opportunistic infections associated with Janus kinase inhibitor treatment for rheumatoid arthritis: A structured literature review. Semin Arthritis Rheum. 2023 Feb:58:152120. doi: 10.1016/j.semarthrit.2022.152120. Epub 2022 Oct 29.
13. Curtis JR, Xie F, Yang S, et al. Risk for Herpes Zoster in Tofacitinib-Treated Rheumatoid Arthritis Patients with and without Concomitant Methotrexate and Glucocorticoids. Arthritis Care Res (Hoboken). 2019 Sep;71(9):1249-1254. doi: 10.1002/acr.23769. Epub 2019 Jul 29.
14. Winthrop KL, Nash P, Yamaoka K, et al. Incidence and risk factors for herpes zoster in patients with rheumatoid arthritis receiving upadacitinib: a pooled analysis of six phase III clinical trials. Ann Rheum Dis. 2022 Feb;81(2): 206-213. doi: 10.1136/annrheumdis-2021-220822. Epub 2021 Oct 6.
15. Chen YM, Huang WN, Wu YD, et al. Reactivation of hepatitis B virus infection in patients with rheumatoid arthritis receiving tofacitinib: a real-world study. Ann Rheum Dis. 2018 May;77(5):780-782. doi: 10.1136/annrheumdis-2017-211322. Epub 2017 Jun 29.
16. Harigai M, Winthrop K, Takeuchi T, et al. Evaluation of hepatitis B virus in clinical trials of baricitinib in rheumatoid arthritis. RMD Open. 2020 Feb;6(1):e001095. doi: 10.1136/rmdopen-2019-001095.
17. Furer V, Rondaan C, Heijstek MW, et al. 2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis. 2020 Jan;79(1):39-52. doi: 10.1136/annrheumdis-2019-215882. Epub 2019 Aug 14.
18. Bass AR, Chakravarty E, Akl EA, et al. 2022 American College of Rheumatology guideline for vaccinations in patients with rheumatic and musculoskeletal diseases. Arthritis Rheumatol. 2023 Mar;75(3):333-348. doi: 10.1002/art.42386. Epub 2023 Jan 4.
19. Ytterberg SR, Bhatt DL, Mikuls TR, et al. Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. N Engl J Med. 2022 Jan 27;386(4):316-326. doi: 10.1056/NEJMoa2109927.
20. Charles-Schoeman C, Wicker P, Gonzalez-Gay MA, et al. Cardiovascular safety findings in patients with rheumatoid arthritis treated with tofacitinib, an oral Janus kinase inhibitor. Semin Arthritis Rheum. 2016 Dec; 46(3):261-271. doi: 10.1016/j.semarthrit.2016.05.014. Epub 2016 Jun 2.
21. Winthrop KL, Yamanaka H, Valdez H, et al. Herpes zoster and tofacitinib: the risk of viral reactivation in the context of JAK inhibition. Arthritis Rheumatol. 2014 Oct;66(10): 2675-84. doi: 10.1002/art.38745.
22. Charles-Schoeman C, Gonzalez-Gay MA, Kaplan I, et al. Effects of tofacitinib and other DMARDs on lipid profiles in rheumatoid arthritis: implications for the rheumatologist. Semin Arthritis Rheum. 2016 Aug;46(1):71-80. doi: 10.1016/j.semarthrit.2016.03.004. Epub 2016 Mar 9.
23. Taylor PC, Takeuchi T, Burmester GR, et al. Safety of baricitinib in patients with active rheumatoid arthritis for up to 9.3 years: an updated integrated analysis. Lancet Rheumatol. 2022;4(2):e105-e118. doi:10.1016/S2665-9913(21)00348-2.
24. Kremer JM, Emery P, Camp HS, et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis: 52-week results from SELECT-COMPARE. Arthritis Rheumatol. 2020 Sep;72(9):1513. doi: 10.1002/art.41495.
25. U.S. Food and Drug Administration (FDA). FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions. Drug Safety Communication. September 1, 2021 (https://www.fda.gov).
26. Huss V, Bower H, Hellgren K, et al. Cancer risks with JAKi and biological diseasemodifying antirheumatic drugs in patients with rheumatoid arthritis or psoriatic arthritis: a national realworld cohort study. Ann Rheum Dis. 2023 Jul;82(7):911-919. doi: 10.1136/ard-2022-223636. Epub 2023 Mar 3.
27. Molina-Collada J, Alonso F, Otero L, et al. Cancer risk with biologic and targeted synthetic DMARDs in patients with rheumatic diseases and previous malignancies: results from the BIOBADASER register. Semin Arthritis Rheum. 2024 Feb:64:152341. doi: 10.1016/j.semarthrit.2023.152341. Epub 2023 Dec 9.
Рецензия
Для цитирования:
Белов БС, Муравьева НВ, Баранова ММ. Безопасность терапии ингибиторами Янус-киназ в ревматологии: современное состояние проблемы. Современная ревматология. 2026;20(1):125-130. https://doi.org/10.14412/1996-7012-2025-4-125-130
For citation:
Belov BS, Muravyeva NV, Baranova MM. Safety of Janus kinase inhibitors in rheumatology: current state of the issue. Sovremennaya Revmatologiya=Modern Rheumatology Journal. 2026;20(1):125-130. (In Russ.) https://doi.org/10.14412/1996-7012-2025-4-125-130
JATS XML





































