Перспективы ингибиции интерлейкина-6 при ревматоидном артрите: олокизумаб (новые моноклональные антитела к ИЛ-6)
https://doi.org/10.47360/1995-4484-2022-505-518
Аннотация
Ревматоидный артрит (РА) – хроническое иммуновоспалительное ревматическое заболевание (ИВРЗ), проявляющееся прогрессирующей деструкцией суставов, системным воспалением внутренних органов и широким спектром коморбидных заболеваний, связанных с хроническим воспалением. В спектре цитокинов, принимающих участие в патогенезе РА и других ИВРЗ, большое внимание уделяется роли интерлейкина (ИЛ) 6. Внедрение в клиническую практику моноклональных антител (мАТ) – тоцилизумаба (ТЦЗ), а затем сарилумаба (САР), блокирующих клеточные эффекты этого цитокина, относится к числу крупнейших достижений в лечении ИВРЗ в начале XXI века. Особое внимание привлекают гуманизированные мАТ к ИЛ-6 – олокизумаб (ОКЗ), разработанные Российской компанией «Р-ФАРМ» в рамках лицензионного соглашения с UCB Pharma. В обзоре рассматриваются новые данные, касающиеся эффективности и безопасности ОКЗ при РА и перспективы применения ОКЗ в ревматологии.
Об авторах
Е. Л. Насонов
ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой»; ФГАОУ ВО «Первый Московский государственный медицинский университет имени И.М. Сеченова» Минздрава России (Сеченовский
Университет)
Россия
Россия
11552, Москва, Каширское шоссе, 34а; 119991, Москва, ул. Трубецкая, 8, стр. 2
Е. Файст
Отделение ревматологии Клиники Гелиос Фогельсанг-Гоммерн, партнер по сотрудничеству Магдебургского университета имени Отто фон Герике
Германия
Германия
39245, Гоммерн, Софи-в.- Беттихер-Штрассе, 1
Список литературы
1. Smolen JS, Aletaha D, McInnes IB. Rheumatoid arthritis. Lancet. 2016;388(10055):2023–2038. doi: 10.1016/S0140-6736(16)30173-8
2. Firestein GS, McInnes IB. Immunopathogenesis of Rheumatoid Arthritis. Immunity. 2017;46(2):183–196. doi: 10.1016/j.immuni. 2017.02.006
3. McInnes IB, Schett G. Pathogenetic insights from the treatment of rheumatoid arthritis. Lancet. 2017;389(10086):2328–2337. doi: 10.1016/S0140-6736(17)31472-1
4. Burmester GR, Bijlsma JWJ, Cutolo M, McInnes IB. Managing rheumatic and musculoskeletal diseases – past, present and future. Nat Rev Rheumatol. 2017;13(7):443–448. doi: 10.1038/nrrheum. 2017.95
5. Насонов ЕЛ. Фармакотерапия ревматоидного артрита: новая стратегия, новые мишени. Научно-практическая ревматология. 2017;55(4):409–419.
6. Smolen JS, Aletaha D, Bijlsma JW, Breedveld FC, Boumpas D, et al.; T2T Expert Committee. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis. 2010;69(4):631–637. doi: 10.1136/ard.2009.123919.
7. Mian A, Ibrahim F, Scott DL. A systematic review of guidelines for managing rheumatoid arthritis. BMC Rheumatol. 2019;3:42. doi: 10.1186/s41927-019-0090-7
8. Burmester GR, Pope JE. Novel treatment strategies in rheumatoid arthritis. Lancet. 2017;389:2338–2348. doi: 10.1016/S0140-6736(17) 31491-5
9. Winthrop KL, Weinblatt ME, Bathon J, Burmester GR, Mease PJ, et al. Unmet need in rheumatology: reports from the Targeted Therapies meeting 2019. Ann Rheum Dis. 2020;79(1):88–93. doi: 10.1136/annrheumdis-2019-216151
10. Schett G, McInnes IB, Neurath MF. Reframing Immune-Mediated Inflammatory Diseases through Signature Cytokine Hubs. N Engl J Med. 2021;385(7):628–639. doi: 10.1056/NEJMra1909094
11. Hunter CA, Jones SA. IL-6 as a keystone cytokine in health and disease. Nat Immunol. 2015;16(5):448–457. doi: 10.1038/ni.3153
12. Choy, E.H., De Benedetti, F., Takeuchi, T. et al. Translating IL-6 biology into effective treatments. Nat Rev Rheumatol. 2020; 16, 335–345. https://doi.org/10.1038/s41584-020-0419-z
13. Kang S, Tanaka T, Narazaki M, Kishimoto T. Targeting Interleukin-6 Signaling in Clinic. Immunity. 2019;50(4):1007–1023. doi: 10.1016/j.immuni.2019.03.026
14. Kishimoto T, Kang S. IL-6 Revisited: From Rheumatoid Arthritis to CAR T Cell Therapy and COVID-19. Annu Rev Immunol. 2022;40:323–348. doi: 10.1146/annurev-immunol-101220-023458
15. Насонов ЕЛ, Лила АМ. Ингибиция интерлейкина-6 при иммуновоспалительных ревматических заболеваниях: достижения, перспективы и надежды. Научно-практическая ревматология. 2017;55(6):590–599.
16. Насонов Е.Л. Применение тоцилизумаба при ревматоидном артрите: новые данные. Научно-практическая ревматология. 2011;49(6):46–56
17. Scott LJ. Tocilizumab: A Review in Rheumatoid Arthritis. Drugs. 2017;77(17):1865-1879. doi: 10.1007/s40265-017-0829-7.
18. Насонов ЕЛ, Лила АМ. Эффективность и безопасность сарилумаба (полностью человеческие моноклональные антитела к рецептору интерлейкина-6) при ревматоидном артрите: новые данные. Научно-практическая ревматология. 2019; 57(5):564–577
19. Raimondo MG, Biggioggero M, Crotti C, Becciolini A, Favalli EG. Profile of sarilumab and its potential in the treatment of rheumatoid arthritis. Drug Des Devel Ther. 2017;11:1593–1603. doi: 10.2147/ DDDT.S100302
20. Pelechas E, Voulgari PV, Drosos AA. Sirukumab: a promising therapy for rheumatoid arthritis. Expert Opin Biol Ther. 2017;17(6):755–763. doi: 10.1080/14712598.2017.1315099
21. Tanaka Y, Martin Mola E. IL-6 targeting compared to TNF targeting in rheumatoid arthritis: studies of olokizumab, sarilumab and sirukumab. Ann Rheum Dis. 2014;73(9):1595–1597. doi: 10.1136/ annrheumdis-2013-205002
22. Serio I, Tovoli F. Rheumatoid arthritis: new monoclonal antibodies. Drugs Today (Barc). 2018;54(3):219–230. doi: 10.1358/ dot.2018.54.3.2788019
23. Shaw S, Bourne T, Meier C, Carrington B, Gelinas R, et al. Discovery and characterization of olokizumab: a humanized antibody targeting interleukin-6 and neutralizing gp130-signaling. MAbs. 2014;6 (3):774–82. doi: 10.4161/mabs.28612
24. Favalli EG. Understanding the Role of Interleukin-6 (IL-6) in the Joint and Beyond: A Comprehensive Review of IL-6 Inhibition for the Management of Rheumatoid Arthritis. Rheumatol Ther. 2020;7(3):473–516. doi: 10.1007/s40744-020-00219-2
25. Narazaki M, Kishimoto T. Current status and prospects of IL6-targeting therapy. Exp Rev Clin Pharm. 2022;15 (5):575–592. doi: 10.1080/17512433.2022.2097905
26. Jarlborg M, Gabay C. Systemic effects of IL-6 blockade in rheumatoid arthritis beyond the joints. Cytokine. 2022;149. doi: org/10.1016/j.cyto.2021.155742
27. Smolen JS, Beaulieu A, Rubbert-Roth A, Ramos-Remus C, Rovensky J, et al.; OPTION Investigators. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Lancet. 2008;371(9617):987–997. doi: 10.1016/ S0140-6736(08)60453-5
28. Kremer JM, Blanco R, Brzosko M, Burgos-Vargas R, Halland AM, Vernon E, Ambs P, Fleischmann R. Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year. Arthritis Rheum. 2011;63(3):609–621. doi: 10.1002/art.30158
29. Genovese MC, McKay JD, Nasonov EL, Mysler EF, da Silva NA, et al. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthritis Rheum. 2008;58(10):2968–2980. doi: 10.1002/art.23940
30. Yazici Y, Curtis JR, Ince A, Baraf H, Malamet RL, Teng LL, Kavanaugh A. Efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis and a previous inadequate response to disease-modifying antirheumatic drugs: the ROSE study. Ann Rheum Dis. 2012;71(2):198–205. doi: 10.1136/ ard.2010.148700
31. Burmester GR, Rubbert-Roth A, Cantagrel A, Hall S, Leszczynski P, et al. A randomised, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional diseasemodifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTA study). Ann Rheum Dis. 2014;73(1):69–74. doi: 10.1136/annrheumdis-2013-203523
32. Kivitz A, Olech E, Borofsky M, Zazueta BM, Navarro-Sarabia F, et al. Subcutaneous tocilizumab versus placebo in combination with disease-modifying antirheumatic drugs in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2014;66(11):1653– 1661. doi: 10.1002/acr.22384
33. Emery P, Keystone E, Tony HP, Cantagrel A, van Vollenhoven R, et al. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to antitumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis. 2008;67(11):1516–1523. doi: 10.1136/ard.2008.092932
34. Gabay C, Emery P, van Vollenhoven R, Dikranian A, Alten R, et al.; ADACTA Study Investigators. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial. Lancet. 2013;381(9877):1541–1550. doi: 10.1016/S0140- 6736(13)60250-0
35. Nishimoto N, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, et al. Study of active controlled tocilizumab monotherapy for rheumatoid arthritis patients with an inadequate response to methotrexate (SATORI): significant reduction in disease activity and serum vascular endothelial growth factor by IL-6 receptor inhibition therapy. Mod Rheumatol. 2009;19(1):12–19. doi: 10.1007/s10165-008- 0125-1
36. Jones G, Sebba A, Gu J, Lowenstein MB, Calvo A, et al. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis. 2010;69(1):88– 96. doi: 10.1136/ard.2008.105197
37. Bijlsma JWJ, Welsing PMJ, Woodworth TG, Middelink LM, Pethö-Schramm A, et al. Early rheumatoid arthritis treated with tocilizumab, methotrexate, or their combination (U-Act-Early): a multicentre, randomised, double-blind, double-dummy, strategy trial. Lancet. 2016;388(10042):343–355. doi: 10.1016/S0140- 6736(16)30363-4.
38. Burmester GR, Rigby WF, van Vollenhoven RF, Kay J, Rubbert-Roth A, et al. Tocilizumab combination therapy or monotherapy or methotrexate monotherapy in methotrexate-naive patients with early rheumatoid arthritis: 2-year clinical and radiographic results from the randomised, placebo-controlled FUNCTION trial. Ann Rheum Dis. 2017;76(7):1279–1284. doi: 10.1136/annrheumdis-2016-210561.
39. Genovese MC, Fleischmann R, Kivitz AJ, Rell-Bakalarska M, Martincova R, et al.. Sarilumab Plus Methotrexate in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: Results of a Phase III Study. Arthritis Rheumatol. 2015;67(6):1424–1437. doi: 10.1002/art.39093
40. Tanaka Y, Wada K, Takahashi Y, Hagino O, van Hoogstraten H, et al. Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a randomized, placebo-controlled phase III trial in Japan. Arthritis Res Ther. 2019;21(1):79. doi: 10.1186/s13075-019-1856-4
41. Fleischmann R, van Adelsberg J, Lin Y, Castelar-Pinheiro GD, Brzezicki J, et al. Sarilumab and Nonbiologic Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Tumor Necrosis Factor Inhibitors. Arthritis Rheumatol. 2017;69(2):277–290. doi: 10.1002/ art.39944
42. Burmester GR, Lin Y, Patel R, van Adelsberg J, Mangan EK, et al. Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallelgroup phase III trial. Ann Rheum Dis. 2017;76(5):840–847. doi: 10.1136/annrheumdis-2016-210310
43. Nasonov E, Fatenejad S, Feist E, Ivanova M, Korneva E, et al. Olokizumab, a monoclonal antibody against interleukin 6, in combination with methotrexate in patients with rheumatoid arthritis inadequately controlled by methotrexate: efficacy and safety results of a randomised controlled phase III study. Ann Rheum Dis. 2022;81(4):469–479. doi: 10.1136/annrheumdis-2021-219876
44. Smolen JS, Feist E, Fatenejad S, Grishin SA, Korneva EV, Nasonov EL, et al. ; CREDO2 Group. Olokizumab versus Placebo or Adalimumab in Rheumatoid Arthritis. N Engl J Med. 2022;387(8):715–726. doi: 10.1056/NEJMoa2201302
45. Feist E, Fatenejad S, Grishin S, Korneva E, Luggen ME, Nasonov E, et al. Olokizumab, a monoclonal antibody against interleukin-6, in combination with methotrexate in patients with rheumatoid arthritis inadequately controlled by tumour necrosis factor inhibitor therapy: efficacy and safety results of a randomised controlled phase III study. Ann Rheum Dis. 2022 Sep 15:annrheumdis-2022-222630. doi: 10.1136/ard-2022-222630
46. Genovese MC, Fleischmann R, Furst D, Janssen N, Carter J, et al. Efficacy and safety of olokizumab in patients with rheumatoid arthritis with an inadequate response to TNF inhibitor therapy: outcomes of a randomised Phase IIb study. Ann Rheum Dis. 2014;73(9):1607–1615. doi: 10.1136/annrheumdis-2013-204760
47. Takeuchi T, Tanaka Y, Yamanaka H, Amano K, Nagamine R, et al. Efficacy and safety of olokizumab in Asian patients with moderate-to-severe rheumatoid arthritis, previously exposed to anti-TNF therapy: Results from a randomized phase II trial. Mod Rheumatol. 2016;26(1):15–23. doi: 10.3109/14397595.2015.1074648
48. Administration USFD (2020). New Drug Application (NDA): 009768, Original Approvals or Tentative Approvals. Silver Spring, MD: US Food and Drug Administration. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=009768 (Accessed May 3, 2020).
49. Мазуров ВИ, Зоткин ЕГ, Гайдукова ИЗ, Иливанова ЕП, Кропотина ТВ, и соавт. Эффективность и безопасность применения левилимаба в комбинации с метотрексатом у пациентов с ревматоидным артритом: результаты II фазы исследования AURORA. Научно-практическая ревматология. 2021;59(2): 141–151.
50. Takeuchi T, Thorne C, Karpouzas G, Sheng S, Xu W, Rao R, Fei K, Hsu B, Tak PP. Sirukumab for rheumatoid arthritis: the phase III SIRROUND-D study. Ann Rheum Dis. 2017;76(12):2001–2008. doi: 10.1136/annrheumdis-2017-211328
51. Aletaha D, Bingham CO 3rd, Tanaka Y, Agarwal P, Kurrasch R, et al. Efficacy and safety of sirukumab in patients with active rheumatoid arthritis refractory to anti-TNF therapy (SIRROUND-T): a randomised, double-blind, placebo-controlled, parallel-group, multinational, phase 3 study. Lancet. 2017;389(10075):1206–1217. doi: 10.1016/S0140-6736(17)30401-4
52. Aletaha D, Kerscbaumer A, Kastrati K, Dejaco C, Dougados M, et al. Consensus statement on blocking interleukin-6 receptor and interleukin-6 in infkammatory conditions: an update. Ann Rheum Dis 2022. doi:10.1136/annrheumdis-2022-222784
53. Kastrati K, Aletaha D, Burmester GR, Chwala E, Dejaco C et al. A systematic literature review informing the consensus statement on efficacy and safety of pharmacological treatment with interleukin-6 pathway inhibition with biological DMARDs in immunemediated inflammatory diseases. RMD Open. 2022;8:e002359. doi: 10.1136/rmdopen-2022-002359
54. Smolen JS, Landewé RBM, Bijlsma JWJ, Burmester GR, Dougados M, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological diseasemodifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79(6):685–699. doi: 10.1136/annrheumdis-2019-216655
55. Fraenkel L, Bathon JM, England BR, St Clair EW, Arayssi T, et al. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2021;73(7):924–939. doi: 10.1002/acr.24596
56. Hetland ML, Haavardsholm EA, Rudin A, Nordström D, Nurmohamed M, et al.; NORD-STAR study group. Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial. BMJ. 2020;371:m4328. doi: 10.1136/bmj.m4328
57. Humby F, Durez P, Buch MH, Lewis MJ, Rizvet H et al. Rituximab versus tocilizumab in anti-TNF inadequate Responder patients with rheumatoid arthritis (R4RA): 16-week outcomes of a stratified, biopsy-driven, multicentre, open-label, phase 4 randomised controlled trial. Lancet. 2021; 397(10271):305–317. doi: 10.1016/S0140-6736(20)32341-2
58. Pappas DA, St John G, Etzel CJ, Fiore S, Blachley T, et al. Comparative effectiveness of first-line tumour necrosis factor inhibitor versus non-tumour necrosis factor inhibitor biologics and targeted synthetic agents in patients with rheumatoid arthritis: results from a large US registry study. Ann Rheum Dis. 2021;80(1): 96–102. doi: 10.1136/annrheumdis-2020-217209
59. Gottenberg JE, Morel J, Perrodeau E, Bardin T, Combe B, et al.; French Society of Rheumatology and the investigators participating in AIR, ORA, and REGATE registries. Comparative effectiveness of rituximab, abatacept, and tocilizumab in adults with rheumatoid arthritis and inadequate response to TNF inhibitors: prospective cohort study. BMJ. 2019;364:l67. doi: 10.1136/bmj.l67
60. Dougados M, Kissel K, Conaghan PG, Mola EM, Schett G, et al. Clinical, radiographic and immunogenic effects after 1 year of tocilizumab-based treatment strategies in rheumatoid arthritis: the ACT-RAY study. Ann Rheum Dis. 2014;73(5):803–809. doi: 10.1136/annrheumdis-2013-204761
61. Burmester GR, Rigby WF, van Vollenhoven RF, Kay J, RubbertRoth A, Kelman A, Dimonaco S, Mitchell N. Tocilizumab in early progressive rheumatoid arthritis: FUNCTION, a randomised controlled trial. Ann Rheum Dis. 2016;75(6):1081–1091. doi: 10.1136/ annrheumdis-2015-207628
62. Kaneko Y, Atsumi T, Tanaka Y, Inoo M, Kobayashi-Haraoka H, et al. Comparison of adding tocilizumab to methotrexate with switching to tocilizumab in patients with rheumatoid arthritis with inadequate response to methotrexate: 52-week results from a prospective, randomised, controlled study (SURPRISE study). Ann Rheum Dis. 2016;75(11):1917–1923. doi: 10.1136/annrheumdis-2015-208426
63. Teitsma XM, Marijnissen AK, Bijlsma JW, Lafeber FP, Jacobs JW. Tocilizumab as monotherapy or combination therapy for treating active rheumatoid arthritis: a meta-analysis of efficacy and safety reported in randomized controlled trials. Arthritis Res Ther. 2016;18(1):211. doi: 10.1186/s13075-016-1108-9
64. Genovese MC, Kremer J, Zamani O, Ludivico C, Krogulec M, et al. Baricitinib in Patients with Refractory Rheumatoid Arthritis. N Engl J Med. 2016;374(13):1243-52. doi: 10.1056/NEJMoa1507247
65. Насонов ЕЛ, Коротаева ТВ. Ингибиторы Янус-киназ при иммуновоспалительных заболеваниях: 10 лет клинической практики в ревматологии. Научно-практическая ревматология. 2022;60(2):131-148.
66. Aletaha D, Smolen JS. Remission in rheumatoid arthritis: missing objectives by using inadequate DAS28 targets. Nat Rev Rheumatol. 2019;15(11):633–634. doi: 10.1038/s41584-019-0279-6
67. Felson DT, Lacaille D, LaValley MP, Aletaha D. Reexamining Remission Definitions in Rheumatoid Arthritis: Considering Disease Activity Score in 28 Joints, C-Reactive Protein, and Patient Global Assessment. ACR Open Rheumatol. 2022;4(2):123–127. doi: 10.1002/acr2.11345
68. Lauper K, Iudici M, Mongin D, Bergstra SA, Choquette D, et al. Effectiveness of TNF-inhibitors, abatacept, IL6-inhibitors and JAK-inhibitors in 31 846 patients with rheumatoid arthritis in 19 registers from the ‘JAK-pot’ collaboration. Ann Rheum Dis. 2022 Jun 15. doi: 10.1136/annrheumdis-2022-222586
69. Shimamoto K, Ito T, Ozaki Y, Amuro H, Tanaka A, et al. Serum interleukin 6 before and after therapy with tocilizumab is a principal biomarker in patients with rheumatoid arthritis. J Rheumatol. 2013;40(7):1074–1081. doi: 10.3899/jrheum.121389
70. Nishimoto N, Amano K, Hirabayashi Y, Horiuchi T, Ishii T, et al. Drug free REmission/low disease activity after cessation of tocilizumab (Actemra) Monotherapy (DREAM) study. Mod Rheumatol. 2014;24(1):17–25. doi: 10.3109/14397595.2013.854079
71. Shafran IH, Alasti F, Smolen JS, Aletaha D. Implication of baseline levels and early changes of C-reactive protein for subsequent clinical outcomes of patients with rheumatoid arthritis treated with tocilizumab. Ann Rheum Dis. 2020;79(7):874–882. doi: 10.1136/annrheumdis-2019-215987
72. Boyapati A, Schwartzman S, Msihid J, Choy E, Genovese MC, et al. Association of High Serum Interleukin-6 Levels With Severe Progression of Rheumatoid Arthritis and Increased Treatment Response Differentiating Sarilumab From Adalimumab or Methotrexate in a Post Hoc Analysis. Arthritis Rheumatol. 2020;72(9):1456–1466. doi: 10.1002/art.41299
73. Gardette A, Ottaviani S, Sellam J, Berenbaum F, Lioté F, et al. Body mass index and response to tocilizumab in rheumatoid arthritis: a real life study. Clin Rheumatol. 2016;35(4):857–861. doi: 10.1007/s10067-016-3183-3
74. Davies R, Vivekanantham A, Lunt M, et al. The effect of bodyweight on response to intravenous or subcutaneous tocilizumab in patients with rheumatoid arthritis. Ann Rheum Dis. 2020;79:981. doi:10.1136/annrheumdis-2020-eular.4164
75. Nouri B, Nair N, Barton A. Predicting treatment response to IL6R blockers in rheumatoid arthritis. Rheumatology (Oxford). 2020;59(12):3603–3610. doi: 10.1093/rheumatology/keaa529
76. Burmester GR, Buttgereit F, Bernasconi C, Álvaro-Gracia JM, Castro N, et al.; SEMIRA collaborators. Continuing versus tapering glucocorticoids after achievement of low disease activity or remission in rheumatoid arthritis (SEMIRA): a double-blind, multicentre, randomised controlled trial. Lancet. 2020;396(10246):267–276. doi: 10.1016/S0140-6736(20)30636-X
77. Crnkic Kapetanovic M, Saxne T, Truedsson L, Geborek P. Persistence of antibody response 1.5 years after vaccination using 7-valent pneumococcal conjugate vaccine in patients with arthritis treated with different antirheumatic drugs. Arthritis Res Ther. 2013;15(1):R1. doi: 10.1186/ar4127
78. Mori S, Ueki Y, Akeda Y, Hirakata N, Oribe M, Shiohira Y, Hidaka T, Oishi K. Pneumococcal polysaccharide vaccination in rheumatoid arthritis patients receiving tocilizumab therapy. Ann Rheum Dis. 2013;72(8):1362–1366. doi: 10.1136/annrheumdis-2012-202658
79. Bingham CO 3rd, Rizzo W, Kivitz A, Hassanali A, Upmanyu R, Klearman M. Humoral immune response to vaccines in patients with rheumatoid arthritis treated with tocilizumab: results of a randomised controlled trial (VISARA). Ann Rheum Dis. 2015;74(5):818–822. doi: 10.1136/annrheumdis-2013-204427
80. Alunno A, Najm A, Machado PM, Bertheussen H, Burmester GR, et al. EULAR points to consider on pathophysiology and use of immunomodulatory therapies in COVID-19. Ann Rheum Dis. 2021;80(6):698–706. doi: 10.1136/annrheumdis-2020-219724
81. Rutherford AI, Patarata E, Subesinghe S, Hyrich KL, Galloway JB. Opportunistic infections in rheumatoid arthritis patients exposed to biologic therapy: results from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis. Rheumatology (Oxford). 2018;57(6):997–1001. doi: 10.1093/ rheumatology/key023.
82. Curtis JR, Xie F, Yun H, Bernatsky S, Winthrop KL. Real-world comparative risks of herpes virus infections in tofacitinib and biologic-treated patients with rheumatoid arthritis. Ann Rheum Dis. 2016;75(10):1843–1847. doi: 10.1136/annrheumdis-2016-209131
83. Souto A, Maneiro JR, Salgado E, Carmona L, Gomez-Reino JJ. Risk of tuberculosis in patients with chronic immune-mediated inflammatory diseases treated with biologics and tofacitinib: a systematic review and meta-analysis of randomized controlled trials and long-term extension studies. Rheumatology (Oxford). 2014;53(10):1872–1885. doi: 10.1093/rheumatology/keu172
84. Wadström H, Frisell T, Askling J; Anti-Rheumatic Therapy in Swe den (ARTIS) Study Group. Malignant Neoplasms in Patients With Rheumatoid Arthritis Treated With Tumor Necrosis Factor Inhibitors, Tocilizumab, Abatacept, or Rituximab in Clinical Practice: A Nationwide Cohort Study From Sweden. JAMA Intern Med. 2017;177(11):1605–1612. doi: 10.1001/jamainternmed.2017.4332
85. Harigai M, Nanki T, Koike R, Tanaka M, Watanabe-Imai K, et al. Risk for malignancy in rheumatoid arthritis patients treated with biological disease-modifying antirheumatic drugs compared to the general population: A nationwide cohort study in Japan. Mod Rheumatol. 2016;26(5):642–650. doi: 10.3109/14397595.2016.1141740.
86. Strangfeld A, Richter A, Siegmund B, Herzer P, Rockwitz K, et al. Risk for lower intestinal perforations in patients with rheumatoid arthritis treated with tocilizumab in comparison to treatment with other biologic or conventional synthetic DMARDs. Ann Rheum Dis. 2017;76(3):504–510. doi: 10.1136/annrheumdis-2016-209773
87. Bulte JP, Postma N, Beukema M, Inberg B, Stegeman AG, van der Hoeven H. COVID 19 and the risk of gastro-intestinal perforation: A case series and literature review. J Crit Care. 2022;67:100– 103. doi: 10.1016/j.jcrc.2021.10.020
88. Genovese MC, Kremer JM, van Vollenhoven RF, Alten R, Scali JJ, еt al. Transaminase Levels and Hepatic Events During Tocilizumab Treatment: Pooled Analysis of Long-Term Clinical Trial Safety Data in Rheumatoid Arthritis. Arthritis Rheumatol. 2017;69(9):1751–1761. doi: 10.1002/art.40176
89. McInnes IB, Thompson L, Giles JT, Bathon JM, Salmon JE, et al. Effect of interleukin-6 receptor blockade on surrogates of vascular risk in rheumatoid arthritis: MEASURE, a randomised, placebo-controlled study. Ann Rheum Dis. 2015;74(4):694-702 doi: 10.1136/annrheumdis-2013-204345
90. Gabay C, McInnes IB, Kavanaugh A, Tuckwell K, Klearman M, et al. Comparison of lipid and lipid-associated cardiovascular risk marker changes after treatment with tocilizumab or adalimumab in patients with rheumatoid arthritis. Ann Rheum Dis. 2016;75(10): 1806–1812. doi: 10.1136/annrheumdis-2015-207872
91. Giles JT, Sattar N, Gabriel S, Ridker PM, Gay S, et al. Cardiovascular Safety of Tocilizumab Versus Etanercept in Rheumatoid Arthritis: A Randomized Controlled Trial. Arthritis Rheumatol. 2020;72(1):31–40. doi: 10.1002/art.41095
92. Kim SC, Solomon DH, Rogers JR, Gale S, Klearman M, Sarsour K, Schneeweiss S. Cardiovascular Safety of Tocilizumab Versus Tumor Necrosis Factor Inhibitors in Patients With Rheumatoid Arthritis: A Multi-Database Cohort Study. Arthritis Rheumatol. 2017;69(6):1154–1164. doi: 10.1002/art.40084
93. Kim SC, Solomon DH, Rogers JR, Gale S, Klearman M, Sarsour K, Schneeweiss S. No difference in cardiovascular risk of tocilizumab versus abatacept for rheumatoid arthritis: A multi-database cohort study. Semin Arthritis Rheum. 2018;48(3):399–405. doi: 10.1016/j.semarthrit.2018.03.012
94. Xie F, Yun H, Levitan EB, Muntner P, Curtis JR. Tocilizumab and the Risk of Cardiovascular Disease: Direct Comparison Among Biologic Disease-Modifying Antirheumatic Drugs for Rheumatoid Arthritis Patients. Arthritis Care Res (Hoboken). 2019;71(8):1004–1018. doi: 10.1002/acr.23737
95. Tyrrell DJ, Goldstein DR. Ageing and atherosclerosis: vascular intrinsic and extrinsic factors and potential role of IL-6. Nat Rev Cardiol. 2021;18(1):58-68. doi: 10.1038/s41569-020-0431-7
96. Feng Y, Ye D, Wang Z, Pan H, Lu X, Wang M, Xu Y, Yu J, Zhang J, Zhao M, Xu S, Pan W, Yin Z, Ye J, Wan J. The Role of Interleukin-6 Family Members in Cardiovascular Diseases. Front Cardiovasc Med. 2022;9:818890. doi: 10.3389/fcvm.2022.818890
97. Ridker PM, Rane M. Interleukin-6 Signaling and AntiInterleukin-6 Therapeutics in Cardiovascular Disease. Circ Res. 2021;128(11):1728–1746. doi: 10.1161/CIRCRESAHA.121.319077
98. Huse C, Anstensrud AK, Michelsen AE, Ueland T, Broch K, et al. Interleukin-6 inhibition in ST-elevation myocardial infarction: Immune cell profile in the randomised ASSAIL-MI trial. EBioMedicine. 2022;80:104013. doi: 10.1016/j.ebiom.2022.104013
99. Ridker PM, Devalaraja M, Baeres FMM, Engelmann MDM, Hovingh GK, et al.; RESCUE Investigators. IL-6 inhibition with ziltivekimab in patients at high atherosclerotic risk (RESCUE): a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. 2021;397(10289):2060–2069. doi: 10.1016/S0140- 6736(21)00520-1
100. Paul SK, Montvida O, Best JH, Gale S, Pethoe-Schramm A, Sarsour K. Effectiveness of biologic and non-biologic antirheumatic drugs on anaemia markers in 153,788 patients with rheumatoid arthritis: New evidence from real-world data. Semin Arthritis Rheum. 2018;47(4):478–484. doi: 10.1016/j.semarthrit.2017.08.001
101. Moots RJ, Sebba A, Rigby W, Ostor A, Porter-Brown B, et al. Effect of tocilizumab on neutrophils in adult patients with rheumatoid arthritis: pooled analysis of data from phase 3 and 4 clinical trials. Rheumatology (Oxford). 2017;56(4):541–549. doi: 10.1093/rheumatology/kew370
102. Chen SK, Lee H, Jin Y, Liu J, Kim SC. Use of biologic or targeted-synthetic disease-modifying anti-rheumatic drugs and risk of diabetes treatment intensification in patients with rheumatoid arthritis and diabetes mellitus. Rheumatol Adv Pract. 2020;4(2):rkaa027. doi: 10.1093/rap/rkaa027
103. Genovese MC, Burmester GR, Hagino O, Thangavelu K, Iglesias-Rodriguez M, et al. Interleukin-6 receptor blockade or TNFα inhibition for reducing glycaemia in patients with RA and diabetes: post hoc analyses of three randomised, controlled trials. Arthritis Res Ther. 2020;22(1):206. doi: 10.1186/s13075- 020-02229-5
104. Otsuka Y, Kiyohara C, Kashiwado Y, Sawabe T, Nagano S, et al.. Effects of tumor necrosis factor inhibitors and tocilizumab on the glycosylated hemoglobin levels in patients with rheumatoid arthritis; an observational study. PLoS One. 2018;13(4):e0196368. doi: 10.1371/journal.pone.0196368
105. Mori S, Yoshitama T, Hidaka T, Hirakata N, Ueki Y. Effectiveness and safety of tocilizumab therapy for patients with rheumatoid arthritis and renal insufficiency: a real-life registry study in Japan (the ACTRA-RI study). Ann Rheum Dis. 2015;74(3):627–630. doi: 10.1136/annrheumdis-2014-206695
106. Okuda Y. AA amyloidosis – Benefits and prospects of IL-6 inhibitors. Mod Rheumatol. 2019;29(2):268–274. doi: 10.1080/14397595.2018.1515145
107. Jung JY, Kim YB, Kim JW, Suh CH, Kim HA. Biologic therapy for amyloid A amyloidosis secondary to rheumatoid arthritis treated with interleukin 6 therapy: Case report and review of literature. Medicine (Baltimore). 2021;100(32):e26843. doi: 10.1097/ MD.0000000000026843
108. Curtis JR, Sarsour K, Napalkov P, Costa LA, Schulman KL. Incidence and complications of interstitial lung disease in users of tocilizumab, rituximab, abatacept and anti-tumor necrosis factor α agents, a retrospective cohort study. Arthritis Res Ther. 2015;17:319. doi: 10.1186/s13075-015-0835-7
109. Strangfeld A, Meissner Y, Schäfer BL. No confirmation of increased risk of idiopathic facial nerve palsy under tocilizumab. Arthritis Rheumatol. 2019;71:2306–2308.
110. Khanna D, Lin CJF, Furst DE, Goldin J, Kim G, et al.; focuSSced investigators. Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2020;8(10):963–974. doi: 10.1016/S2213-2600(20)30318-0
111. Roofeh D, Lin CJF, Goldin J, Kim GH, Furst DE, et al.; focuSSced Investigators. Tocilizumab Prevents Progression of Early Systemic Sclerosis-Associated Interstitial Lung Disease. Arthritis Rheumatol. 2021;73(7):1301–1310. doi: 10.1002/art.41668
112. Zhang C, Zhang M, Qiu W, Ma H, Zhang X, et al.; TANGO Study Investigators. Safety and efficacy of tocilizumab versus azathioprine in highly relapsing neuromyelitis optica spectrum disorder (TANGO): an open-label, multicentre, randomised, phase 2 trial. Lancet Neurol. 2020;19(5):391-401. doi: 10.1016/S1474-4422(20)30070-3
113. Shin A, Park EH, Dong YH, Ha YJ, Lee YJ, et al. Comparative risk of osteoporotic fracture among patients with rheumatoid arthritis receiving TNF inhibitors versus other biologics: a cohort study. Osteoporos Int. 2020;31(11):2131–2139. doi: 10.1007/s00198- 020-05488-9
114. Kume K, Amano K, Yamada S, Kanazawa T, Ohta H, et al. The effect of tocilizumab on bone mineral density in patients with methotrexate-resistant active rheumatoid arthritis. Rheumatology (Oxford). 2014;53(5):900–903. doi: 10.1093/rheumatology/ket468
115. Chen YM, Chen HH, Huang WN, Liao TL, Chen JP, et al. Tocilizumab potentially prevents bone loss in patients with anticitrullinated protein antibody-positive rheumatoid arthritis. PLoS One. 2017;12(11):e0188454. doi: 10.1371/journal. pone.0188454
116. Yun H, Xie F, Beyl RN, Chen L, Lewis JD, et al. Risk of Hypersensitivity to Biologic Agents Among Medicare Patients With Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2017;69(10):1526–1534. doi: 10.1002/acr.23141
117. Burmester GR, Choy E, Kivitz A, Ogata A, Bao M, et al.. Low immunogenicity of tocilizumab in patients with rheumatoid arthritis. Ann Rheum Dis. 2017;76(6):1078–1085. doi: 10.1136/ annrheumdis-2016-210297
118. Nasonov E, Samsonov M. The role of Interleukin 6 inhibitors in therapy of severe COVID-19. Biomed Pharmacother. 2020;131:110698. doi: 10.1016/j.biopha.2020.110698
119. McElvaney OJ, Curley GF, Rose-John S, McElvaney NG. Interleukin-6: obstacles to targeting a complex cytokine in critical illness. Lancet Respir Med. 2021;9(6):643–654. doi: 10.1016/ S2213-2600(21)00103-X
120. van de Veerdonk FL, Giamarellos-Bourboulis E, Pickkers P, Derde L, Leavis H, et al. A guide to immunotherapy for COVID-19. Nat Med. 2022;28(1):39–50. doi: 10.1038/ s41591-021-01643-9
121. Antonov VN, Ignatova GL, Pribytkova OV, Sleptsova SS, Strebkova EA, et al. [Experience of olokizumab use in COVID-19 patients]. Ter Arkh. 2020;92(12):148–154. Russian. doi: 10.26442/00403660.2 020.12.200522
122. Бобкова СС, Жуков ФФ, Проценко ДН, Самойленко ВВ, Тюрин ИН. Сравнительная эффективность и безопасность применения препаратов моноклональных антитед к ИЛ-6 у пациентов с новой коронавирусной инфекцией тяжелого течения. Ретроспективное когортное исследование. Вестник интенсивной терапии им. А.И. Салтанова. 2021;1:69–76. doi:10.21320/1818-474X-2021-1-69-76
123. Kang S, Narazaki M, Metwally H, Kishimoto T. Historical overview of the interleukin-6 family cytokine. J Exp Med. 2020;217(5):e20190347. doi: 10.1084/jem.20190347.
124. Гордеев АВ, Галушко ЕА, Насонов ЕЛ. Концепция мультиморбидности в ревматологической практике. Научнопрактическая ревматология. 2014;52(4):362-365.
125. Taylor PC, Atzeni F, Balsa A, Gossec L, Müller-Ladner U, Pope J. The Key Comorbidities in Patients with Rheumatoid Arthritis: A Narrative Review. J Clin Med. 2021;10(3):509. doi: 10.3390/ jcm10030509
126. Hill J, Harrison J, Christian D, Reed J, Clegg A, Duffield SJ, Goodson N, Marson T. The prevalence of comorbidity in rheumatoid arthritis: a systematic review and meta-analysis. Br J Community Nurs. 2022;27(5):232–241. doi: 10.12968/bjcn.2022.27.5.232
127. Ting EY, Yang AC, Tsai SJ. Role of Interleukin-6 in Depressive Disorder. Int J Mol Sci. 2020 Mar 22;21(6):2194. doi: 10.3390/ ijms21062194
128. Лисицына ТА, Вельтищев ДЮ, Лила АМ, Насонов ЕЛ. Интерлейкин-6 как патогенетический фактор, опосредующий формирование клинических проявлений, и мишень для терапии ревматических заболеваний и депрессивных расстройств. Научно-практическая ревматология. 2019;57(3):318–327.
129. Roohi E, Jaafari N, Hashemian F. On inflammatory hypothesis of depression: what is the role of IL-6 in the middle of the chaos? J Neuroinflammation. 2021;18(1):45. doi: 10.1186/s12974-021- 02100-7
130. Sebba A. Pain: A Review of Interleukin-6 and Its Roles in the Pain of Rheumatoid Arthritis. Open Access Rheumatol. 2021;13:31–43. doi: 10.2147/OARRR.S291388
131. Antonio AA, Santos RN, Abariga SA. Tocilizumab for giant cell arteritis. Cochrane Database Syst Rev. 2021;8(8):CD013484. doi: 10.1002/14651858.CD013484.pub2. Update in: Cochrane Database Syst Rev. 2022;5:CD013484.
132. Conway R, Putman MS, Mackie SL. Benchmarking tocilizumab use for giant cell arteritis. Rheumatol Adv Pract. 2022;6(2):rkac037. doi: 10.1093/rap/rkac037
133. Бекетова ТВ, Ушакова МА, Никишина НЮ, ХелковскаяСергеева АН, Николаева ЕВ, и соавт. Опыт применения ингибитора интерлейкина-6 тоцилизумаба для лечения гигантоклеточного артериита с тяжелой коморбидной патологией. Научно-практическая ревматология. 2018;56(2):228– 234.
134. Li H, Shuai Z. Efficacy of tocilizumab for refractory Takayasu arteritis: a retrospective study and literature review. Heart Vessels. 2022;37(5):884–894. doi: 10.1007/s00380-021-01981-1
135. Akioka S. Interleukin-6 in juvenile idiopathic arthritis. Mod Rheumatol. 2019;29(2):275–286. doi: 10.1080/14397595.2019. 1574697
136. Castañeda S, Martínez-Quintanilla D, Martín-Varillas JL, García-Castañeda N, Atienza-Mateo B, et al. Tocilizumab for the treatment of adult-onset Still’s disease. Expert Opin Biol Ther. 2019;19(4):273–286. doi: 10.1080/14712598.2019.1590334
137. Koga T, Kawakami A. Interleukin-6 inhibition in the treatment of autoinflammatory diseases. Front Immunol. 2022;13:956795. doi: 10.3389/fimmu.2022.956795
138. Si S, Teachey DT. Spotlight on Tocilizumab in the Treatment of CAR-T-Cell-Induced Cytokine Release Syndrome: Clinical Evidence to Date. Ther Clin Risk Manag. 2020;16:705–714. doi: 10.2147/TCRM.S223468
139. Zhang J, Luo W, Miao C, Zhong J. Hypercatabolism and Anticatabolic Therapies in the Persistent Inflammation, Immunosuppression, and Catabolism Syndrome. Front Nutr. 2022; 9:941097. doi: 10.3389/fnut.2022.941097
Рецензия
Для цитирования:
Насонов Е.Л., Файст Е. Перспективы ингибиции интерлейкина-6 при ревматоидном артрите: олокизумаб (новые моноклональные антитела к ИЛ-6). Научно-практическая ревматология. 2022;60(5):505-518. https://doi.org/10.47360/1995-4484-2022-505-518
For citation:
Nasonov E.L., Feist E. The prospects of interleukin-6 inhibition in rheumatoid arthritis: Olokizumab (novel monoclonal antibodies to IL-6). Rheumatology Science and Practice. 2022;60(5):505-518. (In Russ.) https://doi.org/10.47360/1995-4484-2022-505-518
Просмотров:
1108
Послать статью по эл. почте 