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Научно-практическая ревматология

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Эффективность и безопасность тофацитиниба при иммуновоспалительных ревматических заболеваниях (часть I)

https://doi.org/10.14412/1995-4484-2020-62-79

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Аннотация

Расшифровка механизмов патогенеза иммуновоспалительных ревматических заболеваний (ИВРЗ) в сочетании с разработкой широкого спектра генно-инженерных биологических препаратов (ГИБП) относятся к числу крупных достижений медицины XXI в. Новое перспективное направление фармакотерапии ИВРЗ связано с созданием так называемых «таргетных» пероральных лекарственных препаратов, к которым в первую очередь относятся ингибиторы Янус-киназ (JanuskinaseJAK), получившие название Якинибы (Jakinibs). Первым представителем класса ингибиторов JAK является тофацитиниб (ТОФА), который зарегистрирован для лечения ревматоидного артрита (РА), псориатического артрита и язвенного колита. В обзоре (часть I) представлены новые данные, касающиеся эффективности и безопасности ТОФА при РА, обсуждается место ТОФА в лечении РА в рамках стратегии «Лечение до достижения цели» и новых рекомендаций EULAR. В части II обзора будут представлены данные, касающиеся применения ТОФА при других ИВРЗ.

Об авторах

Е. Л. Насонов
ФГБНУ Научно-исследовательский институт ревматологии им. В.А. Насоновой; ФГБОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет)
Россия

Евгений Львович Насонов - научный руководитель ФГБНУ«НИИР им. В.А. Насоновой», академик РАН, профессор, доктор медицинских наук.

115522, Москва, Каширское шоссе, 34А; 119991, Москва, ул. Трубецкая, 8, стр. 2



А. С. Авдеева
ФГБНУ Научно-исследовательский институт ревматологии им. В.А. Насоновой
Россия

Научный сотрудник лаборатории стандартизации терапии ревматических заболеваний ФГБНУ «НИИР им. В.А. Насоновой», кандидат медицинских наук.

115522, Москва, Каширское шоссе, 34А



А. М. Лила
ФГБНУ Научно-исследовательский институт ревматологии им. В.А. Насоновой; ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России
Россия

Директор ФГБНУ «НИИР им. В.А. Насоновой», профессор, доктор медицинских наук.

115522, Москва, Каширское шоссе, 34А; 125993, Москва, ул. Баррикадная, 2/1, стр.1



Список литературы

1. Baker KF, Isaacs JD. Novel therapies for immune-mediated inflammatory diseases: What can we learn from their use in rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, psoriasis, Crohn's disease and ulcerative colitis? Ann Rheum Dis. 2018;77(2):175-87. doi: 10.1136/annrheumdis-2017-211555

2. Насонов ЕЛ. Фармакотерапия ревматоидного артрита: новая стратегия, новые мишени. Научно-практическая ревматология. 2017;55(4):409-19 doi: 10.14412/1995-4484-2017-409-419

3. Schwartz DM, Kanno Y, Villarino A, et al. JAK inhibition as a therapeutic strategy for immune and inflammatory diseases. Nat Rev DrugDiscov. 2017;16(12):843-62. doi: 10.1038/nrd.2017.201

4. Насонов ЕЛ, Лила АМ. Ингибиторы Янус-киназ при иммуновоспалительных ревматических заболеваниях: новые возможности и перспективы. Научно-практическая ревматология. 2019;57(1):8-16 doi: 10.14412/1995-4484-2019-8-16

5. Насонов ЕЛ. Новые подходы к фармакотерапии ревматоидного артрита: тофацитиниб. Научно-практическая ревматология. 2014;52(2):209-21 doi: 10.14412/1995-4484-2014-209-221

6. Dhillon S. Tofacitinib: A Review in Rheumatoid Arthritis. Drugs. 2017 Dec;77(18):1987-2001. doi: 10.1007/s40265-017-0835-9

7. Berekmeri A, Mahmood F, Wittmann M, Helliwell P. Tofacitinib for the treatment of psoriasis and psoriatic arthritis. Expert Rev Clin Immunol. 2018;14(9):719-30. doi: 10.1080/1744666X.2018

8. Ly K, Beck KM, Smith MP, et al. Tofacitinib in the management of active psoriatic arthritis: patient selection and perspectives. Psoriasis (Auckl). 2019;9:97-107. doi: 10.2147/PTT.S161453

9. D'Amico F, Parigi TL, Fiorino G, et al. Tofacitinib in the treatment of ulcerative colitis: efficacy and safety from clinical trials to real-world experience. Ther Adv Gastroenterol. 2019 May 16;12:1756284819848631. doi: 10.1177/1756284819848631

10. Насонов ЕЛ, Абдулганиева ДИ, Файрушина ИФ. Место то-фацитиниба в лечении воспалительных заболеваний кишечника. Терапевтический архив. 2019;91(2):101-8 doi: 10.26442/004036602019;2

11. Howell MD, Kuo FI, Smith PA. Targeting the Janus Kinase Family in Autoimmune Skin Diseases. Front Immunol. 2019 Oct 9;10:2342. doi: 10.3389/fimmu.2019.02342

12. Jamilloux Y, El Jammal T, Vuitton L, et al. JAK inhibitors for the treatment of autoimmune and inflammatory diseases. Autoimmun Rev. 2019 Sep 11:102390. doi: 10.1016/j.autrev.2019.10

13. Virtanen A, Haikarainen T, Raivola J, Silvennoinen O. Selective JAKinibs: Prospects in Inflammatory and Autoimmune Diseases. BioDrugs. 2019;33(1):15-32. doi: 10.1007/s40259-019-00333

14. El Jammal T, Gerfaud-Valentin M, Seve P, Jamilloux Y. Inhibition of JAK/STAT signaling in rheumatologic disorders: The expanding spectrum. Joint Bone Spine. 2019 Sep 12. doi: 10.1016/j.jbspin.2019.09.005

15. Smolen JS, van der Heijde D, Machold KP, et al. Proposal for a new nomenclature of disease-modifying antirheumatic drugs. Ann Rheum Dis. 2014;73(1):3-5. doi: 10.1136/annrheumdis-2013-204317

16. Smolen JS, Landewe R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017;76(6):960-77. doi: 10.1136/annrheumdis-2016-210715

17. Singh JA, Saag KG, Bridges SL, et al. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheum. 2016;68(1):1-26. doi: 10.1002/art.39480

18. Daien C, Hua C, Gaujoux-Viala C, et al. Update of French society for rheumatology recommendations for managing rheumatoid arthritis. Joint Bone Spine. 2019 Mar;86(2):135-50. doi: 10.1016/j.jbspin.2018.10.002

19. Lau CS, Chia F, Harrison A, et al. Asia Pacific League of Associations for Rheumatology APLAR rheumatoid arthritis treatment recommendations. Int J Rheum Dis. 2015;18:685-713. doi: 10.1111/1756-185X.12754

20. Cardiel MH, Diaz-Borjon A, Vazquez del Mercado Espinosa M, et al. Mexican College of Rheumatology Update of the Mexican College of Rheumatology guidelines for the pharmacologic treatment of rheumatoid arthritis. Reumatol Clin. 2014;10:227-40. doi: 10.1016/j.reuma.2013.10.006

21. Mota LMHD, Kakehasi AM, Gomides APM, et al. 2017 recommendations of the Brazilian Society of Rheumatology for the pharmacological treatment of rheumatoid arthritis. Adv Rheumatol. 2018 May 24;58(1):2. doi: 10.1186/s42358-018-0005-0

22. Ataman S, Sunar I, Yilmaz G, et al. Turkish League Against Rheumatism (TLAR) Recommendations for the Pharmacological Management of Rheumatoid Arthritis: 2018 Update Under Guidance of Current Recommendations. Arch Rheumatol. 2018 Jul 9;33(3):251-71. doi: 10.5606/ArchRheumatol.2018.6911

23. Ho CTK, Mok CC, Cheung TT, et al. Hong Kong Society of Rheumatology. Management of rheumatoid arthritis: 2019 updated consensus recommendations from the Hong Kong Society of Rheumatology. Clin Rheumatol. 2019 Sep 4. doi: 10.1007/s10067-019-04761-5

24. Alhajeri H, Abutiban F, Al-Adsani W, et al. Kuwait association of rheumatology 2018 treatment recommendations for patients with rheumatoid arthritis. Rheumatol Int. 2019 Sep;39(9):1483-97. doi: 10.1007/s00296-019-04372-y

25. Cardiel MH, Carrillo S, Perez M, et al. Update of the Mexican College of Rheumatology Guidelines for the Pharmacological Treatment of Rheumatoid Arthritis, 2018. Reumatol Clin. 2019 May 15. doi: 10.1016/j.reuma.2019.04.002

26. Насонов ЕЛ, редактор. Ревматология. Российские клинические рекомендации. Москва: ГЭОТАР-Медиа; 2017. 456 с.

27. Singh JA, Guyatt G, Ogdie A, et al. Special Article: 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2019;71(1):2-29. doi: 10.1002/acr.23789

28. Villarino AV, Kanno Y, O'Shea JJ. Mechanisms and consequences of Jak-STAT signaling in the immune system. Nat Immunol. 2017;18(4):374-84. doi: 10.1038/ni.3691

29. McInnes IB, Byers NL, Higgs RE, et al. Comparison of barici-tinib, upadacitinib, and tofacitinib mediated regulation of cytokine signaling in human leukocyte subpopulations. Arthritis Res Ther. 2019;21(1):183. doi: 10.1186/s13075-019-1964-1

30. Choy EH. Clinical significance of Janus Kinase inhibitor selectivity. Rheumatology (Oxford). 2019;58(6):953-62. doi: 10.1093/rheumatology/key339. Erratum in: Rheumatology (Oxford). 2019 Jun 1;58(6):1122.

31. Dowty ME, Lin TH, Jesson MI, et al. Janus kinase inhibitors for the treatment of rheumatoid arthritis demonstrate similar profiles of in vitro cytokine receptor inhibition. Pharmacol Res Perspect. 2019;7(6):e00537. doi: 10.1002/prp2.537

32. Cohen S, Zwillich SH, Chow L, et al. Co-administration of JAK inhibitor CP-690,550 and methotrexate is well tolerated in patients with rheumatoid arthritis without need for dose adjustment. Br J Clin Pharmacol. 2010;69:143-51. doi: 10.1m/j.1365-2125.2009.03570.x

33. Smolen JS, Aletaha D, Barton A, et al. Rheumatoid arthritis. Nat Rev Dis Primers. 2018;4:18001. doi: 10.1038/nrdp.2018

34. Ghoreshi K, Jesson M, Li X, et al. Modulation of innate and adaptive immunity responses by tofacitinib. J Immunol. 2011;186:4234-43. doi: 10.4049/jimmunol.1003668

35. Hodge JA, Kawabata TT, Krishnaswami S, et al. The mechanism of action of tofacitinib — an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. Clin Exp Rheumatol. 2016;34(2):318-28.

36. Schwartz DM, Bonelli M, Gadina M, O'Shea JJ. Type I/II cytokines, JAKs, and new strategies for treating autoimmune diseases. Nat Rev Rheumatol. 2016;12(1):25-36. doi: 10.1038/nrrheum.2015.167

37. Fleischmann R, Cutolo M, Genovese MC, et al. Phase Ilb doseranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs. Arthritis Rheum. 2012;64(3):617-29. doi: 10.1002/art.33383

38. Kremer JM, Bloom BJ, Breedveld FC, et al. The safety and efficacy of a JAK inhibitor in patients with active rheumatoid arthritis: results of a double-blind, placebo-controlled phase IIa trial of three dosage levels of CP-690,550 versus placebo. Arthritis Rheum. 2009;60(7):1895-905. doi: 10.1002/art.24567

39. Kremer JM, Cohen S, Wilkinson BE, et al. A phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) versus placebo in combination with background MTX in patients with active rheumatoid arthritis and an inadequate response to MTX alone. Arthritis Rheum. 2012;64(4):970-81. doi: 10.1002/art.33419

40. Tanaka Y, Suzuki M, Nakamura H, et al. Tofacitinib Study Investigators. Phase II study of tofacitinib (CP-690,550) combined with MTX in patients with rheumatoid arthritis and an inadequate response to MTX. Arthritis Care Res (Hoboken). 2011;63:1150-8. doi: 10.1002/acr.20494

41. Tanaka Y, Takeuchi T, Yamanaka H, et al. Efficacy and safety of tofacitinib as monotherapy in Japanese patients with active rheumatoid arthritis: a 12-week, randomized, Phase 2 study. Mod Rheumatol. 2015;25:514-21. doi: 10.3109/14397595.2014.995875

42. Van der Heijde D, Tanaka Y, Fleischmann R, et al. Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving MTX twelve-month data from a twenty-four-month phase III randomized radiographic study. Arthritis Rheum. 2013;65(3):559-70. doi: 10.1002/art.37816

43. Van der Heijde D, Strand V, Tanaka Y, et al. ORAL Scan Investigators. Tofacitinib in Combination "With Methotrexate in Patients With Rheumatoid Arthritis: Clinical Efficacy, Radiographic, and Safety Outcomes From a Twenty-Four-Month, Phase III Study. Arthritis Rheum. 2019;71(6):878-91. doi: 10.1002/art.40803

44. Van Vollenhoven R, Fleischmann R, Cohen S, et al. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med. 2012;367:508-19. doi: 10.1056/NEJMoa1112072

45. Burmester GR, Blanco R, Charles-Schoeman CH, Wollenhaupt J. Tofacitinib (CP-690,550) in combination with MTX in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase III trial. Lancet. 2013;381:451-60. doi: 10.1016/S0140-6736(12)61424-X

46. Fleischmann R, Kremer J, Cush J, et al. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med. 2012;367(6):495-507. doi: 10.1056/NEJMoa1109071

47. Fleischmann R, Mysler E, Hall S, et al; ORAL Strategy Investigators. Efficacy and safety of tofacitinib monotherapy, tofacitinib with MTX, and adalimumab with MTX in patients with rheumatoid arthritis (ORAL Strategy): a phase IIIb/IV, double-blind, head-to-head, randomised controlled trial. Lancet. 2017;390(10093):457-68. doi: 10.1016/S0140-6736(17)31618-5

48. Kremer J, Li ZG, Hall S, et al. Tofacitinib in combination with nonbiologic disease-modifying antirheumatic drugs in patients with active rheumatoid arthritis: a randomized trial. Ann Intern Med. 2013;159(4):253-61. doi: 10.7326/0003-4819-159-4-201308200-00006

49. Lee EB, Fleischmann R, Hall S, et al. Tofacitinib versus MTX in rheumatoid arthritis. N Engl J Med. 2014;370:2377-86. doi: 10.1056/NEJMoa1310476

50. Genovese MC, van Vollenhoven RF, Wilkinson B, et al. Switching from adalimumab to tofacitinib in the treatment of patients with rheumatoid arthritis. Arthritis Res Ther. 2016;18:145. doi: 10.1186/s13075-016-1049-3

51. Gossec L, Dougados M, Dixon W. Patient-reported outcomes as endpoints in clinical trials in rheumatoid arthritis. RMD Open. 2015;1(1):e000019. doi: 10.1136/rmdopen-2014-000019

52. Fautrel B, Alten R, Kirkham B, et al. Call for action: how to improve use of patient-reported outcomes to guide clinical decision making in rheumatoid arthritis. Rheumatol Int. 2018;38(6):935-47. doi: 10.1007/s00296-018-4005-5

53. Strand V, Khanna D. The impact of rheumatoid arthritis and treatment on patients' lives. Clin Exp Rheumatol. 2010;28:S32-40.

54. Rendas-Baum R, Bayliss M, Kosinski M, et al. Measuring the effect of therapy in rheumatoid arthritis clinical trials from the patient's perspective. Curr Med Res Opin. 2014;30:1391-403. doi: 10.1185/03007995.2014.896328

55. Matcham F, Scott IC, Rayner L, et al. The impact of rheumatoid arthritis on quality-of-life assessed using the SF-36: a systematic review and meta-analysis. Semin Arthritis Rheum. 2014;44:123-30. doi: 10.1016/j.semarthrit.2014.05.001

56. Strand V, van Vollenhoven RF, Lee EB, et al. Tofacitinib or adali-mumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis. Rheumatology (Oxford). 2016;55:1031-41. doi: 10.1093/rheumatology/kev442

57. Strand V, Kremer JM, Gruben D, et al. Tofacitinib in combination with conventional disease-modifying antirheumatic drugs in patients with active rheumatoid arthritis: patient-reported outcomes from a phase III randomized controlled trial. Arthritis Care Res (Hoboken). 2017;69:592-8. doi: 10.1002/acr.23004

58. Strand V, Burmester GR, Zerbini CA, et al. Tofacitinib with methotrexate in third-line treatment of patients with active rheumatoid arthritis: patient-reported outcomes from a phase III trial. Arthritis Care Res (Hoboken). 2015;67:475-83. doi: 10.1002/acr.22453

59. Strand V, Lee EB, Fleischmann R, et al. Tofacitinib versus methotrexate in rheumatoid arthritis: patient-reported outcomes from the randomised phase III ORAL Start trial. RMD Open. 2016;2:e000308. doi: 10.1136/rmdopen-2016-000308

60. Strand V, Kremer J, Wallenstein G, et al. Effects of tofacitinib monotherapy on patient-reported outcomes in a randomized phase 3 study of patients with active rheumatoid arthritis and inadequate responses to DMARDs. Arthritis Res Ther. 2015;17:307. doi: 10.1186/s13075-015-0825-9

61. Strand V, Mysler E, Moots RJ, et al. Patient-reported outcomes for tofacitinib with and without methotrexate, or adalimumab with methotrexate, in rheumatoid arthritis: a phase IIIB/IV trial. RMD Open. 2019;5(2):e001040. doi: 10.1136/rmdopen-2019-001040

62. Strand V, Kavanaugh A, Kivitz AJ, et al. Long-Term Radiographic and Patient-Reported Outcomes in Patients with Rheumatoid Arthritis Treated with Tofacitinib: ORAL Start and ORAL Scan Post-hoc Analyses. Rheumatol Ther. 2018;5(2):341-53. doi: 10.1007/s40744-018-0113-7

63. Choy EH. Effect of biologics and targeted synthetic disease-modifying anti-rheumatic drugs on fatigue in rheumatoid arthritis. Rheumatology (Oxford). 2019 Nov 1;58 Suppl 5:v51-v55. doi: 10.1093/rheumatology/kez389

64. Citera G, Jain R, Irazoque F, et al. Tofacitinib in Patients with Rheumatoid Arthritis and Indicative of Depression And/or Anxiety: A Post Hoc Analysis of Phase 3 and Phase 3b/4 Clinical Trials [abstract]. Arthritis Rheum. 2019; 71 Suppl 10. Available from: https://acrabstracts.org/abstract/tofacitinib-in-patients-with-rheumatoid-arthritis-and-indicative-of-depression-and-or-anxiety-a-post-hoc-analysis-of-phase-3-and-phase-3b-4-clinical-trials/

65. Wollenhaupt J, Silverfield J, Lee EB, et al. Safety and efficacy of tofacitinib, an oral janus kinase inhibitor, for the treatment of rheumatoid arthritis in open label, long term extension studies. J Rheumatol. 2014;41:837-52. doi: 10.3899/jrheum.130683

66. Yamanaka H, Tanaka Y, Takeuchi T, et al. Tofacitinib, an oral Janus kinase inhibitor, as monotherapy or with background MTX, in Japanese patients with rheumatoid arthritis: an open-label, long-term extension study. Arthritis Res Ther. 2016;18:34. doi: 10.1186/s13075-016-0932-2

67. Cohen SB, Tanaka Y, Mariette X, et al. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017;76:1253-62. doi: 10.1136/annrheumdis-2016-210457

68. Wollenhaupt J, Lee EB, Curtis JR, et al. Safety and efficacy of tofacitinib for up to 9.5 years in the treatment of rheumatoid arthritis: final results of a global, open-label, long-term extension study. Arthritis Res Ther. 2019;21(1):89. doi: 10.1186/s13075-019-1866-2

69. Pope JE, Keystone E, Jamal S, et al. Persistence of tofacitinib in the treatment of rheumatoid arthritis in open-label, long-term extension studies up to 9.5 years. ACR Open. 2019;1:73-82. doi: 10.1002/acr2/1010

70. Fleischmann R, Wollenhaupt J, Cohen S, et al. Effect of Discontinuation or Initiation of Methotrexate or Glucocorticoids on Tofacitinib Efficacy in Patients with Rheumatoid Arthritis: A Post Hoc Analysis. Rheumatol Ther. 2018;5(1):203-14. doi: 10.1007/s40744-018-0093-7

71. Charles-Schoeman C, van der Heijde D, Burmester GR, et al. Effect of Glucocorticoids on the Clinical and Radiographic Efficacy of Tofacitinib in Patients with Rheumatoid Arthritis: A Posthoc Analysis of Data from 6 Phase III Studies. J Rheumatol. 2018;45(2):177-87. doi: 10.3899/jrheum.170486

72. Fleischmann R, Mease PJ, Schwartzman S, et al. Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by background methotrexate dose group. Clin Rheumatol. 2017;36(1):15-24. doi: 10.1007/s10067-016-3436-1

73. Emery P, Pope JE, Kruger K, et al Efficacy of Monotherapy with Biologics and JAK Inhibitors for the Treatment of Rheumatoid Arthritis: A Systematic Review. Adv Ther. 2018;35(10):1535-63. doi: 10.1007/s12325-018-0757-2

74. Doria A, Zavaglia D. Monotherapy is a relevant option in rheumatoid arthritis treatment: a literature review. Clin Exp Rheumatol. 2019;37(5):862-71.

75. Luis M, Freitas J, Costa F, et al. An updated review of glucocorticoid-related adverse events in patients with rheumatoid arthritis. Expert Opin Drug Saf. 2019;18(7):581-90. doi: 10.1080/14740338.2019.1615052

76. Petta I, Peene I, Elewaut D, et al. Risks and benefits of corticosteroids in arthritic diseases in the clinic. Biochem Pharmacol. 2019;165:112-25. doi: 10.1016/j.bcp.2019.04.009

77. Cohen SB, Pope J, Haraoui B, et al. Methotrexate withdrawal in patients with rheumatoid arthritis who achieve low disease activity with tofacitinib modified-release 11 mg once daily plus methotrexate (ORAL Shift): a randomized, phase 3b/4, non-inferiority trial. Lancet. 2019 Aug 06. doi: 10.1016/S2665-9913(19)30005-0

78. Cohen S, Pope J, Haraoui B, et al. Efficacy and Safety of Tofacitinib Modified-Release 11 Mg Once Daily + MTX in RA Patients with an Inadequate Response to MTX: Open-Label Phase Results from a Global Phase 3b/4 MTX Withdrawal Study [abstract]. Arthritis Rheum. 2019;71 Suppl 10.

79. Strand V, Pope J, Woolcott J, et al. MTX Withdrawal in Patients with RA Who Achieve Low Disease Activity with Tofacitinib Modified-Release 11 Mg Once Daily + MTX: An Assessment of the Impact on the Short Form-36 Patient-Reported Outcome [abstract]. Arthritis Rheum. 2019; 71 Suppl 10. Available from: https://acrabstracts.org/abstract/mtx-withdrawal-in-patients-with-ra-who-achieve-low-disease-activity-with-tofacitinib-modi-fied-release-11-mg-once-daily-mtx-an-assessment-of-the-impact-on-the-short-form-36-patient-reported-outcome/

80. Lamba M, Wang R, Fletcher T, et al. Extended-release once-daily formulation of tofacitinib: evaluation of pharmacokinetics compared with immediate-release tofacitinib and impact of food. J Clin Pharmacol. 2016;56:1362-71. doi: 10.1002/jcph.734

81. Lamba M, Hutmacher MM, Furst DE, et al. Model-informed development and registration of a once-daily regimen of extended-release tofacitinib. Clin Pharmacol Ther. 2017;101:745-53. doi: 10.1002/cpt.576

82. Tanaka Y, Sugiyama N, Toyoizumi S, et al. Modified- versus immediate-release tofacitinib in Japanese rheumatoid arthritis patients: a randomized, phase III, non-inferiority study. Rheumatology (Oxford). 2019;58(1):70-9. doi: 10.1093/rheumatol-ogy/key250

83. Van Vollenhoven RF, Lee EB, Fallon L, et al. Tofacitinib in Rheumatoid Arthritis: Lack of Early Change in Disease Activity and the Probability of Achieving Low Disease Activity at Month 6. Arthritis Care Res (Hoboken). 2019;71(1):71-9. doi: 10.1002/acr.23585

84. Aletaha D, Alasti F, Smolen JS. Optimisation of a treat-to-target approach in rheumatoid arthritis: strategies for the 3-month time point. Ann Rheum Dis. 2016;75:1479-85. doi: 10.1136/annrheumdis-2015-208324

85. Aletaha D, Funovits J, Keystone EC, et al. Disease activity early in the course of treatment predicts response to therapy after one year in rheumatoid arthritis patients. Arthritis Rheum. 2007;56:3226-35. doi: 10.1002/art.22943

86. Van der Heijde D, Keystone EC, Curtis JR, et al. Timing and magnitude of initial change in disease activity score 28 predicts the likelihood of achieving low disease activity at 1 year in rheumatoid arthritis patients treated with certolizumab pegol: a post-hoc analysis of the RAPID 1 trial. J Rheumatol. 2012;39:1326-33. doi: 10.3899/jrheum.111171

87. Kawashiri SY, Nishino A, Suzuki T, et al. Rapid improvement of clinical disease activity index (CDAI) at 3 months predicts a preferable CDAI outcome at 1 year in active rheumatoid arthritis patients treated with tocilizumab: results from an observational investigation of daily clinical practice. Clin Exp Rheumatol. 2016;34:808-12.

88. Norvang V, Sexton J, Kristianslund EK, et al. Predicting achievement of the treatment targets at 6 months from 3-month response levels in rheumatoid arthritis: data from real-life follow-up in the NOR-DMARD study. RMD Open. 2018;4(2):e000773. doi: 10.1136/rmdopen-2018-0007

89. Conaghan PG, Оstergaard M, Troum O, et al. Very early MRI responses to therapy as a predictor of later radiographic progression in early rheumatoid arthritis. Arthritis Res Ther. 2019;21(1):214. doi: 10.1186/s13075-019-2000-1

90. Smolen JS, Breedveld FC, Burmester GR, et al. Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task force. Ann Rheum Dis. 2016 Jan;75(1):3-15. doi: 10.1136/annrheumdis-2015-207524

91. Van Vollenhoven R. Treat-to-target in rheumatoid arthritis — are we there yet? Nat Rev Rheumatol. 2019;15(3):180-6. doi: 10.1038/s41584-019-0170-5

92. Bird P, Hall S, Nash P, et al. Treatment outcomes in patients with seropositive versus seronegative rheumatoid arthritis in Phase III randomised clinical trials of tofacitinib. RMD Open. 2019;5(1):e000742. doi: 10.1136/rmdopen-2018-0007

93. Fleischmann RM, Huizinga TW, Kavanaugh AF, et al. Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis. RMD Open. 2016;2:e000262. doi: 10.1136/rmdopen-2016-000262

94. Takeuchi T, Tanaka Y, Sugiyama N, et al. Efficacy of Tofacitinib Monotherapy, Tofacitinib with Methotrexate and Adalimumab with Methotrexate in Patients with Early (<2 Years) vs Established (>2 Years) Rheumatoid Arthritis: A Post Hoc Analysis of Data from ORAL Strategy [abstract]. Arthritis Rheum. 2019;71 Suppl 10. Available from: https://acrabstracts.org/abstract/efficacy-of-tofaci-tinib-monotherapy-tofacitinib-with-methotrexate-and-adalimum-ab-with-methotrexate-in-patients-with-early-%e2%89%a4-2-years-vs-established-2-years-rheumatoid-arthritis-a-p/

95. Schwartzman S, van Vollenoven R, Matsumoto A, et al. Efficacy of tofacitinib in patients with moderate to severe rheumatoid arthritis by baseline-C-reactive proteins levels and erythrocyte sedimentation rate. Ann Rheum Dis. 2018. doi: 10.1136/annrheumdis-2018-eular.2676

96. Favalli EG, Bugatti S, Biggioggero M, Caporali R. Treatment comparison in rheumatoid arthritis: head-to-head trials and innovative study designs. BiomedRes Int. 2014;2014:831603. doi: 10.1155/2014/831603

97. Buch MH, Pavitt S, Parmar M, Emery P. Creative trial design in RA: optimizing patient outcomes. Nat Rev Rheumatol. 2013;9(3):183-94. doi: 10.1038/nrrheum.2013.5

98. Pincus T, Bergman MJ, Yazici Y. Limitations of clinical trials in chronic diseases: is the efficacy of methotrexate (MTX) underestimated in polyarticular psoriatic arthritis on the basis of limitations of clinical trials more than on limitations of MTX, as was seen in rheumatoid arthritis? Clin Exp Rheumatol. 2015;33(5 Suppl 93):S82-93.

99. Eichler HG, Abadie E, Breckenridge A, et al. Bridging the efficacy-effectiveness gap: a regulator's perspective on addressing variability of drug response. Nat Rev Drug Discov. 2011;10:495-506. doi: 10.1038/nrd3501

100. Насонов ЕЛ, Каратеев ДЕ, Сатыбалдыев АМ и др. Ревматоидный артрит в Российской Федерации по данным Российского регистра больных артритом (сообщение I). Научнопрактическая ревматология. 2015;53(5):472-84. doi: 10.14412/1995-4484-2015-472-484

101. Nikiphorou E, Buch MH, Hyrich KL. Biologics registers in RA: methodological aspects, current role and future applications. Nat Rev Rheumatol. 2017 Aug;13(8):503-10. doi: 10.1038/nrrheum.2017.81

102. Finckh A, Courvoisier D. Lessons learned from rheumatoid arthritis registries. Joint Bone Spine. 2018 May;85(3):271-4. doi: 10.1016/j.jbspin.2017.12.005

103. Pombo-Suarez M, Gomez-Reino J. The role of registries in the treatment of rheumatoid arthritis with biologic disease-modifying anti-rheumatic drugs. Pharmacol Res. 2019 Oct;148:104410. doi: 10.1016/j.phrs.2019.104410

104. Monti S, Grosso V, Todoerti M, Caporali R. Randomized controlled trials and real-world data: differences and similarities to untangle literature data. Rheumatology (Oxford). 2018 Oct 1;57 (57 Suppl 7):vii54-vii58. doi: 10.1093/rheumatology/key109

105. Caporali R, Zavaglia D. Real-world experience with tofacitinib for the treatment of rheumatoid arthritis. Clin Exp Rheumatol. 2019;37:485-95.

106. Harnett J, Gerber R, Gruben D, et al. Evaluation of real-world ex perience with tofacitinib compared with adalimumab, etanercept, and abatacept in RA patients with 1 previous biologic DMARD: Data from a U.S. Administrative Claims Database. JManag Care Spec Pharm. 2016;22:1457-71. doi: 10.18553/jmcp.2016.22.12.1457

107. Smith T, Harnett J, Gruben D, et al. Real-world ex perience with tofacitinib versus adalimumab and etanercept in biologic-naive patients with RA previously treated with methotrexate: Data from a US Administrative Healthcare Insurance Claims Database. Arthritis Rheum. 2017;69(S10):abstract 2831.

108. Reed GW, Gerber RA, Shan Y, et al. Real-World Comparative Effectiveness of Tofacitinib and Tumor Necrosis Factor Inhibitors as Monotherapy and Combination Therapy for Treatment of Rheumatoid Arthritis. Rheumatol Ther. 2019 Nov 9. doi: 10.1007/s40744-019-00177-4

109. Kavanaugh A, Reed GW, Saunders KC, et al. Clinical characteristics of RA patients newly prescribed tofacitinib citrate (tofaci-tinib) in the United States after food and drug administration approval: results from the CORRONA US rheumatoid arthritis registry. Ann Rheum Dis. 2015;74:1041. doi: 10.1136/annrheumdis-2015-eular.1760

110. Kavanaugh AF, Geier J, Bingham CI, et al. Real world results from a post-approval safety surveillance of tofacitinib (Xeljanz): Over 3 year results from an ongoing US- based rheumatoid arthritis registry. Arthritis Rheum. 2016;68(S10):abstract 2595.

111. Mori S, Yoshitama T, Ueki Y. Tofacitinib therapy for rheumatoid arthritis: A direct comparison study between biologic-naive and experienced patients. Intern Med. 2018;57:663-70. doi: 10.2169/internalmedicine.9341-17

112. Iwamoto N, Tsuji S, Tanakatani A, et al. Efficacy and safety at 24 weeks of daily clinical use of tofacitinib in patients with rheumatoid arthritis. PLoSOne. 2017;12:e0177057. doi: 10.1371/journal.pone.0177057

113. Finckh A, Herzog L, Scherer A. Drug retention of tofacitinib versus biologic antirheumatic agents in rheumatoid arthritis: observational data from the Swiss SCQM registry. Ann Rheum Dis. 2017;76 Suppl. 2:267. doi: 10.1136/annrheumdis-2017-eular.6804

114. Meissner V, Baganz L, Schneider M, et al. Baricitinib and tofaci-tinib in real life-does obesity impact response to Janus kinase inhibitor therapy in rheumatoid arthritis? Arthritis Rheum. 2018;70 Suppl 10:abstract 1518.

115. Pope J, Bessette L, Jones N, et al. Experience with tofacitinib in Canada: patient characteristics and treatment patterns in rheumatoid arthritis over 3 years. Rheumatology (Oxford). 2019 Aug 13. doi: 10.1093/rheumatology/kez324

116. Choquette D, Bessette L, Brown J, et al. Tofacitinib show similar retention when used with and without methotrexate. Analysis from Rhumadata® Clinical Database and Registry. Arthritis Rheum. 2018;70 Suppl 10:abstract 1531.

117. Marshall AC, Bowen K, Starner CI, Gleason PP. Tofacitinib (Xeljanz) utilization patterns and persistency among 4.4 million continuously enrolled commercially insured members over 4 years. AMCPNexus. 2016; Poster 18349.

118. Movahedi M, Cesta A, Li X, et al, Other OBRI Investigators A. Time to Discontinuation of Tofacitinib in Rheumatoid Arthritis Patients with and Without Methotrexate: Results from a Rheumatoid Arthritis Cohort [abstract]. Arthritis Rheum. 2019;71 Suppl 10. Available from: https://acrabstracts.org/abstract/time-to-discontinuation-of-tofacitinib-in-rheumatoid-arthritis-patients-with-and-without-methotrexate-results-from-a-rheuma-toid-arthritis-cohort/

119. Mueller RB, Hasler C, Popp F, et al. Effectiveness, Tolerability, and Safety of Tofacitinib in Rheumatoid Arthritis: A Retrospective Analysis of Real-World Data from the St. Gallen and Aarau Cohorts. J Clin Med. 2019;8(10). doi: 10.3390/jcm8101548

120. Machado MAA, Moura CS, Guerra SF, et al. Effectiveness and safety of tofacitinib in rheumatoid arthritis: a cohort study. Arthritis Res Ther. 2018;20(1):60. doi: 10.1186/s13075-018-1539-6

121. Croiteru A, Lidar M, Reitblat T, et al. Real Life Retention of Tofacitinib in Patients with Rheumatoid Arthritis [abstract]. Arthritis Rheum. 2019;71 Suppl 10. Available from: https://acrab-stracts.org/abstract/real-life-retention-of-tofacitinib-in-patients-with-rheumatoid-arthritis/

122. Bird P, Littlejohn G, Butcher B, et al. Evaluation of Effectiveness and Usage Patterns of Tofacitinib in Treatment of Rheumatoid Arthritis in Australia: An Analysis from the OPAL-QUMI Real World Dataset [abstract]. Arthritis Rheum. 2019;71 Suppl 10. Available from: https://acrabstracts.org/abstract/evaluation-of-effectiveness-and-usage-patterns-of-tofacitinib-in-treatment-of-rheuma-toid-arthritis-in-australia-an-analysis-from-the-opal-qumi-real-world-dataset/

123. Harnett J, Smith T, Woolcott J, et al. Impact of TNF Inhibitor Cycling with Adalimumab and Etanercept vs Switching to Tofacitinib [abstract]. Arthritis Rheum. 2019;71 Suppl 10. Available from: https://acrabstracts.org/abstract/impact-of-tnf-inhibitor-cycling-with-adalimumab-and-etanercept-vs-switch-ing-to-tofacitinib/

124. Stamp LK, Chan SJ, Marra C, et al. Tapering biologic therapy for people with rheumatoid arthritis in remission: A review of patient perspectives and associated clinical evidence. Musculoskeletal Care. 2019;17(3):161-9. doi: 10.1002/msc.1404

125. Schett G, Emery P, Tanaka Y, et al. Tapering biologic and conventional DMARD therapy in rheumatoid arthritis: current evidence and future directions. Ann Rheum Dis. 2016;75(8):1428-37. doi: 10.1136/annrheumdis-2016-209201

126. Kubo S, Yamaoka K, Amano K, et al. Discontinuation of tofaci-tinib after achieving low disease activity in patients with rheumatoid arthritis: a multicentre, observational study. Rheumatology (Oxford). 2017;56(8):1293-301. doi: 10.1093/rheumatology/kex068

127. Perez-Roman DI, Ortiz-Haro AB, Ruiz-Medrano E, et al. Outcomes after rheumatoid arthritis patients complete their participation in a long-term observational study with tofacitinib combined with methotrexate: practical and ethical implications in vulnerable populations after tofacitinib discontinuation. RheumatolInt. 2018;38(4):599-606. doi: 10.1007/s00296-017-3910-3

128. Mori S, Ueki Y. Outcomes of dose reduction, withdrawal, and restart of tofacitinib in patients with rheumatoid arthritis: a prospective observational study. Clin Rheumatol. 2019 Aug 9. doi: 10.1007/s10067-019-04721-z

129. Kaine J, Tesser J, DeMasi R, et al. Efficacy of tofacitinib after temporary discontinuation in patients with rheumatoid arthritis: analysis of Data from open-label long-term extension studies. Ann Rheum Dis. 2018. doi: 10.1136/annrheumdis-2018-eular.3755

130. Takeuchi T, Genovese MC, Haraoui B, et al. Dose reduction of baricitinib in patients with rheumatoid arthritis achieving sustained disease control: results of a prospective study. Ann Rheum Dis. 2019;78(2):171-8. doi: 10.1136/annrheumdis-2018-213271

131. Atzeni F, Masala IF, di Franco M, Sarzi-Puttini P. Infections in rheumatoid arthritis. Curr Opin Rheumatol. 2017;29(4):323-30. doi: 10.1097/BOR.0000000000000389

132. Kivitz AJ, Cohen S, Keystone E, et al. A pooled analysis of the safety of tofacitinib as monotherapy or in combination with background conventional synthetic disease-modifying antirheumatic drugs in a Phase 3 rheumatoid arthritis population. Semin Arthritis Rheum. 2018;48(3):406-15. doi: 10.1016/j.semarthrit.2018.07.006

133. Winthrop KL. The emerging safety profile of JAK inhibitors in rheumatic disease. Nat Rev Rheumatol. 2017;13(5):320. doi: 10.1038/nrrheum.2017.51

134. Harigai M. Growing evidence of the safety of JAK inhibitors in patients with rheumatoid arthritis. Rheumatology (Oxford). 2019;58 Suppl 1:i34-i42. doi: 10.1093/rheumatology/key287

135. Charles-Schoeman C, DeMasi R, Valdez H, et al. Risk Factors for Major Adverse Cardiovascular Events in Phase III and LongTerm Extension Studies of Tofacitinib in Patients With Rheumatoid Arthritis. Arthritis Rheum. 2019;71(9):1450-9. doi: 10.1002/art.40911

136. Xie W, Huang Y, Xiao S, et al. Impact of Janus kinase inhibitors on risk of cardiovascular events in patients with rheumatoid arthritis: systematic review and meta-analysis of randomised controlled trials. Ann Rheum Dis. 2019;78(8):1048-54. doi: 10.1136/annrheumdis-2018-214846

137. Nurmohamed M, Choy E, Lula S, et al. The Impact of Biologics and Tofacitinib on Cardiovascular Risk Factors and Outcomes in Patients with Rheumatic Disease: A Systematic Literature Review. Drug Saf. 2018;41(5):473-88. doi: 10.1007/s40264-017-0628-9

138. Charles-Schoeman C, Fleischmann R, Davignon J, et al. Potential mechanisms leading to the abnormal lipid profile in patients with rheumatoid arthritis versus healthy volunteers and reversal by tofacitinib. Arthritis Rheum. 2015;67(3):616-25. doi: 10.1002/art.38974

139. McInnes IB, Kim HY, Lee SH, et al. Open-label tofacitinib and double-blind atorvastatin in rheumatoid arthritis patients: a randomised study. Ann Rheum Dis. 2014;73(1):124-31. doi: 10.1136/annrheumdis-2012-2024

140. Kume K, Amano K, Yamada S, et al. Tofacitinib improves atherosclerosis despite up-regulating serum cholesterol in patients with active rheumatoid arthritis: a cohort study. Rheumatol Int. 2017;37(12):2079-85. doi: 10.1007/s00296-017-3844-9

141. Luisse A, Pierini F, Gandino I, et al. Effect of tofacitinib on the qualityve profile of high density lipoproteins molecules in patients with rheumatoid arthritis. Arthritis Rheum. 2019;71 Suppl 10:abstract 1415.

142. Schulze-Koops H, Strand V, Nduaka C, et al. Analysis of haemato-logical changes in tofacitinib-treated patients with rheumatoid arthritis across phase 3 and long-term extension studies. Rheumatology (Oxford). 2017;56(1):46-57. doi: 10.1093/rheumatology/kew329

143. Mariette X, Chen C, Biswas P, et al. Lymphoma in the tofacitinib rheumatoid arthritis clinical development program. Arthritis Care Res (Hoboken). 2017. doi: 10.1002/acr.23421

144. Curtis JR, Lanas A, John A, et al. Factors associated with gastrointestinal perforation in a cohort of patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2012;64(12):1819-28. doi: 10.1002/acr.21764

145. Charles-Schoeman C, Burmester G, Nash P, et al. Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2016;75(7):1293-301. doi: 10.1136/annrheumdis-2014-207178

146. Winthrop KL, Curtis JR, Lindsey S, et al. Herpes Zoster and Tofacitinib: Clinical Outcomes and the Risk of Concomitant Therapy. Arthritis Rheum. 2017;69(10):1960-8. doi: 10.1002/art.40189

147. Curtis JR, Xie F, Bernatsky S, et al. Herpes zoster in tofacitinib users with and without concomitant methotrexate and glucocorticoids. Arthritis Rheum. 2019;70 Suppl 10:abstract 665.

148. Desai RJ, Pawar A, Weinblatt ME, Kim SC. Comparative Risk of Venous Thromboembolism in Rheumatoid Arthritis Patients Receiving Tofacitinib Versus Those Receiving Tumor Necrosis Factor Inhibitors: An Observational Cohort Study. Arthritis Rheum. 2019;71(6):892-900. doi: 10.1002/art.40798

149. Weinblatt MTP, Burmester GR, Witt S, et al. Cardiovascular safety during treatment with baricitinib in rheumatoid arthritis [abstract]. Arthritis Rheum. (Hoboken, NJ). 2017;69 Suppl 10.

150. Kim SC, Schneeweiss S, Liu J, Solomon DH. Risk of venous thromboembolism in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2013;65:1600-7. doi: 10.1002/acr.22039

151. Clowse MEB, Feldman SR, Isaacs JD, et al. Pregnancy outcomes in the tofacitinib safety databases for rheumatoid arthritis and psoriasis. Drug Saf. 2016;39(8):755-62. doi: 10.1007/s40264-016-0431-z

152. He Y, Wong AYS, Chan EW, et al. Efficacy and safety of tofacitinib in the treatment of rheumatoid arthritis: a systemic review and meta-analysis. BMCMusculoskelet Disord. 2013;14:298. doi: 10.1186/1471-2474-14-298

153. Berhan A. Efficacy, safety and tolerability of tofacitinib in patients with an inadequate response to disease modifying anti-rheumatic drugs: a meta-analysis of randomized double-blind controlled studies. BMC Musculoskelet Disord. 2013;14:332. doi: 10.1186/147-2474-14-332

154. Kawalec P, Mikrut A, Wisniewska N, Pilc A. The effectiveness of tofacitinib, a novel Janus kinase inhibitor. In the treatment of rheumatoid arthritis: a systemic review and metha-analysis. Clin Rheumatol. 2013;32:1414-24. doi. 10.1007/s10067-013-2329-9

155. Singh JA, Hossain A, Tanjong Ghogomu E, et al. Biologics or tofacitinib for rheumatoid arthritis in incomplete responders to methotrexate or other traditional disease-modifying anti-rheumatic drugs: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2016 May 13;(5):CD012183. doi: 10.1002/14651858.CD012183

156. Singh JA, Hossain A, Tanjong Ghogomu E, et al. Biologic or tofacitinib monotherapy for rheumatoid arthritis in people with traditional disease-modifying anti-rheumatic drug (DMARD) failure: a Cochrane Systematic Review and network meta-analysis (NMA). Cochrane Database Syst Rev. 2016 Nov 17;11:CD012437. doi: 10.1002/14651858.CD012437

157. Singh JA, Hossain A, Mudano AS, et al. Biologics or tofacitinib for people with rheumatoid arthritis naive to methotrexate: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2017;5:CD012657. doi: 10.1002/14651858.CD012657

158. Singh JA, Hossain A, Tanjong Ghogomu E, et al. Biologics or tofacitinib for people with rheumatoid arthritis unsuccessfully treated with biologics: a systematic review and network metaanalysis. Cochrane Database Syst Rev. 2017;3:CD012591. doi: 10.1002/14651858.CD012591

159. Bergrath E, Gerber RA, Gruben D, et al. Tofacitinib versus Biologic Treatments in Moderate-to-Severe Rheumatoid Arthritis Patients Who Have Had an Inadequate Response to Nonbiologic DMARDs: Systematic Literature Review and Network MetaAnalysis. Int JRheumatol. 2017;2017:8417249. doi: 10.1155/2017/8417249

160. Camean-Castillo M, Gimeno-Ballester V, Rios-Sanchez E, et al. Network meta-analysis of tofacitinib versus biologic treatments in moderate-to-severe rheumatoid arthritis patients. J Clin Pharm Then. 2019;44(3):384-96. doi: 10.1111/jcpt.12795

161. Venerito V, Lopalco G, Cacciapaglia F, et al. A Bayesian mixed treatment comparison of efficacy of biologics and small molecules in early rheumatoid arthritis. Clin Rheumatol. 2019;38(5):1309-17. doi: 10.1007/s10067-018-04406-z

162. Huang F, Luo Z-C. Adverse drug events associated with 5 mg versus 10 mg tofacitinib (Janus kinase inhibitor) twice daily for the treatment of autoimmune diseases: a systemic review and meta-analysis of randomized controlled trials. Clin Rheumatol. 2019;38:523-34. doi: 10.1007/s10067-018-4299-5

163. Song GG, Choi SJ, Lee YH. Comparison of the efficacy and safety of tofacitinib and upadacitinib in patients with active rheumatoid arthritis: A Bayesian network meta-analysis of randomized controlled trials. Int J Rheum Dis. 2019;22(8):1563-71. doi: 10.1111/1756-185X.136

164. Jegatheeswaran J, Turk M, Pope JE. Comparison of Janus kinase inhibitors in the treatment of rheumatoid arthritis: a systemic literature review. Immunotherapy. 2019;11(8):737-54. doi: 10.2217/imt-2018-0178

165. Edwards C, Sawant R, Du E, et al. A matching-adjusted indirect comparison (MAIC) of upadacitinib versus tofacitinib in csDMARD-IR with moderate to severe rheumatoid arthritis. (RA). Ann Rheum Dis. 2019. doi: 10.1136/annrheumdis-2019-eular.7189

166. Dougados M, van der Heijde D, Chen Y, et al. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study. Ann Rheum Dis. 2017;76(1):88-95. doi: 10.1136/annrheumdis-2016-210094

167. Genovese MC, Kremer J, Zamani O, et al. Baricitinib in patients with refractory rheumatoid arthritis. N Engl J Med. 2016;374(13):1243-52. doi: 10.1056/NEJMoa1507247

168. Fleischmann R, Schiff M, van der Heijde D, et al. Baricitinib, methotrexate, or combination in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment. Arthritis Rheum. 2017;69(3):506-17.

169. Taylor PC, Keystone EC, van der Heijde D, et al. Baricitinib versus placebo or adalimumab in rheumatoid arthritis. N Engl J Med. 2017;376(7):652-62. doi: 10.1056/NEJMoa1608345

170. Genovese MC, Smolen JS, Weinblatt ME, et al. Efficacy and safety of ABT-494, a selective JAK-1 inhibitor, in a Phase IIb study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Arthritis Rheum. 2016;68(12):2857-66. doi: 10.1002/art.39808

171. Burmester GR, Kremer JM, van den Bosch F, et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomized, double-blind, placebo-controlled Phase III trial. Lancet. 2018;391(10139):2503-12. doi: 10.1016/S0140-6736(18)31115-2

172. Kremer JM, Emery P, Camp HS, et al. A Phase IIb study of ABT-494, a selective JAK-1 inhibitor, in patients with rheumatoid arthritis and an inadequate response to antitumor necrosis factor therapy. Arthritis Rheum. 2016;68(12):2867-77. doi: 10.1002/art.39801

173. Genovese MC, Fleischmann R, Combe B, et al. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomized controlled Phase III trial. Lancet. 2018;391(10139):2513-24. doi: 10.1016/S0140-6736(18)31116-4

174. Van Vollenhoven R, Takeuchi T, Pangan AL, et al. A Phase 3, Randomized, Controlled Trial Comparing Upadacitinib Monotherapy to MTX Monotherapy in MTX-Naive Patients with Active Rheumatoid Arthritis [abstract]. Arthritis Rheum. 2018;70 Suppl 10. doi: 10.1093/rheumatology/kez106.058

175. Fleischmann R, Pangan AL, Song IH, et al. Upadacitinib Versus Placebo or Adalimumab in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double-Blind, Randomized Controlled Trial. Arthritis Rheum. 2019 Nov;71(11):1788-800. doi: 10.1002/art.41032

176. Tofacitinib: Summary of Product Characteristics. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004214/WC500224911.pdf

177. Smolen JS, Aletaha D, Gruben D, et al. Brief Report: Remission Rates With Tofacitinib Treatment in Rheumatoid Arthritis: A Comparison of Various Remission Criteria. Arthritis Rheum. 2017;69(4):728-34. doi: 10.1002/art.39996

178. Meissner Y, Baganz L, Schneider M, et al. Baricitinib and Tofacitinib in Real Life - Does Obesity Impact Response to Janus Kinase Inhibitor Therapy in Rheumatoid Arthritis? [abstract]. Arthritis Rheum. 2018;70 Suppl 10.

179. Singh S, Facciorusso A, Singh AG, et al. Obesity and response to anti-tumor necrosis factor-а agents in patients with select immune-mediated inflammatory diseases: A systematic review and meta-analysis. PLoSOne. 2018;13(5):e0195123. doi: 10.1371/journal.pone.0195123

180. Rigby WFC, Lampl K, Low JM, Furst DE. Review of Routine Laboratory Monitoring for Patients with Rheumatoid Arthritis Receiving Biologic or Nonbiologic DMARDs. Int J Rheumatol. 2017;2017:9614241. doi: 10.1155/2017/9614241

181. Calabrese LH, Abud-Mendoza C, Lindsey SM, et al. Live Zoster Vaccine in Patients with Rheumatoid Arthritis Treated with Tofacitinib with or without Methotrexate, or Adalimumab with Methotrexate. Arthritis Care Res (Hoboken). 2019 Jun 17. doi: 10.1002/acr.24010

182. Winthrop KL, Silverfield J, Racewicz A, et al. The effect of tofacitinib on pneumococcal and influenza vaccine responses in rheumatoid arthritis. Ann Rheum Dis. 2016;75:687-95. doi: 10.1136/annrheumdis-2014-207191

183. Goodman SM, Springer B, Guyatt G, et al. 2017 American College of Rheumatology/American Association of Hip and Knee Surgeons Guideline for the Perioperative Management of Antirheumatic Medication in Patients With Rheumatic Diseases Undergoing Elective Total Hip or Total Knee Arthroplasty. Arthritis Rheum. 2017;69:1538-51. doi: 10.1002/art.40149

184. Gremese E, Alivernini S, Tolusso B, et al. JAK inhibition by methotrexate (and csDMARDs) may explain clinical efficacy as monotherapy and combination therapy. J Leukoc Biol. 2019;106(5):1063-8. doi: 10.1002/JLB.5RU0519-145R

185. Kronzer VL, Crowson CS, Sparks JA, et al. Family history of rheumatologic, autoimmune, and non-autoimmune diseases and risk of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2019 Nov 30. doi: 10.1002/acr.24115

186. Emamifar A, Jensen Hansen IM. The influence of thyroid diseases, diabetes mellitus, primary hyperparathyroidism, vitamin B12 deficiency and other comorbid autoimmune diseases on treatment outcome in patients with rheumatoid arthritis: An exploratory cohort study. Medicine (Baltimore). 2018;97(21):e10865. doi: 10.1097/MD.0000000000010865


Для цитирования:


Насонов Е.Л., Авдеева А.С., Лила А.М. Эффективность и безопасность тофацитиниба при иммуновоспалительных ревматических заболеваниях (часть I). Научно-практическая ревматология. 2020;58(1):62-79. https://doi.org/10.14412/1995-4484-2020-62-79

For citation:


Nasonov E.L., Avdeeva A.S., Lila A.M. Efficacy and safety of tofacitinib for immune-mediated inflammatory rheumatic diseases (Part I). Rheumatology Science and Practice. 2020;58(1):62-79. (In Russ.) https://doi.org/10.14412/1995-4484-2020-62-79

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ISSN 1995-4484 (Print)
ISSN 1995-4492 (Online)