Ингибитор интерлейкина 17А секукинумаб в лечении пациентов с псориатическим артритом

Псориатический артрит – хроническое воспалительное заболевание суставов, связанное с псориазом, которое отличается разнообразием в проявлении болезни, течении и реакции на лечение. Лучшее понимание патогенеза привело к разработке целевых терапевтических агентов и инновационных стратегий лечения псориатического артрита. Статья посвящена препарату, нацеленному на путь Т-хелперов 17, в частности интерлейкину 17A. Секукинумаб – полностью человеческое моноклональное антитело, которое избирательно нацелено на интерлейкин 17А, провоспалительный цитокин, участвующий в патогенезе псориатического артрита. Секукинумаб – первый среди антител против интерлейкина 17, одобрен во многих странах мира для лечения взрослых пациентов с псориатическим артритом. В III фазе исследования FUTURE секукинумаб, вводимый подкожно в дозах 150 и 300 мг, показал высокую эффективность в отношении активности заболевания у пациентов, ранее получавших лечение нестероидными противовоспалительными препаратами, базисными противоревматическими препаратами и / или ингибиторами фактора некроза опухоли, и сохранение эффекта в течение длительного времени лечения (более 5 лет). Кроме того, в исследованиях FUTURE 1 и 5 секукинумаб подавлял структурное повреждение суставов и был связан с устойчиво низкими показателями рентгенологического прогрессирования через 1–3 года лечения. Лечение секукинумабом улучшило физическую функцию и качество жизни и в целом хорошо переносилось как в краткосрочной, так и в долгосрочной перспективе. Секукинумаб эффективен во всех ключевых доменах псориатического артрита и поэтому представляет собой вариант лечения, который может быть альтернативой ингибиторам фактора некроза опухоли и другим базисным противоревматическим препаратам у взрослых пациентов с данным заболеванием

1. Hackett S., Coates L. Psoriatic arthritis: an up to date overview. Indian J Rheumatol 2020;15(1):45–51. DOI: 10.4103/0973-3698.284751

2. Лила А.М., Насонов Е.Л., Коротаева Т.В. Псориатический артрит: патогенетические особенности и инновационные методы терапии. Научно-практическая ревматология 2018;56(6):685–91. DOI: 10.14412/1995-4484-2018-685-691

3. Ogdie A., Coates L.C., Gladman D.D. Treatment guidelines in psoriatic arthritis. Rheumatology (Oxford) 2020;59(1):37–46. DOI: 10.1093/rheumatology/kez383

4. Коротаева Т.В., Корсакова Ю.Л. Псориатический артрит: классификация, клиническая картина, диагностика, лечение. Научно-практическая ревматология 2018;56(1):60–9. DOI: 10.14412/1995-4484-2018-60-69

5. Мишина О.С., Дворников А.С., Донцова Е.В. Анализ заболеваемости псориазом и псориатическим артритом в Российской Федерации за 2009–2011 гг. Доктор.Ру Review 2013;4(82):52–5.

6. Toussi A., Maverakis N., Le S.T. et al. Updated therapies for the management of psoriatic arthritis. Clin Immunol 2020;220:108536. DOI: 10.1016/j.clim.2020.108536

7. Clegg D.O., Reda D.J., Mejias E. et al. Comparison of sulfasalazine and placebo in the treatment of psoriatic arthritis. A Department of Veterans Affairs Cooperative Study. Arthritis Rheum 1996;39(12):2013–20. DOI: 10.1002/art.1780391210

8. Mease P.J., Goffe B.S., Metz J. et al. Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial. Lancet 2000;356(9227):385–90. DOI: 10.1016/S0140-6736(00)02530-7

9. Antoni C.E., Kavanaugh A., Kirkham B. et al. Sustained benefits of infliximab therapy for dermatologic and articular manifestations of psoriatic arthritis: results from the infliximab multinational psoriatic arthritis-controlled trial (IMPACT). Arthritis Rheum 2005;52(4):1227–36. DOI: 10.1002/art.20967

10. Mease P., Kivitz A., Burch F. et al. Etanercept treatment of psoriatic arthritis: safety, efficacy, and effect on disease progression. Arthritis Rheum 2004;50(7):2264–72. DOI: 10.1002/art.20335

11. Antoni C., Krueger G.G., de Vlam K. et al. Infliximab improves signs and symptoms of psoriatic arthritis: results of the IMPACT 2 trial. Ann Rheum Dis 2005;64(8):1150–57. DOI: 10.1136/ard.2004.032268

12. Mease P., Gladman D., Ritchlin C. Adalimumab in the treatment of patients with moderately to severely active psoriatic arthritis: Results of ADEPT. Arthritis Rheum 2005;52(10):3279–89. DOI: 10.1002/art.21306

13. Kavanaugh A., Mcinnes I., Mease P. et al. Golimumab, a new human tumor necrosis factor alpha antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twentyfour-week efficacy and safety results of a randomized, placebocontrolled study. Arthritis Rheum 2009;60(4):976–86. DOI: 10.1002/art.24403

14. Mease P.J., Fleischmann R., Deodhar A.A. et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 doubleblind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis 2014;73(1):48–55. DOI: 10.1136/annrheumdis-2013-eular.2023

15. Mease P.J. Measures of psoriatic arthritis: Tender and Swollen Joint Assessment, Psoriasis Area and Severity Index (PASI), Nail Psoriasis Severity Index (NAPSI), Modified Nail Psoriasis Severity Index (mNAPSI), Mander/Newcastle Enthesitis Index (MEI), Leeds Enthesitis Index (LEI), Spondyloarthritis Research Consortium of Canada (SPARCC), Maastricht Ankylosing Spondylitis Enthesis Score (MASES), Leeds Dactylitis Index (LDI), Patient Global for Psoriatic Arthritis, Dermatology Life Quality Index (DLQI), Psoriatic Arthritis Quality of Life (PsAQOL), Functional Assessment of Chronic Illness TherapyFatigue (FACIT-F), Psoriatic Arthritis Response Criteria (PsARC), Psoriatic Arthritis Joint Activity Index (PsAJAI), Disease Activity in Psoriatic Arthritis (DAPSA), and Composite Psoriatic Disease Activity Index (CPDAI). Arthritis Care Res (Hoboken) 2011;63 (11):64–85. DOI: 10.1002/acr.20577

16. Mease P. Psoriatic arthritis and spondyloarthritis assessment and management update. Curr Opin Rheumatol 2013;25(3):287–96. DOI: 10.1136/ard.2010.140582

17. Mease P., Collier D., Karki C. et al. Persistence and predictors of biologic TNFi therapy among biologic naïve psoriatic arthritis patients in a US registry. Arthritis Rheum 2014;66(10):abs 1853. DOI: 10.21203/rs.3.rs-78064/v1

18. Fagerli K.M., Lie E., van der Heijde D. et al. The role of methotrexate co-medication in TNF-inhibitor treatment in patients with psoriatic arthritis: results from 440 patients included in the NOR-DMARD study. Ann Rheum Dis 2014;73(1):132–7. DOI: 10.1136/annrheumdis-2012-202347

19. Jorgensen T.S., Kristensen L.E., Christensen R. et al. Effectiveness and drug adherence of biologic monotherapy in routine care of patients with rheumatoid arthritis: a cohort study of patients registered in the Danish biologic’s registry. Rheumatology (Oxford) 2015;54(12):2156–65. DOI: 10.1093/rheumatology/kev216

20. Mease P.J., Gladman D.D., Keystone E.C. Alefacept in combination with methotrexate for the treatment of psoriatic arthritis: Results of a randomized, double-blind, placebocontrolled study. Arthritis Rheum 2006;54(5):1638–45. DOI: 10.1002/art.21870

21. Mease P.J. Psoriatic arthritis: update on pathophysiology, assessment and management. Ann Rheum Dis 2011;70(1):77–84. DOI: 10.1136/ard.2010.140582

22. Patel D.D., Lee D.M., Kolbinger F. et al. Effect of IL-17A blockade with secukinumab in autoimmune diseases. Ann Rheum Dis 2013;72(2):116–23. DOI: 10.14412/1996-7012-2013-04

23. Van den Berg W.B., Mclnnes I.B. Th17 cells and IL-17a – focus on immunopathogenesis and therapeutics. Semin Arthritis Rheum 2013;43(2):158–70. DOI: 10.1016/j.semarthrit.2013.04.006

24. Frleta M., Siebert S., Mclnnes I.B. The interleukin-17 pathway in psoriasis and psoriatic arthritis: disease pathogenesis and possibilities of treatment. Curr Rheumatol Rep 2014;16(4):414. DOI: 10.1007/s11926-014-0414-y

25. Lories R.J., Mclnnes I.B. Primed for inflammation: enthesisresident T cells. Nat Med 2012;18(7):1018–9. DOI: 10.1038/nm.2854

26. McGonagle D., Lories R.J., Tan A.L. et al. The concept of a “synovio-entheseal complex” and its implications for understanding joint inflammation and damage in psoriatic arthritis and beyond. Arthritis Rheum 2007;56(8):2482–91. DOI: 10.1002/art.22758

27. Mease P.J. Inhibition of interleukin-17, interleukin-23 and the TH17 cell pathway in the treatment of psoriatic arthritis and psoriasis. Curr Opin Rheumatol 2015;27(2):127–33. DOI: 10.1097/BOR.0000000000000147

28. Novartis. COSENTYX® (secukinumab) injection: US prescribing information. 2020. https://dailymed.nlm.nih.gov. Accessed 18 Jan 2021.

29. European Medicines Agency. Secukinumab (Cosentyx): EU summary of product characteristics. 2020. https://www.ema.europa.eu. Accessed 18 Jan 2021.

30. Mease P.J., Mclnnes I.B., Kirkham B. Secukinumab inhibition of interleukin-17A in patients with psoriatic arthritis. N Engl J Med 2015;373(14):1329–39. DOI: 10.1056/NEJMoa1412679

31. Mclnnes I.B., Mease P.J., Kirkham B. Secukinumab, a human antiinterleukin-17A monoclonal antibody, in patients with psoriatic Secukinumab: A Review 493 arthritis (FUTURE 2): a randomised, double-blind, placebocontrolled, phase 3 trial. Lancet 2015;386(9999):1137–46. DOI: 10.1016/S0140-6736(15)61134-5

32. Nash P., Mease P.J., McInnes I.B. et al. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther 2018;20(1):47. DOI: 10.1186/s13075-018-1551-x

33. Kivitz A.J., Nash P., Tahir H. et al. Efficacy and safety of subcutaneous secukinumab 150 mg with or without loading regimen in psoriatic arthritis: results from the FUTURE 4 study. Rheumatol Ther 2019;6(3):393–407. DOI: 10.1007/s40744-019-0163-5

34. Mease P., van der Heijde D., Landewe R. et al. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis 2018;77(6):890–7. DOI: 10.1136/annrheumdis-2017-212687

35. Baraliakos X., Gossec L., Pournara E. et al. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis 2021;80(5):582–90. DOI: 10.1136/annrheumdis2020-218808

36. Оstino M., Schett G., Lopez-Rdz A. et al. Secukinumab signifcantly decreased joint synovitis measured by power doppler ultrasonography in biologic-naive patients with active psoriatic arthritis: primary (12-week) results from a randomized, placebo-controlled phase III study. Br J Rheumatol 2020; 60(1):100–1. DOI: 10.1093/rheumatology/keab247.182

37. Mclnnes I.B., Behrens F., Mease P.J. et al. Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active controlled, phase 3b trial. Lancet 2020;395(10235):1496–5. DOI: 10.1016/S0140-6736(20)31205-8

38. Van der Heijde D., Mease P.J., Landewe R.B.M. et al. Secukinumab provides sustained low rates of radiographic progression in psoriatic arthritis: 52-week results from a phase 3 study, FUTURE 5. Rheumatology (Oxford) 2020;59(6):1325–34. DOI: 10.1093/rheumatology/kez420

39. Mease P.J., Landewe R.B.M., Rahman P. et al. Subcutaneous secukinumab 300 mg and 150 mg provides sustained inhibition of radiographic progression in psoriatic arthritis over 2 years: results from the phase 3 FUTURE-5 trial [abstract no. LB0006]. Ann Rheum Dis 2019;78(2):262. DOI: 10.1136/annrheumdis-2019-eular.8808

40. Mclnnes I.B., Mease P.J., Ritchlin C.T. et al. Secukinumab sustains improvement in signs and symptoms of psoriatic arthritis: 2-year results from the phase 3 FUTURE 2 study. Rheumatology (Oxford) 2017;56(11):1993–2003. DOI: 10.1093/rheumatology/kex301

41. Kavanaugh A., Mease P.J., Reimold A.M. et al. Secukinumab for long-term treatment of psoriatic arthritis: a two-year followup from a phase III, randomized, double-blind placebo-controlled study. Arthritis Care Res 2017;69(3):347–55. DOI: 10.1002/acr.23111.

42. Mease P.J., Kavanaugh A., Reimold A. et al. Secukinumab provides sustained improvements in the signs and symptoms of psoriatic arthritis: final 5-year results from the phase 3 FUTURE 1 study. ACR Open Rheumatol 2020;2(1):18–25. DOI: 10.1002/acr2.11097

43. Mease P.J., Kavanaugh A., Reimold A. et al. Secukinumab in the treatment of psoriatic arthritis: efcacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial. RMD Open 2018;4(2):e000723. DOI: 10.1136/rmdopen-2018-000723

44. Nash P., McInnes I.B., Rahman P. et al. Secukinumab provides sustained improvements in the signs and symptoms of active psoriatic arthritis: 3-year results from the phase 3 FUTURE 2 study [abstract no. THU0322]. Ann Rheum Dis 2018;77(2):379. DOI: 10.1136/rmdopen-2018-000723.

45. Mclnnes I.B., Mease P.J., Kivitz A.J. et al. Long-term efcacy and safety of secukinumab in patients with psoriatic arthritis: 5-year (end-of-study) results from the phase 3 FUTURE 2 study. Lancet Rheumatol 2020;2(4):e227–35. DOI: 10.1016/S2665-9913(20)30036-9

46. Van der Heijde D., Landewe R.B., Mease P.J. et al. Secukinumab provides signifcant and sustained inhibition of joint structural damage in a phase III study of active psoriatic arthritis. Arthritis Rheumatol 2016;68(8):1914–21. DOI: 10.1002/art.39685

47. Strand V., Mease P., Gossec L. et al. Secukinumab improves patient-reported outcomes in subjects with active psoriatic arthritis: results from a randomised phase III trial (FUTURE 1). Ann Rheum Dis 2017;76(1):203–7. DOI: 10.1136/annrheumdis-2015-209055

48. Mclnnes I.B., Mease P.J., Schett G. et al. Secukinumab provides rapid and sustained pain relief in psoriatic arthritis over 2 years: results from the FUTURE 2 study. Arthritis Res Ther 2018;20(1):113. DOI: 10.1136/annrheumdis-2015-209055

49. Coates L.C., Mease P.J., Gossec L. et al. Minimal disease activity among active psoriatic arthritis patients treated with secukinumab: 2-year results from a multicenter, randomized, double-blind, parallel-group, placebo-controlled phase III study. Arthritis Care Res 2018;70(10):1529–35. DOI: 10.1002/acr.23537

50. Coates L.C., Gladman D.D., Nash P. et al. Secukinumab provides sustained PASDAS-defned remission in psoriatic arthritis and improves health-related quality of life in patients achieving remission: 2-year results from the phase III FUTURE 2 study. Arthritis Res Ther 2018;20(1):272. DOI: 10.1186/s13075-018-1773-y

51. Coates L.C., Nash P., Kvien T.K. et al. Comparison of remission and low disease activity states with DAPSA, MDA and VLDA in a clinical trial setting in psoriatic arthritis patients: 2-year results from the FUTURE 2 study. Semin Arthritis Rheum 2020;50(4):709–18. DOI: 10.1016/j.semarthrit.2020.03.015

52. D’Agostino M., Schett G., Lopez-Rdodriguez A. et al. Secukinumab significantly decreased joint synovitis measured by power doppler ultrasonography in biologic-naive patients with active psoriatic arthritis: primary (12-week) results from a randomized, placebo-controlled phase 3 study. Rheumatology (Oxford) 2021;60(1):P187. DOI: 10.1093/rheumatology/keab247.182

53. Chimenti M.S., Fonti G.L., Conigliaro P. et al. One-year effectiveness, retention rate, and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: a real-life multicenter study. Expert Opin Biol Ther 2020;20(7):813–21. DOI: 10.1080/14712598.2020.1761957

54. Conaghan P.G., Holdsworth E., Tian H. et al. Real world efectiveness of secukinumab in psoriatic arthritis: fndings from a recent cross-sectional survey of rheumatologists and patients in Europe [abstract no. AB0755]. Ann Rheum Dis 2020;79(1):1674–5. DOI: 10.1136/annrheumdis2020-eular.1374

55. Kiltz U., Peterlik D., Winkelmann V. et al. AQUILA study in Germany – real world data on secukinumab’s efectiveness in psoriatic arthritis patients – results from an interim analysis [abstract no. FRI0405]. Ann Rheum Dis 2019;78(2):889–90. DOI: 10.1136/annrheumdis-2019-eular.436

56. Mease P.J., Blachley T., Glynn M. et al. Secukinumab improves clinical and patient-reported outcomes at 6 months among patients with psoriatic arthritis in the US-based Corrona psoriatic arthritis/ spondyloarthritis (PsA/SpA) registry [abstract no. SAT0429]. Ann Rheum Dis 2020;79(1):1169. DOI: 10.1136/annrheumdis-2020-eular.1014

57. Favalli E.G., Marchesoni A., Balduzzi S. et al. Effectiveness and retention rate of secukinumab for psoriatic arthritis and axial spondyloarthritis: real-life data from the Italian LORHEN registry [abstract no. FRI0273]. Ann Rheum Dis 2020;79(1):722–3. DOI: 10.1136/annrheumdis-2020-eular.3197

58. Lorenzin M., Carletto A., Foti R. et al. Effectiveness and safety of secukinumab in naive or TNF-inhibitors failure psoriatic arthritis patients in real life: a 24-months prospective multicenter study [abstract no. FRI0284]. Ann Rheum Dis 2020;79(1):730. DOI: 10.1136/annrheumdis-2020-eular.3702

59. Magrey M., Bozyczko M., Wolin D. et al. Evaluation of the feasibility of a web-based survey to assess patient-reported symptom improvement and treatment satisfaction among patients with psoriatic arthritis receiving secukinumab. Clin Drug Investig 2019;39(12):1205–12. DOI: 10.1007/s40261-019-00856-8

60. Martin L.M., Valero M., Emperiale V. et al. Real-world experience of secukinumab for psoriatic arthritis [abstract no. FRI0448]. Ann Rheum Dis. 2019;78(2):915. DOI: 10.1136/annrheumdis-2019-eular.7452

61. Holdsworth E., Booth N., Lobosco S. et al. Real-world physician satisfaction with secukinumab in psoriatic arthritis and ankylosing spondylitis in Europe [abstract no. THU0635]. Ann Rheum Dis 2019;78(2):611–2. DOI: 10.1136/annrheumdis-2019-eular.4167

62. Michelsen B., Georgiadis S., Giuseppe D.I. et al. Secukinumab effectiveness in 1543 patients with psoriatic arthritis treated in routine clinical practice in 13 European countries in the EuroSpA research collaboration network [abstract no. SAT0430]. Ann Rheum Dis 2020;79(1):1169–71. DOI: 10.1136/annrheumdis2020-eular.1413

63. Kiltz U., Peterlik D., Winkelmann V. AQUILA study in Germany – real world adherence and persistence of secukinumab treatment in ankylosing spondylitis and psoriatic arthritis patients – an interim analysis [abstract no. AB0705]. Ann Rheum Dis. 2019;78(2):1814–5. DOI: 10.1136/annrheumdis-2019-eular.435

64. Oelke K.R., Chambenoit O., Majjhoo A.Q. et al. Persistence and adherence of biologics in US patients with psoriatic arthritis: analyses from a claims database. J Comp Ef Res 2019;8(8):607–22. DOI: 10.2217/cer-2019-002

65. Elewski B.E., Baddley J.W., Deodhar A.A. et al. Association of secukinumab treatment with tuberculosis reactivation in patients with psoriasis, psoriatic arthritis, or ankylosing spondylitis. JAMA Dermatol 2021;157(1):43–51. DOI: 10.1001/jamadermatol.2020.3257

66. Deodhar A., McInnes I., Baraliakos X. et al. Secukinumab demonstrates a consistent safety profle in patients with psoriasis, psoriatic arthritis and ankylosing spondylitis over long term: updated pooled safety analysis [abstract no. FRI0272]. Ann Rheum Dis 2020;79(1):722. DOI: 10.1093/rheumatology/kez107.073

67. Deodhar A., Gladman D.D., Mclnnes I.B. et al. Secukinumab immunogenicity over 52 weeks in patients with psoriatic arthritis and ankylosing spondylitis. J Rheumatol 2020;47(4):539–47. DOI: 10.3899/jrheum.190116

68. Gossec L., Baraliakos X., Kerschbaumer A. et al. EULAR recommendations for the management of psoriatic rthritis with pharmacological therapies: 2019 update. Ann Rheum Dis 2020;79(6):700–12. DOI: 10.1136/annrheumdis-2020-217159

69. Coates L.C., Kavanaugh A., Mease P.J. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis 2015 treatment recommendations for psoriatic arthritis. Arthritis Rheumatol 2016;68(5):1060–71. DOI: 10.1002/art.39573

70. Singh J.A., Guyatt G., Ogdie A. et al. 2018 American College of Rheumatology/National Psoriasis Foundation guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol 2019;71(1):5–32. DOI: 10.1002/acr.23789