Выбор генно-инженерной биологической терапии в лечении тяжелых форм псориаза
https://doi.org/10.21518/ms2023-280
Аннотация
Псориаз – иммуноопосредованное заболевание кожи, ассоциирующееся с повышенным риском возникновения коморбидной патологии и существенным отрицательным влиянием на качество жизни пациентов. При среднетяжелых и тяжелых формах псориаза необходимо назначение системных методов терапии. Новейшая парадигма лечения стала возможной благодаря постоянному углублению знаний патофизиологии заболевания. В настоящее время известен четкий механизм, вплоть до молекулярного уровня, относительно того, какие цитокины вовлечены в патогенез псориатической болезни. Интерлейкин (ИЛ) 23 опосредованно активирует путь Th17, что, согласно гипотезе, вносит основной вклад в воспаление, наблюдаемое при псориазе, что в том числе доказывается высокой эффективностью применения биологических агентов – ингибиторов ИЛ-23. Очевидно, что в области генно-инженерной биологической терапии псориаза достигнут большой прогресс как в плане безопасности, так и в плане эффективности. Однако остро стоит вопрос выбора биологического препарата индивидуально у каждого пациента, в том числе в случае инициации первого генно-инженерного биологического препарата (ГИБП) у бионаивного больного. В статье приведен обзор ключевых моментов при выборе ГИБП в зависимости от коморбидного фона, а также описан клинический случай успешной терапии бионаивного пациента с сопутствующим депрессивным расстройством в анамнезе на фоне тяжелого течения псориаза. Успешное применение ингибитора ИЛ-23 (препарата гуселькумаб) позволило добиться стойкой ремиссии и улучшения качества жизни, что в свою очередь положительно повлияло и на коморбидный фон пациента. Данное наблюдение позволяет сделать вывод о том, что выбор в качестве первого биологического агента препарата гуселькумаб является достаточно эффективной, безопасной и перспективной опцией в лечении тяжелых форм псориаза.
Об авторах
О. В. Жукова
Российский университет дружбы народов;
Московский научно-практический центр дерматовенерологии и косметологии
Россия
Россия
Жукова Ольга Валентиновна, д.м.н., профессор, заведующая кафедрой дерматовенерологии и аллергологии с курсом иммунологии медицинского института, 117198, Москва, ул. Миклухо-Маклая, д. 6;
главный врач, 19071, Москва, Ленинский проспект, д. 17
С. И. Артемьева
Московский научно-практический центр дерматовенерологии и косметологии
Россия
Россия
Артемьева Софья Иосифовна, научный сотрудник отдела клинической дерматовенерологии и косметологии, врач-дерматовенеролог,
119071, Москва, Ленинский проспект, д. 17
Список литературы
1. Tonel G, Conrad C, Laggner U, Di Meglio P, Grys K, McClanahan TK et al. Cutting edge: A critical functional role for IL-23 in psoriasis. J Immunol. 2010;185(10):5688–5691. https://doi.org/10.4049/jimmunol.1001538.
2. Gisondi P, Bellinato F, Girolomoni G, Albanesi C. Pathogenesis of chronic plaque psoriasis and its intersection with cardio-metabolic comorbidities. Front Pharmacol. 2020;11:117. https://doi.org/10.3389/fphar.2020.00117.
3. Paroutoglou K, Papadavid E, Christodoulatos GS, Dalamaga M. Deciphering the association between psoriasis and obesity: current evidence and treatment considerations. Curr Obesity Rep. 2020;9(3):165–178. https://doi.org/10.1007/s13679-020-00380-3.
4. Hjuler KF, Gormsen LC, Vendelbo MH, Egeberg A, Nielsen J, Iversen L. Increased global arterial and subcutaneous adipose tissue inflammation in patients with moderate-to-severe psoriasis. Br J Dermatol. 2017;176(3): 732–740. https://doi.org/10.1111/bjd.15149.
5. Mease PJ, Fleischmann R, Deodhar AA, Wollenhaupt M, Khraishi M, Kielar D et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheumatic Dis. 2014;73(1):48–55. https://doi.org/10.1136/annrheumdis-2013-203696.
6. Syversen SW, Jorgensen KK, Goll GL, Brun MK, Sandanger Q, Bjorlykke KH et al. Effect of therapeutic drug monitoring vs standard therapy during maintenance infliximab therapy on disease control in patients with immune-mediated inflammatory diseases: a randomized clinical trial. JAMA. 2021;326(23):2375–2384. https://doi.org/10.1001/jama.2021.21316.
7. McInnes IB, Sawyer LM, Markus K, LeReun C, Sabry-Grant C, Helliwell PS. Targeted systemic therapies for psoriatic arthritis: a systematic review and comparative synthesis of short-term articular, dermatological, enthesitis and dactylitis outcomes. RMD Open. 2022;8(1):е002074. https://doi.org/10.1136/rmdopen-2021-002074.
8. Baraliakos X, Gossec L, Pournara E, Jeka S, Mera-Varela A, D´Angelo S et al. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheumc Dis. 2021;80(5):582–590. https://doi.org/10.1136/annrheumdis2020-218808.
9. Mease PJ, Landewe R, Rahman P, Tahir H, Singhal A, Boettcher E et al. Secukinumab provides sustained improvement in signs and symptoms and low radiographic progression in patients with psoriatic arthritis: 2-year (end-of-study) results from the FUTURE 5 study. RMD Open. 2021;7(2):е001600. https://doi.org/10.1136/rmdopen-2021-001600.
10. Gottlieb AB, Merola JF, Reich K, Behrens F, Nash P, Griffiths CEM et al. Efficacy of secukinumab and adalimumab in patients with psoriatic arthritis and concomitant moderate-to-severe plaque psoriasis: results from EXCEED, a randomized, double-blind head-to-head monotherapy study. Br J Dermatol. 2021;185(6):1124–1134. https://doi.org/10.1111/bjd.20413.
11. Gottlieb AB, Strand V, Kishimoto M, Mease P, Thaci D, Birt J et al. Ixekizumab improves patient-reported outcomes up to 52 weeks in bDMARD-naive patients with active psoriatic arthritis (SPIRIT-P1). Rheumatology. 2018;57(10):1777–1788. https://doi.org/10.1093/rheumatology/key161.
12. Deodhar A, Helliwell PS, Boehncke W-H, Kollmeier A, Hsia EC, Subramanian RA et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNF alpha inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1115–1125. https://doi.org/10.1016/s0140-6736(20)30265-8.
13. Mease PJ, Rahman P, Gottlieb AB, Kollmeier AP, Hsia EC, Xu XL et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a doubleblind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230): 1126–1136. https://doi.org/10.1016/s0140-6736(20)30263-4.
14. Sweet K, Song Q, Loza MJ, McInnes IB, Ma K, Leander K et al. Guselkumab induces robust reduction in acute phase proteins and type 17 effector cytokines in active psoriatic arthritis: results from phase 3 trials. RMD Open. 2021;7(2):е001679. https://doi.org/10.1136/rmdopen-2021-001679.
15. Stefan S, Loza MJ, Song Q, Mcinnes I, Sweet K. “THU0052 ustekinumab and guselkumab treatment results in differences in serum IL17A, IL17F and CRP levels in psoriatic arthritis patients: a comparison from ustekinumab ph3 and guselkumab ph2 programs.” BMJ. 2019;78(2):293. Available at: https://ard.bmj.com/content/annrheumdis/78/Suppl_2/293.1.full.pdf.
16. Bonifati C, Graceffa D. How effective is ustekinumab in controlling psoriatic arthritis? Dermatol Ther. 2016;(3):155–159. https://doi.org/10.1111/dth.12322.
17. Snekvik I, Smith CH, Nilsen TIL, Langan SM, Modalsli EH, Romundstad PR, Saunes M. Obesity, waist circumference, weight change, and risk of incident psoriasis: prospective data from the HUNT Study. J Invest Dermatol. 2017;137(12):2484–2490. https://doi.org/10.1016/j.jid.2017.07.822.
18. Petridis A, Panagakis P, Moustou E, Vergou T, Kallidis P, Mandekou-Lefaki I et al. A multicenter, prospective, observational study examining the impact of risk factors, such as BMI and waist circumference, on quality of life improvement and clinical response in moderate-to-severe plaque-type psoriasis patients treated with infliximab in routine care settings of Greece. J Eur Acad Dermatol Venereol. 2018;32(5):768–775. https://doi.org/10.1111/jdv.14802.
19. Araujo EP, De Souza CT, Ueno M, Cintra DE, Bertolo MB, Carvalheira JB et al. Infliximab restores glucose homeostasis in an animal model of diet-induced obesity and diabetes. Endocrinology. 2007;148(12):5991–5997. https://doi.org/10.1210/en.2007-0132.
20. Bykerk VP, Blauvelt A, Curtis JR, Gaujoux-Viala C, Kvien TK, Winthrop K et al. Associations between safety of certolizumab pegol, disease activity, and patient characteristics, including corticosteroid use and body mass index. ACR Open Rheumatol. 2021;3(8):501–511. https://doi.org/10.1002/acr2.11259.
21. Mahe E, Reguiai Z, Barthelemy H, Quiles-Tsimaratos, Chaby C, Esteve E et al. Evaluation of risk factors for body weight increment in psoriatic patients on infliximab: a multicentre, cross-sectional study. J Eur Acad Dermatol Venereol. 2014;28(2):151–159. https://doi.org/10.1111/jdv.12066.
22. Gisondi P, Conti A, Galdo G, Piaserico S, De Simone C, Girolomoni G. Ustekinumab does not increase body mass index in patients with chronic plaque psoriasis: a prospective cohort study. Br J Dermatol. 2013;168(5):1124–1127. https://doi.org/10.1111/bjd.12235.
23. Dalal RS, Allegretti JR. Ustekinumab dose optimization in Crohn disease: one size does not fit all. Inflamm Bowel Dis. 2021;27(6):e70. https://doi.org/10.1093/ibd/izab019.
24. Papp KA, Langley RG, Sigurgeirsson B, Abe M, Baker DR, Konno P et al. Efficacy and safety of secukinumab in the treatment of moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled phase II dose-ranging study. Br J Dermatol. 2013;168(2):412–421. https://doi.org/10.1111/bjd.12110.
25. Gerdes S, Pinter A, Papavassilis C, Reinhardt M. Effects of secukinumab on metabolic and liver parameters in plaque psoriasis patients. J Eur Acad Dermatol Venereol. 2020;34(3):533–541. https://doi.org/10.1111/jdv.16004.
26. Papp K, Crowley J, Rubel D, Landells I, Song M, Wasfi Y et al. Consistency of response by weight across subgroups of patients with psoriasis treated with guselkumabl: results from the VOYAGE 1 and 2 Trials. Acta Dermato Venereol. 2018;79(3):20. https://doi.org/10.1016/j.jaad.2018.05.378.
27. Galluzzo M, Tofani L, Lombardo P, Petruzzellis A, Silvaggio D, Egan CG et al. Use of guselkumab for the treatment of moderate-to-severe plaque psoriasis: a 1 year real-life study. J Clin Med. 2020;9(7):2170. https://doi.org/10.3390/jcm9072170.
28. Regueiro M, Kip KE, Baidoo L, Swoger JM, Schraut W. Postoperative therapy with infliximab prevents long-term Crohn’s disease recurrence. Clin Gastroenterol Hepatol. 2014;12(9):1494-502.e1. https://doi.org/10.1016/j.cgh.2013.12.035.
29. Feagan BG, Sandborn WJ, Gasink C, Jacobstein D, Lang Y, Friedman JR et al. Ustekinumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2016;375(20):1946–1960. https://doi.org/10.1056/NEJMoa1602773.
30. Singh S, Murad MH, Fumery M, Dulai PS, Sandborn WJ. First- and second-line pharmacotherapies for patients with moderate to severely active ulcerative colitis: an updated network meta-analysis. Clin Gastroenterol Hepatol. 2020;18(10):2179–2191. https://doi.org/10.1016/j.cgh.2020.01.008.
31. Hueber W, Sands BE, Lewitzky S, Vandemeulebroecke M, Reinisch W, Higgins PDR et al. Secukinumab, a human anti-IL-17A monoclonal antibody, for moderate to severe Crohn’s disease: unexpected results of a randomised, double-blind placebo-controlled trial. Gut. 2012;61(12):1693–1700. https://doi.org/10.1136/gutjnl-2011-301668.
32. van de Kerkhof PCM, Griffiths CEM, Reich K, Leonardi CL, Blauvelt A, Tsai T-F et al. Secukinumab long-term safety experience: a pooled analysis of 10 phase II and III clinical studies in patients with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2016;75(1):83–98. https://doi.org/10.1016/j.jaad.2016.03.024.
33. Gordon KB, Colombel J-F, Hardin DS. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis reply. N Engl J Med. 2016;375(21):2102. https://doi.org/10.1056/NEJMc1610828.
34. Sandborn WJ, D’Haens GR, Reinisch W, Panes J, Chan D, Gonzalez S et al. Guselkumab for the treatment of Crohn’s disease: induction results from the phase 2 GALAXI-1 study. Gastroenterology. 2022;162(6):1650–1664. https://doi.org/10.1053/j.gastro.2022.01.047.
35. Berman HS, Villa NM, Shi VY, Hsiao JL. Guselkumab in the treatment of concomitant hidradenitis suppurativa, psoriasis, and Crohn’s disease. J Dermatol Treat. 2021;32(2):261–263. https://doi.org/10.1080/09546634.2019.1654067.
36. Grossberg LB. A case report of successful treatment of Crohn’s disease and psoriasis with guselkumab. Inflamm Bowel Dis. 2019;25(7):E84-E. https://doi.org/10.1093/ibd/izz033.
37. Wu JJ, Guerin A, Sundaram M, Dea K, Cloutier M, Mulani P. Cardiovascular event risk assessment in psoriasis patients treated with tumor necrosis factor-alpha inhibitors versus methotrexate. J Am Acad Dermatol. 2017;76(1):81–90. https://doi.org/10.1016/j.jaad.2016.07.042.
38. Poizeau F, Nowak E, Kerbrat S, Le Nautout B, Droitcourt C, Drici M-D et al. Association between early severe cardiovascular events and the initiation of treatment with the anti-interleukin 12/23p40 antibody ustekinumab. JAMA Dermatol. 2020;156(11):1208–1215. https://doi.org/10.1001/jamadermatol.2020.2977.
39. Kimball AB, Papp KA, Wasfi Y, Chan D, Bissonnette R, Sofen H et al. Longterm efficacy of ustekinumab in patients with moderate-to-severe psoriasis treated for up to 5 years in the PHOENIX 1 study. J Eur Acad Dermatol Venereol. 2013;27(12):1535–1545. https://doi.org/10.1111/jdv.12046.
40. Papp K, Gottlieb AB, Naldi L, Pariser D, Ho V, Goyal K et al. Safety surveillance for ustekinumab and other psoriasis treatments from the Psoriasis Longitudinal Assessment and Registry (PSOLAR). J Drugs Dermatol. 2015;14(7):58–66. Available at: https://pubmed.ncbi.nlm.nih.gov/?term=39.%09Papp+K%2C+Gottlieb+AB%2C+Naldi+L+et+al.+Safety+surveillance+for+ustekinumab+and+other+psoriasis+treatments+from+the+Psoriasis+Longitudinal+Assessment+and+Registry+%28PSOLAR%29.+J+Drugs+Dermatology.+2015%3B14%3A5.
41. Lockshin B, Balagula Y, Merola JF. Interleukin 17, inflammation, and cardiovascular risk in patients with psoriasis. J Am Acad Dermatol. 2018;79(2): 345–352. https://doi.org/10.1016/j.jaad.2018.02.040.
42. de Brito M, Yiu ZZN. Cardiovascular Safety of biologics targeting interleukin (IL)-12 and/or IL-23: what does the evidence say? Am J Clin Dermatol. 2021;22(5):587–601. https://doi.org/10.1007/s40257-021-00612-9.
43. Crowley JJ, Warren RB, Cather JC. Safety of selective IL-23p19 inhibitors for the treatment of psoriasis. J Eur Acad Dermatol Venereol. 2019;33(9):1676–1684. https://doi.org/10.1111/jdv.15653.
44. Blauvelt A, Tsai T-F, Langley RG, Miller M, Shen Y-K, You Y et al. Consistent safety profile with up to 5 years of continuous treatment with guselkumab: pooled analyses from the phase 3 VOYAGE 1 and VOYAGE 2 trials of patients with moderate-to-severe psoriasis. J Am Acad Dermatol. 2022;86(4):827–834. https://doi.org/10.1016/j.jaad.2021.11.004.
45. Margolis D, Bilker W, Hennessy S, Vittorio C, Santanna J, Strom BL. The risk of malignancy associated with psoriasis. Arch Dermatol. 2001;137(6):778–783. Available at: https://pubmed.ncbi.nlm.nih.gov/?term=44.%09Margolis+D%2C+Bilker+W%2C+Hennessy+S%2C+Vittorio+C%2C+Santanna+J%2C+Strom+BL.+The+risk+of+malignancy+associated+with+psoriasis.+Arch+Dermatol.+2001%3B137%3A778%E2%80%93783.
46. Askling J, Fahrbach K, Nordstrom B, Ross S, Schmid CH, Symmons D. Cancer risk with tumor necrosis factor alpha (TNF) inhibitors: meta-analysis of randomized controlled trials of adalimumab, etanercept, and infliximab using patient level data. Pharmacoepidemiol Drug Saf. 2011;20(2):119–130. https://doi.org/10.1002/pds.2046.
47. Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V. AntiTNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies–systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA. 2006;295(19):2275–2285. https://doi.org/10.1001/jama.295.19.2275.
48. Gottlieb A, Lebwohl M, Liu C. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020;21(3):421–430. https://doi.org/10.1007/s40257-020-00512-4.
49. Strober B, Leonardi C, Papp KA, Mrowietz U, Ohtsuki M, Bissonnette R et al. Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: etanercept comparisons and integrated data. J Am Acad Dermatol. 2017;76(3):432–440. https://doi.org/10.1016/j.jaad.2016.09.026.
50. Papp KA, Griffiths CEM, Gordon K, Lebwohl M, Szapary Po, Wasfi Y et al. Long-term safety of ustekinumab in patients with moderate-to-severe psoriasis: final results from 5 years of follow-up. B J Dermatol. 2013;168(4):844–854. https://doi.org/10.1111/bjd.12214.
51. Gordon KB, Papp KA, Langley RG, Ho V, Kimball AB, Guzzo C et al. Long-term safety experience of ustekinumab in patients with moderate to severe psoriasis (part II of II): results from analyses of infections and malignancy from pooled phase II and III clinical trials. J Am Acad Dermatol. 2012;66(5):742–751. https://doi.org/10.1016/j.jaad.2011.06.041.
52. Strober B, Gooderham M, de Jong EMGJ, Kimball AB, Langley RG, Lakdawala N et al. Depressive symptoms, depression, and the effect of biologic therapy among patients in Psoriasis Longitudinal Assessment and Registry (PSOLAR). J Am Acad Dermatol. 2018;78(1):70–80. https://doi.org/10.1016/j.jaad.2017.08.051.
53. Langley RG, Feldman SR, Han C, Schenkel B, Szapary P, Hsu M-C et al. Ustekinumab significantly improves symptoms of anxiety, depression, and skin-related quality of life in patients with moderate-to-severe psoriasis: results from a randomized, double-blind, placebo-controlled phase III trial. J Am Acad Dermatol. 2010;63(3):457–465. https://doi.org/10.1016/j.jaad.2009.09.014.
54. Griffiths CEM, Fava M, Miller AH, Russell J, Ball SG, Xu W et al. Impact of ixekizumab treatment on depressive symptoms and systemic inflammation in patients with moderate-to-severe psoriasis: an integrated analysis of three phase 3 clinical studies. Psychother Psychosom. 2017;86(5):260–267. https://doi.org/10.1159/000479163.
55. Strober BE, Langley RGB, Menter A, Magid M, Porter B, Fox T et al. No elevated risk for depression, anxiety or suicidality with secukinumab in a pooled analysis of data from 10 clinical studies in moderate-to-severe plaque psoriasis. Br J Dermatol. 2018;178(2):E105-107. https://doi.org/10.1111/bjd.16051.
56. Komori T, Otsuka A, Honda Y, Kanameishi S, Honda T, Kabashima K. Exacerbation of depression in a psoriatic arthritis patient possibly induced by secukinumab. Eur J Dermatol. 2016;26(5):506–507. https://doi.org/10.1684/ejd.2016.2832.
57. Reich K, Gordon B, Strober BE, Armstrong AW, Miller M, Shen YK. Five‐year maintenance of clinical response and health‐related quality of life improvements in patients with moderate‐to‐severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2. British Journal of Dermatol. 2021;185(6):1146–1159. https://doi.org/10.1111/bjd.20568.
Рецензия
Для цитирования:
Жукова О.В., Артемьева С.И. Выбор генно-инженерной биологической терапии в лечении тяжелых форм псориаза. Медицинский Совет. 2023;(14):24-34. https://doi.org/10.21518/ms2023-280
For citation:
Zhukova O.V., Artemyeva S.I. The selection of the initial drug in the treatment of severe psoriasis. Meditsinskiy sovet = Medical Council. 2023;(14):24-34. (In Russ.) https://doi.org/10.21518/ms2023-280
Просмотров: 106
Послать статью по эл. почте 