medalphabetМедицинский алфавитMedical alphabet2078-56312949-2807ООО «Альфмед»10.33667/2078-5631-2020-24-18-22medalphabet-1779Research ArticleКЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯВыбор биологических генно-инженерных препаратов первой линии при средней и тяжелой степени тяжести псориаза у пациентов с коморбидной патологиейChoice of first-line genetically engineered biological drugs for moderate and severe psoriasis in patients with comorbid pathologyКругловаЛ. С.KruglovaL. S.

д.м.н., проректор по учебной работе, зав. кафедрой дерматовенерологии и косметологии,

Москва

Moscow

ХоткоА. А.HotkoA. A.

к.м.н., зам. главврача по медицинской части,

г. Краснодар

Krasnodar

ФГБУ ДПО «Центральная государственная медицинская академия» Управления делами Президента Российской ФедерацииРоссияCentral State Medical Academy of the Administrative Department of the President of RussiaRussian FederationГБУЗ «Клинический кожно-венерологический диспансер» Минздрава Краснодарского краяРоссияClinical Dermatovenerologic DispensaryRussian Federation202018122020024Дерматология (2)1822Copyright © Круглова Л.С., Хотко А.А., 20202020Круглова Л.С., Хотко А.А.Kruglova L.S., Hotko A.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.med-alphabet.com/jour/article/view/1779

Изучение иммунопатогенеза привело к разработке новых методов терапии псориаза средней и тяжелой степени. Ингибиторы фактора некроза опухоли, блокаторы ИЛ‑17, ИЛ‑12/-23, ИЛ‑23 интегрированы в схемы терапии распространенных форм псориаза. Результаты клинических исследований и реальной практики показали высокую эффективность и хороший профиль безопасности биологических препаратов при псориазе, однако вопросы дифференцированного применения, в том числе в зависимости от коморбидной патологии, требуют дальнейшего изучения. Принятие клинических решений должно проводиться с учетом наиболее рационального подхода, а также преимуществ и ограничений применения генно-инженерных препаратов. В статье обсуждаются рекомендации относительно выбора биологической терапии первой линии для пациентов с псориазом и различными сопутствующими заболеваниями и факторами, связанными с пациентом. Представлены данные об эффективности и безопасности применения препарата нетакимаб у пациентов с псориазом и коморбидной патологией.

The study of immunopathogenesis has led to the development of new methods of therapy for moderate-to-severe psoriasis. Tumor necrosis factor inhibitors, blockers of IL‑17, IL‑12/-23, IL‑23 are integrated into the therapy regimens for common forms of psoriasis. The results of clinical studies and real practice have shown high efficacy and a good safety profile of biological agents in psoriasis, however, the issues of differentiated use, including depending on comorbid pathology, require further study. Clinical decision-making should be carried out taking into account the most rational approach, as well as taking into account the advantages and limitations of the use of genetically engineered drugs. This article discusses recommendations regarding the choice of first-line biological therapy for patients with psoriasis and various comorbidities and patient-related factors. In addition, the article presents data on the efficacy and safety of using the original IL‑17 inhibitor netakimab in patients with psoriasis and comorbid pathology.

псориазсреднетяжелое и тяжелое течениепсориатический артритартериальная гипертензияхроническая сердечная недостаточностьблокатор интерлейкина‑17Анетакимаб.psoriasismoderate-to-severe and severe coursepsoriatic arthritiscardiovascular diseaseschronic heart failureinterleukin‑17A blockernetakimabReferencesПотекаев Н. Н., Круглова Л. С. Псориатическая болезнь. Москва. МДВ. 2014. 264 с.Потекаев Н. Н., Круглова Л. С. Псориатическая болезнь. Москва. МДВ. 2014. 264 с.Yeung H, Takeshita J, Mehta NN, et al. Psoriasis severity and the prevalence of major medical comorbidity: a population-based study. JAMA Dermatol. 2013; 149 (10): 1173–9.Yeung H, Takeshita J, Mehta NN, et al. Psoriasis severity and the prevalence of major medical comorbidity: a population-based study. JAMA Dermatol. 2013; 149 (10): 1173–9.Tsai TF, Wang TS, Hung ST, et al. Epidemiology and comorbidities of psoriasis patients in a national database in Taiwan. J Dermatol Sci. 2011; 63 (1): 40–6.Tsai TF, Wang TS, Hung ST, et al. Epidemiology and comorbidities of psoriasis patients in a national database in Taiwan. J Dermatol Sci. 2011; 63 (1): 40–6.Takeshita J, Grewal S, Langan SM, et al. Psoriasis and comorbid diseases: epidemiology. J Am Acad Dermatol. 2017; 76 (3): 377–90.Takeshita J, Grewal S, Langan SM, et al. Psoriasis and comorbid diseases: epidemiology. J Am Acad Dermatol. 2017; 76 (3): 377–90.Fitch E, Harper E, Skorcheva I, et al. Pathophysiology of psoriasis: recent advances on IL 23 and Th17 cytokines. Current rheumatology reports. 2007. Т. 9. N6. Р. 461–467.Fitch E, Harper E, Skorcheva I, et al. Pathophysiology of psoriasis: recent advances on IL 23 and Th17 cytokines. Current rheumatology reports. 2007. Т. 9. N6. Р. 461–467.Bettelli E, Carrier Y, Gao W, et al. Reciprocal developmental pathways for the generation of pathogenic effector TH17 and regulatory T cells Nature. 2006. Т. 441. N7090. Р. 235–238.Bettelli E, Carrier Y, Gao W, et al. Reciprocal developmental pathways for the generation of pathogenic effector TH17 and regulatory T cells Nature. 2006. Т. 441. N7090. Р. 235–238.Mangan PR, Harrington LE, O’Quinn DB, et al. Transforming growth factor-β induces development of the TH 17 lineage. Nature. 2006. Т. 441. N7090. Р. 231–234.Mangan PR, Harrington LE, O’Quinn DB, et al. Transforming growth factor-β induces development of the TH 17 lineage. Nature. 2006. Т. 441. N7090. Р. 231–234.Martin DA, Towne JE, Kricorian G, et al. The emerging role of IL 17 in the pathogenesis of psoriasis: preclinical and clinical findings. Journal of Investigative Dermatology. 2013. Т. 133. N1. Р. 17–26.Martin DA, Towne JE, Kricorian G, et al. The emerging role of IL 17 in the pathogenesis of psoriasis: preclinical and clinical findings. Journal of Investigative Dermatology. 2013. Т. 133. N1. Р. 17–26.Ely LK., Fischer S., Garcia KC. Structural basis of receptor sharing by interleukin 17 cytokines. Nature immunology. 2009. Т. 10. N12. Р. 1245–49.Ely LK., Fischer S., Garcia KC. Structural basis of receptor sharing by interleukin 17 cytokines. Nature immunology. 2009. Т. 10. N12. Р. 1245–49.Krueger JG, Fretzin S, Suárez-Fariñas M, et al. IL 17A is essential for cell activation and inflammatory gene circuits in subjects with psoriasis. Journal of Allergy and Clinical Immunology. 2012. Т. 130. N1. Р. 145–154.Krueger JG, Fretzin S, Suárez-Fariñas M, et al. IL 17A is essential for cell activation and inflammatory gene circuits in subjects with psoriasis. Journal of Allergy and Clinical Immunology. 2012. Т. 130. N1. Р. 145–154.Kao CY, Chen Y, Thai P, et al. IL 17 markedly up-regulates beta-defensin 2 expression in human airway epithelium via JAK and NF-kappa B signaling pathways. J Immunol. 2004; 173: 3482–91.Kao CY, Chen Y, Thai P, et al. IL 17 markedly up-regulates beta-defensin 2 expression in human airway epithelium via JAK and NF-kappa B signaling pathways. J Immunol. 2004; 173: 3482–91.Miossec P, Kolls JK. Targeting IL 17 and TH17 cells in chronic inflammation. Nature reviews Drug discovery. 2012. Т. 11. N10. Р. 763–776.Miossec P, Kolls JK. Targeting IL 17 and TH17 cells in chronic inflammation. Nature reviews Drug discovery. 2012. Т. 11. N10. Р. 763–776.Chiricozzi A, Guttman-Yassky E, Suárez-Fariñas M, et al. Integrative responses to IL 17 and TNF-α in human keratinocytes account for key inflammatory pathogenic circuits in psoriasis. Journal of Investigative Dermatology. 2011. Т. 131. N3. Р. 677–687.Chiricozzi A, Guttman-Yassky E, Suárez-Fariñas M, et al. Integrative responses to IL 17 and TNF-α in human keratinocytes account for key inflammatory pathogenic circuits in psoriasis. Journal of Investigative Dermatology. 2011. Т. 131. N3. Р. 677–687.Moseley TA, Haudenschild DR, Rose L, et al. Interleukin 17 family and IL 17 receptors. Cytokine & growth factor reviews. 2003. Т. 14. N2. Р. 155–174.Moseley TA, Haudenschild DR, Rose L, et al. Interleukin 17 family and IL 17 receptors. Cytokine & growth factor reviews. 2003. Т. 14. N2. Р. 155–174.Harper EG, Guo C, Rizzo H, et al. Th17 cytokines stimulate CCL20 expression in keratinocytes in vitro and in vivo: implications for psoriasis pathogenesis. Journal of Investigative Dermatology. 2009. Т. 129. N9. Р. 2175–2183.Harper EG, Guo C, Rizzo H, et al. Th17 cytokines stimulate CCL20 expression in keratinocytes in vitro and in vivo: implications for psoriasis pathogenesis. Journal of Investigative Dermatology. 2009. Т. 129. N9. Р. 2175–2183.Yilmaz SB, Cicek N, Coskun M, et al. Serum and tissue levels of IL- 17 in different clinical subtypes of psoriasis. Archiv Dermatol Res. 2012; 304: 465–9.Yilmaz SB, Cicek N, Coskun M, et al. Serum and tissue levels of IL- 17 in different clinical subtypes of psoriasis. Archiv Dermatol Res. 2012; 304: 465–9.Krueger JG, Fretzin S, Suárez-Fariñas M, et al. IL 17A is essential for cell activation and inflammatory gene circuits in subjects with psoriasis. Journal of Allergy and Clinical Immunology. 2012. Т. 130. N1. Р. 145–154.Krueger JG, Fretzin S, Suárez-Fariñas M, et al. IL 17A is essential for cell activation and inflammatory gene circuits in subjects with psoriasis. Journal of Allergy and Clinical Immunology. 2012. Т. 130. N1. Р. 145–154.Кубанов А. А., Бакулев А. Л., Самцов А. В., Хайрутдинов В. Р. Нетакимаб – новый ингибитор ИЛ 17а: результаты 12 недель клинического исследования III фазы BCD 085–7/PLANETA у пациентов со среднетяжелым и тяжелым вульгарным псориазом. Вестник дерматологии и венерологии. 2019. Т. 95. № 2. С. 15–28.Кубанов А. А., Бакулев А. Л., Самцов А. В., Хайрутдинов В. Р. Нетакимаб – новый ингибитор ИЛ 17а: результаты 12 недель клинического исследования III фазы BCD 085–7/PLANETA у пациентов со среднетяжелым и тяжелым вульгарным псориазом. Вестник дерматологии и венерологии. 2019. Т. 95. № 2. С. 15–28.Бакулев А.Л., Самцов А.В., Кубанов А.А., Хайрутдинова В.Р. Долгосрочная эффективность и безопасность препарата нетакимаб у пациентов со среднетяжелым и тяжелым вульгарным псориазом. Результаты открытого продленного клинического исследования II фазы BCD 085–2-ext. Вестник дерматологии и венерологии. 2019. Т. 95. № 3. С. 54–64.Бакулев А.Л., Самцов А.В., Кубанов А.А., Хайрутдинова В.Р. Долгосрочная эффективность и безопасность препарата нетакимаб у пациентов со среднетяжелым и тяжелым вульгарным псориазом. Результаты открытого продленного клинического исследования II фазы BCD 085–2-ext. Вестник дерматологии и венерологии. 2019. Т. 95. № 3. С. 54–64.Коротаева Т.В., Мазуров В.И., Лила А.М., Гайдукова И.З., Бакулев А.Л., Самцов А.В., Хайрутдинов В.Р., Еремеева А.В., Морозова М.А. Эффективность и безопасность нетакимаба у пациентов с псориатическим артритом: результаты клинического исследования III фазы PATERA. Научно-практическая ревматология. 2020; 58 (5): 480–488.Коротаева Т.В., Мазуров В.И., Лила А.М., Гайдукова И.З., Бакулев А.Л., Самцов А.В., Хайрутдинов В.Р., Еремеева А.В., Морозова М.А. Эффективность и безопасность нетакимаба у пациентов с псориатическим артритом: результаты клинического исследования III фазы PATERA. Научно-практическая ревматология. 2020; 58 (5): 480–488.Gelfand JM, Gladman DD, Mease PJ, et al. Epidemiology of psoriatic arthritis in the population of the United States. J Am Acad Dermatol. 2005; 53 (4): 573.Gelfand JM, Gladman DD, Mease PJ, et al. Epidemiology of psoriatic arthritis in the population of the United States. J Am Acad Dermatol. 2005; 53 (4): 573.Zachariae H, Zachariae R, Blomqvist K, et al. Quality of life and prevalence of arthritis reported by 5795 members of the Nordic Psoriasis Associations. Acta Dermato Venereol. 2002; 82 (2): 108–13.Zachariae H, Zachariae R, Blomqvist K, et al. Quality of life and prevalence of arthritis reported by 5795 members of the Nordic Psoriasis Associations. Acta Dermato Venereol. 2002; 82 (2): 108–13.Чамурлиева М.Н., Логинова Е.Ю., Коротаева Т.В., Баткаев Э.А. Поражение костно-суставного аппарата у больных псориазом по данным скринингового опросника PEST (Psoriasis Epydemiology Screening Tool) и ревматологического клинико-инструментального обследования. Научно-практическая ревматология. 2014; 52 (6): 636–642.Чамурлиева М.Н., Логинова Е.Ю., Коротаева Т.В., Баткаев Э.А. Поражение костно-суставного аппарата у больных псориазом по данным скринингового опросника PEST (Psoriasis Epydemiology Screening Tool) и ревматологического клинико-инструментального обследования. Научно-практическая ревматология. 2014; 52 (6): 636–642.Абдулганиева Д.И. и соавт. Проект междисциплинарных рекомендаций по диагностике, методам оценки степени активности, терапевтической эффективности иприменению генно-инженерных биологических препаратов у пациентов с сочетанными иммуновоспалительными заболеваниями (псориаз, псориатический артрит, болезнь Крона). Современная ревматология 2018. 12 (3): 4–18.Абдулганиева Д.И. и соавт. Проект междисциплинарных рекомендаций по диагностике, методам оценки степени активности, терапевтической эффективности иприменению генно-инженерных биологических препаратов у пациентов с сочетанными иммуновоспалительными заболеваниями (псориаз, псориатический артрит, болезнь Крона). Современная ревматология 2018. 12 (3): 4–18.Mease PJ, Gladman DD, Ritchlin CT, et al. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 2005; 52 (10): 3279–89.Mease PJ, Gladman DD, Ritchlin CT, et al. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 2005; 52 (10): 3279–89.Mease PJ, Kivitz AJ, Burch FX, et al. Continued inhibition of radiographic progression in patients with psoriatic arthritis following 2 years of treatment with etanercept. J Rheumatol. 2006; 33 (4): 712–21.Mease PJ, Kivitz AJ, Burch FX, et al. Continued inhibition of radiographic progression in patients with psoriatic arthritis following 2 years of treatment with etanercept. J Rheumatol. 2006; 33 (4): 712–21.van der Heijde D, Kavanaugh A, et al. Infliximab inhibits progression of radiographic damage in patients with active psoriatic arthritis through 1 year of treatment: results from the induction and maintenance psoriatic arthritis clinical trial 2. Arthritis Rheum. 2007; 56 (8): 2698–707.van der Heijde D, Kavanaugh A, et al. Infliximab inhibits progression of radiographic damage in patients with active psoriatic arthritis through 1 year of treatment: results from the induction and maintenance psoriatic arthritis clinical trial 2. Arthritis Rheum. 2007; 56 (8): 2698–707.Fenix-Caballero S, Alegre-del Rey EJ, Castano-Lara R, et al. Direct and indirect comparison of the efficacy and safety of adalimumab, etanercept, infliximab and golimumab in psoriatic arthritis. J Clin Pharm Ther. 2013; 38 (4): 286–93.Fenix-Caballero S, Alegre-del Rey EJ, Castano-Lara R, et al. Direct and indirect comparison of the efficacy and safety of adalimumab, etanercept, infliximab and golimumab in psoriatic arthritis. J Clin Pharm Ther. 2013; 38 (4): 286–93.Strand V, Balsa A, Al-Saleh J, et al. Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review // BioDrugs. Springer International Publishing, 2017. Vol. 31, N4. P. 299–316.Strand V, Balsa A, Al-Saleh J, et al. Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review // BioDrugs. Springer International Publishing, 2017. Vol. 31, N4. P. 299–316.McInnes IB, Mease PJ, Kirkham B, et al. Secukinumab, a human anti-interleukin 17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015; 386 (9999): 1137–46.McInnes IB, Mease PJ, Kirkham B, et al. Secukinumab, a human anti-interleukin 17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015; 386 (9999): 1137–46.Mease PJ, Genovese MC, Greenwald MW, et al. Brodalumab, an anti-IL17RA monoclonal antibody, in psoriatic arthritis. N Engl J Med. 2014; 370 (24): 2295–306.Mease PJ, Genovese MC, Greenwald MW, et al. Brodalumab, an anti-IL17RA monoclonal antibody, in psoriatic arthritis. N Engl J Med. 2014; 370 (24): 2295–306.Nash P, Kirkham B, Okada M, et al. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, doubleblind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017; 389 (10086): 2317–27.Nash P, Kirkham B, Okada M, et al. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, doubleblind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017; 389 (10086): 2317–27.Kavanaugh A, Ritchlin C, Rahman P, et al. Ustekinumab, an anti-IL 12/23 p40 monoclonal antibody, inhibits radiographic progression in patients with active psoriatic arthritis: results of an integrated analysis of radiographic data from the phase 3, multicentre, randomised, double-blind, placebo-controlled PSUMMIT 1 and PSUMMIT 2 trials. Ann Rheum Dis. 2014;73 (6): 1000–6.Kavanaugh A, Ritchlin C, Rahman P, et al. Ustekinumab, an anti-IL 12/23 p40 monoclonal antibody, inhibits radiographic progression in patients with active psoriatic arthritis: results of an integrated analysis of radiographic data from the phase 3, multicentre, randomised, double-blind, placebo-controlled PSUMMIT 1 and PSUMMIT 2 trials. Ann Rheum Dis. 2014;73 (6): 1000–6.Cantini F, Niccoli L, Nannini C, et al. Tailored first-line biologic therapy in patients with rheumatoid arthritis, spondyloarthritis, and psoriatic arthritis. Semin Arthritis Rheum. 2016; 45 (5): 519–32.Cantini F, Niccoli L, Nannini C, et al. Tailored first-line biologic therapy in patients with rheumatoid arthritis, spondyloarthritis, and psoriatic arthritis. Semin Arthritis Rheum. 2016; 45 (5): 519–32.Buckley C., Cavill C., Taylor G. et al. Mortality in psoriatic arthritis – a single-center study from the UK. J Rheumatol 2010; 37: 2141–2144.Buckley C., Cavill C., Taylor G. et al. Mortality in psoriatic arthritis – a single-center study from the UK. J Rheumatol 2010; 37: 2141–2144.Gelfand J.M., Dommasch E.D., Shin D.B. et al. The risk of stroke in patients with psoriasis. J Invest Dermatol 2009; 129 (10): 2411–2418.Gelfand J.M., Dommasch E.D., Shin D.B. et al. The risk of stroke in patients with psoriasis. J Invest Dermatol 2009; 129 (10): 2411–2418.Gelfand J.M., Neimann A. L., Shin D.B. et al. Risk of myocardial infarction in patients with psoriasis. JAMA 2006; 296 (14): 1735–1741.Gelfand J.M., Neimann A. L., Shin D.B. et al. Risk of myocardial infarction in patients with psoriasis. JAMA 2006; 296 (14): 1735–1741.Lin H.W., Wang K.H., Lin H.C. Increased risk of acute myocardial infarction in patients with psoriasis: a 5-year population-based study in Taiwan. J Am Acad Dermatol 2011; 64 (3): 495–501.Lin H.W., Wang K.H., Lin H.C. Increased risk of acute myocardial infarction in patients with psoriasis: a 5-year population-based study in Taiwan. J Am Acad Dermatol 2011; 64 (3): 495–501.Chung ES, Packer M, Lo KH, et al. Randomized, double-blind, placebo-controlled, pilot trial of infliximab, a chimeric monoclonal antibody to tumor necrosis factor-a, in patients with moderate-to-severe heart failure. Circulation. 2003; 107 (25): 3133–40.Chung ES, Packer M, Lo KH, et al. Randomized, double-blind, placebo-controlled, pilot trial of infliximab, a chimeric monoclonal antibody to tumor necrosis factor-a, in patients with moderate-to-severe heart failure. Circulation. 2003; 107 (25): 3133–40.Kwon HJ, Cote´ TR, Cuffe MS, et al. Case reports of heart failure after therapy with a tumor necrosis factor antagonist. Ann Intern Med. 2003; 138 (10): 807–11.Kwon HJ, Cote´ TR, Cuffe MS, et al. Case reports of heart failure after therapy with a tumor necrosis factor antagonist. Ann Intern Med. 2003; 138 (10): 807–11.Desai SB, Furst DE. Problems encountered during anti-tumor necrosis factor therapy. Best Pract Res. 2006; 20 (4): 757–90.Desai SB, Furst DE. Problems encountered during anti-tumor necrosis factor therapy. Best Pract Res. 2006; 20 (4): 757–90.Papp KA, Griffiths CE, Gordon K, et al. Long-term safety of ustekinumab in patients with moderate-to-severe psoriasis: final results from 5 years of follow-up. Br J Dermatol. 2013; 168 (4): 844–54.Papp KA, Griffiths CE, Gordon K, et al. Long-term safety of ustekinumab in patients with moderate-to-severe psoriasis: final results from 5 years of follow-up. Br J Dermatol. 2013; 168 (4): 844–54.Gordon KB, Blauvelt A, Papp KA, et al. Phase 3 trials of ixekizumab in moderate-tosevere plaque psoriasis. N Engl J Med. 2016; 375 (4): 345–56.Gordon KB, Blauvelt A, Papp KA, et al. Phase 3 trials of ixekizumab in moderate-tosevere plaque psoriasis. N Engl J Med. 2016; 375 (4): 345–56.

The authors declare that there are no conflicts of interest present.