Journal of Volgograd State Medical UniversityJournal of Volgograd State Medical UniversityВестник Волгоградского государственного медицинского университета1994-94801994-9499Volgograd State Medical University13917410.19163/1994-9480-2022-19-4-3-9ArticlesСтатьиResearch ArticleANALYSIS OF THE EFFICACY AND SAFETY OF GENETICALLY ENGINEERED BIOLOGICAL THERAPY FOR MODERATELY SEVERE AND SEVERE FORMS OF PSORIASISАНАЛИЗ ЭФФЕКТИВНОСТИ И БЕЗОПАСНОСТИ ГЕННО-ИНЖЕНЕРНОЙ БИОЛОГИЧЕСКОЙ ТЕРАПИИ УМЕРЕННО ТЯЖЕЛЫХ И ТЯЖЕЛЫХ ФОРМ ПСОРИАЗАPetrovV. IПетровВ. И

Academician of the Russian Academy of Sciences, Doctor of Medical Sciences, Professor, Head of the Department of Clinical Pharmacology and Intensive Care

академик РАН, доктор медицинских наук, профессор, заведующий кафедрой клинической фармакологии и интенсивной терапии

brain@sprintnet.ruShatalovaO. VШаталоваО. В

Doctor of Medical Sciences, Professor of the Department of Clinical Pharmacology and Intensive Care

доктор медицинских наук, профессор кафедры клинической фармакологии и интенсивной терапии

shov_med@mail.ruPopovV. VПоповВ. В

Assistant of the Department of Dermatovenerology

ассистент кафедры дерматовенерологии

derma_18@mail.ruShchavaS. NЩаваС. Н

Head of the Department of Dermatovenerology

заведующая кафедрой дерматовенерологии

snchava@rambler.ruVolgograd State Medical UniversityВолгоградский государственный медицинский университет15122022194VOL 19, NO4 (2022)ТОМ 19, №4 (2022)3926012023Copyright ©; 2022, Petrov V.I., Shatalova O.V., Popov V.V., Shchava S.N.Copyright ©; 2022, Петров В.И., Шаталова О.В., Попов В.В., Щава С.Н.2022Petrov V.I., Shatalova O.V., Popov V.V., Shchava S.N.Петров В.И., Шаталова О.В., Попов В.В., Щава С.Н.https://creativecommons.org/licenses/by/4.0https://journals.eco-vector.com/1994-9480/article/view/139174

The article presents the data of the analysis of modern data on the efficacy and safety of genetically engineered biological drugs registered in the Russian Federation for the treatment of moderately severe and severe forms of psoriasis. The review of modern domestic and foreign literature showed a higher efficacy and safety of biological preparations compared with basic anti-inflammatory therapy and the expediency of prescribing TNF-a inhibitors, IL-12/23, IL-17, IL-23 inhibitors in various forms of psoriasis, given the degree severity and comorbid conditions. This review will help practitioners to determine the most optimal treatment regimen for moderately severe and severe forms of psoriasis.

В статье представлены данные анализа современных данных, посвященных эффективности и безопасности генно-инженерных биологических препаратов, зарегистрированных на территории Российской Федерации, для лечения умеренно тяжелых и тяжелых форм псориаза. Проведенный обзор современной отечественной и зарубежной литературы показал более высокую эффективность и безопасность биологических препаратов по сравнению с базисной противовоспалительной терапией и целесообразность назначения ингибиторов ФНО-а, ингибиторов ИЛ-12/23, ИЛ-17, ИЛ-23 при различных формах псориаза, учитывая степень тяжести и коморбидные состояния. Приведенный обзор поможет практическим врачам определить наиболее оптимальную схему терапии умеренно тяжелых и тяжелых форм псориаза.

psoriasisbiological therapyTNF-a inhibitorsIL-17IL-12/23IL-23 inhibitorsпсориазбиологическая терапияингибиторы ФНО-аингибиторы ИЛ-17ИЛ-12/23ИЛ-23Psoriasis. Clinical guidelines. AU-Russian Public Organization "Russian Society of Dermatovenereologists and Cosmetologists". 2020. URL: https://www.rodv.ru/klinicheskie-rekomendacii.Michalek I.M. Loring B., John S.M. A systematic review of worldwide epidemiology of psoriasis. J Eur Acad Dermatol Venereol. 2017;31(2):205-212. doi: 10.1111/jdv.13854.McArdle A., Pennington S., FitzGerald O. Clinical features of psoriatic arthritis: a comprehensive review of unmet clinical needs. Clin Rev Allergy Immunol. 2018;55:271-294. doi: 10.1007/s12016-017-8630-7.Ritchlin C.T., Colbert R.A., Gladman D.D. Psoriatic arthritis. N Engl J Med. 2017;376:957-970. doi: 10.1056/ NEJMra1505557.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):108-113. doi: 10.1080/00015550252948130.Gustafson B., Hammarsledt A., Andersson C.X., Smith U. Inflamed adipose tissue a culprit underlying the metabolic syndrome and atherosclerosis. Arteriosclerosis, Thrombosis, and Vascular Biology. 2007;27:2276-2283. doi: 10.1161/ ATVBAHA.107.147835.Yeung H., Takeshita J., Mehta N.N. et al. Psoriasis severity and the prevalence of major medical comorbidity: a population-based study. JAMA Dermatol. 2013;149(10):1173-1179. doi: 10.1001/jamadermatol.2013.5015.Tsai T.F., Wang T.S., Hung S.T. et al. Epidemiology and comorbidities of psoriasis patients in a national database in Taiwan. J Dermatol Sci. 2011;63(1):40-46. doi: 10.1016/j.jdermsci.2011.03.002.Takeshita J., Grewal S., Langan S.M. et al. Psoriasis and comorbid diseases: epidemiology. J Am Acad Dermatol. 2017;76(3):377-390. doi: 10.1016/j.jaad.2016.07.064.Burns T., Breathnach S., Cox N., Griffiths C. Rook's Textbook of Dermatology. 8th. Hoboken, NJ, USA: Wiley Blackwell; 2010.Pompili M., Innamorati M., Trovarelli S. et al. Suicide risk and psychiatric comorbidity in patients with psoriasis. Journal of International Medical Research. 2016;44(1):61-66. doi: 10.1177/0300060515593253.Gladman D.D., Farewell W.T., Wong K., Husted J. Mortality studies in psoriatic arthritis. Arthr. Reum. 1998: 41(6):1103-1110. doi: 10.1002/1529-0131(199806).Pathirana D., Ormerod A.D., Saiag P. et al. European S3-guidelines on the systemic treatment of psoriasis vulgaris. J Eur Acad Dermatol Venerol. 2009;23(2):1-70.Reich K., Wozel G., Zheng H., van Hoogstraten H.J., Flint L., Barker J. Efficacy and safety of infliximab as continuous or intermittent therapy in patients with moderate-to-severe plaque psoriasis: results of a randomized, long-term extension trial (RESTORE2). Br J Dermatol. 2013;168(6):1325-1334. doi: 10.1111/bjd.12404.Menter A., Feldman S.R., Weinstein G.D, et al. A randomized comparison of continuous vs.intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2007;56(1): e31-e15. doi:10.1016/j.jaadMease P.J., Goffe B.S., Metz J., Vander Stoep A., Finck B., Burge D.J. Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial. Lancet. 2000;356:385-390. doi: 10.1016/S0140-6736(00)02530-7.Leonardi C.L., Powers J.L., Matheson R.T. et al. Gottlieb Etanercept as monotherapy in patients with psoriasis. N Engl J Med. 2003;349:2014-2022. doi: 10.1056/NEJMoa030409.Papp K.A., Tyring S., Lahfa M. et al. A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermatol. 2005:1304-13127. doi: 10.1111/j.1365-2133.2005.06688.x.Maul J.T., Djamei V., Kolios A.G.A. et al. Efficacy and survival of systemic psoriasis treatments: an analysis of the Swiss Registry SDNTT. Dermatology. 2016;232:640-647. doi: 10.1159/000452740.Lin P.T., Wang S.H., Chi C.C. Drug survival of biologics in treating psoriasis: a meta-analysis of real-world evidence. Sci Rep. 2018;8(2018);16068. doi: 10.1038/s41598-018-34293-y.Zweegers J., van den Reek J.M., van de Kerkhof P.C. et al. Body mass index predicts discontinuation due to ineffectiveness and female sex predicts discontinuation due to side-effects in patients with psoriasis treated with adalimumab, etanercept or ustekinumab in daily practice: a prospective, comparative, long-term drug-survival study from the BioCAPTURE registry. Br J Dermatol. 2016;175:340-347. doi: 10.1111/bjd.14552.Menter A., Tyring S.K., Gordon K. et al. Adalimumab therapy for moderate to severe psoriasis: a randomized, controlled phase III trial. J Am Acad Dermatol. 2008;58:106-115. doi: 10.1016/j.jaad.2007.09.010.Saurat J.H., Stingl G., Dubertret L. et al. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION). Br J Dermatol. 2008; 158(2008):558-566.Dand N., Duckworth M., Baudry D. et al. BADBIR Study Group; BSTOP Study Group; PSORT Consortium. HLA-C*06:02 genotype is a predictive biomarker of biologic treatment response in psoriasis. J Allergy Clin Immunol. 2019;143(6):2120-2130. doi: 10.1016/j.jaci.2018.11.038.Gottlieb A.B., Blauvelt A., Thagi D. et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2). J Am Acad Dermatol. 2018;79:302-314.Lebwohl M., Blauvelt A., Paul C. et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: results through 48 weeks of a phase 3, multicenter, randomized, double-blind, etanercept- and placebo-controlled study (CIMPACT). J Am Acad Dermatol. 2018;79;266-276. doi: 10.1016/j.jaad.2018.04.013.Garcia-Doval I., Cohen A.D., Cazzaniga S. et al. Risk of serious infections, cutaneous bacterial infections, and granulomatous infections in patients with psoriasis treated with anti-tumor necrosis factor agents versus classic therapies: prospective meta-analysis of Psonet registries. J Am Acad Dermatol. 2017;76(2017):299-308. doi: 10.1016/j.jaad.2016.07.039.Murdaca G., Negrini S., Pellecchio M. et al. Update upon the infection risk in patients receiving TNF alpha inhibitors. Expert Opin Drug Saf. 2019;18(3):219-229. doi: 10.1080/14740338.2019.1577817.Kemanetzoglou E., Andreadou E. CNS Demyelination with TNF-a Blockers. Curr Neurol Neurosci Rep. 2017; 17(4):36. doi: 10.1007/s11910-017-0742-1.Momen S.E., Kirkham B., Barker J.N., Smith C.H. Tumour necrosis factor antagonist-induced lupus: a Critically Appraised Topic. Br J Dermatol. 2017;177(6):1519-1526. doi: 10.1111/bjd.15866.Kwon H.J., Cote T.R., Cuffe M.S., Kramer J.M., Braun M.M. Case reports of heart failure after therapy with a tumor necrosis factor antagonist. Ann Intern Med. 2003;138: 807-811. doi: 10.7326/0003-4819-138-10-200305200-00008.Fiorentino D., Ho V., Lebwohl M.G. et al. Risk of malignancy with systemic psoriasis treatment in the Psoriasis Longitudinal Assessment Registry. J Am Acad Dermatol. 2017;77:845-854. doi: 10.1016/j.jaad.2017.07.013.van LQmig P.P., Menting S.P., van den Reek J.M. et al. An increased risk of non-melanoma skin cancer during TNF-inhibitor treatment in psoriasis patients compared to rheumatoid arthritis patients probably relates to disease-related factors. J Eur Acad Dermatol Venereol. 2015;29:752-760. doi: 10.1111/jdv.12675.Gisondi P., Cotena C., Tessari G., Girolomoni G. Antitumour necrosis factor-alpha therapy increases body weight in patients with chronic plaque psoriasis: a retrospective cohort study. J Eur Acad Dermatol Venereol. 2008;22:341-344. doi: 10.1111/j.1468-3083.2007.02429.x.Kaushik S.B., Lebwohl M.G. Psoriasis: which therapy for which patient: psoriasis comorbidities and preferred systemic agents. J Am Acad Dermatol. 2019;80:27-40. doi: 10.1016/j.jaad.2018.06.057.Gordon K.B., Papp K.A., Langley R.G. 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;66:742-751. doi: 10.1016/j.jaad.2011.06.041.Rungapiromnan W., Yiu Z.Z.N., Warren R.B., Griffiths C.E.M., Ashcroft D.M. Impact of biologic therapies on risk of major adverse cardiovascular events in patients with psoriasis: systematic review and meta-analysis of randomized controlled trials. Br J Dermatol. 2017;176:890-901. doi: 10.1111/bjd.14964.Whitlock S.M., Enos C.W., Armstrong A.W. et al. Management of psoriasis in patients with inflammatory bowel disease: from the Medical Board of the National Psoriasis Foundation. J Am Acad Dermatol. 2018;78:383-394. doi: 10.1016/j.jaad.2017.06.043.Sofen H., Smith S., Matheson R.T. et al. Guselkumab (an IL-23-specific mAb) demonstrates clinical and molecular response in patients with moderate-to-severe psoriasis. J Allergy Clin Immunol. 2014;133(4):1032-1040. doi: 10.1016/j.jaci.2014.01.025.Blauvelt A., Papp K.A., Griffiths C.E, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76(3):405-417. doi: 10.1016/j.jaad.2016.11.041.Reich K., Armstrong A.W., Foley P,. et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017;76(3):418-431. doi: 10.1016/j.jaad.2016.11.042.Griffiths C.E.M., Papp K.A., Song M. et al. Continuous treatment with guselkumab maintains clinical responses through 4 years in patients with moderate-to-severe psoriasis: results from VOYAGE 1. J Dermatol Treat. 2020. doi: 10.1080/09546634.2020.1782817.Reich K., Armstrong A.W., Foley P. et al. Maintenance of response through up to 4 years of continuous guselkumab treatment of psoriasis in the VOYAGE 2 phase 3 study. Am J Clin Dermatol. 2020;1(6):881-890. doi: 10.1007/ s40257-020-00555-7.Ohtsuki M., Kubo H., Morishima H., Goto R., Zheng R., Nakagawa H. Guselkumab, an anti-interleukin-23 monoclonal antibody, for the treatment of moderate to severe plaque-type psoriasis in Japanese patients: efficacy and safety results from a phase 3, randomized, double-blind, placebo-controlled study. J Dermatol. 2018;45(9):1053-1062. doi: 10.1111/1346-8138.14504.Langley R.G., Elewski B.E., Lebwohl M. et al. Secukinumab in plaque psoriasis - results of two phase 3 trials. N Engl J Med. 2014;371:326-338. doi: 10.1056/ NEJMoa1314258.Gordon K.B., Blauvelt A., Papp K.A. et al. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375:345-356. doi: 10.1056/NEJMoa1512711.Van de Kerkhof P.C., Griffiths C.E., Reich K. et al. Secukinumab longterm 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;75:83-98. doi: 10.1016/j.jaad.2016.03.024.Reichert J. Anti-IL17 netakimab registered in Russia antibodysociety.org: antibody Society. 2019. URL: https://www.antibodysociety.org/antibody-therapeutic/anti-il17-netakimab-registered-in-russia.Bakulev A.L., Samtsov A.V., Kubanov A.A. et al. Long-term efficacy and safety of netakimab in patients with moderate-to-severe psoriasis. Results of phase II open-label extension clinical study BCD-085-2-ext. Bulletin of dermatology and venereology. 2019;95:56-64.Bakulev A., Samtsov A., Artemeva A. et al.Netakimab: 12-week results from planeta study, a phase III trial of a novel IL-17 inhibitor in moderate-to-severe plaque psoriasis. Abstract of the 24th World Congress of Dermatology (WCD) in Milan. 10-15 June 2019.