References

medsovet

Медицинский Совет

Meditsinskiy sovet = Medical Council

2079-701X2658-5790

REMEDIUM GROUP Ltd.

10.21518/2079-701X-2020-12-64-70

medsovet-5867

Research Article

ЗАБОЛЕВАНИЯ КОЖИ

DERMAL DISEASES

Успешное применение препарата нетакимаб при лечении псориаза, сопровождающегося явлениями псориатической ониходистрофии

Successful use of Netakimab in the treatment of psoriasis accompanied by the psoriatic onychodystrophy

https://orcid.org/0000-0002-9578-5490

Потекаев

Н. Н.

Potekaev

N. N.

Потекаев Николай Николаевич – доктор медицинских наук, профессор, заведующий кафедрой кожных болезней и косметологии факультета дополнительного профессионального образования, РНИМУ имени Н.И. ПироговаМЗ РФ; директор, МНПЦДК ДЗМ.117997, Москва, ул. Островитянова, д. 1;119071, Москва, Ленинский проспект, д. 17.

Nikolay N. Potekaev - Dr. of Sci. (Med.), Professor, Head of Department of Skin Diseases and Cosmetology, Pirogov Russian National Research Medical University of the Ministry of Health of the Russian Federation; Director, Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of Moscow Health Department.1, Ostrovityanov St., Moscow, 117997; 17, Leninskiy Prospect, Moscow, 119071.

klinderma@mail.ru

https://orcid.org/0000-0001-5723-6573

Жукова

О. В.

Zhukova

O. V.

Жукова Ольга Валентиновна - доктор медицинских наук, профессор, заведующая кафедрой кожных и венерических болезней медицинского института, РУДН; главный врач, МНПЦДК ДЗМ.117198, Москва, ул. Миклухо-Маклая, д. 6; 119071, Москва, Ленинский проспект, д. 17.

Olga V. Zhukova - Dr. of Sci. (Med.), Professor, Head of Department of Skin and Sexually Transmitted Diseases, Institute of Medicine, Peoples' Friendship University of Russia; Chief Medical Officer, Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of Moscow Health Department.6, Miklukho-Maklai St., Moscow, 117198; 17, Leninskiy Prospect, Moscow, 119071.

klinderma@inbox.ru

https://orcid.org/0000-0002-2793-8862

Артемьева

С. И.

Artemyeva

S. I.

Артемьева Софья Иосифовна - младший научный сотрудник, врач-дерматовенеролог.119071, Москва, Ленинский проспект, д. 17.

Sofya I. Artemyeva - Junior Researcher, Dermatologist.17, Leninskiy Prospect, Moscow, 119071.

sofya.chern@gmail.com

Российский национальный исследовательский медицинский университет им. Н.И. Пирогова; Московский научно-практический центр дерматовенерологии и косметологииРоссияPirogov Russian National Research Medical University; Moscow Scientific and Practical Center of Dermatovenereology and CosmetologyRussian Federation

Московский научно-практический центр дерматовенерологии и косметологии; Российский университет дружбы народовРоссияMoscow Scientific and Practical Center of Dermatovenereology and Cosmetology; Peoples' Friendship University of RussiaRussian Federation

Московский научно-практический центр дерматовенерологии и косметологииРоссияMoscow Scientific and Practical Center of Dermatovenereology and CosmetologyRussian Federation

2020

14112020

0126470

2020

Потекаев Н.Н., Жукова О.В., Артемьева С.И.

Potekaev N.N., Zhukova O.V., Artemyeva S.I.

This work is licensed under a Creative Commons Attribution 4.0 License.

https://www.med-sovet.pro/jour/article/view/5867

Псориаз — хроническое иммуноопосредованное заболевание, которое сопровождается значительным количеством комор-бидных патологий. Поражение ногтевых пластин широко распространено среди пациентов с псориазом и связано со значительными функциональными, а также психосоциальными нарушениями. Несмотря на то что ногти составляют небольшой процент поверхности тела человека, поражение именно этого участка может привести к ухудшению качества жизни и потере трудоспособности. Кроме того, исследования показали, что псориаз ногтей свидетельствует о более тяжелом течении заболевания, а также может быть связан с псориатическим артритом, являться предиктором его развития. Текущие варианты терапии псориаза с поражением ногтевых пластин включают в себя множество топических и системных методов, однако пациенты зачастую отмечают неудовлетворенность результатами лечения из-за низкой эффективности или множества побочных эффектов. Достижение более высокой эффективности возможно с применением генно-инженерных биологических препаратов (ГИБП). В настоящее время разработан широкий спектр ГИБП, модулирующих ключевые звенья иммунопатогенеза псориаза.Патогенез псориаза - мультифакториальный процесс, однако именно сигнальный путь ИЛ23/ТИ17 - ключевой в данном процессе. Интерлейкин-17А является первичным эффектором этого пути, а сверхэкспрессия ИЛ-17А ведет к эпидермальной гиперплазии и чрезмерному воспалительному ответу, наблюдаемому при псориазе. Таким образом, интерлейкин-17А является перспективной терапевтической мишенью.С учетом критической патогенетической роли, высокой эффективности и безопасности ингибиторов ИЛ-17А изучение их влияния на проявления псориатической ониходистрофии имеет большое клиническое значение.Нетакимаб - первый отечественный оригинальный ингибитор ИЛ-17, который представляет собой перспективное современное средство для лечения среднетяжелых и тяжелых форм псориаза. Полученные реальные клинические данные свидетельствуют о высокой эффективности и безопасности применения препарата нетакимаб у пациентов как с бляшечным псориазом, так и с псориазом сложных, тяжело поддающихся терапии локализаций, таких как поражение ногтевых пластин.

Psoriasis is a chronic immune-mediated disease that is accompanied by a significant number of comorbid pathologies. Damage to the nail plates (psoriatic onychodystrophy) is widespread among patients with psoriasis and is associated with significant functional as well as psychosocial impairments. Despite the fact that nails constitute a small percentage of the surface of the human body, the damage to this particular area can lead to a deterioration in the quality of life and irreversible disability. In addition, studies have shown that nail psoriasis is indicative of a more severe course of the disease and it can also be associated with psoriatic arthritis or it can be a predictor of its development. Current treatment options for psoriasis accompanied by the nail plates damage include many topical and systemic methods, however, patients often report dissatisfaction with the results of treatment due to low efficacy or many side effects. Achieving higher efficiency is possible with the use of biologic therapy. Currently, a wide range of biologics have been developed that modulate key elements in the immunopathogenesis of psoriasis.The pathogenesis of psoriasis is a multifactorial process, however, it is the IL23 / Th17 signaling pathway that is key in this process. Interleukin-17A is the principal effector of this pathway and overexpression of IL-17A leads to epidermal hyperplasia and an excessive inflammatory response seen in psoriasis. Therefore, interleukin-17A is a promising therapeutic target.Considering the critical pathogenetic role as well as the high efficacy and safety of IL-17A inhibitors, the study of their effect on the psoriatic onychodystrophy manifestations is of great clinical importance.Netakimab is the first Russian original IL-17 inhibitor which is a promising modern agent for the treatment of moderate-to-severe plaque psoriasis. The obtained real clinical data indicate the high efficacy and safety of the use of Netakimab in patients with both plaque psoriasis and «severe» psoriasis in difficult to treat localizations, such as damage of the nail plate.

псориазнетакимабпсориаз ногтейцитокиныбиологические препаратыИЛ-17

psoriasisnetakimabnail psoriasiscytokinesbiologic(s)IL-17

References1

Liang Y., Sarkar M.K., Tsoi L.C., Gudjonsson J.E. Psoriasis: a mixed autoimmune and autoinflammatory disease. Curr Opin Immunol. 2017;49:1-8. doi: 10.1016/j.coi.2017.07.007.

Christophers E., van de Kerkhof P.C.M. Severity, heterogeneity and systemic inflammation in psoriasis. J Eur Acad Dermatol Venereol. 2019;33(4):643-647. doi: 10.1111/jdv.15339.

Mitra A., Fallen R.S., Lima H.C. Cytokine-based therapy in psoriasis. Clin Rev Allergy Immunol. 2013;44:173-182. doi: 10.1007/s12016-012-8306-2.

Baran R. The burden of nail psoriasis: an introduction. Dermatology. 2010;221(suppl 1):1-5. doi: 10.1159/000316169.

Klaassen K.M., van de Kerkhof P.C., Pasch M.C. Nail psoriasis, the unknown burden of disease. J Eur Acad Dermatol Venereol. 2014;28(12):1690-1695. doi: 10.1111/jdv.12368.

De Jong E.M., Seegers B.A., Gulinck M.K., Boezeman J.B., van de Kerkhof P.C. Psoriasis of the nails associated with disability in a large number of patients: results of a recent interview with 1,728 patients. Dermatology. 1996;193:300-303. doi: 10.1159/000246274.

Papp K., Poulin Y., Vieira A., Shelton J., Poulin-Costello M. Disease characteristics in patients with and without psoriatic arthritis treated with etanercept. J Eur Acad Dermatol Venereol. 2014;28(5):581-589. doi: 10.1111/jdv.12138.

Шеклаков Н.Д. Болезни ногтей: монография. М.: Медицина; 1975. 216 с.

Sheklakov N.D. Nails Diseases: monograph. Moscow: Medicine; 1975. 216 p. (In Russ.)

Petraskiene R., Valiukeviciene S., Macijauskiene J. Associations of the quality of life and psychoemotional state with sociodemographic factors in patients with psoriasis. Medicina. 2016;52(4):238-243. doi: 10.1016/j.med-ici.2016.07.001.

Taylor W., Gladman D., Helliwell P., Marchesoni A., Mease P., Mielants H. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum. 2006;54(8):2665-2673. doi: 10.1002/art.21972.

Lawry M. Biological therapy and nail psoriasis. Dermatol Ther. 2007;20(1):60-67. doi: 10.1111/j.1529-8019.2007.00112.x.

Ash Z.R., Tinazzi I., Gallego C.C., Kwok C., Wilson C., Goodfield M. et al. Psoriasis patients with nail disease have a greater magnitude of underlying systemic subclinical enthesopathy than those with normal nails. Ann Rheum Dis. 2012;71(4):553-556. doi: 10.1136/annrheumdis-2011-200478.

Reich K. Approach to managing patients with nail psoriasis. J Eur Acad Dermatol Venereol. 2009;23(Suppl. 1):15-21. doi: 10.1111/j.1468-3083.2009.03364.x.

Круглова Л.С., Львов А.Н. Ранняя диагностика псориатического артрита и возможности контроля над заболеванием (обзор литературы). Медицинский алфавит. 2019;2(26);401:44-48. doi: 10.33667/2078-5631-2019-2-26(401)-44-48.

Kruglova L.S., Lvov A.N. Early diagnosis of psoriatic arthritis and possibility of its control (literature review). Meditsinskiy alfavit = Medical alphabet. 2019;2(26):44-48. (In Russ.) doi: 10.33667/2078-5631-2019-2-26(401)-44-48.

Weissleder R., Wittenberg J., Harisinghani M. Primer of Diagnostic Imaging. 5th ed. Maryland Heights, MO: Mosby Inc.; 2011. 1049 p.

Williamson L., Dalbeth N., Dockerty J.L., Gee B.C., Weatherall R., Wordsworth B.P. Extended report: Nail disease in psoriatic arthritis: Clinically important, potentially treatable and often overlooked. Rheumatology (Oxford). 2004;43(6):790-794. doi: 10.1093/rheumatology/keh198.

McGonagle D., Benjamin M., Tan A.L. The pathogenesis of psoriatic arthritis and associated nail disease: not autoimmune after all? Curr Opin Rheumatol. 2009;21(4):340-347. doi: 10.1097/BOR.0b013e32832c6ab9.

Tan E.S.T., Chong W., Tey H.L. Nail Psoriasis. Am J Clin Dermatol. 2012;13:375-388. doi: 10.2165/11597000-000000000-00000.

Rich P., Griffiths C.E., Reich K., Nestle F., Scher R., Li S. et al. Baseline nail disease in patients with moderate to severe psoriasis and response to treatment with infliximab during 1 year. J Am Acad Dermatol. 2008;58(2):224-231. doi: 10.1016/j.jaad.2007.07.042.

Poulin Y., Crowley J.J., Langley R.G., Unnebrink K., Goldblum O.M, Valdecantos W.C. Efficacy of adalimumab across subgroups of patients with moderate-to-severe chronic plaque psoriasis of the hands and/or feet: post hoc analysis of REACH. J Eur Acad Dermatol Venereol. 2014;28(7):882-890. doi: 10.1111/jdv.12198.

Paul C., Reich K., Gottlieb A.B., Mrowietz U., Philipp S., Nakayama J. et al. Secukinumab improves hand, foot and nail lesions in moderate-to-severe plaque psoriasis: subanalysis of a randomized, double-blind, placebo-controlled, regimen-finding phase 2 trial. J Eur Acad Dermatol Venereol. 2014;28(12):1670-1675. doi: 10.1111/jdv.12359.

de Vries A.C., Bogaards N.A., Hooft L., Velema M., Pasch M., Lebwohl M., Spuls P. Interventions for nail psoriasis. Cochrane Database Syst Rev. 2013;(1):CD007633. doi: 10.1002/14651858.CD007633.pub2.

Farber E.M., Nall L. Nail psoriasis. Cutis. 1992;50(3):174-178. Available at: https://pubmed.ncbi.nlm.nih.gov/1526170/.

Jiaravuthisan M.M., Sasseville D., Vender R.B., Murphy F., Muhn C.Y. Psoriasis of the nail: anatomy, pathology, clinical presentation, and a review of the literature on therapy. J Am Acad Dermatol. 2007;57(1):1-27. doi: 10.1016/j.jaad.2005.07.073.

Jemec G.B., Ibler K.S. Treatment of nail psoriasis with TNF-a or IL12/23 inhibitors. J Drugs Dermatol. 2012;11(8):939-942. Available at: https://pub-med.ncbi.nlm.nih.gov/22859238/.

Kyriakou A., Patsatsi A., Sotiriadis D. Anti-TNF agents and nail psoriasis: a single-center, retrospective, comparative study. J Dermato- log Treat. 2013;24(3):162-168. doi: 10.3109/09546634.2011.646939.

Bardazzi F., Antonucci V.A., Tengattini V., Odorici G., Balestri R., Patrizi A. A 36-week retrospective open trial comparing the efficacy of biological therapies in nail psoriasis. J Dtsch Dermatol Ges. 2013;11(11):1065-1070. doi: 10.1111/ddg.12173.

Rich P., Gooderham M., Bachelez H., Goncalves J., Day R.M., Chen R., Crowley J. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with difficult-to-treat nail and scalp psoriasis: results of 2 phase III randomized, controlled trials (ESTEEM 1 and ESTEEM 2). J Am Acad Dermatol. 2016;74(1):134-142. doi: 10.1016/j.jaad.2015.09.001.

Reich K., Gooderham M., Bewley A., Green L., Soung J., Petric R. et al. Safety and efficacy of apremilast through 104 weeks in patients with moderate to severe psoriasis who continued on apremilast or switched from etanercept treatment: findings from the LIBERATE study. J Eur Acad Dermatol Venereol. 2018;32(3):397-402. doi: 10.1111/jdv.14738.

Merola J.F., Elewski B., Tatulych S., Lan S., Tallman A., Kaur M. Efficacy of tofacitinib for the treatment of nail psoriasis: two 52-week, randomized, controlled phase 3 studies in patients with moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2017;77(1):79-87.E1. doi: 10.1016/j.jaad.2017.01.053.

Abe M., Nishigori C., Torii H., Ihn H., Ito K., Nagaoka M. et al. Tofacitinib for the treatment of moderate to severe chronic plaque psoriasis in Japanese patients: subgroup analyses from a randomized, placebo-controlled phase 3 trial. J Dermatol. 2017;44(11):1228-1237. doi: 10.1111/1346-8138.13956.

Luger T.A., Barker J., Lambert J., Yang S., Robertson D., Foehl J. et al. Sustained improvement in joint pain and nail symptoms with etanercept therapy in patients with moderate- to-severe psoriasis. J Eur Acad Dermatol Venereol. 2009;23(8):896-804. doi: 10.1111/j.1468-3083.2009.03211.x.

Ortonne J.P., Paul C., Berardesca E., Marino V., Gallo G., Brault Y., Germain J.M. A 24-week randomized clinical trial investigating the efficacy and safety of two doses of etanercept in nail psoriasis. Br J Dermatol. 2013;168(5):1080-1087. doi: 10.1111/bjd.1206O.

Van den Bosch F., Manger B., Goupille P., McHugh N., R0devand E., Holck P. et al. Effectiveness of adalimumab in treating patients with active psoriatic arthritis and predictors of good clinical responses for arthritis, skin and nail lesions. Ann Rheum Dis. 2010;69(2):394-399. doi: 10.1136/ard.2009.111856.

Rigopoulos D., Gregoriou S., Lazaridou E., Belyayeva E., Apalla Z., Makris M. et al. Treatment of nail psoriasis with adalimumab: an open label unblinded study. J Eur Acad Dermatol Venereol. 2010;24(5):530-534. doi: 10.1111/j.1468-3083.2009.03453.x.

Leonardi C., Langley R.G., Papp K., Tyring S.K., Wasel N., Vender R. et al. Adalimumab for treatment of moderate to severe chronic plaque psoriasis of the hands and feet: efficacy and safety results from REACH, a randomized, placebo-controlled, double-blind trial. Arch Dermatol. 2011;147(4):429-436. doi: 10.1001/archdermatol.2010.384.

Thagi D., Unnebrink K., Sundaram M., Sood S., Yamaguchi Y.Adalimumab for the treatment of moderate to severe psoriasis: subanalysis of effects on scalp and nails in the BELIEVE study. J Eur Acad Dermatol Venereol. 2015;29(2):353-360. doi: 10.1111/jdv.12553.

Elewski B.E., Okun M.M., Papp K., Baker C.S., Crowley J.J., Guillet G. et al. Adalimumab for nail psoriasis: efficacy and safety from the first 26 weeks of a phase 3, randomized, placebo-controlled trial. J Am Acad Dermatol. 2018;78(1):90-91. doi: 10.1016/j.jaad.2017.08.O29.

Elewski B.E., Baker C.S., Crowley J.J., Poulin Y., Okun M.M., Calimlim B. et al. Adalimumab for nail psoriasis: efficacy and safety over 52 weeks from a phase-3, randomized, placebo- controlled trial. J Eur Acad Dermatol Venereol. 2019;33(11):2168-2178. doi: 10.1111/jdv.15793.

Fabroni C., Gori A., Troiano M., Prignano F., Lotti T. Infliximab efficacy in nail psoriasis. A retrospective study in 48 patients. J Eur Acad Dermatol Venereol. 2011;25(5):549-553. doi: 10.1111/j.1468-3083.2010.03826.x

Rich P., Bourcier M., Sofen H., Fakharzadeh S., Wasfi Y., Wang Y. et al. Ustekinumab improves nail disease in patients with moderate-to-severe psoriasis: results from PHOENIX 1. Br J Dermatol. 2014;170(2):398-407. doi: 10.1111/bjd.12632.

Galluzzo M., D'Adamio S., Chimenti M.S., Teoli M., Bianchi L., Talamonti M. Successful treatment of psoriatic crumbly nails with ustekinumab. Dermatol Ther. 2019;32(3):e12914. doi: 10.1111/dth.12914.

Nakamura M., Lee K., Jeon C., Sekhon S., Afifi L., Yan D. et al. Guselkumab for the treatment of psoriasis: a review of phase III trials. Dermatol Ther. 2017;7(3):281-292. doi: 10.1007/s13555-017-O187-0.

Foley P., Gordon K., Griffiths C.E.M., Wasfi Y., Randazzo B., Song M. et al. Efficacy of guselkumab compared with adalimumab and placebo for psoriasis in specific body regions: a secondary analysis of 2 randomized clinical trials. JAMA Dermatol. 2018;154(6):676-683. doi: 10.10O1/jamadermatol.2018.0793.

Hueber W., Patel D.D., Dryja T., Wright A.M., Koroleva I., Bruin G. et al. Effects of AIN457, a fully human antibody to interleukin-17A, on psoriasis, rheumatoid arthritis, and uveitis. Sci Transl Med. 2010;2(52):52ra72. doi: 10.1126/scitranslmed.3001107.

Ivanov S., Linden A. Interleukin-17 as a drug target in human disease. Trends Pharmacol Sci. 2OO9;30(2):95-103. doi: 10.1016/j.tips.2008.11.0O4.

Reich K., Sullivan .J, Arenberger P., Mrowietz U., Jazayeri S., Augustin M. et al. Effect of secukinumab on the clinical activity and disease burden of nail psoriasis: 32-week results from the randomized placebo-controlled TRANSFIGURE trial. Br J Dermatol. 2019;181(5):954-966. doi: 10.1111/bjd.17351.

Augustin M., Von Kiedrowsky R., Rigopoulos D., Sator P.G., Orsenigo R., Gathman S. et al. Effectiveness and safety of secukinumab in real-world clinical setting in Europe: 1-year results from an interim analysis of the SERENA study. Poster 8674, Presented at the 2019 AAD Annual Meeting; 2019 March 1-5. Washington, DC; 2019. doi: 10.1016/j.jaad.2019.O6.215.

Langley R.G., Rich P., Menter A., Krueger G., Goldblum O., Dutronc Y. et al. Improvement of scalp and nail lesions with ixekizumab in a phase 2 trial in patients with chronic plaque psoriasis. J Eur Acad Dermatol Venereol. 2015;29(9):1763-1770. doi: 10.1111/jdv.12996.

Ghislain P.D., Conrad C., Dutronc Y., Henneges C., Calderon D.S., Vincent M. et al. Comparison of Ixekizumab and Ustekinumab efficacy in the treatment of nail lesions of patients with moderate-to-severe plaque psoriasis: 24-week data from a phase 3 trial. 2017 ACR/ARHP Annual Meeting; 2017 November 3-8. San Diego, CA; 2017. Available at: https://acrabstracts.org/abstract/comparison-of-ixekizumab-and-ustekinumab-efficacy-in-the-treatment-of-nail-lesions-of-patients-with-moderate-to-severe-plaque-psoriasis-24-week-data-from-a-phase-3-trial/.

Van de Kerkhof P., Guenther L., Gottlieb A.B., Sebastian M., Wu J.J., Foley P. et al. Ixekizumab treatment improves fingernail psoriasis in patients with moderate-to-severe psoriasis: results from the randomized, controlled and open-label phases of UNCOVER-3. J Eur Acad Dermatol Venereol. 2017;31(3):477-482. doi: 10.1111/jdv.14033.

Leonardi C., Maari C., Philipp S., Goldblum O., Zhang L., Burkhardt N. et al. Maintenance of skin clearance with ixekizumab treatment of psoriasis: three-year results from the UNCOVER-3 study. J Am Acad Dermatol. 2018;79(5): 824-830.e2. doi: 10.1016/j.jaad.2018.05.032.

Lanna C., Zangrilli A., Bavetta M., Campione E., Bianchi L. Efficacy and safety of adalimumab in difficult-to-treat psoriasis. Dermatol Ther. 2020;33(3):e13374. doi: 10.1111/dth.13374.

Kostareva O., Kolyadenko I., Ulitin A., Ekimova V., Evdokimov S., Garber M. et al. Fab fragment of VHH-based antibody netakimab: crystal structure and modeling interaction with cytokine IL-17A. Crystals. 2019;9(3):177. doi: 10.3390/cryst9030177.

Кубанов А.А., Бакулев А.Л., Самцов А.В., Хайрутдинов В.Р., Соколовский Е.В., Кохан М.М. и др. 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;95(2):15-28. doi: 10.25208/0042-4609-2019-95-2-15-28.

Kubanov A.A., Bakulev A.L., Samtsov A.V., Khairutdinov V.R., Sokolovskiy E.V., Kokhan M.M. et al. Netakimab — new IL-Па inhibitor: 12-week results of phase III clinical study BCD-085-7/PLANETA in patients with moderate-to-severe plaque psoriasis. Vestnik Dermatologii i Venerologii = Dermatology and Venereology Bulletin. 2019;95(2):15-28. (In Russ.) doi: 10.25208/0042-46092019-95-2-15-28.

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