Терапия нетакимабом псориатической ониходистрофии

Введение. Степень тяжести псориаза ногтей не всегда соответствует выраженности кожного процесса, но часто коррелирует с более тяжелым, длительным и агрессивным течением заболевания.

Цель. Изучить эффективность и безопасность монотерапии нетакимабом псориатической ониходистрофии.

Материалы и методы. Под наблюдением находилось 48 взрослых пациентов с псориатическим поражением ногтей. Степень тяжести ониходистрофии определяли с помощью индекса NAPSI (Nail Psoriasis Severity Index). Оценку проводили до начала лечения, а затем каждые 4 нед. до 52-й нед. включительно. Все пациенты в амбулаторных условиях получали монотерапию ингибитором интерлейкина-17 (ИЛ-17) нетакимабом в дозе 120 мг в виде 2 подкожных инъекций по 1 мл (60 мг) препарата, каждую из которых вводили 1 раз в 7 дней на неделях 0, 1 и 2, затем – 1 раз каждые 4 нед. Общая продолжительность лечения одного пациента составила 52 нед. Безопасность нетакимаба оценивали на основании развития нежелательных явлений и местных реакций на введение препарата.

Результаты. Монотерапия нетакимабом псориатической ониходистрофии в течение 52 нед. доказала высокую клиническую эффективность препарата. На 12-й нед. терапии индекс NAPSI сократился в среднем по группе на 33,1% от исходного уровня, а к концу 52-й нед. – на 72,3%. Дерматологический индекс качества жизни (ДИКЖ) за время лечения сократился в 5,7 раза, что свидетельствует о значительном улучшении качества жизни пациентов. Серьезных нежелательных явлений и досрочного выбывания участников из исследования по причине нежелательных явлений не зарегистрировано.

Заключение. Полученные данные позволяют рекомендовать нетакимаб больным псориатической ониходистрофией.

1. Samman PD, Fenton DA. The nails in disease. 5th ed. London: Butterworth-Heinemann Ltd.; 1994. 238 р.

2. Baran R, Sigurgeirsson B. Psoriatic nail disease, a predictor of psoriatic arthritis. Br J Dermatol. 2014;171(5):935–936. https://doi.org/10.1111/bjd.13398.

3. Langley RG, Daudén E. Treatment and management of psoriasis with nail involvement: a focus on biologic therapy. Dermatology. 2010;221(Suppl 1):29–42. https://doi.org/10.1159/000316179.

4. Salomon J, Szepietowski JC, Proniewicz A. Psoriatic nails: a prospective clinical study. J Cutan Med Surg. 2003;7(4):317–321. https://doi.org/10.1007/s10227-002-0143-0.

5. Cohen MR, Reda DJ, Clegg DO. Baseline relationships between psoriasis and psoriatic arthritis: analysis of 221 patients with active psoriatic arthritis. Department of Veterans Affairs Cooperative Study Group on Seronegative Spondyloarthropathies. J Rheumatol. 1999;26(8):1752–1756. Available at: https://pubmed.ncbi.nlm.nih.gov/10451073/.

6. Lebwohl MG, Kavanaugh A, Armstrong AW, Van Voorhees AS. US Perspectives in the Management of Psoriasis and Psoriatic Arthritis: Patient and Physician Results from the Population-Based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) Survey. Am J Clin Dermatol. 2016;17(1):87–97. https://doi.org/10.1007/s40257-015-0169-x.

7. Pala E, Melikoğlu M, Karaşahin Ö, Alkan Melikoğlu M. The Frequency of Association of Nail Involvement and Psoriatic Arthritis in Psoriasis Patients. Eurasian J Med. 2023;55(2):158–164. https://doi.org/10.5152/eurasianjmed.2023.53.

8. Langenbruch A, Radtke MA, Krensel M, Jacobi A, Reich K, Augustin M. Nail involvement as a predictor of concomitant psoriatic arthritis in patients with psoriasis. Br J Dermatol. 2014;171(5):1123–1128. https://doi.org/10.1111/bjd.13272.

9. Canal-García E, Bosch-Amate X, Belinchón I, Puig L. Nail Psoriasis. Actas Dermo-Sifiliográficas. 2022;113(5):T481–T490. https://doi.org/10.1016/j.ad.2022.01.006.

10. Mease PJ, Liu M, Rebello S, McLean RR, Dube B, Glynn M et al. Association of Nail Psoriasis With Disease Activity Measures and Impact in Psoriatic Arthritis: Data From the Corrona Psoriatic Arthritis/Spondyloarthritis Registry. J Rheumatol. 2021;48(4):520–526. https://doi.org/10.3899/jrheum.190923.

11. Peng YT, Yu RT, Chen AJ, Wen ZY, Xu J, Huang K, Wang P. Predicting the Risk of Nail Involvement in Psoriasis Patients: Development and Assessment of a Predictive Nomogram. Diagnostics (Basel). 2023;13(4):633. https://doi.org/10.3390/diagnostics13040633.

12. Williamson L, Dalbeth N, Dockerty JL, Gee BC, Weatherall R, Wordsworth BP. Extended report: nail disease in psoriatic arthritis--clinically important, potentially treatable and often overlooked. Rheumatology (Oxford). 2004;43(6):790–794. https://doi.org/10.1093/rheumatology/keh198.

13. Asili P, Tootoonchi N, Nasimi M, Daneshpajooh M, Sedaghatzadeh M, Mirahmad M. Demographic aspects, clinical characteristics, and therapeutic approaches in geriatric psoriasis: A study from a tertiary center. Dermatol Ther. 2022;35(8):e15628. https://doi.org/10.1111/dth.15628.

14. Trettel A, Spehr C, Körber A, Augustin M. The impact of age on psoriasis health care in Germany. J Eur Acad Dermatol Venereol. 2017;31(5):870–875. https://doi.org/10.1111/jdv.14115.

15. Klaassen KM, van de Kerkhof PC, Pasch MC. Nail psoriasis: a questionnaire-based survey. Br J Dermatol. 2013;169(2):314–319. https://doi.org/10.1111/bjd.12354.

16. Tan AL, Benjamin M, Toumi H, Grainger AJ, Tanner SF, Emery P, McGonagle D. The relationship between the extensor tendon enthesis and the nail in distal interphalangeal joint disease in psoriatic arthritis--a high-resolution MRI and histological study. Rheumatology (Oxford). 2007;46(2):253–256. https://doi.org/10.1093/rheumatology/kel214.

17. McGonagle D, Tan AL, Benjamin M. The nail as a musculoskeletal append-age – implications for an improved understanding of the link between psoriasis and arthritis. Dermatology. 2009;218(2):97–102. https://doi.org/10.1159/000182250.

18. Choi JW, Kim BR, Seo E, Youn SW. Identification of nail features associated with psoriasis severity. J Dermatol. 2017;44(2):147–153. https://doi.org/10.1111/1346-8138.13565.

19. Mashal ZR, Elgamal EEA, Zaky MS, Elsaie ML. Dermoscopic Features of Psoriatic Nails and Their Correlation to Disease Severity. Dermatol Res Pract. 2023;2023:4653177. https://doi.org/10.1155/2023/4653177.

20. Lawry M, Daniel CR 3rd. Nails in systemic disease. In: Scher RK, Daniel CR (eds). Nails: Diagnosis, Therapy, Surgery. 3rd ed. Philadelphia: Elsevier Science Limited; 2005. 352 p.

21. Gregoriou S, Argyriou G, Larios G, Rigopoulos D. Nail disorders and systemic disease: what the nails tell us. J Fam Pract. 2008;57(8):509–514. Available at: https://pubmed.ncbi.nlm.nih.gov/18687226/.

22. Schneider SL, Tosti A. Tips to diagnose uncommon nail disorders. Dermatol Clin. 2015;33(2):197–205. https://doi.org/10.1016/j.det.2014.12.003.

23. van der Velden HM, Klaassen KM, van de Kerkhof PC, Pasch MC. Fingernail psoriasis reconsidered: a case-control study. J Am Acad Dermatol. 2013;69(2):245–252. https://doi.org/10.1016/j.jaad.2013.02.009.

24. Marina EM, Botar-Jid C, Bolboaca SD, Roman II, Senila CS, Mihu CM, Tataru DA. Patterns of clinical nail appearances in patients with cutaneous psoriasis. Clujul Med. 2017;90(1):22–27. https://doi.org/10.15386/cjmed-679.

25. Wanniang N, Navya A, Pai V, Ghodge R. Comparative Study of Clinical and Dermoscopic Features in Nail Psoriasis. Indian Dermatol Online J. 2020;11(1):35–40. https://doi.org/10.4103/idoj.IDOJ_51_19.

26. Haneke E. Nail psoriasis: clinical features, pathogenesis, differential diagnoses, and management. Psoriasis (Auckl). 2017;(7):51–63. https://doi.org/10.2147/PTT.S126281.

27. Arora S, Paul D, Kumar R, Bhatnagar A, Arora G, Mech S, Suhag DK. Study of Nail Psoriasis and Dermoscopic Correlation with Dermoscopic and Modified Dermoscopic Nail Psoriasis Severity Indexes (dNAPSI and dmNAPSI). Dermatol Pract Concept. 2022;12(1):e2022010. https://doi.org/10.5826/dpc.1201a10.

28. Schons KR, Beber AA, Beck Mde O, Monticielo OA. Nail involvement in adult patients with plaque-type psoriasis: prevalence and clinical features. An Bras Dermatol. 2015;90(3):314–319. https://doi.org/10.1590/abd1806-4841.20153736.

29. Chauhan A, Singal A, Grover C, Sharma S. Dermoscopic Features of Nail Psoriasis: An Observational, Analytical Study. Skin Appendage Disord. 2020;6(4):207–215. https://doi.org/10.1159/000508165.

30. Yorulmaz A, Artuz F. A study of dermoscopic features of nail psoriasis. Postepy Dermatol Alergol. 2017;34(1):28–35. https://doi.org/10.5114/ada.2017.65618.

31. Klaassen KM, Dulak MG, van de Kerkhof PC, Pasch MC. The prevalence of onychomycosis in psoriatic patients: a systematic review. J Eur Acad Dermatol Venereol. 2014;28(5):533–541. https://doi.org/10.1111/jdv.12239.

32. Jendoubi F, Ben Lagha I, Rabhi F, Doss N, Mrabet A, Jaber K, Dhaoui MR. Nail Involvement in Psoriatic Patients and Association with Onychomycosis: Results from a Cross-Sectional Study Performed in a Military Hospital in Tunisia. Skin Appendage Disord. 2019;5(5):299–303. https://doi.org/10.1159/000497825.

33. 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. https://doi.org/10.1111/dth.13374.

34. Lanna C, Galluzzi C, Zangrilli A, Bavetta M, Bianchi L, Campione E. Psoriasis in difficult to treat areas: treatment role in improving health-related quality of life and perception of the disease stigma. J Dermatolog Treat. 2022;33(1):531–534. https://doi.org/10.1080/09546634.2020.1770175.

35. Ковалева ЮС, Ведлер АА, Субботин ЕА, Грибова ГВ. Псориатическая ониходистрофия как маркер тяжести псориаза и сопутствующей коморбидности. Вестник СурГУ. Медицина. 2020;(4):51–57. https://doi.org/10.34822/2304-9448-2020-4-51-57.

36. de Jong EM, Seegers BA, Gulinck MK, Boezeman JB, van de Kerkhof PC. 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(4):300–303. https://doi.org/10.1159/000246274.

37. Rigopoulos D, Baran R, Chiheb S, Daniel CR 3rd, Di Chiacchio N, Gregoriou S et al. Recommendations for the definition, evaluation, and treatment of nail psoriasis in adult patients with no or mild skin psoriasis: A dermatologist and nail expert group consensus. J Am Acad Dermatol. 2019;81(1):228–240. https://doi.org/10.1016/j.jaad.2019.01.072.

38. Hadeler E, Mosca M, Hong J, Brownstone N, Bhutani T, Liao W. Nail Psoriasis: A Review of Effective Therapies and Recommendations for Management. Dermatol Ther (Heidelb). 2021;11(3):799–831. https://doi.org/10.1007/s13555-021-00523-x.

39. Langley RG, Saurat JH, Reich K. Recommendations for the treatment of nail psoriasis in patients with moderate to severe psoriasis: a dermatology expert group consensus. J Eur Acad Dermatol Venereol. 2012;26(3):373–381. https://doi.org/10.1111/j.1468-3083.2011.04349.x.

40. Laheru D, Antony A, Carneiro S, Di Lernia V, Garg A, Love TJ et al. Management of Nail Disease in Patients With Psoriatic Arthritis: An Updated Literature Review Informing the 2021 GRAPPA Treatment Recommendations. J Rheumatol. 2023;50(3):433–437. https://doi.org/10.3899/jrheum.220313.

41. Amatore F, Villani AP, Tauber M, Viguier M, Guillot B. French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults. J Eur Acad Dermatol Venereol. 2019;33(3):464–483. https://doi.org/10.1111/jdv.15340.

42. Кубанов АА, Карамова АЭ, Притуло ОА, Аршинский МИ, Знаменская ЛФ, Чикин ВВ и др. Псориаз: клинические рекомендации. М.; 2023. 78 с. Режим доступа: https://www.rodv.ru/upload/iblock/a84/q6gxj2hn1mip4m1vaaqg1vyvsy05u11y.pdf.

43. Rich P, Scher RK. Nail Psoriasis Severity Index: a useful tool for evaluation of nail psoriasis. J Am Acad Dermatol. 2003;49(2):206–212. https://doi.org/10.1067/s0190-9622(03)00910-1.

44. 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. https://doi.org/10.1111/bjd.17351.

45. Galluzzo M, Talamonti M, Cioni A, Maffei V, Shumak RG, Tofani L et al. Efficacy of Tildrakizumab for the Treatment of Difficult-to-Treat Areas: Scalp, Nail, Palmoplantar and Genital Psoriasis. J Clin Med. 2022;11(9):2631. https://doi.org/10.3390/jcm11092631.

46. Thaçi 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. https://doi.org/10.1111/jdv.12553.

47. Elewski BE, Baker CS, Crowley JJ, Poulin Y, Okun MM, 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. https://doi.org/10.1111/jdv.15793.

48. Reich K, Burden AD, Eaton JN, Hawkins NS. Efficacy of biologics in the treatment of moderate to severe psoriasis: a network meta-analysis of randomized controlled trials. Br J Dermatol. 2012;166(1):179–188. https://doi.org/10.1111/j.1365-2133.2011.10583.x.

49. Кубанов АА, Бакулев АЛ, Самцов АВ, Хайрутдинов ВР, Соколовский ЕВ, Кохан ММ 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. https://doi.org/10.25208/0042-4609-2019-95-2-15-28.

50. Круглова ЛС, Руднева НС, Бакулев АЛ, Хотко АА. Инверсный псориаз и псориаз «трудных» локализаций: эффективность нетакимаба. Медицинский алфавит. 2022;1(27):14–20. https://doi.org/10.33667/2078-5631-2022-27-14-20.

51. Жукова ОВ, Артемьева СИ, Аль-Хаватми АA-ХM. Псориаз ногтей: динамика клинического течения на фоне терапии препаратами ИЛ-17. Медицинский совет. 2022;16(3):38–45. https://doi.org/10.21518/2079-701X-2022-16-3-38-45.

52. Kyriakou A, Zagalioti SC, Trakatelli MG, Fotiadou C, Apalla Z, Lazaridou E, Patsatsi A. Fungal Infections and Nail Psoriasis: An Update. J Fungi (Basel). 2022;8(2):154. https://doi.org/10.3390/jof8020154.