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Адалимумаб: ключевой элемент в стратегии лечения иммуноопосредованных воспалительных заболеваний
Адалимумаб: ключевой элемент в стратегии лечения иммуноопосредованных воспалительных заболеваний
Гилавян М.А., Трунова Д.В., Устинова А.В., Суханова А.М. Адалимумаб: ключевой элемент в стратегии лечения иммуноопосредованных воспалительных заболеваний. Consilium Medicum. 2024;26(8):492–497. DOI: 10.26442/20751753.2024.8.202909
© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.
DOI: 10.26442/20751753.2024.8.202909
© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.
________________________________________________
DOI: 10.26442/20751753.2024.8.202909
Материалы доступны только для специалистов сферы здравоохранения. Авторизуйтесь или зарегистрируйтесь.
Аннотация
Адалимумаб – биологический препарат, который эффективно используется в лечении иммуноопосредованных воспалительных заболеваний, таких как анкилозирующий спондилит, ювенильный идиопатический артрит и псориаз. В данном исследовании подробно проанализированы терапевтические и экономические преимущества адалимумаба. У пациентов с анкилозирующим спондилитом наблюдались значительные улучшения в качестве жизни и производительности труда после лечения адалимумабом, что подтверждает его клиническую и экономическую эффективность. При лечении псориаза и ювенильного идиопатического артрита адалимумаб продемонстрировал высокую эффективность и безопасность, значительно улучшая состояние пациентов, что сделало его «золотым стандартом» терапии. Кроме того, биоаналоги адалимумаба – это более доступные альтернативы оригинальным препаратам, расширяющие возможности лечения и уменьшающие экономическое бремя пациентов. Полученные результаты подчеркивают важность применения адалимумаба в современной медицине и его значительный вклад в улучшение качества жизни пациентов с хроническими воспалительными заболеваниями.
Ключевые слова: адалимумаб, анкилозирующий спондилит, псориаз, юношеский (ювенильный) идиопатический артрит, фактор некроза опухоли, эффективность, безопасность, рандомизированные контролируемые клинические исследования
Keywords: adalimumab, ankylosing spondylitis, psoriasis, juvenile idiopathic arthritis, tumor necrosis factor, efficacy, safety, randomized controlled clinical trials
Ключевые слова: адалимумаб, анкилозирующий спондилит, псориаз, юношеский (ювенильный) идиопатический артрит, фактор некроза опухоли, эффективность, безопасность, рандомизированные контролируемые клинические исследования
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Keywords: adalimumab, ankylosing spondylitis, psoriasis, juvenile idiopathic arthritis, tumor necrosis factor, efficacy, safety, randomized controlled clinical trials
Полный текст
Список литературы
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4. Sieper J, Poddubnyy D. Axial spondyloarthritis. Lancet. 2017;390(10089):73-84. DOI:10.1016/S0140-6736(16)31591-4
5. Taurog JD, Chhabra A, Colbert RA. Ankylosing Spondylitis and Axial Spondyloarthritis. N Engl J Med. 2016;374(26):2563-74. DOI:10.1056/NEJMra1406182
6. Burmester GR, Panaccione R, Gordon KB, et al. Adalimumab: Long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn’s disease. Ann Rheum Dis. 2013;72(4):517-24. DOI:10.1136/annrheumdis-2011-201244
7. Huang F, Gu J, Zhu P, et al. Efficacy and safety of adalimumab in Chinese adults with active ankylosing spondylitis: Results of a randomised, controlled trial. Ann Rheum Dis. 2014;73(3):587-94. DOI:10.1136/annrheumdis-2012-202533
8. Terslev L, Naredo E, Iagnocco A, et al. Defining Enthesitis in Spondyloarthritis by Ultrasound: Results of a Delphi Process and of a Reliability Reading Exercise. Arthritis Care Res (Hoboken). 2014;66(5):741-8. DOI:10.1002/acr.22191
9. Zaripova LN, Midgley A, Christmas SE, et al. Juvenile idiopathic arthritis: from aetiopathogenesis to therapeutic approaches. Pediatr Rheumatol Online J. 2021;19(1):135. DOI:10.1186/s12969-021-00629-8
10. Barut K, Adrovic A, Şahin S, Kasapçopur Ö. Juvenile idiopathic arthritis. Balkan Med J. 2017;34(2):90-101. DOI:10.4274/balkanmedj.2017.0111
11. Reich K, Gooderham M, Thaçi D, et al. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): A randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019;394(10198):576-86. DOI:10.1016/S0140-6736(19)30952-3
12. Ravelli A, Martini A. Juvenile idiopathic arthritis. Lancet. 2007;369(9563):767-78. DOI:10.1016/S0140-6736(07)60363-8
13. De Silvestri A, Capittini C, Poddighe D, et al. HLA-DRB1 alleles and juvenile idiopathic arthritis: Diagnostic clues emerging from a meta-analysis. Autoimmun Rev. 2017;16(12):1230-6. DOI:10.1016/j.autrev.2017.10.007
14. Prelog M, Schwarzenbrunner N, Sailer-Höck M, et al. Premature aging of the immune system in children with juvenile idiopathic arthritis. Arthritis Rheum. 2008;58(7):2153-62. DOI:10.1002/art.23599
15. Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: Recommendations for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Rheum. 2013;65(10):2499-512. DOI:10.1002/art.38092
16. Lovell DJ, Giannini EH, Reiff A, et al. Etanercept in children with polyarticular juvenile rheumatoid arthritis. Pediatric Rheumatology Collaborative Study Group. N Engl J Med. 2000;342(11):763-9. DOI:10.1056/NEJM200003163421103
17. Vanoni F, Minoia F, Malattia C. Biologics in juvenile idiopathic arthritis: A narrative review. Eur J Pediatr. 2017;176(9):1147-53. DOI:10.1007/s00431-017-2960-6
18. Ruperto N, Lovell DJ, Cuttica R, et al. Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis: Findings from an open-label treatment extension. Ann Rheum Dis. 2010;69(4):718-22. DOI:10.1136/ard.2009.100354
19. Ramanan AV, Dick AD, Jones AP, et al. Adalimumab in combination with methotrexate for refractory uveitis associated with juvenile idiopathic arthritis: A RCT. Health Technol Assess. 2019;23(15):1-140. DOI:10.3310/hta23150
20. Imagawa T, Takei S, Umebayashi H, et al. Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan. Clin Rheumatol. 2012;31(12):1713-21. DOI:10.1007/s10067-012-2082-5
21. Burgos-Vargas R, Tse S ML, Horneff G, et al. A Randomized, double-blind, placebo-controlled multicenter study of adalimumab in pediatric patients with enthesitis-related arthritis. Arthritis Care Res (Hoboken). 2015;67(11):1503-12. DOI:10.1002/acr.22657
22. Ramanan AV, Dick AD, Jones AP, et al. Adalimumab plus methotrexate for uveitis in juvenile idiopathic arthritis. N Engl J Med. 2017;376(17):1637-46. DOI:10.1056/NEJMoa1614160
23. Lovell DJ, Ruperto N, Goodman S, et al. Adalimumab with or without methotrexate in juvenile rheumatoid arthritis. N Engl J Med. 2008;359(8):810-20. DOI:10.1056/NEJMoa0706290
24. Li C, Sunhe Y, Zhou H, Dong W. Efficacy and safety evaluations of adalimumab biosimilars in the treatment of psoriasis. J Dermatolog Treat. 2023;34(1):2249145. DOI:10.1080/09546634.2023.2249145
25. Torales J, Echeverría C, Barrios I, et al. Psychodermatological mechanisms of psoriasis. Dermatol Ther. 2020;33(6):e13827. DOI:10.1111/dth.13827
26. Griffiths CEM, Armstrong AW, Gudjonsson JE, Barker JNWN. Psoriasis. Lancet. 2021;397(10281):1301-15. DOI:10.1016/S0140-6736 (20)32549-6
27. Takeshita J, Gelfand JM, Li P, et al. Psoriasis in the US medicare population: Prevalence, treatment, and factors associated with biologic use. J Invest. 2015;135(12):2955-63. DOI:10.1038/jid.2015.296
28. Parisi R, Iskandar IYK, Kontopantelis E, et al. National, regional, and worldwide epidemiology of psoriasis: Systematic analysis and modelling study. BMJ. 2020;369:m1590. DOI:10.1136/ bmj.m1590
29. Committee on Psoriasis CSoD. Guideline for the diagnosis and treatment of psoriasis in China (2018 simplified edition). Chin J Dermatol. 2019;52(4):223-30.
30. Nast A, Amelunxen L, Augustin M, et al. S3 guideline for the treatment of psoriasis vulgaris, update – Short version part 1 – Systemic treatment. J Dtsch Dermatol Ges. 2018;16(5):645-69. DOI:10.1111/ddg.13516
31. Singh JA, Guyatt G, Ogdie A, et al. Special article: 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol. 2019;71(1):5-32. DOI:10.1002/art. 40726
32. Zweegers J, de Jong EM, Nijsten TE, et al. Summary of the Dutch S3-guidelines on the treatment of psoriasis 2011. Dutch Society of Dermatology and Venereology. Dermatol Online J. 2014;20(3):doj_21769.
33. Nast A, Gisondi P, Ormerod AD, et al. European S3-guidelines on the systemic treatment of psoriasis vulgaris – update 2015 – short version – EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol. 2015;29(12):2277-94. DOI:10.1111/jdv.13354
34. Christophers E, Griffiths CE, Gaitanis G, van de Kerkhof P. The unmet treatment need for moderate to severe psoriasis: results of a survey and chart review. J Eur Acad Dermatol Venereol. 2006;20(8):921-5. DOI:10.1111/j.1468-3083.2006.01667.x
35. Gladman DD, Mease PJ, Ritchlin CT, et al. Adalimumab for long-term treatment of psoriatic arthritis: Forty-eight week data from the adalimumab effectiveness in psoriatic arthritis trial. Arthritis Rheum. 2007;56(2):476-88. DOI:10.1002/art. 22379
36. 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. DOI:10.1002/art.21306
37. Gordon K, Papp K, Poulin Y, et al. Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: Results from an open-label extension study for patients from REVEAL. J Am Acad Dermatol. 2012;66(2):241-51. DOI:10.1016/j.jaad.2010.12.005
38. Mease PJ, Ory P, Sharp JT, et al. Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann Rheum Dis. 2009;68(5):702-9. DOI:10.1136/ard.2008.092767
39. Cai L, Gu J, Zheng J, et al. Efficacy and safety of adalimumab in Chinese patients with moderate-to-severe plaque psoriasis: Results from a phase 3, randomized, placebo-controlled, double-blind study. J Eur Acad Dermatol Venereol. 2017;31(1): 89-95. DOI:10.1111/jdv.13746
40. Papp K, Thaçi D, Marcoux D, et al. Efficacy and safety of adalimumab every other week versus methotrexate once weekly in children and adolescents with severe chronic plaque psoriasis: A randomised, double-blind, phase 3 trial. Lancet. 2017;390(10089):40-9. DOI:10.1016/S0140-6736 (17)31189-3
41. Sator P. Safety and tolerability of adalimumab for the treatment of psoriasis: A review summarizing 15 years of real-life experience. Ther Adv Chronic Dis. 2018;9(8):147-58. DOI:10.1177/2040622318772705(47)
42. Cai L, Li L, Cheng H, et al. Efficacy and safety of HLX03, an adalimumab biosimilar, in patients with moderate-to-severe plaque psoriasis: A randomized, double-blind, phase iii study. Adv Ther. 2022;39(1):583-97. DOI:10.1007/s12325-021-01899-0
43. Feldman SR, Reznichenko N, Pulka G, et al. Efficacy, safety and immunogenicity of AVT02 versus originator adalimumab in subjects with moderate to severe chronic plaque psoriasis: A multicentre, double-blind, randomised, parallel group, active control, phase iii study. BioDrugs. 2021;35(6):735-48. DOI:10.1007/s40259-021-00502-w
44. Samtsov AV, Bakulev AL, Khairutdinov VR, et al. Long-term data on the proposed adalimumab biosimilar BCD-057 in patients with moderate to severe psoriasis: A randomized controlled trial. PLoS One. 2022;17(2):e0263214. DOI:10.1371/journal.pone.0263214
45. Hercogová J, Papp KA, Chyrok V, et al. AURIEL-PsO: A randomized, double-blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB 11022 to reference adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol. 2020;182(2):316-26. DOI:10.1111/bjd.18220
46. Rudwaleit M, Claudepierre P, Wordsworth P, et al. Effectiveness, safety, and predictors of good clinical response in 1250 patients treated with adalimumab for active ankylosing spondylitis. J Rheumatol. 2009;36(4):801-8. DOI:10.3899/jrheum.081048
47. Revicki DA, Luo MP, Wordsworth P, et al. Adalimumab reduces pain, fatigue, and stiffness in patients with ankylosing spondylitis: results from the adalimumab trial evaluating long-term safety and efficacy for ankylosing spondylitis (ATLAS). J Rheumatol. 2008;35(7):1346-53.
48. Davis JC Jr, Revicki D, van der Heijde DM, et al. Health-related quality of life outcomes in patients with active ankylosing spondylitis treated with adalimumab: results from a randomized controlled study. Arthritis Rheum. 2007;57(6):1050-7. DOI:10.1002/art.22887
49. Haranaka M, Tanaka T, Kim S, et al. Pharmacokinetics and safety of CT-P17 (40 mg/0.4 ml) versus reference adalimumab: Randomized study in healthy Japanese adults. Immunotherapy. 2023;15(3):149-61. DOI:10.2217/imt-2022-0181
50. Wang H, Zuo D, Sun M, et al. Randomized, placebo controlled and double-blind trials of efficacy and safety of adalimumab for treating ankylosing spondylitis: A meta-analysis. Int J Rheum Dis. 2014;17(2):142-8. DOI:10.1111/1756-185X.12245
51. Xu H, Li Z, Wu J, et al. IBI303, a biosimilar to adalimumab, for the treatment of patients with ankylosing spondylitis in China: A randomised, double-blind, phase 3 equivalence trial. Lancet Rheumatol. 2019;1(1):e35-43. DOI:10.1016/S2665-9913(19)30013-X
52. Tu L, Xie Y, Liao Z, et al. Cost of illness, quality of life, and work outcomes in active ankylosing spondylitis patients treated with adalimumab in China. Front Public Health. 2020;8:602334. DOI:10.3389/fpubh.2020.602334
2. Mounach A, El Maghraoui A. Efficacy and safety of adalimumab in ankylosing spondylitis. Open Access Rheumatol. 2014;6:83-90. DOI:10.2147/OARRR.S44550
3. Su J, Li M, He L, et al. Comparison of the efficacy and safety of adalimumab (Humira) and the adalimumab biosimilar candidate (HS016) in Chinese patients with active ankylosing spondylitis: A multicenter, randomized, double-blind, parallel, phase iii clinical trial. BioDrugs. 2020;34(3):381-93. DOI:10.1007/s40259-020-00408-z
4. Sieper J, Poddubnyy D. Axial spondyloarthritis. Lancet. 2017;390(10089):73-84. DOI:10.1016/S0140-6736(16)31591-4
5. Taurog JD, Chhabra A, Colbert RA. Ankylosing Spondylitis and Axial Spondyloarthritis. N Engl J Med. 2016;374(26):2563-74. DOI:10.1056/NEJMra1406182
6. Burmester GR, Panaccione R, Gordon KB, et al. Adalimumab: Long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn’s disease. Ann Rheum Dis. 2013;72(4):517-24. DOI:10.1136/annrheumdis-2011-201244
7. Huang F, Gu J, Zhu P, et al. Efficacy and safety of adalimumab in Chinese adults with active ankylosing spondylitis: Results of a randomised, controlled trial. Ann Rheum Dis. 2014;73(3):587-94. DOI:10.1136/annrheumdis-2012-202533
8. Terslev L, Naredo E, Iagnocco A, et al. Defining Enthesitis in Spondyloarthritis by Ultrasound: Results of a Delphi Process and of a Reliability Reading Exercise. Arthritis Care Res (Hoboken). 2014;66(5):741-8. DOI:10.1002/acr.22191
9. Zaripova LN, Midgley A, Christmas SE, et al. Juvenile idiopathic arthritis: from aetiopathogenesis to therapeutic approaches. Pediatr Rheumatol Online J. 2021;19(1):135. DOI:10.1186/s12969-021-00629-8
10. Barut K, Adrovic A, Şahin S, Kasapçopur Ö. Juvenile idiopathic arthritis. Balkan Med J. 2017;34(2):90-101. DOI:10.4274/balkanmedj.2017.0111
11. Reich K, Gooderham M, Thaçi D, et al. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): A randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019;394(10198):576-86. DOI:10.1016/S0140-6736(19)30952-3
12. Ravelli A, Martini A. Juvenile idiopathic arthritis. Lancet. 2007;369(9563):767-78. DOI:10.1016/S0140-6736(07)60363-8
13. De Silvestri A, Capittini C, Poddighe D, et al. HLA-DRB1 alleles and juvenile idiopathic arthritis: Diagnostic clues emerging from a meta-analysis. Autoimmun Rev. 2017;16(12):1230-6. DOI:10.1016/j.autrev.2017.10.007
14. Prelog M, Schwarzenbrunner N, Sailer-Höck M, et al. Premature aging of the immune system in children with juvenile idiopathic arthritis. Arthritis Rheum. 2008;58(7):2153-62. DOI:10.1002/art.23599
15. Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: Recommendations for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Rheum. 2013;65(10):2499-512. DOI:10.1002/art.38092
16. Lovell DJ, Giannini EH, Reiff A, et al. Etanercept in children with polyarticular juvenile rheumatoid arthritis. Pediatric Rheumatology Collaborative Study Group. N Engl J Med. 2000;342(11):763-9. DOI:10.1056/NEJM200003163421103
17. Vanoni F, Minoia F, Malattia C. Biologics in juvenile idiopathic arthritis: A narrative review. Eur J Pediatr. 2017;176(9):1147-53. DOI:10.1007/s00431-017-2960-6
18. Ruperto N, Lovell DJ, Cuttica R, et al. Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis: Findings from an open-label treatment extension. Ann Rheum Dis. 2010;69(4):718-22. DOI:10.1136/ard.2009.100354
19. Ramanan AV, Dick AD, Jones AP, et al. Adalimumab in combination with methotrexate for refractory uveitis associated with juvenile idiopathic arthritis: A RCT. Health Technol Assess. 2019;23(15):1-140. DOI:10.3310/hta23150
20. Imagawa T, Takei S, Umebayashi H, et al. Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan. Clin Rheumatol. 2012;31(12):1713-21. DOI:10.1007/s10067-012-2082-5
21. Burgos-Vargas R, Tse S ML, Horneff G, et al. A Randomized, double-blind, placebo-controlled multicenter study of adalimumab in pediatric patients with enthesitis-related arthritis. Arthritis Care Res (Hoboken). 2015;67(11):1503-12. DOI:10.1002/acr.22657
22. Ramanan AV, Dick AD, Jones AP, et al. Adalimumab plus methotrexate for uveitis in juvenile idiopathic arthritis. N Engl J Med. 2017;376(17):1637-46. DOI:10.1056/NEJMoa1614160
23. Lovell DJ, Ruperto N, Goodman S, et al. Adalimumab with or without methotrexate in juvenile rheumatoid arthritis. N Engl J Med. 2008;359(8):810-20. DOI:10.1056/NEJMoa0706290
24. Li C, Sunhe Y, Zhou H, Dong W. Efficacy and safety evaluations of adalimumab biosimilars in the treatment of psoriasis. J Dermatolog Treat. 2023;34(1):2249145. DOI:10.1080/09546634.2023.2249145
25. Torales J, Echeverría C, Barrios I, et al. Psychodermatological mechanisms of psoriasis. Dermatol Ther. 2020;33(6):e13827. DOI:10.1111/dth.13827
26. Griffiths CEM, Armstrong AW, Gudjonsson JE, Barker JNWN. Psoriasis. Lancet. 2021;397(10281):1301-15. DOI:10.1016/S0140-6736 (20)32549-6
27. Takeshita J, Gelfand JM, Li P, et al. Psoriasis in the US medicare population: Prevalence, treatment, and factors associated with biologic use. J Invest. 2015;135(12):2955-63. DOI:10.1038/jid.2015.296
28. Parisi R, Iskandar IYK, Kontopantelis E, et al. National, regional, and worldwide epidemiology of psoriasis: Systematic analysis and modelling study. BMJ. 2020;369:m1590. DOI:10.1136/ bmj.m1590
29. Committee on Psoriasis CSoD. Guideline for the diagnosis and treatment of psoriasis in China (2018 simplified edition). Chin J Dermatol. 2019;52(4):223-30.
30. Nast A, Amelunxen L, Augustin M, et al. S3 guideline for the treatment of psoriasis vulgaris, update – Short version part 1 – Systemic treatment. J Dtsch Dermatol Ges. 2018;16(5):645-69. DOI:10.1111/ddg.13516
31. Singh JA, Guyatt G, Ogdie A, et al. Special article: 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol. 2019;71(1):5-32. DOI:10.1002/art. 40726
32. Zweegers J, de Jong EM, Nijsten TE, et al. Summary of the Dutch S3-guidelines on the treatment of psoriasis 2011. Dutch Society of Dermatology and Venereology. Dermatol Online J. 2014;20(3):doj_21769.
33. Nast A, Gisondi P, Ormerod AD, et al. European S3-guidelines on the systemic treatment of psoriasis vulgaris – update 2015 – short version – EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol. 2015;29(12):2277-94. DOI:10.1111/jdv.13354
34. Christophers E, Griffiths CE, Gaitanis G, van de Kerkhof P. The unmet treatment need for moderate to severe psoriasis: results of a survey and chart review. J Eur Acad Dermatol Venereol. 2006;20(8):921-5. DOI:10.1111/j.1468-3083.2006.01667.x
35. Gladman DD, Mease PJ, Ritchlin CT, et al. Adalimumab for long-term treatment of psoriatic arthritis: Forty-eight week data from the adalimumab effectiveness in psoriatic arthritis trial. Arthritis Rheum. 2007;56(2):476-88. DOI:10.1002/art. 22379
36. 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. DOI:10.1002/art.21306
37. Gordon K, Papp K, Poulin Y, et al. Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: Results from an open-label extension study for patients from REVEAL. J Am Acad Dermatol. 2012;66(2):241-51. DOI:10.1016/j.jaad.2010.12.005
38. Mease PJ, Ory P, Sharp JT, et al. Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann Rheum Dis. 2009;68(5):702-9. DOI:10.1136/ard.2008.092767
39. Cai L, Gu J, Zheng J, et al. Efficacy and safety of adalimumab in Chinese patients with moderate-to-severe plaque psoriasis: Results from a phase 3, randomized, placebo-controlled, double-blind study. J Eur Acad Dermatol Venereol. 2017;31(1): 89-95. DOI:10.1111/jdv.13746
40. Papp K, Thaçi D, Marcoux D, et al. Efficacy and safety of adalimumab every other week versus methotrexate once weekly in children and adolescents with severe chronic plaque psoriasis: A randomised, double-blind, phase 3 trial. Lancet. 2017;390(10089):40-9. DOI:10.1016/S0140-6736 (17)31189-3
41. Sator P. Safety and tolerability of adalimumab for the treatment of psoriasis: A review summarizing 15 years of real-life experience. Ther Adv Chronic Dis. 2018;9(8):147-58. DOI:10.1177/2040622318772705(47)
42. Cai L, Li L, Cheng H, et al. Efficacy and safety of HLX03, an adalimumab biosimilar, in patients with moderate-to-severe plaque psoriasis: A randomized, double-blind, phase iii study. Adv Ther. 2022;39(1):583-97. DOI:10.1007/s12325-021-01899-0
43. Feldman SR, Reznichenko N, Pulka G, et al. Efficacy, safety and immunogenicity of AVT02 versus originator adalimumab in subjects with moderate to severe chronic plaque psoriasis: A multicentre, double-blind, randomised, parallel group, active control, phase iii study. BioDrugs. 2021;35(6):735-48. DOI:10.1007/s40259-021-00502-w
44. Samtsov AV, Bakulev AL, Khairutdinov VR, et al. Long-term data on the proposed adalimumab biosimilar BCD-057 in patients with moderate to severe psoriasis: A randomized controlled trial. PLoS One. 2022;17(2):e0263214. DOI:10.1371/journal.pone.0263214
45. Hercogová J, Papp KA, Chyrok V, et al. AURIEL-PsO: A randomized, double-blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB 11022 to reference adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol. 2020;182(2):316-26. DOI:10.1111/bjd.18220
46. Rudwaleit M, Claudepierre P, Wordsworth P, et al. Effectiveness, safety, and predictors of good clinical response in 1250 patients treated with adalimumab for active ankylosing spondylitis. J Rheumatol. 2009;36(4):801-8. DOI:10.3899/jrheum.081048
47. Revicki DA, Luo MP, Wordsworth P, et al. Adalimumab reduces pain, fatigue, and stiffness in patients with ankylosing spondylitis: results from the adalimumab trial evaluating long-term safety and efficacy for ankylosing spondylitis (ATLAS). J Rheumatol. 2008;35(7):1346-53.
48. Davis JC Jr, Revicki D, van der Heijde DM, et al. Health-related quality of life outcomes in patients with active ankylosing spondylitis treated with adalimumab: results from a randomized controlled study. Arthritis Rheum. 2007;57(6):1050-7. DOI:10.1002/art.22887
49. Haranaka M, Tanaka T, Kim S, et al. Pharmacokinetics and safety of CT-P17 (40 mg/0.4 ml) versus reference adalimumab: Randomized study in healthy Japanese adults. Immunotherapy. 2023;15(3):149-61. DOI:10.2217/imt-2022-0181
50. Wang H, Zuo D, Sun M, et al. Randomized, placebo controlled and double-blind trials of efficacy and safety of adalimumab for treating ankylosing spondylitis: A meta-analysis. Int J Rheum Dis. 2014;17(2):142-8. DOI:10.1111/1756-185X.12245
51. Xu H, Li Z, Wu J, et al. IBI303, a biosimilar to adalimumab, for the treatment of patients with ankylosing spondylitis in China: A randomised, double-blind, phase 3 equivalence trial. Lancet Rheumatol. 2019;1(1):e35-43. DOI:10.1016/S2665-9913(19)30013-X
52. Tu L, Xie Y, Liao Z, et al. Cost of illness, quality of life, and work outcomes in active ankylosing spondylitis patients treated with adalimumab in China. Front Public Health. 2020;8:602334. DOI:10.3389/fpubh.2020.602334
________________________________________________
2. Mounach A, El Maghraoui A. Efficacy and safety of adalimumab in ankylosing spondylitis. Open Access Rheumatol. 2014;6:83-90. DOI:10.2147/OARRR.S44550
3. Su J, Li M, He L, et al. Comparison of the efficacy and safety of adalimumab (Humira) and the adalimumab biosimilar candidate (HS016) in Chinese patients with active ankylosing spondylitis: A multicenter, randomized, double-blind, parallel, phase iii clinical trial. BioDrugs. 2020;34(3):381-93. DOI:10.1007/s40259-020-00408-z
4. Sieper J, Poddubnyy D. Axial spondyloarthritis. Lancet. 2017;390(10089):73-84. DOI:10.1016/S0140-6736(16)31591-4
5. Taurog JD, Chhabra A, Colbert RA. Ankylosing Spondylitis and Axial Spondyloarthritis. N Engl J Med. 2016;374(26):2563-74. DOI:10.1056/NEJMra1406182
6. Burmester GR, Panaccione R, Gordon KB, et al. Adalimumab: Long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn’s disease. Ann Rheum Dis. 2013;72(4):517-24. DOI:10.1136/annrheumdis-2011-201244
7. Huang F, Gu J, Zhu P, et al. Efficacy and safety of adalimumab in Chinese adults with active ankylosing spondylitis: Results of a randomised, controlled trial. Ann Rheum Dis. 2014;73(3):587-94. DOI:10.1136/annrheumdis-2012-202533
8. Terslev L, Naredo E, Iagnocco A, et al. Defining Enthesitis in Spondyloarthritis by Ultrasound: Results of a Delphi Process and of a Reliability Reading Exercise. Arthritis Care Res (Hoboken). 2014;66(5):741-8. DOI:10.1002/acr.22191
9. Zaripova LN, Midgley A, Christmas SE, et al. Juvenile idiopathic arthritis: from aetiopathogenesis to therapeutic approaches. Pediatr Rheumatol Online J. 2021;19(1):135. DOI:10.1186/s12969-021-00629-8
10. Barut K, Adrovic A, Şahin S, Kasapçopur Ö. Juvenile idiopathic arthritis. Balkan Med J. 2017;34(2):90-101. DOI:10.4274/balkanmedj.2017.0111
11. Reich K, Gooderham M, Thaçi D, et al. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): A randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019;394(10198):576-86. DOI:10.1016/S0140-6736(19)30952-3
12. Ravelli A, Martini A. Juvenile idiopathic arthritis. Lancet. 2007;369(9563):767-78. DOI:10.1016/S0140-6736(07)60363-8
13. De Silvestri A, Capittini C, Poddighe D, et al. HLA-DRB1 alleles and juvenile idiopathic arthritis: Diagnostic clues emerging from a meta-analysis. Autoimmun Rev. 2017;16(12):1230-6. DOI:10.1016/j.autrev.2017.10.007
14. Prelog M, Schwarzenbrunner N, Sailer-Höck M, et al. Premature aging of the immune system in children with juvenile idiopathic arthritis. Arthritis Rheum. 2008;58(7):2153-62. DOI:10.1002/art.23599
15. Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: Recommendations for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Rheum. 2013;65(10):2499-512. DOI:10.1002/art.38092
16. Lovell DJ, Giannini EH, Reiff A, et al. Etanercept in children with polyarticular juvenile rheumatoid arthritis. Pediatric Rheumatology Collaborative Study Group. N Engl J Med. 2000;342(11):763-9. DOI:10.1056/NEJM200003163421103
17. Vanoni F, Minoia F, Malattia C. Biologics in juvenile idiopathic arthritis: A narrative review. Eur J Pediatr. 2017;176(9):1147-53. DOI:10.1007/s00431-017-2960-6
18. Ruperto N, Lovell DJ, Cuttica R, et al. Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis: Findings from an open-label treatment extension. Ann Rheum Dis. 2010;69(4):718-22. DOI:10.1136/ard.2009.100354
19. Ramanan AV, Dick AD, Jones AP, et al. Adalimumab in combination with methotrexate for refractory uveitis associated with juvenile idiopathic arthritis: A RCT. Health Technol Assess. 2019;23(15):1-140. DOI:10.3310/hta23150
20. Imagawa T, Takei S, Umebayashi H, et al. Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan. Clin Rheumatol. 2012;31(12):1713-21. DOI:10.1007/s10067-012-2082-5
21. Burgos-Vargas R, Tse S ML, Horneff G, et al. A Randomized, double-blind, placebo-controlled multicenter study of adalimumab in pediatric patients with enthesitis-related arthritis. Arthritis Care Res (Hoboken). 2015;67(11):1503-12. DOI:10.1002/acr.22657
22. Ramanan AV, Dick AD, Jones AP, et al. Adalimumab plus methotrexate for uveitis in juvenile idiopathic arthritis. N Engl J Med. 2017;376(17):1637-46. DOI:10.1056/NEJMoa1614160
23. Lovell DJ, Ruperto N, Goodman S, et al. Adalimumab with or without methotrexate in juvenile rheumatoid arthritis. N Engl J Med. 2008;359(8):810-20. DOI:10.1056/NEJMoa0706290
24. Li C, Sunhe Y, Zhou H, Dong W. Efficacy and safety evaluations of adalimumab biosimilars in the treatment of psoriasis. J Dermatolog Treat. 2023;34(1):2249145. DOI:10.1080/09546634.2023.2249145
25. Torales J, Echeverría C, Barrios I, et al. Psychodermatological mechanisms of psoriasis. Dermatol Ther. 2020;33(6):e13827. DOI:10.1111/dth.13827
26. Griffiths CEM, Armstrong AW, Gudjonsson JE, Barker JNWN. Psoriasis. Lancet. 2021;397(10281):1301-15. DOI:10.1016/S0140-6736 (20)32549-6
27. Takeshita J, Gelfand JM, Li P, et al. Psoriasis in the US medicare population: Prevalence, treatment, and factors associated with biologic use. J Invest. 2015;135(12):2955-63. DOI:10.1038/jid.2015.296
28. Parisi R, Iskandar IYK, Kontopantelis E, et al. National, regional, and worldwide epidemiology of psoriasis: Systematic analysis and modelling study. BMJ. 2020;369:m1590. DOI:10.1136/ bmj.m1590
29. Committee on Psoriasis CSoD. Guideline for the diagnosis and treatment of psoriasis in China (2018 simplified edition). Chin J Dermatol. 2019;52(4):223-30.
30. Nast A, Amelunxen L, Augustin M, et al. S3 guideline for the treatment of psoriasis vulgaris, update – Short version part 1 – Systemic treatment. J Dtsch Dermatol Ges. 2018;16(5):645-69. DOI:10.1111/ddg.13516
31. Singh JA, Guyatt G, Ogdie A, et al. Special article: 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol. 2019;71(1):5-32. DOI:10.1002/art. 40726
32. Zweegers J, de Jong EM, Nijsten TE, et al. Summary of the Dutch S3-guidelines on the treatment of psoriasis 2011. Dutch Society of Dermatology and Venereology. Dermatol Online J. 2014;20(3):doj_21769.
33. Nast A, Gisondi P, Ormerod AD, et al. European S3-guidelines on the systemic treatment of psoriasis vulgaris – update 2015 – short version – EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol. 2015;29(12):2277-94. DOI:10.1111/jdv.13354
34. Christophers E, Griffiths CE, Gaitanis G, van de Kerkhof P. The unmet treatment need for moderate to severe psoriasis: results of a survey and chart review. J Eur Acad Dermatol Venereol. 2006;20(8):921-5. DOI:10.1111/j.1468-3083.2006.01667.x
35. Gladman DD, Mease PJ, Ritchlin CT, et al. Adalimumab for long-term treatment of psoriatic arthritis: Forty-eight week data from the adalimumab effectiveness in psoriatic arthritis trial. Arthritis Rheum. 2007;56(2):476-88. DOI:10.1002/art. 22379
36. 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. DOI:10.1002/art.21306
37. Gordon K, Papp K, Poulin Y, et al. Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: Results from an open-label extension study for patients from REVEAL. J Am Acad Dermatol. 2012;66(2):241-51. DOI:10.1016/j.jaad.2010.12.005
38. Mease PJ, Ory P, Sharp JT, et al. Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann Rheum Dis. 2009;68(5):702-9. DOI:10.1136/ard.2008.092767
39. Cai L, Gu J, Zheng J, et al. Efficacy and safety of adalimumab in Chinese patients with moderate-to-severe plaque psoriasis: Results from a phase 3, randomized, placebo-controlled, double-blind study. J Eur Acad Dermatol Venereol. 2017;31(1): 89-95. DOI:10.1111/jdv.13746
40. Papp K, Thaçi D, Marcoux D, et al. Efficacy and safety of adalimumab every other week versus methotrexate once weekly in children and adolescents with severe chronic plaque psoriasis: A randomised, double-blind, phase 3 trial. Lancet. 2017;390(10089):40-9. DOI:10.1016/S0140-6736 (17)31189-3
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Авторы
М.А. Гилавян*, Д.В. Трунова, А.В. Устинова, А.М. Суханова
ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия
*gilavyan_m_a@student.sechenov.ru
Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia
*gilavyan_m_a@student.sechenov.ru
ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия
*gilavyan_m_a@student.sechenov.ru
________________________________________________
Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia
*gilavyan_m_a@student.sechenov.ru
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