Preview

Современная ревматология

Расширенный поиск

Ингибитор фактора некроза опухоли α голимумаб в лечении ревматоидного артрита

https://doi.org/10.14412/1996-7012-2014-4-76-85

Полный текст:

Аннотация

Для лечения ревматических заболеваний – ревматоидного артрита (РА), анкилозирующего спондилита, псориатического артрита – в 2012 г. в России зарегистрирован ингибитор фактора некроза опухоли (ФНО)α голимумаб (ГЛМ), который представляет собой полностью человеческое моноклональное антитело. Его отличительными чертами являются высокая аффинность к ФНО α, а также удобство применения: препарат вводится 1 раз в месяц подкожно в виде раствора, объемом 0,5 мл. Регистрации препарата предшествовало проведение массивной программы клинических исследований. Рандомизированные плацебоконтролируемые исследования GO-FORWARD, GO-BEFORE, GO-AFTER показали, что ГЛМ эффективен у пациентов с РА из различных подгрупп и обладает благоприятным профилем безопасности, соответствующим таковому всего класса генно-инженерных биологических препаратов. По данным этих исследований, ГЛМ оказывал позитивное влияние на функцию и качество жизни больных РА: отмечено достоверно большее снижение индекса HAQ как в ранние сроки лечения, так и на протяжении длительной открытой фазы (до 5 лет), достоверно большее уменьшение утомляемости, достоверно большее, чем в контрольной группе (р=0,032), улучшение физического и ментального состояния по опроснику SF-36, достоверное уменьшение времени нетрудоспособности.

Об авторе

Наталия Владимировна Чичасова
ГБОУ ВПО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России
Россия
105043, Россия, Москва, ул. Б. Пироговская, д. 2, стр. 4


Литература

1. Lee DM, Weinblatt ME. Rheumatoid arthritis. Lancet. 2001;358:903–11. DOI: http://dx.doi.org/10.1016/S0140-6736(01)06075-5.

2. Насонов ЕЛ, Каратеев ДЕ, Балабанова РМ. Ревматоидный артрит. В кн.: Ревматология. Национальное руководство. Под ред. Е.Л. Насонова, В.А. Насоновой. Москва: ГЕОТАР-Медиа; 2008. С. 290–331 [Nasonov EL, Karateev DE, Balabanova RM. Rheumatoid arthritis. In: Revmatologiya. Natsional’noe rukovodstvo [Rheumatology. National Guide]. Nasonov EL, Nasonova VA, editors. Moscow: GEOTAR-media; 2008. P. 290–331.]

3. McInnes IB, Schett G. Cytokines in the pathogenesis of rheumatoid arthritis. Nat Rev Immunol. 2007;7:429–42. DOI: http://dx.doi.org/10.1038/nri2094.

4. Александрова ЕН, Насонов ЕЛ. Иммунопатология ревматоидного артрита. В кн.: Генно-инженерные биологические препараты в лечении ревматоидного артрита. Под ред. Е.Л. Насонова. Москва: ИМА-ПРЕСС; 2013. С. 19–46. [Aleksandrova EN, Nasonov EL. Immunopathology of rheumatoid arthritis. In: Genno-inzhenernye biologicheskie preparaty v lechenii revmatoidnogo artrita [Genetically engineered biological preparations in treatment of rheumatoid arthritis]. Nasonov EL, editor. Moscow: IMA-PRESS; 2013. P. 19–46.]

5. Breedveld FC, Combe B. Understanding emerging treatment paradigms in rheumatoid arthriris. Arthritis Res Ther. 2011;13 (Suppl 1):S3.

6. McIlnes IB. Attitudes of rheumatologists to rapidly progressing rheumatoid arthritis. Rheumatology (Oxford). 2007;6 (Suppl 1):i89.

7. Smolen JS, Landewe R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum is. 2010;69:964–75. DOI: http://dx.doi.org/10.1136/ard.2009.126532.

8. Smolen JS, Landewe R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014;73:492–509. DOI: http://dx.doi.org/10.1136/annrheumdis-2013-204573.

9. Smolen J, Aletaha D, Koeller M, et al. New therapies for treatment of rheumatoid arthritis. Lancet. 2007;370:1861–74. DOI: http://dx.doi.org/10.1016/S0140-6736(07)60784-3.

10. Smolen JS, Landewe R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014;73:492–509. DOI: http://dx.doi.org/10.1136/annrheumdis-2013-204573.

11. Shealy D, Cai A, Lacy A, et al. Characterisation of golimumab (CNTO 148), a novel monoclonal antibody specific for human TNFα. Ann Rheum Dis. 2007;66:151.

12. Voulgari PV. Emerging drugs for rheumatoid arthritis. Expert Opin Emerg Drugs. 2008;13:175–96. DOI: http://dx.doi.org/10.1517/14728214.13.1.175.

13. Feldman M, Bernan FM, Maini RN. Rheumatoid arthritis. Cell. 1996;85:307–10. DOI: рttp://dx.doi.org/10.1016/S0092-8674(00)81109-5.

14. Braun J, Baraliakos X, Brandt J, Sipper J. Therapy of Ankylosing spondylitis. Part II: biological therapies in the spondyloarthritides. Scand J Rheumatol. 2005;34:178–90. DOI: http://dx.doi.org/10.1080/03009740510026599.

15. Veale DJ, Ritchlin C, FitzGerald O. Immunopathology of psoriasis and psoriatic arthritis. Ann Rheum Dis. 2005;64 (Suppl 2):ii26–9. DOI: http://dx.doi.org/10.1136/ard.2004.031740.

16. Choy EH, Panayi GS. Cytokine pathways and joint inflammation in rheumatoid arthritis. N Engl J Med. 2001;344:907–16. DOI: http://dx.doi.org/10.1056/NEJM200103223441207.

17. Kay J, Matteson EL, Dagupta B, et al. Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebo-controlled, dose ranging study. Arthritis Rheum. 2008;58:954–75. DOI: http://dx.doi.org/10.1002/art.23383.

18. Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727–35. DOI: gttp://dx.doi.org/10.1002/art.1780380602.

19. Van Gestel AM, Revoo ML, van't Hof MA, et al. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis: comparison with preliminariua American Colledge of Rheumatology and the World Health Organisation/International League against Rheumatism criteria. Arthritis Rheum. 1996;39:34–40. DOI: http://dx.doi.org/10.1002/art.1780390105.

20. Keystone E, Genovese M, Klareskog L, et al. Golimumab, a human antibody to tumour necrosis factor α given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study. Ann Rheum Dis. 2009;68:789–96. DOI: http://dx.doi.org/10.1136/ard.2008.099010.

21. Keystone E, Genovese MC, Hall S, et al. Five-year safety and efficacy of golimumab in patients with active rheumatoid arthritis despite prior treatment with methothrexate: final study results of the phase 3, randomized placebo-controlled GO-FORWARD trial. Ann Rheum Dis. 2013;72 (Suppl 3):867–8. DOI: http://dx.doi.org/10.1136/annrheumdis-2013-eular.2589.

22. Van der Heijde D. Plain x-rays in rheumatoid arthritis: overview of scoring methods, their reliability and applicability. Baillieres Clin Rheumatol. 1996;10:435–53. DOI: http://dx.doi.org/10.1016/S0950-3579(96)80043-4.

23. Emery P, Fleischmann RM, Moreland LW, et al. Golimumab, a human anti-tumor necrosis factor a monoclonal antibody, injected subcutaneous every four weeks in methotrexate-naive patients with active rheumatoid arthritis. Arthritis Rheum. 2009;60:2272–83. DOI: http://dx.doi.org/10.1002/art.24638.

24. Emery P, Fleischmann R, van der Heijde D, et al. The effect of golimumab on radiographic progression in rheumatoid arthritis: results of randomized controlled studies of golimumab before methotrexate therapy and golimumab after methotrxate therapy. Arthritis Rheum. 2011;63(5):1200–10. DOI: http://dx.doi.org/10.1002/art.30263.

25. Smolen JS, Kay J, Doyle MK, et al. Goloimab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor α inhibitor (GO-AFTER study): a multicenter, randomised, doubleblind, placebo controlled, phase III trial. Lancet. 2009;374:210–21. DOI: http://dx.doi.org/10.1016/S0140-6736(09)60506-7.

26. Emery P. Optimizing outcomes in patients with rheumatoid arthritis and an inadequate response to anti-TNF treatment. Rheumatology (Oxford). 2012;51:v22–30. DOI: http://dx.doi.org/10.1093/rheumatology/kes115.

27. Bombardieri S, Ruiz AA, Fardellone P, et al. Effectiveness of adalimumab for rheumatoid arthritis in patients with a history of TNF-antagonist therapy in clinical practice. Rheumatology (Oxford). 2007;46:1191–9. DOI: http://dx.doi.org/10.1093/rheumatology/kem091.

28. Hyrich KL, Lunt M, Watson KD, et al.; British Society for Rheumatology Biologics Register. Outcomes after switching from one anti-tumor necrosis factor alpha agent to a second anti-tumor necrosis factor alpha agent in patients with rheumatoid arthritis: results from a large UK national cohort study. Arthritis Rheum. 2007;56:13–20. DOI: http://dx.doi.org/10.1002/art.22331.

29. Gomez-Reino JJ, Carmona L; BIOBADASER Group. Switching TNF antagonist in patients with chrons arthritis: an observational study of 488 patients over fouryear period. Arthritis Res Ther. 2006;8:R29. DOI: http://dx.doi.org/10.1186/ar1881.

30. Hyrich KL, Lunt M, Dixon WG, et al.; BSR Biologics Register. Effects of switching between anti-TNF therapyes on HAQ response in patients who do not respond to their first anti-TNF drug. Rheumatology (Oxford). 2008;47:1000–5. DOI: http://dx.doi.org/10.1093/rheumatology/ ken127.

31. Karisson JA, Kristensen LE, Kapetanovich MC, et al. Treatment response to a second or third TNF-inhibitor in RA: results from the South Swedish Arthritis Treatment Group Register. Rheumatology (Oxford). 2009;47:507–13. DOI: http://dx.doi.org/10.1093/rheumatology/ ken034.

32. Nam JL, Wintrop KL, van Vollenchoven RF, et al. Extendet report: current evidence for the management of rheumatoid arthritis with biological diseasemodifying antirheumatic drugs: a systematic literature review informing the EULAR recommendations for the management of RA. Ann Rheum Dis. 2010;69:976–86. DOI: http://dx.doi.org/10.1136/ard.2009.126573.

33. Schoels M, Aletaha D, Smolen JS, Wong JB. Comparative effectiveness and safety of biological treatment options after tumour necrosis factor a inhibitor failure in rheumatoid arthritis: a systematic review and indirect pairwise meta-analysis. Ann Rheum Dis. 2012;71:1303–8. DOI: http://dx.doi.org/10.1136/annrheumdis-2011-200490.

34. Cohen SB, Emery P, Greenwald MW, et al. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluation primary efficacy and safety at twenty-four weeks. Arthritis Rheum. 2006;54:2793–806. DOI: http://dx.doi.org/10.1002/art.22025.

35. Emery P, Keystone E, Tony HP, et al. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumor necrosis factor biological: results from 24-week multicenter randomised placebocontrolled trial. Ann Rheum Dis. 2008;67:1516–23. DOI: http://dx.doi.org/10.1136/ard.2008.092932.

36. Genovese MC, Becker JC, Schiff M, et al. Abatacept for rheumatoid arthritis refractory to anti-tumor necrosis factor alpha inhibition. N Engl J Med. 2005;353:210–21. DOI: http://dx.doi.org/10.1056/NEJMoa050524.

37. Singh JA, Noorbaloochi S, Singh G. Golimumab for rheumatoid arthritis: a systematic review. Rheumatology (Oxford). 2010;37:1096–104. DOI: http://dx.doi.org/10.3899/jrheum.091466.

38. Blay LE, Mouterde G, Barnetche T, et al. Short-term risk of total malignancy and nonmelanoma skin cancers with certolizumab and golimumab in patients with rheumatoid arthritis: metanalysis of randomised controlled trials. Rheumatology (Oxford). 2012;39:712–5. DOI: http://dx.doi.org/10.3899/jrheum.110982.

39. Bongartz T, Sutton AJ, Sweeting MJ, et al. Anti-TNF antibody terapy in rheumatoid arthritis and the risk of serious infections and malignancies. Systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA. 2006;295:2275–85. DOI: http://dx.doi.org/10.1001/jama.295.19.2275.

40. Dixon W, Silman A. Is there an association between anti-TNF monoclonal antibody therapy in rheumatoid arthritis and risk of malignancy and serious infection? Commentary on the meta-analysis by Bongartz et al. Arthritis Res Ther. 2006;8(5):111. DOI: http://dx.doi.org/10.1186/ar2026.

41. Wolfe F, Michaud K. Biologic treatment of the rheumatoid arthritis and the risk of malignancy. Arthritis Rheum. 2007;56:2886–95. DOI: http://dx.doi.org/10.1002/art.22864.

42. Askling J, Fored CM, Drandt L, et al. Risks of solid cancers in patients with rheumatoid arthritis and after treatment with timour nacrosis factor antagonists. Ann Rheum Dis. 2005;64:1421–6. DOI: http://dx.doi.org/10.1136/ard.2004.033993.

43. Geborek P, Bladstrom A, Turesson C, et al. Tumour nacrosis factor blokers do not increase overall tumour risk in patients with rheumatoid arthritis, but may be associated with an increased risk of lymphomas. Ann Rheum Dis. 2005;64:699–703. DOI: http://dx.doi.org/10.1136/ard.2004.030528.

44. Genovese MC, Han C, Keystone EC, et al. Effect of golimumab on patient-reported outcomes in rheumatoid arthritis : results from the GO-FORWARD study. Rheumatology (Oxford). 2012;39:1185–91. DOI: http://dx.doi.org/10.3899/jrheum.111195.

45. Buchanan J, Emery P, Keystone EC, et al. Golimumab significantly reduced time lost from work for patients with rheumatoid arthritis: pooled results from three phase 3 studies. Value in Helth. 2009;12:A69. DOI: http://dx.doi.org/10.1016/S1098-3015(10)73405-7.

46. Ellis L, Bolge S, Rice P. Golimumab utilization patterns and refill adherence in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Value in Health. 2014;17:A49–50. DOI:http://dx.doi.org/10.1016/j.jval.2014.03.294.

47. Combe B, Dasgupta B, Louw I, et al. Efficacy and safety of golimumab as add-on therapy to disease-modifying antirheumatic drugs: results of the GO-MORE study. Ann Rheum Dis. 2014 Aug;73(8):1477–86. DOI: 10.1136/annrheumdis-2013-203229. Epub 2013 Jun 5.

48. Tandon N, Bolce R, Naim A, et al. Satisfaction with and prefegence for Golimumab and its autoinjector among rheumatoid arthritis patients switched from adalimumab or etanercept. Value in Health. 2012;15:A45–6. DOI: http://dx.doi.org/10.1016/j.jval.2012.03.255 .


Для цитирования:


Чичасова Н.В. Ингибитор фактора некроза опухоли α голимумаб в лечении ревматоидного артрита. Современная ревматология. 2014;8(4):76-85. https://doi.org/10.14412/1996-7012-2014-4-76-85

For citation:


Chichasova N.V. The tumor necrosis factor-α inhibitor golimumab in the treatment of rheumatoid arthritis. Modern Rheumatology Journal. 2014;8(4):76-85. (In Russ.) https://doi.org/10.14412/1996-7012-2014-4-76-85

Просмотров: 578


Creative Commons License
Контент доступен под лицензией Creative Commons Attribution 4.0 License.


ISSN 1996-7012 (Print)
ISSN 2310-158X (Online)