Национальный саммит по ревматологии. Место адалимумаба в современной стратегии фармакотерапии ревматоидного артрита

25 апреля 2015 г. в Сочи в рамках Национального саммита по ревматологии состоялась сессия ревматоидного артрита (РА). Ведущие зарубежные и отечественные эксперты обсудили основные положения рекомендаций Европейской антиревматической лиги (EULAR)-2013 и Ассоциации ревматологов России по лечению РА, рассмотрели оптимальные сроки назначения генно-инженерных биологических препаратов для достижения цели лечения при раннем и длительно текущем РА на примере адалимумаба (АДА), проанализировали результаты исследований эффективности и безопасности комбинированной терапии АДА и метотрексатом. Особое внимание было уделено результатам внедрения концепции «Лечение до достижения цели» в российскую клиническую практику и мониторинга больных РА.

Национальный саммит по ревматологии, ревматоидный артрит, концепция «Лечение до достижения цели» (Т2Т), генно-инженерные биологические препараты, ингибиторы фактора некроза опухоли α, адалимумаб, метотрексат

1. Keystone EC, Breedveld FC, van der Heijde D, et al. Longterm effect of delaying combination therapy with tumor necrosis factor inhibitor in patients with aggressive early rheumatoid arthritis: 10-year efficacy and safety of adalimumab from the randomized controlled PREMIER trial with open-label extension. J Rheumatol. 2014 Jan;41(1):5–14. doi: 10.3899/jrheum.130543. Epub 2013 Nov 15.

2. Насонов ЕЛ, Мазуров ВИ, Каратеев ДЕ и др. Проект рекомендаций по лечению ревматоидного артрита Общероссийской общественной организации «Ассоциация ревматологов России» – 2014 (часть 1). Научно-практическая ревматология. 2014;52(5):477–94. [Nasonov EL, Mazurov VI, Karateev DE, et al. Project: recommendations on treatment of rheumatoid arthritis developed by all-russian public organization «Association of Rheumatologists of Russia» – 2014 (part 1). Nauchno-prakticheskaya revmatologiya = Rheumatology Science and Practice. 2014;52(5):477–94. (In Russ.)]. DOI: http://dx.doi.org/10.14412/1995-4484-2014-477-494

3. Smolen JS, Landewе 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 Mar;73(3):492–509. doi: 10.1136/annrheumdis-2013-204573. Epub 2013 Oct 25.

4. Hetland ML, Christensen IJ, Tarp U, et al. Direct comparison of treatment responses, remission rates, and drug adherence in patients with rheumatoid arthritis treated with adalimumab, etanercept, or infliximab: results from eight years of surveillance of clinical practice in the nationwide Danish DANBIO registry. Arthritis Rheum. 2010 Jan;62(1):22–32. doi: 10.1002/art.27227.

5. Keystone EC, van der Heijde D, Kavanaugh A, et al. Clinical, functional, and radiographic benefits of longterm adalimumab plus methotrexate: final 10-year data in longstanding rheumatoid arthritis. J Rheumatol. 2013 Sep;40(9):1487–97. doi: 10.3899/jrheum.120964. Epub 2013 Jul 1.

6. Dougados MR, van der Heijde DM, Brault Y, et al. When to adjust therapy in patients with rheumatoid arthritis after initiation of etanercept plus methotrexate or methotrexate alone: findings from a randomized study (COMET). J Rheumatol. 2014 Oct;41(10):1922–34. doi: 10.3899/jrheum.131238. Epub 2014 Aug 15.

7. Emery P. Why is there persistent disease despite biologic therapy? Importance of early intervention. Arthritis Res Ther. 2014;16(3):115.

8. Breedveld FC, Weisman MH, Kavanaugh AF, et al. The PREMIER study: A multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 2006 Jan;54(1):26–37.

9. Breedveld FC, Keystone E, van der Heijde D, et al. Initial combination therapy with adalimumab plus methotrexate leads to better long-term outcomes than with either monotherapy in patients with early rheumatoid arthritis: 8-year results of an open-label extension of a phase 3 trial. ACR, 2011. Poster 1231.

10. Keystone EC, Kavanaugh AF, Sharp JT, et al. Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial. Arthritis Rheum. 2004 May;50(5):1400–11.

11. Burmester G, Kivitz A, Kupper H, et al. Efficacy, pharmacokinetics and safety of different doses of metotrexate in combination with adalimumab: results from the CONCERTO Trial. EULAR, 2013. Abs. OPO067.

12. Visser K, van der Heijde D. Optimal dosage and route of administration of methotrexate in rheumatoid arthritis: a systematic review of the literature. Ann Rheum Dis. 2009 Jul;68(7):1094–9. doi: 10.1136/ard.2008.092668. Epub 2008 Nov 25.

13. Kaeley G. Impact of Methotrexate Dose Reduction upon initiation of adalimumab on clinical and ultrasonographic parameters in patients with moderate to severe rheumatoid arthritis. ACR, 2013. Abs. 2686.

14. Fabbroni M, Cantarini L, Caso F, et al. Drug retention rates and treatment discontinuation among anti-TNF-α agents in psoriatic arthritis and ankylosing spondylitis in clinical practice. Mediators Inflamm. 2014;2014:862969. doi:10.1155/2014/862969. Epub 2014 Jul 8.

15. Selmi C, Ceribelli A, Naguwa SM, et al. Safety issues and concerns of new immunomodulators in rheumatology. Expert Opin Drug Saf. 2015 Mar;14(3):389–99. doi: 10.1517/14740338.2015.993605. Epub 2014 Dec 18.

16. Singh JA, Wells GA, Christensen R, et al. Adverse effects of biologics: a network metaanalysis and Cochrane overview. Cochrane Database Syst Rev. 2011 Feb 16;(2):CD008794. doi: 10.1002/14651858.CD008794.pub2.

17. Kievit W, Fransen J, Adang EM, et al. Long-term effectiveness and safety of TNF-blocking agents in daily clinical practice: results from the Dutch Rheumatoid Arthritis Monitoring register. Rheumatology (Oxford). 2011 Jan;50(1):196–203. doi: 10.1093/rheumatology/keq325. Epub 2010 Nov 14.

18. Curtis JR, Jain A, Askling J, et al. A comparison of patient characteristics and outcomes in selected European and U.S. rheumatoid arthritis registries. Semin Arthritis Rheum. 2010 Aug;40(1):2–14.e1. doi: 10.1016/j.semarthrit.2010.03.003.

19. Yun H, Xie F, Delzell ES, et al. Comparative Safety Of Biological Agents Among Medicare Rheumatoid Arthritis Patients. ACR, 2013. Abs. 2319.

20. Yun H, Xie F, Delzell ES, et al. Risks of herpes zoster in patients with rheumatoid arthritis according to biologic disease-modifying therapy. Arthritis Care Res (Hoboken). 2015 May;67(5):731–6. doi: 10.1002/acr.22470.

21. Accort NA, Bonafede M, Collier D. A retrospective database analysis describing reccurent infection risk among patients using TNF inhibitors, other biologic DMARDs and non-biologic DMARDs. Ann Rheum Dis 2014;73:476–7.

22. Burmester GR, Mease P, Dijkmans BA, et al. Adalimumab safety and mortality rates from global clinical trials of six immunemediated inflammatory diseases. Ann Rheum Dis. 2009 Dec;68(12):1863–9. doi: 10.1136/ard.2008.102103. Epub 2009 Jan 15.

23. Hellgren K, Smedby KE, Backlin C, et al. Ankylosing spondylitis, psoriatic arthritis, and risk of malignant lymphoma: a cohort study based on nationwide prospectively recorded data from Sweden. Arthritis Rheumatol. 2014 May;66(5):1282–90. doi: 10.1002/art.38339.

24. Davies R, Galloway JB, Watson KD, et al. Venous thrombotic events are not increased in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the British Society for Rheumatology Biologics Register. Ann Rheum Dis. 2011 Oct;70(10):1831–4. doi: 10.1136/ard.2011.153536. Epub 2011 Jul 22.

25. van Vollenhoven RF. Treatment of rheumatoid arthritis: state of the art 2009. Nat Rev Rheumatol. 2009 Oct;5(10):531–41. doi: 10.1038/nrrheum.2009.182.

26. Yazici Y. Treatment of rheumatoid arthritis: we are getting there. Lancet. 2009 Jul 18;374(9685):178–80. doi: 10.1016/S0140-6736(09)60792-3. Epub 2009 Jun 26.

27. Calabrese LH. Molecular differences in anticytokine therapies. Clin Exp Rheumatol. 2003 Mar–Apr;21(2):241–8.

28. Alzabin S, Abraham SM, Taher TE, et al. Incomplete response of inflammatory arthritis to TNFα blockade is associated with the Th17 pathway. Ann Rheum Dis. 2012;71 (10):1741–8.

29. Schellekens H. Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov. 2002 Jun;1(6):457–62. 30. Jamnitski A, Krieckaert CL, Nurmohamed MT, et al. Patients nonresponding to etanercept obtain lower etanercept concentrations compared with responding patients. Ann Rheum Dis. 2012 Jan;71(1):88–91. doi: 10.1136/annrheumdis-2011-200184. Epub 2011 Sep 12.

30. Bartelds GM, Krieckaert CL, Nurmohamed MT, et al. Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA. 2011 Apr 13;305(14):1460–8. doi: 10.1001/jama.2011.406.

31. Krieckaert CL, Nurmohamed MT, Wolbink GJ. Methotrexate reduces immunogenicity in adalimumab treated rheumatoid arthritis patients in a dose dependent manner. Ann Rheum Dis. 2012 Nov;71(11):1914–5. doi: 10.1136/annrheumdis-2012-201544. Epub 2012 May 14.