TUMOR NECROSIS FACTOR-α INHIBITORS IN THE TREATMENT OF AXIAL SPONDYLOARTHRITIS, INCLUDING ANKYLOSING SPONDYLITIS

The paper provides guidelines for the use of tumor necrosis factor-α  (TNF-α) inhibitors in the treatment of patients with axial spondyloarthritis  (axSpA), including ankylosing spondylitis. It gives data on the efficacy of TNF-α inhibitors in patients with non-radiographic axSpA. By using international and Russian guidelines, the authors lay down indications for this therapy and criteria for evaluation of its efficiency and safety.

1. Насонов ЕЛ, редактор. Ревматология: Клинические рекомендации. 2-е изд. Москва: ГЭОТАР-Медиа; 2010. 752 c. [Nasonov EL, editor. Revmatologiya: Klinicheskie rekomendatsii. [Rheumatology: Clinical guidelines]. 2nd ed. Moscow: GEOTAR-Media; 2010. 752 p.].

2. Эрдес ШФ. Основные принципы терапии анкилозирующего спондилита (болезни Бехтерева). Научно-практическая ревматология. 2013;51(6):686-95 [Erdes ShF. The basic principles of treatment of ankylosing spondylitis (Bechterew’s disease). NauchnoPrakticheskaya Revmatologiya=Rheumatology Science and Practice. 2013;51(6):686-95 (In Russ.)]. doi: 10.14412/1995-4484-2013-686-95

3. Furst DE, Keystone EC, Braun J, et al. Updated consensus statement on biological agents for the treatment of rheumatic diseases, 2011. Ann Rheum Dis. 2012;71 Suppl 2:i2-45. doi: 10.1136/annrheumdis-2011-201036

4. Wang D, Ma L, Wu D. Efficacy of etanercept in ankylosing spondylitis hip lesions. Joint Bone Spine. 2011 Oct;78(5):531-2. doi: 10.1016/j.jbspin.2011.03.023

5. Эрдес ШФ. Применение голимумаба при анкилозирующем спондилите. Научно-практическая ревматология. 2012;50(Прил. 3):11-6 [Erdes ShF. The use of golimumab in ankylosing spondylitis. Nauchno-Prakticheskaya Revmatologiya=Rheumatology Science and Practice. 2012;50(Suppl. 3):11-6 (In Russ.)].

6. Эрдес ШФ. Этанерцепт в терапии анкилозирующего спондилита. Научно-практическая ревматология. 2012;50(Прил. 4):28-34 [Erdes ShF. Etanercept in the treatment of ankylosing spondylitis. Nauchno-Prakticheskaya Revmatologiya=Rheumatology Science and Practice. 2012;50(Suppl. 4): 28-34 (In Russ.)].

7. Haroon N, Inman RD, Learch TJ, et al. The Impact of TNFinhibitors on radiographic progression in ankylosing spondylitis. Arthritis Rheum. 2013 Oct;65(10):2645-54. doi: 10.1002/art.38070

8. Van den Bosch F, Kruithof E, Baeten D, et al. Effects of a loading dose regimen of three infusions of chimeric monoclonal antibody to tumour necrosis factor α (infliximab) in spondyloarthropathy: an open pilot study. Ann Rheum Dis. 2000 Jun;59(6):428-33. doi: 10.1136/ard.59.6.428

9. Brandt J, Haibel H, Sieper J, et al. Treatment of patients with severe ankylosing spondylitis with infliximab – a one year follow up. Arthritis Rheum. 2001 Dec;44(12):2936-7. doi: 10.1002/1529-0131(200112)44:12<2936::AID-ART483>3.0.CO;2-M

10. Kruithof E, van den Bosch F, Baeten D, et al. Repeated infusions of infliximab, a chimeric anti-TNF-α monoclonal antibody, in patients with active spondyloarthropathy: one year follow up. Ann Rheum Dis. 2002 Mar;61(3):207-12. doi: 10.1136/ard.61.3.207

11. Marzo-Ortega H, McGonagle D, O'Connor P, Emery P. Efficacy of etanercept in the treatment of the entheseal pathology in resistant spondylarthropathy: a clinical and magnetic resonance imaging study. Arthritis Rheum. 2001 Sep;44(9):2112-7. doi: 10.1002/1529-0131(200109)44:9<2112::AID-ART363>3.0.CO;2-H

12. Inman RD, Davis JC Jr, van der Heijde D, et al. Efficacy and safety of golimumab in patients with ankylosing spondylitis: results of a randomized, double-blind, placebo-controlled, phase III trial. Arthritis Rheum. 2008 Nov;58(11):3402-12. doi: 10.1002/art.23969

13. Spadaro A, Scarno A, Carboni A, et al. Rapid effectiveness of certolizumab pegol in non-radiographic axial spondyloarthritis. Reumatismo. 2013 Jul 24;65(3):134-7. doi: 10.4081/reumatismo.2013.134

14. Braun J, Pham T, Sieper J, et al; ASAS Working Group. International ASAS consensus statement for the use of anti-tumour necrosis factor agents in patients with ankylosing spondylitis. Ann Rheum Dis. 2003 Sep;62(9):817-24. doi: 10.1136/ard.62.9.817

15. Van der Heijde D, Sieper J, Maksymowych WP, et al, for the Assessment of SpondyloArthritis international Society. 2010 Update of the international ASAS recommendations for the use of anti-TNF agents in patients with axial spondyloarthritis. Ann Rheum Dis. 2011;70(6):905-8. doi: 10.1136/ard.2011.151563

16. Smolen JS, Braun J, Dougados M, et al. Treating spondyloarthritis, including ankylosing spondylitis and psoriatic arthritis, to target: recommendations of an international task force. Ann Rheum Dis. 2014 Jan;73(1):6-16. doi: 10.1136/annrheumdis-2013-203419

17. Rudwaleit M, van der Heijde D, Landewe R, et al. The development of assessment of spondyloarthritis international society classiс cation criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009;68:777-83. doi: 10.1136/ard.2009.108233

18. Lukas C, Landewe R, Sieper J, et al. Development of an ASASendorsed disease activity score (ASDAS) in patients with ankylosing spondylitis. Assessment of SpondyloArthritis international Society. Ann Rheum Dis. 2009 Jan;68(1):18-24. doi: 10.1136/ard.2008.094870

19. Maxwell LJ, Zochling J, Boonen A, et al. TNF-alpha inhibitors for ankylosing spondylitis. Cochrane Database Syst Rev. 2015 Apr 18;4:CD005468. doi: 10.1002/14651858.CD005468.pub2

20. Rudwaleit M, van den Bosch F, Kron M, et al. Effectiveness and safety of adalimumab in patients with ankylosing spondylitis or psoriatic arthritis and history of anti-tumor necrosis factor therapy. Arthritis Res Ther. 2010;12:R117. doi: 10.1186/ar3054

21. Dougados M, Combe B, Braun J, et al. A randomised, multicentre, double-blind, placebo-controlled trial of etanercept in adults with refractory heel enthesitis in spondyloarthritis: the HEEL trial. Ann Rheum Dis. 2010;69:1430-5. doi: 10.1136/ard.2009.121533

22. Braun J, Baraliakos X, Hermann K-GA, et al. The effect of two golimumab doses on radiographic progression in ankylosing spondylitis: results through 4 years of the GO-RAISE trial. Ann Rheum Dis. 2014 Jun;73(6):1107-13. doi: 10.1136/annrheumdis-2012-203075

23. Song IH, WeiІ A, Hermann KG, et al. Similar response rates in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis after 1 year of treatment with etanercept: results from the ESTHER trial. Ann Rheum Dis. 2013;72(6);823-5. doi: 10.1136/annrheumdis-2012-202389

24. Song IH, Hermann K, Haibel H, et al. Effects of etanercept versus sulfasalazine in early axial spondyloarthritis on active inflammatory lesions as detected by whole-body MRI (ESTHER): a 48-week randomised controlled trial. Ann Rheum Dis. 2011;70(4);590-6. doi: 10.1136/ard.2010.139667

25. Sieper J, Lenaerts J, Wollenhaupt J, et al. Efficacy and safety of infliximab plus naproxen versus naproxen alone in patients with early, active axial spondyloarthritis: results from the double-blind, placebo-controlled INFAST study, Part 1. Ann Rheum Dis. 2014 Jan;73(1):101-7. doi: 10.1136/annrheumdis-2012-203201

26. Бочкова АГ, Румянцева OA, Дубинина ТВ и др. Первый опыт применения адалимумаба у больных анкилозирующим спондилитом: клиническое и МРТ-сопоставление результатов терапии. Научно-практическая ревматология. 2010;48(1):67-74 [Bochkova AG, Rumyantseva OA, Dubinina TV, et al. The first experience in using adalimumab in patients with ankylosing spondylitis: clinical and mricomparisons of the results of therapy. NauchnoPrakticheskaya Revmatologiya = Rheumatology Science and Practice. 2010;48(1):67-74 (In Russ.)]. doi: 10.14412/1995-4484-2010-1408.

27. Vastesaeger N, van der Heijde D, Inman RD, et al. Predicting the outcome of ankylosing spondylitis therapy. Ann Rheum Dis. 2011;70:6973-81. doi: 10.1136/ard.2010.147744

28. Poddubnyy D. Axial spondyloarthritis: is there a treatment of choice? Ther Adv Musculoskelet Dis. 2013 Feb;5(1):45-54. doi: 10.1177/1759720X12468658

29. Bennett N, McGonagle D, O'Connor P, et al. Severity of baseline magnetic resonance imaging-evident sacroiliitis and HLA-B27 status in early inflammatory back pain predict radiographically evident ankylosing spondylitis at eight years. Arthritis Rheum. 2008;58(11):3413-8. doi: 10.1002/art.24024

30. Poddubnyy D, RudwaleitM. Rates and predictors of radiographic sacroiliitis progression over 2 years in patients with axial spondyloarthritis. Ann Rheum Dis. 2011 Aug;70(8):1369-74. doi: 10.1136/ard.2010.145995

31. Poddubnyy D, Sieper J. Radiographic progression in ankylosing spondylitis/axial spondyloarthritis: how fast and how clinically meaningful? Curr Opin Rheumatol. 2012 Jul;24(4):363-9. doi: 10.1097/BOR.0b013e328352b7bd

32. Эрдес ШФ, Бочкова АГ, Дубинина ТВ и др. Ранняя диагностика анкилозирующего спондилита. Научно-практическая ревматология. 2013;51(4):365-7 [Erdes SF, Bochkova AG, Dubinina TV, et al. Early diagnosis of ankylosing spondylitis. NauchnoPrakticheskaya Revmatologiya = Rheumatology Science and Practice. 2013;51(4):365-7 (In Russ.)]. doi: 10.14412/1995-4484-2013-1245

33. Inman RD, Maksymowich WP for the CANDLE Study Group. A double-blind, placebo-controlled trial of low dose infliximab in ankylosing spondylitis. J Rheumatol. 2010;37:6. doi: 10.3899/jrheum.091042

34. Cantini F, Niccoli L, Cassara E, et al. Duration of remission after halving of the etanercept dose in patients with ankylosing spondylitis: a randomized, prospective, long-term, follow-upstudy. Biologics. 2013;7:1-6. doi: 10.2147/BTT.S31474

35. Arends S, van der Veer E, Kamps FB, et al. Patient-tailored dose reduction of TNF-α blocking agents in ankylosing spondylitis patients with stable low disease activity in daily clinical practice. Clin Exp Rheumatol. 2015 Mar-Apr;33(2):174-80.

36. Olivieri I, D'Angelo S, Padula A, et al. Can we reduce the dosage of biologics in spondyloarthritis? Autoimmun Rev. 2013 May;12(7):691-3. doi: 10.1016/j.autrev.2012.08.013

37. Song IH, Haibel H, Poddubnyy D, et al. Withdrawal of biologic therapy in axial spondyloarthritis: the experience in early disease. Clin Exp Rheumatol. 2013 Jul-Aug;31(4 Suppl. 78):S37-42.

38. Spadaro A, Punzi L, Marchesoni A, et al. Switching from infliximab or etanercept to adalimumab in resistant or intolerant patients with spondyloarthritis: a 4-year study. Rheumatology (Oxford). Jun 2010;49(6):1107-11. doi: 10.1093/rheumatology/keq008

39. Румянцева ОА, Бочкова АГ, Кузикянц КХ и др. Опыт длительной терапии инфликсимабом у больных анкилозирующим спондилитом. Научно-практическая ревматология. 2010;48(6):16-22 [Rumyantseva OA, Bochkova AG, Kuzikyants KK, et al. Experience with long-term infliximab therapy in patients with ankylosing spondylitis. Nauchno-Prakticheskaya Revmatologiya = Rheumatology Science and Practice. 2010;48(6):16-22. (In Russ.)]. doi: 10.14412/1995-4484-2010-818

40. Braun J, Sieper J. Remission and possible discontinuation of biological therapy in axial spondyloarthritis. Clin Exp Rheumatol. 2013;31(Suppl. 78):S33-6.

41. Song IH, Althoff CE, Haibel H, et al. Frequency and duration of drug-free remission after 1 year of treatment with etanercept versus sulfasalazine in early axial spondyloarthritis: 2 year data of the ESTHER trial. Ann Rheum Dis. 2012;71(7);1212-5. doi: 10.1136/annrheumdis-2011-201010

42. Wu D, Guo YY, Xu NN, et al. Efficacy of anti-tumor necrosis factor therapy for extra-articular manifestations in patients with ankylosing spondylitis: a meta-analysis. BMC Musculoskelet Disord. 2015 Feb 10;16:19. doi: 10.1186/s12891-015-0489-2

43. Эрдес ШФ. Эффективность адалимумаба при увеитах у больных анкилозирующим спондилитом. Современная ревматология. 2012;6(1):65-8 [Erdes SF. Efficacy of adalimumab in uveitis in patients with ankylosing spondylitis. Sovremennaya Revmatologiya = Modern Rheumatology Journal. 2012;6(1):65-8. (In Russ.)]. doi: 10.14412/1996-7012-2012-719

44. Braun J, van den Berg R, Baraliakos X, et al. 2010 update of the ASAS/EULAR recommendations for the management of AS. Ann Rheum Dis. 2011;70:896-904. doi: 10.1136/ard.2011.151027

45. Emi Aikawa N, de Carvalho JF, Artur Almeida Silva C, Bonfa E. Immunogenicity of Anti-TNF-alpha agents in autoimmune diseases. Clin Rev Allergy Immunol. 2010 Apr;38(2-3):82-9. doi: 10.1007/s12016-009-8140-3

46. Arends S, Lebbink HR, Spoorenberg A, et al. The formation of autoantibodies and antibodies to TNF-α blocking agents in relation to clinical response in patients with ankylosing spondylitis. Clin Exp Rheumatol. 2010 Sep-Oct;28(5):661-8.

47. Plasencia C, Pascual-Salcedo D, Nuno L, et al. Influence of immunogenicity on the efficacy of longterm treatment of spondyloarthritis with infliximab. Ann Rheum Dis. 2012 Dec;71(12):1955-60. doi: 10.1136/annrheumdis-2011-200828

48. Murdaca G, Spano F, Contatore M, et al. Immunogenicity of infliximab and adalimumab: what is its role in hypersensitivity and modulation of therapeutic efficacy and safety? Expert Opin Drug Saf. 2016 Jan;15(1):43-52. doi: 10.1517/14740338.2016.1112375.