Выживаемость терапии ингибиторами фактора некроза опухоли α: основные причины и тактика замены препаратов

В статье приведены данные об эффективности и безопасности ингибиторов фактора некроза опухоли α(иФНОα), применяемых в первой и второй линиях терапии. Описаны варианты оптимизации лечения иФНОαв первой линии терапии: за счет повышения дозы, что сопровождается увеличением эффекта только при использовании инфликсимаба; за счет изменения дозы сопутствующих базисных противовоспалительных препаратов, в первую очередь МТ, использование которого увеличивает вероятность достижения эффекта иФНОα, выраженность эффекта возрастает с увеличением дозы МТ или при использовании его парентеральной формы. Представлены данные об эффективности переключения с первого иФНОαна второй иФНОαлибо на генно-инженерный биологический препарат с другим механизмом действия.

1. Singh JA, Hossain A., Tanjong GE, et al. Biologics or tofacitinib for people with rheumatoid arthritis unsuccessfully treated with biologics: a systematic review and network meta-analysis (Review). Cochrane Database Syst Rev.2017 Mar 10;3:CD012591. doi: 10.1002/14651858.CD012591.

2. Finckh A, Ciurea A, Brulhart L, et al. Which subgroup of patients with rheumatoid arthritis benefits from switching to rituximab versus alternative antitumour necrosis factor (TNF) agents after previsious failure of antiTNF agent? Ann Rheum Dis.2010 Feb;69(2): 387-93. doi: 10.1136/ard.2008.105064. Epub 2009 May 4.

3. Hyrich KL, Lunt M, Dixon WG, et al. Effect of switching between anti-TNF therapies on HAQ response in patients who do not respond to their first anti-TNF drug. Rheumatology (Oxford). 2008 Jul;47(7):1000-5. doi: 10.1093/rheumatology/ken127. Epub 2008 Apr 17.

4. Hjardem E, Ostergaard M, Podenphant J, et al. Do rheumatoid arthritis patients in clinical practice benefit from switching from infliximab to a second tumor necrosis factor alpha inhibitor? Ann Rheum Dis. 2007 Sep;66(9):1184-9. Epub 2007 Mar 27.

5. Smolen JS, Kay J, Doyle MK, et al. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicenter, randomised, doubleblind, placebo-controlled, phase III trial. Lancet. 2009 Jul 18;374(9685):210-21. doi: 10.1016/S0140-6736(09)60506-7. Epub 2009 Jun 26.

6. Genovese MC, Beeker JC, Schiff M, et al. Abatacept for rheumatoid arthritis refractory to tumour necrosis factor alpha inhibition. N Engl J Med. 2005 Sep 15;353(11):1114-23.

7. Hyrich KL, Lunt M, Watson KD, et al. Outcomes after switching from one antitumour necrosis alpha agent to a second antitumour necrosis alpha agent in patients with rheumatoid arthritis: result from a large UK national cohort study. Arthritis Rheum.2007 Jan;56(1):13-20.

8. Favalli EG, Pregnolato F, Biggioggero M, et al. Twelve-Year Retention rate of first-line tumor necrosis factor inhibitors in rheumatoid arthritis: real-life data from a local registry. Arthritis Care Res (Hoboken). 2016 Apr;68(4):432-9. doi: 10.1002/acr.22788.

9. Bombardiri S, Ruiz AA, Fardellone P, et al. Effectiveness of adalimumab for rheumatoid arthritis in patients with history of TNF-antagonist therapy in clinical practice. Rheumatology (Oxford).2007 Jul;46(7):1191-9. Epub 2007 May 15.

10. Van der Bijl AE, Breedveld FC, Antoni CE, et al. An open-label pilot study of the effectiveness of adalimumab in patients with rheumatoid arthritis and previous infliximab treatment: relationship to reason for failure and anti-infliximab antibody status. Clin Rheumatol.2008 Aug;27(8):1021-8. doi: 10.1007/s10067-008-0866-4. Epub 2008 Mar 19.

11. Du Pan SM, Dehler S, Ciurea A, et al. Comparison of drug retention rates and causes of drug discontinuation between antitumour necrosis factor agents in rheumatoid arthritis.Arthritis Rheum. 2009 May 15; 61(5):560-8. doi: 10.1002/art.24463.

12. Gomez-Reino JJ, Carmona L. Switching TNF antagonist in patients with chronic arthritis: an observational study of 488 patients over a four-year period. Arthritis Res Ther. 2006;8(1):R29. Epub 2006 Jan 6.

13. Yazici Y, Krasnokutsky S, Barnes, et al. Changing patterns of tumour necrosis factor inhibitor use in 9074 patients with rheumatoid arthritis. J Rheumatol.2009 May;36(5): 907-13. doi: 10.3899/jrheum.080592. Epub 2009 Mar 30.

14. Oei HB, Hooker RS, Cipher DJ, Reimond A. High rates of stopping or switching biological medications in veteran with rheumatoid arthritis. Clin Exp Rheumatol. 2009 Nov-Dec;27(6):926-34.

15. Schaeverbeke T, Truchetet ME, Kostine M, et al. Immunogenicity of biologic agents in rheumatoid arthritis patients: lessons for clinical practice. Rheumatology (Oxford).2016 Feb; 55(2):210-20. doi: 10.1093/rheumatology/kev277. Epub 2015 Aug 12.

16. Smolen JS, Aletaha D, Bijlsma JW, et al. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis. 2010 Apr;69(4):631-7. doi: 10.1136/ard.2009.123919. Epub 2010 Mar 9.

17. Насонов ЕЛ, редактор. Российские клинические рекомендации. Ревматология. Москва: ГЕОТАР-Медиа; 2017. 456 с. [Nasonov EL, editor. Rossiiskie klinicheskie rekomendatsii. Revmatologiya[Russian clinical guidelines. Rheumatology]. Moscow: GEOTAR-Media; 2017. 456 p.].

18. Aletaha D, Nell VP, Stamm T, et al. Acute phase reactants add little to composite disease activity indices for rheumatoid arthritis: validation of clinical activity score.Arthritis Res Ther.2005;7(4):R796-806. Epub 2005 Apr 7.

19. Zhang J, Shan Y, Reed G, et al. Thresholds in disease activity for switching biologics in RA patoents: experience from a large United States cohort. Arthritis Care Res (Hoboken).2011 Dec;63(12):1672-9. doi: 10.1002/acr.20643.

20. Satybaldiev A, Karateev D, Nasonov E, et al. The reason for withdrawal of biological DMARD’s according to the russin registry of patients with rheumatoid arthritis. Ann Rheum Dis2016;75:1002.

21. Dennis G, Holweg CT, Kummerfeld SK, et al. Synovial phenotypes in rheumatoid arthritis correlate with response to biologic therapeutics/ Arthritis Res Ther.2014;16(2): R90. Epub 2014 Apr 30.

22. Vincent FB, Morand EF, Murphy K, et al. Antidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralizing agents in chronic inflammatory diseases: a real issue, a clinical perspective. Ann Rheum Dis. 2013 Feb;72(2):165-78. doi: 10.1136/annrheumdis-2012-202545. Epub 2012 Nov 24.

23. Schaeverbeke T, Truchetet ME, Kostine M, et al. Immunogenecitu of biologic agents in rheumatoid arthritis patients: lessons for clinical practice. Ann Rheum Dis.2013 Feb;72(2): 165-78. doi: 10.1136/annrheumdis-2012-202545. Epub 2012 Nov 24.

24. Bartelds GM, Wijbrandts CA, Nurmohamed MT, et al. Clincal response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis. 2007 Jul;66(7):921-6. Epub 2007 Feb 14.

25. De Vries MK, Wolbink GJ, Stapel SO, et al. Decreased clinical response to infliximab in ankylosing spondylitis is correlated with anti-infliximab formation. Ann Rheum Dis. 2007 Sep;66(9):1252-4. Epub 2007 May 1.

26. Hoxha A, Calligaro A, Tonello M, et al. Clinical significance of anti-adalimumab antibodies in rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. Ann Rheum Dis.2014;73(Suppl 2):927

27. Moots RJ, Xavier RM, Mok CC, et al. The impact of anti-drug antibodies on drug concentrations and clinical outcomes in rheumatoid arthritis patients treated with adalimumab, etanercept, or infliximab: Results from a multinational, real-world clinical practice, non-interventional study. PLoS One. 2017 Apr 27;12(4):e0175207. doi: 10.1371/journal.pone.0175207. eCollection 2017.

28. De Vries MK, Van der Horst-Bruimsma IE, Nurmohamed MT, et al. Immunogenicity does not influence treatment with etanercept in patients with Ankylosing spondylitis. Ann Rheum Dis.2009 Apr;68(4):531-5. doi: 10.1136/ard.2008.089979. Epub 2008 Mar 28.

29. Leu JH, Adedokun OJ, Gargano C, et al. Immunogenicity of golimumab and its clinical relevance in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.Rheumatology (Oxford).2018 Nov 8. doi: 10.1093/rheumatology/key309. [Epub ahead of print]

30. Favalli EG, Pontiakaki I, Becciolini A, et al. Real-life 10-year retention rate of first-line anti-TNF drugs for inflammatory arthritides in adult- and juvenile-onset populations: similarities and differences. Clin Rheumatol.2017 Aug;36(8):1747-1755. doi: 10.1007/s10067-017-3712-8. Epub 2017 Jun 8.

31. Soliman MM, Ashcroft DM, Watson KD, et al. Impact of concomitant use of DMARDS on the persistence with anti-TNF therapies in patients with rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register. Ann Rheum Dis. 2011 Apr; 70(4):583-9. doi: 10.1136/ard.2010.139774. Epub 2011 Feb 17.

32. Kievit W, Fransen J, Adang EM, et al. Long-term effectiveness and safety of TNFblocking 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.

33. Neovius M, Arkema EV, Olsson H, et al. Drug survival on TNF inhibitors in patients with rheumatoid arthritis comparison of adalimumab, etanercept and infliximab. Ann Rheum Dis. 2015 Feb;74(2):354-60. doi: 10.1136/annrheumdis-2013-204128. Epub 2013 Nov 27.

34. Dalen J, Svedbom A, ChristopherM, et al. Treatment persistence among patients with immune-mediated rheumatic disease newly treated with subcutaneous TNF-alpha inhibitors and costs associated with non persistence. Rheumatol Int. 2016 Jul;36(7):987-95. doi: 10.1007/s00296-016-3423-5. Epub 2016 Jan 16.

35. Aaltonen KJ, Joensuu J, PiriläL, et al Drug survival on TNF inhibitors in patients with rheumatoid arthritis in Finland. Ann Rheum Dis.2016;75(Suppl 2):500

36. St Clair EW, Wagner CL, Fasanmade AA, et al. The relationship of serum infliximab concentrations to clinical improvement in rheumatoid arthritis: results from ATTRACT, a multicenter, randomized, double-blind, placebo-controlled trial.Arthritis Rheum. 2002 Jun;46(6):1451-9.

37. Rahman MU, Strusberg I, Geusens P, et al. Double-blinded infliximab dose escalation in patients with rheumatoid arthritis. Ann Rheum Dis. 2007 Sep;66(9):1233-8. Epub 2007 Mar 28.

38. Breedveld FC, Weisman MH, Kavanaugh A, 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.

39. Weinblatt ME, Schiff MH, Ruderman EM, et al. Efficacy and safety of etanercept 50 mg twice a week in patients with rheumatoid arthritis who had a suboptimal response to etanercept 50 mg once a week: results of a multicenter, randomized, double-blind, active drug-controlled study.Arthritis Rheum. 2008 Jul;58(7):1921-30. doi: 10.1002/art.23493.

40. Curtis JR, Chen L, Luijtens K, et al. Dose escalation of certolizumab pegol from 200 to 400 mg every other week provides no additional efficacy in rheumatoid arthritis: an analysis of individual patient-level data. Arthritis Rheum. 2011 Aug;63(8):2203-8. doi: 10.1002/art.30387.

41. Finckh A, Simard JF, Gabay C, Guerne PA; SCOM physicians. Evidence for differential acquired drug resistance to anti tumour necrosis factor agents in rheumatoid arthritis. Ann Rheum Dis.2006 Jun;65(6):746-52. Epub 2005 Dec 8.

42. Smolen JS, Landewe R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017 Jun;76(6):960-977. doi: 10.1136/annrheumdis-2016-210715. Epub 2017 Mar 6.

43. Klareskog L, Van der Heijde DM, de Jager JP, et al. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: doubleblind randomised controlled trial. Lancet. 2004 Feb 28;363(9410):675-81.

44. Emery P, Fleischmann RM, Moreland LW, et al. Golimumab, a human anti-tumor necrosis factor monoclonal antibody, injected subcutaneously every four weeks in methotrexate-na?ve patients with active rheumatoid arthritis: twenty-four-weeks results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of Golimumab before methotrexate as firstline therapy for early-onset rheumatoid arthritis. Arthritis Rheum.2009 Aug;60(8):2272-83. doi: 10.1002/art.24638.

45. Becciolini A, Biggioggero M, Favalli EG. The role of methotrexate as combination therapy with etanercept in rheumatoid arthritis: retrospective analysis of a local registry. J Int Med Res. 2016 Sep;44(1 suppl):113-118.

46. Gabay C, Riek M, Scherer A, Finckh A; SCQM collaborating physicians. Effectiveness of biologic DMARDs in monotherapy versus in combination with synthetic DMARDs in rheumatoid arthritis; data from the Swiss Clinical Management Registry. Rheumatology (Oxford).2015 Sep; 54(9):1664-72. doi: 10.1093/rheumatology/kev019. Epub 2015 Apr 27.

47. Burmester GR, Kivitz AJ, Kupper H, et al. Efficacy and safety of ascending methotrexate dose in combination with adalimumab: the randomised CONCERTO trial. Ann Rheum Dis.2015 Jun;74(6):1037-44. doi: 10.1136/annrheumdis-2013-204769. Epub 2014 Feb 18.

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

49. Bianchi G, Caporali R, Todoerti M, Mattana P. Methotrexate and rheumatoid arthritis: current evidence regarding subcutaneous versus oral routes of administration. Adv Ther.2016 Mar;33(3):369-78. doi: 10.1007/s12325-016-0295-8. Epub 2016 Feb 4.

50. Schiff MH, Jaffe JS, Freundlich B. Headto-head, randomised, crossover study of oral versus cubcutaneous methotrexate in patients with rheumatoid arthritis: drug-exposure limitations of oral methotrexate at doses>=15 mg may be overcome with subcutaneous administration. Ann Rheum Dis.2014 Aug; 73(8):1549-51. doi: 10.1136/annrheumdis-2014-205228. Epub 2014 Apr 12.

51. Braun J, Kastner P, Flaxenberg P, et al. Comparison of the clinical efficacy and safety of subcutaneous versus oral administration of methotrexate in patients with active rheumatoid arthritis: results of a six-month, multicenter, randomized, double-blind, controlled, phase IV trial. Arthritis Rheum.2008 Jan; 58(1):73-81. doi: 10.1002/art.23144.

52. Monti S, Klersy C, Gorla R, et al. Factor influencing the choice of first- and secondline biologic therapy for the treatment of rheumatoid arthritis: real-life data from the Italian LORHEN registry. Clin Rheumatol. 2017 Apr;36(4):753-761. doi: 10.1007/s10067-016-3528-y. Epub 2017 Jan 5.

53. Strangefeld A, Hierse F, Kekov J, et al. Comparative effectiveness of tumour necrosis factor alpha inhibitors in combination with either methotrexate or leflunomide.Ann Rheum Dis.2009 Dec;68(12):1856-62. doi: 10.1136/ard.2008.098467. Epub 2009 Jan 6.

54. De Stefano R, Frati E, Nargi F, et al. Comparison of combination therapies in the treatment of rheumatoid arthritis: leflunomide-anti-TNF-alpha versus methotrexateanti-TNF-alpha. Clin Rheumatol. 2010 May; 29(5):517-24. doi: 10.1007/s10067-009-1349-y. Epub 2010 Jan 16.

55. Furst DE, Gaylis N, Bray V, et al. Openlabel, pilot protocol of patients with rheumatoid arthritis who switch to infliximab after an incomplete response to etanercept: the opposite study. Ann Rheum Dis. 2007 Jul;66(7): 893-9. Epub 2007 Apr 5.

56. Smolen JS, Kay J, Doyle MK, et al. Golimumab in patoents with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicenter, randomised, doubleblind, placebo-controlled, phase III trial. Lancet. 2009 Jul 18;374(9685):210-21. doi: 10.1016/S0140-6736(09)60506-7. Epub 2009 Jun 26.

57. Smolen JS, Burmester GR, Combe B, et al. Head-to-head comparison of certolizumab pegol versus adalimumab in rheumatoid arthritis: 2 year efficacy and safety from the randomised EXXELERATE study. Lancet. 2016 Dec 3;388(10061):2763-2774. doi: 10.1016/ S0140-6736(16)31651-8. Epub 2016 Nov 15.

58. Weinblatt ME, Fleischmann RM, Huizinga TWJ, et al. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology (Oxford).2012 Dec; 51(12):2204-14. doi: 10.1093/rheumatology/ kes150. Epub 2012 Aug 25.

59. Lloyd S, Bujkiewicz S, Wailoo AJ, et al. The effectiveness of anti-TNF-therapies when used sequentially in rheumatoid arthritis patients: a systematic review and metaanalysis. Rheumatology (Oxford). 2010 Dec;49(12):2313-21. doi: 10.1093/rheumatology/keq169. Epub 2010 Jun 21.

60. Greenberg JD, Reed G, Dector D, et al. A comparative effectiveness study of adalimumab, etanercept and infliximab inn biologically na?ve and switched rheumatoid arthritis patients: results from US CORRONA registry. Ann Rheum Dis.2012 Jul; 71(7):1134-42. doi: 10.1136/annrheumdis-2011-150573. Epub 2012 Jan 30.

61. Favalli EG, Caporali R, Monti S, et al. Two-year retention rate of subcutaneous antitumor necrosis factor agents for rheumatoid arthritis: a retrospective analysis of the Lorhen Registry. Ann Rheum Dis. 2016; 75(Suppl 2):492

62. Favalli EG, Sinigaglia L, Becciolini A, et al. Two-year persistence of golimumab as second-line biologic agent in rheumatoid arthritis as compared to other subcutaneous tumor necrosis factor inhibitors: real-life data from the LORHEN registry. Int J Rheum Dis. 2018 Feb;21(2):422-430. doi: 10.1111/1756-185X.13199. Epub 2017 Oct 30.

63. Hyrich KL, Lunt M, Watson KD, et al. British Society for Rheumatology Biologics Register. Outcomes after switching from one anti-timor 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 Jan;56(1):13-20.

64. Virkki LM, Valleala H, Takakubo Y, et al. Outcomes of switching anti-TNF drugs in rheumatoid arthritis – a study based on observational data from Finnish Register of Biological Treatment (ROB-FIN). Clin Rheumatol. 2011 Nov;30(11):1447-54. doi: 10.1007/s10067-011-1779-1. Epub 2011 Jun 7.

65. Chatzidionysiou K, Askling J, Eriksson J, et al; ARTIS group. Effectiveness of TNF inhibitor switch in RA: results from the national Swedish register.Ann Rheum Dis. 2015 May;74(5):890-6. doi: 10.1136/annrheumdis-2013-204714. Epub 2014 Jan 15.

66. Blom M, Kievit W, Fransen J, et al. The reason for discontinuation of the first tumor necrosis factor (TNF) blocking agent does not influence the effect of a second TNF blocking agent in patients with rheumatoid arthritis.J Rheumatol.2009 Oct;36(10):2171-7. doi: 10.3899/jrheum.090054. Epub 2009 Sep 1.

67. Huffstutter JE, Kafka S, Brent LH, et al. Clinical response to golimumab in rheumatoid arthritis patients who were receiving etanercept or adalimumab: results of a multicenter active treatment study. Curr Med Res Opin. 2017 Apr;33(4):657-666. doi: 10.1080/ 03007995.2016.1277195. Epub 2017 Jan 25.

68. Genovese MC, Becker JC, Schiff MH, et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. N Engl J Med.2005 Sep 15;353(11):1114-23.

69. Genovese MC, Schiff MH, Luggen M, et al. Efficacy and safety of the selective costimulation modulator abatacept following 2 years of treatment in patients with rheumatoid arthritis and an inadequate response to anti-tumour necrosis factor therapy.Ann Rheum Dis.2008 Apr;67(4):547-54. Epub 2007 Oct 5.

70. 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 evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum. 2006 Sep;54(9):2793-806.

71. Emery P, Keystone EC, Tony HP, et al. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biological: results from 240 week multicenter randomised placebo-controlled trial.Ann Rheum Dis.2008 Nov;67(11): 1516-23. doi: 10.1136/ard.2008.092932. Epub 2008 Jul 14.

72. Gomez-Reino JJ, Maneiro JR, Ruiz J, et al. Comparative effectiveness of switching to alternative tumour necrosis factor (TNF) antagonists versus switching to rituximab in patients with rheumatoid arthritis who failed previous TNF antagonists: the MIRAR Study. Ann Rheum Dis. 2012 Nov;71(11):1861-4. doi: 10.1136/annrheumdis-2012-201324. Epub 2012 Jun 26.

73. Emery P, Gottenberg JE, Rubbert-Roth A, et al. Rituximab versus alternative TNF inhibitor in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor: SWITCH-RA, a global, observational, comparative effectiveness study. Ann Rheum Dis. 2015 Jun;74(6):979-84. doi: 10.1136/annrheumdis-2013-203993. Epub 2014 Jan 17.

74. Manders SH, Kievit W, Adang E, et al. Cost-effectiveness of abatacept, rituximab, and TNFi treatment after previous failure with TNFi treatment in rheumatoid arthritis: a pragmatic multi-centre randomised trial. Arthritis Res Ther.2015 May 22;17:134. doi: 10.1186/s13075-015-0630-5.

75. Favalli EG, Biggioggero M, Marchesoni A, Merloni PL. Survival on treatment with second-line biologic therapy; a cohort study comparing cycling and swap strategies. Rheumatology (Oxford). 2014 Sep;53(9):1664-8. doi: 10.1093/rheumatology/keu158. Epub 2014 Apr 12.

76. Harrold LR, Reed GW, Solomon DH, et al. Comparative effectiveness of abatacept versus tocilizumab in rheumatoid arthritis patients with prior TNFi exposure in the US CORRONA registry. Arthritis Res Ther. 2016 Dec 1; 18(1):280.

77. Harold LR, Reed GW, Kremer JM, et al. The comparative effectiveness of abatacept versus anti-tumour necrosis factor switching for rheumatoid arthritis patients previously treated an anti-tumour necrosis factor. Ann Rheum Dis.2015 Feb;74(2):430-6. doi: 10.1136/annrheumdis-2013-203936. Epub 2013 Dec 2.

78. Schoels M, Aletaha D, Smolen JS, et al. Comparative effectiveness and safety of biological treatment options after tumor necrosis factor inhibitor failure in rheumatoid arthritis; a systematic review and indirect pair wise meta-analysis. Ann Rheum Dis.2012 Aug;71(8): 1303-8. doi: 10.1136/annrheumdis-2011-200490. Epub 2012 Jan 30.

79. Hirabara S, Takahashi N, Fukaya N, et al. Clinical efficacy of abatacept, tocilizumab, and etanercept in Japanese rheumatoid arthritis patients with in adequate response to anti-TNF monoclonal antibodies. Ann Rheum Dis.2012 Aug;71(8):1303-8. doi: 10.1136/annrheumdis-2011-200490. Epub 2012 Jan 30.

80. Manders HM, Kievit W, Adang E, et al. Cost-effectiveness of abatacept, Rituximab, and TNFi treatment after previous failure with TNFi treatment in rheumatoid arthritis: a pragmatic multi-center randomized trial. Arthritis Res Ther.2015 May 22;17:134. doi: 10.1186/s13075-015-0630-5.

81. Zhou ZY, Griffith J, Du EX, Chin D, Betts KA, Ganguli A. Economic Burden of Switching to a Non-Tumor Necrosis Factor Inhibitor Versus a Tumor Necrosis Factor Inhibitor Biologic Therapy among Patients with Rheumatoid Arthritis. Adv Ther. 2016 May;33(5):807-23. doi: 10.1007/s12325-016-0318-5. Epub 2016 Mar 24.

82. Smolen J, Landewe R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis.2017 Jun;76(6):960-977. doi: 10.1136/annrheumdis-2016-210715. Epub 2017 Mar 6.

83. Schulze-Koops H, Giacomelli R, et al. Patient evaluations of subcutaneous golimumab delivery by autoinjector (SmartJect) for treatment of rheumatoid arthritis. Arthritis Rheum.2013 Oct;65(10 Suppl):S998

84. Keystone EC, Genovese MC, Hall S, et al. Safety and Efficacy of Subcutaneous Golimumab in Patients with Active Rheumatoid Arthritis despite Methotrexate Therapy: Final 5-year Results of the GO-FORWARD Trial. J Rheumatol. 2016 Feb;43(2):298-306. doi: 10.3899/jrheum.150712. Epub 2015 Dec 15.

85. Kruger K, Burmester GR, Wassenberg S, et al. A non-interventional clinical study evaluating the ust of Golimumab in patients with rheumatoid arthritis (RA)? Psoriatic arthritis (PSA), and Ankylosing spondilitis (AS) in a real-life setting in Germany. Ann Rheum Dis. 2016;75(Suppl 2):232

86. Desai RJ, Rao J, Biddle AK. Cost-effectiveness analysis of Golimumab for the treatment of rheumatoid arthritis. Value in health. 2012;15:A39.

87. SIMPONI SPC EMA. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000992/WC500052372.pdf

88. CIMZIA SPC EMA. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001037/smops/Positive/human_smop_000905.jsp&mid=WC0b01ac058001d127

89. HUMIRA® SPC EMA. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000481/human_med_000822.jsp&mid=WC0b01ac058001d124.

90. Enbrel ® SPC EMA. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000262/human_med_000764.jsp&mid=WC0b01ac058001d124.

91. Laursen T, Hansen B, Fisker S. Pain perception after subcutaneous injections of media containing different buffers. Basic Clin Pharmacol Toxicol.2006 Feb;98(2):218-21.