2017 recommendations of the Czech Society for Rheumatology for the pharmacological treatment of rheumatoid arthritis.

Czech version

Authors: L. Šenolt; H. Mann; J. Závada; K. Pavelka; J. Vencovský
Authors‘ workplace: Revmatologický ústav, Revmatologická klinika 1. LF UK, Praha
Published in: Čes. Revmatol., 25, 2017, No. 1, p. 8-24.
Category: Recommendation

Overview

Based on the current knowledge about the treatment of rheumatoid arthritis (RA), the working group of the Czech Society for Rheumatology presents the updated recommendations for the pharmacotherapy of RA. The basic prerequisite for successful treatment is early diagnosis of the disease and prompt initiation of effective therapy. Pharmacotherapy of RA should be based on the treat to target strategy, the substance of which is the assessment of disease activity using composite indices at regular time intervals and adjustment of the therapy according to whether the predetermined target for treatment has been reached. Treat to target approach applies generally, irrespective of the medication. The goal of treatment for RA is a state of remission or at least low clinical disease activity, which should be achieved quickly, usually within six months of commencement of the treatment, and this condition should be permanently maintained. The treatment should be initiated with a monotherapy using a conventional synthetic disease-modifying anti-rheumatic drug (csDMARD), in most cases, methotrexate. In case of contraindication of or intolerance to methotrexate administration of leflunomide or sulfasalazine can be considered. In patients with high activity at the onset of the disease or with relapse during established RA glucocorticoids can be used with a gradual reduction of the dose until withdrawal (ideally for a period shorter than three months). If high disease activity persists after 3 months of intensive treatment, or if the treatment target is not achieved after 6 months, the treatment should be adjusted accordingly. The treatment approach after the failure of the first csDMARD is driven by the presence of unfavorable prognostic factors (high disease activity, positivity of autoantibodies, and early erosive joint damage). If there are no risk factors for severe disease course present, changing to a different csDMARD, possibly a combination of more csDMARD, can be considered. In patients with unfavorable prognostic factors after failure of csDMARD administration of biologic therapy is recommended. There are no substantial differences in efficiency among the various biological agents. Thus, as the first-line drug TNFα inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, including biosimilar products) are usually employed. However, abatacept, rituximab or tocilizumab can be used as well. Once targeted synthetic agents (tsDMARD, e.g. Janus kinase inhibitors) are available in the Czech Republic, it will be possible to consider these products as well. If a loss of response to first-line biological therapy occurs, it is appropriate to switch to another biological agent or tsDMARD. After treatment failure of a TNFα inhibitor, a different TNFα inhibitor or a drug with a different mechanism of action can be used. In patients in sustained remission lasting at least six months, who are not receiving glucocorticoids anymore, it is possible to consider reducing the dose of the biological agent or extending its administration interval. Discontinuation of biological therapy often leads to a flare, especially in patients with longstanding RA. The presented recommendations of the Czech Society for Rheumatology are not a binding regulation, rather a practical guide on how to proceed with treatment of patients with RA. In their application another aspects must also be taken into account, such as the general health condition, other diseases, concomitant therapy, and contraindications that can modify the treatment approach.

Keywords:
Rheumatoid arthritis, recommendations, disease- modifying anti-rheumatic drugs, remission

Sources

1. Smolen JS, Aletaha D, McInnes IB. Rheumatoid arthritis. Lancet. 2016; 388(10055): 2023–2038.

2. Pavelka K, Vencovský J. Doporučení České revmatologické společnosti pro léčbu revmatoidní artritidy Čes Revmatol 2010; 4: 182–191.

3. Smolen JS, Landewé 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 Mar 6. pii: annrheumdis-2016-210715. doi: 10.1136/annrheumdis-2016-210715. [Epub ahead of print]

4. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol. 2016; 68(1): 1–26.

5. Aletaha D, Neogi T, Silman A, et al. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/ European League Against Rheumatism collaborative initiative. Ann Rheum Dis 2010; 69: 1580–88.

6. van der Heijde D, van der Helm-van Mil AH, Aletaha D, et al. EULAR definition of erosive disease in light of the 2010 ACR/EULAR rheumatoid arthritis classification criteria. Ann Rheum Dis 2013; 72: 479–81.

7. Farheen K, Agarwal SK. Assessment of disease activity and treatment outcomes in rheumatoid arthritis. J Manag Care Pharm 2011; 17(9 Suppl B): S09–13.

8. Felson DT, Smolen JS, Wells G, et al. American College of Rheumatology/European League against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. Ann Rheum Dis 2011; 70(3): 404–13.

9. Naredo E, Bonilla G, Gamero F, et al. Assessment of inflammatory activity in rheumatoid arthritis: a comparative study of clinical evaluation with grey scale and power Doppler ultrasonography. Ann Rheum Dis 2005; 64: 375–81.

10. Dale J, Stirling A, Zhang R, et al. Targeting ultrasound remission in early rheumatoid arthritis: the results of the TaSER study, a randomised clinical trial. Ann Rheum Dis 2016; 75(6): 1043–50.

11. Maska L, Anderson J, Michaud K. Measures of functional status and quality of life in rheumatoid arthritis: Health Assessment Questionnaire Disability Index (HAQ), Modified Health Assessment Questionnaire (MHAQ), Multidimensional Health Assessment Questionnaire (MDHAQ), Health Assessment Questionnaire II (HAQ-II), Improved Health Assessment Questionnaire (Improved HAQ), and Rheumatoid Arthritis Quality of Life (RAQoL). Arthritis Care Res (Hoboken) 2011; 63 Suppl 11: S4–13.

12. Šléglová O, Dušek L, Olejárová M, Tegzová D, Vencovský J, Pavelka K. Posuzování funkční schopnosti u pacientů s revmatoidní artritidou; validace české verze Stanfordského dotazníku Health Assessment Questionnaire (HAQ). Čes Revmatol 2010; 18: 73–83.

13. van der Heijde DM, van Riel PL, Nuver-Zwart IH, Gribnau FW, vad de Putte LB. Effects of hydroxychloroquine and sulphasalazine on progression of joint damage in rheumatoid arthritis. Lancet 1989; 1(8646): 1036–8.

14. Lindqvist E, Jonsson K, Saxne T, Eberhardt K. Course of radiographic damage over 10 years in a cohort with early rheumatoid arthritis. Ann Rheum Dis 2003; 62(7): 611–6.

15. Colebatch AN, Edwards CJ, Østergaard M, et al. EULAR recommendations for the use of imaging of the joints in the clinical management of rheumatoid arthritis. Ann Rheum Dis 2013; 72(6): 804–14.

16. Pincus T, Cutolo M. Clinical trials documenting the efficacy of low-dose glucocorticoids in rheumatoid arthritis. Neuroimmunomodulation 2015; 22: 46–50.

17. van der Goes MC, Jacobs JW, Bijlsma JW. Toward safer treatment with glucocorticoids: via patient and rheumatologist perspectives to recommendations on monitoring for adverse events. Clin Exp Rheumatol 2011; 29(5 Suppl 68): S116–20.

18. Hoes JN, Jacobs JW, Verstappen SM, et al. Adverse events of low- to medium-dose oral glucocorticoids in inflammatory diseases: a meta-analysis. Ann Rheum Dis 2009; 68(12): 1833–8.

19. den Uyl D, ter Wee M, Boers M, et al. A non-inferiority trial of an attenuated combination strategy (‘COBRA-light’) compared to the original COBRA strategy: clinical results after 26 weeks. Ann Rheum Dis 2014; 73(6): 1071–8.

20. Kuijper TM, Luime JJ, de Jong PH, et al. Tapering conventional synthetic DMARDs in patients with early arthritis in sustained remission: 2-year follow-up of the tREACH trial. Ann Rheum Dis 2016; 75(12): 2119–2123.

21. Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Allaart CF, et al. Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial. Arthritis Rheum 2005; 52: 3381–90.

22. Hafström I, Albertsson K, Boonen A, et al. BARFOT Study Group. Remission achieved after 2 years’ treatment with low-dose prednisolone in addition to disease-modifying anti-rheumatic drugs in early rheumatoid arthritis is associated with reduced joint destruction still present after 4 years: an open 2-year continuation study. Ann Rheum Dis 2009; 68(4): 508–13.

23. Hørslev-Petersen K, Hetland ML, Ørnbjerg LM, et al. OPERA Study-Group. Clinical and radiographic outcome of a treat-to-target strategy using methotrexate and intra-articular glucocorticoids with or without adalimumab induction: a 2-year investigator-initiated, double-blinded, randomised, controlled trial (OPERA). Ann Rheum Dis. 2016; 75(9): 1645–53.

24. Konai MS, Vilar Furtado RN, Dos Santos MF, Natour J. Monoarticular corticosteroid injection versus systemic administration in the treatment of rheumatoid arthritis patients: a randomized double-blind controlled study. Clin Exp Rheumatol 2009; 27(2): 214–21.

25. Grigor C, Capell H, Stirling A, et al. Effect of a treatment strategy of tight control for rheumatoid arthritis (the TICORA study): a single-blind randomised controlled trial. Lancet 2004; 364(9430): 263–9.

26. Hetland ML, Stengaard-Pedersen K, Junker P, et al. CIMESTRA Study Group. Combination treatment with methotrexate, cyclosporine, and intraarticular betamethasone compared with methotrexate and intraarticular betamethasone in early active rheumatoid arthritis: an investigator-initiated, multicenter, randomized, double-blind, parallel-group, placebo-controlled study. Arthritis Rheum 2006; 54(5): 1401–9.

27. Gaujoux-Viala C, Smolen JS, Landewé R, et al. Current evidence for the management of rheumatoid arthritis with synthetic disease-modifying antirheumatic drugs: a systematic literature review informing the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis 2010; 69(6): 1004–9.

28. Pincus T. Folic and folinic acid supplementation reduces methotrexate gastrointestinal side effects in rheumatoid arthritis. Clin Exp Rheumatol 1998; 16(6): 667–8.

29. Hazlewood GS, Barnabe C, Tomlinson G, et al. Methotrexate monotherapy and methotrexate combination therapy with traditional and biologic disease modifying antirheumatic drugs for rheumatoid arthritis: abridged Cochrane systematic review and network meta-analysis. BMJ 2016; 353: i1777.

30. O’Dell JR, Haire CE, Erikson N, et al. Treatment of rheumatoid arthritis with methotrexate alone, sulfasalazine and hydroxychloroquine, or a combination of all three medications. N Engl J Med 1996; 334(20):1287–91.

31. Götestam Skorpen C, Hoeltzenbein M, Tincani A, et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis 2016; 75(5): 795–810.

32. Zeidler HK, Kvien TK, Hannonen P, et al. Progression of joint damage in early active severe rheumatoid arthritis during 18 months of treatment: comparison of low-dose cyclosporin and parenteral gold. Br J Rheumatol 1998; 37(8): 874–82.

33. Gabay C, Emery P, van Vollenhoven R, et al. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial. Lancet 2013; 381(9877): 1541–50.

34. Burmester GR, Lin Y, Patel R, et al. Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trial. Ann Rheum Dis 2016 Nov 17 [Epub ahead of print].

35. Fleischmann R, Kremer J, Cush J, et al. ORAL Solo Investigators. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med 2012; 367(6): 495–507.

36. Fleischmann R, Schiff M, van der Heijde D, et al. Baricitinib, Methotrexate, or Combination in Patients with Rheumatoid Arthritis and No or Limited Prior Disease-Modifying Antirheumatic Drug Treatment. Arthritis Rheumatol. 2016 doi: 10.1002/art.39953. [Epub ahead of print]

37. Smolen JS, Burmester GR, Combe B. Head-to-head comparison of certolizumab pegol versus adalimumab in rheumatoid arthritis: 2-year efficacy and safety results from the randomised EXXELERATE study. Lancet 2016; 388(10061): 2763–74.

38. Thomas SS, Borazan N, Barroso N, et al. Comparative Immunogenicity of TNF Inhibitors: Impact on Clinical Efficacy and Tolerability in the Management of Autoimmune Diseases. A Systematic Review and Meta-Analysis. BioDrugs. 2015; 29(4): 241–58.

39. Stoffer MA, Schoels MM, Smolen JS, et al. Evidence for treating rheumatoid arthritis to target: results of a systematic literature search update. Ann Rheum Dis 2016; 75(1): 16–22.

40. Smolen JS, Breedveld FC, Burmester GR, et al. Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task force. Ann Rheum Dis 2016; 75(1): 3–15.

41. Aletaha D, Alasti F, Smolen JS. Optimisation of a treat-to-target approach in rheumatoid arthritis: strategies for the 3-month time point. Ann Rheum Dis. 2016; 75(8): 1479–85.

42. Möttönen T, Hannonen P, Leirisalo-Repo M, et al. Comparison of combination therapy with single-drug therapy in early rheumatoid arthritis: a randomised trial. FIN-RACo trial group. Lancet 1999; 353(9164): 1568–73.

43. de Jong PH, Hazes JM, Han HK, et al. Randomised comparison of initial triple DMARD therapy with methotrexate monotherapy in combination with low-dose glucocorticoid bridging therapy; 1-year data of the tREACH trial. Ann Rheum Dis 2014; 73(7): 1331–9.

44. Verschueren P, De Cock D, Corluy L, et al. Effectiveness of methotrexate with step-down glucocorticoid remission induction (COBRA Slim) versus other intensive treatment strategies for early rheumatoid arthritis in a treat-to-target approach: 1-year results of CareRA, a randomised pragmatic open-label superiority trial. Ann Rheum Dis 2016 Jul 18. pii: annrheumdis-2016-209212. doi: [Epub ahead of print].

45. ter Wee MM, den Uyl D, Boers M, et al. Intensive combination treatment regimens, including prednisolone, are effective in treating patients with early rheumatoid arthritis regardless of additional etanercept: 1-year results of the COBRA-light open-label, randomised, non-inferiority trial. Ann Rheum Dis 2015; 74(6): 1233–40.

46. Gaujoux-Viala C, Nam J, Ramiro S, et al. Efficacy of conventional synthetic disease-modifying antirheumatic drugs, glucocorticoids and tofacitinib: a systematic literature review informing the 2013 update of the EULAR recommendations for management of rheumatoid arthritis. Ann Rheum Dis 2014; 73(3): 510–5.

47. Bird P, Griffiths H, Tymms K, et al. The SMILE study – safety of methotrexate in combination with leflunomide in rheumatoid arthritis. J Rheumatol 2013; 40(3): 228–35.

48. Smolen JS, Emery P, Fleischmann R, et al. Adjustment of therapy in rheumatoid arthritis on the basis of achievement of stable low disease activity with adalimumab plus methotrexate or methotrexate alone: the randomised controlled OPTIMA trial. Lancet 2014; 383(9914): 321–32.

49. Bijlsma JW, Welsing PM, Woodworth TG, et al. Early rheumatoid arthritis treated with tocilizumab, methotrexate, or their combination (U-Act-Early): a multicentre, randomised, double-blind, double-dummy, strategy trial. Lancet 2016; 388(10042): 343–55.

50. Porter D, van Melckebeke J, Dale J, et al. Tumour necrosis factor inhibition versus rituximab for patients with rheumatoid arthritis who require biological treatment (ORBIT): an open-label, randomised controlled, non-inferiority, trial. Lancet 2016; 388(10041): 239–47.

51. Braun-Moscovici Y, Markovits D, Zinder O, et al. Anti-cyclic citrullinated protein antibodies as a predictor of response to anti-tumor necrosis factor-α therapy in patients with rheumatoid arthritis. J Rheumatol 2006; 33: 497–500.

52. Van den Broek M, Dirven L, Klarenbeek NB, et al. The association of treatment response and joint damage with ACPA-status in recent-onset RA: a subanalysis of the 8-year follow-up of the BeSt study. Ann Rheum Dis 2012; 71: 245–8.

53. Emery P, Gottenberg JE, Rubbert-Roth A, et al. Rituximab versus an 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; 74(6): 979–84.

54. Sokolove J, Schiff M, Fleischmann R, et al. Impact of baseline anti-cyclic citrullinated peptide-2 antibody concentration on efficacy outcomes following treatment with subcutaneous abatacept or adalimumab: 2-year results from the AMPLE trial. Ann Rheum Dis 2016; 75(4): 709–14.

55. Yun H, Xie F, Delzell E, et al. Comparative Risk of Hospitalized Infection Associated With Biologic Agents in Rheumatoid Arthritis Patients Enrolled in Medicare. Arthritis Rheumatol 2016; 68(1): 56–66.

56. Gottenberg JE, Brocq O, Perdriger A, et al. Non-TNF-Targeted Biologic vs a Second Anti-TNF Drug to Treat Rheumatoid Arthritis in Patients with Insufficient Response to a First Anti-TNF Drug: A Randomized Clinical Trial. JAMA 2016; 316(11): 1172–1180.

57. Schett G, Emery P, Tanaka Y, et al. Tapering biologic and conventional DMARD therapy in rheumatoid arthritis: current evidence and future directions. Ann Rheum Dis 2016;75(8): 1428–37.

58. van der Woude D, Young A, Jayakumar K, et al. Prevalence of and predictive factors for sustained disease-modifying anti-rheumatic drug-free remission in rheumatoid arthritis: results from two large early arthritis cohorts. Arthritis Rheum 2009; 60: 2262–71.

59. Kuijper TM, Luime JJ, de Jong PH, et al. Tapering conventional synthetic DMARDs in patients with early arthritis in sustained remission: 2-year follow-up of the tREACH trial. Ann Rheum Dis 2016 Jun 9 pii: annrheumdis-2016-209272. doi: 10.1136/annrheumdis-2016-209272. [Epub ahead of print].

60. Klarenbeek NB, van der Kooij SM, Güler-Yüksel M, et al. Discontinuing treatment in patients with rheumatoid arthritis in sustained clinical remission: exploratory analyses from the BeSt study. Ann Rheum Dis 2011; 70(2): 315–9.

61. van der Woude D, Visser K, Klarenbeek NB, et al. Sustained drug-free remission in rheumatoid arthritis after DAS-driven or non-DAS-driven therapy: a comparison of two cohort studies. Rheumatology (Oxford) 2012; 51(6): 1120–8.

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Czech Rheumatology

2017 Issue 1