Quality appraisal of clinical practice guidelines and consensus statements on the use of biologic agents in rheumatoid arthritis: A systematic review

Arthritis Care and Research

Volumn 59, Issue 11, 2008, Pages 1625-1638

  Lopez Olivo, Maria A ^a   Kallen, Michael A ^a   Ortiz, Zulma ^b   Skidmore, Becky ^c   Suarez Almazor, Maria E ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b ACADEMIA NACIONAL DE MEDICINA   (Argentina)

^c The Society of Obstetricians and Gynaecologists of Canada   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; DISEASE MODIFYING ANTIRHEUMATIC DRUG; ETANERCEPT; INFLIXIMAB; METHOTREXATE; MONOCLONAL ANTIBODY; TUMOR NECROSIS FACTOR ALPHA INHIBITOR;

CLINICAL TRIAL; CONSENSUS; DATA BASE; EMBASE; GOVERNMENT; HUMAN; MANAGEMENT; MEDICAL SOCIETY; MEDLINE; METHODOLOGY; PATIENT ASSESSMENT; PRACTICE GUIDELINE; REGISTER; REVIEW; RHEUMATOID ARTHRITIS; SCORING SYSTEM; SCREENING; SYSTEMATIC REVIEW;

ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; CONSENSUS; HUMANS; PRACTICE GUIDELINES AS TOPIC; QUALITY CONTROL; TUMOR NECROSIS FACTOR-ALPHA;

EID: 56149096680     PISSN: 21514658     EISSN: None     Source Type: Journal    
DOI: 10.1002/art.24207     Document Type: Review

References (84)

1. Institute of Medicine. Clinical practice guidelines: directions for a new program. Washington, DC: National Academy Press; 1990.
2. Campbell F, Dickinson HO, Cook JV, Beyer FR, Eccles M, Mason JM. Methods underpinning national clinical guidelines for hypertension: describing the evidence shortfall. BMC Health Serv Res 2006;6:47.
3. The AGREE Collaboration. Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. 2001. URL: http://www.agreetrust.org/.
4. Shekelle PG, Ortiz E, Rhodes S, Morton SC, Eccles MP, Grimshaw JM, et al. Validity of the Agency for Healthcare Research and Quality clinical practice guidelines: how quickly do guidelines become outdated? JAMA 2001;286:1461-7.
5. Shaneyfelt TM, Mayo-Smith MF, Rothwangl J. Are guidelines following guidelines? The methodological quality of clinical practice guidelines in the peer-reviewed medical literature. JAMA 1999;281:1900-5.
6. Oxman AD, Schunemann HJ, Fretheim A. Improving the use of research evidence in guideline development: 14. Reporting guidelines. Health Res Policy Syst 2006;4:26.
7. AGREE Collaboration. Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project. Qual Saf Health Care 2003;12:18-23.
8. The AGREE Collaboration. Appraisal of Guidelines for Research and Evaluation (AGREE) instrument training manual. 2003. URL: http://www. agreecollaboration.org/pdf/aitraining.pdf.
9. Burgers JS, Fervers B, Haugh M, Brouwers M, Browman G, Philip T, et al. International assessment of the quality of clinical practice guidelines in oncology using the Appraisal of Guidelines and Research and Evaluation Instrument. J Clin Oncol 2004;22:2000-7.
10. Kuek A, Hazleman BL, Ostor AJ. Immune-mediated inflammatory diseases (IMIDs) and biologic therapy: a medical revolution. Postgrad Med J 2007;83:251-60.
11. Suarez-Almazor M, Ortiz Z, Lopez-Olivo M, Moffett M, Pak C, Skidmore B, et al. Infliximab and etanercept in rheumatoid arthritis: systematic review of long-term clinical effectiveness, safety, and cost-effectiveness. Technology report no 85. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2007.
12. Scottish Intercollegiate Guidelines Network. Management of early rheumatoid arthritis: SIGN publication no. 48. 2000. URL: http://www.sign.ac.uk/ guidelines/fulltext/48/index.html.
13. Bykerk VP, Baron M, Boire G, Haraoui B, Khraishi M, LeClerq S, et al. Canadian consensus statement on early optimal therapy in early rheumatoid arthritis. 2004. URL: http://www.rheum.ca/Resources/Pdf/ERA.pdf.
14. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis: 2002 update. Arthritis Rheum 2002;46:328-46.
15. Sociedad Argentina de Reumatologia. Primeras guias Argentinas de practica clinica en el tratamiento de la artritis reumatoidea. 2005. URL: http://www.reumatologia.org.ar/.
16. Ferraccioli G, Fiocco U, Govoni M, Salaffi F, Sinigaglia L, Trotta F. Linee guida per la diagnosi precoce e la terapia dell' artrite reumatoide. 2004. URL: http://www.reumatologia.it/.
17. Laurindo IM, Ximenes AC, Lima FA, Pinheiro GR, Batistella LR, Bertolo MB, et al. Artrite reumatóide: diagnóstico e tratamento. 2002. URL: http://www.projetodiretrizes.org.br.
18. GUIPCAR group. Clinical practice guideline for the management of rheumatoid arthritis. 2001. URL: http://www.ser.es.
19. Kalla AA, Stanwix A, Gotlieb D, Asherson RA, Mody GM. Rheumatoid arthritis: clinical guideline 2003. S Afr Med J 2003;93:991-1012.
20. Luqmani R, Hennell S, Estrach C, Birrell F, Bosworth A, Davenport G, et al. British Society for Rheumatology and British Health Professionals in Rheumatology guideline for the management of rheumatoid arthritis (the first two years). Rheumatology (Oxford) 2006;45:1167-9.
21. Working Party of the British Society for Rheumatology. Guidelines for prescribing TNF-α blockers in adults with rheumatoid arthritis. 2001. URL: http://www.rheumatology.org.uk/guidelines/clinicalguidelines.
22. National Institute for Clinical Excellence. Guidance on the use of etanercept and infliximab for the treatment of rheumatoid arthritis: technology appraisal guidance no. 36. 2002. URL: http://www.nice.org.uk.
23. Royal College of Nursing. Assessing, managing and monitoring biologic therapies for inflammatory arthritis: guidance for rheumatology practitioners. 2003. URL: http://www.rcn.org.uk.
24. Devlin J, Ramakrishnan SA, FitzGerald O, for the Irish Society for Rheumatology. Guidelines for prescribing TNFα blockers in adults with rheumatoid arthritis. 2005. URL: http://www.isr.ie/_fileupload/File/ ISR%20Guidelines%20A4%20(3).pdf.
25. Fautrel B, Constantin A, Morel J, Vittecoq O, Cantagrel A, Combe B, et al. Recommendations of the French Society for Rheumatology: TNFα antagonist therapy in rheumatoid arthritis. Joint Bone Spine 2006;73:433-41.
26. Ledingham J, Deighton C. Update on the British Society for Rheumatology guidelines for prescribing TNFα blockers in adults with rheumatoid arthritis (update of previous guidelines of April 2001). Rheumatology (Oxford) 2005;44:157-63.
27. Miyasaka N, Takeuchi T, Eguchi K. Official Japanese guidelines for the use of infliximab for rheumatoid arthritis. Mod Rheumatol 2005;15:4-8.
28. Miyasaka N, Takeuchi T, Eguchi K. Guidelines for the proper use of etanercept in Japan. Mod Rheumatol 2006;16:63-7.
29. Furst DE, Breedveld FC, Burmester GR, Crofford L, Emery P, Feldman M, et al. Access to disease modifying treatments for rheumatoid arthritis patients. Ann Rheum Dis 1999;58 Suppl 1:I129-30.
30. Furst DE, Breedveld FC, Burmester GR, Crofford JJ, Emery P, Feldmann M, et al. Updated consensus statement on tumour necrosis factor blocking agents for the treatment of rheumatoid arthritis (May 2000). Ann Rheum Dis 2000;59 Suppl 1:i1-2.
31. Pharmacotherapy Committee of the German Society of Rheumatology. Recommendations of the German Society of Rheumatology for therapy with tumor necrosis factor inhibitors. Z Rheumatol 2000;59:291-2. In German.
32. Smolen JS, Breedveld FC, Burmester GR, Combe B, Emery P, Kalden JR, et al. Consensus statement on the initiation and continuation of tumour necrosis factor blocking therapies in rheumatoid arthritis. Ann Rheum Dis 2000;59:504-5.
33. Emery P, Reginster JY, Appelboom T, Breedveld FC, Edelmann E, Kekow J, et al. WHO Collaborating Centre consensus meeting on anti-cytokine therapy in rheumatoid arthritis. Rheumatology (Oxford) 2001;40:699-702.
34. Furst DE, Keystone EC, Breedveld FC, Kalden JR, Smolen JS, Antoni CE, et al. Updated consensus statement on tumour necrosis factor blocking agents for the treatment of rheumatoid arthritis and other rheumatic diseases (April 2001). Ann Rheum Dis 2001;60 Suppl 3:iii2-5.
35. Akkoc N, Direskeneli H, Ertenli I, Fresko I, Gul A, Hamuryudan V, et al. Evaluation of patients for tuberculosis prior to treatment with anti-tumor necrosis factor-α biological agents. Marmara Med J 2002;15:273-6.
36. Furst DE, Breedveld FC, Kalden JR, Smolen JS, Antoni CE, Bijlsma JW, et al. Updated consensus statement on biological agents for the treatment of rheumatoid arthritis and other rheumatic diseases (May 2002). Ann Rheum Dis 2002;61 Suppl 2:ii2-7.
37. Haraoui B, for the CRA sub-committee on biologic agents. Canadian Rheumatology Association position on the use of biologic agents for the treatment of rheumatoid arthritis. 2002. URL: http://www.rheum.ca/Resources/Pdf/ Biologics_for_RA.pdf.
38. Hulsemann JL, Hohlfeld JM, Schnarr S, Stoll M, Zeidler H. Recommendations for tuberculosis screening and treatment of latent tuberculosis in case of anti-TNFα-therapy with infliximab. Aktuelle Rheumatol 2002;27:97-100. In German.
39. Manger B, for the Pharmacotherapy Committee of the German Society of Rheumatology. Revised recommendations of the Deutsche Gesellschaft für Rheumatologie on therapy with tumor necrosis factor-inhibiting active substances on inflammatory diseases. Z Rheumatol 2007;61:694-7. In German.
40. Furst DE, Breedveld FC, Kalden JR, Smolen JS, Burmester GR, Dougados M, et al. Updated consensus statement on biological agents for the treatment of rheumatoid arthritis and other immune mediated inflammatory diseases (May 2003). Ann Rheum Dis 2003;62 Suppl 2:ii2-9.
41. Nederlandse Vereniging voor Reumatologie. Medicijnen: het toepassen van TNF-blokkade in de behandeling van reumatoïde artritis. Overig: tuberculose en TNF-α-blokkerende therapie. 2003. URL: http://www.nvr.nl.
42. Furst DE, Breedveld FC, Kalden JR, Smolen JS, Burmester GR, Bijlsma JW, et al. Updated consensus statement on biological agents, specifically tumour necrosis factor α (TNFα) blocking agents and interleukin-1 receptor antagonist (IL-1ra), for the treatment of rheumatic diseases, 2004. Ann Rheum Dis 2004;63 Suppl 2:ii2-12.
43. Rodriguez-Valverde V, Alvaro-Gracia Alvaro JM, Andreu Sanchez JL, Batlle Gualda E, Tornero Molina J. II Actualización del consenso de la Sociedad Española de Reumatología sobre la terapia biológica en la artritis reumatoide. Rev Esp Reumatol 2004;31:394-401.
44. Furst DE, Breedveld FC, Kalden JR, Smolen JS, Burmester GR, Bijlsma JW, et al. Updated consensus statement on biological agents, specifically tumour necrosis factor α (TNFα) blocking agents and interleukin-1 receptor antagonist (IL-1ra), for the treatment of rheumatic diseases, 2005. Ann Rheum Dis 2005;64 Suppl 4:iv2-14.
45. Hong Kong Society of Rheumatology. Consensus on the use and monitoring of anti-TNF-α therapies for rheumatic diseases in Hong Kong 2005. APLAR J Rheumatol 2006;9:175-80.
46. Manger B, for the Pharmacotherapy Committee of the German Society of Rheumatology Position on choice of agents among TNF inhibitors. Z Rheumatol 2005;64:88-9. In German.
47. Grupo de Estudos de Artrite Reumatóide (GEAR) da Sociedade Portuguesa de Ruematologia (SPR). Consensos para a utilização de Dezembro de 2005. Acta Reumatol Port 2005;30:349-53.
48. Scottish Intercollegiate Guidelines Network. SIGN 50: a guideline developers' handbook. 2001. URL: http://www.sign.ac.uk/pdf/sign50.pdf.
49. Hadorn DC, Baker D, Hodges JS, Hicks N. Rating the quality of evidence for clinical practice guidelines. J Clin Epidemiol 1996;49:749-54.
50. West S, King V, Carey TS, Lohr KN, McKoy N, Sutton SF, et al. Evidence report/technology assessment number 47: systems to rate the strength of scientific evidence. 2002. URL: http://www.ncbi.nlm.nih.gov/books/bv.fcqi?rid= hstat1.chapter70996.
51. Cook DJ, Guyatt GH, Laupacis A, Sackett DL. Rules of evidence and clinical recommendations on the use of antithrombotic agents. Chest 1992;102(4 Suppl):305S-11S.
52. Sackett DL. Rules of evidence and clinical recommendations on the use of antithrombotic agents. Chest 1989;95(2 Suppl):2S-4S.
53. Pearson M, Turner-Stokes L, Bunn AM. Concise guidance to good practice. 2003. URL: http://www.rcplondon.ac.uk/college/ceeu/ conciseguidelinedevelopmentnotes.pdx.
54. Shekelle PG, Woolf SH, Eccles M, Grimshaw J. Clinical guidelines: developing guidelines. BMJ 1999;318:593-6.
55. Lipsky PE, van der Heijde DM, St Clair EW, Furst DE, Breedveld FC, Kalden JR, et al, for the Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. Infliximab and methotrexate in the treatment of rheumatoid arthritis. N Engl J Med 2000;343:1594-602.
56. Bathon JM, Martin RW, Fleischmann RM, Tesser JR, Schiff MH, Keystone EC, et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med 2000;343:1586-93.
57. Weinblatt ME, Keystone EC, Furst DE, Moreland LW, Weisman MH, Birbara CA, et al. Adalimumab, a fully human anti-tumor necrosis factor α monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum 2003;48:35-45.
58. Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727-35.
59. Vlayen J, Aertgeerts B, Hannes K, Sermeus W, Ramaekers D. A systematic review of appraisal tools for clinical practice guidelines: multiple similarities and one common deficit. Int J Qual Health Care 2005;17:235-42.
60. MacDermid JC, Brooks D, Solway S, Switzer-McIntyre S, Brosseau L, Graham ID. Reliability and validity of the AGREE instrument used by physical therapists in assessment of clinical practice guidelines. BMC Health Serv Res 2005;5:18.
61. Appleyard TL, Mann CH, Khan KS. Guidelines for the management of pelvic pain associated with endometriosis: a systematic appraisal of their quality. BJOG 2006;113:749-57.
62. Weinblatt ME, Kremer JM, Bankhurst AD, Bulpitt KJ, Fleischmann RM, Fox RI, et al. A trial of etanercept, a recombinant tumor necrosis factor receptor:Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med 1999;340:253-9.
63. Maini R, St Clair EW, Breedveld F, Furst D, Kalden J, Weisman M, et al, for the ATTRACT Study Group. Infliximab (chimeric anti-tumour necrosis factor α monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. Lancet 1999;354:1932-9.
64. Moreland LW, Baumgartner SW, Schiff MH, Tindall EA, Fleischmann RM, Weaver AL, et al. Treatment of rheumatoid arthritis with a recombinant human tumor necrosis factor receptor (p75)-Fc fusion protein. N Engl J Med 1997;337:141-7.
65. Moreland LW, Schiff MH, Baumgartner SW, Tindall EA, Fleischmann RM, Bulpitt KJ, et al. Etanercept therapy in rheumatoid arthritis: a randomized, controlled trial. Ann Intern Med 1999;130:478-86.
66. Elliott MJ, Maini RN, Feldmann M, Kalden JR, Antoni C, Smolen JS, et al. Randomised double-blind comparison of chimeric monoclonal antibody to tumour necrosis factor α (cA2) versus placebo in rheumatoid arthritis. Lancet 1994;344:1105-10.
67. Maini RN, Breedveld FC, Kalden JR, Smolen JS, Davis D, Macfarlane JD, et al. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor α monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum 1998;41:1552-63.
68. Kavanaugh A, St Clair EW, McCune WJ, Braakman T, Lipsky P. Chimeric anti-tumor necrosis factor-α monoclonal antibody treatment of patients with rheumatoid arthritis receiving methotrexate therapy. J Rheumatol 2000;27:841-50.
69. Jobanputra P, Barton P, Bryan S, Burls A. The effectiveness of infliximab and etanercept for the treatment of rheumatoid arthritis: a systematic review and economic evaluation. Health Technol Assess 2002;6:1-110.
70. Furst DE, Schiff MH, Fleischmann RM, Strand V, Birbara CA, Compagnone D, et al. Adalimumab, a fully human anti tumor necrosis factor-α monoclonal antibody, and concomitant standard antirheumatic therapy for the treatment of rheumatoid arthritis: results of STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis). J Rheumatol 2003;30:2563-71.
71. Weisman MH, Moreland LW, Furst DE, Weinblatt ME, Keystone EC, Paulus HE, et al. Efficacy, pharmacokinetic, and safety assessment of adalimumab, a fully human anti-tumor necrosis factor-α monoclonal antibody, in adults with rheumatoid arthritis receiving concomitant methotrexate: a pilot study. Clin Ther 2003;25:1700-21.
72. Klareskog L, van der Heijde D, de Jager JP, Gough A, Kalden J, Malaise M, et al. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial. Lancet 2004;363:675-81.
73. Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, et al, for the PREMIER Investigators. 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;54:26-37.
74. Den Broeder A, van de Putte L, Rau R, Schattenkirchner M, van Riel P, Sander O, et al. A single dose, placebo controlled study of the fully human anti-tumor necrosis factor-α antibody adalimumab (D2E7) in patients with rheumatoid arthritis. J Rheumatol 2002;29:2288-98.
75. Keystone EC, Kavanaugh AF, Sharp JT, Tannenbaum H, Hua Y, Teoh LS, 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;50:1400-11.
76. Rau R, Simianer S, van Riel PL, van de Putte LB, Kruger K, Schattenkirchner M, et al. Rapid alleviation of signs and symptoms of rheumatoid arthritis with intravenous or subcutaneous administration of adalimumab in combination with methotrexate. Scand J Rheumatol 2004;33:145-53.
77. Van de Putte LB, Rau R, Breedveld FC, Kalden JR, Malaise MG, van Riel PL, et al. Efficacy and safety of the fully human anti-tumour necrosis factor α monoclonal antibody adalimumab (D2E7) in DMARD refractory patients with rheumatoid arthritis: a 12 week, phase II study. Ann Rheum Dis 2003;62:1168-77.
78. Van de Putte LB, Atkins C, Malaise M, Sany J, Russell AS, van Riel PL, et al. Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed. Ann Rheum Dis 2004;63:508-16.
79. Keystone EC, Schiff MH, Kremer JM, Kafka S, Lovy M, DeVries T, et al. Once-weekly administration of 50 mg etanercept in patients with active rheumatoid arthritis: results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2004;50:353-63.
80. St.Clair EW, van der Heijde DM, Smolen JS, Maini RN, Bathon JM, Emery P, et al, for the Active-Controlled Study of Patients Receiving Infliximab for the Treatment of Rheumatoid Arthritis of Early Onset Study Group. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum 2004;50:3432-43.
81. Genovese MC, Cohen S, Moreland L, Lium D, Robbins S, Newmark R, et al, for the 20000223 Study Group. Combination therapy with etanercept and anakinra in the treatment of patients with rheumatoid arthritis who have been treated unsuccessfully with methotrexate. Arthritis Rheum 2004;50:1412-9.
82. Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Allaart CF, van Zeben D, Kerstens PJ, Hazes JM, 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.
83. Miembros del Panel. Actualizacion de la Conferencia de Consenso de la Sociedad Española de Reumatologia sobre terapia anti-TNF en artritis reumatoide. Rev Esp Reumatol 2002;29:51-5.
84. Quinn MA, Conaghan PG, O'Connor PJ, Karim Z, Greenstein A, Brown A, et al. Very early treatment with infliximab in addition to methotrexate in early, poor-prognosis rheumatoid arthritis reduces magnetic resonance imaging evidence of synovitis and damage, with sustained benefit after infliximab withdrawal: results from a twelve-month randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2005;52:27-35.