Outcome and safety of TNFα antagonist therapy in 475 consecutive outpatients (with rheumatoid arthritis or spondyloarthropathies) treated by a single physician according to their eligibility for clinical trials

Joint Bone Spine

Volumn 77, Issue 6, 2010, Pages 564-569

  Berthelot, Jean Marie ^a   Benoist Gérard, Stéphanie ^a   le Goff, Benoît ^a   Muller Chevalet, Florence ^a   Maugars, Yves ^a  

^a HÔTEL DIEU   (France)

Author keywords

Adalimumab; Ankylosing spondylitis; Daily practice; Death; Effectiveness; Eligibility; Etanercept; Infliximab; Outcome; Real life; Recommendations; Rheumatoid arthritis; Side effects; Spondyloarthropathies; TNF antagonists; Toxicity; Trials

Indexed keywords

PREDNISONE; TUMOR NECROSIS FACTOR ALPHA ANTAGONIST; TUMOR NECROSIS FACTOR ALPHA INHIBITOR; UNCLASSIFIED DRUG;

ADOLESCENT; ADULT; ARTICLE; CONTROLLED STUDY; DEATH; DRUG SAFETY; FIBROMYALGIA; HOSPITAL ADMISSION; HUMAN; JUVENILE RHEUMATOID ARTHRITIS; MAJOR CLINICAL STUDY; MEDICAL RECORD REVIEW; OUTCOME ASSESSMENT; PHYSICIAN; RHEUMATOID ARTHRITIS; SPONDYLOARTHROPATHY; TREATMENT DURATION; TREATMENT RESPONSE; TREATMENT WITHDRAWAL;

ADOLESCENT; ADULT; ANTIBODIES, MONOCLONAL; ARTHRITIS, JUVENILE RHEUMATOID; ARTHRITIS, RHEUMATOID; DISABILITY EVALUATION; ELIGIBILITY DETERMINATION; FEMALE; HEALTH STATUS; HUMANS; MALE; MIDDLE AGED; RETROSPECTIVE STUDIES; SEVERITY OF ILLNESS INDEX; SPONDYLARTHROPATHIES; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA; YOUNG ADULT;

EID: 78649907358     PISSN: 1297319X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jbspin.2010.05.011     Document Type: Article

References (40)

1. Falgarone G., Duclos M., Boissier M.C. TNF-alpha antagonists in rheumatoid arthritis patients seen in everyday practice. Joint Bone Spine 2007, 74:523-526.
2. Sokka T., Pincus T. Eligibility of patients in routine care for major clinical trials of anti-tumor necrosis factor alpha agents in rheumatoid arthritis. Arthritis Rheum 2003, 48:313-318.
3. Kievit W., Fransen J., Oerlemans A.J., et al. The efficacy of anti-TNF in rheumatoid arthritis, a comparison between randomized controlled trials and clinical practice. Ann Rheum Dis 2007, 66:1473-1478.
4. Greenberg J.D., Kishimoto M., Vibek X., et al. TNF antagonist responsiveness in a United States rheumatoid arthritis cohort. Am J Med 2008, 121:532-538.
5. Hooker R.S., Prescott K., Cipher D., et al. Fit for study: eligibility of veterans with rheumatoid arthritis in major clinical trials of biological therapies. Arthritis Rheum 2008, 58 Suppl.(9):S764.
6. Gérard S., Le Goff B., Maugars Y., et al. Six-month response to anti-TNF drugs in axial spondylarthropathy according to the fulfillment or not of New-York criteria for ankylosing spondylitis or French recommendations for anti-TNF use. A " real life" retrospective study on 175 patients. Joint Bone Spine 2008, 75:680-687.
7. Karlsson J.A., Kristensen L.E., Kapetanovic M.C., et al. Treatment response to a second or third TNF-inhibitor in RA: results from the South Swedish Arthritis Treatment group Register. Rheumatology (Oxford) 2008, 47:507-513.
8. Kay L.J., Griffiths I.D. BSR Biologic Register Management committee. UK consultant rheumatologists' access to biological agents and views on the BSR biologic register. Rheumatology (Oxford) 2006, 45:1376-1379.
9. Ostergaard M., Unkerskov J., Linde L., et al. Low remission rates but long drug survival in rheumatoid arthritis patients treated with infliximab or etanercept: results form the nationwide Danish DANBIO database. Scand J Rheumatol 2007, 36:151-154.
10. Carmona L., Gomez-Reino J.J. Survival of TNF antagonists in spondylarthritis is better than in rheumatoid arthritis. Data from the Spanish registry BIOBADASER. Arthritis Res Ther 2006, 8:R72. BIOBADASER Group.
11. Strangfeld A., Listing J., Herzer P., et al. Risk of herpes zoster in patients with rheumatoid arthritis treated with anti-TNF-alpha agents. JAMA 2009, 301:737-744.
12. Kievit W., Fransen J., Adang E.M., et al. Evaluating guidelines of continuation of anti-TNF treatment after three months: clinical, effectiveness and costs of observed care and different alternative strategies. Ann Rheum Dis 2008.
13. Gibofsky A., Palmer W.R., Goldman J.A., et al. Real-world utilization of DMARDs and biologics in rheumatoid arthritis: the RADIUS (Rheumatoid arthritis disease-modifying anti-rheumatic drug intervention and utilization study) study. Curr Med Res Opin 2006, 22:169-183.
14. Fautrel B., Flipo R.M., Saraux A. Eligibility of rheumatoid arthritis patients for anti-TNF-alpha therapy according to the 2005 recommendations of the French and British Societies for Rheumatology. Rheumatology 2008, 47:1698-1703.
15. Coates L.C., Cawkwell L.S., Nq N.W., et al. Real life experience confirms sustained response to long-term biologics and switching in ankylosing spondylitis. Rheumatology (Oxford) 2008, 47:897-900.
16. Amor B., Dougados M., Mijiyawa M. Criteria of the classification of spondylarthropathies. Rev Rhum Mal Osteoartic 1990, 57:85-89.
17. Arnett F.C., Edworthy S.M., Bloch D.A., et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988, 31:315-324.
18. Cassidy J.T., Levinson J.E., Bass J.C., et al. A study of classification criteria for a diagnosis of juvenile rheumatoid arthritis. Arthritis Rheum 1986, 29:274-281.
19. Burgos-Vargas R. The juvenile-onset spondyloarthritides. Rheum Dis Clin North Am 2002, 28:531-560.
20. Fautrel B., Constantin A., Morel J., et al. Recommendations of the French Society for Rheumatology. TNFalpha antagonist therapy in rheumatoid arthritis. Joint Bone Spine 2006, 73:433-441.
21. Pham T., Fautrel B., Dernis E., et al. Recommendations of the French Society for Rheumatology regarding TNF alpha antagonist therapy in patients with ankylosing spondylitis or psoriatic arthritis: 2007 update. Joint Bone Spine 2007, 74:638-646.
22. Harden R.N., Revivo G., Song S., et al. A critical analysis of the tender points in fibromyalgia. Pain Med 2007, 8:147-156.
23. Kristensen L.E., Saxne T., Geborek P. The LUNDEX, a new index of drug efficacy in clinical practice: results of a five year observational study of treatment with infliximab and etanercept among rheumatoid arthritis patients in southern Sweden. Arthritis Rheum 2006, 54:600-606.
24. Heiberg T., Kvien T.K., Dale O., et al. Daily health status registration (patient diary) in patients with rheumatoid arthritis: a comparison between personal digital assistant and paper-pencil format. Arthritis Rheum 2007, 57:454-460.
25. Berthelot J.M., Tortellier L., Lavy-Bregeon D., et al. High intra-individual week-to-week variability in BASDAI and BASFI values: are several evaluations needed before starting or stopping TNFalpha antagonist therapy for spondylarthropathies?. Joint Bone Spine 2008, 5:167-171.
26. Brocq O., Milasseau E., Albert C., et al. Effect of discontinuing TNFalpha antagonist therapy in patients with remission of rheumatoid arthritis. Joint Bone Spine 2009, 76:350-355.
27. Juillard-Condat B., Constantin A., Cambon-Thomsen A., et al. Impact of etanercept on the costs of rheumatoid arthritis (RA): results from a French observational study. Joint Bone Spine 2008, 75:25-28.
28. Doan Q.V., Chiou C.F., Dubois R.W. Review of eight pharmacoeconomic studies of the value of biologic DMARDs (adalimumab, etanercept, and infliximab) in the management of rheumatoid arthritis. J Manag Care Pharm 2006, 12:555-569.
29. Zink A., Strangfeld A., Schneider M., et al. Effectiveness of tumor necrosis factor inhibitors in rheumatoid arthritis in an observational cohort study: comparison of patients according to their eligibility for major randomized clinical trials. Arthritis Rheum 2006, 54:3399-3407.
30. Tang B., Rahman M., Waters H.C., et al. Treatment persistence with adalimumab, etanercept, or infliximab in combination with methotrexate and the effects on health care costs in patients with rheumatoid arthritis. Clin Ther 2008, 30:1375-1384.
31. Karlsson J.A., Kristensen L.E., Kapetanovic M.C., et al. Treatment response to a second or third TNF-inhibitor in RA: results from the south Swedish arthritis treatment group register. Rheumatology (Oxford) 2008, 47:507-513.
32. American College of Rheumatology Committee to reevaluate improvement criteria A proposed revision to the ACR20: the hybrid measure of American College of Rheumatology Response. Arthritis Rheum 2007, 57:193-202.
33. Van Gestel A.M., Prevoo M.L., van't Hof M.A., et al. Development and validation of the European League against Rheumatism response criteria for rheumatoid arthritis. Comparison with the preliminary American College of Rheumatology and the World Health Organization/International League against rheumatism criteria. Arthritis Rheum 1996, 39:34-40.
34. Van Gestel A.M., Anderson J.J., van Riel P.L., et al. ACR and EULAR improvement criteria have comparable validity in rheumatoid arthritis trials. American College of Rheumatology European League of Associations for Rheumatology. J Rheumatol 1999, 26:705-711.
35. Karonitsch T., Aletaha D., Boers M., et al. Methods of deriving EULAR/ACR recommendations on reporting disease activity in clinical trials of patients with rheumatoid arthritis. Ann Rheum Dis 2008, 67:1365-1373.
36. Gülfe A., Geborek P., Saxne T. Response criteria for rheumatoid arthritis in clinical practice: how useful are they?. Ann Rheum Dis 2005, 64:1186-1189.
37. Pincus T., Amara I., Koch G.G. Continuous indices of core data set measures in rheumatoid arthritis clinical trials: lower responses to placebo than seen with categorical responses with the American College of Rheumatology 20% criteria. Arthritis Rheum 2005, 52:1031-1036.
38. Caplan L., Wolfe F., Russell A.S., et al. Corticosteroid use in rheumatoid arthritis: prevalence, predictors, correlates, and outcomes. J Rheumatol 2007, 34:696-705.
39. Weyand C.M., Goronzy J.J. Premature immunosenescence in rheumatoid arthritis. J Rheumatol 2002, 29:1141-1146.
40. Prelog P., Schwarzennbrunner N., Sailer-Höck M., et al. Premature aging of the immune system in children with juvenile idiopathic arthritis. Arthritis Rheum 2008, 58:2153-2162.