Adalimumab and methotrexate is more effective than adalimumab alone in patients with established rheumatoid arthritis: Results from a 6-month longitudinal, observational, multicentre study

Annals of the Rheumatic Diseases

Volumn 65, Issue 10, 2006, Pages 1379-1383

  Heiberg, M S ^a   Rodevand E ^b   Mikkelsen, K ^c   Kaufmann, C ^d   Didriksen, A ^e   Mowinckel, P ^a   Kvien, T K ^a  

^a DIAKONHJEMMET HOSPITAL   (Norway)

^b TRONDHEIM UNIVERSITY HOSPITAL   (Norway)

^c Hospital for Rheumatic Diseases   (Norway)

^d Buskerud Central Hospital   (Norway)

^e UNIVERSITY HOSPITAL OF NORTH NORWAY   (Norway)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; C REACTIVE PROTEIN; METHOTREXATE; PREDNISOLONE;

ADULT; AGED; ARTICLE; CONTROLLED STUDY; DISEASE ACTIVITY; DRUG EFFICACY; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; HEALTH STATUS; HEALTH SURVEY; HUMAN; LONGITUDINAL STUDY; MAJOR CLINICAL STUDY; MALE; NORWAY; OBSERVATIONAL STUDY; PRIORITY JOURNAL; REMISSION; RHEUMATOID ARTHRITIS; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; LONGITUDINAL STUDIES; MALE; METHOTREXATE; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA;

EID: 33750003823     PISSN: 00034967     EISSN: None     Source Type: Journal    
DOI: 10.1136/ard.2006.051540     Document Type: Article

References (28)

1. Emery P. Evidence supporting the benefit of early intervention in rheumatoid arthritis. J Rheumatol Suppl 2002;66:3-8.
2. Olsen NJ, Stein CM. New drugs for rheumatoid arthritis. N Engl J Med 2004;350:2167-79.
3. Genovese MC, Bathon JM, Martin RW, Fleischmann RM, Tesser JR, Schiff MH, et al. Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes. Arthritis Rheum 2002;46:1443-50.
4. van de Putte LB, Atkins C, Malaise M, Sony 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.
5. 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.
6. Weinblalt ME, Keystone EC, Furst DE, Moreland LW, Weisman MH, Birbara CA, et al. Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum 2003;48:35-45.
7. Maini SR. Infliximab treatment of rheumatoid arthritis. Rheum Dis Clin North Am 2004;30:329-47.
8. van der Heijde D, Klareskog L, Singh A, Tornero J, Melo-Gomes J, Codreanu C, et al. Patient-reported outcomes in a trial of combination therapy with etanercept and methotrexate for rheumatoid arthritis: the TEMPO trial. Ann Rheum Dis 2006;65:328-34.
9. van Vollenhoven RF, Ernestam S, Harju A, Bratt J, Klareskog L. Etanercept versus etanercept plus methotrexate: a registry-based study suggesting that the combination is clinically more efficacious. Arthritis Res Ther 2003;5:R347-51.
10. 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.
11. Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, Vollenhoven RV, 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;54:26-37.
12. 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;48:313-8.
13. Wolfe F, Michaud K, Dewitt EM. Why results of clinical trials and observational studies of antitumour necrosis factor (anti-TNF) therapy differ: methodological and interpretive issues. Ann Rheum Dis 2004;63(Suppl 2):ii13-17.
14. Bombardier C, Maetzel A. Pharmacoeconomic evaluation of new treatments: efficacy versus effectiveness studies? Ann Rheum Dis 1999;58(Suppl 1):I82-5.
15. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis: 2002 Update. Arthritis Rheum 2002;46:328-46.
16. Prevoo ML, van't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 1995;38:44-8.
17. van Gestel AM, Haagsma CJ, van Riel PL. Validation of rheumatoid arthritis improvement criteria that include simplified joint counts. Arthritis Rheum 1998;41:1845-50.
18. van Riel PL, van Gestel AM. Clinical outcome measures in rheumatoid arthritis. Ann Rheum Dis 2000;59(Suppl 1):i28-31.
19. Pincus T, Summey JA, Soraci SA Jr, Wallston KA, Hummon NP. Assessment of patient satisfaction in activities of dairy living using a modified Stanford Health Assessment Questionnaire. Arthritis Rheum 1983;26:1346-53.
20. McHorney CA, Ware JE Jr, Lu JF, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care 1994;32:40-66.
21. Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ 2002;21:271-92.
22. Kleinbaum DG. Applied regression analysis and other multivariable methods. Boston: PWS-Kent Publishing Company, 1988.
23. Cohen J. Statistical power analysis for behavorial sciences, 2nd edn. Hillsdale, NJ: Laurence Erlbaun Associates, 1988.
24. Furst DE, Schiff MH, Fleischmann RM, Strand V, Birbara CA, Compagnone D, et al. Adalimumab, a fully human anti tumor necrosis factor-alpha monoclonal antibody, and concomitant standard antirheumatic therapy for the treatment of rheumatoid arthritis: results of STAR (Safely Trial of Adalimumab in Rheumatoid Arthritis). J Rheumatol 2003;30:2563-71.
25. 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.
26. Navarro-Sarabia F, Ariza-Ariza R, Hernandez-Cruz B, Villanueva I. Adalimumab for treating rheumatoid arthritis. Cochrane Database Syst Rev 2005;(3):CD005113.
27. Bennett AN, Peterson P, Zain A, Grumley J, Panayi G, Kirkham B. Adalimumab in clinical practice. Outcome in 70 rheumatoid arthritis patients, including comparison of patients with and without previous anti-TNF exposure. Rheumatology (Oxford) 2005;44:1026-31.
28. Landewe RB. The benefits of early treatment in rheumatoid arthritis: confounding by indication, and the issue of timing. Arthritis Rheum 2003;48:1-5.