Real-world effectiveness of select biologic and DMARD monotherapy and combination therapy in the treatment of rheumatoid arthritis: Results from the RADIUS observational registry

Current Medical Research and Opinion

Volumn 22, Issue 1, 2006, Pages 185-198

  Weaver, Arthur L ^a   Lautzenheiser, Richard L ^b   Schiff, Michael H ^c   Gibofsky, Allan ^d   Perruquet, James L ^e   Luetkemeyer, John ^f   Paulus, Harold E ^g   Xia, H Amy ^h   Leff, Jonathan A ^h  

^a UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^b Rheumatology Associates   (United States)

^c Denver Arthritis Clinic PC   (United States)

^d HOSPITAL FOR SPECIAL SURGERY   (United States)

^e GEISINGER MEDICAL CENTER   (United States)

^f Baptist Hospital Pensacola   (United States)

^g UCLA MEDICAL CENTER   (United States)

^h AMGEN INC   (United States)

Author keywords

Biologics; Combination therapy; Disease modifying anti rheumatic drug (DMARD); Effectiveness; Monotherapy; RADIUS

Indexed keywords

CHLOROQUINE; CYCLOSPORIN; DAPSONE; DISEASE MODIFYING ANTIRHEUMATIC DRUG; ETANERCEPT; GOLD; HYDROXYCHLOROQUINE; IMMUNOSUPPRESSIVE AGENT; INFLIXIMAB; INTERFERON; LEFLUNOMIDE; METHOTREXATE; NEW DRUG; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; SALAZOSULFAPYRIDINE; STEROID; TETRACYCLINE DERIVATIVE; THALIDOMIDE;

ADULT; ADVERSE DRUG REACTION; AGED; ARTICLE; CLINICAL PRACTICE; CONFIDENCE INTERVAL; COVARIANCE; DRUG EFFICACY; DRUG RESPONSE; DRUG USE; EVALUATION; FEMALE; FOLLOW UP; HUMAN; LOGISTIC REGRESSION ANALYSIS; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NON PARTICIPANT OBSERVATION; PROSPECTIVE STUDY; REGISTER; RHEUMATOID ARTHRITIS;

ADOLESCENT; ADULT; AGED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIOLOGICAL PRODUCTS; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; MALE; MIDDLE AGED; REGISTRIES; TREATMENT OUTCOME;

EID: 30844434332     PISSN: 03007995     EISSN: None     Source Type: Journal    
DOI: 10.1185/030079905X65510     Document Type: Article

References (39)

1. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis: 2002 Update. Arthritis Rheum 2002;46:328-46
2. Tsakonas E, Fitzgerald AA, Fitzcharles MA, et al. Consequences of delayed therapy with second-line agents in rheumatoid arthritis: a 3 year followup on the hydroxychloroquine in early rheumatoid arthritis (HERA) study. J Rheumatol 2000;27:623-9
3. van der Heide A, Jacobs JW, Bijlsma JW, et al. The effectiveness of early treatment with 'second-line' antirheumatic drugs. A randomized, controlled trial. Ann Intern Med 1996;124:699-707
4. Weinblatt ME, Kaplan H, Germain BF, et al. Methotrexate in rheumatoid arthritis. A five-year prospective multicenter study. Arthritis Rheum 1994;37:1492-8
5. Furst DE, Schiff MH, Fleischmann RM, 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 (Safety Trial of Adalimumab in Rheumatoid Arthritis). J Rheumatol 2003;30:2563-71
6. Lipsky PE, van der Heijde DM, St Clair EW, et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-tumor necrosis factor trial in rheumatoid arthritis with concomitant therapy study group. N Engl J Med 2000;343:1594-602
7. Sharp JT, Strand V, Leung H, et al. Treatment with leflunomide slows radiographic progression of rheumatoid arthritis: results from three randomized controlled trials of leflunomide in patients with active rheumatoid arthritis. Leflunomide rheumatoid arthritis investigators group. Arthritis Rheum 2000;43:495-505
8. Weinblatt ME, Kremer JM, Bankhurst AD, 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
9. Bathon JM, Martin RW, Fleischmann RM, et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med 2000;343:1586-93
10. Baumgartner SW, Fleischmann RM, Moreland LW, et al. Etanercept (Enbrel) in patients with rheumatoid arthritis with recent onset versus established disease: improvement in disability. J Rheumatol 2004;31:1532-7
11. Boers M, Verhoeven AC, Markusse HM, et al. Randomised comparison of combined step-down prednisolone, methotrexate and sulphasalazine with sulphasalazine alone in early rheumatoid arthritis. Lancet 1997;350:309-18
12. Breedveld FC, Emery P, Keystone EC, et al. Infliximab in active early rheumatoid arthritis. Ann Rheum Dis 2004;63:149-54
13. Genovese MC, Bathon JM, Martin RW, et al. Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes. Arthritis Rheum 2002;46:1443-50
14. Keystone EC, Haraoui B, Bykerk VP. Role of adalimumab in the treatment of early rheumatoid arthritis. Clin Exp Rheumatol 2003;21:S198-9
15. Smolen J, van der Heijde D, Emery P, et al. Infliximab inhibits radiographic joint damage in patients with early rheumatoid arthritis regardless of clinical response after 54-week treatment. Ann Rheum Dis 2004;63:260 [abstract]
16. Klareskog L, van der Heijde D, de Jager JP, 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
17. Kremer JM, Weinblatt ME, Bankhurst AD, et al. Etanercept added to background methotrexate therapy in patients with rheumatoid arthritis: continued observations. Arthritis Rheum 2003;48:1493-9
18. Maini R, St Clair EW, Breedveld F, et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT study group. Lancet 1999;354:1932-9
19. van Vollenhoven RF, Ernestam S, Harju A, et al. Etanercept versus etanercept plus methotrexate: a registry-based study suggesting that the combination is clinically more efficacious. Arthritis Res Ther 2003;5:R347-51
20. Weinblatt ME, Keystone EC, Furst DE, 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
21. Keystone EC, Kavanaugh AF, Sharp JT, 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
22. van der Heijde D, Landewe R, Klareskog L, et al. Presentation and analysis of data on radiographic outcome in clinical trials: experience from the TEMPO study. Arthritis Rheum 2005;52:49-60
23. O'Dell JR, Leff R, Paulsen G, et al. Treatment of rheumatoid arthritis with methotrexate and hydroxychloroquine, methotrexate and sulfasalazine, or a combination of the three medications: results of a two-year, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2002;46:1164-70
24. Gibofsky A, Palmer WR, Goldman JA, 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;22:169-83
25. Enbrel® (etanercept) [package insert]. Thousand Oaks, Calif.: Amgen Inc. and Wyeth-Ayerst Pharmaceuticals, 2004
26. Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727-35
27. Goldman JA, Cush JJ, Xia HA, et al. Validation of a modified ACR20 scoring system in patients with rheumatoid arthritis receiving etanercept (Enbrel®) therapy: exclusion of ESR/CRP from the ACR response criteria. Arthritis Rheum 2004;50(Suppl):s388 [abstract]
28. Zeger SL, Liang KY, Albert PS. Models for longitudinal data: a generalized estimating equation approach. Biometrics 1988;44:1049-60
29. Lunceford JK, Davidian M. Stratification and weighting via the propensity score in estimation of causal treatment effects: a comparative study. Stat Med 2004;23:2937-60
30. Rosenbaum PR. The central role of the propensity score in observational studies for casual effects. Biometrika 1983;70:41-55
31. St Clair EW, van der Heijde DM, Smolen JS, et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum 2004;50:3432-43
32. Maini RN, Breedveld FC, Kalden JR, et al. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum 1998;41:1552-63
33. Kremer J, Genovese M, Cannon GW, et al. Combination leflunomide and methotrexate (MTX) therapy for patients with active rheumatoid arthritis failing MTX monotherapy: open-label extension of a randomized, double-blind, placebo controlled trial. J Rheumatol 2004;31:1521-31
34. 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;334:1287-91
35. Kremer JM, Genovese MC, Cannon GW, et al. Concomitant leflunomide therapy in patients with active rheumatoid arthritis despite stable doses of methotrexate. A randomized, double-blind, placebo-controlled trial. Ann Intern Med 2002;137:726-33
36. Strand V, Cohen S, Schiff M, et al. Treatment of active rheumatoid arthritis with leflunomide compared with placebo and methotrexate. Leflunomide rheumatoid arthritis investigators group. Arch Intern Med 1999;159:2542-50
37. Elliott MJ, Maini RN, Feldmann M, et al. Repeated therapy with monoclonal antibody to tumour necrosis factor alpha (cA2) in patients with rheumatoid arthritis. Lancet 1994;344:1125-7
38. Paulus HE, Weaver A, Wallace DJ, et al. The CORRONA patient registry for patients with rheumatic diseases. Arthritis Rheum 2004;50:s376 [abstract]
39. Wolfe F. A short history of data banking in the United States from 1974 to 2003. J Rheumatol Suppl 2004;69:41-5