A randomized comparative effectiveness study of oral triple therapy versus etanercept plus methotrexate in early aggressive rheumatoid arthritis: The Treatment of Early Aggressive Rheumatoid Arthritis trial

Objective To assess whether it is better to intensively treat all patients with early rheumatoid arthritis (RA) using combinations of drugs or to reserve this approach for patients who do not have an appropriate response (as determined by a Disease Activity Score in 28 joints using the erythrocyte s...

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Published inArthritis & rheumatology (Hoboken, N.J.) Vol. 64; no. 9; pp. 2824 - 2835
Main Authors Moreland, Larry W., O'Dell, James R., Paulus, Harold E., Curtis, Jeffrey R., Bathon, Joan M., St.Clair, E. William, Bridges Jr, S. Louis, Zhang, Jie, McVie, Theresa, Howard, George, van der Heijde, Désirée, Cofield, Stacey S.
Format Journal Article
LanguageEnglish
Published Hoboken Wiley Subscription Services, Inc., A Wiley Company 01.09.2012
Wiley Subscription Services, Inc
Subjects
Administration, Oral
Adult
Aged
Antirheumatic Agents - administration & dosage
Antirheumatic Agents - therapeutic use
Arthritis, Rheumatoid - diagnostic imaging
Arthritis, Rheumatoid - drug therapy
Blood Sedimentation
Double-Blind Method
Drug Administration Schedule
Drug therapy
Drug Therapy, Combination
Etanercept
Female
HIV
Human immunodeficiency virus
Humans
Hydroxychloroquine - administration & dosage
Immunoglobulin G - administration & dosage
Immunoglobulin G - therapeutic use
Male
Methotrexate
Methotrexate - administration & dosage
Methotrexate - therapeutic use
Middle Aged
Radiography
Receptors, Tumor Necrosis Factor - administration & dosage
Receptors, Tumor Necrosis Factor - therapeutic use
Rheumatoid arthritis
Severity of Illness Index
Sulfasalazine - administration & dosage
Treatment Outcome
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Abstract Objective To assess whether it is better to intensively treat all patients with early rheumatoid arthritis (RA) using combinations of drugs or to reserve this approach for patients who do not have an appropriate response (as determined by a Disease Activity Score in 28 joints using the erythrocyte sedimentation rate [DAS28‐ESR] of ≥3.2 at week 24) to methotrexate (MTX) monotherapy, and to assess whether combination therapy with MTX plus etanercept is superior to the combination of MTX plus sulfasalazine plus hydroxychloroquine. Methods The Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) study is a 2‐year, randomized, double‐blind trial. A 2 × 2 factorial design was used to randomly assign subjects to 1 of 4 treatment arms: immediate treatment with MTX plus etanercept, immediate oral triple therapy (MTX plus sulfasalazine plus hydroxychloroquine), or step‐up from MTX monotherapy to one of the combination therapies (MTX plus etanercept or MTX plus sulfasalazine plus hydroxychloroquine) at week 24 if the DAS28‐ESR was ≥3.2. All treatment arms included matching placebos. The primary outcome was an observed‐group analysis of DAS28‐ESR values from week 48 to week 102. Results At week 24 (beginning of the step‐up period), subjects in the 2 immediate‐treatment groups demonstrated a greater reduction in the DAS28‐ESR compared with those in the 2 step‐up groups (3.6 versus 4.2; P < 0.0001); no differences between the combination‐therapy regimens were observed. Between week 48 and week 102, subjects randomized to the step‐up arms had a DAS28‐ESR clinical response that was not different from that of subjects who initially received combination therapy, regardless of the treatment arm. There was no significant difference in the DAS28‐ESR between subjects randomized to oral triple therapy and those randomized to receive MTX plus etanercept. By week 102, there was a statistically significant difference in the change in radiographic measurements from baseline between the group receiving MTX plus etanercept and the group receiving oral triple therapy (0.64 versus 1.69; P = 0.047). Conclusion There were no differences in the mean DAS28‐ESR during weeks 48–102 between subjects randomized to receive MTX plus etanercept and those randomized to triple therapy, regardless of whether they received immediate combination treatment or step‐up from MTX monotherapy. At 102 weeks, immediate combination treatment with either strategy was more effective than MTX monotherapy prior to the initiation of step‐up therapy. Initial use of MTX monotherapy with the addition of sulfasalazine plus hydroxychloroquine (or etanercept, if necessary, after 6 months) is a reasonable therapeutic strategy for patients with early RA. Treatment with the combination of MTX plus etanercept resulted in a statistically significant radiographic benefit compared with oral triple therapy.
AbstractList To assess whether it is better to intensively treat all patients with early rheumatoid arthritis (RA) using combinations of drugs or to reserve this approach for patients who do not have an appropriate response (as determined by a Disease Activity Score in 28 joints using the erythrocyte sedimentation rate [DAS28-ESR] of ≥ 3.2 at week 24) to methotrexate (MTX) monotherapy, and to assess whether combination therapy with MTX plus etanercept is superior to the combination of MTX plus sulfasalazine plus hydroxychloroquine.OBJECTIVETo assess whether it is better to intensively treat all patients with early rheumatoid arthritis (RA) using combinations of drugs or to reserve this approach for patients who do not have an appropriate response (as determined by a Disease Activity Score in 28 joints using the erythrocyte sedimentation rate [DAS28-ESR] of ≥ 3.2 at week 24) to methotrexate (MTX) monotherapy, and to assess whether combination therapy with MTX plus etanercept is superior to the combination of MTX plus sulfasalazine plus hydroxychloroquine.The Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) study is a 2-year, randomized, double-blind trial. A 2 × 2 factorial design was used to randomly assign subjects to 1 of 4 treatment arms: immediate treatment with MTX plus etanercept, immediate oral triple therapy (MTX plus sulfasalazine plus hydroxychloroquine), or step-up from MTX monotherapy to one of the combination therapies (MTX plus etanercept or MTX plus sulfasalazine plus hydroxychloroquine) at week 24 if the DAS28-ESR was ≥ 3.2. All treatment arms included matching placebos. The primary outcome was an observed-group analysis of DAS28-ESR values from week 48 to week 102.METHODSThe Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) study is a 2-year, randomized, double-blind trial. A 2 × 2 factorial design was used to randomly assign subjects to 1 of 4 treatment arms: immediate treatment with MTX plus etanercept, immediate oral triple therapy (MTX plus sulfasalazine plus hydroxychloroquine), or step-up from MTX monotherapy to one of the combination therapies (MTX plus etanercept or MTX plus sulfasalazine plus hydroxychloroquine) at week 24 if the DAS28-ESR was ≥ 3.2. All treatment arms included matching placebos. The primary outcome was an observed-group analysis of DAS28-ESR values from week 48 to week 102.At week 24 (beginning of the step-up period), subjects in the 2 immediate-treatment groups demonstrated a greater reduction in the DAS28-ESR compared with those in the 2 step-up groups (3.6 versus 4.2; P < 0.0001); no differences between the combination-therapy regimens were observed. Between week 48 and week 102, subjects randomized to the step-up arms had a DAS28-ESR clinical response that was not different from that of subjects who initially received combination therapy, regardless of the treatment arm. There was no significant difference in the DAS28-ESR between subjects randomized to oral triple therapy and those randomized to receive MTX plus etanercept. By week 102, there was a statistically significant difference in the change in radiographic measurements from baseline between the group receiving MTX plus etanercept and the group receiving oral triple therapy (0.64 versus 1.69; P = 0.047).RESULTSAt week 24 (beginning of the step-up period), subjects in the 2 immediate-treatment groups demonstrated a greater reduction in the DAS28-ESR compared with those in the 2 step-up groups (3.6 versus 4.2; P < 0.0001); no differences between the combination-therapy regimens were observed. Between week 48 and week 102, subjects randomized to the step-up arms had a DAS28-ESR clinical response that was not different from that of subjects who initially received combination therapy, regardless of the treatment arm. There was no significant difference in the DAS28-ESR between subjects randomized to oral triple therapy and those randomized to receive MTX plus etanercept. By week 102, there was a statistically significant difference in the change in radiographic measurements from baseline between the group receiving MTX plus etanercept and the group receiving oral triple therapy (0.64 versus 1.69; P = 0.047).There were no differences in the mean DAS28-ESR during weeks 48-102 between subjects randomized to receive MTX plus etanercept and those randomized to triple therapy, regardless of whether they received immediate combination treatment or step-up from MTX monotherapy. At 102 weeks, immediate combination treatment with either strategy was more effective than MTX monotherapy prior to the initiation of step-up therapy. Initial use of MTX monotherapy with the addition of sulfasalazine plus hydroxychloroquine (or etanercept, if necessary, after 6 months) is a reasonable therapeutic strategy for patients with early RA. Treatment with the combination of MTX plus etanercept resulted in a statistically significant radiographic benefit compared with oral triple therapy.CONCLUSIONThere were no differences in the mean DAS28-ESR during weeks 48-102 between subjects randomized to receive MTX plus etanercept and those randomized to triple therapy, regardless of whether they received immediate combination treatment or step-up from MTX monotherapy. At 102 weeks, immediate combination treatment with either strategy was more effective than MTX monotherapy prior to the initiation of step-up therapy. Initial use of MTX monotherapy with the addition of sulfasalazine plus hydroxychloroquine (or etanercept, if necessary, after 6 months) is a reasonable therapeutic strategy for patients with early RA. Treatment with the combination of MTX plus etanercept resulted in a statistically significant radiographic benefit compared with oral triple therapy.
To assess whether it is better to intensively treat all patients with early rheumatoid arthritis (RA) using combinations of drugs or to reserve this approach for patients who do not have an appropriate response (as determined by a Disease Activity Score in 28 joints using the erythrocyte sedimentation rate [DAS28-ESR] of ≥ 3.2 at week 24) to methotrexate (MTX) monotherapy, and to assess whether combination therapy with MTX plus etanercept is superior to the combination of MTX plus sulfasalazine plus hydroxychloroquine. The Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) study is a 2-year, randomized, double-blind trial. A 2 × 2 factorial design was used to randomly assign subjects to 1 of 4 treatment arms: immediate treatment with MTX plus etanercept, immediate oral triple therapy (MTX plus sulfasalazine plus hydroxychloroquine), or step-up from MTX monotherapy to one of the combination therapies (MTX plus etanercept or MTX plus sulfasalazine plus hydroxychloroquine) at week 24 if the DAS28-ESR was ≥ 3.2. All treatment arms included matching placebos. The primary outcome was an observed-group analysis of DAS28-ESR values from week 48 to week 102. At week 24 (beginning of the step-up period), subjects in the 2 immediate-treatment groups demonstrated a greater reduction in the DAS28-ESR compared with those in the 2 step-up groups (3.6 versus 4.2; P < 0.0001); no differences between the combination-therapy regimens were observed. Between week 48 and week 102, subjects randomized to the step-up arms had a DAS28-ESR clinical response that was not different from that of subjects who initially received combination therapy, regardless of the treatment arm. There was no significant difference in the DAS28-ESR between subjects randomized to oral triple therapy and those randomized to receive MTX plus etanercept. By week 102, there was a statistically significant difference in the change in radiographic measurements from baseline between the group receiving MTX plus etanercept and the group receiving oral triple therapy (0.64 versus 1.69; P = 0.047). There were no differences in the mean DAS28-ESR during weeks 48-102 between subjects randomized to receive MTX plus etanercept and those randomized to triple therapy, regardless of whether they received immediate combination treatment or step-up from MTX monotherapy. At 102 weeks, immediate combination treatment with either strategy was more effective than MTX monotherapy prior to the initiation of step-up therapy. Initial use of MTX monotherapy with the addition of sulfasalazine plus hydroxychloroquine (or etanercept, if necessary, after 6 months) is a reasonable therapeutic strategy for patients with early RA. Treatment with the combination of MTX plus etanercept resulted in a statistically significant radiographic benefit compared with oral triple therapy.
Objective To assess whether it is better to intensively treat all patients with early rheumatoid arthritis (RA) using combinations of drugs or to reserve this approach for patients who do not have an appropriate response (as determined by a Disease Activity Score in 28 joints using the erythrocyte sedimentation rate [DAS28‐ESR] of ≥3.2 at week 24) to methotrexate (MTX) monotherapy, and to assess whether combination therapy with MTX plus etanercept is superior to the combination of MTX plus sulfasalazine plus hydroxychloroquine. Methods The Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) study is a 2‐year, randomized, double‐blind trial. A 2 × 2 factorial design was used to randomly assign subjects to 1 of 4 treatment arms: immediate treatment with MTX plus etanercept, immediate oral triple therapy (MTX plus sulfasalazine plus hydroxychloroquine), or step‐up from MTX monotherapy to one of the combination therapies (MTX plus etanercept or MTX plus sulfasalazine plus hydroxychloroquine) at week 24 if the DAS28‐ESR was ≥3.2. All treatment arms included matching placebos. The primary outcome was an observed‐group analysis of DAS28‐ESR values from week 48 to week 102. Results At week 24 (beginning of the step‐up period), subjects in the 2 immediate‐treatment groups demonstrated a greater reduction in the DAS28‐ESR compared with those in the 2 step‐up groups (3.6 versus 4.2; P < 0.0001); no differences between the combination‐therapy regimens were observed. Between week 48 and week 102, subjects randomized to the step‐up arms had a DAS28‐ESR clinical response that was not different from that of subjects who initially received combination therapy, regardless of the treatment arm. There was no significant difference in the DAS28‐ESR between subjects randomized to oral triple therapy and those randomized to receive MTX plus etanercept. By week 102, there was a statistically significant difference in the change in radiographic measurements from baseline between the group receiving MTX plus etanercept and the group receiving oral triple therapy (0.64 versus 1.69; P = 0.047). Conclusion There were no differences in the mean DAS28‐ESR during weeks 48–102 between subjects randomized to receive MTX plus etanercept and those randomized to triple therapy, regardless of whether they received immediate combination treatment or step‐up from MTX monotherapy. At 102 weeks, immediate combination treatment with either strategy was more effective than MTX monotherapy prior to the initiation of step‐up therapy. Initial use of MTX monotherapy with the addition of sulfasalazine plus hydroxychloroquine (or etanercept, if necessary, after 6 months) is a reasonable therapeutic strategy for patients with early RA. Treatment with the combination of MTX plus etanercept resulted in a statistically significant radiographic benefit compared with oral triple therapy.
Objective To assess whether it is better to intensively treat all patients with early rheumatoid arthritis (RA) using combinations of drugs or to reserve this approach for patients who do not have an appropriate response (as determined by a Disease Activity Score in 28 joints using the erythrocyte sedimentation rate [DAS28-ESR] of ≥3.2 at week 24) to methotrexate (MTX) monotherapy, and to assess whether combination therapy with MTX plus etanercept is superior to the combination of MTX plus sulfasalazine plus hydroxychloroquine. Methods The Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) study is a 2-year, randomized, double-blind trial. A 2 × 2 factorial design was used to randomly assign subjects to 1 of 4 treatment arms: immediate treatment with MTX plus etanercept, immediate oral triple therapy (MTX plus sulfasalazine plus hydroxychloroquine), or step-up from MTX monotherapy to one of the combination therapies (MTX plus etanercept or MTX plus sulfasalazine plus hydroxychloroquine) at week 24 if the DAS28-ESR was ≥3.2. All treatment arms included matching placebos. The primary outcome was an observed-group analysis of DAS28-ESR values from week 48 to week 102. Results At week 24 (beginning of the step-up period), subjects in the 2 immediate-treatment groups demonstrated a greater reduction in the DAS28-ESR compared with those in the 2 step-up groups (3.6 versus 4.2; P < 0.0001); no differences between the combination-therapy regimens were observed. Between week 48 and week 102, subjects randomized to the step-up arms had a DAS28-ESR clinical response that was not different from that of subjects who initially received combination therapy, regardless of the treatment arm. There was no significant difference in the DAS28-ESR between subjects randomized to oral triple therapy and those randomized to receive MTX plus etanercept. By week 102, there was a statistically significant difference in the change in radiographic measurements from baseline between the group receiving MTX plus etanercept and the group receiving oral triple therapy (0.64 versus 1.69; P = 0.047). Conclusion There were no differences in the mean DAS28-ESR during weeks 48-102 between subjects randomized to receive MTX plus etanercept and those randomized to triple therapy, regardless of whether they received immediate combination treatment or step-up from MTX monotherapy. At 102 weeks, immediate combination treatment with either strategy was more effective than MTX monotherapy prior to the initiation of step-up therapy. Initial use of MTX monotherapy with the addition of sulfasalazine plus hydroxychloroquine (or etanercept, if necessary, after 6 months) is a reasonable therapeutic strategy for patients with early RA. Treatment with the combination of MTX plus etanercept resulted in a statistically significant radiographic benefit compared with oral triple therapy. [PUBLICATION ABSTRACT]
Author Paulus, Harold E.
Curtis, Jeffrey R.
Bridges Jr, S. Louis
McVie, Theresa
Howard, George
Cofield, Stacey S.
St.Clair, E. William
O'Dell, James R.
Zhang, Jie
Moreland, Larry W.
Bathon, Joan M.
van der Heijde, Désirée
Author_xml – sequence: 1
  givenname: Larry W.
  surname: Moreland
  fullname: Moreland, Larry W.
  email: lwm5@pitt.edu
  organization: University of Pittsburgh, Pittsburgh, Pennsylvania
– sequence: 2
  givenname: James R.
  surname: O'Dell
  fullname: O'Dell, James R.
  organization: University of Nebraska Medical Center at Omaha
– sequence: 3
  givenname: Harold E.
  surname: Paulus
  fullname: Paulus, Harold E.
  organization: University of California at Los Angeles
– sequence: 4
  givenname: Jeffrey R.
  surname: Curtis
  fullname: Curtis, Jeffrey R.
  organization: University of Alabama at Birmingham
– sequence: 5
  givenname: Joan M.
  surname: Bathon
  fullname: Bathon, Joan M.
  organization: Columbia University, New York, New York
– sequence: 6
  givenname: E. William
  surname: St.Clair
  fullname: St.Clair, E. William
  organization: Duke University, Durham, North Carolina
– sequence: 7
  givenname: S. Louis
  surname: Bridges Jr
  fullname: Bridges Jr, S. Louis
  organization: University of Alabama at Birmingham
– sequence: 8
  givenname: Jie
  surname: Zhang
  fullname: Zhang, Jie
  organization: University of Alabama at Birmingham
– sequence: 9
  givenname: Theresa
  surname: McVie
  fullname: McVie, Theresa
  organization: University of Alabama at Birmingham
– sequence: 10
  givenname: George
  surname: Howard
  fullname: Howard, George
  organization: University of Alabama at Birmingham
– sequence: 11
  givenname: Désirée
  surname: van der Heijde
  fullname: van der Heijde, Désirée
  organization: Leiden University Medical Center, Leiden, The Netherlands
– sequence: 12
  givenname: Stacey S.
  surname: Cofield
  fullname: Cofield, Stacey S.
  organization: University of Alabama at Birmingham
BackLink https://www.ncbi.nlm.nih.gov/pubmed/22508468$$D View this record in MEDLINE/PubMed
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CODEN ARHEAW
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Notes The study drugs were provided by Amgen (etanercept and placebo), Barr Pharmaceuticals (methotrexate), and Pharmacia (sulfasalazine and placebo).
ark:/67375/WNG-7M6NWDF9-R
Amgen through a grant to the University of Alabama at Birmingham
ArticleID:ART34498
ClinicalTrials.gov identifier: NCT00259610.
istex:7637A3983778C4FB75119991D6D2A24CA2D3A8B8
NIH planning grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases - No. 1-R34-AR-055122
Dr. Cofield has received consulting fees from Teva Neuroscience (less than $10,000) and receives compensation as a member of the Data and Safety Monitoring Board of Centocor Ortho Biotech Service.
Dr. Curtis has received consulting fees, speaking fees, and/or honoraria from Abbott, Bristol‐Myers Squibb, Crescendo Bioscience, Pfizer (less than $10,000 each) and from Roche/Genentech, UCB, Centocor, and Amgen (more than $10,000 each).
Dr. van der Heijde has received consulting fees from Abbott, Amgen, AstraZeneca, Bristol‐Myers Squibb, Centocor, Chugai, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Otsuka, Pfizer, Roche, Sanofi‐Aventis, Schering‐Plough, UCB, and Wyeth (less than $10,000 each).
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PublicationTitle Arthritis & rheumatology (Hoboken, N.J.)
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References Schoels M, Wong J, Scott DL, Zink A, Richards P, Landewe R, et al. Economic aspects of treatment options in rheumatoid arthritis: a systematic literature review informing the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis 2010; 69: 995-1003.
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.
O'Dell JR, Haire CE, Erikson N, Drymalski W, Palmer W, Eckhoff PJ, 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.
Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics 1982; 38: 963-74.
Smolen JS, van der Heijde DM, St Clair EW, Emery P, Bathon JM, Keystone E, et al. Predictors of joint damage in patients with early rheumatoid arthritis treated with high-dose methotrexate with or without concomitant infliximab: results from the ASPIRE trial. Arthritis Rheum 2006; 54: 702-10.
Smolen JS, Landewe R, Breedveld FC, Dougados M, Emery P, Gaujoux-Viala C, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis 2010; 69: 964-75.
Boers M, Verhoeven AC, Markusse HM, van de Laar MA, Westhovens R, van Denderen JC, et al. Randomised comparison of combined step-down prednisolone, methotrexate and sulphasalazine with sulphasalazine alone in early rheumatoid arthritis. Lancet 1997; 350: 309-18.
Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, 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.
Nurmohamed MT, Dijkmans BA. Are biologics more effective than classical disease-modifying antirheumatic drugs? Arthritis Res Ther 2008; 10: 118.
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.
Van der Heijde D, Klareskog L, Rodriguez-Valverde V, Codreanu C, Bolosiu H, Melo-Gomes J, et al. Comparison of etanercept and methotrexate, alone and combined, in the treatment of rheumatoid arthritis: two-year clinical and radiographic results from the TEMPO study, a double-blind, randomized trial. Arthritis Rheum 2006; 54: 1063-74.
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.
Saag KG, Teng GG, Patkar NM, Anuntiyo J, Finney C, Curtis JR, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum 2008; 59: 762-84.
Van der Velde G, Pham B, Machado M, Ieraci L, Witteman W, Bombardier C, et al. Cost-effectiveness of biologic response modifiers compared to disease-modifying antirheumatic drugs for rheumatoid arthritis: a systematic review. Arthritis Care Res (Hoboken) 2011; 63: 65-78.
Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988; 31: 315-24.
Aletaha D, Landewe R, Karonitsch T, Bathon J, Boers M, Bombardier C, et al. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations. Arthritis Rheum 2008; 59: 1371-7.
Smolen JS, Aletaha D, Grisar JC, Stamm TA, Sharp JT. Estimation of a numerical value for joint damage-related physical disability in rheumatoid arthritis clinical trials. Ann Rheum Dis 2010; 69: 1058-64.
Van der Heijde D, Klareskog L, Boers M, Landewe R, Codreanu C, Bolosiu HD, et al. Comparison of different definitions to classify remission and sustained remission: 1 year TEMPO results. Ann Rheum Dis 2005; 64: 1582-7.
Van Vollenhoven RF, Ernestam S, Geborek P, Petersson IF, Coster L, Waltbrand E, et al. Addition of infliximab compared with addition of sulfasalazine and hydroxychloroquine to methotrexate in patients with early rheumatoid arthritis (Swefot trial): 1-year results of a randomised trial. Lancet 2009; 374: 459-66.
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.
Emery P, Breedveld FC, Hall S, Durez P, Chang DJ, Robertson D, et al. Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trial. Lancet 2008; 372: 375-82.
Van der Heijde D. How to read radiographs according to the Sharp/van der Heijde method. J Rheumatol 1999; 26: 743-5.
Van der Heijde D, Klareskog L, Landewe R, Bruyn GA, Cantagrel A, Durez P, et al. Disease remission and sustained halting of radiographic progression with combination etanercept and methotrexate in patients with rheumatoid arthritis. Arthritis Rheum 2007; 56: 3928-39.
Ware JE Jr, Kosinski M, Keller SD. A 12-item Short Form health survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996; 34: 220-33.
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.
Emery P, Fleischmann RM, Moreland LW, Hsia EC, Strusberg I, Durez P, et al. Golimumab, a human anti-tumor necrosis factor α monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis. Arthritis Rheum 2009; 60: 2272-83.
Pincus T, Summey JA, Soraci SA Jr, Wallston KA, Hummon NP. Assessment of patient satisfaction in activities of daily living using a modified Stanford Health Assessment Questionnaire. Arthritis Rheum 1983; 26: 1346-53.
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.
Weinblatt M, Fleischmann R, Emery P, Goel N, Bingham C, Pope J, et al. Efficacy and safety of certolizumab pegol in a clinically representative population of patients (Pts) with active rheumatoid arthritis (RA): results of the REALISTIC phase IIIb randomized controlled study [abstract]. Arthritis Rheum 2010; 63 Suppl: S752-S3.
Mottonen T, Hannonen P, Leirisalo-Repo M, Nissila M, Kautiainen H, Korpela 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: 1568-73.
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References_xml – reference: Ware JE Jr, Kosinski M, Keller SD. A 12-item Short Form health survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996; 34: 220-33.
– reference: Aletaha D, Landewe R, Karonitsch T, Bathon J, Boers M, Bombardier C, et al. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations. Arthritis Rheum 2008; 59: 1371-7.
– reference: Smolen JS, Landewe R, Breedveld FC, Dougados M, Emery P, Gaujoux-Viala C, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis 2010; 69: 964-75.
– reference: Saag KG, Teng GG, Patkar NM, Anuntiyo J, Finney C, Curtis JR, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum 2008; 59: 762-84.
– reference: Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics 1982; 38: 963-74.
– reference: Van der Heijde D. How to read radiographs according to the Sharp/van der Heijde method. J Rheumatol 1999; 26: 743-5.
– reference: Emery P, Fleischmann RM, Moreland LW, Hsia EC, Strusberg I, Durez P, et al. Golimumab, a human anti-tumor necrosis factor α monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis. Arthritis Rheum 2009; 60: 2272-83.
– reference: 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.
– reference: Pincus T, Summey JA, Soraci SA Jr, Wallston KA, Hummon NP. Assessment of patient satisfaction in activities of daily living using a modified Stanford Health Assessment Questionnaire. Arthritis Rheum 1983; 26: 1346-53.
– reference: Van der Heijde D, Klareskog L, Rodriguez-Valverde V, Codreanu C, Bolosiu H, Melo-Gomes J, et al. Comparison of etanercept and methotrexate, alone and combined, in the treatment of rheumatoid arthritis: two-year clinical and radiographic results from the TEMPO study, a double-blind, randomized trial. Arthritis Rheum 2006; 54: 1063-74.
– reference: Smolen JS, Aletaha D, Grisar JC, Stamm TA, Sharp JT. Estimation of a numerical value for joint damage-related physical disability in rheumatoid arthritis clinical trials. Ann Rheum Dis 2010; 69: 1058-64.
– reference: Boers M, Verhoeven AC, Markusse HM, van de Laar MA, Westhovens R, van Denderen JC, et al. Randomised comparison of combined step-down prednisolone, methotrexate and sulphasalazine with sulphasalazine alone in early rheumatoid arthritis. Lancet 1997; 350: 309-18.
– reference: Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, 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.
– reference: Smolen JS, van der Heijde DM, St Clair EW, Emery P, Bathon JM, Keystone E, et al. Predictors of joint damage in patients with early rheumatoid arthritis treated with high-dose methotrexate with or without concomitant infliximab: results from the ASPIRE trial. Arthritis Rheum 2006; 54: 702-10.
– reference: Weinblatt M, Fleischmann R, Emery P, Goel N, Bingham C, Pope J, et al. Efficacy and safety of certolizumab pegol in a clinically representative population of patients (Pts) with active rheumatoid arthritis (RA): results of the REALISTIC phase IIIb randomized controlled study [abstract]. Arthritis Rheum 2010; 63 Suppl: S752-S3.
– reference: Nurmohamed MT, Dijkmans BA. Are biologics more effective than classical disease-modifying antirheumatic drugs? Arthritis Res Ther 2008; 10: 118.
– reference: Van der Velde G, Pham B, Machado M, Ieraci L, Witteman W, Bombardier C, et al. Cost-effectiveness of biologic response modifiers compared to disease-modifying antirheumatic drugs for rheumatoid arthritis: a systematic review. Arthritis Care Res (Hoboken) 2011; 63: 65-78.
– reference: Emery P, Breedveld FC, Hall S, Durez P, Chang DJ, Robertson D, et al. Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trial. Lancet 2008; 372: 375-82.
– reference: Van der Heijde D, Klareskog L, Landewe R, Bruyn GA, Cantagrel A, Durez P, et al. Disease remission and sustained halting of radiographic progression with combination etanercept and methotrexate in patients with rheumatoid arthritis. Arthritis Rheum 2007; 56: 3928-39.
– reference: Schoels M, Wong J, Scott DL, Zink A, Richards P, Landewe R, et al. Economic aspects of treatment options in rheumatoid arthritis: a systematic literature review informing the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis 2010; 69: 995-1003.
– reference: Van der Heijde D, Klareskog L, Boers M, Landewe R, Codreanu C, Bolosiu HD, et al. Comparison of different definitions to classify remission and sustained remission: 1 year TEMPO results. Ann Rheum Dis 2005; 64: 1582-7.
– reference: 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.
– reference: 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.
– reference: 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.
– reference: O'Dell JR, Haire CE, Erikson N, Drymalski W, Palmer W, Eckhoff PJ, 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.
– reference: 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.
– reference: Mottonen T, Hannonen P, Leirisalo-Repo M, Nissila M, Kautiainen H, Korpela 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: 1568-73.
– reference: Van Vollenhoven RF, Ernestam S, Geborek P, Petersson IF, Coster L, Waltbrand E, et al. Addition of infliximab compared with addition of sulfasalazine and hydroxychloroquine to methotrexate in patients with early rheumatoid arthritis (Swefot trial): 1-year results of a randomised trial. Lancet 2009; 374: 459-66.
– reference: 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.
– reference: Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988; 31: 315-24.
– volume: 337
  start-page: 141
  year: 1997
  end-page: 7
  article-title: Treatment of rheumatoid arthritis with a recombinant human tumor necrosis factor receptor (p75)‐Fc fusion protein
  publication-title: N Engl J Med
– volume: 26
  start-page: 1346
  year: 1983
  end-page: 53
  article-title: Assessment of patient satisfaction in activities of daily living using a modified Stanford Health Assessment Questionnaire
  publication-title: Arthritis Rheum
– volume: 63
  start-page: 65
  year: 2011
  end-page: 78
  article-title: Cost‐effectiveness of biologic response modifiers compared to disease‐modifying antirheumatic drugs for rheumatoid arthritis: a systematic review
  publication-title: Arthritis Care Res (Hoboken)
– volume: 31
  start-page: 315
  year: 1988
  end-page: 24
  article-title: The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis
  publication-title: Arthritis Rheum
– volume: 343
  start-page: 1594
  year: 2000
  end-page: 602
  article-title: Infliximab and methotrexate in the treatment of rheumatoid arthritis
  publication-title: N Engl J Med
– volume: 54
  start-page: 1063
  year: 2006
  end-page: 74
  article-title: Comparison of etanercept and methotrexate, alone and combined, in the treatment of rheumatoid arthritis: two‐year clinical and radiographic results from the TEMPO study, a double‐blind, randomized trial
  publication-title: Arthritis Rheum
– volume: 60
  start-page: 2272
  year: 2009
  end-page: 83
  article-title: Golimumab, a human anti–tumor necrosis factor α monoclonal antibody, injected subcutaneously every four weeks in methotrexate‐naive patients with active rheumatoid arthritis: twenty‐four–week results of a phase III, multicenter, randomized, double‐blind, placebo‐controlled study of golimumab before methotrexate as first‐line therapy for early‐onset rheumatoid arthritis
  publication-title: Arthritis Rheum
– volume: 34
  start-page: 220
  year: 1996
  end-page: 33
  article-title: A 12‐item Short Form health survey: construction of scales and preliminary tests of reliability and validity
  publication-title: Med Care
– volume: 59
  start-page: 1371
  year: 2008
  end-page: 7
  article-title: Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations
  publication-title: Arthritis Rheum
– volume: 69
  start-page: 1058
  year: 2010
  end-page: 64
  article-title: Estimation of a numerical value for joint damage‐related physical disability in rheumatoid arthritis clinical trials
  publication-title: Ann Rheum Dis
– volume: 363
  start-page: 675
  year: 2004
  end-page: 81
  article-title: Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double‐blind randomised controlled trial
  publication-title: Lancet
– volume: 54
  start-page: 702
  year: 2006
  end-page: 10
  article-title: Predictors of joint damage in patients with early rheumatoid arthritis treated with high‐dose methotrexate with or without concomitant infliximab: results from the ASPIRE trial
  publication-title: Arthritis Rheum
– volume: 350
  start-page: 309
  year: 1997
  end-page: 18
  article-title: Randomised comparison of combined step‐down prednisolone, methotrexate and sulphasalazine with sulphasalazine alone in early rheumatoid arthritis
  publication-title: Lancet
– volume: 64
  start-page: 1582
  year: 2005
  end-page: 7
  article-title: Comparison of different definitions to classify remission and sustained remission: 1 year TEMPO results
  publication-title: Ann Rheum Dis
– volume: 334
  start-page: 1287
  year: 1996
  end-page: 91
  article-title: Treatment of rheumatoid arthritis with methotrexate alone, sulfasalazine and hydroxychloroquine, or a combination of all three medications
  publication-title: N Engl J Med
– volume: 63
  start-page: S752
  issue: Suppl
  year: 2010
  end-page: S3
  article-title: Efficacy and safety of certolizumab pegol in a clinically representative population of patients (Pts) with active rheumatoid arthritis (RA): results of the REALISTIC phase IIIb randomized controlled study
  publication-title: Arthritis Rheum
– volume: 69
  start-page: 995
  year: 2010
  end-page: 1003
  article-title: Economic aspects of treatment options in rheumatoid arthritis: a systematic literature review informing the EULAR recommendations for the management of rheumatoid arthritis
  publication-title: Ann Rheum Dis
– volume: 38
  start-page: 963
  year: 1982
  end-page: 74
  article-title: Random‐effects models for longitudinal data
  publication-title: Biometrics
– volume: 353
  start-page: 1568
  year: 1999
  end-page: 73
  article-title: Comparison of combination therapy with single‐drug therapy in early rheumatoid arthritis: a randomised trial
  publication-title: Lancet
– volume: 343
  start-page: 1586
  year: 2000
  end-page: 93
  article-title: A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis
  publication-title: N Engl J Med
– volume: 54
  start-page: 26
  year: 2006
  end-page: 37
  article-title: 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
  publication-title: Arthritis Rheum
– volume: 374
  start-page: 459
  year: 2009
  end-page: 66
  article-title: Addition of infliximab compared with addition of sulfasalazine and hydroxychloroquine to methotrexate in patients with early rheumatoid arthritis (Swefot trial): 1‐year results of a randomised trial
  publication-title: Lancet
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Snippet Objective To assess whether it is better to intensively treat all patients with early rheumatoid arthritis (RA) using combinations of drugs or to reserve this...
To assess whether it is better to intensively treat all patients with early rheumatoid arthritis (RA) using combinations of drugs or to reserve this approach...
Objective To assess whether it is better to intensively treat all patients with early rheumatoid arthritis (RA) using combinations of drugs or to reserve this...
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SubjectTerms Administration, Oral
Adult
Aged
Antirheumatic Agents - administration & dosage
Antirheumatic Agents - therapeutic use
Arthritis, Rheumatoid - diagnostic imaging
Arthritis, Rheumatoid - drug therapy
Blood Sedimentation
Double-Blind Method
Drug Administration Schedule
Drug therapy
Drug Therapy, Combination
Etanercept
Female
HIV
Human immunodeficiency virus
Humans
Hydroxychloroquine - administration & dosage
Immunoglobulin G - administration & dosage
Immunoglobulin G - therapeutic use
Male
Methotrexate
Methotrexate - administration & dosage
Methotrexate - therapeutic use
Middle Aged
Radiography
Receptors, Tumor Necrosis Factor - administration & dosage
Receptors, Tumor Necrosis Factor - therapeutic use
Rheumatoid arthritis
Severity of Illness Index
Sulfasalazine - administration & dosage
Treatment Outcome
Title A randomized comparative effectiveness study of oral triple therapy versus etanercept plus methotrexate in early aggressive rheumatoid arthritis: The Treatment of Early Aggressive Rheumatoid Arthritis trial
URI https://api.istex.fr/ark:/67375/WNG-7M6NWDF9-R/fulltext.pdf
https://onlinelibrary.wiley.com/doi/abs/10.1002%2Fart.34498
https://www.ncbi.nlm.nih.gov/pubmed/22508468
https://www.proquest.com/docview/1517120280
https://www.proquest.com/docview/1036875676
Volume 64
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