title: Short-term efficacy of etanercept plus methotrexate vs combinations of disease-modifying anti-rheumatic drugs with methotrexate in established rheumatoid arthritis.
abstract: OBJECTIVE
  The aims of this study were to investigate the short-term benefit of etanercept (ETN) + MTX vs conventional synthetic DMARDs (csDMARDs; HCQ, LEF or SSZ) + MTX in subjects with established RA. The effect of disease duration (≤2 years vs >2 years) and severity (moderate vs severe) on treatment outcomes was also assessed. Methods. Data from Asian and Latin American subjects with inadequate response to MTX were pooled from the APPEAL (ETN 25 mg biweekly + MTX or csDMARD + MTX; NCT00422227) and Latin RA (ETN 50 mg/week + MTX or csDMARD + MTX; NCT00848354) studies. Endpoints included the 28-joint DAS with ESR (DAS28-ESR) low disease activity (LDA; ≤3.2), DAS28 remission (<2.6) and HAQ score ≤0.5.
  
  
  RESULTS
  Four hundred seventy-eight subjects received ETN + MTX, 245 subjects received csDMARD + MTX [HCQ + MTX (n = 81), LEF + MTX (n = 69), SSZ + MTX (n = 95)]. At week 16, significantly more subjects receiving ETN + MTX vs subjects on csDMARDs + MTX achieved DAS28-ESR LDA (39% vs 18%, P < 0.001), remission (18% vs 7%, P < 0.001) and HAQ ≤0.5 (48% vs 34%, P < 0.001). For both treatment arms, these endpoints were achieved by a greater proportion of subjects with ≤2 years vs >2 years disease duration and with moderate vs severe disease activity.
  
  
  CONCLUSIONS
  Overall, ETN + MTX was more effective in treating subjects with established RA than csDMARDs + MTX at 16 weeks. More subjects with shorter disease duration and moderate disease activity achieved optimal response regardless of treatment regimen.
  
  
  BACKGROUND
  clinicaltrials.gov, NCT00422227 and NCT00848354.
authors.affiliation: Department of Medicine, Division of Rheumatology, University of Texas Southwestern Medical Center, Dallas, TX, Pfizer Inc., Collegeville, PA, USA and Pfizer Europe, Rome, Italy RFleischmann@arthdocs.com.
authors.forename: Roy
authors.initials: R
authors.lastname: Fleischmann
authors.affiliation: Department of Medicine, Division of Rheumatology, University of Texas Southwestern Medical Center, Dallas, TX, Pfizer Inc., Collegeville, PA, USA and Pfizer Europe, Rome, Italy.
authors.forename: Andrew S
authors.initials: AS
authors.lastname: Koenig
authors.affiliation: Department of Medicine, Division of Rheumatology, University of Texas Southwestern Medical Center, Dallas, TX, Pfizer Inc., Collegeville, PA, USA and Pfizer Europe, Rome, Italy.
authors.forename: Annette
authors.initials: A
authors.lastname: Szumski
authors.affiliation: Department of Medicine, Division of Rheumatology, University of Texas Southwestern Medical Center, Dallas, TX, Pfizer Inc., Collegeville, PA, USA and Pfizer Europe, Rome, Italy.
authors.forename: Henk W
authors.initials: HW
authors.lastname: Nab
authors.affiliation: Department of Medicine, Division of Rheumatology, University of Texas Southwestern Medical Center, Dallas, TX, Pfizer Inc., Collegeville, PA, USA and Pfizer Europe, Rome, Italy.
authors.forename: Lisa
authors.initials: L
authors.lastname: Marshall
authors.affiliation: Department of Medicine, Division of Rheumatology, University of Texas Southwestern Medical Center, Dallas, TX, Pfizer Inc., Collegeville, PA, USA and Pfizer Europe, Rome, Italy.
authors.forename: Eustratios
authors.initials: E
authors.lastname: Bananis
mesh_terms: D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D000068800:Etanercept; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept; D008727:Methotrexate
keywords: DMARDs; etanercept; hydroxychloroquine; leflunomide; methotrexate; rheumatoid arthritis; sulfasalazine