title: Efficacy of etanercept in combination with methotrexate in moderate-to-severe rheumatoid arthritis is not dependent on methotrexate dosage.
abstract: OBJECTIVE
  To evaluate the impact of methotrexate (MTX) dosage on clinical, functional and quality of life outcomes in patients with rheumatoid arthritis (RA) from two previous etanercept (ETN) trials after 24 months of treatment.
  
  
  METHODS
  Patients with active RA in the ETN+MTX combination treatment arms of the Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes (TEMPO) and COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis (COMET) studies were pooled in this post hoc analysis and stratified by MTX dosage at 24 months, having MTX monotherapy groups as control: low dose, <10.0 mg/week; medium dose, 10.0-17.5 mg/week; and high dose, >17.5 mg/week. Data from these patient subgroups were included in descriptive summaries of demographic and disease characteristics at baseline. The following outcomes at 24 months were also evaluated for each subgroup: Disease Activity Score in 28 joints (DAS28) low disease activity (LDA) and remission; American College of Rheumatology 20%, 50% and 70% improvement criteria (ACR20, 50 and 70) responses; and changes from baseline in DAS28, Health Assessment Questionnaire Disease Index (HAQ-DI) and EuroQol 5-dimensions visual analogue scale (EQ-5D VAS).
  
  
  RESULTS
  Baseline demographics were similar between the low, medium and high MTX dose groups in the ETN+MTX combination and MTX monotherapy arms, with the exception of disease duration (ETN+MTX low 5.5; medium 5.1; high 0.8 years vs MTX low 8.3; medium 4.7; high 0.8 years). Responses to ETN+MTX combination therapy at 24 months were consistently high across MTX dosage groups, with very similar rates of DAS28 LDA/remission and ACR20/50/70. Improvements in DAS28, HAQ-DI and EQ-5D VAS were also not dependent on MTX dosage in the combination treatment arm.
  
  
  CONCLUSIONS
  Patients with RA in the TEMPO and COMET trials who received ETN+MTX showed similar efficacy outcomes at 24 months, regardless of MTX dosage.
  
  
  BACKGROUND
  NCT00195494 (COMET) and NCT00393471 (TEMPO).
authors.affiliation: Pfizer Europe , Rome , Italy.
authors.forename: G
authors.initials: G
authors.lastname: Gallo
authors.affiliation: Statistical Consultancy, Quanticate Ltd. , Hitchin , UK.
authors.forename: F
authors.initials: F
authors.lastname: Brock
authors.affiliation: Pfizer Europe , Rome , Italy.
authors.forename: U
authors.initials: U
authors.lastname: Kerkmann
authors.affiliation: Pfizer Europe , Rome , Italy.
authors.forename: B
authors.initials: B
authors.lastname: Kola
authors.affiliation: Leiden University Medical Center , Leiden , The Netherlands.
authors.forename: T W J
authors.initials: TW
authors.lastname: Huizinga
keywords: Anti-TNF; DMARDs (biologic); DMARDs (synthetic); Rheumatoid Arthritis