title: Two-Year Safety and Efficacy Experience in Patients with Methotrexate-Resistant Active Rheumatoid Arthritis Treated with Etanercept and Conventional Disease-Modifying Anti-rheumatic Drugs in the Latin American Region.
abstract: BACKGROUND
  Although long-term data are available from biologic studies in North American/European populations with rheumatoid arthritis (RA), long-term findings in Latin American RA populations are limited.
  
  
  OBJECTIVE
  To examine long-term safety/efficacy of etanercept, methotrexate, and/or other disease-modifying anti-rheumatic drugs (DMARDs) in Latin American patients with moderate-to-severe active RA.
  
  
  METHODS
  In the first phase of this open-label study, patients were randomized to etanercept 50 mg weekly plus methotrexate or conventional DMARD (hydroxychloroquine or sulfasalazine) plus methotrexate for 24 weeks. At the start of the second phase (week 24), investigators selected a treatment regimen that included any combination/dosage of etanercept, methotrexate, hydroxychloroquine, or sulfasalazine based on previous treatment response, preference, and local product labeling, and was continued for the 104-week extension.
  
  
  RESULTS
  In the extension, in the group previously randomized to etanercept-plus-methotrexate therapy, etanercept was continued in 259/260 patients; methotrexate continued in 260/260; and hydroxychloroquine and sulfasalazine added in 8/260 and 3/260, respectively. In the group previously randomized to conventional DMARD-plus-methotrexate therapy, conventional DMARD was discontinued in 86/126 and etanercept added in 105/126. Among etanercept-exposed patients (total exposure, 798.1 patient-year [PY]), rates of adverse events, serious adverse events, and serious infections per PY were 1.7, 0.07, and 0.02 events per PY. In both groups, after treatment modification was permitted, clinical response rates and improvements in clinical/patient-reported outcomes from baseline were sustained to week 128.
  
  
  CONCLUSIONS
  After investigators were permitted to modify treatment, etanercept was part of the treatment regimen in 95% of patients. Continuation or addition of etanercept in the 2-year extension resulted in a consistently good risk:benefit profile.
  
  
  BACKGROUND
  Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy; ClinicalTrials.gov, number NCT00848354; https://clinicaltrials.gov/ct2/show/NCT00848354.
authors.affiliation: CAICI Institute, Rosario, Santa Fe, Argentina.
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Machado
authors.affiliation: IDEARG; Saludcoop Clinic, Bogota, Colombia.
authors.forename: Renato
authors.initials: R
authors.lastname: Guzman
authors.affiliation: Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
authors.forename: Ricardo M
authors.initials: RM
authors.lastname: Xavier
authors.affiliation: Universidad Marista de Mérida; BIOCEM/Hospital CEM, Mérida, Yucatán, Mexico.
authors.forename: Jesus A
authors.initials: JA
authors.lastname: Simon
authors.affiliation: Pfizer, Collegeville, PA, USA.
authors.forename: Linda
authors.initials: L
authors.lastname: Mele
authors.affiliation: Pfizer, Collegeville, PA, USA.
authors.forename: Qi
authors.initials: Q
authors.lastname: Shen
authors.affiliation: Pfizer, Collegeville, PA, USA.
authors.forename: Ronald
authors.initials: R
authors.lastname: Pedersen
authors.affiliation: Pfizer, Collegeville, PA, USA.
authors.forename: Sameer
authors.initials: S
authors.lastname: Kotak
authors.affiliation: Pfizer, Collegeville, PA, USA.
authors.forename: Bonnie
authors.initials: B
authors.lastname: Vlahos
keywords: Disease-modifying antirheumatic drugs; Latin America; etanercept; methotrexate; rheumatoid arthritis