title: Full dose, reduced dose or discontinuation of etanercept in rheumatoid arthritis.
abstract: BACKGROUND
  The aim of the Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Patients Who Have Achieved a Stable Low Disease Activity-State study was to investigate the effect of etanercept (ETN) dose maintenance, reduction or withdrawal on patients with rheumatoid arthritis (RA) who had already achieved stable low disease activity (LDA) on ETN 50 mg+methotrexate (MTX).
  
  
  METHODS
  Patients with RA (n=91) and stable LDA with ETN 50 mg once weekly (QW)+MTX were included. After 8 weeks with unchanged treatment, 73 patients were randomised in a double-blind design to ETN 50 mg QW+MTX (ETN50), ETN 25 mg QW+MTX (ETN25) or placebo QW+MTX (PBO) for 48 weeks. Patients who flared were declared failures and treated with open-label ETN50 until week 48. The primary outcome was the proportion of patients on ETN50 versus PBO who were non-failures after 48 weeks.
  
  
  RESULTS
  The proportion of non-failure patients was significantly lower with ETN50 (52%; p=0.007) and ETN25 (44%; p=0.044) versus PBO (13%). Median time to failure was significantly shorter with PBO (6 weeks) compared with ETN50 (48 weeks; p=0.001) and ETN25 (36 weeks; p<0.001). The majority of patients who flared regained LDA with open-label ETN50 quickly. Adverse events were consistent with the known side effect profiles of these medications.
  
  
  CONCLUSIONS
  In patients with established RA who have achieved stable LDA on ETN50+MTX, continuing both is superior to PBO+MTX. Reduced dose ETN was also more effective than PBO in maintaining a favourable response, suggesting that a maintenance strategy with reduced dose ETN may be possible in a number of patients with established RA.
  
  
  BACKGROUND
  NCT00858780.
authors: Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), the Karolinska Institute, Stockholm, Sweden Rheumatology Clinic, Karolinska University Hospital, Stockholm, Sweden.
authors: Ronald F
authors: RF
authors: van Vollenhoven
authors: Faculty of Health Sciences, Copenhagen Center for Arthritis Research, Centre for Rheumatology and Spine Diseases, Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark.
authors: Mikkel
authors: M
authors: Østergaard
authors: Helsinki University Central Hospital, and Institute of Clinical Medicine, University of Helsinki, Helsinki, Finland.
authors: Marjatta
authors: M
authors: Leirisalo-Repo
authors: National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
authors: Till
authors: T
authors: Uhlig
authors: Pfizer Sweden, Sollentuna, Sweden.
authors: Marita
authors: M
authors: Jansson
authors: Pfizer Sweden, Sollentuna, Sweden.
authors: Esbjörn
authors: E
authors: Larsson
authors: Statistical Consultancy, Quanticate, Hitchin, UK.
authors: Fiona
authors: F
authors: Brock
authors: Department of Medical Sciences, University of Uppsala, Uppsala, Sweden.
authors: Karin
authors: K
authors: Franck-Larsson
mesh_terms: D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D000068800:Etanercept / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D012008:Recurrence; D012720:Severity of Illness Index; D016896:Treatment Outcome; D028761:Withholding Treatment
chemical_list: D018501:Antirheumatic Agents; D000068800:Etanercept; D008727:Methotrexate
keywords: Anti-TNF; Methotrexate; Rheumatoid Arthritis