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Extended report
Full dose, reduced dose or discontinuation of etanercept in rheumatoid arthritis
  1. Ronald F van Vollenhoven1,2,
  2. Mikkel Østergaard3,
  3. Marjatta Leirisalo-Repo4,
  4. Till Uhlig5,
  5. Marita Jansson6,
  6. Esbjörn Larsson6,
  7. Fiona Brock7,
  8. Karin Franck-Larsson8
  1. 1Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), the Karolinska Institute, Stockholm, Sweden
  2. 2Rheumatology Clinic, Karolinska University Hospital, Stockholm, Sweden
  3. 3Faculty of Health Sciences, Copenhagen Center for Arthritis Research, Centre for Rheumatology and Spine Diseases, Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark
  4. 4Helsinki University Central Hospital, and Institute of Clinical Medicine, University of Helsinki, Helsinki, Finland
  5. 5National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
  6. 6Pfizer Sweden, Sollentuna, Sweden
  7. 7Statistical Consultancy, Quanticate, Hitchin, UK
  8. 8Department of Medical Sciences, University of Uppsala, Uppsala, Sweden
  1. Correspondence to Professor Ronald F van Vollenhoven, Clinical Therapy Research, Inflammatory Diseases (ClinTRID), The Karolinska Institute, Stockholm 17176, Sweden; ronald.van.vollenhoven{at}ki.se

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.

Trial registration number NCT00858780.

  • Rheumatoid Arthritis
  • Methotrexate
  • Anti-TNF

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