Ann Rheum Dis doi:10.1136/ard.2008.094524

Improvements in clinical response between 12 and 24 weeks in patients with rheumatoid arthritis on etanercept therapy with or without methotrexate

  1. Arthur Kavanaugh (akavanaugh{at}
  1. Center for Innovative Therapy, Division of Rheumatology, Allergy, Immunology, UCSD, United States
    1. Lars Klareskog (lars.klareskog{at}
    1. Rheumatology Unit, Department of Medicine, Karolinska Institutet, Sweden
      1. Désirée van der Heijde (d.vanderheijde{at}
      1. Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands
        1. Juan Li (juli{at}
        1. Amgen Inc, United States
          1. Bruce Freundlich (freundb{at}
          1. Wyeth Pharmaceuticals, United States
            1. Michele Hooper (hooperm{at}
            1. Amgen Inc, United States
              • Published Online First 5 June 2008


              Background: While many patients respond quickly to treatment with tumor necrosis factor (TNF) inhibitors, some patients may experience significant but delayed responses.

              Objective: To evaluate clinical response between 12 and 24 weeks in subjects with rheumatoid arthritis (RA) from the Trial of Etanercept (ETN) and Methotrexate (MTX) with Radiographic Patient Outcomes (TEMPO). Methods. We assessed clinical response at 24 weeks in 12-week non-responders, according to ACR response criteria. The proportion of subjects who successfully maintained response through 52 weeks was analyzed, as were radiographic outcomes.

              Results: Data from 682 subjects were included in the analysis. Non- and partial responders in all three groups (ETN, MTX, ETN + MTX) at week 12 showed improvement in responses at week 24. Over 80% of the week 24 ACR20/50/70 responders in the ETN+MTX arm sustained their response through 52 weeks. In the ETN arms, a delayed clinical response was not associated with increased radiographic progression at week 52.

              Conclusion A significant proportion of non- and partial responders to ETN+/- MTX therapy at week 12 achieved a good clinical response or improved their overall clinical response at week 24. Discontinuing TNF-inhibitor therapy at 12 weeks may be premature in some RA patients.