Original Article

Rheumatology International

, Volume 32, Issue 6, pp 1511-1519

First online:

Open Access This content is freely available online to anyone, anywhere at any time.

Safety and effectiveness responses to etanercept for rheumatoid arthritis in Japan: a sub-analysis of a post-marketing surveillance study focusing on the duration of rheumatoid arthritis

  • Takao KoikeAffiliated withHokkaido University Graduate School of Medicine
  • , Masayoshi HarigaiAffiliated withTokyo Medical Dental University Graduate School
  • , Shigeko InokumaAffiliated withJapanese Red Cross Medical Center
  • , Naoki IshiguroAffiliated withNagoya University Graduate School of Medicine
  • , Junnosuke RyuAffiliated withNihon University School of Medicine
  • , Tsutomu TakeuchiAffiliated withKeio University
  • , Yoshiya TanakaAffiliated withUniversity of Occupational and Environmental Health, Japan
  • , Hisashi YamanakaAffiliated withTokyo Women’s Medical University
  • , Koichi FujiiAffiliated withPfizer Japan Inc., Medical Affairs
    • , Takunari YoshinagaAffiliated withPfizer Japan Inc., Post Marketing Surveillance
    • , Bruce FreundlichAffiliated withUniversity of Pennsylvania Email author 
    • , Michio SuzukawaAffiliated withPfizer Japan Inc., Medical Affairs


The aim is to investigate the relationship of duration of rheumatoid arthritis (RA) with safety and effectiveness of etanercept (ETN) in Japan. Post-marketing surveillance data for 7,099 patients treated with ETN were analyzed. Baseline characteristics, treatment effectiveness, incidence of adverse events (AEs), and serious AEs (SAEs) in relation to duration of RA were studied. At baseline, patients with RA for longer duration were older, weighed less, had more comorbidities, allergies, and corticosteroid use, but smoked less and had less morning stiffness. By 2–5 years with RA, more than half of the patients had advanced to Steinbrocker radiographic stage III or IV. Methotrexate (MTX) was the most commonly used pre-treatment disease-modifying antirheumatic drug; however, concomitant MTX use and its dose were lower among patients with longer duration of RA. Remission rates (26.6%) were greatest among patients having RA for <2 years. Less AEs and SAEs were observed among patients with shorter duration of RA. These results suggest that RA treatment in Japan in the era pre-biologics may not have been adequate to control disease activity and prevent joint destruction. Patients with shorter duration of RA may have better physical status which allows the opportunity to treat more intensively putting a higher percentage of patients in remission and possibly decreasing exposure to SAEs.


Antirheumatic agents/adverse effects Antirheumatic agents/therapeutic use Arthritis, rheumatoid/drug therapy Product surveillance, Postmarketing/statistics & numerical data Receptors, tumor necrosis factor/therapeutic use Japan