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 Koike, Masayoshi Harigai, Shigeko Inokuma, Naoki Ishiguro, Junnosuke Ryu, Tsutomu Takeuchi, Yoshiya Tanaka, Hisashi Yamanaka, Koichi Fujii, Takunari Yoshinaga, Bruce Freundlich, Michio Suzukawa

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

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 pretreatment 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.

Original languageEnglish
Pages (from-to)1511-1519
Number of pages9
JournalRheumatology International
Volume32
Issue number6
DOIs
Publication statusPublished - 2012 Jun

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Marketing
Rheumatoid Arthritis
Japan
Safety
Methotrexate
Etanercept
Antirheumatic Agents
Biological Products
Comorbidity
Adrenal Cortex Hormones
Hypersensitivity
Joints
Incidence

Keywords

  • Antirheumatic agents/adverse effects
  • Antirheumatic agents/therapeutic use
  • Arthritis
  • Japan
  • Postmarketing/statistics & numerical data
  • Product surveillance
  • Receptors
  • Rheumatoid/drug therapy
  • Tumor necrosis factor/therapeutic use

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Immunology and Allergy

Cite this

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. / Koike, Takao; Harigai, Masayoshi; Inokuma, Shigeko; Ishiguro, Naoki; Ryu, Junnosuke; Takeuchi, Tsutomu; Tanaka, Yoshiya; Yamanaka, Hisashi; Fujii, Koichi; Yoshinaga, Takunari; Freundlich, Bruce; Suzukawa, Michio.

In: Rheumatology International, Vol. 32, No. 6, 06.2012, p. 1511-1519.

Research output: Contribution to journalArticle

Koike, Takao ; Harigai, Masayoshi ; Inokuma, Shigeko ; Ishiguro, Naoki ; Ryu, Junnosuke ; Takeuchi, Tsutomu ; Tanaka, Yoshiya ; Yamanaka, Hisashi ; Fujii, Koichi ; Yoshinaga, Takunari ; Freundlich, Bruce ; Suzukawa, Michio. / 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. In: Rheumatology International. 2012 ; Vol. 32, No. 6. pp. 1511-1519.
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AU - Tanaka, Yoshiya

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