title: 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.
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 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.
authors.affiliation: Hokkaido University Graduate School of Medicine, Sapporo, Japan.
authors.forename: Takao
authors.initials: T
authors.lastname: Koike
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Harigai
authors.forename: Shigeko
authors.initials: S
authors.lastname: Inokuma
authors.forename: Naoki
authors.initials: N
authors.lastname: Ishiguro
authors.forename: Junnosuke
authors.initials: J
authors.lastname: Ryu
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Takeuchi
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
authors.forename: Hisashi
authors.initials: H
authors.lastname: Yamanaka
authors.forename: Koichi
authors.initials: K
authors.lastname: Fujii
authors.forename: Takunari
authors.initials: T
authors.lastname: Yoshinaga
authors.forename: Bruce
authors.initials: B
authors.lastname: Freundlich
authors.forename: Michio
authors.initials: M
authors.lastname: Suzukawa
mesh_terms: D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology; D044466:Asian People; D016009:Chi-Square Distribution; D057915:Drug Substitution; D004359:Drug Therapy, Combination; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan / Q000453:epidemiology; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011358:Product Surveillance, Postmarketing; D016016:Proportional Hazards Models; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept