title: Trend of patient characteristics and its impact on the response to adalimumab in patients with rheumatoid arthritis: post hoc time-course analysis of an all-case PMS in Japan.
abstract: OBJECTIVE
  To investigate the relationship between changes in patient characteristics over time and the effectiveness and safety of adalimumab in the treatment of rheumatoid arthritis (RA) in clinical practice.
  
  
  METHODS
  Patients enrolled in the post-marketing registry study in Japan were divided into 5 subgroups based on the time adalimumab treatment was initiated. Demographic and baseline characteristics and responses to adalimumab were compared among the 5 subgroups to detect any time-course trend. Multiple logistic regression analysis was performed to identify characteristics that were significantly associated with the effectiveness or safety of adalimumab and to estimate response rates and the incidence of adverse drug reactions in individual subgroups.
  
  
  RESULTS
  During the study period, patient characteristics changed significantly over time, in particular with regard to prior biologic use and concomitant methotrexate therapy. There was a significant trend toward higher response rates and lower incidence of infections and injection-site reactions in patients initiating adalimumab later in the study. Patient characteristics, such as concomitant methotrexate therapy and early stage RA, were significant predictors of the effectiveness and safety of adalimumab.
  
  
  CONCLUSIONS
  Patient characteristics have changed since adalimumab became available for the treatment of RA; several of these characteristics were significant predictors of adalimumab effectiveness and safety.
authors.affiliation: Institute of Rheumatology, Tokyo Women's Medical University , Tokyo Japan.
authors.forename: Hisashi
authors.initials: H
authors.lastname: Yamanaka
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Harigai
authors.forename: Naoki
authors.initials: N
authors.lastname: Ishiguro
authors.forename: Shigeko
authors.initials: S
authors.lastname: Inokuma
authors.forename: Syuji
authors.initials: S
authors.lastname: Takei
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Takeuchi
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
authors.forename: Haruko
authors.initials: H
authors.lastname: Suzuki
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Shinmura
authors.forename: Takao
authors.initials: T
authors.lastname: Koike
mesh_terms: D000068879:Adalimumab / Q000627:therapeutic use*; D000368:Aged; D018501:Antirheumatic Agents / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000453:epidemiology; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006801:Humans; D015994:Incidence; D007564:Japan / Q000453:epidemiology; D008297:Male; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D000068879:Adalimumab
keywords: Adalimumab; Effectiveness; Post-marketing surveillance; Rheumatoid arthritis; Safety