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

Hisashi Yamanaka, Masayoshi Harigai, Naoki Ishiguro, Shigeko Inokuma, Syuji Takei, Tsutomu Takeuchi, Yoshiya Tanaka, Haruko Suzuki, Yasuhiko Shinmura, Takao Koike

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Objectives. To investigate the relationship between changes in patient characteristics over time and the eff ectiveness 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 signifi cantly associated with the eff ectiveness 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 signifi cantly over time, in particular with regard to prior biologic use and concomitant methotrexate therapy. There was a signifi cant 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 signifi cant predictors of the eff ectiveness and safety of adalimumab. Conclusions. Patient characteristics have changed since adalimumab became available for the treatment of RA; several of these characteristics were signifi cant predictors of adalimumab eff ectiveness and safety.

Original languageEnglish
Pages (from-to)495-502
Number of pages8
JournalModern Rheumatology
Volume25
Issue number4
DOIs
Publication statusPublished - 2015

Fingerprint

Rheumatoid Arthritis
Japan
Safety
Methotrexate
Therapeutics
Adalimumab
Incidence
Marketing
Drug-Related Side Effects and Adverse Reactions
Registries
Logistic Models
Regression Analysis
Demography
Injections
Infection

Keywords

  • Adalimumab
  • Efectiveness
  • Post-marketing surveillance
  • Rheumatoid arthritis
  • Safety

ASJC Scopus subject areas

  • Rheumatology

Cite this

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. / Yamanaka, Hisashi; Harigai, Masayoshi; Ishiguro, Naoki; Inokuma, Shigeko; Takei, Syuji; Takeuchi, Tsutomu; Tanaka, Yoshiya; Suzuki, Haruko; Shinmura, Yasuhiko; Koike, Takao.

In: Modern Rheumatology, Vol. 25, No. 4, 2015, p. 495-502.

Research output: Contribution to journalArticle

Yamanaka, Hisashi ; Harigai, Masayoshi ; Ishiguro, Naoki ; Inokuma, Shigeko ; Takei, Syuji ; Takeuchi, Tsutomu ; Tanaka, Yoshiya ; Suzuki, Haruko ; Shinmura, Yasuhiko ; Koike, Takao. / 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. In: Modern Rheumatology. 2015 ; Vol. 25, No. 4. pp. 495-502.
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abstract = "Objectives. To investigate the relationship between changes in patient characteristics over time and the eff ectiveness 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 signifi cantly associated with the eff ectiveness 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 signifi cantly over time, in particular with regard to prior biologic use and concomitant methotrexate therapy. There was a signifi cant 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 signifi cant predictors of the eff ectiveness and safety of adalimumab. Conclusions. Patient characteristics have changed since adalimumab became available for the treatment of RA; several of these characteristics were signifi cant predictors of adalimumab eff ectiveness and safety.",
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AU - Ishiguro, Naoki

AU - Inokuma, Shigeko

AU - Takei, Syuji

AU - Takeuchi, Tsutomu

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