Comparison of the Characteristics of Rheumatoid Arthritis Patients in Clinical Trials and Clinical Practice

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  • MORITA Waki
    Asmo Clinical Pharmacology Laboratories Ltd. (Tokyo Women's Medical University Office)
  • YAMAOKA Hisako
    Asmo Clinical Pharmacology Laboratories Ltd. (Tokyo Women's Medical University Office)
  • IWAKATA Asuka
    Asmo Clinical Pharmacology Laboratories Ltd. (Tokyo Women's Medical University Office)
  • SUZUKI Takeo
    Asmo Clinical Pharmacology Laboratories Ltd. (Tokyo Women's Medical University Office)
  • KONDO Miwa
    Institute of Rheumatology, Tokyo Women's Medical University
  • TANIGUCHI Atsuo
    Institute of Rheumatology, Tokyo Women's Medical University
  • YOSHIOKA Toshimasa
    The Center for Clinical Research, Tokyo Women's Medical University
  • YAMANAKA Hisashi
    Institute of Rheumatology, Tokyo Women's Medical University

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  • 臨床試験と日常臨床における関節リウマチ患者背景の比較

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Rheumatoid arthritis (RA) is a chronic, progressive inflammatory disease with cartilage destruction and bone erosions. Recently, many randomized controlled trials (RCTs) have shown that biologic response modifiers including tumor necrosis factor (TNF) inhibitors reduce disease activity and prevent tissue destruction. However, the results of RCTs may not be directly applicable to routine clinical practice because of the different situations including patient selection between RCTs and clinical practice, although the differences in patients' characteristics between RCTs and clinical practice have not been investigated in Japanese. In this study, we compared the demographic and disease characteristics of RA patients recruited in RCTs and those encountered in routine clinical practice.<BR> We selected 52 patients who participated in RCTs of biologics or an anti-rheumatic drug that has been demonstrated to have comparable efficacy to biologics. As the comparator arm, 513 patients who were treated with TNF inhibitors (infliximab, etanercept, and adalimumab) or an IL-6 inhibitor (tocilizumab) in the outpatient clinic of Institute of Rheumatology, Tokyo Women's Medical University were selected. Demographic characteristics of the patients were not substantially different between two groups.In the analysis of disease characteristics, the disease severity assessed by disease activity score (DAS 28) and modified Health Assessment Questionnaire was not different between two groups. However, the proportion of patients treated with ≥7.5 mg/day prednisolone was significantly higher in RCTs than in routine clinical practice. Methotrexate dose was significantly higher in routine clinical practice than in RCTs. These results may reflect the differences in disease characteristics including comorbidities between patients recruited in clinical trials and those encountered in routine clinical practice.

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