Vol.22 No.3

Original Article

Study protocol of a multicenter registry of patients with rheumatoid arthritis starting biologic therapy in Japan: Tsurumai Biologics Communication Registry (TBCR) Study

Authors

Toshihisa Kojima1 , Atsushi Kaneko2 , Yuji Hirano3 , Hisato Ishikawa4 , Hiroyuki Miyake5 , Takeshi Oguchi6 , Hideki Takagi7 , Yuichiro Yabe8 , Takefumi Kato9 , Takayasu Ito10 , Kenya Terabe11 , Naoki Fukaya12, Yasuhide Kanayama7, Tomone Shioura13, Koji Funahashi1, Masatoshi Hayashi1, Daizo Kato1, Hiroyuki Matsubara1, Takayoshi Fujibayashi14, Masayo Kojima15, Naoki Ishiguro1,16

  • Department of Orthopedic Surgery and Rheumatology, Nagoya University, School of Medicine, 65 Tsurumai, Showa, Nagoya, Japan
  • Department of Orthopedic Surgery, Nagoya Medical Center, Nagoya, Japan
  • Department of Rheumatology, Toyohashi Municipal Hospital, Toyohashi, Japan
  • Department of Rheumatology, Nagano Red Cross Hospital, Nagano, Japan
  • Department of Orthopedic Surgery, Ichinomiya Municipal Hospital, Ichinomiya, Japan
  • Department of Orthopedic Surgery, Anjo Kosei Hospital, Anjo, Japan
  • Department of Orthopedic Surgery, Nagoya Kyoritsu Hospital, Nagoya, Japan
  • Department of Rheumatology, Tokyo Koseinenkin Hospital, Tokyo, Japan
  • Kato Orthopedic Clinic, Okazaki, Japan
  • Ito Orthopedic Clinic, Nagoya, Japan
  • Department of Orthopedic Surgery, Fukuroi Municipal Hospital, Fukuroi, Japan
  • Department of Orthopedic Surgery, Kariya-Toyota General Hospital, Kariya, Japan
  • Department of Orthopedic Surgery, Shizuoka Kosei Hospital, Shizuoka, Japan
  • Department of Orthopedic Surgery, Konan Kosei Hospital, Konan, Japan
  • Department of Public Health, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
  • Department of Orthopedic Surgery, Nagoya University, Faculty and Graduate School of Medicine, Nagoya, Japan
Received:

10 May 2011

Accepted:

16 August 2011

Published online:

3 September 2011

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Abstract

Biologic agents have proven to be effective against rheumatoid arthritis (RA) in clinical trials and postmarketing surveillance (PMS) studies. However, limited follow-up periods and strict criteria for recruitment might lead to an underestimation of adverse events. To document the long-term course of patients with RA treated with biologics in clinical settings, we established the Tsurumai Biologics Communication Registry (TBCR). First, we retrospectively collected data of patients registered for any biologic PMS study or clinical trial at participating institutes. Thus far, thirteen institutes have joined the registry and 860 patients have been identified. Comparing baseline characteristics by age and initiation year of biologics, young patients had significantly less joint damage and dysfunction and a higher dose of concomitant methotrexate (MTX) compared to older patients. Older age and functional class were significantly related to the incidence of adverse events that resulted in discontinuation of the 1st biologic treatment. The TBCR is in its initial stages, and information on all patients newly starting biologic therapy at participating institutes is being collected prospectively. Differences in baseline characteristics by age and initiation year of biologics need to be carefully evaluated in order to report on drug-related survival and long-term prognosis, using follow-up data in the near future.

Key words

Rheumatoid arthritis - Biologics - Methotrexate - Registry - Age