title: Study protocol of a multicenter registry of patients with rheumatoid arthritis starting biologic therapy in Japan: Tsurumai Biologics Communication Registry (TBCR) study.
abstract: Biologic agents have proven to be effective against rheumatoid arthritis (RA) in clinical trials and post-marketing 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.
authors: Department of Orthopedic Surgery, Nagoya University, School of Medicine, 65 Tsurumai, Showa, Nagoya, Japan. toshik@med.nagoya-u.ac.jp
authors: Toshihisa
authors: T
authors: Kojima
authors: Atsushi
authors: A
authors: Kaneko
authors: Yuji
authors: Y
authors: Hirano
authors: Hisato
authors: H
authors: Ishikawa
authors: Hiroyuki
authors: H
authors: Miyake
authors: Takeshi
authors: T
authors: Oguchi
authors: Hideki
authors: H
authors: Takagi
authors: Yuichiro
authors: Y
authors: Yabe
authors: Takefumi
authors: T
authors: Kato
authors: Takayasu
authors: T
authors: Ito
authors: Kenya
authors: K
authors: Terabe
authors: Naoki
authors: N
authors: Fukaya
authors: Yasuhide
authors: Y
authors: Kanayama
authors: Tomone
authors: T
authors: Shioura
authors: Koji
authors: K
authors: Funahashi
authors: Masatoshi
authors: M
authors: Hayashi
authors: Daizo
authors: D
authors: Kato
authors: Hiroyuki
authors: H
authors: Matsubara
authors: Takayoshi
authors: T
authors: Fujibayashi
authors: Masayo
authors: M
authors: Kojima
authors: Naoki
authors: N
authors: Ishiguro
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D002985:Clinical Protocols; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects / Q000627:therapeutic use*; D000069285:Infliximab; D007564:Japan; D008297:Male; D008875:Middle Aged; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D012042:Registries; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000069285:Infliximab; D000068879:Adalimumab; C502936:tocilizumab; D000068800:Etanercept