title: An observational study of tocilizumab and TNF-α inhibitor use in a Japanese community hospital: different remission rates, similar drug survival and safety.
abstract: OBJECTIVE
  To assess the effectiveness, drug survival and safety of tocilizumab compared with TNF-α inhibitors in clinical practice.
  
  
  METHODS
  Patients in the Cohort of Arthritis Biologic Users at Kameda Institute (CABUKI) registry who were on biologics during July 2003 to October 2010 were included. Remission rates at 6 months, Kaplan-Meier drug survival estimates and serious adverse event (SAE) rates were compared.
  
  
  RESULTS
  A total of 247 RA patients were analysed. For first-line biologic users, the 6-month 28-joint DAS (DAS-28)-ESR remission rates were 66.7% for tocilizumab vs 25.8% for TNF inhibitors (P < 0.001, Fisher's exact test). This advantage disappeared with the application of the newly suggested Boolean remission criterion for clinical trials: 0% for tocilizumab vs 8.2% for TNF inhibitors (P = 0.367, Fisher's exact test). Tocilizumab users in DAS-28-ESR remission had lower mean ESR (3.9  mm/h for tocilizumab vs 7.9  mm/h for TNF inhibitors, P = 0.026, t-test) and higher mean swollen joint count (2.6 for tocilizumab vs 1.3 for TNF inhibitors, P = 0.036, t-test), thus failing to meet the more stringent Boolean criteria. First- and second-line tocilizumab users showed similar drug survival and SAE rates compared with TNF inhibitor users.
  
  
  CONCLUSIONS
  Tocilizumab had drug survival and safety profiles similar to those of TNF inhibitors in this Japanese single-centre registry. Tocilizumab was superior to TNF inhibitors when compared at 6 months by DAS-28-ESR remission. However, the newly suggested Boolean criteria are more appropriate measures of effectiveness as DAS-28-ESR remission by tocilizumab was mainly due to very low ESR in our study population.
authors: Department of Rheumatology, Kameda Medical Center, 929 Higashi-Cho, Kamogawa City, Chiba Prefecture 296-8602, Japan. kazukiyoshid@gmail.com
authors: Kazuki
authors: K
authors: Yoshida
authors: Yasuharu
authors: Y
authors: Tokuda
authors: Hideto
authors: H
authors: Oshikawa
authors: Masako
authors: M
authors: Utsunomiya
authors: Tatsuo
authors: T
authors: Kobayashi
authors: Makiko
authors: M
authors: Kimura
authors: Gautam A
authors: GA
authors: Deshpande
authors: Kazuo
authors: K
authors: Matsui
authors: Mitsumasa
authors: M
authors: Kishimoto
mesh_terms: D000068879:Adalimumab; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001168:Arthritis / Q000188:drug therapy* / Q000503:physiopathology; D001688:Biological Products / Q000009:adverse effects / Q000627:therapeutic use*; D004361:Drug Tolerance; D064420:Drug-Related Side Effects and Adverse Reactions; D000068800:Etanercept; D005260:Female; D006764:Hospitals, Community; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use; D000069285:Infliximab; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use; D012074:Remission Induction; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D001688:Biological Products; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068879:Adalimumab; C502936:tocilizumab; D000068800:Etanercept