title: Evaluation of golimumab for the treatment of patients with active rheumatoid arthritis.
abstract: BACKGROUND
  Golimumab is a human anti-TNF monoclonal antibody that was derived from human antibody-transgenic mice. Golimumab demonstrated meaningful clinical benefit and tolerable safety in patients with active rheumatoid arthritis (RA) who were methotrexate (MTX)-naïve, or who inadequately responded to MTX or who had previously been treated with a TNF inhibitor.
  
  
  METHODS
  This review summarizes published data on the clinical efficacy and safety for golimumab (including its pharmacodynamic and pharmacokinetic characteristics) from multiple global phase III and Japanese phase II/III clinical trials. In the long term extension of three Phase III studies with subcutaneous golimumab, the reported retention rate is high.
  
  
  CONCLUSIONS
  Golimumab binds TNF with high affinity and can be delivered subcutaneously every 4 weeks. Like other IgG1 antibodies, FcγR functions suggests that antibody dependent cellular cytotoxicity is observed but the contribution of cell lysis to efficacy is unclear. Although anti-TNFα agents made it possible to achieve clinical remission in RA patients, there is still an unmet need to develop treatments that will enable them to discontinue all RA medication and maintain drug-free remission.
authors.affiliation: a The First Department of Internal Medicine, School of Medicine , University of Occupational & Environmental Health , Kitakyushu , Japan.
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
authors.affiliation: b Research & Development, Janssen Pharmaceutical K.K ., Tokyo , Japan.
authors.forename: Asako
authors.initials: A
authors.lastname: Senoo
authors.affiliation: b Research & Development, Janssen Pharmaceutical K.K ., Tokyo , Japan.
authors.forename: Hideji
authors.initials: H
authors.lastname: Fujii
authors.affiliation: c Janssen Research & Development , LLC , Spring House , PA , USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Baker
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D008727:Methotrexate / Q000627:therapeutic use; D051379:Mice; D008822:Mice, Transgenic; D012074:Remission Induction / Q000379:methods; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha; C529000:golimumab; D008727:Methotrexate
keywords: Biological DMARD; TNF; golimumab; remission; rheumatoid arthritis