title: Golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: 52-week results of the GO-FORWARD study.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of golimumab to 52 weeks in patients with active rheumatoid arthritis despite methotrexate.
  
  
  METHODS
  Patients were randomly assigned to receive placebo plus methotrexate (group 1), golimumab 100 mg plus placebo (group 2), golimumab 50 mg plus methotrexate (group 3) and golimumab 100 mg plus methotrexate (group 4). At week 16, patients in groups 1, 2 and 3 who had less than 20% improvement in tender and swollen joints entered early escape. At week 24, patients in group 1 who had not entered early escape crossed over to 50 mg golimumab plus methotrexate.
  
  
  RESULTS
  At week 16, 31%, 27% and 17% of patients in groups 1, 2 and 3, respectively, entered early escape. At week 52, 44%, 45%, 64% and 58% of patients in groups 1, 2, 3 and 4, respectively, achieved 20% improvement in the American College of Rheumatology criteria; and 34%, 31%, 42% and 53%, respectively, achieved low disease activity (< or = 3.2) according to the 28-joint disease activity score. Patients in group 4 appeared to have an increased risk of serious adverse events and serious infections.
  
  
  CONCLUSIONS
  The results of various outcome measures showed that the response rates achieved by patients receiving golimumab to 24 weeks were sustained to 52 weeks. The safety profile appeared to be consistent with the known safety profile of tumour necrosis factor inhibitors.
authors.affiliation: University of Toronto and Mount Sinai Hospital, 60 Murray Street, 2nd Floor, Room 2-006, Toronto, Ontario M5G 1X5, Canada. edkeystone@mtsinai.on.ca
authors.forename: Edward
authors.initials: E
authors.lastname: Keystone
authors.forename: Mark C
authors.initials: MC
authors.lastname: Genovese
authors.forename: Lars
authors.initials: L
authors.lastname: Klareskog
authors.forename: Elizabeth C
authors.initials: EC
authors.lastname: Hsia
authors.forename: Stephen
authors.initials: S
authors.lastname: Hall
authors.forename: Pedro C
authors.initials: PC
authors.lastname: Miranda
authors.forename: Jacek
authors.initials: J
authors.lastname: Pazdur
authors.forename: Sang-Cheol
authors.initials: SC
authors.lastname: Bae
authors.forename: William
authors.initials: W
authors.lastname: Palmer
authors.forename: Stephen
authors.initials: S
authors.lastname: Xu
authors.forename: Mahboob U
authors.initials: MU
authors.lastname: Rahman
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D007166:Immunosuppressive Agents; C529000:golimumab; D008727:Methotrexate