title: Association of serum markers with improvement in clinical response measures after treatment with golimumab in patients with active rheumatoid arthritis despite receiving methotrexate: results from the GO-FORWARD study.
abstract: BACKGROUND
  The goal of this study was to identify serum markers that are modulated by treatment with golimumab with or without methotrexate (MTX) and are associated with clinical response.
  
  
  METHODS
  Sera were collected at weeks 0 and 4 from a total of 336 patients (training dataset, n = 100; test dataset, n = 236) from the GO-FORWARD study of patients with active rheumatoid arthritis despite MTX. Patients were randomly assigned to receive placebo plus MTX; golimumab, 100 mg plus placebo; golimumab, 50 mg plus MTX; or golimumab, 100 mg plus MTX. Subcutaneous injections were administered every 4 weeks. Samples were tested for select inflammatory, bone, and cartilage markers and for protein profiling using multianalyte profiles.
  
  
  RESULTS
  Treatment with golimumab with or without MTX resulted in significant decreases in a variety of serum proteins at week 4 as compared with placebo plus MTX. The American College of Rheumatology (ACR) 20, ACR 50, and Disease Activity Score (DAS) 28 responders showed a distinct biomarker profile compared with nonresponding patients.
  
  
  CONCLUSIONS
  ACR 20 and ACR 50 responders among the golimumab/golimumab + MTX-treated patients had a distinct change from baseline to week 4 in serum protein profile as compared with nonresponders. Some of these changed markers were also associated with multiple clinical response measures and improvement in outcome measures in golimumab/golimumab + MTX-treated patients. Although the positive and negative predictive values of the panel of markers were modest, they were stronger than C-reactive protein alone in predicting clinical response to golimumab.
  
  
  BACKGROUND
  http://ClinicalTrials.gov identification number: NCT00264550.
authors.affiliation: Centocor Research and Development, Inc, 200 Great Valley Parkway, Malvern, PA 19355, USA.
authors.forename: Sudha
authors.initials: S
authors.lastname: Visvanathan
authors.forename: Mahboob U
authors.initials: MU
authors.lastname: Rahman
authors.forename: Edward
authors.initials: E
authors.lastname: Keystone
authors.forename: Mark
authors.initials: M
authors.lastname: Genovese
authors.forename: Lars
authors.initials: L
authors.lastname: Klareskog
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Hsia
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.forename: Jacqui
authors.initials: J
authors.lastname: Buchanan
authors.forename: Michael
authors.initials: M
authors.lastname: Elashoff
authors.forename: Carrie
authors.initials: C
authors.lastname: Wagner
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000097:blood* / Q000188:drug therapy*; D015415:Biomarkers / Q000097:blood*; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D008727:Methotrexate / Q000627:therapeutic use
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D015415:Biomarkers; C529000:golimumab; D008727:Methotrexate