title: Evaluation of serum biomarkers associated with radiographic progression in methotrexate-naive rheumatoid arthritis patients treated with methotrexate or golimumab.
abstract: OBJECTIVE
  To evaluate associations between biomarkers and radiographic progression in methotrexate (MTX)-naive patients with rheumatoid arthritis (RA) treated with MTX or golimumab, a tumor necrosis factor inhibitor (with or without MTX).
  
  
  METHODS
  Serum samples from 152 MTX-naive adults with active RA who received placebo + MTX (n = 37) or golimumab (combined 50 mg + MTX or 100 mg ± MTX; n = 115) were analyzed for selected markers of inflammation and bone/cartilage turnover. One hundred patients were randomly selected for additional protein profiling using multianalyte profiles (HumanMap v1.6, Rules Based Medicine). Radiographs at baseline, Week 28, and Week 52 were scored using van der Heijde-Sharp (vdH-S) methodology. Correlations were assessed between biomarker levels (baseline and change at Week 4) and joint space narrowing, erosion, and total vdH-S scores (changes at Weeks 28 and 52). Statistical significance was defined as a correlation coefficient with an absolute value ≥ 0.3 and p < 0.05.
  
  
  RESULTS
  Biomarker correlations with changes in vdH-S scores at Week 28 and/or 52 were observed predominantly in the placebo + MTX group and rarely in the combined golimumab treatment group. Changes in epidermal growth factor (EGF) and CD40 ligand (CD40L) at Week 4 were positively correlated with changes in total vdH-S scores at Weeks 28 and 52 in the placebo + MTX group.
  
  
  CONCLUSIONS
  These preliminary findings indicate that EGF and CD40L may have utility in monitoring MTX-treated patients with RA who are more likely to have radiographic progression as measured by increases in vdH-S scores.
authors: Immunology, Biostatistics, and R&D Informatics, Janssen Research & Development LLC, Spring House, Pennsylvania 19477, USA. cwagner@its.jnj.com
authors: Carrie
authors: C
authors: Wagner
authors: Dion
authors: D
authors: Chen
authors: Hongtao
authors: H
authors: Fan
authors: Elizabeth C
authors: EC
authors: Hsia
authors: Michael
authors: M
authors: Mack
authors: Paul
authors: P
authors: Emery
authors: Roy M
authors: RM
authors: Fleischmann
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000097:blood / Q000000981:diagnostic imaging / Q000188:drug therapy; D015415:Biomarkers / Q000097:blood; D023201:CD40 Ligand / Q000097:blood*; D018450:Disease Progression; D004359:Drug Therapy, Combination; D004815:Epidermal Growth Factor / Q000097:blood*; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D011859:Radiography; D012720:Severity of Illness Index
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D015415:Biomarkers; D023201:CD40 Ligand; D004815:Epidermal Growth Factor; C529000:golimumab; D008727:Methotrexate
keywords: BIOMARKERS; GOLIMUMAB; METHOTREXATE; RADIOGRAPHIC PROGRESSION; RHEUMATOID ARTHRITIS; TUMOR NECROSIS FACTOR