title: Effects of golimumab, an anti-tumour necrosis factor-α human monoclonal antibody, on lipids and markers of inflammation.
abstract: OBJECTIVE
  To assess the effect of golimumab, with or without methotrexate (MTX), on serum lipids and inflammatory markers of cardiovascular disease (CVD) in patients with rheumatoid arthritis (RA) in two phase 3, randomised, placebo-controlled trials (GO-BEFORE and GO-FORWARD).
  
  
  METHODS
  Patients in GO-BEFORE (n=637, MTX-naïve) and GO-FORWARD (n=444, MTX-inadequate response) were randomised to placebo+MTX, golimumab 100 mg+placebo, golimumab 50 mg+MTX, or golimumab 100 mg+MTX. Subcutaneous injections (placebo and golimumab) were given every 4 weeks. Patients with an insufficient response entered early escape at week 16 (GO-FORWARD) or 28 (GO-BEFORE). All placebo+MTX patients in GO-FORWARD crossed over to golimumab 50 mg+MTX at week 24. Changes from baseline to weeks 14 (GO-FORWARD) or 24 (GO-BEFORE), and 52 in serum lipid levels and inflammatory markers were assessed.
  
  
  RESULTS
  At week 14 in the GO-FORWARD trial, total cholesterol (TC), high-density lipoprotein (HDL) and low-density lipoprotein (LDL) increased in golimumab+MTX patients versus MTX-only patients (16.00 vs 2.00 (p<0.001); 3.00 vs 0.00 (p<0.05); 8.00 vs 4.00 (p<0.001); respectively); favourable changes in LDL subfractions were only observed in golimumab-treated patients. At week 24 in GO-BEFORE, TC and LDL increased, and LDL subfractions improved in the MTX-only and golimumab+MTX groups. Inflammatory markers of CVD risk improved significantly with golimumab+MTX versus placebo+MTX in both studies and were generally maintained through week 52. Atherogenic indices were generally stable.
  
  
  CONCLUSIONS
  While TC and LDL levels increased mildly in RA patients receiving golimumab+MTX, atherogenic indices generally remained stable, favourable changes in LDL subfractions were observed, and inflammatory markers improved.
authors.affiliation: Rheumatology Department, Guy's and St Thomas' NHS Foundation Trust, , London, UK.
authors.forename: Bruce W
authors.initials: BW
authors.lastname: Kirkham
authors.forename: Mary Chester
authors.initials: MC
authors.lastname: Wasko
authors.forename: Elizabeth C
authors.initials: EC
authors.lastname: Hsia
authors.forename: Roy M
authors.initials: RM
authors.lastname: Fleischmann
authors.forename: Mark C
authors.initials: MC
authors.lastname: Genovese
authors.forename: Eric L
authors.initials: EL
authors.lastname: Matteson
authors.forename: Hongjuan
authors.initials: H
authors.lastname: Liu
authors.forename: Mahboob U
authors.initials: MU
authors.lastname: Rahman
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000276:immunology*; D015415:Biomarkers / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008055:Lipids / Q000097:blood; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D010919:Placebos; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D015415:Biomarkers; D008055:Lipids; D010919:Placebos; D014409:Tumor Necrosis Factor-alpha; C529000:golimumab; D008727:Methotrexate
keywords: Anti-TNF; Cardiovascular Disease; Lipids