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Clinical and epidemiological research
Extended report
Effects of golimumab, an anti-tumour necrosis factor-α human monoclonal antibody, on lipids and markers of inflammation
  1. Bruce W Kirkham1,
  2. Mary Chester Wasko2,3,
  3. Elizabeth C Hsia4,5,
  4. Roy M Fleischmann6,
  5. Mark C Genovese7,
  6. Eric L Matteson8,
  7. Hongjuan Liu3,
  8. Mahboob U Rahman3,4,9
  1. 1Rheumatology Department, Guy's and St Thomas’ NHS Foundation Trust, London, UK
  2. 2Temple University School of Medicine, West Penn Allegheny Health System, Pittsburgh, Pennsylvania, USA
  3. 3The Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, USA
  4. 4Janssen Research & Development, LLC, Malvern, Pennsylvania, USA
  5. 5University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA
  6. 6Department of Rheumatology, University of Texas, Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, Texas, USA
  7. 7Department of Rheumatology, Stanford University, Palo Alto, California, USA
  8. 8Mayo Clinic, Rochester, Minnesota, USA
  9. 9Pfizer, Inc., Collegeville, Pennsylvania, USA
  1. Correspondence to Bruce W Kirkham, Rheumatology Department, Guy's and St Thomas’ NHS Foundation Trust, London SE1 9RT, UK; bruce.kirkham{at}gstt.nhs.uk

Abstract

Objectives 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.

  • Anti-TNF
  • Cardiovascular Disease
  • Lipids

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

https://doi.org/10.1136/annrheumdis-2012-202089

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