Effect of golimumab on carotid atherosclerotic disease measures and cardiovascular events in inflammatory arthritides

Mary Chester Wasko, Elizabeth C. Hsia, Bruce Kirkham, Pierre Jean Touboul, Roy Fleischmann, Mark C. Genovese, Eric Lawrence Matteson, Jiandong Lu, Weichun Xu, Mahboob U. Rahman

Research output: Contribution to journalArticle

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Abstract

OBJECTIVE: The objective of this study was to assess the effect of golimumab on carotid ultrasound measures and cardiovascular serious adverse events (SAEs) in patients with inflammatory arthritides. METHODS: An exploratory carotid artery ultrasound substudy was performed in the GO-BEFORE study of methotrexate (MTX)-naive rheumatoid arthritis patients, with ultrasounds performed at weeks 0, 24, and 52 to measure common carotid artery intima-media thickness, distensibility coefficient, interadventitial diameter, and plaque count. Cardiovascular SAEs reported over 2 years of follow-up were assessed in 5 golimumab phase 3 clinical trials of patients with rheumatoid arthritis (GO-BEFORE, GO-FORWARD, and GO-AFTER), psoriatic arthritis (GO-REVEAL), and ankylosing spondylitis (GO-RAISE). In GO-BEFORE and GO-FORWARD, patients received placebo + MTX, golimumab 50 mg + MTX, or golimumab 100 mg +/-MTX at baseline and every 4 weeks; in the other 3 trials, patients received placebo or golimumab 50 or 100 mg. RESULTS: The carotid ultrasound substudy showed inconsistent changes in common carotid artery intima-media thickness in the golimumab + MTX groups over time, and there was large variability in the measurements. Increases in interadventitial diameter were observed in the golimumab 100 mg + placebo group, but not in the golimumab + MTX groups. There were no significant differences in the distensibility coefficient and plaque count between the golimumab and placebo groups. Very few patients overall experienced a cardiovascular SAE, and the incidence of cardiovascular SAEs was not statistically different between the golimumab and placebo groups. CONCLUSIONS: The results of the carotid ultrasound substudy were inconclusive, and no increase or decrease in cardiovascular SAEs was observed following 2 years of treatment with golimumab with or without MTX.

Original languageEnglish (US)
Pages (from-to)1-10
Number of pages10
JournalJournal of Clinical Rheumatology
Volume20
Issue number1
DOIs
StatePublished - 2014

Fingerprint

Carotid Artery Diseases
Arthritis
Methotrexate
Placebos
Carotid Intima-Media Thickness
Common Carotid Artery
Rheumatoid Arthritis
golimumab
Phase III Clinical Trials
Psoriatic Arthritis
Ankylosing Spondylitis
Carotid Arteries

Keywords

  • Biological therapies
  • Cardiovascular
  • Rheumatoid arthritis
  • Spondyloarthropathies
  • Ultrasonography

ASJC Scopus subject areas

  • Rheumatology

Cite this

Wasko, M. C., Hsia, E. C., Kirkham, B., Touboul, P. J., Fleischmann, R., Genovese, M. C., ... Rahman, M. U. (2014). Effect of golimumab on carotid atherosclerotic disease measures and cardiovascular events in inflammatory arthritides. Journal of Clinical Rheumatology, 20(1), 1-10. https://doi.org/10.1097/RHU.0000000000000053

Effect of golimumab on carotid atherosclerotic disease measures and cardiovascular events in inflammatory arthritides. / Wasko, Mary Chester; Hsia, Elizabeth C.; Kirkham, Bruce; Touboul, Pierre Jean; Fleischmann, Roy; Genovese, Mark C.; Matteson, Eric Lawrence; Lu, Jiandong; Xu, Weichun; Rahman, Mahboob U.

In: Journal of Clinical Rheumatology, Vol. 20, No. 1, 2014, p. 1-10.

Research output: Contribution to journalArticle

Wasko, MC, Hsia, EC, Kirkham, B, Touboul, PJ, Fleischmann, R, Genovese, MC, Matteson, EL, Lu, J, Xu, W & Rahman, MU 2014, 'Effect of golimumab on carotid atherosclerotic disease measures and cardiovascular events in inflammatory arthritides', Journal of Clinical Rheumatology, vol. 20, no. 1, pp. 1-10. https://doi.org/10.1097/RHU.0000000000000053
Wasko, Mary Chester ; Hsia, Elizabeth C. ; Kirkham, Bruce ; Touboul, Pierre Jean ; Fleischmann, Roy ; Genovese, Mark C. ; Matteson, Eric Lawrence ; Lu, Jiandong ; Xu, Weichun ; Rahman, Mahboob U. / Effect of golimumab on carotid atherosclerotic disease measures and cardiovascular events in inflammatory arthritides. In: Journal of Clinical Rheumatology. 2014 ; Vol. 20, No. 1. pp. 1-10.
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abstract = "OBJECTIVE: The objective of this study was to assess the effect of golimumab on carotid ultrasound measures and cardiovascular serious adverse events (SAEs) in patients with inflammatory arthritides. METHODS: An exploratory carotid artery ultrasound substudy was performed in the GO-BEFORE study of methotrexate (MTX)-naive rheumatoid arthritis patients, with ultrasounds performed at weeks 0, 24, and 52 to measure common carotid artery intima-media thickness, distensibility coefficient, interadventitial diameter, and plaque count. Cardiovascular SAEs reported over 2 years of follow-up were assessed in 5 golimumab phase 3 clinical trials of patients with rheumatoid arthritis (GO-BEFORE, GO-FORWARD, and GO-AFTER), psoriatic arthritis (GO-REVEAL), and ankylosing spondylitis (GO-RAISE). In GO-BEFORE and GO-FORWARD, patients received placebo + MTX, golimumab 50 mg + MTX, or golimumab 100 mg +/-MTX at baseline and every 4 weeks; in the other 3 trials, patients received placebo or golimumab 50 or 100 mg. RESULTS: The carotid ultrasound substudy showed inconsistent changes in common carotid artery intima-media thickness in the golimumab + MTX groups over time, and there was large variability in the measurements. Increases in interadventitial diameter were observed in the golimumab 100 mg + placebo group, but not in the golimumab + MTX groups. There were no significant differences in the distensibility coefficient and plaque count between the golimumab and placebo groups. Very few patients overall experienced a cardiovascular SAE, and the incidence of cardiovascular SAEs was not statistically different between the golimumab and placebo groups. CONCLUSIONS: The results of the carotid ultrasound substudy were inconclusive, and no increase or decrease in cardiovascular SAEs was observed following 2 years of treatment with golimumab with or without MTX.",
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AB - OBJECTIVE: The objective of this study was to assess the effect of golimumab on carotid ultrasound measures and cardiovascular serious adverse events (SAEs) in patients with inflammatory arthritides. METHODS: An exploratory carotid artery ultrasound substudy was performed in the GO-BEFORE study of methotrexate (MTX)-naive rheumatoid arthritis patients, with ultrasounds performed at weeks 0, 24, and 52 to measure common carotid artery intima-media thickness, distensibility coefficient, interadventitial diameter, and plaque count. Cardiovascular SAEs reported over 2 years of follow-up were assessed in 5 golimumab phase 3 clinical trials of patients with rheumatoid arthritis (GO-BEFORE, GO-FORWARD, and GO-AFTER), psoriatic arthritis (GO-REVEAL), and ankylosing spondylitis (GO-RAISE). In GO-BEFORE and GO-FORWARD, patients received placebo + MTX, golimumab 50 mg + MTX, or golimumab 100 mg +/-MTX at baseline and every 4 weeks; in the other 3 trials, patients received placebo or golimumab 50 or 100 mg. RESULTS: The carotid ultrasound substudy showed inconsistent changes in common carotid artery intima-media thickness in the golimumab + MTX groups over time, and there was large variability in the measurements. Increases in interadventitial diameter were observed in the golimumab 100 mg + placebo group, but not in the golimumab + MTX groups. There were no significant differences in the distensibility coefficient and plaque count between the golimumab and placebo groups. Very few patients overall experienced a cardiovascular SAE, and the incidence of cardiovascular SAEs was not statistically different between the golimumab and placebo groups. CONCLUSIONS: The results of the carotid ultrasound substudy were inconclusive, and no increase or decrease in cardiovascular SAEs was observed following 2 years of treatment with golimumab with or without MTX.

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