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 L. Matteson; Jiandong Lu; Weichun Xu; Mahboob U. Rahman

doi:10.1097/RHU.0000000000000053

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 L. Matteson, Jiandong Lu, Weichun Xu, Mahboob U. Rahman

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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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 language	English
Pages (from-to)	1-10
Number of pages	10
Journal	JOURNAL OF CLINICAL RHEUMATOLOGY
Volume	20
Issue number	1
DOIs	https://doi.org/10.1097/RHU.0000000000000053
Publication status	Published - Jan 2014

Keywords

rheumatoid arthritis
spondyloarthropathies
cardiovascular
ultrasonography
biological therapies
NECROSIS-FACTOR-ALPHA
INTIMA-MEDIA THICKNESS
ACTIVE RHEUMATOID-ARTHRITIS
EVERY 4 WEEKS
MYOCARDIAL-INFARCTION
DOUBLE-BLIND
RISK-FACTORS
PHASE-III
TRIAL
METHOTREXATE

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1097/RHU.0000000000000053

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@article{7490e597decb4afe9e5c2e673f91a9a1,

title = "Effect of Golimumab on Carotid Atherosclerotic Disease Measures and Cardiovascular Events in Inflammatory Arthritides",

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.",

keywords = "rheumatoid arthritis, spondyloarthropathies, cardiovascular, ultrasonography, biological therapies, NECROSIS-FACTOR-ALPHA, INTIMA-MEDIA THICKNESS, ACTIVE RHEUMATOID-ARTHRITIS, EVERY 4 WEEKS, MYOCARDIAL-INFARCTION, DOUBLE-BLIND, RISK-FACTORS, PHASE-III, TRIAL, METHOTREXATE",

author = "Wasko, {Mary Chester} and Hsia, {Elizabeth C.} and Bruce Kirkham and Pierre-Jean Touboul and Roy Fleischmann and Genovese, {Mark C.} and Matteson, {Eric L.} and Jiandong Lu and Weichun Xu and Rahman, {Mahboob U.}",

year = "2014",

month = jan,

doi = "10.1097/RHU.0000000000000053",

language = "English",

volume = "20",

pages = "1--10",

journal = "JOURNAL OF CLINICAL RHEUMATOLOGY",

issn = "1076-1608",

publisher = "Lippincott Williams and Wilkins",

number = "1",

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TY - JOUR

T1 - Effect of Golimumab on Carotid Atherosclerotic Disease Measures and Cardiovascular Events in Inflammatory Arthritides

AU - Wasko, Mary Chester

AU - Hsia, Elizabeth C.

AU - Kirkham, Bruce

AU - Touboul, Pierre-Jean

AU - Fleischmann, Roy

AU - Genovese, Mark C.

AU - Matteson, Eric L.

AU - Lu, Jiandong

AU - Xu, Weichun

AU - Rahman, Mahboob U.

PY - 2014/1

Y1 - 2014/1

N2 - 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.

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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KW - spondyloarthropathies

KW - cardiovascular

KW - ultrasonography

KW - biological therapies

KW - NECROSIS-FACTOR-ALPHA

KW - INTIMA-MEDIA THICKNESS

KW - ACTIVE RHEUMATOID-ARTHRITIS

KW - EVERY 4 WEEKS

KW - MYOCARDIAL-INFARCTION

KW - DOUBLE-BLIND

KW - RISK-FACTORS

KW - PHASE-III

KW - TRIAL

KW - METHOTREXATE

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DO - 10.1097/RHU.0000000000000053

M3 - Article

SN - 1076-1608

VL - 20

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JO - JOURNAL OF CLINICAL RHEUMATOLOGY

JF - JOURNAL OF CLINICAL RHEUMATOLOGY

IS - 1

ER -

Effect of Golimumab on Carotid Atherosclerotic Disease Measures and Cardiovascular Events in Inflammatory Arthritides

Abstract

Keywords

UN SDGs

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