A Phase 4 interventional study of Guselkumab in Psoriasis, sponsored by Janssen-Cilag Ltd.. Terminated at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by Janssen-Cilag Ltd. · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate the effect of guselkumab on coronary flow reserve (CFR), measured by transthoracic doppler-echocardiography, in participants with moderate-to-severe psoriasis and intermediate cardiovascular risk.
Psoriasis is a common chronic inflammatory disease that affects 2 percent (%)-3% of the population and has an impact on physical and emotional health-related quality-of-life that is comparable to major illnesses such as cancer, heart disease and depression. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody that binds to the p19 protein subunit of human interleukin 23 (IL-23) with high specificity and affinity. Binding of guselkumab to the IL-23 p19 subunit blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23 specific intracellular signaling and subsequent cytokine production. Guselkumab is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy. This study aims to investigate the efficacy of guselkumab in reducing surrogate parameters of vascular dysfunction and cardiovascular risk. This study will consist of two Screening Visits (Screening Visit S1 at a maximum of 2 weeks prior to Screening Visit S2, to occur at a minimum of 2 weeks and maximum of 4 weeks prior to Week 0), a Treatment Phase (up to 28 weeks), Final Efficacy Visit 4 weeks later (Week 32), and Final Safety Visit (Week 40). The efficacy assessments will be done locally at the sites and safety will be monitored by assessment of adverse events, clinical laboratory tests, physical examinations, vital signs, and concomitant medication review. The total duration of the study will be 40 weeks.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 15 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Janssen-Cilag Ltd. is the lead sponsor of 35 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive guselkumab 100 milligrams (mg) by subcutaneous injection at Weeks 0, 4, 12, 20 and 28.
Drug: Guselkumab
Guselkumab will be administered by subcutaneous injection.
Change From Baseline in Coronary Flow Reserve (CFR) at Week 32
Change from baseline in CFR at Week 32 were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 micrograms per kilogram per minute (mcg/kg/min; coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest.
Time frame: Baseline (Week 0) and Week 32
Change From Baseline in CFR at Week 16
Change from baseline in CFR at Week 16 were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest.
Time frame: Baseline (Week 0) and Week 16
Change From Baseline in Absolute Global Longitudinal Strain (GLS) at Week 16
Change from baseline in absolute GLS at Week 16 were reported. GLS is a myocardial deformation analysis that predominantly reflects the function of sub-endocardial longitudinally oriented fibers, which are most prone to ischemic damage and wall stress. The GLS is calculated at systole and diastole. Speckle tracking echocardiography (STE) were employed for the detection of left-ventricular (LV) myocardial strain. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values.
Time frame: Baseline (Week 0) and Week 16
Change From Baseline in Absolute GLS at Week 32
Change from baseline in absolute GLS is a myocardial deformation analysis that predominantly reflects the function of sub-endocardial longitudinally oriented fibers, which are most prone to ischemic damage and wall stress. The GLS is calculated at systole and diastole. Speckle tracking echocardiography (STE) were employed for the detection of left-ventricular (LV) myocardial strain. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values.
Time frame: Baseline (Week 0) and Week 32
Change From Baseline in Carotid-femoral Pulse Wave Velocity (cfPWV) at Week 16
Change from baseline in cfPWV at Week 16 were reported. cfPWV is a direct measurement, and the most simple, non-invasive, robust, and reproducible method to determine arterial stiffness. cfPWV was determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. cfPWV was calculated as cfPWV = distance (meters) / transit time (seconds).
Time frame: Baseline (Week 0) and Week 16
Change From Baseline in cfPWV at Week 32
Change from baseline in cfPWV at Week 32 were reported. cfPWV is a direct measurement, and the most simple, non-invasive, robust, and reproducible method to determine arterial stiffness. cfPWV was determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. cfPWV was calculated as cfPWV = distance (meters) / transit time (seconds).
Time frame: Baseline (Week 0) and Week 32
Change From Baseline in CFR at Week 16 Among Participants With CFR >=2 to Less Than (<) 2.75 at Baseline
Change from baseline in CFR at Week 16 among participants with CFR \>=2 to \<2.75 at baseline were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest
Time frame: Baseline (Week 0) and Week 16
Change From Baseline in CFR at Week 32 Among Participants With CFR >=2 to <2.75 at Baseline
Change from baseline in CFR at Week 32 among participants with CFR \>=2 to \<2.75 at baseline were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest
Time frame: Baseline (Week 0) and Week 32
Change From Baseline in CFR at Week 16 Among Participants With CFR >=2.75 to <=3.5 at Baseline
Change from baseline in CFR at Week 16 among participants with CFR \>=2.75 to \<=3.5 at baseline were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest
Time frame: Baseline (Week 0) and Week 16
Change From Baseline in CFR at Week 32 Among Participants With CFR >=2.75 to <=3.5 at Baseline
Change from baseline in CFR at Week 32 among participants with CFR \>=2.75 to \<=3.5 at baseline were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest
Time frame: Baseline (Week 0) and Week 32
Change From Baseline in CFR Among Nicotine Users and Non-nicotine Users at Weeks 16
Change from baseline in CFR among nicotine users and non-users at Week 16 were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest
Time frame: Baseline (Week 0) and Week 16
Change From Baseline in CFR Among Nicotine Users and Non-nicotine Users at Weeks 32
Change from baseline in CFR among nicotine users and non-nicotine users at Weeks 32 were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest
Time frame: Baseline (Week 0) and Week 32
Change From Baseline in Absolute GLS Among Nicotine Users and Non-users at Week 16
Change from baseline in absolute GLS among nicotine users and non-nicotine users at Week 16 were reported. GLS is a myocardial deformation analysis that predominantly reflects the function of sub-endocardial longitudinally oriented fibers, which are most prone to ischemic damage and wall stress. The GLS is calculated at systole and diastole. Speckle tracking echocardiography (STE) were employed for the detection of left-ventricular (LV) myocardial strain. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values.
Time frame: Baseline (Week 0) and Week 16
Change From Baseline in Absolute GLS Among Nicotine Users and Non-users at Week 32
Change from baseline in absolute GLS among nicotine users and non-nicotine users at Week 32 were reported. GLS is a myocardial deformation analysis that predominantly reflects the function of sub-endocardial longitudinally oriented fibers, which are most prone to ischemic damage and wall stress. The GLS is calculated at systole and diastole. Speckle tracking echocardiography (STE) were employed for the detection of left-ventricular (LV) myocardial strain. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values.
Time frame: Baseline (Week 0) and Week 32
Change From Baseline in cfPWV Among Nicotine Users and Non-users at Week 16
Change from baseline in cfPWV among nicotine users and non-nicotine users at Week 16 were reported. cfPWV is a direct measurement, and the most simple, non-invasive, robust, and reproducible method to determine arterial stiffness. cfPWV was determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. cfPWV was calculated as cfPWV= distance (meters)/ transit time (seconds).
Time frame: Baseline (Week 0) and Week 16
Change From Baseline in cfPWV Among Nicotine Users and Non-users at Week 32
Change from baseline in cfPWV among nicotine users and non-nicotine users at Week 32 were reported. cfPWV is a direct measurement, and the most simple, non-invasive, robust, and reproducible method to determine arterial stiffness. cfPWV was determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. cfPWV was calculated as cfPWV= distance (meters)/ transit time (seconds).
Time frame: Baseline (Week 0) and Week 32
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Number of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after initial administration study intervention (guselkumab) through the day of last dose within the study phase plus 12 weeks or the date of the Final Safety visit, whichever was the latest, was considered to be TEAE.
Time frame: Week 0 up to 12 weeks post last dose of study drug (up to Week 40)
A total of 15 adult participants diagnosed with moderate-to-severe plaque psoriasis (with or without psoriatic arthritis) for at least 6 months prior to the first dose of guselkumab at Week 0 (baseline) of the study entry were enrolled and treated with at least one dose of guselkumab.
| Milestone | Guselkumab 100 mg: Nicotine Users | Guselkumab 100 mg: Non-Nicotine Users |
|---|---|---|
| Started | 7 | 8 |
| Participants with intermediate cardiovascular risk (icr) | 3 | 5 |
| Completed | 5 | 3 |
| Not completed | 2 | 5 |
| Withdrew: Study terminated by sponsor | 2 | 5 |
Change from baseline in CFR at Week 32 were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 micrograms per kilogram per minute (mcg/kg/min; coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest.
| ratio | Guselkumab 100 mg: Nicotine Users | Guselkumab 100 mg: Non-Nicotine Users |
|---|---|---|
| Change From Baseline in Coronary Flow Reserve (CFR) at Week 32 | -0.080 ± 0.2773 | 0.173 ± 0.6478 |
Change from baseline in CFR at Week 16 were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest.
| ratio | Guselkumab 100 mg: Nicotine Users | Guselkumab 100 mg: Non-Nicotine Users |
|---|---|---|
| Change From Baseline in CFR at Week 16 | 0.113 ± 0.3099 | 0.435 ± 0.2899 |
Change from baseline in absolute GLS at Week 16 were reported. GLS is a myocardial deformation analysis that predominantly reflects the function of sub-endocardial longitudinally oriented fibers, which are most prone to ischemic damage and wall stress. The GLS is calculated at systole and diastole. Speckle tracking echocardiography (STE) were employed for the detection of left-ventricular (LV) myocardial strain. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values.
| percentage of myocardial shortening | Guselkumab 100 mg: Nicotine Users | Guselkumab 100 mg: Non-Nicotine Users |
|---|---|---|
| Change From Baseline in Absolute Global Longitudinal Strain (GLS) at Week 16 | -1.377 ± 0.9660 | -2.625 ± 0.9829 |
Change from baseline in absolute GLS is a myocardial deformation analysis that predominantly reflects the function of sub-endocardial longitudinally oriented fibers, which are most prone to ischemic damage and wall stress. The GLS is calculated at systole and diastole. Speckle tracking echocardiography (STE) were employed for the detection of left-ventricular (LV) myocardial strain. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values.
| percentage of myocardial shortening | Guselkumab 100 mg: Nicotine Users | Guselkumab 100 mg: Non-Nicotine Users |
|---|---|---|
| Change From Baseline in Absolute GLS at Week 32 | 0.850 ± 0.6065 | -3.063 ± 3.0593 |
Change from baseline in cfPWV at Week 16 were reported. cfPWV is a direct measurement, and the most simple, non-invasive, robust, and reproducible method to determine arterial stiffness. cfPWV was determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. cfPWV was calculated as cfPWV = distance (meters) / transit time (seconds).
| meter per second (m/s) | Guselkumab 100 mg: Nicotine Users | Guselkumab 100 mg: Non-Nicotine Users |
|---|---|---|
| Change From Baseline in Carotid-femoral Pulse Wave Velocity (cfPWV) at Week 16 | 0.77 ± 0.503 | -0.35 ± 0.495 |
Change from baseline in cfPWV at Week 32 were reported. cfPWV is a direct measurement, and the most simple, non-invasive, robust, and reproducible method to determine arterial stiffness. cfPWV was determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. cfPWV was calculated as cfPWV = distance (meters) / transit time (seconds).
| meter per second (m/s) | Guselkumab 100 mg: Nicotine Users | Guselkumab 100 mg: Non-Nicotine Users |
|---|---|---|
| Change From Baseline in cfPWV at Week 32 | 1.37 ± 1.332 | -1.00 ± 0.283 |
Change from baseline in CFR at Week 16 among participants with CFR \>=2 to \<2.75 at baseline were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest
| ratio | Guselkumab 100 mg: Nicotine Users | Guselkumab 100 mg: Non-Nicotine Users |
|---|---|---|
| Change From Baseline in CFR at Week 16 Among Participants With CFR >=2 to Less Than (<) 2.75 at Baseline | — | 0.435 ± 0.2899 |
Change from baseline in CFR at Week 32 among participants with CFR \>=2 to \<2.75 at baseline were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest
| ratio | Guselkumab 100 mg: Nicotine Users | Guselkumab 100 mg: Non-Nicotine Users |
|---|---|---|
| Change From Baseline in CFR at Week 32 Among Participants With CFR >=2 to <2.75 at Baseline | — | 0.173 ± 0.6478 |
Change from baseline in CFR at Week 16 among participants with CFR \>=2.75 to \<=3.5 at baseline were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest
| ratio | Guselkumab 100 mg: Nicotine Users | Guselkumab 100 mg: Non-Nicotine Users |
|---|---|---|
| Change From Baseline in CFR at Week 16 Among Participants With CFR >=2.75 to <=3.5 at Baseline | 0.113 ± 0.3099 | — |
Change from baseline in CFR at Week 32 among participants with CFR \>=2.75 to \<=3.5 at baseline were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest
| ratio | Guselkumab 100 mg: Nicotine Users | Guselkumab 100 mg: Non-Nicotine Users |
|---|---|---|
| Change From Baseline in CFR at Week 32 Among Participants With CFR >=2.75 to <=3.5 at Baseline | -0.080 ± 0.2773 | — |
Change from baseline in CFR among nicotine users and non-users at Week 16 were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest
| ratio | Guselkumab 100 mg (Nicotine Users) | Guselkumab 100 mg (Non-Nicotine Users) |
|---|---|---|
| Change From Baseline in CFR Among Nicotine Users and Non-nicotine Users at Weeks 16 | 0.024 ± 0.6124 | 0.132 ± 0.7874 |
Change from baseline in CFR among nicotine users and non-nicotine users at Weeks 32 were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest
| ratio | Guselkumab 100 mg (Nicotine Users) | Guselkumab 100 mg (Non-Nicotine Users) |
|---|---|---|
| Change From Baseline in CFR Among Nicotine Users and Non-nicotine Users at Weeks 32 | 0.487 ± 1.1418 | -0.253 ± 0.7173 |
Change from baseline in absolute GLS among nicotine users and non-nicotine users at Week 16 were reported. GLS is a myocardial deformation analysis that predominantly reflects the function of sub-endocardial longitudinally oriented fibers, which are most prone to ischemic damage and wall stress. The GLS is calculated at systole and diastole. Speckle tracking echocardiography (STE) were employed for the detection of left-ventricular (LV) myocardial strain. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values.
| percentage of myocardial shortening | Guselkumab 100 mg (Nicotine Users) | Guselkumab 100 mg (Non-Nicotine Users) |
|---|---|---|
| Change From Baseline in Absolute GLS Among Nicotine Users and Non-users at Week 16 | -1.496 ± 0.8452 | -0.780 ± 2.3553 |
Change from baseline in absolute GLS among nicotine users and non-nicotine users at Week 32 were reported. GLS is a myocardial deformation analysis that predominantly reflects the function of sub-endocardial longitudinally oriented fibers, which are most prone to ischemic damage and wall stress. The GLS is calculated at systole and diastole. Speckle tracking echocardiography (STE) were employed for the detection of left-ventricular (LV) myocardial strain. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values.
| percentage of myocardial shortening | Guselkumab 100 mg (Nicotine Users) | Guselkumab 100 mg (Non-Nicotine Users) |
|---|---|---|
| Change From Baseline in Absolute GLS Among Nicotine Users and Non-users at Week 32 | -0.060 ± 2.2065 | -2.490 ± 2.3020 |
Change from baseline in cfPWV among nicotine users and non-nicotine users at Week 16 were reported. cfPWV is a direct measurement, and the most simple, non-invasive, robust, and reproducible method to determine arterial stiffness. cfPWV was determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. cfPWV was calculated as cfPWV= distance (meters)/ transit time (seconds).
| meter per second (m/s) | Guselkumab 100 mg (Nicotine Users) | Guselkumab 100 mg (Non-Nicotine Users) |
|---|---|---|
| Change From Baseline in cfPWV Among Nicotine Users and Non-users at Week 16 | 0.34 ± 0.716 | -0.38 ± 0.330 |
Change from baseline in cfPWV among nicotine users and non-nicotine users at Week 32 were reported. cfPWV is a direct measurement, and the most simple, non-invasive, robust, and reproducible method to determine arterial stiffness. cfPWV was determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. cfPWV was calculated as cfPWV= distance (meters)/ transit time (seconds).
| meter per second (m/s) | Guselkumab 100 mg (Nicotine Users) | Guselkumab 100 mg (Non-Nicotine Users) |
|---|---|---|
| Change From Baseline in cfPWV Among Nicotine Users and Non-users at Week 32 | 0.84 ± 1.191 | -0.80 ± 0.791 |
Number of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after initial administration study intervention (guselkumab) through the day of last dose within the study phase plus 12 weeks or the date of the Final Safety visit, whichever was the latest, was considered to be TEAE.
| Participants | Guselkumab 100 mg: Nicotine Users | Guselkumab 100 mg: Non-Nicotine Users |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 1 | 2 |
Collected over Week 0 up to 12 weeks post last dose of study drug (up to Week 40). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Guselkumab 100 mg: Nicotine Users | 0/7 (0%) | 0/7 (0%) | 1/7 (14.3%) |
| Guselkumab 100 mg: Non-Nicotine Users | 0/8 (0%) | 1/8 (12.5%) | 2/8 (25%) |
| Event | Guselkumab 100 mg: Nicotine Users | Guselkumab 100 mg: Non-Nicotine Users |
|---|---|---|
| Ligament RuptureInjury, poisoning and procedural complications | 0/7 | 1/8 |
| Event | Guselkumab 100 mg: Nicotine Users | Guselkumab 100 mg: Non-Nicotine Users |
|---|---|---|
| PruritusSkin and subcutaneous tissue disorders | 1/7 | 0/8 |
| Atrial FibrillationCardiac disorders | 0/7 | 1/8 |
| Ligament RuptureInjury, poisoning and procedural complications | 0/7 | 1/8 |
| Age, Continuous(years) | Guselkumab 100 mg: Nicotine Users | Guselkumab 100 mg: Non-Nicotine Users | Total |
|---|---|---|---|
| Mean | 49.9 ± 14.09 | 39.1 ± 12.8 | 44.1 ± 14.06 |
| Age, Customized(Participants) | Guselkumab 100 mg: Nicotine Users | Guselkumab 100 mg: Non-Nicotine Users | Total |
|---|---|---|---|
| Children (2-11 years) | 0 | 0 | 0 |
| Adolescents (12-17 years) | 0 | 0 | 0 |
| Adults (18-64 years) | 6 | 8 | 14 |
| From 65 to 84 years | 1 | 0 | 1 |
| 85 years and over | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Guselkumab 100 mg: Nicotine Users | Guselkumab 100 mg: Non-Nicotine Users | Total |
|---|---|---|---|
| Female | 0 | 5 | 5 |
| Male | 7 | 3 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Guselkumab 100 mg: Nicotine Users | Guselkumab 100 mg: Non-Nicotine Users | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 6 | 7 | 13 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Guselkumab 100 mg: Nicotine Users | Guselkumab 100 mg: Non-Nicotine Users | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 5 | 8 | 13 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical- trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu
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