Cardiovascular Diseases, Psoriasis
Conditions
Brief summary
The purpose of the VIP-A study is to determine the effect of apremilast on aortic vascular inflammation, cardiometabolic biomarkers and body composition in patients with moderate-severe psoriasis.
Detailed description
The primary objectives of this study are to determine the effect of apremilast on aortic vascular inflammation, cardiometabolic biomarkers and body composition in patients with moderate-severe psoriasis. Fluorodeoxyglucose (FDG) - positron emission tomography (PET)/computed tomography (CT) will be used to assess vascular inflammation, with multi-volumetric product, tissue-to-background ratio and total atherosclerotic burden, and body composition via volumetric quantification. This is a year-long, single arm, open label study.
Interventions
DRUGApremilast
Apremilast (brand name Otezla) is a medication for the treatment of certain types of psoriasis and psoriatic arthritis.
Sponsors
Celgene Corporation
National Heart, Lung, and Blood Institute (NHLBI)
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Imaging data files will be sent to the central core of the National Institutes of Health (NIH) Imaging Lab for measuring the standardized uptake values (SUVs). The NIH central PET/CT readers will be blinded to time point of scan via Digital Imaging and Communication in Medicine (DICOM) file editing applied by the University of Pennsylvania.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females 18 years of age and older. * Clinical diagnosis of psoriasis for at least 6 months as determined by medical history interview and confirmation of diagnosis through physical examination by Investigator. * Stable plaque psoriasis for at least 2 months before screening and at baseline (Week 0) as determined by medical history interview. * Moderate to severe psoriasis defined by ≥ 10 percent Body Surface Area (BSA) involvement at the baseline (Week 0) visit. * Psoriasis Area and Severity Index (PASI) score of ≥ 12 at the Baseline (Week 0) visit. * Participant is a candidate for systemic therapy and has active psoriasis despite prior treatment with topical agents. * Women are eligible to participate in the study if they meet one of the following criteria: * Females of childbearing potential (FCBP) must have a negative pregnancy test at screening and baseline. Women of childbearing potential must undergo periodic pregnancy testing during the study and agree to use at least one of the following methods of contraception throughout the study duration and for at least 28 days after taking the last dose of investigational product: * Oral contraceptives * Transdermal contraceptives * Injectable or implantable methods * Intrauterine devices * Vaginal ring * Vasectomized partner * Barrier methods (Male or female condom (latex condom or non-latex condom NOT made out of natural \[animal\] membrane \[for example, polyurethane\]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.); * Women who are postmenopausal (for at least one year), sterile, or hysterectomized; * Women who have undergone tubal ligation will be required to undergo periodic pregnancy testing during the duration of the study * Sexual abstinence, defined as total abstinence from sexual intercourse, is considered an adequate form of contraception. (Agreement to comply with sexual abstinence must be recorded in the source document). * Participants using oral or parenteral forms of contraceptives must have been using these methods for at least 90 days prior to baseline visit. * Men (including those who have had a vasectomy), who engage in activity in which conception is possible, are eligible to participate if they: * Use barrier contraception (male latex condom or non-latex condom NOT made out of natural \[animal\] membrane \[for example, polyurethane\]) while on investigational product and for at least 28 days after the last dose of investigational product. * Participant is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, laboratory profile and physical examination performed at screening.
Exclusion criteria
* Prior treatment with apremilast. * Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis. * Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis. * Cannot avoid topical prescription medications for psoriasis for at least 14 days prior to the baseline visit (week 0) and during the study, with the exception of hydrocortisone 2.5% for the face and intertriginous areas. * Cannot avoid ultraviolet B (UVB) phototherapy or Excimer laser for at least 14 days prior to the Baseline (Week 0) visit and during the study. * Cannot avoid psoralen-ultraviolet A (UVA) phototherapy for at least 30 days prior to the Baseline (Week 0) visit and during the study. * Use of systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis, during the study: * Systemic therapies must be discontinued at least 30 days prior to the Baseline (Week 0) visit except for biologics. * All biologics, except interleukin (IL)-12/IL-23 antagonists, must be discontinued for at least 90 days prior to Baseline (Week 0). * Any IL-12/IL-23 antagonist (e.g., ustekinumab, briakinumab) must be discontinued for at least 180 days prior to Baseline (Week 0). * Investigational agents must be discontinued at least 30 days or 5 half-lives (whichever is longer) prior to the Baseline (Week 0) visit. * Participant is ≥ 300lbs * Participant is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed. * Participant is taking a medication that interferes with metabolism of apremilast, including but not limited to rifampin, phenobarbital, carbamazepine, phenytoin * Poorly controlled medical condition, such as unstable ischemic heart disease, cerebrovascular accident or myocardial infarction within the prior 6 months, psychiatric disease requiring frequent hospitalization, and any other condition, which, in the opinion of the Investigator, would put the participant at risk by participation in the study. * Prior history of suicide attempt at any time in the participant's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years. * Uncontrolled hypertension, with measured systolic blood pressure \>180 mmHg or diastolic blood pressure \>95 mmHg * Participant has infection or risk factors for severe infections, for example * Positive serology or known history of HIV, hepatitis B or C, or other severe, recurrent, or persistent infections; * Excessive immunosuppression or other factors associated with it, including human immunodeficiency virus infection; * Active tuberculosis (TB) disease; * Any other significant infection requiring hospitalization or intravenous (IV) antibiotics in the 30 days prior to baseline; * Infection requiring treatment with oral or parenteral (other than IV) antibiotics within 14 days prior to baseline; * Participant has received vaccination with a live viral agent within 30 days prior to screening or will require a live vaccination during study participation including up to 30 days after the last dose of study drug. * Participant has history of hematological or solid malignancy other than successfully treated basal cell carcinoma, non-metastatic cutaneous squamous cell carcinoma or cervical intraepithelial neoplasia or carcinoma in situ of cervix with no evidence of recurrence within the previous 5 years. * Female participant who is pregnant or breast-feeding or considering becoming pregnant during the study. * Screening clinical laboratory analyses showing any of the following abnormal results: * White blood cell (WBC) count \<3.0 x 109/L. (Subject can be included if WBC count is \<3.0 x 109/L and absolute neutrophil count (ANC) is \>1000 cells / mm3.) * WBC count \> 15 x 109/L; * Hemoglobin (Hgb) \< 9.0 x 109/L; * Platelet count \< 100 x 109/L; * Serum creatinine \>1.5 mg/dL ; * Serum aspartate transaminase or alanine transaminase \>2.0 upper limits of normal * Recent history of substance abuse or psychiatric illness that could preclude compliance with the protocol. * History of substance abuse within 365 days of screening visit. * Alcohol use of more than 14 drinks per week within 14 days of the baseline visit * If subject is on cholesterol-lowering medication (e.g. statin), dose and form of medication must be stable for 90 days prior to week 0 and remain stable throughout the duration of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Acetone | After the completion of week 16 visit by all study participants. | Acetone is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: LDL-P | After the completion of week 16 visit by all study participants. | LDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: LDL-Z | After the completion of week 16 visit by all study participants. | LDL-Z is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: S-LDL-P | After the completion of week 16 visit by all study participants. | S-LDL-P is a marker of lipid function and metabolism. |
| Change in Total Vascular Inflammation of the Aorta as Measured by FDG-PET/CT Between Baseline and Week 16. | After the completion of week 16 visit by all study participants. | The primary analysis will consist of comparisons of total vascular inflammation of the aorta between week 16 and baseline using \[18F\]-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) / Computed Tomography (CT) (FDG-PET/CT). Tissue-to-background ratio (TBR) of the standardized uptake value (SUV) is used to assess the level of inflammation of the aorta relative to the venous blood pool (background reference). |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Ferritin | After the completion of week 16 visit by all study participants. | Ferritin is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: C Reactive Protein (CRP) | After the completion of week 16 visit by all study participants. | CRP is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Intercellular Adhesion Molecule (ICAM)-1 | After the completion of week 16 visit by all study participants. | ICAM-1 is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Serum Amyloid-A (SAA) | After the completion of week 16 visit by all study participants. | SAA is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Vascular Cell Adhesion Molecule (VCAM)-1 | After the completion of week 16 visit by all study participants. | VCAM-1 is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Interferon (IFN)-Gamma | After the completion of week 16 visit by all study participants. | IFN-gamma is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Interleukin (IL)-1b | After the completion of week 16 visit by all study participants. | IL-1b is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-10 | After the completion of week 16 visit by all study participants. | IL-10 is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-17A | After the completion of week 16 visit by all study participants. | IL-17A is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: L-LDL-P | After the completion of week 16 visit by all study participants. | L-LDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Very Large (VL)-LDL-P | After the completion of week 16 visit by all study participants. | VL-LDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-6 | After the completion of week 16 visit by all study participants. | IL-6 is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-8 | After the completion of week 16 visit by all study participants. | IL-8 is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-9 | After the completion of week 16 visit by all study participants. | IL-9 is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Monocyte Chemoattractant Protein (MCP)-1 | After the completion of week 16 visit by all study participants. | MCP-1 is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Tumor Necrosis Factor (TNF)-Alpha | After the completion of week 16 visit by all study participants. | TNF-alpha is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: IL2RA | After the completion of week 16 visit by all study participants. | IL2RA is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: GlycA | After the completion of week 16 visit by all study participants. | GlycA is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Cholesterol Efflux Capacity | After the completion of week 16 visit by all study participants. | Cholesterol Efflux Capacity is a marker of lipid function and metabolism. The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: \[(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)\]. Cholesterol efflux capacity is inversely correlated with incidence of cardiovascular events (i.e. higher cholesterol efflux capacity is better for patients). |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Triglyceride | After the completion of week 16 visit by all study participants. | Triglyceride is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Total Cholesterol | After the completion of week 16 visit by all study participants. | Total Cholesterol is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: High-density Lipoprotein (HDL) - Cholesterol (C) | After the completion of week 16 visit by all study participants. | HDL-C is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: HDL-Particle Number (P) | After the completion of week 16 visit by all study participants. | HDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: HDL-Particle Size (Z) | After the completion of week 16 visit by all study participants. | HDL-Z is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Small (S)-HDL-P | After the completion of week 16 visit by all study participants. | S-HDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Medium (M)-HDL-P | After the completion of week 16 visit by all study participants. | M-HDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Large and Medium (LM)-HDL-P | After the completion of week 16 visit by all study participants. | LM-HDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Large (L)-HDL-P | After the completion of week 16 visit by all study participants. | L-HDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Low-density Lipoprotein (LDL)-C | After the completion of week 16 visit by all study participants. | LDL-C is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Very Low-density Lipoprotein (VLDL)-P | After the completion of week 16 visit by all study participants. | VLDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: VLDL-Z | After the completion of week 16 visit by all study participants. | VLDL-Z is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: VLDL-Triglycerides (TG) | After the completion of week 16 visit by all study participants. | VLDL-TG is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: S-VLDL-P | After the completion of week 16 visit by all study participants. | S-VLDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: M-VLDL-P | After the completion of week 16 visit by all study participants. | M-VLDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: LM-VLDL-P | After the completion of week 16 visit by all study participants. | LM-VLDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: L-VLDL-P | After the completion of week 16 visit by all study participants. | L-VLDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Intermediate-density Lipoprotein (IDL)-P | After the completion of week 16 visit by all study participants. | IDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Apolipoprotein A1 (ApoA1) | After the completion of week 16 visit by all study participants. | ApoA1 is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Apolipoprotein B (ApoB) | After the completion of week 16 visit by all study participants. | ApoB is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: TRLTG | After the completion of week 16 visit by all study participants. | TRLTG is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: (Triglyceride-Rich Lipoprotein Cholesterol) TRLC | After the completion of week 16 visit by all study participants. | TRLC is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: (Triglyceride-Rich Lipoprotein) TRLP | After the completion of week 16 visit by all study participants. | TRLP is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: VS-TRLP | After the completion of week 16 visit by all study participants. | VS-TRLP is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: S-TRLP | After the completion of week 16 visit by all study participants. | S-TRLP is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: M-TRLP | After the completion of week 16 visit by all study participants. | M-TRLP is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: L-TRLP | After the completion of week 16 visit by all study participants. | L-TRLP is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: VL-TRLP | After the completion of week 16 visit by all study participants. | VL-TRLP is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Insulin | After the completion of week 16 visit by all study participants. | Insulin is a marker of glucose metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | After the completion of week 16 visit by all study participants. | HOMA-IR is a marker of glucose metabolism. HOMA-IR, a method used to quantify insulin resistance and beta-cell function, is expressed using fasting blood glucose and insulin levels. It is calculated using the formula (HOMA-IR = fasting glucose \[mg/dl\] \* fasting insulin \[mU/ml\]/405). |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Glucose | After the completion of week 16 visit by all study participants. | Glucose is a marker of metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Diabetes Risk Index (DRI) | After the completion of week 16 visit by all study participants. | DRI is a marker of glucose metabolism. DRI is a nuclear magnetic resonance spectroscopy (NMR)-derived multimarker score (values 1-100) that predicts a patient's risk of developing type 2 diabetes mellitus (T2D) independent of glycemic status. DRI derives its performance from the weighted addition of the Lipoprotein Insulin Resistance Index (LP-IR) scores with simultaneously-measured levels of branched-chain amino acids (BCAA). Higher scores indicate greater risk. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Lipoprotein Insulin Resistance Index (LP-IR) | After the completion of week 16 visit by all study participants. | LP-IR is a marker of glucose metabolism. LP-IR is a marker of insulin resistance, and as such the LP-IR score predicts a patient's likelihood of future development of type 2 diabetes. LP-IR is a multimarker index (values 0-100) based on the concentrations of particular lipoprotein subclasses. Greater score indicates higher likelihood of developing diabetes. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Leptin | After the completion of week 16 visit by all study participants. | Leptin is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Adiponectin | After the completion of week 16 visit by all study participants. | Adiponectin is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Fetuin A | After the completion of week 16 visit by all study participants. | Fetuin A is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Citrate | After the completion of week 16 visit by all study participants. | Citrate is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Valine | After the completion of week 16 visit by all study participants. | Valine is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Leucine | After the completion of week 16 visit by all study participants. | Leucine is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Isoleucine | After the completion of week 16 visit by all study participants. | Isoleucine is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Alanine | After the completion of week 16 visit by all study participants. | Alanine is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: BCAA | After the completion of week 16 visit by all study participants. | Branched-chain amino acids (BCAA) is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Ketone Bodies | After the completion of week 16 visit by all study participants. | Ketone Bodies are markers of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Beta Hydroxybutyrate | After the completion of week 16 visit by all study participants. | Beta Hydroxybutyrate is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Baseline and Week 16: Acetoacetic Acid | After the completion of week 16 visit by all study participants. | Acetoacetic Acid is a marker of adipose dysfunction and general metabolism. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Isoleucine | After the completion of week 52 visit by all study participants. | Isoleucine is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Alanine | After the completion of week 52 visit by all study participants. | Alanine is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): BCAA | After the completion of week 52 visit by all study participants. | BCAA is a marker of adipose dysfunction and general metabolism. |
| Changes in Body Composition as Measured by FDG-PET/CT Between Week 52 and and Earlier Time Points (Baseline and Week 16): Visceral Adipose Tissue | After the completion of week 52 visit by all study participants. | Secondary analysis will consist of comparisons of change in body composition between weeks 52, 16, and baseline. Visceral adipose tissue quantification using a single CT slice at the level of the umbilicus using computer-assisted tissue segmentation (Pescatori LC et al. Quantification of visceral adipose tissue by computed tomography and magnetic resonance imaging: reproducibility and accuracy. Radiol Bras. 2019 15(1):1-6.). The values represent the cross-sectional area of the tissue segmented on the CT slice (cm\^2); higher values indicate greater amount of visceral adipose tissue. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Beta Hydroxybutyrate | After the completion of week 52 visit by all study participants. | Beta Hydroxybutyrate is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Acetoacetic Acid | After the completion of week 52 visit by all study participants. | Acetoacetic Acid is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Acetone | After the completion of week 52 visit by all study participants. | Acetone is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Ketone Bodies | After the completion of week 52 visit by all study participants. | Ketone Bodies are markers of adipose dysfunction and general metabolism. |
| Changes in Body Composition as Measured by FDG-PET/CT Between Week 52 and and Earlier Time Points (Baseline and Week 16): Subcutaneous Adipose Tissue | After the completion of week 52 visit by all study participants. | Secondary analysis will consist of comparisons of change in body composition between weeks 52, 16, and baseline. Subcutaneous adipose tissue quantification using a single CT slice at the level of the umbilicus using computer-assisted tissue segmentation (Pescatori LC et al. Quantification of visceral adipose tissue by computed tomography and magnetic resonance imaging: reproducibility and accuracy. Radiol Bras. 2019 15(1):1-6.). The values represent the cross-sectional area of the tissue segmented on the CT slice (cm\^2); higher values indicate greater amount of subcutaneous adipose tissue. |
| Changes in Physician Reported Outcomes: Psoriasis Area and Severity Index (PASI) | Baseline, week 16, and week 52. | Secondary analysis will consist of comparisons of change in PASI scores. PASI is the most widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). |
| Changes in Physician Reported Outcomes: Physician Global Assessment (PGA) | Baseline, week 16, and week 52. | Secondary analysis will consist of comparisons of change in PGA scores. Physician Global Assessment (PGA) is calculated by averaging three subcomponent scores (induration, erythema, and scaling) that are graded from 0 (no involvement) to 5 (maximum involvement) that are averaged over all psoriatic lesions. Higher scores indicate greater disease burden. |
| Changes in Patient Reported Outcomes: Dermatology Life Quality Index (DLQI) | Baseline, week 16, and week 52. | Secondary analysis will consist of comparisons of change in DLQI scores. DLQI is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. The score ranges from 0 to 30; 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. |
| Changes in Patient Reported Outcomes: Pruritis by Visual Analog Scales (VAS) | Baseline, week 16, and week 52. | Secondary analysis will consist of comparisons of change in Pruritus VAS scores. A visual analogue scale for pruritus (itch), ranging from 0 (no itch) to 100 (worst imaginable itch). |
| Change in Vascular Inflammation of the Five Aortic Segments as Measured by FDG-PET/CT Between Week 52, 16, and Baseline. | After the completion of week 52 visit by all study participants. | Secondary analysis will consist of comparisons of vascular inflammation of the five aortic segments using TBR between week 52, 16, and baseline. |
| Change in Total Vascular Inflammation of the Aorta as Measured by FDG-PET/CT Between Week 52 and Earlier Time Points. | After the completion of week 52 visit by all study participants. | Secondary analysis will consist of comparisons of total vascular inflammation of the aorta using TBR between week 52, 16, and baseline. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Ferritin | After the completion of week 52 visit by all study participants. | Ferritin is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): CRP | After the completion of week 52 visit by all study participants. | CRP is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): ICAM-1 | After the completion of week 52 visit by all study participants. | ICAM-1 is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): SAA | After the completion of week 52 visit by all study participants. | SAA is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VCAM-1 | After the completion of week 52 visit by all study participants. | VCAM-1 is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IFN-gamma | After the completion of week 52 visit by all study participants. | IFN-gamma is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-1b | After the completion of week 52 visit by all study participants. | IL-1b is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-10 | After the completion of week 52 visit by all study participants. | IL-10 is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-17A | After the completion of week 52 visit by all study participants. | IL-17A is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-6 | After the completion of week 52 visit by all study participants. | IL-6 is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-8 | After the completion of week 52 visit by all study participants. | IL-8 is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-9 | After the completion of week 52 visit by all study participants. | IL-9 is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): MCP-1 | After the completion of week 52 visit by all study participants. | MCP-1 is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TNF-alpha | After the completion of week 52 visit by all study participants. | TNF-alpha is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL2RA | After the completion of week 52 visit by all study participants. | IL2RA is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): GlycA | After the completion of week 52 visit by all study participants. | GlycA is a marker of inflammation. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Cholesterol Efflux Capacity | After the completion of week 52 visit by all study participants. | Cholesterol Efflux Capacity is a marker of lipid function and metabolism. The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: \[(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)\]. Cholesterol efflux capacity is inversely correlated with incidence of cardiovascular events (i.e. higher cholesterol efflux capacity is better for patients). |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Triglyceride | After the completion of week 52 visit by all study participants. | Triglyceride is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Total Cholesterol | After the completion of week 52 visit by all study participants. | Total Cholesterol is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HDL-C | After the completion of week 52 visit by all study participants. | HDL-C is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HDL-P | After the completion of week 52 visit by all study participants. | HDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HDL-Z | After the completion of week 52 visit by all study participants. | HDL-Z is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-HDL-P | After the completion of week 52 visit by all study participants. | S-HDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): M-HDL-P | After the completion of week 52 visit by all study participants. | M-HDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LM-HDL-P | After the completion of week 52 visit by all study participants. | LM-HDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-HDL-P | After the completion of week 52 visit by all study participants. | L-HDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LDL-C | After the completion of week 52 visit by all study participants. | LDL-C is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LDL-P | After the completion of week 52 visit by all study participants. | LDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LDL-Z | After the completion of week 52 visit by all study participants. | LDL-Z is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-LDL-P | After the completion of week 52 visit by all study participants. | S-LDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-LDL-P | After the completion of week 52 visit by all study participants. | L-LDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VL-LDL-P | After the completion of week 52 visit by all study participants. | VL-LDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VLDL-P | After the completion of week 52 visit by all study participants. | VLDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VLDL-Z | After the completion of week 52 visit by all study participants. | VLDL-Z is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VLDL-TG | After the completion of week 52 visit by all study participants. | VLDL-TG is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-VLDL-P | After the completion of week 52 visit by all study participants. | S-VLDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): M-VLDL-P | After the completion of week 52 visit by all study participants. | M-VLDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LM-VLDL-P | After the completion of week 52 visit by all study participants. | LM-VLDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-VLDL-P | After the completion of week 52 visit by all study participants. | L-VLDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IDL-P | After the completion of week 52 visit by all study participants. | IDL-P is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): ApoA1 | After the completion of week 52 visit by all study participants. | ApoA1 is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): ApoB | After the completion of week 52 visit by all study participants. | ApoB is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLTG | After the completion of week 52 visit by all study participants. | TRLTG is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLC | After the completion of week 52 visit by all study participants. | TRLC is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLP | After the completion of week 52 visit by all study participants. | TRLP is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VS-TRLP | After the completion of week 52 visit by all study participants. | VS-TRLP is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-TRLP | After the completion of week 52 visit by all study participants. | S-TRLP is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): M-TRLP | After the completion of week 52 visit by all study participants. | M-TRLP is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-TRLP | After the completion of week 52 visit by all study participants. | L-TRLP is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VL-TRLP | After the completion of week 52 visit by all study participants. | VL-TRLP is a marker of lipid function and metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Insulin | After the completion of week 52 visit by all study participants. | Insulin is a marker of glucose metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HOMA-IR | After the completion of week 52 visit by all study participants. | HOMA-IR is a marker of glucose metabolism. HOMA-IR, a method used to quantify insulin resistance and beta-cell function, is expressed using fasting blood glucose and insulin levels. It is calculated using the formula (HOMA-IR = fasting glucose \[mg/dl\] \* fasting insulin \[mU/ml\]/405). |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Glucose | After the completion of week 52 visit by all study participants. | Glucose is a marker of glucose metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): DRI | After the completion of week 52 visit by all study participants. | DRI is a marker of glucose metabolism. DRI is a nuclear magnetic resonance spectroscopy (NMR)-derived multimarker score (values 1-100) that predicts a patient's risk of developing type 2 diabetes mellitus (T2D) independent of glycemic status. DRI derives its performance from the weighted addition of the Lipoprotein Insulin Resistance Index (LP-IR) scores with simultaneously-measured levels of branched-chain amino acids (BCAA). Higher scores indicate greater risk. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LP-IR | After the completion of week 52 visit by all study participants. | LP-IR is a marker of glucose metabolism. LP-IR is a marker of insulin resistance, and as such the LP-IR score predicts a patient's likelihood of future development of type 2 diabetes. LP-IR is a multimarker index (values 0-100) based on the concentrations of particular lipoprotein subclasses. Greater score indicates higher likelihood of developing diabetes. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Leptin | After the completion of week 52 visit by all study participants. | Leptin is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Adiponectin | After the completion of week 52 visit by all study participants. | Adiponectin is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Fetuin A | After the completion of week 52 visit by all study participants. | Fetuin A is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Citrate | After the completion of week 52 visit by all study participants. | Citrate is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Valine | After the completion of week 52 visit by all study participants. | Valine is a marker of adipose dysfunction and general metabolism. |
| Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Leucine | After the completion of week 52 visit by all study participants. | Leucine is a marker of adipose dysfunction and general metabolism. |
Countries
United States
Participant flow
Recruitment details
One hundred and one patients were screened, and 70 patients met inclusion and exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Apremilast Apremilast (Otezla), 30mg oral tablet twice per day for 52 weeks. Single arm, open label study.
Apremilast: Apremilast (brand name Otezla) is a medication for the treatment of certain types of psoriasis and psoriatic arthritis. | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Fear of study procedure | 1 |
| Overall Study | Lack of Efficacy | 9 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Protocol Violation | 6 |
| Overall Study | Scheduling conflict | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Apremilast |
|---|---|
| Age at psoriasis diagnosis | 31.21 years STANDARD_DEVIATION 16.86 |
| Age, Continuous | 47.47 years STANDARD_DEVIATION 14.61 |
| Baseline DLQI | 11.60 score on a scale STANDARD_DEVIATION 6.72 |
| Baseline PASI | 18.62 units on a scale STANDARD_DEVIATION 5.96 |
| Baseline PGA | 0.32 score on a scale STANDARD_DEVIATION 0.54 |
| Baseline Pruritus VAS | 57.18 units on a scale STANDARD_DEVIATION 30.03 |
| Body mass index (BMI) | 30.22 kg/m^2 STANDARD_DEVIATION 5.02 |
| Drink alcohol No | 31 Participants |
| Drink alcohol Yes | 39 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| History of psoriatic arthritis | 8 Participants |
| Medical history Diabetes | 6 Participants |
| Medical history Hyperlipidemia | 16 Participants |
| Medical history Hypertension | 19 Participants |
| Medical history Statin use | 12 Participants |
| Psoriasis treatment history Any biologics | 30 Participants |
| Psoriasis treatment history Any investigational agents | 7 Participants |
| Psoriasis treatment history Any oral systemics | 24 Participants |
| Psoriasis treatment history Any phototherapy | 21 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 58 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 54 Participants |
| Smoking status Current smoker | 17 Participants |
| Smoking status Former smoker | 23 Participants |
| Smoking status Never smoked | 30 Participants |
| Weight | 90.36 kg STANDARD_DEVIATION 17.41 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 70 |
| other Total, other adverse events | 31 / 70 |
| serious Total, serious adverse events | 6 / 70 |
Outcome results
Primary
Change in Total Vascular Inflammation of the Aorta as Measured by FDG-PET/CT Between Baseline and Week 16.
The primary analysis will consist of comparisons of total vascular inflammation of the aorta between week 16 and baseline using \[18F\]-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) / Computed Tomography (CT) (FDG-PET/CT). Tissue-to-background ratio (TBR) of the standardized uptake value (SUV) is used to assess the level of inflammation of the aorta relative to the venous blood pool (background reference).
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Change in Total Vascular Inflammation of the Aorta as Measured by FDG-PET/CT Between Baseline and Week 16. | -0.017 ratio | Standard Error 0.033 |
p-value: 0.612t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Acetoacetic Acid
Acetoacetic Acid is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Acetoacetic Acid | 0.711 µmol/L | Standard Error 1.134 |
p-value: 0.533t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Acetone
Acetone is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Acetone | -17.171 µmol/L | Standard Error 11.389 |
p-value: 0.137t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Adiponectin
Adiponectin is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Adiponectin | -1.430 µg/ml | Standard Error 1.521 |
p-value: 0.351t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Alanine
Alanine is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Alanine | -20.059 µmol/L | Standard Error 18.497 |
p-value: 0.283t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Apolipoprotein A1 (ApoA1)
ApoA1 is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Apolipoprotein A1 (ApoA1) | 0.939 mg/dL | Standard Error 2.17 |
p-value: 0.667t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Apolipoprotein B (ApoB)
ApoB is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Apolipoprotein B (ApoB) | 0.308 mg/dL | Standard Error 1.519 |
p-value: 0.84t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: BCAA
Branched-chain amino acids (BCAA) is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: BCAA | -29.505 µmol/L | Standard Error 11.118 |
p-value: 0.01t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Beta Hydroxybutyrate
Beta Hydroxybutyrate is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Beta Hydroxybutyrate | -13.859 µmol/L | Standard Error 23.337 |
p-value: 0.555t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Cholesterol Efflux Capacity
Cholesterol Efflux Capacity is a marker of lipid function and metabolism. The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: \[(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)\]. Cholesterol efflux capacity is inversely correlated with incidence of cardiovascular events (i.e. higher cholesterol efflux capacity is better for patients).
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Cholesterol Efflux Capacity | -0.010 unitless measure | Standard Error 0.033 |
p-value: 0.771t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Citrate
Citrate is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Citrate | 0.429 µmol/L | Standard Error 2.921 |
p-value: 0.884t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: C Reactive Protein (CRP)
CRP is a marker of inflammation.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: C Reactive Protein (CRP) | -414.175 µg/ml | Standard Error 823.144 |
p-value: 0.617t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Diabetes Risk Index (DRI)
DRI is a marker of glucose metabolism. DRI is a nuclear magnetic resonance spectroscopy (NMR)-derived multimarker score (values 1-100) that predicts a patient's risk of developing type 2 diabetes mellitus (T2D) independent of glycemic status. DRI derives its performance from the weighted addition of the Lipoprotein Insulin Resistance Index (LP-IR) scores with simultaneously-measured levels of branched-chain amino acids (BCAA). Higher scores indicate greater risk.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Diabetes Risk Index (DRI) | -2.978 index | Standard Error 1.551 |
p-value: 0.06t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Ferritin
Ferritin is a marker of inflammation.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Ferritin | -13.416 ng/ml | Standard Error 7.614 |
p-value: 0.083t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Fetuin A
Fetuin A is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Fetuin A | -50.732 µg/ml | Standard Error 24.231 |
p-value: 0.041t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Glucose
Glucose is a marker of metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Glucose | 2.615 mg/dL | Standard Error 4.074 |
p-value: 0.523t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: GlycA
GlycA is a marker of inflammation.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: GlycA | 10.690 µmol/L | Standard Error 6.145 |
p-value: 0.087t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: HDL-Particle Number (P)
HDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: HDL-Particle Number (P) | 0.058 µmol/L | Standard Error 0.585 |
p-value: 0.922t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: HDL-Particle Size (Z)
HDL-Z is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: HDL-Particle Size (Z) | -0.071 nm | Standard Error 0.054 |
p-value: 0.192t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: High-density Lipoprotein (HDL) - Cholesterol (C)
HDL-C is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: High-density Lipoprotein (HDL) - Cholesterol (C) | 0.136 mg/dL | Standard Error 0.812 |
p-value: 0.868t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR is a marker of glucose metabolism. HOMA-IR, a method used to quantify insulin resistance and beta-cell function, is expressed using fasting blood glucose and insulin levels. It is calculated using the formula (HOMA-IR = fasting glucose \[mg/dl\] \* fasting insulin \[mU/ml\]/405).
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 0.551 index | Standard Error 0.791 |
p-value: 0.488t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-10
IL-10 is a marker of inflammation.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-10 | -0.054 pg/ml | Standard Error 0.063 |
p-value: 0.39t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-17A
IL-17A is a marker of inflammation.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-17A | -0.947 pg/ml | Standard Error 0.593 |
p-value: 0.116t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: IL2RA
IL2RA is a marker of inflammation.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: IL2RA | -3.308 ng/ml | Standard Error 1.94 |
p-value: 0.094t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-6
IL-6 is a marker of inflammation.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-6 | 2.727 pg/ml | Standard Error 2.779 |
p-value: 0.331t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-8
IL-8 is a marker of inflammation.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-8 | 24.014 pg/ml | Standard Error 19.571 |
p-value: 0.225t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-9
IL-9 is a marker of inflammation.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-9 | -0.090 pg/ml | Standard Error 0.061 |
p-value: 0.141t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Insulin
Insulin is a marker of glucose metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Insulin | 159.448 ng/ml | Standard Error 120.095 |
p-value: 0.189t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Intercellular Adhesion Molecule (ICAM)-1
ICAM-1 is a marker of inflammation.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Intercellular Adhesion Molecule (ICAM)-1 | -169.902 µg/ml | Standard Error 264.98 |
p-value: 0.524t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Interferon (IFN)-Gamma
IFN-gamma is a marker of inflammation.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Interferon (IFN)-Gamma | -1.944 pg/ml | Standard Error 2.514 |
p-value: 0.443t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Interleukin (IL)-1b
IL-1b is a marker of inflammation.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Interleukin (IL)-1b | -0.472 pg/ml | Standard Error 0.208 |
p-value: 0.027t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Intermediate-density Lipoprotein (IDL)-P
IDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Intermediate-density Lipoprotein (IDL)-P | -11.763 nmol/L | Standard Error 19.357 |
p-value: 0.546t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Isoleucine
Isoleucine is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Isoleucine | -6.018 µmol/L | Standard Error 2.462 |
p-value: 0.018t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Ketone Bodies
Ketone Bodies are markers of adipose dysfunction and general metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Ketone Bodies | -30.319 µmol/L | Standard Error 33.598 |
p-value: 0.371t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Large and Medium (LM)-HDL-P
LM-HDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Large and Medium (LM)-HDL-P | -0.442 µmol/L | Standard Error 0.561 |
p-value: 0.434t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Large (L)-HDL-P
L-HDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Large (L)-HDL-P | -0.231 µmol/L | Standard Error 0.234 |
p-value: 0.329t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: LDL-P
LDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: LDL-P | -21.712 nmol/L | Standard Error 25.618 |
p-value: 0.4t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: LDL-Z
LDL-Z is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: LDL-Z | 0.086 nm | Standard Error 0.07 |
p-value: 0.223t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Leptin
Leptin is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Leptin | -84.193 ng/ml | Standard Error 1232.36 |
p-value: 0.946t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Leucine
Leucine is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Leucine | -9.185 µmol/L | Standard Error 4.509 |
p-value: 0.046t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Lipoprotein Insulin Resistance Index (LP-IR)
LP-IR is a marker of glucose metabolism. LP-IR is a marker of insulin resistance, and as such the LP-IR score predicts a patient's likelihood of future development of type 2 diabetes. LP-IR is a multimarker index (values 0-100) based on the concentrations of particular lipoprotein subclasses. Greater score indicates higher likelihood of developing diabetes.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Lipoprotein Insulin Resistance Index (LP-IR) | -0.763 index | Standard Error 2.679 |
p-value: 0.777t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: L-LDL-P
L-LDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: L-LDL-P | 21.763 µmol/L | Standard Error 23.001 |
p-value: 0.348t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: LM-VLDL-P
LM-VLDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: LM-VLDL-P | -0.214 nmol/L | Standard Error 2.245 |
p-value: 0.925t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Low-density Lipoprotein (LDL)-C
LDL-C is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Low-density Lipoprotein (LDL)-C | 0.119 mg/dL | Standard Error 2.549 |
p-value: 0.963t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: L-TRLP
L-TRLP is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: L-TRLP | -0.811 nmol/L | Standard Error 0.663 |
p-value: 0.226t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: L-VLDL-P
L-VLDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: L-VLDL-P | -0.900 nmol/L | Standard Error 0.633 |
p-value: 0.161t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Medium (M)-HDL-P
M-HDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Medium (M)-HDL-P | -0.203 µmol/L | Standard Error 0.553 |
p-value: 0.714t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Monocyte Chemoattractant Protein (MCP)-1
MCP-1 is a marker of inflammation.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Monocyte Chemoattractant Protein (MCP)-1 | 3.056 pg/ml | Standard Error 20.557 |
p-value: 0.882t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: M-TRLP
M-TRLP is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: M-TRLP | 0.115 nmol/L | Standard Error 1.616 |
p-value: 0.944t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: M-VLDL-P
M-VLDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: M-VLDL-P | 0.625 nmol/L | Standard Error 2.351 |
p-value: 0.791t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Serum Amyloid-A (SAA)
SAA is a marker of inflammation.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Serum Amyloid-A (SAA) | 46.047 µg/ml | Standard Error 1324.285 |
p-value: 0.972t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: S-LDL-P
S-LDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: S-LDL-P | -31.780 nmol/L | Standard Error 26.849 |
p-value: 0.241t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Small (S)-HDL-P
S-HDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Small (S)-HDL-P | 0.507 µmol/L | Standard Error 0.671 |
p-value: 0.453t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: S-TRLP
S-TRLP is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: S-TRLP | 0.534 nmol/L | Standard Error 4.778 |
p-value: 0.911t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: S-VLDL-P
S-VLDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: S-VLDL-P | 1.371 nmol/L | Standard Error 2.212 |
p-value: 0.538t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Total Cholesterol
Total Cholesterol is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Total Cholesterol | 0.254 mg/dL | Standard Error 2.663 |
p-value: 0.924t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Triglyceride
Triglyceride is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Triglyceride | -3.542 mg/dL | Standard Error 5.108 |
p-value: 0.491t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: (Triglyceride-Rich Lipoprotein Cholesterol) TRLC
TRLC is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: (Triglyceride-Rich Lipoprotein Cholesterol) TRLC | -0.352 mg/dL | Standard Error 1.215 |
p-value: 0.773t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: (Triglyceride-Rich Lipoprotein) TRLP
TRLP is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: (Triglyceride-Rich Lipoprotein) TRLP | 0.283 nmol/L | Standard Error 6.945 |
p-value: 0.968t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: TRLTG
TRLTG is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: TRLTG | -5.142 mg/dL | Standard Error 5.655 |
p-value: 0.367t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Tumor Necrosis Factor (TNF)-Alpha
TNF-alpha is a marker of inflammation.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Tumor Necrosis Factor (TNF)-Alpha | 17.914 pg/ml | Standard Error 18.095 |
p-value: 0.326t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Valine
Valine is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Valine | -14.301 µmol/L | Standard Error 5.858 |
p-value: 0.018t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Vascular Cell Adhesion Molecule (VCAM)-1
VCAM-1 is a marker of inflammation.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Vascular Cell Adhesion Molecule (VCAM)-1 | -11.201 µg/ml | Standard Error 11.061 |
p-value: 0.315t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Very Large (VL)-LDL-P
VL-LDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Very Large (VL)-LDL-P | -18.678 nmol/L | Standard Error 23.175 |
p-value: 0.424t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: Very Low-density Lipoprotein (VLDL)-P
VLDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: Very Low-density Lipoprotein (VLDL)-P | 1.227 nmol/L | Standard Error 2.842 |
p-value: 0.667t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: VLDL-Triglycerides (TG)
VLDL-TG is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: VLDL-Triglycerides (TG) | -4.393 mg/dL | Standard Error 4.48 |
p-value: 0.331t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: VLDL-Z
VLDL-Z is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: VLDL-Z | -1.607 nm | Standard Error 1.06 |
p-value: 0.135t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: VL-TRLP
VL-TRLP is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: VL-TRLP | -0.000 nmol/L | Standard Error 0.009 |
p-value: 0.988t-test, 2 sided
Primary
Changes in Cardiometabolic Markers Between Baseline and Week 16: VS-TRLP
VS-TRLP is a marker of lipid function and metabolism.
Time frame: After the completion of week 16 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Baseline and Week 16: VS-TRLP | 0.445 nmol/L | Standard Error 7.569 |
p-value: 0.953t-test, 2 sided
Secondary
Change in Total Vascular Inflammation of the Aorta as Measured by FDG-PET/CT Between Week 52 and Earlier Time Points.
Secondary analysis will consist of comparisons of total vascular inflammation of the aorta using TBR between week 52, 16, and baseline.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Change in Total Vascular Inflammation of the Aorta as Measured by FDG-PET/CT Between Week 52 and Earlier Time Points. | -0.069 ratio | Standard Error 0.04 |
| Week 52 vs. Baseline | Change in Total Vascular Inflammation of the Aorta as Measured by FDG-PET/CT Between Week 52 and Earlier Time Points. | -0.016 ratio | Standard Error 0.038 |
p-value: 0.092t-test, 2 sided
p-value: 0.678t-test, 2 sided
Secondary
Change in Vascular Inflammation of the Five Aortic Segments as Measured by FDG-PET/CT Between Week 52, 16, and Baseline.
Secondary analysis will consist of comparisons of vascular inflammation of the five aortic segments using TBR between week 52, 16, and baseline.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Apremilast | Change in Vascular Inflammation of the Five Aortic Segments as Measured by FDG-PET/CT Between Week 52, 16, and Baseline. | Abdominal aorta (suprarenal) | -0.026 ratio | Standard Error 0.035 |
| Apremilast | Change in Vascular Inflammation of the Five Aortic Segments as Measured by FDG-PET/CT Between Week 52, 16, and Baseline. | Descending aorta | -0.000 ratio | Standard Error 0.037 |
| Apremilast | Change in Vascular Inflammation of the Five Aortic Segments as Measured by FDG-PET/CT Between Week 52, 16, and Baseline. | Ascending aorta | -0.067 ratio | Standard Error 0.04 |
| Apremilast | Change in Vascular Inflammation of the Five Aortic Segments as Measured by FDG-PET/CT Between Week 52, 16, and Baseline. | Aortic arch | -0.062 ratio | Standard Error 0.036 |
| Apremilast | Change in Vascular Inflammation of the Five Aortic Segments as Measured by FDG-PET/CT Between Week 52, 16, and Baseline. | Abdominal aorta (infrarenal) | -0.030 ratio | Standard Error 0.055 |
| Week 52 vs. Baseline | Change in Vascular Inflammation of the Five Aortic Segments as Measured by FDG-PET/CT Between Week 52, 16, and Baseline. | Descending aorta | -0.057 ratio | Standard Error 0.041 |
| Week 52 vs. Baseline | Change in Vascular Inflammation of the Five Aortic Segments as Measured by FDG-PET/CT Between Week 52, 16, and Baseline. | Ascending aorta | -0.099 ratio | Standard Error 0.046 |
| Week 52 vs. Baseline | Change in Vascular Inflammation of the Five Aortic Segments as Measured by FDG-PET/CT Between Week 52, 16, and Baseline. | Aortic arch | -0.080 ratio | Standard Error 0.047 |
| Week 52 vs. Baseline | Change in Vascular Inflammation of the Five Aortic Segments as Measured by FDG-PET/CT Between Week 52, 16, and Baseline. | Abdominal aorta (suprarenal) | -0.075 ratio | Standard Error 0.042 |
| Week 52 vs. Baseline | Change in Vascular Inflammation of the Five Aortic Segments as Measured by FDG-PET/CT Between Week 52, 16, and Baseline. | Abdominal aorta (infrarenal) | -0.118 ratio | Standard Error 0.073 |
| Week 52 vs. Week 16 | Change in Vascular Inflammation of the Five Aortic Segments as Measured by FDG-PET/CT Between Week 52, 16, and Baseline. | Abdominal aorta (infrarenal) | -0.038 ratio | Standard Error 0.052 |
| Week 52 vs. Week 16 | Change in Vascular Inflammation of the Five Aortic Segments as Measured by FDG-PET/CT Between Week 52, 16, and Baseline. | Abdominal aorta (suprarenal) | -0.017 ratio | Standard Error 0.043 |
| Week 52 vs. Week 16 | Change in Vascular Inflammation of the Five Aortic Segments as Measured by FDG-PET/CT Between Week 52, 16, and Baseline. | Ascending aorta | 0.028 ratio | Standard Error 0.039 |
| Week 52 vs. Week 16 | Change in Vascular Inflammation of the Five Aortic Segments as Measured by FDG-PET/CT Between Week 52, 16, and Baseline. | Descending aorta | -0.019 ratio | Standard Error 0.042 |
| Week 52 vs. Week 16 | Change in Vascular Inflammation of the Five Aortic Segments as Measured by FDG-PET/CT Between Week 52, 16, and Baseline. | Aortic arch | 0.010 ratio | Standard Error 0.036 |
Secondary
Changes in Body Composition as Measured by FDG-PET/CT Between Week 52 and and Earlier Time Points (Baseline and Week 16): Subcutaneous Adipose Tissue
Secondary analysis will consist of comparisons of change in body composition between weeks 52, 16, and baseline. Subcutaneous adipose tissue quantification using a single CT slice at the level of the umbilicus using computer-assisted tissue segmentation (Pescatori LC et al. Quantification of visceral adipose tissue by computed tomography and magnetic resonance imaging: reproducibility and accuracy. Radiol Bras. 2019 15(1):1-6.). The values represent the cross-sectional area of the tissue segmented on the CT slice (cm\^2); higher values indicate greater amount of subcutaneous adipose tissue.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Body Composition as Measured by FDG-PET/CT Between Week 52 and and Earlier Time Points (Baseline and Week 16): Subcutaneous Adipose Tissue | -19.857 cm^2 | Standard Error 5.405 |
| Week 52 vs. Baseline | Changes in Body Composition as Measured by FDG-PET/CT Between Week 52 and and Earlier Time Points (Baseline and Week 16): Subcutaneous Adipose Tissue | -19.585 cm^2 | Standard Error 7.17 |
| Week 52 vs. Week 16 | Changes in Body Composition as Measured by FDG-PET/CT Between Week 52 and and Earlier Time Points (Baseline and Week 16): Subcutaneous Adipose Tissue | 0.638 cm^2 | Standard Error 6.133 |
p-value: 0.001t-test, 2 sided
p-value: 0.01t-test, 2 sided
p-value: 0.918t-test, 2 sided
Secondary
Changes in Body Composition as Measured by FDG-PET/CT Between Week 52 and and Earlier Time Points (Baseline and Week 16): Visceral Adipose Tissue
Secondary analysis will consist of comparisons of change in body composition between weeks 52, 16, and baseline. Visceral adipose tissue quantification using a single CT slice at the level of the umbilicus using computer-assisted tissue segmentation (Pescatori LC et al. Quantification of visceral adipose tissue by computed tomography and magnetic resonance imaging: reproducibility and accuracy. Radiol Bras. 2019 15(1):1-6.). The values represent the cross-sectional area of the tissue segmented on the CT slice (cm\^2); higher values indicate greater amount of visceral adipose tissue.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Body Composition as Measured by FDG-PET/CT Between Week 52 and and Earlier Time Points (Baseline and Week 16): Visceral Adipose Tissue | -10.681 cm^2 | Standard Error 3.052 |
| Week 52 vs. Baseline | Changes in Body Composition as Measured by FDG-PET/CT Between Week 52 and and Earlier Time Points (Baseline and Week 16): Visceral Adipose Tissue | -12.519 cm^2 | Standard Error 4.898 |
| Week 52 vs. Week 16 | Changes in Body Composition as Measured by FDG-PET/CT Between Week 52 and and Earlier Time Points (Baseline and Week 16): Visceral Adipose Tissue | 2.189 cm^2 | Standard Error 3.517 |
p-value: 0.001t-test, 2 sided
p-value: 0.015t-test, 2 sided
p-value: 0.537t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Acetoacetic Acid
Acetoacetic Acid is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Acetoacetic Acid | 1.616 µmol/L | Standard Error 2.094 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Acetoacetic Acid | 0.993 µmol/L | Standard Error 1.936 |
p-value: 0.446t-test, 2 sided
p-value: 0.611t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Acetone
Acetone is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Acetone | -32.489 µmol/L | Standard Error 12.565 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Acetone | -10.939 µmol/L | Standard Error 12.987 |
p-value: 0.014t-test, 2 sided
p-value: 0.405t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Adiponectin
Adiponectin is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Adiponectin | -2.106 µg/ml | Standard Error 1.975 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Adiponectin | 1.268 µg/ml | Standard Error 1.353 |
p-value: 0.293t-test, 2 sided
p-value: 0.355t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Alanine
Alanine is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Alanine | 23.209 µmol/L | Standard Error 24.631 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Alanine | 39.496 µmol/L | Standard Error 28.893 |
p-value: 0.352t-test, 2 sided
p-value: 0.18t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): ApoA1
ApoA1 is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): ApoA1 | 5.792 mg/dL | Standard Error 2.799 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): ApoA1 | 5.272 mg/dL | Standard Error 3.011 |
p-value: 0.046t-test, 2 sided
p-value: 0.088t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): ApoB
ApoB is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): ApoB | 2.225 mg/dL | Standard Error 2.568 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): ApoB | 3.360 mg/dL | Standard Error 2.443 |
p-value: 0.392t-test, 2 sided
p-value: 0.177t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): BCAA
BCAA is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): BCAA | -24.353 µmol/L | Standard Error 14.136 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): BCAA | 12.785 µmol/L | Standard Error 14.474 |
p-value: 0.094t-test, 2 sided
p-value: 0.383t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Beta Hydroxybutyrate
Beta Hydroxybutyrate is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Beta Hydroxybutyrate | -48.450 µmol/L | Standard Error 22.919 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Beta Hydroxybutyrate | -38.228 µmol/L | Standard Error 29.792 |
p-value: 0.042t-test, 2 sided
p-value: 0.208t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Cholesterol Efflux Capacity
Cholesterol Efflux Capacity is a marker of lipid function and metabolism. The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: \[(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)\]. Cholesterol efflux capacity is inversely correlated with incidence of cardiovascular events (i.e. higher cholesterol efflux capacity is better for patients).
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Cholesterol Efflux Capacity | -0.159 unitless measure | Standard Error 0.053 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Cholesterol Efflux Capacity | -0.111 unitless measure | Standard Error 0.036 |
p-value: 0.005t-test, 2 sided
p-value: 0.004t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Citrate
Citrate is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Citrate | -5.547 µmol/L | Standard Error 3.643 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Citrate | -4.766 µmol/L | Standard Error 3.684 |
p-value: 0.137t-test, 2 sided
p-value: 0.204t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): CRP
CRP is a marker of inflammation.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): CRP | 36.050 µg/ml | Standard Error 1043.6 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): CRP | -246.058 µg/ml | Standard Error 988.627 |
p-value: 0.973t-test, 2 sided
p-value: 0.805t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): DRI
DRI is a marker of glucose metabolism. DRI is a nuclear magnetic resonance spectroscopy (NMR)-derived multimarker score (values 1-100) that predicts a patient's risk of developing type 2 diabetes mellitus (T2D) independent of glycemic status. DRI derives its performance from the weighted addition of the Lipoprotein Insulin Resistance Index (LP-IR) scores with simultaneously-measured levels of branched-chain amino acids (BCAA). Higher scores indicate greater risk.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): DRI | -2.834 index | Standard Error 1.875 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): DRI | 1.765 index | Standard Error 1.865 |
p-value: 0.139t-test, 2 sided
p-value: 0.35t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Ferritin
Ferritin is a marker of inflammation.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Ferritin | -22.645 ng/ml | Standard Error 9.287 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Ferritin | -1.736 ng/ml | Standard Error 5.68 |
p-value: 0.02t-test, 2 sided
p-value: 0.762t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Fetuin A
Fetuin A is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Fetuin A | -53.518 µg/ml | Standard Error 31.837 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Fetuin A | 36.686 µg/ml | Standard Error 26.223 |
p-value: 0.101t-test, 2 sided
p-value: 0.17t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Glucose
Glucose is a marker of glucose metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Glucose | 8.032 mg/dL | Standard Error 7.746 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Glucose | 2.604 mg/dL | Standard Error 6.386 |
p-value: 0.307t-test, 2 sided
p-value: 0.686t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): GlycA
GlycA is a marker of inflammation.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): GlycA | 4.324 µmol/L | Standard Error 7.836 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): GlycA | -8.703 µmol/L | Standard Error 6.533 |
p-value: 0.584t-test, 2 sided
p-value: 0.191t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HDL-C
HDL-C is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HDL-C | 1.842 mg/dL | Standard Error 1.1 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HDL-C | 1.711 mg/dL | Standard Error 1.173 |
p-value: 0.102t-test, 2 sided
p-value: 0.153t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HDL-P
HDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HDL-P | 0.953 µmol/L | Standard Error 0.774 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HDL-P | 1.092 µmol/L | Standard Error 0.879 |
p-value: 0.226t-test, 2 sided
p-value: 0.222t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HDL-Z
HDL-Z is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HDL-Z | 0.053 nm | Standard Error 0.06 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HDL-Z | 0.089 nm | Standard Error 0.055 |
p-value: 0.384t-test, 2 sided
p-value: 0.112t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HOMA-IR
HOMA-IR is a marker of glucose metabolism. HOMA-IR, a method used to quantify insulin resistance and beta-cell function, is expressed using fasting blood glucose and insulin levels. It is calculated using the formula (HOMA-IR = fasting glucose \[mg/dl\] \* fasting insulin \[mU/ml\]/405).
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HOMA-IR | 1.814 index | Standard Error 1.438 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HOMA-IR | 0.753 index | Standard Error 1.471 |
p-value: 0.215t-test, 2 sided
p-value: 0.612t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): ICAM-1
ICAM-1 is a marker of inflammation.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): ICAM-1 | 41.059 µg/ml | Standard Error 667.553 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): ICAM-1 | 292.802 µg/ml | Standard Error 662.249 |
p-value: 0.951t-test, 2 sided
p-value: 0.661t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IDL-P
IDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IDL-P | -12.316 nmol/L | Standard Error 18.508 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IDL-P | 18.211 nmol/L | Standard Error 27.738 |
p-value: 0.51t-test, 2 sided
p-value: 0.516t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IFN-gamma
IFN-gamma is a marker of inflammation.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IFN-gamma | 0.281 pg/ml | Standard Error 5.509 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IFN-gamma | 4.717 pg/ml | Standard Error 4.194 |
p-value: 0.96t-test, 2 sided
p-value: 0.268t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-10
IL-10 is a marker of inflammation.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-10 | 0.631 pg/ml | Standard Error 0.551 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-10 | 0.689 pg/ml | Standard Error 0.551 |
p-value: 0.259t-test, 2 sided
p-value: 0.219t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-17A
IL-17A is a marker of inflammation.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-17A | -1.383 pg/ml | Standard Error 0.917 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-17A | 0.141 pg/ml | Standard Error 0.294 |
p-value: 0.14t-test, 2 sided
p-value: 0.633t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-1b
IL-1b is a marker of inflammation.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-1b | 0.285 pg/ml | Standard Error 0.419 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-1b | 0.624 pg/ml | Standard Error 0.517 |
p-value: 0.501t-test, 2 sided
p-value: 0.235t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL2RA
IL2RA is a marker of inflammation.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL2RA | -1.557 ng/ml | Standard Error 2.432 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL2RA | 0.782 ng/ml | Standard Error 1.618 |
p-value: 0.526t-test, 2 sided
p-value: 0.632t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-6
IL-6 is a marker of inflammation.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-6 | 22.680 pg/ml | Standard Error 21.683 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-6 | 18.344 pg/ml | Standard Error 21.769 |
p-value: 0.302t-test, 2 sided
p-value: 0.405t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-8
IL-8 is a marker of inflammation.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-8 | 369.437 pg/ml | Standard Error 349.058 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-8 | 330.646 pg/ml | Standard Error 330.466 |
p-value: 0.297t-test, 2 sided
p-value: 0.324t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-9
IL-9 is a marker of inflammation.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-9 | -0.025 pg/ml | Standard Error 0.103 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-9 | 0.080 pg/ml | Standard Error 0.07 |
p-value: 0.812t-test, 2 sided
p-value: 0.264t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Insulin
Insulin is a marker of glucose metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Insulin | 421.436 ng/ml | Standard Error 361.693 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Insulin | 330.523 ng/ml | Standard Error 334.064 |
p-value: 0.251t-test, 2 sided
p-value: 0.329t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Isoleucine
Isoleucine is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Isoleucine | -3.541 µmol/L | Standard Error 3.519 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Isoleucine | 5.203 µmol/L | Standard Error 4.025 |
p-value: 0.321t-test, 2 sided
p-value: 0.204t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Ketone Bodies
Ketone Bodies are markers of adipose dysfunction and general metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Ketone Bodies | -79.323 µmol/L | Standard Error 33.786 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Ketone Bodies | -48.175 µmol/L | Standard Error 42.608 |
p-value: 0.266t-test, 2 sided
p-value: 0.024t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LDL-C
LDL-C is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LDL-C | 1.158 mg/dL | Standard Error 4.414 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LDL-C | 4.737 mg/dL | Standard Error 4.358 |
p-value: 0.795t-test, 2 sided
p-value: 0.284t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LDL-P
LDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LDL-P | 5.605 nmol/L | Standard Error 36.791 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LDL-P | 78.105 nmol/L | Standard Error 34.245 |
p-value: 0.88t-test, 2 sided
p-value: 0.028t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LDL-Z
LDL-Z is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LDL-Z | 0.037 nm | Standard Error 0.113 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LDL-Z | -0.118 nm | Standard Error 0.091 |
p-value: 0.746t-test, 2 sided
p-value: 0.199t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Leptin
Leptin is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Leptin | -498.841 ng/ml | Standard Error 1993.62 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Leptin | 304.320 ng/ml | Standard Error 1149.111 |
p-value: 0.804t-test, 2 sided
p-value: 0.793t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Leucine
Leucine is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Leucine | -8.223 µmol/L | Standard Error 5.198 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Leucine | 1.313 µmol/L | Standard Error 5.585 |
p-value: 0.122t-test, 2 sided
p-value: 0.815t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-HDL-P
L-HDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-HDL-P | 0.332 µmol/L | Standard Error 0.301 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-HDL-P | 0.503 µmol/L | Standard Error 0.288 |
p-value: 0.089t-test, 2 sided
p-value: 0.278t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-LDL-P
L-LDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-LDL-P | 25.105 µmol/L | Standard Error 36.371 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-LDL-P | -1.658 µmol/L | Standard Error 32.843 |
p-value: 0.494t-test, 2 sided
p-value: 0.96t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LM-HDL-P
LM-HDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LM-HDL-P | 0.595 µmol/L | Standard Error 0.761 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LM-HDL-P | 1.061 µmol/L | Standard Error 0.757 |
p-value: 0.44t-test, 2 sided
p-value: 0.17t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LM-VLDL-P
LM-VLDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LM-VLDL-P | 1.676 nmol/L | Standard Error 2.725 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LM-VLDL-P | 2.432 nmol/L | Standard Error 2.534 |
p-value: 0.542t-test, 2 sided
p-value: 0.344t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LP-IR
LP-IR is a marker of glucose metabolism. LP-IR is a marker of insulin resistance, and as such the LP-IR score predicts a patient's likelihood of future development of type 2 diabetes. LP-IR is a multimarker index (values 0-100) based on the concentrations of particular lipoprotein subclasses. Greater score indicates higher likelihood of developing diabetes.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LP-IR | -1.158 index | Standard Error 3.219 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LP-IR | 2.684 index | Standard Error 2.474 |
p-value: 0.721t-test, 2 sided
p-value: 0.285t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-TRLP
L-TRLP is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-TRLP | 0.233 nmol/L | Standard Error 0.976 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-TRLP | 1.981 nmol/L | Standard Error 0.96 |
p-value: 0.813t-test, 2 sided
p-value: 0.046t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-VLDL-P
L-VLDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-VLDL-P | 0.095 nmol/L | Standard Error 0.912 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-VLDL-P | 1.724 nmol/L | Standard Error 0.787 |
p-value: 0.918t-test, 2 sided
p-value: 0.035t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): MCP-1
MCP-1 is a marker of inflammation.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): MCP-1 | 101.704 pg/ml | Standard Error 93.377 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): MCP-1 | 78.605 pg/ml | Standard Error 67.289 |
p-value: 0.283t-test, 2 sided
p-value: 0.25t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): M-HDL-P
M-HDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): M-HDL-P | 0.203 µmol/L | Standard Error 0.793 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): M-HDL-P | 0.500 µmol/L | Standard Error 0.83 |
p-value: 0.8t-test, 2 sided
p-value: 0.551t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): M-TRLP
M-TRLP is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): M-TRLP | 1.976 nmol/L | Standard Error 2.141 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): M-TRLP | 2.204 nmol/L | Standard Error 1.768 |
p-value: 0.362t-test, 2 sided
p-value: 0.221t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): M-VLDL-P
M-VLDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): M-VLDL-P | 1.753 nmol/L | Standard Error 2.866 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): M-VLDL-P | 1.008 nmol/L | Standard Error 2.507 |
p-value: 0.545t-test, 2 sided
p-value: 0.69t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): SAA
SAA is a marker of inflammation.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): SAA | 1586.025 µg/ml | Standard Error 3114.549 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): SAA | 2799.836 µg/ml | Standard Error 2695.059 |
p-value: 0.614t-test, 2 sided
p-value: 0.306t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-HDL-P
S-HDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-HDL-P | 0.434 µmol/L | Standard Error 0.91 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-HDL-P | 0.118 µmol/L | Standard Error 0.902 |
p-value: 0.636t-test, 2 sided
p-value: 0.896t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-LDL-P
S-LDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-LDL-P | -9.184 nmol/L | Standard Error 38.768 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-LDL-P | 53.605 nmol/L | Standard Error 24.61 |
p-value: 0.814t-test, 2 sided
p-value: 0.036t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-TRLP
S-TRLP is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-TRLP | 2.714 nmol/L | Standard Error 6.936 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-TRLP | -2.990 nmol/L | Standard Error 7.959 |
p-value: 0.698t-test, 2 sided
p-value: 0.709t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-VLDL-P
S-VLDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-VLDL-P | 2.913 nmol/L | Standard Error 2.548 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-VLDL-P | -1.842 nmol/L | Standard Error 2.876 |
p-value: 0.26t-test, 2 sided
p-value: 0.526t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TNF-alpha
TNF-alpha is a marker of inflammation.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TNF-alpha | 100.589 pg/ml | Standard Error 71.944 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TNF-alpha | 72.650 pg/ml | Standard Error 62.065 |
p-value: 0.17t-test, 2 sided
p-value: 0.249t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Total Cholesterol
Total Cholesterol is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Total Cholesterol | 4.316 mg/dL | Standard Error 4.447 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Total Cholesterol | 7.474 mg/dL | Standard Error 4.302 |
p-value: 0.338t-test, 2 sided
p-value: 0.091t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Triglyceride
Triglyceride is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Triglyceride | 4.684 mg/dL | Standard Error 7.448 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Triglyceride | 12.526 mg/dL | Standard Error 6.936 |
p-value: 0.533t-test, 2 sided
p-value: 0.079t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLC
TRLC is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLC | 1.547 mg/dL | Standard Error 1.902 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLC | 2.598 mg/dL | Standard Error 1.742 |
p-value: 0.421t-test, 2 sided
p-value: 0.145t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLP
TRLP is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLP | 5.539 nmol/L | Standard Error 10.787 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLP | 8.555 nmol/L | Standard Error 8.946 |
p-value: 0.611t-test, 2 sided
p-value: 0.345t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLTG
TRLTG is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLTG | 4.520 mg/dL | Standard Error 8.18 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLTG | 14.465 mg/dL | Standard Error 7.589 |
p-value: 0.584t-test, 2 sided
p-value: 0.065t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Valine
Valine is a marker of adipose dysfunction and general metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Valine | -12.589 µmol/L | Standard Error 7.799 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Valine | 6.269 µmol/L | Standard Error 7.017 |
p-value: 0.115t-test, 2 sided
p-value: 0.378t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VCAM-1
VCAM-1 is a marker of inflammation.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VCAM-1 | 10.253 µg/ml | Standard Error 10.22 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VCAM-1 | 24.967 µg/ml | Standard Error 11.215 |
p-value: 0.322t-test, 2 sided
p-value: 0.032t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VLDL-P
VLDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VLDL-P | 4.934 nmol/L | Standard Error 4.144 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VLDL-P | 0.645 nmol/L | Standard Error 3.879 |
p-value: 0.241t-test, 2 sided
p-value: 0.869t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VLDL-TG
VLDL-TG is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VLDL-TG | 3.553 mg/dL | Standard Error 6.558 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VLDL-TG | 10.458 mg/dL | Standard Error 5.958 |
p-value: 0.591t-test, 2 sided
p-value: 0.088t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VLDL-Z
VLDL-Z is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VLDL-Z | -0.039 nm | Standard Error 1.347 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VLDL-Z | 3.113 nm | Standard Error 1.177 |
p-value: 0.977t-test, 2 sided
p-value: 0.012t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VL-LDL-P
VL-LDL-P is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VL-LDL-P | 9.605 nmol/L | Standard Error 33.684 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VL-LDL-P | 71.605 nmol/L | Standard Error 31.228 |
p-value: 0.777t-test, 2 sided
p-value: 0.028t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VL-TRLP
VL-TRLP is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VL-TRLP | -0.003 nmol/L | Standard Error 0.011 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VL-TRLP | -0.002 nmol/L | Standard Error 0.008 |
p-value: 0.752t-test, 2 sided
p-value: 0.808t-test, 2 sided
Secondary
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VS-TRLP
VS-TRLP is a marker of lipid function and metabolism.
Time frame: After the completion of week 52 visit by all study participants.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VS-TRLP | 0.619 nmol/L | Standard Error 11.281 |
| Week 52 vs. Baseline | Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VS-TRLP | 7.361 nmol/L | Standard Error 9.13 |
p-value: 0.957t-test, 2 sided
p-value: 0.425t-test, 2 sided
Secondary
Changes in Patient Reported Outcomes: Dermatology Life Quality Index (DLQI)
Secondary analysis will consist of comparisons of change in DLQI scores. DLQI is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. The score ranges from 0 to 30; 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect.
Time frame: Baseline, week 16, and week 52.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Patient Reported Outcomes: Dermatology Life Quality Index (DLQI) | -6.050 score on a scale | Standard Error 0.723 |
| Week 52 vs. Baseline | Changes in Patient Reported Outcomes: Dermatology Life Quality Index (DLQI) | -5.692 score on a scale | Standard Error 1.125 |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary
Changes in Patient Reported Outcomes: Pruritis by Visual Analog Scales (VAS)
Secondary analysis will consist of comparisons of change in Pruritus VAS scores. A visual analogue scale for pruritus (itch), ranging from 0 (no itch) to 100 (worst imaginable itch).
Time frame: Baseline, week 16, and week 52.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Patient Reported Outcomes: Pruritis by Visual Analog Scales (VAS) | -27.527 score on a scale | Standard Error 4.349 |
| Week 52 vs. Baseline | Changes in Patient Reported Outcomes: Pruritis by Visual Analog Scales (VAS) | -19.110 score on a scale | Standard Error 6.249 |
p-value: <0.001t-test, 2 sided
p-value: 0.004t-test, 2 sided
Secondary
Changes in Physician Reported Outcomes: Physician Global Assessment (PGA)
Secondary analysis will consist of comparisons of change in PGA scores. Physician Global Assessment (PGA) is calculated by averaging three subcomponent scores (induration, erythema, and scaling) that are graded from 0 (no involvement) to 5 (maximum involvement) that are averaged over all psoriatic lesions. Higher scores indicate greater disease burden.
Time frame: Baseline, week 16, and week 52.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Physician Reported Outcomes: Physician Global Assessment (PGA) | -1.200 score on a scale | Standard Error 0.106 |
| Week 52 vs. Baseline | Changes in Physician Reported Outcomes: Physician Global Assessment (PGA) | -1.067 score on a scale | Standard Error 0.169 |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary
Changes in Physician Reported Outcomes: Psoriasis Area and Severity Index (PASI)
Secondary analysis will consist of comparisons of change in PASI scores. PASI is the most widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).
Time frame: Baseline, week 16, and week 52.
Population: The number of subjects analyzed reflect availability of analyzable samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apremilast | Changes in Physician Reported Outcomes: Psoriasis Area and Severity Index (PASI) | -10.778 score on a scale | Standard Error 0.852 |
| Week 52 vs. Baseline | Changes in Physician Reported Outcomes: Psoriasis Area and Severity Index (PASI) | -9.903 score on a scale | Standard Error 1.095 |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided