Trial Outcomes & Findings for Vascular Inflammation in Psoriasis - Apremilast (NCT NCT03082729)
NCT ID: NCT03082729
Last Updated: 2022-11-10
Results Overview
IDL-P is a marker of lipid function and metabolism.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
After the completion of week 16 visit by all study participants.
Results posted on
2022-11-10
Participant Flow
One hundred and one patients were screened, and 70 patients met inclusion and exclusion criteria.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
Per Protocol Population Week 16
|
60
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lack of Efficacy
|
9
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
Fear of study procedure
|
1
|
|
Overall Study
Scheduling conflict
|
1
|
Baseline Characteristics
Vascular Inflammation in Psoriasis - Apremilast
Baseline characteristics by cohort
| Measure |
Apremilast
n=70 Participants
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.
|
|---|---|
|
Age, Continuous
|
47.47 years
STANDARD_DEVIATION 14.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Drink alcohol
Yes
|
39 Participants
n=5 Participants
|
|
Drink alcohol
No
|
31 Participants
n=5 Participants
|
|
Smoking status
Current smoker
|
17 Participants
n=5 Participants
|
|
Smoking status
Former smoker
|
23 Participants
n=5 Participants
|
|
Smoking status
Never smoked
|
30 Participants
n=5 Participants
|
|
Body mass index (BMI)
|
30.22 kg/m^2
STANDARD_DEVIATION 5.02 • n=5 Participants
|
|
Weight
|
90.36 kg
STANDARD_DEVIATION 17.41 • n=5 Participants
|
|
Medical history
Diabetes
|
6 Participants
n=5 Participants
|
|
Medical history
Hyperlipidemia
|
16 Participants
n=5 Participants
|
|
Medical history
Hypertension
|
19 Participants
n=5 Participants
|
|
Medical history
Statin use
|
12 Participants
n=5 Participants
|
|
Age at psoriasis diagnosis
|
31.21 years
STANDARD_DEVIATION 16.86 • n=5 Participants
|
|
History of psoriatic arthritis
|
8 Participants
n=5 Participants
|
|
Psoriasis treatment history
Any phototherapy
|
21 Participants
n=5 Participants
|
|
Psoriasis treatment history
Any oral systemics
|
24 Participants
n=5 Participants
|
|
Psoriasis treatment history
Any biologics
|
30 Participants
n=5 Participants
|
|
Psoriasis treatment history
Any investigational agents
|
7 Participants
n=5 Participants
|
|
Baseline PASI
|
18.62 units on a scale
STANDARD_DEVIATION 5.96 • n=5 Participants
|
|
Baseline PGA
|
0.32 score on a scale
STANDARD_DEVIATION 0.54 • n=5 Participants
|
|
Baseline DLQI
|
11.60 score on a scale
STANDARD_DEVIATION 6.72 • n=5 Participants
|
|
Baseline Pruritus VAS
|
57.18 units on a scale
STANDARD_DEVIATION 30.03 • n=5 Participants
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
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).
Outcome measures
| Measure |
Apremilast
n=57 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Ferritin is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Ferritin
|
-13.416 ng/ml
Standard Error 7.614
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
CRP is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: C Reactive Protein (CRP)
|
-414.175 µg/ml
Standard Error 823.144
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
ICAM-1 is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Intercellular Adhesion Molecule (ICAM)-1
|
-169.902 µg/ml
Standard Error 264.980
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
SAA is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Serum Amyloid-A (SAA)
|
46.047 µg/ml
Standard Error 1324.285
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
VCAM-1 is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Vascular Cell Adhesion Molecule (VCAM)-1
|
-11.201 µg/ml
Standard Error 11.061
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
IFN-gamma is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Interferon (IFN)-Gamma
|
-1.944 pg/ml
Standard Error 2.514
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
IL-1b is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Interleukin (IL)-1b
|
-0.472 pg/ml
Standard Error 0.208
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
IL-10 is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-10
|
-0.054 pg/ml
Standard Error 0.063
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
IL-17A is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-17A
|
-0.947 pg/ml
Standard Error 0.593
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
IL-6 is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-6
|
2.727 pg/ml
Standard Error 2.779
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
IL-8 is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-8
|
24.014 pg/ml
Standard Error 19.571
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
IL-9 is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-9
|
-0.090 pg/ml
Standard Error 0.061
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
MCP-1 is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Monocyte Chemoattractant Protein (MCP)-1
|
3.056 pg/ml
Standard Error 20.557
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
TNF-alpha is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Tumor Necrosis Factor (TNF)-Alpha
|
17.914 pg/ml
Standard Error 18.095
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
IL2RA is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: IL2RA
|
-3.308 ng/ml
Standard Error 1.940
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
GlycA is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: GlycA
|
10.690 µmol/L
Standard Error 6.145
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
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).
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Cholesterol Efflux Capacity
|
-0.010 unitless measure
Standard Error 0.033
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Triglyceride is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Triglyceride
|
-3.542 mg/dL
Standard Error 5.108
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Total Cholesterol is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Total Cholesterol
|
0.254 mg/dL
Standard Error 2.663
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
HDL-C is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: High-density Lipoprotein (HDL) - Cholesterol (C)
|
0.136 mg/dL
Standard Error 0.812
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
HDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: HDL-Particle Number (P)
|
0.058 µmol/L
Standard Error 0.585
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.HDL-Z is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: HDL-Particle Size (Z)
|
-0.071 nm
Standard Error 0.054
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
S-HDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Small (S)-HDL-P
|
0.507 µmol/L
Standard Error 0.671
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
M-HDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Medium (M)-HDL-P
|
-0.203 µmol/L
Standard Error 0.553
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
LM-HDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Large and Medium (LM)-HDL-P
|
-0.442 µmol/L
Standard Error 0.561
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
L-HDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Large (L)-HDL-P
|
-0.231 µmol/L
Standard Error 0.234
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
LDL-C is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Low-density Lipoprotein (LDL)-C
|
0.119 mg/dL
Standard Error 2.549
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
LDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: LDL-P
|
-21.712 nmol/L
Standard Error 25.618
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
LDL-Z is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: LDL-Z
|
0.086 nm
Standard Error 0.070
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
S-LDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: S-LDL-P
|
-31.780 nmol/L
Standard Error 26.849
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
L-LDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: L-LDL-P
|
21.763 µmol/L
Standard Error 23.001
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
VL-LDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Very Large (VL)-LDL-P
|
-18.678 nmol/L
Standard Error 23.175
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
VLDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Very Low-density Lipoprotein (VLDL)-P
|
1.227 nmol/L
Standard Error 2.842
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
VLDL-Z is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: VLDL-Z
|
-1.607 nm
Standard Error 1.060
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
VLDL-TG is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: VLDL-Triglycerides (TG)
|
-4.393 mg/dL
Standard Error 4.480
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
S-VLDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: S-VLDL-P
|
1.371 nmol/L
Standard Error 2.212
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
M-VLDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: M-VLDL-P
|
0.625 nmol/L
Standard Error 2.351
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
LM-VLDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: LM-VLDL-P
|
-0.214 nmol/L
Standard Error 2.245
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
L-VLDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: L-VLDL-P
|
-0.900 nmol/L
Standard Error 0.633
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
IDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Intermediate-density Lipoprotein (IDL)-P
|
-11.763 nmol/L
Standard Error 19.357
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
ApoA1 is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Apolipoprotein A1 (ApoA1)
|
0.939 mg/dL
Standard Error 2.170
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
ApoB is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Apolipoprotein B (ApoB)
|
0.308 mg/dL
Standard Error 1.519
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
TRLTG is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: TRLTG
|
-5.142 mg/dL
Standard Error 5.655
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
TRLC is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: (Triglyceride-Rich Lipoprotein Cholesterol) TRLC
|
-0.352 mg/dL
Standard Error 1.215
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
TRLP is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: (Triglyceride-Rich Lipoprotein) TRLP
|
0.283 nmol/L
Standard Error 6.945
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
VS-TRLP is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: VS-TRLP
|
0.445 nmol/L
Standard Error 7.569
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
S-TRLP is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: S-TRLP
|
0.534 nmol/L
Standard Error 4.778
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
M-TRLP is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: M-TRLP
|
0.115 nmol/L
Standard Error 1.616
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
L-TRLP is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: L-TRLP
|
-0.811 nmol/L
Standard Error 0.663
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
VL-TRLP is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: VL-TRLP
|
-0.000 nmol/L
Standard Error 0.009
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Insulin is a marker of glucose metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Insulin
|
159.448 ng/ml
Standard Error 120.095
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
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).
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
|
0.551 index
Standard Error 0.791
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Glucose is a marker of metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Glucose
|
2.615 mg/dL
Standard Error 4.074
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
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.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Diabetes Risk Index (DRI)
|
-2.978 index
Standard Error 1.551
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
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.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Lipoprotein Insulin Resistance Index (LP-IR)
|
-0.763 index
Standard Error 2.679
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Leptin is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Leptin
|
-84.193 ng/ml
Standard Error 1232.360
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Adiponectin is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=59 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Adiponectin
|
-1.430 µg/ml
Standard Error 1.521
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Fetuin A is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=57 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Fetuin A
|
-50.732 µg/ml
Standard Error 24.231
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Citrate is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Citrate
|
0.429 µmol/L
Standard Error 2.921
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Valine is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Valine
|
-14.301 µmol/L
Standard Error 5.858
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Leucine is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Leucine
|
-9.185 µmol/L
Standard Error 4.509
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Isoleucine is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Isoleucine
|
-6.018 µmol/L
Standard Error 2.462
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Alanine is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Alanine
|
-20.059 µmol/L
Standard Error 18.497
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Branched-chain amino acids (BCAA) is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: BCAA
|
-29.505 µmol/L
Standard Error 11.118
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Ketone Bodies are markers of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Ketone Bodies
|
-30.319 µmol/L
Standard Error 33.598
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Beta Hydroxybutyrate is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Beta Hydroxybutyrate
|
-13.859 µmol/L
Standard Error 23.337
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Acetoacetic Acid is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Acetoacetic Acid
|
0.711 µmol/L
Standard Error 1.134
|
—
|
—
|
PRIMARY outcome
Timeframe: After the completion of week 16 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Acetone is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=58 Participants
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.
|
Week 52 vs. Baseline
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Baseline and Week 16: Acetone
|
-17.171 µmol/L
Standard Error 11.389
|
—
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
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.
Outcome measures
| Measure |
Apremilast
n=57 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
n=38 Participants
Assessment of differences between Week 52 and 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
|
-10.681 cm^2
Standard Error 3.052
|
-12.519 cm^2
Standard Error 4.898
|
2.189 cm^2
Standard Error 3.517
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
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.
Outcome measures
| Measure |
Apremilast
n=57 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
n=38 Participants
Assessment of differences between Week 52 and 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
|
-19.857 cm^2
Standard Error 5.405
|
-19.585 cm^2
Standard Error 7.170
|
0.638 cm^2
Standard Error 6.133
|
SECONDARY outcome
Timeframe: Baseline, week 16, and week 52.Population: The number of subjects analyzed reflect availability of analyzable samples.
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).
Outcome measures
| Measure |
Apremilast
n=60 Participants
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.
|
Week 52 vs. Baseline
n=39 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Physician Reported Outcomes: Psoriasis Area and Severity Index (PASI)
|
-10.778 score on a scale
Standard Error 0.852
|
-9.903 score on a scale
Standard Error 1.095
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 16, and week 52.Population: The number of subjects analyzed reflect availability of analyzable samples.
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.
Outcome measures
| Measure |
Apremilast
n=60 Participants
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.
|
Week 52 vs. Baseline
n=39 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Physician Reported Outcomes: Physician Global Assessment (PGA)
|
-1.200 score on a scale
Standard Error 0.106
|
-1.067 score on a scale
Standard Error 0.169
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 16, and week 52.Population: The number of subjects analyzed reflect availability of analyzable samples.
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.
Outcome measures
| Measure |
Apremilast
n=60 Participants
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.
|
Week 52 vs. Baseline
n=39 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Patient Reported Outcomes: Dermatology Life Quality Index (DLQI)
|
-6.050 score on a scale
Standard Error 0.723
|
-5.692 score on a scale
Standard Error 1.125
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 16, and week 52.Population: The number of subjects analyzed reflect availability of analyzable samples.
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).
Outcome measures
| Measure |
Apremilast
n=60 Participants
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.
|
Week 52 vs. Baseline
n=39 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Patient Reported Outcomes: Pruritis by Visual Analog Scales (VAS)
|
-27.527 score on a scale
Standard Error 4.349
|
-19.110 score on a scale
Standard Error 6.249
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Secondary analysis will consist of comparisons of vascular inflammation of the five aortic segments using TBR between week 52, 16, and baseline.
Outcome measures
| Measure |
Apremilast
n=57 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
n=38 Participants
Assessment of differences between Week 52 and 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
|
-0.067 ratio
Standard Error 0.040
|
-0.099 ratio
Standard Error 0.046
|
0.028 ratio
Standard Error 0.039
|
|
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
|
-0.080 ratio
Standard Error 0.047
|
0.010 ratio
Standard Error 0.036
|
|
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
|
-0.057 ratio
Standard Error 0.041
|
-0.019 ratio
Standard Error 0.042
|
|
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
|
-0.075 ratio
Standard Error 0.042
|
-0.017 ratio
Standard Error 0.043
|
|
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
|
-0.118 ratio
Standard Error 0.073
|
-0.038 ratio
Standard Error 0.052
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Secondary analysis will consist of comparisons of total vascular inflammation of the aorta using TBR between week 52, 16, and baseline.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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 0.040
|
-0.016 ratio
Standard Error 0.038
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Ferritin is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Ferritin
|
-22.645 ng/ml
Standard Error 9.287
|
-1.736 ng/ml
Standard Error 5.680
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
CRP is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): CRP
|
36.050 µg/ml
Standard Error 1043.600
|
-246.058 µg/ml
Standard Error 988.627
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
ICAM-1 is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
292.802 µg/ml
Standard Error 662.249
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
SAA is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): SAA
|
1586.025 µg/ml
Standard Error 3114.549
|
2799.836 µg/ml
Standard Error 2695.059
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
VCAM-1 is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VCAM-1
|
10.253 µg/ml
Standard Error 10.220
|
24.967 µg/ml
Standard Error 11.215
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
IFN-gamma is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
4.717 pg/ml
Standard Error 4.194
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
IL-1b is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
0.624 pg/ml
Standard Error 0.517
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
IL-10 is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
0.689 pg/ml
Standard Error 0.551
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
IL-17A is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
0.141 pg/ml
Standard Error 0.294
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
IL-6 is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
18.344 pg/ml
Standard Error 21.769
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
IL-8 is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
330.646 pg/ml
Standard Error 330.466
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
IL-9 is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
0.080 pg/ml
Standard Error 0.070
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
MCP-1 is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
78.605 pg/ml
Standard Error 67.289
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
TNF-alpha is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
72.650 pg/ml
Standard Error 62.065
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
IL2RA is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL2RA
|
-1.557 ng/ml
Standard Error 2.432
|
0.782 ng/ml
Standard Error 1.618
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
GlycA is a marker of inflammation.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): GlycA
|
4.324 µmol/L
Standard Error 7.836
|
-8.703 µmol/L
Standard Error 6.533
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
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).
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
-0.111 unitless measure
Standard Error 0.036
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Triglyceride is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Triglyceride
|
4.684 mg/dL
Standard Error 7.448
|
12.526 mg/dL
Standard Error 6.936
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Total Cholesterol is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
7.474 mg/dL
Standard Error 4.302
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
HDL-C is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HDL-C
|
1.842 mg/dL
Standard Error 1.100
|
1.711 mg/dL
Standard Error 1.173
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
HDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
1.092 µmol/L
Standard Error 0.879
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
HDL-Z is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HDL-Z
|
0.053 nm
Standard Error 0.060
|
0.089 nm
Standard Error 0.055
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
S-HDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-HDL-P
|
0.434 µmol/L
Standard Error 0.910
|
0.118 µmol/L
Standard Error 0.902
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
M-HDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
0.500 µmol/L
Standard Error 0.830
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
LM-HDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
1.061 µmol/L
Standard Error 0.757
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
L-HDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
0.503 µmol/L
Standard Error 0.288
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
LDL-C is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
4.737 mg/dL
Standard Error 4.358
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
LDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
78.105 nmol/L
Standard Error 34.245
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
LDL-Z is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LDL-Z
|
0.037 nm
Standard Error 0.113
|
-0.118 nm
Standard Error 0.091
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
S-LDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
53.605 nmol/L
Standard Error 24.610
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
L-LDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
-1.658 µmol/L
Standard Error 32.843
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
VL-LDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
71.605 nmol/L
Standard Error 31.228
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
VLDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
0.645 nmol/L
Standard Error 3.879
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
VLDL-Z is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VLDL-Z
|
-0.039 nm
Standard Error 1.347
|
3.113 nm
Standard Error 1.177
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
VLDL-TG is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
10.458 mg/dL
Standard Error 5.958
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
S-VLDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
-1.842 nmol/L
Standard Error 2.876
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
M-VLDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
1.008 nmol/L
Standard Error 2.507
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
LM-VLDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
2.432 nmol/L
Standard Error 2.534
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
L-VLDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
1.724 nmol/L
Standard Error 0.787
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
IDL-P is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
18.211 nmol/L
Standard Error 27.738
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
ApoA1 is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): ApoA1
|
5.792 mg/dL
Standard Error 2.799
|
5.272 mg/dL
Standard Error 3.011
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
ApoB is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): ApoB
|
2.225 mg/dL
Standard Error 2.568
|
3.360 mg/dL
Standard Error 2.443
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
TRLTG is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLTG
|
4.520 mg/dL
Standard Error 8.180
|
14.465 mg/dL
Standard Error 7.589
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
TRLC is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLC
|
1.547 mg/dL
Standard Error 1.902
|
2.598 mg/dL
Standard Error 1.742
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
TRLP is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLP
|
5.539 nmol/L
Standard Error 10.787
|
8.555 nmol/L
Standard Error 8.946
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
VS-TRLP is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
7.361 nmol/L
Standard Error 9.130
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
S-TRLP is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
-2.990 nmol/L
Standard Error 7.959
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
M-TRLP is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
2.204 nmol/L
Standard Error 1.768
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
L-TRLP is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
1.981 nmol/L
Standard Error 0.960
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
VL-TRLP is a marker of lipid function and metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
-0.002 nmol/L
Standard Error 0.008
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Insulin is a marker of glucose metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Insulin
|
421.436 ng/ml
Standard Error 361.693
|
330.523 ng/ml
Standard Error 334.064
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
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).
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HOMA-IR
|
1.814 index
Standard Error 1.438
|
0.753 index
Standard Error 1.471
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Glucose is a marker of glucose metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Glucose
|
8.032 mg/dL
Standard Error 7.746
|
2.604 mg/dL
Standard Error 6.386
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
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.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): DRI
|
-2.834 index
Standard Error 1.875
|
1.765 index
Standard Error 1.865
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
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.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LP-IR
|
-1.158 index
Standard Error 3.219
|
2.684 index
Standard Error 2.474
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Leptin is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Leptin
|
-498.841 ng/ml
Standard Error 1993.620
|
304.320 ng/ml
Standard Error 1149.111
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Adiponectin is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=38 Participants
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.
|
Week 52 vs. Baseline
n=38 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Adiponectin
|
-2.106 µg/ml
Standard Error 1.975
|
1.268 µg/ml
Standard Error 1.353
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Fetuin A is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
36.686 µg/ml
Standard Error 26.223
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Citrate is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Citrate
|
-5.547 µmol/L
Standard Error 3.643
|
-4.766 µmol/L
Standard Error 3.684
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Valine is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Valine
|
-12.589 µmol/L
Standard Error 7.799
|
6.269 µmol/L
Standard Error 7.017
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Leucine is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Leucine
|
-8.223 µmol/L
Standard Error 5.198
|
1.313 µmol/L
Standard Error 5.585
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Isoleucine is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Isoleucine
|
-3.541 µmol/L
Standard Error 3.519
|
5.203 µmol/L
Standard Error 4.025
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Alanine is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Alanine
|
23.209 µmol/L
Standard Error 24.631
|
39.496 µmol/L
Standard Error 28.893
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
BCAA is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): BCAA
|
-24.353 µmol/L
Standard Error 14.136
|
12.785 µmol/L
Standard Error 14.474
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Ketone Bodies are markers of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
-48.175 µmol/L
Standard Error 42.608
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Beta Hydroxybutyrate is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
-38.228 µmol/L
Standard Error 29.792
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Acetoacetic Acid is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
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
|
0.993 µmol/L
Standard Error 1.936
|
—
|
SECONDARY outcome
Timeframe: After the completion of week 52 visit by all study participants.Population: The number of subjects analyzed reflect availability of analyzable samples.
Acetone is a marker of adipose dysfunction and general metabolism.
Outcome measures
| Measure |
Apremilast
n=37 Participants
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.
|
Week 52 vs. Baseline
n=37 Participants
Assessment of difference between Week 52 and Baseline
|
Week 52 vs. Week 16
Assessment of differences between Week 52 and Week 16
|
|---|---|---|---|
|
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Acetone
|
-32.489 µmol/L
Standard Error 12.565
|
-10.939 µmol/L
Standard Error 12.987
|
—
|
Adverse Events
Apremilast
Serious events: 6 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Apremilast
n=70 participants at risk
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.
|
|---|---|
|
Vascular disorders
Stroke
|
1.4%
1/70 • Number of events 1 • Baseline to Week 52
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
1/70 • Number of events 1 • Baseline to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Soft tissue mass
|
1.4%
1/70 • Number of events 1 • Baseline to Week 52
|
|
General disorders
Hospitalization due to fall
|
2.9%
2/70 • Number of events 2 • Baseline to Week 52
|
|
Musculoskeletal and connective tissue disorders
Fracture due to fall
|
1.4%
1/70 • Number of events 1 • Baseline to Week 52
|
Other adverse events
| Measure |
Apremilast
n=70 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
15.7%
11/70 • Baseline to Week 52
|
|
Gastrointestinal disorders
Nausea
|
20.0%
14/70 • Baseline to Week 52
|
|
General disorders
Headache
|
15.7%
11/70 • Baseline to Week 52
|
|
Infections and infestations
Upper respiratory infection
|
7.1%
5/70 • Baseline to Week 52
|
|
General disorders
Dizziness
|
5.7%
4/70 • Baseline to Week 52
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place