Trial Outcomes & Findings for Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis (NCT NCT02690701)
NCT ID: NCT02690701
Last Updated: 2021-01-05
Results Overview
Change from baseline in the target to background ratio from the whole aorta. Effect of secukinumab 300 mg subcutaneous (sc) compared to placebo on aortic vascular inflammation with respect to the change from baseline in the target (arterial vascular uptake) to background (venous blood pool) ratio from the aorta. The primary analysis time point was at Week 12. Increased aortic vascular inflammation as measured by (18F) fluorodeoxyglucose positron emission tomography with computer assisted tomography (FDG-PET/CT)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
91 participants
Primary outcome timeframe
baseline, 12 weeks
Results posted on
2021-01-05
Participant Flow
Randomized Set consisted of all 91 participants who were randomly assigned to a treatment group
Participant milestones
| Measure |
Secukinumab
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Treatment Period 1
STARTED
|
46
|
45
|
|
Treatment Period 1
COMPLETED
|
44
|
42
|
|
Treatment Period 1
NOT COMPLETED
|
2
|
3
|
|
Treatment Period 2
STARTED
|
44
|
42
|
|
Treatment Period 2
COMPLETED
|
41
|
37
|
|
Treatment Period 2
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Secukinumab
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Treatment Period 1
Adverse Event
|
2
|
2
|
|
Treatment Period 1
Withdrawal by Subject
|
0
|
1
|
|
Treatment Period 2
Adverse Event
|
2
|
0
|
|
Treatment Period 2
Lack of Efficacy
|
1
|
0
|
|
Treatment Period 2
Lost to Follow-up
|
0
|
2
|
|
Treatment Period 2
Withdrawal by Subject
|
0
|
2
|
|
Treatment Period 2
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
80 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
36 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: baseline, 12 weeksPopulation: Full Analysis Set (FAS) included all participants assigned medication. Patients inappropriately randomized (eg, IRT was called in error for randomization of a screen failed patient) were excluded from this analysis set. Following intent-to-treat principle, participants were analyzed according to treatment they were assigned to at randomization
Change from baseline in the target to background ratio from the whole aorta. Effect of secukinumab 300 mg subcutaneous (sc) compared to placebo on aortic vascular inflammation with respect to the change from baseline in the target (arterial vascular uptake) to background (venous blood pool) ratio from the aorta. The primary analysis time point was at Week 12. Increased aortic vascular inflammation as measured by (18F) fluorodeoxyglucose positron emission tomography with computer assisted tomography (FDG-PET/CT)
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Aortic Vascular Inflammation as Measured by FDG-PET/CT
Baseline
|
1.6615 target to background ratio (TBR)
Standard Deviation 0.37380
|
1.6333 target to background ratio (TBR)
Standard Deviation 0.33228
|
|
Aortic Vascular Inflammation as Measured by FDG-PET/CT
Change from Baseline at Week 12
|
0.0143 target to background ratio (TBR)
Standard Deviation 0.25520
|
0.0655 target to background ratio (TBR)
Standard Deviation 0.28086
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Change from baseline in Adiponectin to measure adiposity
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Change in Adiponectin Total
Baseline
|
18799.0 ng/mL
Standard Deviation 18608.48
|
19475.00 ng/mL
Standard Deviation 18343.00
|
|
Change in Adiponectin Total
Change from Baseline at Week 12
|
1594.90 ng/mL
Standard Deviation 15146.84
|
-1076.40 ng/mL
Standard Deviation 14565.60
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Change from baseline in Apolipoprotein B levels, a marker predictive of diabetes
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Change in Apolipoprotein B
Baseline
|
0.1014 ng/mL
Standard Deviation 0.04651
|
0.1033 ng/mL
Standard Deviation 0.04451
|
|
Change in Apolipoprotein B
Change from Baseline at Week 12
|
0.0020 ng/mL
Standard Deviation 0.06331
|
0.0017 ng/mL
Standard Deviation 0.04835
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Change from baseline in C reactive protein (CRP), a measure of inflammation
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Change in CRP
Baseline
|
6.1525 mg/L
Standard Deviation 8.23016
|
7.8676 mg/L
Standard Deviation 7.59860
|
|
Change in CRP
Change from Baseline at Week 12
|
-1.0016 mg/L
Standard Deviation 9.45281
|
1.1622 mg/L
Standard Deviation 15.84088
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Change from baseline in Cholesterol level
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Change in Cholesterol
Baseline
|
179.350 mg/dL
Standard Deviation 30.01243
|
178.707 mg/dL
Standard Deviation 38.92573
|
|
Change in Cholesterol
Change from Baseline at Week 12
|
10.6000 mg/dL
Standard Deviation 30.27379
|
-8.4878 mg/dL
Standard Deviation 35.18247
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Change from baseline in Fetuin A, a marker predictive of diabetes
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Change in Fetuin A
Baseline
|
988677.800781 ng/mL
Standard Deviation 488494.3491043
|
1169947.724848 ng/mL
Standard Deviation 79644.6884632
|
|
Change in Fetuin A
Change from Baseline at Week 12
|
90810.212003 ng/mL
Standard Deviation 444791.4700461
|
45731.298018 ng/mL
Standard Deviation 452743.5932412
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Change from baseline in Ferritin, a marker predictive of diabetes
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Change in Ferritin
Baseline
|
111.953 ng/mL
Standard Deviation 91.17931
|
122.040 ng/mL
Standard Deviation 114.8715
|
|
Change in Ferritin
Change from Baseline at Week 12
|
-6.1006 ng/mL
Standard Deviation 60.71995
|
-17.118 ng/mL
Standard Deviation 63.86703
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Change from baseline in glycoprotein acetylation (GlycA), a marker of inflammation
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Change in GlycA
Baseline
|
413.860 μmol/L
Standard Deviation 65.34929
|
439.622 μmol/L
Standard Deviation 60.44873
|
|
Change in GlycA
Change from Baseline at Week 12
|
0.5152 μmol/L
Standard Deviation 59.46394
|
-1.5420 μmol/L
Standard Deviation 40.25958
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Change from baseline in High Density Lipoprotein (HDL) Cholesterol, a cardiometabolic biomarker
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Change in HDL Cholesterol
Baseline
|
43.3000 mg/dL
Standard Deviation 10.20357
|
43.0732 mg/dL
Standard Deviation 12.52276
|
|
Change in HDL Cholesterol
Change from Baseline at Week 12
|
-0.7500 mg/dL
Standard Deviation 8.80195
|
-1.1220 mg/dL
Standard Deviation 8.10924
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Change from baseline in High Density Lipoprotein (HDL) Cholesterol (cholesterol efflux) , a cardiometabolic biomarker Ratio of the pleated serum to removal of Cholesterol
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Change in HDL Function (Cholesterol Efflux)
Baseline
|
0.9535 ratio
Standard Deviation 0.18986
|
1.0456 ratio
Standard Deviation 0.17819
|
|
Change in HDL Function (Cholesterol Efflux)
Change from Baseline at Week 12
|
0.1473 ratio
Standard Deviation 0.23262
|
0.0541 ratio
Standard Deviation 0.21902
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Change from baseline in High Density Lipoprotein (HDL) Cholesterol Particle Total
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
HDL Particle Total
Baseline
|
29.2875 μmol/L
Standard Deviation 5.38184
|
29.3634 μmol/L
Standard Deviation 6.27442
|
|
HDL Particle Total
Change from Baseline at Week 12
|
-0.1375 μmol/L
Standard Deviation 5.22900
|
-0.1707 μmol/L
Standard Deviation 5.12973
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Change from baseline in High Density Lipoprotein (HDL) Cholesterol size
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
HDL Size
Baseline
|
8.9350 nm
Standard Deviation 0.53280
|
8.9585 nm
Standard Deviation 0.56656
|
|
HDL Size
Change from Baseline at Week 12
|
0.0500 nm
Standard Deviation 0.47932
|
0.0073 nm
Standard Deviation 0.34161
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) Insulin \[uIU/mL (mU/L)\] x Glucose (mg/dL) = HOMA-IR
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
HOMA-IR
Baseline
|
3.4901 HOMA-IR units
Standard Deviation 3.02479
|
5.5112 HOMA-IR units
Standard Deviation 6.22334
|
|
HOMA-IR
Change from Baseline at Week 12
|
0.9563 HOMA-IR units
Standard Deviation 2.23669
|
-1.2764 HOMA-IR units
Standard Deviation 5.13505
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Interleukin-2 Receptor A (IL-2RA) is a marker predictive of diabetes
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Change in IL-2 Receptor A
Baseline
|
25.5554 pg/mL
Standard Deviation 59.47232
|
21.0665 pg/mL
Standard Deviation 61.46295
|
|
Change in IL-2 Receptor A
Change from Baseline at Week 12
|
-3.3606 pg/mL
Standard Deviation 38.52458
|
-1.1162 pg/mL
Standard Deviation 6.31189
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Interleukin-18 (IL-18) is a marker predictive of diabetes
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Change in IL-18
Change from Baseline at Week 12
|
34555.1 pg/mL
Standard Deviation 231199.6
|
-627.77 pg/mL
Standard Deviation 1874.377
|
|
Change in IL-18
Baseline
|
1259.45 pg/mL
Standard Deviation 1910.327
|
1308.47 pg/mL
Standard Deviation 2454.672
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Interleukin 6 (IL-6) is a marker of inflammation
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Change in IL-6
Baseline
|
5.6477 pg/mL
Standard Deviation 20.81242
|
1.6658 pg/mL
Standard Deviation 1.50954
|
|
Change in IL-6
Change from Baseline at Week 12
|
0.1334 pg/mL
Standard Deviation 29.35524
|
-0.0900 pg/mL
Standard Deviation 1.78692
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Intermediate-density lipoprotein (IDL) particle is a marker of cardiometabolic function
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Change in Intermediate-Density Lipoprotein (IDL) Particle
Baseline
|
284.350 nmol/mL
Standard Deviation 179.6482
|
271.049 nmol/mL
Standard Deviation 155.7413
|
|
Change in Intermediate-Density Lipoprotein (IDL) Particle
Change from Baseline at Week 12
|
47.0500 nmol/mL
Standard Deviation 167.6253
|
2.3902 nmol/mL
Standard Deviation 160.6046
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Change from baseline in Low-Density Lipoprotein (LDL) Cholesterol as a marker of cardiometabolic function
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Change LDL Cholesterol
Baseline
|
122.475 mg/dL
Standard Deviation 28.86040
|
121.049 mg/dL
Standard Deviation 36.39708
|
|
Change LDL Cholesterol
Change from Baseline at Week 12
|
9.9750 mg/dL
Standard Deviation 29.84532
|
-6.2927 mg/dL
Standard Deviation 34.42401
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Change from baseline in Leptin a marker of adiposity
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Change in Leptin
Baseline
|
19913.4 pg/mL
Standard Deviation 21835.66
|
36813.3 pg/mL
Standard Deviation 62138.25
|
|
Change in Leptin
Change from Baseline at Week 12
|
-1886.0 pg/mL
Standard Deviation 11701.00
|
-5595.9 pg/mL
Standard Deviation 17042.08
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Change from baseline in Low Density Lipoprotein (LDL) Cholesterol Particle Total
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
LDL Particle Total
Baseline
|
1236.35 nmol/L
Standard Deviation 317.9542
|
1263.00 nmol/L
Standard Deviation 447.3457
|
|
LDL Particle Total
Change from Baseline at Week 12
|
114.250 nmol/L
Standard Deviation 294.8695
|
-111.39 nmol/L
Standard Deviation 343.2109
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Change from baseline in Low Density Lipoprotein (LDL) Cholesterol size
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
LDL Size
Baseline
|
21.2200 nm
Standard Deviation 0.74977
|
21.1171 nm
Standard Deviation 0.76384
|
|
LDL Size
Change from Baseline at Week 12
|
-0.0025 nm
Standard Deviation 0.70036
|
0.1439 nm
Standard Deviation 0.53807
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Triglycerides are a marker of cardiometabolic function
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Change in Triglycerides
Baseline
|
123.200 mg/dL
Standard Deviation 52.90398
|
125.293 mg/dL
Standard Deviation 79.10633
|
|
Change in Triglycerides
Change from Baseline at Week 12
|
11.5000 mg/dL
Standard Deviation 62.56279
|
-10.732 mg/dL
Standard Deviation 60.25281
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Change in Tumor necrosis factor (TNF, tumor necrosis factor alpha, TNFα is a marker of inflammation Also written as TNF-alpha
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Change in TNF-α
Baseline
|
2.3919 pg/mL
Standard Deviation 1.79049
|
2.8089 pg/mL
Standard Deviation 4.11492
|
|
Change in TNF-α
Change from Baseline at Week 12
|
-0.3577 pg/mL
Standard Deviation 1.52948
|
-0.9818 pg/mL
Standard Deviation 3.85715
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Change in Very-low-density lipoprotein (VLDL) cholesterol level
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Change VLDL Particle Total
Baseline
|
52.9125 nmol/L
Standard Deviation 26.92102
|
54.5829 nmol/L
Standard Deviation 27.57024
|
|
Change VLDL Particle Total
Change from Baseline at Week 12
|
3.2500 nmol/L
Standard Deviation 28.56421
|
3.2024 nmol/L
Standard Deviation 25.40299
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Change from baseline in Very Low Density Lipoprotein (VLDL) Cholesterol size
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
VLDL Size
Baseline
|
51.5650 nm
Standard Deviation 9.11152
|
50.1195 nm
Standard Deviation 9.51641
|
|
VLDL Size
Change from Baseline at Week 12
|
-0.3950 nm
Standard Deviation 9.30271
|
-0.7927 nm
Standard Deviation 7.72572
|
SECONDARY outcome
Timeframe: week 12Population: FAS
Percentage of participants with PASI75 response (yes, no) PASI75 response = at least a 75% improvement (reduction) in PASI score compared to baseline Psoriasis Area and Severity Index ( PASI) is a tool for measuring the 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 |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Area and Severity Index 75 (PASI 75)
|
84.8 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: week 12Population: FAS
Percentage of participants with PASI90 response (yes, no) PASI90 response = at least a 90\& improvement (reduction) in PASI score compared to baseline
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Psoriasis Area and Severity Index 90 (PASI 90)
|
73.9 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: week 12Population: FAS
Percentage of participants with PASI100 response (yes, no) PASI100 response = complete clearing of psoriasis
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Psoriasis Area and Severity Index 100 (PASI100)
|
37.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: week 12Population: FAS
percentage of participants with IGA mod 2011 score of 0 or 1 (yes, no) Investigator's Global Assessment modified 2011 (IGA mod 2011) score of 0 or 1 Statistical analysis (Cochran-Mantel-Haenszel test) of Novartis Investigator's Global Assessment Modified 2011 0 or 1 response by visit (Non-responder Imputation)
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Investigator's Global Assessment Modified 2011 (IGA Mod 2011) Score of 0 or 1
|
78.3 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: FAS
Change from baseline in the DLQI total score Summary of analysis of change from baseline in DLQI at Week 12 and statistical analysis (using Analysis of Covariance) of change from baseline in DLQI at Week 12 The higher the score, the more quality of life is impaired. 0 - 1 no effect at all on patient's life 2 - 5 small effect on patient's life 6 - 10 moderate effect on patient's life 11 - 20 very large effect on patient's life 21 - 30 extremely large effect on patient's life
Outcome measures
| Measure |
Secukinumab
n=46 Participants
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
|
Placebo
n=45 Participants
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
|
|---|---|---|
|
Dermatology Life Quality Index (DLQI) Total Score
Baseline
|
12.30 scores on a scale
Standard Deviation 7.65
|
12.6 scores on a scale
Standard Deviation 7.21
|
|
Dermatology Life Quality Index (DLQI) Total Score
Change from baseline at Week 12
|
-9.4 scores on a scale
Standard Deviation 7.91
|
-0.5 scores on a scale
Standard Deviation 3.97
|
Adverse Events
Secukinumab 300 mg
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo/Secukinumab 300 mg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Total
Serious events: 5 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Secukinumab 300 mg
n=46 participants at risk
Secukinumab 300 mg
|
Placebo/Secukinumab 300 mg
n=45 participants at risk
Placebo/Secukinumab 300 mg
|
Total
n=91 participants at risk
Total
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
1/46 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
0.00%
0/45 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
1.1%
1/91 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
|
Injury, poisoning and procedural complications
Rib fracture
|
2.2%
1/46 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
0.00%
0/45 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
1.1%
1/91 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
2.2%
1/46 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
0.00%
0/45 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
1.1%
1/91 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.2%
1/46 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
0.00%
0/45 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
1.1%
1/91 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
|
Vascular disorders
Aortic stenosis
|
2.2%
1/46 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
0.00%
0/45 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
1.1%
1/91 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
Other adverse events
| Measure |
Secukinumab 300 mg
n=46 participants at risk
Secukinumab 300 mg
|
Placebo/Secukinumab 300 mg
n=45 participants at risk
Placebo/Secukinumab 300 mg
|
Total
n=91 participants at risk
Total
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
3/46 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
4.4%
2/45 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
5.5%
5/91 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
|
Infections and infestations
Bronchitis
|
6.5%
3/46 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
0.00%
0/45 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
3.3%
3/91 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
|
Infections and infestations
Nasopharyngitis
|
19.6%
9/46 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
15.6%
7/45 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
17.6%
16/91 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
|
Infections and infestations
Sinusitis
|
0.00%
0/46 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
6.7%
3/45 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
3.3%
3/91 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
|
Infections and infestations
Upper respiratory tract infection
|
13.0%
6/46 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
8.9%
4/45 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
11.0%
10/91 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.9%
5/46 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
6.7%
3/45 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
8.8%
8/91 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
|
Nervous system disorders
Dizziness
|
2.2%
1/46 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
6.7%
3/45 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
4.4%
4/91 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
|
Nervous system disorders
Headache
|
0.00%
0/46 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
8.9%
4/45 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
4.4%
4/91 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
1/46 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
8.9%
4/45 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
5.5%
5/91 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks
Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg. Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER