Trial Outcomes & Findings for Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab (NCT NCT02008890)
NCT ID: NCT02008890
Last Updated: 2019-01-04
Results Overview
The primary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
237 participants
Primary outcome timeframe
Baseline to Week 16
Results posted on
2019-01-04
Participant Flow
A total of 337 patients were screened, and 237 of these patients completed the screening phase and were randomized to treatment.
At baseline patients were randomized at 61 study centers to one of the three treatment groups in a 1:1:1 ratio.
Participant milestones
| Measure |
AIN457 150mg
Secukinumab 150mg at each dosing.
|
AIN457 300mg
Secukinumab 300mg at each dosing.
|
Placebo
Placebo at each dosing.
|
Placebo - AIN457 150 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
|
Placebo - AIN457 300 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
|
|---|---|---|---|---|---|
|
Period 1
STARTED
|
80
|
79
|
78
|
0
|
0
|
|
Period 1
COMPLETED
|
65
|
64
|
66
|
0
|
0
|
|
Period 1
NOT COMPLETED
|
15
|
15
|
12
|
0
|
0
|
|
Period 2
STARTED
|
65
|
64
|
10
|
27
|
28
|
|
Period 2
COMPLETED
|
38
|
49
|
9
|
13
|
20
|
|
Period 2
NOT COMPLETED
|
27
|
15
|
1
|
14
|
8
|
|
Extension Period
STARTED
|
31
|
36
|
0
|
10
|
17
|
|
Extension Period
COMPLETED
|
26
|
31
|
0
|
6
|
13
|
|
Extension Period
NOT COMPLETED
|
5
|
5
|
0
|
4
|
4
|
Reasons for withdrawal
| Measure |
AIN457 150mg
Secukinumab 150mg at each dosing.
|
AIN457 300mg
Secukinumab 300mg at each dosing.
|
Placebo
Placebo at each dosing.
|
Placebo - AIN457 150 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
|
Placebo - AIN457 300 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
|
|---|---|---|---|---|---|
|
Period 1
Withdrawal by Subject
|
7
|
7
|
5
|
0
|
0
|
|
Period 1
Pregnancy
|
1
|
0
|
0
|
0
|
0
|
|
Period 1
Physician Decision
|
1
|
0
|
1
|
0
|
0
|
|
Period 1
Adverse Event
|
6
|
8
|
6
|
0
|
0
|
|
Period 2
Adverse Event
|
12
|
7
|
0
|
5
|
5
|
|
Period 2
Withdrawal by Subject
|
11
|
8
|
0
|
7
|
2
|
|
Period 2
Physician Decision
|
4
|
0
|
0
|
2
|
1
|
|
Period 2
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
|
Extension Period
Withdrawal by Subject
|
3
|
2
|
0
|
4
|
2
|
|
Extension Period
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
|
Extension Period
Adverse Event
|
1
|
3
|
0
|
0
|
2
|
Baseline Characteristics
Randomized (Started)
Baseline characteristics by cohort
| Measure |
AIN457 150mg
n=80 Participants
Secukinumab 150mg at each dosing in period 1.
|
AIN457 300mg
n=79 Participants
Secukinumab 300mg at each dosing in period 1.
|
Placebo
n=78 Participants
Placebo at each dosing in period 1.
|
Total
n=237 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.7 Years
STANDARD_DEVIATION 13.68 • n=5 Participants • Randomized (Started)
|
50.6 Years
STANDARD_DEVIATION 14.77 • n=7 Participants • Randomized (Started)
|
52.9 Years
STANDARD_DEVIATION 11.33 • n=5 Participants • Randomized (Started)
|
51.4 Years
STANDARD_DEVIATION 13.33 • n=4 Participants • Randomized (Started)
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants • Randomized (Started)
|
64 Participants
n=7 Participants • Randomized (Started)
|
59 Participants
n=5 Participants • Randomized (Started)
|
186 Participants
n=4 Participants • Randomized (Started)
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants • Randomized (Started)
|
15 Participants
n=7 Participants • Randomized (Started)
|
19 Participants
n=5 Participants • Randomized (Started)
|
51 Participants
n=4 Participants • Randomized (Started)
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
78 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
232 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16Population: Full Analysis Set (FAS = Started). A patient with a missing ppPASI assessment at Week 16 was considered as a responder if he/she has met the response criterion already at the time of drop-out. Otherwise he/she was considered as a non-responder.
The primary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Outcome measures
| Measure |
AIN457 150mg
n=80 Participants
Secukinumab 150mg at each dosing.
|
AIN457 300mg
n=79 Participants
Secukinumab 300mg at each dosing
|
Placebo
n=78 Participants
Placebo at each dosing.
|
Placebo - AIN457 150 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
|
Placebo - AIN457 300 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
|
|---|---|---|---|---|---|
|
Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1)
|
17.5 percentage of participants
|
26.6 percentage of participants
|
14.1 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: FAS - Including only Patients with ppPASI Scores at Baseline and Week 16
A secondary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI). The mean change of ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Outcome measures
| Measure |
AIN457 150mg
n=68 Participants
Secukinumab 150mg at each dosing.
|
AIN457 300mg
n=69 Participants
Secukinumab 300mg at each dosing
|
Placebo
n=70 Participants
Placebo at each dosing.
|
Placebo - AIN457 150 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
|
Placebo - AIN457 300 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
|
|---|---|---|---|---|---|
|
ppPASI: Absolute Change From Baseline to Week 16
Baseline
|
21.79 units on a scale
Standard Deviation 8.211
|
23.01 units on a scale
Standard Deviation 10.787
|
23.10 units on a scale
Standard Deviation 10.198
|
—
|
—
|
|
ppPASI: Absolute Change From Baseline to Week 16
Change from Baseline to Week 16
|
-6.99 units on a scale
Standard Deviation 10.904
|
-9.74 units on a scale
Standard Deviation 12.130
|
-6.73 units on a scale
Standard Deviation 9.868
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: FAS
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Outcome measures
| Measure |
AIN457 150mg
n=80 Participants
Secukinumab 150mg at each dosing.
|
AIN457 300mg
n=79 Participants
Secukinumab 300mg at each dosing
|
Placebo
n=78 Participants
Placebo at each dosing.
|
Placebo - AIN457 150 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
|
Placebo - AIN457 300 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
|
|---|---|---|---|---|---|
|
Percentage of Participants With ppPASI 75 Response Over Time (Period 1)
Week 1
|
0 percentage of participants
|
1.3 percentage of participants
|
1.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With ppPASI 75 Response Over Time (Period 1)
Week 2
|
1.3 percentage of participants
|
1.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With ppPASI 75 Response Over Time (Period 1)
Week 3
|
2.6 percentage of participants
|
5.4 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With ppPASI 75 Response Over Time (Period 1)
Week 4
|
6.5 percentage of participants
|
9.1 percentage of participants
|
1.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With ppPASI 75 Response Over Time (Period 1)
Week 8
|
13.0 percentage of participants
|
13.3 percentage of participants
|
9.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants With ppPASI 75 Response Over Time (Period 1)
Week 12
|
14.7 percentage of participants
|
23.9 percentage of participants
|
10.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With ppPASI 75 Response Over Time (Period 1)
Week 16
|
17.5 percentage of participants
|
26.6 percentage of participants
|
14.1 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16 to Week 52Population: FAS - Including only patients entering period 2
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Outcome measures
| Measure |
AIN457 150mg
n=64 Participants
Secukinumab 150mg at each dosing.
|
AIN457 300mg
n=64 Participants
Secukinumab 300mg at each dosing
|
Placebo
n=10 Participants
Placebo at each dosing.
|
Placebo - AIN457 150 mg
n=27 Participants
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
|
Placebo - AIN457 300 mg
n=28 Participants
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
|
|---|---|---|---|---|---|
|
Percentage of Participants With ppPASI 75 Response Over Time (Period 2)
Week 16
|
18.8 percentage of participants
|
31.3 percentage of participants
|
90.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With ppPASI 75 Response Over Time (Period 2)
Week 20
|
20.3 percentage of participants
|
31.3 percentage of participants
|
80.0 percentage of participants
|
7.7 percentage of participants
|
17.9 percentage of participants
|
|
Percentage of Participants With ppPASI 75 Response Over Time (Period 2)
Week 24
|
30.2 percentage of participants
|
37.5 percentage of participants
|
80.0 percentage of participants
|
19.2 percentage of participants
|
38.5 percentage of participants
|
|
Percentage of Participants With ppPASI 75 Response Over Time (Period 2)
Week 32
|
36.4 percentage of participants
|
48.3 percentage of participants
|
80.0 percentage of participants
|
25.0 percentage of participants
|
44.0 percentage of participants
|
|
Percentage of Participants With ppPASI 75 Response Over Time (Period 2)
Week 40
|
44.4 percentage of participants
|
56.4 percentage of participants
|
70.0 percentage of participants
|
37.5 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With ppPASI 75 Response Over Time (Period 2)
Week 48
|
52.4 percentage of participants
|
58.0 percentage of participants
|
60.0 percentage of participants
|
40.0 percentage of participants
|
47.4 percentage of participants
|
|
Percentage of Participants With ppPASI 75 Response Over Time (Period 2)
Week 52
|
57.9 percentage of participants
|
58.8 percentage of participants
|
66.7 percentage of participants
|
50.0 percentage of participants
|
60.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52 to Week 148Population: FAS - Including only patients entering extension period (Placebo Week 16 responders not eligible)
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to each post-baseline visit was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Outcome measures
| Measure |
AIN457 150mg
n=31 Participants
Secukinumab 150mg at each dosing.
|
AIN457 300mg
n=36 Participants
Secukinumab 300mg at each dosing
|
Placebo
n=10 Participants
Placebo at each dosing.
|
Placebo - AIN457 150 mg
n=17 Participants
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
|
Placebo - AIN457 300 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
|
|---|---|---|---|---|---|
|
Percentage of Participants With ppPASI 75 Response Over Time (Extension Period)
Week 52
|
64.5 percentage of participants
|
63.9 percentage of participants
|
50.0 percentage of participants
|
64.7 percentage of participants
|
—
|
|
Percentage of Participants With ppPASI 75 Response Over Time (Extension Period)
Week 64
|
56.7 percentage of participants
|
66.7 percentage of participants
|
40.0 percentage of participants
|
82.4 percentage of participants
|
—
|
|
Percentage of Participants With ppPASI 75 Response Over Time (Extension Period)
Week 76
|
68.2 percentage of participants
|
67.7 percentage of participants
|
62.5 percentage of participants
|
60.0 percentage of participants
|
—
|
|
Percentage of Participants With ppPASI 75 Response Over Time (Extension Period)
Week 88
|
88.2 percentage of participants
|
80.0 percentage of participants
|
42.9 percentage of participants
|
75.0 percentage of participants
|
—
|
|
Percentage of Participants With ppPASI 75 Response Over Time (Extension Period)
Week 100
|
100.0 percentage of participants
|
75.0 percentage of participants
|
33.3 percentage of participants
|
54.5 percentage of participants
|
—
|
|
Percentage of Participants With ppPASI 75 Response Over Time (Extension Period)
Week 112
|
100.0 percentage of participants
|
75.0 percentage of participants
|
60.0 percentage of participants
|
66.7 percentage of participants
|
—
|
|
Percentage of Participants With ppPASI 75 Response Over Time (Extension Period)
Week 124
|
93.3 percentage of participants
|
78.3 percentage of participants
|
40.0 percentage of participants
|
70.0 percentage of participants
|
—
|
|
Percentage of Participants With ppPASI 75 Response Over Time (Extension Period)
Week 136
|
93.3 percentage of participants
|
77.3 percentage of participants
|
40.0 percentage of participants
|
66.7 percentage of participants
|
—
|
|
Percentage of Participants With ppPASI 75 Response Over Time (Extension Period)
Week 148
|
100.0 percentage of participants
|
78.3 percentage of participants
|
75.0 percentage of participants
|
77.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 16 (Period 1)Population: Safety Set
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Outcome measures
| Measure |
AIN457 150mg
n=80 Participants
Secukinumab 150mg at each dosing.
|
AIN457 300mg
n=79 Participants
Secukinumab 300mg at each dosing
|
Placebo
n=78 Participants
Placebo at each dosing.
|
Placebo - AIN457 150 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
|
Placebo - AIN457 300 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)
Nasopharyngitis
|
10.0 percentage of participants
|
20.3 percentage of participants
|
14.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)
Pustular psoriasis
|
12.5 percentage of participants
|
16.5 percentage of participants
|
5.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)
Headache
|
5.0 percentage of participants
|
12.7 percentage of participants
|
14.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)
Pruritus
|
6.3 percentage of participants
|
8.9 percentage of participants
|
5.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)
Psoriasis
|
6.3 percentage of participants
|
5.1 percentage of participants
|
3.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)
Urinary tract infection
|
2.5 percentage of participants
|
5.1 percentage of participants
|
3.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)
Cough
|
6.3 percentage of participants
|
3.8 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)
Folliculitis
|
3.8 percentage of participants
|
5.1 percentage of participants
|
1.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)
Nausea
|
3.8 percentage of participants
|
5.1 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)
Oral herpes
|
5.0 percentage of participants
|
1.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)
Rash pustular
|
5.0 percentage of participants
|
1.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16 to Week 52 (Period 2)Population: Safety Set - Including only patients entering period 2
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Outcome measures
| Measure |
AIN457 150mg
n=64 Participants
Secukinumab 150mg at each dosing.
|
AIN457 300mg
n=64 Participants
Secukinumab 300mg at each dosing
|
Placebo
n=10 Participants
Placebo at each dosing.
|
Placebo - AIN457 150 mg
n=27 Participants
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
|
Placebo - AIN457 300 mg
n=28 Participants
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Eczema
|
1.6 percentage of participants
|
9.4 percentage of participants
|
0.0 percentage of participants
|
7.4 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Psoriasis
|
3.1 percentage of participants
|
4.7 percentage of participants
|
20.0 percentage of participants
|
7.4 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Pruritus
|
3.1 percentage of participants
|
4.7 percentage of participants
|
10.0 percentage of participants
|
0.0 percentage of participants
|
7.1 percentage of participants
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Folliculitis
|
3.1 percentage of participants
|
6.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.6 percentage of participants
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Pain in extremity
|
0.0 percentage of participants
|
7.8 percentage of participants
|
0.0 percentage of participants
|
7.4 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Cough
|
0.0 percentage of participants
|
6.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.6 percentage of participants
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Sinusitis
|
0.0 percentage of participants
|
1.6 percentage of participants
|
10.0 percentage of participants
|
7.4 percentage of participants
|
3.6 percentage of participants
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Skin infection
|
1.6 percentage of participants
|
3.1 percentage of participants
|
0.0 percentage of participants
|
7.4 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Urinary tract infection
|
0.0 percentage of participants
|
4.7 percentage of participants
|
0.0 percentage of participants
|
7.4 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Pruritus generalised
|
1.6 percentage of participants
|
1.6 percentage of participants
|
0.0 percentage of participants
|
7.4 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Rash
|
0.0 percentage of participants
|
6.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Nasopharyngitis
|
12.5 percentage of participants
|
21.9 percentage of participants
|
10.0 percentage of participants
|
11.1 percentage of participants
|
21.4 percentage of participants
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Pustular psoriasis
|
18.8 percentage of participants
|
10.9 percentage of participants
|
10.0 percentage of participants
|
14.8 percentage of participants
|
21.4 percentage of participants
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Bronchitis
|
4.7 percentage of participants
|
9.4 percentage of participants
|
0.0 percentage of participants
|
3.7 percentage of participants
|
10.7 percentage of participants
|
|
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Headache
|
4.7 percentage of participants
|
6.3 percentage of participants
|
0.0 percentage of participants
|
3.7 percentage of participants
|
7.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52 to Week 148 (extension period)Population: Safety Set - including only patients entering the extension period
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Outcome measures
| Measure |
AIN457 150mg
n=41 Participants
Secukinumab 150mg at each dosing.
|
AIN457 300mg
n=53 Participants
Secukinumab 300mg at each dosing
|
Placebo
Placebo at each dosing.
|
Placebo - AIN457 150 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
|
Placebo - AIN457 300 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety)
Viral upper respiratory tract infection
|
12.2 percentage of participants
|
18.9 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety)
Headache
|
7.3 percentage of participants
|
5.7 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety)
Upper respiratory tract infection
|
2.4 percentage of participants
|
9.4 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety)
Urinary tract infection
|
9.8 percentage of participants
|
3.8 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety)
Diarrhoea
|
4.9 percentage of participants
|
5.7 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety)
Tonsillitis
|
2.4 percentage of participants
|
5.7 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety)
Ear infection
|
7.3 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety)
Oropharyngeal pain
|
0.0 percentage of participants
|
5.7 percentage of participants
|
—
|
—
|
—
|
Adverse Events
Initial AIN457 150 mg
Serious events: 9 serious events
Other events: 73 other events
Deaths: 0 deaths
Initial AIN457 300 mg
Serious events: 13 serious events
Other events: 73 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 53 other events
Deaths: 0 deaths
AIN457 150 mg in Any Period
Serious events: 11 serious events
Other events: 92 other events
Deaths: 0 deaths
AIN457 300 mg in Any Period
Serious events: 17 serious events
Other events: 94 other events
Deaths: 0 deaths
Any AIN457
Serious events: 28 serious events
Other events: 186 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Initial AIN457 150 mg
n=80 participants at risk
AEs for patients randomized to Secukinumab 150 mg at start of study.
|
Initial AIN457 300 mg
n=79 participants at risk
AEs for patients randomized to Secukinumab 300 mg at start of study.
|
Placebo
n=78 participants at risk
AEs for patients randomized to Placebo at start of study while treated with Placebo (AEs that occurred after re-randomization to Secukinumab are not counted in this group).
|
AIN457 150 mg in Any Period
n=107 participants at risk
AEs for patients initially randomized to AIN457 150mg and placebo non-responder re-randomized to AIN457 150 mg at Week 16
|
AIN457 300 mg in Any Period
n=107 participants at risk
AEs for patients initially randomized to AIN457 300mg and placebo non-responder re-randomized to AIN457 300 mg at Week 16
|
Any AIN457
n=214 participants at risk
Any Secukinumab
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Cardiac disorders
Cardiomyopathy
|
1.2%
1/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Cardiac disorders
Coronary artery stenosis
|
1.2%
1/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Cardiac disorders
Tachycardia
|
1.2%
1/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Gastrointestinal disorders
Abdominal mass
|
1.2%
1/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
General disorders
Drug ineffective
|
0.00%
0/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.00%
0/214 • Baseline to Week 148
|
|
Infections and infestations
Cellulitis
|
0.00%
0/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Infections and infestations
Erysipelas
|
0.00%
0/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.00%
0/214 • Baseline to Week 148
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Infections and infestations
Rash pustular
|
1.2%
1/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Infections and infestations
Superinfection bacterial
|
0.00%
0/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.00%
0/214 • Baseline to Week 148
|
|
Investigations
Aspartate aminotransferase increased
|
1.2%
1/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Investigations
Transaminases increased
|
0.00%
0/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
1.2%
1/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.00%
0/214 • Baseline to Week 148
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
1.2%
1/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.2%
1/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.2%
1/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
1.2%
1/80 • Baseline to Week 148
|
5.1%
4/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
3.7%
4/107 • Baseline to Week 148
|
2.3%
5/214 • Baseline to Week 148
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Vascular disorders
Hypotension
|
0.00%
0/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
Other adverse events
| Measure |
Initial AIN457 150 mg
n=80 participants at risk
AEs for patients randomized to Secukinumab 150 mg at start of study.
|
Initial AIN457 300 mg
n=79 participants at risk
AEs for patients randomized to Secukinumab 300 mg at start of study.
|
Placebo
n=78 participants at risk
AEs for patients randomized to Placebo at start of study while treated with Placebo (AEs that occurred after re-randomization to Secukinumab are not counted in this group).
|
AIN457 150 mg in Any Period
n=107 participants at risk
AEs for patients initially randomized to AIN457 150mg and placebo non-responder re-randomized to AIN457 150 mg at Week 16
|
AIN457 300 mg in Any Period
n=107 participants at risk
AEs for patients initially randomized to AIN457 300mg and placebo non-responder re-randomized to AIN457 300 mg at Week 16
|
Any AIN457
n=214 participants at risk
Any Secukinumab
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
1.2%
1/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
1.9%
4/214 • Baseline to Week 148
|
|
Cardiac disorders
Tachycardia
|
2.5%
2/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
1.9%
4/214 • Baseline to Week 148
|
|
Ear and labyrinth disorders
Vertigo
|
2.5%
2/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
2/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
2.8%
6/214 • Baseline to Week 148
|
|
Gastrointestinal disorders
Aphthous ulcer
|
1.2%
1/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
Gastrointestinal disorders
Constipation
|
3.8%
3/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
5/80 • Baseline to Week 148
|
10.1%
8/79 • Baseline to Week 148
|
5.1%
4/78 • Baseline to Week 148
|
4.7%
5/107 • Baseline to Week 148
|
8.4%
9/107 • Baseline to Week 148
|
6.5%
14/214 • Baseline to Week 148
|
|
Gastrointestinal disorders
Nausea
|
3.8%
3/80 • Baseline to Week 148
|
7.6%
6/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
3.7%
4/107 • Baseline to Week 148
|
6.5%
7/107 • Baseline to Week 148
|
5.1%
11/214 • Baseline to Week 148
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
2/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
1.9%
4/214 • Baseline to Week 148
|
|
General disorders
Asthenia
|
0.00%
0/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
General disorders
Chest pain
|
2.5%
2/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
General disorders
Fatigue
|
1.2%
1/80 • Baseline to Week 148
|
3.8%
3/79 • Baseline to Week 148
|
3.8%
3/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
1.9%
4/214 • Baseline to Week 148
|
|
General disorders
Feeling hot
|
0.00%
0/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
2.6%
2/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.00%
0/214 • Baseline to Week 148
|
|
General disorders
Injection site urticaria
|
0.00%
0/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
General disorders
Pyrexia
|
5.0%
4/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
3.7%
4/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
2.3%
5/214 • Baseline to Week 148
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
Infections and infestations
Bacterial vaginosis
|
2.5%
2/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
Infections and infestations
Bronchitis
|
6.2%
5/80 • Baseline to Week 148
|
7.6%
6/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
5.6%
6/107 • Baseline to Week 148
|
10.3%
11/107 • Baseline to Week 148
|
7.9%
17/214 • Baseline to Week 148
|
|
Infections and infestations
Cellulitis
|
1.2%
1/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
Infections and infestations
Conjunctivitis
|
5.0%
4/80 • Baseline to Week 148
|
3.8%
3/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
3.7%
4/107 • Baseline to Week 148
|
3.7%
4/107 • Baseline to Week 148
|
3.7%
8/214 • Baseline to Week 148
|
|
Infections and infestations
Cystitis
|
3.8%
3/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
3.7%
4/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
2.8%
6/214 • Baseline to Week 148
|
|
Infections and infestations
Ear infection
|
1.2%
1/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
3.7%
4/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
1.9%
4/214 • Baseline to Week 148
|
|
Infections and infestations
Eczema impetiginous
|
2.5%
2/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
Infections and infestations
Erysipelas
|
1.2%
1/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
Infections and infestations
Folliculitis
|
6.2%
5/80 • Baseline to Week 148
|
10.1%
8/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
4.7%
5/107 • Baseline to Week 148
|
8.4%
9/107 • Baseline to Week 148
|
6.5%
14/214 • Baseline to Week 148
|
|
Infections and infestations
Fungal skin infection
|
2.5%
2/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
1.9%
4/214 • Baseline to Week 148
|
|
Infections and infestations
Furuncle
|
2.5%
2/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
1.9%
4/214 • Baseline to Week 148
|
|
Infections and infestations
Gastroenteritis
|
2.5%
2/80 • Baseline to Week 148
|
3.8%
3/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
2.3%
5/214 • Baseline to Week 148
|
|
Infections and infestations
Impetigo
|
0.00%
0/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
Infections and infestations
Influenza
|
6.2%
5/80 • Baseline to Week 148
|
3.8%
3/79 • Baseline to Week 148
|
2.6%
2/78 • Baseline to Week 148
|
4.7%
5/107 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
3.7%
8/214 • Baseline to Week 148
|
|
Infections and infestations
Laryngitis
|
0.00%
0/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
2.6%
2/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.00%
0/214 • Baseline to Week 148
|
|
Infections and infestations
Localised infection
|
1.2%
1/80 • Baseline to Week 148
|
3.8%
3/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
1.9%
4/214 • Baseline to Week 148
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/80 • Baseline to Week 148
|
6.3%
5/79 • Baseline to Week 148
|
2.6%
2/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
4.7%
5/107 • Baseline to Week 148
|
2.3%
5/214 • Baseline to Week 148
|
|
Infections and infestations
Oral herpes
|
5.0%
4/80 • Baseline to Week 148
|
3.8%
3/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
3.7%
4/107 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
3.3%
7/214 • Baseline to Week 148
|
|
Infections and infestations
Otitis externa
|
2.5%
2/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
Infections and infestations
Paronychia
|
2.5%
2/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
Infections and infestations
Pharyngitis
|
3.8%
3/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
3.7%
4/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
2.3%
5/214 • Baseline to Week 148
|
|
Infections and infestations
Pharyngotonsillitis
|
1.2%
1/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
1.9%
4/214 • Baseline to Week 148
|
|
Infections and infestations
Rash pustular
|
3.8%
3/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
1.9%
4/214 • Baseline to Week 148
|
|
Infections and infestations
Sinusitis
|
1.2%
1/80 • Baseline to Week 148
|
3.8%
3/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
3.7%
4/107 • Baseline to Week 148
|
3.3%
7/214 • Baseline to Week 148
|
|
Infections and infestations
Skin bacterial infection
|
3.8%
3/80 • Baseline to Week 148
|
3.8%
3/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
3.7%
4/107 • Baseline to Week 148
|
3.3%
7/214 • Baseline to Week 148
|
|
Infections and infestations
Skin infection
|
1.2%
1/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
2.3%
5/214 • Baseline to Week 148
|
|
Infections and infestations
Staphylococcal skin infection
|
3.8%
3/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
1.9%
4/214 • Baseline to Week 148
|
|
Infections and infestations
Subcutaneous abscess
|
2.5%
2/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
Infections and infestations
Tinea pedis
|
1.2%
1/80 • Baseline to Week 148
|
3.8%
3/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
3.7%
4/107 • Baseline to Week 148
|
2.3%
5/214 • Baseline to Week 148
|
|
Infections and infestations
Tonsillitis
|
3.8%
3/80 • Baseline to Week 148
|
3.8%
3/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
4.7%
5/107 • Baseline to Week 148
|
3.7%
8/214 • Baseline to Week 148
|
|
Infections and infestations
Tooth abscess
|
1.2%
1/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
1.9%
4/214 • Baseline to Week 148
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
4/80 • Baseline to Week 148
|
8.9%
7/79 • Baseline to Week 148
|
5.1%
4/78 • Baseline to Week 148
|
3.7%
4/107 • Baseline to Week 148
|
7.5%
8/107 • Baseline to Week 148
|
5.6%
12/214 • Baseline to Week 148
|
|
Infections and infestations
Urinary tract infection
|
6.2%
5/80 • Baseline to Week 148
|
6.3%
5/79 • Baseline to Week 148
|
3.8%
3/78 • Baseline to Week 148
|
6.5%
7/107 • Baseline to Week 148
|
5.6%
6/107 • Baseline to Week 148
|
6.1%
13/214 • Baseline to Week 148
|
|
Infections and infestations
Viral upper respiratory tract infection
|
21.2%
17/80 • Baseline to Week 148
|
39.2%
31/79 • Baseline to Week 148
|
15.4%
12/78 • Baseline to Week 148
|
18.7%
20/107 • Baseline to Week 148
|
37.4%
40/107 • Baseline to Week 148
|
28.0%
60/214 • Baseline to Week 148
|
|
Infections and infestations
Vulvovaginal candidiasis
|
1.2%
1/80 • Baseline to Week 148
|
3.8%
3/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
1.9%
4/214 • Baseline to Week 148
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.2%
1/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
Investigations
Alanine aminotransferase increased
|
2.5%
2/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
1.9%
4/214 • Baseline to Week 148
|
|
Investigations
Blood pressure increased
|
1.2%
1/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
2.6%
2/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
2.5%
2/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.0%
4/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
3.8%
3/78 • Baseline to Week 148
|
3.7%
4/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
2.3%
5/214 • Baseline to Week 148
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
5/80 • Baseline to Week 148
|
5.1%
4/79 • Baseline to Week 148
|
6.4%
5/78 • Baseline to Week 148
|
5.6%
6/107 • Baseline to Week 148
|
3.7%
4/107 • Baseline to Week 148
|
4.7%
10/214 • Baseline to Week 148
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
4/80 • Baseline to Week 148
|
8.9%
7/79 • Baseline to Week 148
|
5.1%
4/78 • Baseline to Week 148
|
4.7%
5/107 • Baseline to Week 148
|
7.5%
8/107 • Baseline to Week 148
|
6.1%
13/214 • Baseline to Week 148
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.8%
3/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
3.7%
4/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
2.3%
5/214 • Baseline to Week 148
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
2/80 • Baseline to Week 148
|
8.9%
7/79 • Baseline to Week 148
|
7.7%
6/78 • Baseline to Week 148
|
3.7%
4/107 • Baseline to Week 148
|
6.5%
7/107 • Baseline to Week 148
|
5.1%
11/214 • Baseline to Week 148
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
1.2%
1/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
2.6%
2/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.47%
1/214 • Baseline to Week 148
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
2.5%
2/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
2.6%
2/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
Nervous system disorders
Dizziness
|
1.2%
1/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
2.6%
2/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
1.9%
4/214 • Baseline to Week 148
|
|
Nervous system disorders
Headache
|
8.8%
7/80 • Baseline to Week 148
|
15.2%
12/79 • Baseline to Week 148
|
12.8%
10/78 • Baseline to Week 148
|
8.4%
9/107 • Baseline to Week 148
|
14.0%
15/107 • Baseline to Week 148
|
11.2%
24/214 • Baseline to Week 148
|
|
Nervous system disorders
Migraine
|
2.5%
2/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
Nervous system disorders
Sciatica
|
2.5%
2/80 • Baseline to Week 148
|
3.8%
3/79 • Baseline to Week 148
|
2.6%
2/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
3.7%
4/107 • Baseline to Week 148
|
2.8%
6/214 • Baseline to Week 148
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
Psychiatric disorders
Depression
|
3.8%
3/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
2.6%
2/78 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
1.9%
4/214 • Baseline to Week 148
|
|
Psychiatric disorders
Insomnia
|
1.2%
1/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
2.6%
2/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
Renal and urinary disorders
Proteinuria
|
2.5%
2/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
5/80 • Baseline to Week 148
|
10.1%
8/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
4.7%
5/107 • Baseline to Week 148
|
8.4%
9/107 • Baseline to Week 148
|
6.5%
14/214 • Baseline to Week 148
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.2%
1/80 • Baseline to Week 148
|
5.1%
4/79 • Baseline to Week 148
|
2.6%
2/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
5.6%
6/107 • Baseline to Week 148
|
3.7%
8/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.2%
1/80 • Baseline to Week 148
|
5.1%
4/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
3.7%
4/107 • Baseline to Week 148
|
2.3%
5/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.8%
3/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
2.5%
2/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
2.5%
2/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
3.8%
3/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.8%
3/80 • Baseline to Week 148
|
8.9%
7/79 • Baseline to Week 148
|
3.8%
3/78 • Baseline to Week 148
|
4.7%
5/107 • Baseline to Week 148
|
6.5%
7/107 • Baseline to Week 148
|
5.6%
12/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.93%
2/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
3.8%
3/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
2.3%
5/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
2.5%
2/80 • Baseline to Week 148
|
1.3%
1/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.5%
6/80 • Baseline to Week 148
|
13.9%
11/79 • Baseline to Week 148
|
5.1%
4/78 • Baseline to Week 148
|
5.6%
6/107 • Baseline to Week 148
|
12.1%
13/107 • Baseline to Week 148
|
8.9%
19/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
2.5%
2/80 • Baseline to Week 148
|
2.5%
2/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
3.7%
4/107 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
2.8%
6/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
6.2%
5/80 • Baseline to Week 148
|
8.9%
7/79 • Baseline to Week 148
|
6.4%
5/78 • Baseline to Week 148
|
6.5%
7/107 • Baseline to Week 148
|
6.5%
7/107 • Baseline to Week 148
|
6.5%
14/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
23.8%
19/80 • Baseline to Week 148
|
20.3%
16/79 • Baseline to Week 148
|
5.1%
4/78 • Baseline to Week 148
|
22.4%
24/107 • Baseline to Week 148
|
21.5%
23/107 • Baseline to Week 148
|
22.0%
47/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
1/80 • Baseline to Week 148
|
6.3%
5/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
5.6%
6/107 • Baseline to Week 148
|
3.3%
7/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
3.8%
3/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
1.3%
1/78 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
2.5%
2/80 • Baseline to Week 148
|
0.00%
0/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
1.9%
2/107 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/80 • Baseline to Week 148
|
3.8%
3/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.00%
0/107 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
1.4%
3/214 • Baseline to Week 148
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/80 • Baseline to Week 148
|
5.1%
4/79 • Baseline to Week 148
|
0.00%
0/78 • Baseline to Week 148
|
0.93%
1/107 • Baseline to Week 148
|
4.7%
5/107 • Baseline to Week 148
|
2.8%
6/214 • Baseline to Week 148
|
|
Vascular disorders
Hypertension
|
2.5%
2/80 • Baseline to Week 148
|
6.3%
5/79 • Baseline to Week 148
|
3.8%
3/78 • Baseline to Week 148
|
2.8%
3/107 • Baseline to Week 148
|
5.6%
6/107 • Baseline to Week 148
|
4.2%
9/214 • Baseline to Week 148
|
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