Trial Outcomes & Findings for Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens (NCT NCT01406938)
NCT ID: NCT01406938
Last Updated: 2015-05-19
Results Overview
PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section(head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
967 participants
Primary outcome timeframe
Week 40 , week 52
Results posted on
2015-05-19
Participant Flow
966 patients randomized to two groups, induction secukinumab 150 mg or secukinumab 300 mg. Most randomized patients, 928/966 completed the 12-week induction period. 928 completed the induction period, a total of 843 were re-randomized to the maintenance period to either fixed interval dosing or start of relapse dosing at their respective dose level
Participant milestones
| Measure |
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
|
AIN457 300 mg - IPO
secukinumab- 2 x 150mg injections per dose
|
AIN457 150 mg - Fixed Interval (FI)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
|
AIN457 300 mg FI
2 s.c. secukinumab 150 mg injections
|
AIN457 150 mg- Start of Relapse (SoR)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
|
AIN457 300 mg- SoR
2 s.c. secukinumab 150 mg injections
|
|---|---|---|---|---|---|---|
|
Induction Period
STARTED
|
482
|
484
|
0
|
0
|
0
|
0
|
|
Induction Period
FAS:Patients Assigned Study Treatment
|
482
|
483
|
0
|
0
|
0
|
0
|
|
Induction Period
COMPLETED
|
464
|
464
|
0
|
0
|
0
|
0
|
|
Induction Period
NOT COMPLETED
|
18
|
20
|
0
|
0
|
0
|
0
|
|
Maintenance Period
STARTED
|
0
|
0
|
203
|
217
|
206
|
217
|
|
Maintenance Period
FAS: Patients Assigned Treatment Drug
|
0
|
0
|
203
|
216
|
206
|
217
|
|
Maintenance Period
COMPLETED
|
0
|
0
|
186
|
199
|
181
|
201
|
|
Maintenance Period
NOT COMPLETED
|
0
|
0
|
17
|
18
|
25
|
16
|
|
Follow up
STARTED
|
26
|
23
|
40
|
39
|
40
|
35
|
|
Follow up
COMPLETED
|
18
|
18
|
32
|
36
|
31
|
32
|
|
Follow up
NOT COMPLETED
|
8
|
5
|
8
|
3
|
9
|
3
|
Reasons for withdrawal
| Measure |
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
|
AIN457 300 mg - IPO
secukinumab- 2 x 150mg injections per dose
|
AIN457 150 mg - Fixed Interval (FI)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
|
AIN457 300 mg FI
2 s.c. secukinumab 150 mg injections
|
AIN457 150 mg- Start of Relapse (SoR)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
|
AIN457 300 mg- SoR
2 s.c. secukinumab 150 mg injections
|
|---|---|---|---|---|---|---|
|
Induction Period
Subject/guardian decision
|
6
|
8
|
0
|
0
|
0
|
0
|
|
Induction Period
Protocol deviation
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period
Adverse Event
|
8
|
9
|
0
|
0
|
0
|
0
|
|
Induction Period
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period
Lost to Follow-up
|
2
|
3
|
0
|
0
|
0
|
0
|
|
Maintenance Period
Adverse Event
|
0
|
0
|
2
|
8
|
4
|
2
|
|
Maintenance Period
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Maintenance Period
Subject/guardian decision
|
0
|
0
|
11
|
7
|
10
|
7
|
|
Maintenance Period
Protocol Violation
|
0
|
0
|
2
|
2
|
2
|
2
|
|
Maintenance Period
Pregnancy
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Maintenance Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
4
|
0
|
|
Maintenance Period
Lack of Efficacy
|
0
|
0
|
2
|
1
|
3
|
5
|
|
Follow up
Lack of Efficacy
|
3
|
2
|
1
|
0
|
0
|
0
|
|
Follow up
Patient/guardian decision
|
4
|
2
|
4
|
2
|
4
|
1
|
|
Follow up
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Follow up
Physician Decision
|
0
|
0
|
2
|
0
|
3
|
1
|
|
Follow up
Lost to Follow-up
|
1
|
1
|
0
|
1
|
2
|
1
|
Baseline Characteristics
Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens
Baseline characteristics by cohort
| Measure |
AIN457150 mg- Induction Period Only(IPO)
n=482 Participants
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
|
AIN457 300 mg - IPO
n=484 Participants
secukinumab- 2 x 150mg injections per dose
|
Total
n=966 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.3 Years
STANDARD_DEVIATION 12.83 • n=5 Participants
|
46.7 Years
STANDARD_DEVIATION 12.83 • n=7 Participants
|
46.0 Years
STANDARD_DEVIATION 12.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
177 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
328 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
305 Participants
n=5 Participants
|
333 Participants
n=7 Participants
|
638 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 40 , week 52Population: Full analysis set (FAS) - All patients to whom study treatment was assigned.
PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section(head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)
Outcome measures
| Measure |
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
|
AIN457 300 mg - IPO
secukinumab- 2 x 150mg injections per dose
|
AIN457 150 mg - Fixed Interval (FI)
n=203 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
|
AIN457 300 mg FI
n=216 Participants
2 s.c. secukinumab 150 mg injections
|
AIN457 150 mg- Start of Relapse (SoR)
n=206 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
|
AIN457 300 mg- SoR
n=217 Participants
2 s.c. secukinumab 150 mg injections
|
|---|---|---|---|---|---|---|
|
For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52
|
—
|
—
|
62.1 Percent of participants
|
78.2 Percent of participants
|
52.4 Percent of participants
|
67.7 Percent of participants
|
SECONDARY outcome
Timeframe: Baseline, week 2, 3 , 4, 8, 12Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)
Outcome measures
| Measure |
AIN457150 mg- Induction Period Only(IPO)
n=482 Participants
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
|
AIN457 300 mg - IPO
n=483 Participants
secukinumab- 2 x 150mg injections per dose
|
AIN457 150 mg - Fixed Interval (FI)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
|
AIN457 300 mg FI
2 s.c. secukinumab 150 mg injections
|
AIN457 150 mg- Start of Relapse (SoR)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
|
AIN457 300 mg- SoR
2 s.c. secukinumab 150 mg injections
|
|---|---|---|---|---|---|---|
|
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12
Week 4
|
-14.18 Units on a scale
Standard Deviation 8.956
|
-15.90 Units on a scale
Standard Deviation 8.838
|
—
|
—
|
—
|
—
|
|
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12
Week 8
|
-18.69 Units on a scale
Standard Deviation 10.147
|
-19.56 Units on a scale
Standard Deviation 9.356
|
—
|
—
|
—
|
—
|
|
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12
Week 12
|
-20.71 Units on a scale
Standard Deviation 10.804
|
-20.89 Units on a scale
Standard Deviation 9.584
|
—
|
—
|
—
|
—
|
|
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12
Week 2
|
-7.46 Units on a scale
Standard Deviation 6.338
|
-9.28 Units on a scale
Standard Deviation 6.752
|
—
|
—
|
—
|
—
|
|
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12
Week 3
|
-11.13 Units on a scale
Standard Deviation 7.826
|
-12.97 Units on a scale
Standard Deviation 7.826
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 12,16,20,24,28,32,36,40,44,48 and week 52Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)
Outcome measures
| Measure |
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
|
AIN457 300 mg - IPO
secukinumab- 2 x 150mg injections per dose
|
AIN457 150 mg - Fixed Interval (FI)
n=203 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
|
AIN457 300 mg FI
n=216 Participants
2 s.c. secukinumab 150 mg injections
|
AIN457 150 mg- Start of Relapse (SoR)
n=206 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
|
AIN457 300 mg- SoR
n=217 Participants
2 s.c. secukinumab 150 mg injections
|
|---|---|---|---|---|---|---|
|
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52
Week 12
|
—
|
—
|
-21.52 Units on a scale
Standard Deviation 9.553
|
-22.32 Units on a scale
Standard Deviation 8.943
|
-23.19 Units on a scale
Standard Deviation 11.063
|
-21.58 Units on a scale
Standard Deviation 9.448
|
|
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52
Week 16
|
—
|
—
|
-21.23 Units on a scale
Standard Deviation 9.676
|
-22.61 Units on a scale
Standard Deviation 9.310
|
-23.26 Units on a scale
Standard Deviation 11.158
|
-21.58 Units on a scale
Standard Deviation 9.626
|
|
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52
Week 20
|
—
|
—
|
-20.79 Units on a scale
Standard Deviation 9.739
|
-22.47 Units on a scale
Standard Deviation 9.237
|
-22.28 Units on a scale
Standard Deviation 11.548
|
-20.97 Units on a scale
Standard Deviation 9.787
|
|
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52
Week 24
|
—
|
—
|
-20.61 Units on a scale
Standard Deviation 9.745
|
-22.30 Units on a scale
Standard Deviation 9.262
|
-21.36 Units on a scale
Standard Deviation 11.938
|
-20.09 Units on a scale
Standard Deviation 9.904
|
|
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52
Week 28
|
—
|
—
|
-20.29 Units on a scale
Standard Deviation 9.730
|
-22.13 Units on a scale
Standard Deviation 9.244
|
-20.53 Units on a scale
Standard Deviation 11.754
|
-19.27 Units on a scale
Standard Deviation 9.844
|
|
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52
Week 32
|
—
|
—
|
-20.11 Units on a scale
Standard Deviation 9.847
|
-21.98 Units on a scale
Standard Deviation 9.195
|
-19.41 Units on a scale
Standard Deviation 10.962
|
-18.68 Units on a scale
Standard Deviation 9.983
|
|
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52
Week 36
|
—
|
—
|
-19.82 Units on a scale
Standard Deviation 9.908
|
-21.79 Units on a scale
Standard Deviation 9.324
|
-18.86 Units on a scale
Standard Deviation 10.625
|
-18.14 Units on a scale
Standard Deviation 9.352
|
|
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52
Week 40
|
—
|
—
|
-19.51 Units on a scale
Standard Deviation 9.821
|
-21.71 Units on a scale
Standard Deviation 9.369
|
-18.30 Units on a scale
Standard Deviation 10.660
|
-17.89 Units on a scale
Standard Deviation 9.837
|
|
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52
Week 44
|
—
|
—
|
-19.40 Units on a scale
Standard Deviation 9.691
|
-21.58 Units on a scale
Standard Deviation 9.398
|
-17.73 Units on a scale
Standard Deviation 11.041
|
-17.03 Units on a scale
Standard Deviation 9.876
|
|
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52
Week 48
|
—
|
—
|
-19.04 Units on a scale
Standard Deviation 10.093
|
-21.34 Units on a scale
Standard Deviation 9.681
|
-17.48 Units on a scale
Standard Deviation 10.638
|
-16.58 Units on a scale
Standard Deviation 9.040
|
|
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52
Week 52
|
—
|
—
|
-18.79 Units on a scale
Standard Deviation 9.904
|
21.47 Units on a scale
Standard Deviation 9.402
|
-17.40 Units on a scale
Standard Deviation 10.719
|
-16.33 Units on a scale
Standard Deviation 8.322
|
SECONDARY outcome
Timeframe: Baseline, week 2, 4, 6, 8, 12Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe
Outcome measures
| Measure |
AIN457150 mg- Induction Period Only(IPO)
n=482 Participants
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
|
AIN457 300 mg - IPO
n=483 Participants
secukinumab- 2 x 150mg injections per dose
|
AIN457 150 mg - Fixed Interval (FI)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
|
AIN457 300 mg FI
2 s.c. secukinumab 150 mg injections
|
AIN457 150 mg- Start of Relapse (SoR)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
|
AIN457 300 mg- SoR
2 s.c. secukinumab 150 mg injections
|
|---|---|---|---|---|---|---|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 2 IGA 0/1
|
1.2 Percent of participant
|
3.1 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 2 PASI 75
|
1.9 Percent of participant
|
5.2 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 2 PASI 50
|
20.2 Percent of participant
|
32.9 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 2 PASI 90
|
0 Percent of participant
|
0.2 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 2 PASI 100
|
0 Percent of participant
|
0.2 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 3 IGA 0/1
|
5.2 Percent of participant
|
9.3 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 3 PASI 75
|
11 Percent of participant
|
19.3 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 3 PASI 50
|
43 Percent of participant
|
63.6 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 3 PASI 90
|
1.5 Percent of participant
|
3.1 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 3 PASI 100
|
0 Percent of participant
|
0.6 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 4 IGA 0/1
|
15.6 Percent of participant
|
25.5 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 4 PASI 75
|
27.9 Percent of participant
|
42.9 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 4 PASI 50
|
66.3 Percent of participant
|
81.8 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 4 PASI 90
|
6.7 Percent of participant
|
13.7 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 4 PASI 100
|
0.4 Percent of participant
|
2.3 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 8 IGA 0/1
|
47.8 Percent of participant
|
59.4 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 8 PASI 75
|
63.8 Percent of participant
|
76.8 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 8 PASI 50
|
88.4 Percent of participant
|
93 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 8 PASI 90
|
32.4 Percent of participant
|
45.8 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 8 PASI 100
|
8.3 Percent of participant
|
13.9 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 12 IGA 0/1
|
62.8 Percent of participant
|
76 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 12 PASI 75
|
84.4 Percent of participant
|
90.1 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 12 PASI 50
|
93.1 Percent of participant
|
96.1 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 12 PASI 90
|
49.3 Percent of participant
|
64.2 Percent of participant
|
—
|
—
|
—
|
—
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Week 12 PASI 100
|
16.2 Percent of participant
|
25.7 Percent of participant
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 16,20,24,28,32,36,40,44,48, and Week 52Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe. The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe
Outcome measures
| Measure |
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
|
AIN457 300 mg - IPO
secukinumab- 2 x 150mg injections per dose
|
AIN457 150 mg - Fixed Interval (FI)
n=203 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
|
AIN457 300 mg FI
n=216 Participants
2 s.c. secukinumab 150 mg injections
|
AIN457 150 mg- Start of Relapse (SoR)
n=206 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
|
AIN457 300 mg- SoR
n=217 Participants
2 s.c. secukinumab 150 mg injections
|
|---|---|---|---|---|---|---|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 48 PASI 50
|
—
|
—
|
83.3 Percent of participants
|
89.8 Percent of participants
|
74.8 Percent of participants
|
82 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 32 IGA 0/1
|
—
|
—
|
64 Percent of participants
|
74.1 Percent of participants
|
33.5 Percent of participants
|
46.1 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 32 PASI 75
|
—
|
—
|
74.9 Percent of participants
|
84.3 Percent of participants
|
50.5 Percent of participants
|
63.1 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 40 PASI 75
|
—
|
—
|
68 Percent of participants
|
81.5 Percent of participants
|
42.2 Percent of participants
|
58.5 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 16 IGA 0/1
|
—
|
—
|
70.9 Percent of participants
|
82.4 Percent of participants
|
74.8 Percent of participants
|
83.4 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 16 PASI 75
|
—
|
—
|
90.1 Percent of participants
|
92.1 Percent of participants
|
92.7 Percent of participants
|
94.9 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 16 PASI 50
|
—
|
—
|
96.1 Percent of participants
|
97.7 Percent of participants
|
98.1 Percent of participants
|
98.2 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 16 PASI 90
|
—
|
—
|
59.1 Percent of participants
|
75.5 Percent of participants
|
68.4 Percent of participants
|
76.5 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 16 PASI 100
|
—
|
—
|
27.6 Percent of participants
|
31.5 Percent of participants
|
22.3 Percent of participants
|
38.2 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 20 IGA 0/1
|
—
|
—
|
69 Percent of participants
|
75.5 Percent of participants
|
64.6 Percent of participants
|
77 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 20 PASI 75
|
—
|
—
|
85.7 Percent of participants
|
90.3 Percent of participants
|
81.6 Percent of participants
|
87.1 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 20 PASI 50
|
—
|
—
|
94.6 Percent of participants
|
97.7 Percent of participants
|
92.2 Percent of participants
|
97.2 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 20 PASI 90
|
—
|
—
|
62.6 Percent of participants
|
74.5 Percent of participants
|
55.8 Percent of participants
|
72.8 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 20 PASI 100
|
—
|
—
|
29.1 Percent of participants
|
35.6 Percent of participants
|
24.8 Percent of participants
|
35.5 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 24 IGA 0/1
|
—
|
—
|
67.5 Percent of participants
|
76.9 Percent of participants
|
56.3 Percent of participants
|
65.9 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 24 PASI 75
|
—
|
—
|
80.3 Percent of participants
|
88 Percent of participants
|
72.3 Percent of participants
|
77.9 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 24 PASI 50
|
—
|
—
|
93.1 Percent of participants
|
94.9 Percent of participants
|
89.3 Percent of participants
|
94 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 24 PASI 90
|
—
|
—
|
66.5 Percent of participants
|
74.1 Percent of participants
|
51.5 Percent of participants
|
59.9 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 24 PASI 100
|
—
|
—
|
29.1 Percent of participants
|
36.1 Percent of participants
|
19.9 Percent of participants
|
26.3 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 28 IGA 0/1
|
—
|
—
|
65.5 Percent of participants
|
72.7 Percent of participants
|
44.7 Percent of participants
|
52.5 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 28 PASI 75
|
—
|
—
|
77.3 Percent of participants
|
85.6 Percent of participants
|
65 Percent of participants
|
71.4 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 28 PASI 50
|
—
|
—
|
92.6 Percent of participants
|
93.5 Percent of participants
|
87.4 Percent of participants
|
94 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 28 PASI 90
|
—
|
—
|
60.6 Percent of participants
|
70.4 Percent of participants
|
40.8 Percent of participants
|
50.2 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 28 PASI 100
|
—
|
—
|
29.6 Percent of participants
|
38 Percent of participants
|
15.5 Percent of participants
|
23 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 32 PASI 50
|
—
|
—
|
91.1 Percent of participants
|
92.6 Percent of participants
|
82 Percent of participants
|
90.3 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 32 PASI 90
|
—
|
—
|
58.6 Percent of participants
|
74.1 Percent of participants
|
32.5 Percent of participants
|
41.5 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 32 PASI 100
|
—
|
—
|
30.5 Percent of participants
|
38.9 Percent of participants
|
10.7 Percent of participants
|
15.7 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 36 IGA 0/1
|
—
|
—
|
59.6 Percent of participants
|
70.4 Percent of participants
|
27.2 Percent of participants
|
33.6 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 36 PASI 75
|
—
|
—
|
71.4 Percent of participants
|
82.9 Percent of participants
|
45.1 Percent of participants
|
58.1 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 36 PASI 50
|
—
|
—
|
87.7 Percent of participants
|
91.2 Percent of participants
|
78.6 Percent of participants
|
94 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 36 PASI 90
|
—
|
—
|
54.7 Percent of participants
|
68.1 Percent of participants
|
24.8 Percent of participants
|
35.5 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 36 PASI 100
|
—
|
—
|
28.6 Percent of participants
|
38.9 Percent of participants
|
2.9 Percent of participants
|
7.4 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 40 IGA 0/1
|
—
|
—
|
53.2 Percent of participants
|
68.5 Percent of participants
|
26.2 Percent of participants
|
35.5 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 40 PASI 50
|
—
|
—
|
87.7 Percent of participants
|
90.7 Percent of participants
|
74.8 Percent of participants
|
88.9 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 40 PASI 90
|
—
|
—
|
52.2 Percent of participants
|
68.5 Percent of participants
|
18.9 Percent of participants
|
26.7 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 40 PASI 100
|
—
|
—
|
26.1 Percent of participants
|
38 Percent of participants
|
1.9 Percent of participants
|
7.4 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 44 IGA 0/1
|
—
|
—
|
52.7 Percent of participants
|
64.8 Percent of participants
|
20.4 Percent of participants
|
27.6 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 44 PASI 75
|
—
|
—
|
66 Percent of participants
|
80.1 Percent of participants
|
37.4 Percent of participants
|
51.2 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 44 PASI 50
|
—
|
—
|
84.2 Percent of participants
|
92.1 Percent of participants
|
72.8 Percent of participants
|
82.5 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 44 PASI 90
|
—
|
—
|
49.8 Percent of participants
|
66.2 Percent of participants
|
16.5 Percent of participants
|
22.1 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 44 PASI 100
|
—
|
—
|
22.7 Percent of participants
|
39.8 Percent of participants
|
1.5 Percent of participants
|
4.6 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 48 IGA 0/1
|
—
|
—
|
51.7 Percent of participants
|
64.8 Percent of participants
|
20.4 Percent of participants
|
21.7 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 48 PASI 75
|
—
|
—
|
65.5 Percent of participants
|
78.7 Percent of participants
|
33 Percent of participants
|
45.6 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 48 PASI 90
|
—
|
—
|
49.8 Percent of participants
|
62.5 Percent of participants
|
12.6 Percent of participants
|
14.7 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 48 PASI 100
|
—
|
—
|
21.2 Percent of participants
|
38.4 Percent of participants
|
1 Percent of participants
|
3.7 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 52 IGA 0/1
|
—
|
—
|
47.3 Percent of participants
|
59.3 Percent of participants
|
18 Percent of participants
|
20.3 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 52 PASI 75
|
—
|
—
|
62.1 Percent of participants
|
78.2 Percent of participants
|
35 Percent of participants
|
41 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 52 PASI 50
|
—
|
—
|
83.7 Percent of participants
|
87.5 Percent of participants
|
73.8 Percent of participants
|
81.1 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 52 PASI 90
|
—
|
—
|
45.8 Percent of participants
|
59.7 Percent of participants
|
11.2 Percent of participants
|
13.8 Percent of participants
|
|
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Week 52 PASI 100
|
—
|
—
|
21.2 Percent of participants
|
36.6 Percent of participants
|
2.4 Percent of participants
|
5.1 Percent of participants
|
SECONDARY outcome
Timeframe: Baseline to week 2, 4, 8, 12Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)
Outcome measures
| Measure |
AIN457150 mg- Induction Period Only(IPO)
n=482 Participants
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
|
AIN457 300 mg - IPO
n=483 Participants
secukinumab- 2 x 150mg injections per dose
|
AIN457 150 mg - Fixed Interval (FI)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
|
AIN457 300 mg FI
2 s.c. secukinumab 150 mg injections
|
AIN457 150 mg- Start of Relapse (SoR)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
|
AIN457 300 mg- SoR
2 s.c. secukinumab 150 mg injections
|
|---|---|---|---|---|---|---|
|
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction)
Week 2
|
5.9 Units on a scale
Standard Deviation 14.64
|
7.6 Units on a scale
Standard Deviation 12.86
|
—
|
—
|
—
|
—
|
|
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction)
Week 4
|
10.8 Units on a scale
Standard Deviation 17.79
|
13.6 Units on a scale
Standard Deviation 18.63
|
—
|
—
|
—
|
—
|
|
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction)
Week 8
|
17.5 Units on a scale
Standard Deviation 20.79
|
18.3 Units on a scale
Standard Deviation 21.51
|
—
|
—
|
—
|
—
|
|
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction)
Week 12
|
20.2 Units on a scale
Standard Deviation 23.47
|
21.2 Units on a scale
Standard Deviation 24.08
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)
Outcome measures
| Measure |
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
|
AIN457 300 mg - IPO
secukinumab- 2 x 150mg injections per dose
|
AIN457 150 mg - Fixed Interval (FI)
n=203 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
|
AIN457 300 mg FI
n=216 Participants
2 s.c. secukinumab 150 mg injections
|
AIN457 150 mg- Start of Relapse (SoR)
n=206 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
|
AIN457 300 mg- SoR
n=217 Participants
2 s.c. secukinumab 150 mg injections
|
|---|---|---|---|---|---|---|
|
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)
Week 52
|
—
|
—
|
18.3 Units on a scale
Standard Deviation 25.63
|
23 Units on a scale
Standard Deviation 22.40
|
16.7 Units on a scale
Standard Deviation 23.30
|
13.4 Units on a scale
Standard Deviation 25.68
|
|
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)
Week 16
|
—
|
—
|
21.4 Units on a scale
Standard Deviation 25.11
|
23 Units on a scale
Standard Deviation 22.44
|
23.4 Units on a scale
Standard Deviation 25.31
|
23.9 Units on a scale
Standard Deviation 26.09
|
|
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)
Week 20
|
—
|
—
|
20.6 Units on a scale
Standard Deviation 25.07
|
23 Units on a scale
Standard Deviation 23.27
|
22.1 Units on a scale
Standard Deviation 26.04
|
22.4 Units on a scale
Standard Deviation 27.45
|
|
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)
Week 24
|
—
|
—
|
20.6 Units on a scale
Standard Deviation 25.05
|
22.9 Units on a scale
Standard Deviation 23.32
|
20 Units on a scale
Standard Deviation 26.66
|
22.3 Units on a scale
Standard Deviation 26.47
|
|
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)
Week 28
|
—
|
—
|
19.4 Units on a scale
Standard Deviation 26.46
|
23 Units on a scale
Standard Deviation 22.71
|
19.3 Units on a scale
Standard Deviation 25.07
|
20.4 Units on a scale
Standard Deviation 26.26
|
|
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)
Week 32
|
—
|
—
|
20.4 Units on a scale
Standard Deviation 24.95
|
22.8 Units on a scale
Standard Deviation 23.22
|
17.9 Units on a scale
Standard Deviation 24.97
|
18.8 Units on a scale
Standard Deviation 25.90
|
|
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)
Week 36
|
—
|
—
|
19.6 Units on a scale
Standard Deviation 25.79
|
23 Units on a scale
Standard Deviation 22.67
|
17.4 Units on a scale
Standard Deviation 24.30
|
17.7 Units on a scale
Standard Deviation 26.15
|
|
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)
Week 40
|
—
|
—
|
19.8 Units on a scale
Standard Deviation 25.39
|
22.8 Units on a scale
Standard Deviation 22.69
|
16.3 Units on a scale
Standard Deviation 23.53
|
16.4 Units on a scale
Standard Deviation 26.38
|
|
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)
Week 44
|
—
|
—
|
19.8 Units on a scale
Standard Deviation 25.53
|
22.3 Units on a scale
Standard Deviation 23.10
|
15.4 Units on a scale
Standard Deviation 23.70
|
14.9 Units on a scale
Standard Deviation 26.81
|
|
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)
Week 48
|
—
|
—
|
19.7 Units on a scale
Standard Deviation 25.33
|
22.7 Units on a scale
Standard Deviation 22.85
|
16.2 Units on a scale
Standard Deviation 23.17
|
13.4 Units on a scale
Standard Deviation 26.65
|
SECONDARY outcome
Timeframe: Baseline to week 2, 4, 8, 12Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Outcome measures
| Measure |
AIN457150 mg- Induction Period Only(IPO)
n=482 Participants
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
|
AIN457 300 mg - IPO
n=483 Participants
secukinumab- 2 x 150mg injections per dose
|
AIN457 150 mg - Fixed Interval (FI)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
|
AIN457 300 mg FI
2 s.c. secukinumab 150 mg injections
|
AIN457 150 mg- Start of Relapse (SoR)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
|
AIN457 300 mg- SoR
2 s.c. secukinumab 150 mg injections
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction)
Week 2 DLQI total score
|
-5.5 Units on a scale
Standard Deviation 5.02
|
-6 Units on a scale
Standard Deviation 5.10
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction)
Week 4 DLQI total score
|
-8.2 Units on a scale
Standard Deviation 6.11
|
-8.7 Units on a scale
Standard Deviation 6.29
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction)
Week 8 DLQI total score
|
-10.2 Units on a scale
Standard Deviation 6.40
|
-10.3 Units on a scale
Standard Deviation 6.73
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction)
Week 12 DLQI total score
|
-10.8 Units on a scale
Standard Deviation 6.75
|
-11 Units on a scale
Standard Deviation 7.01
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Outcome measures
| Measure |
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
|
AIN457 300 mg - IPO
secukinumab- 2 x 150mg injections per dose
|
AIN457 150 mg - Fixed Interval (FI)
n=203 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
|
AIN457 300 mg FI
n=216 Participants
2 s.c. secukinumab 150 mg injections
|
AIN457 150 mg- Start of Relapse (SoR)
n=206 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
|
AIN457 300 mg- SoR
n=217 Participants
2 s.c. secukinumab 150 mg injections
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)
Week 16
|
—
|
—
|
-11 Units on a scale
Standard Deviation 6.63
|
-11.4 Units on a scale
Standard Deviation 7.12
|
-11.4 Units on a scale
Standard Deviation 6.98
|
-11.3 Units on a scale
Standard Deviation 7.58
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)
Week 20
|
—
|
—
|
-10.6 Units on a scale
Standard Deviation 6.50
|
-11 Units on a scale
Standard Deviation 7.18
|
-10.6 Units on a scale
Standard Deviation 7.55
|
-11 Units on a scale
Standard Deviation 7.64
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)
Week 24
|
—
|
—
|
-10.5 Units on a scale
Standard Deviation 6.67
|
-11.1 Units on a scale
Standard Deviation 7.39
|
-10.1 Units on a scale
Standard Deviation 7.65
|
-10.3 Units on a scale
Standard Deviation 7.71
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)
Week 28
|
—
|
—
|
-10.5 Units on a scale
Standard Deviation 6.68
|
-11 Units on a scale
Standard Deviation 7.22
|
-9.7 Units on a scale
Standard Deviation 7.39
|
-9.5 Units on a scale
Standard Deviation 7.46
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)
Week 32
|
—
|
—
|
-10.5 Units on a scale
Standard Deviation 6.76
|
-10.9 Units on a scale
Standard Deviation 7.17
|
-8.6 Units on a scale
Standard Deviation 7.66
|
-8.9 Units on a scale
Standard Deviation 7.61
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)
Week 36
|
—
|
—
|
-10.2 Units on a scale
Standard Deviation 6.94
|
-10.9 Units on a scale
Standard Deviation 7.30
|
-8.6 Units on a scale
Standard Deviation 7.55
|
-8.5 Units on a scale
Standard Deviation 7.79
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)
Week 40
|
—
|
—
|
-10.1 Units on a scale
Standard Deviation 6.83
|
-10.8 Units on a scale
Standard Deviation 7.33
|
-8.4 Units on a scale
Standard Deviation 7.22
|
-8.5 Units on a scale
Standard Deviation 7.59
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)
Week 44
|
—
|
—
|
-10.2 Units on a scale
Standard Deviation 6.72
|
-10.8 Units on a scale
Standard Deviation 7.46
|
-8.4 Units on a scale
Standard Deviation 7.07
|
-8.6 Units on a scale
Standard Deviation 7.29
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)
Week 48
|
—
|
—
|
-10 Units on a scale
Standard Deviation 6.57
|
-10.8 Units on a scale
Standard Deviation 7.38
|
-8.6 Units on a scale
Standard Deviation 7.41
|
7.9 Units on a scale
Standard Deviation 7.02
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)
Week 52
|
—
|
—
|
-9.8 Units on a scale
Standard Deviation 7.06
|
-10.9 Units on a scale
Standard Deviation 7.31
|
-8.4 Units on a scale
Standard Deviation 7.46
|
-7.6 Units on a scale
Standard Deviation 7.14
|
SECONDARY outcome
Timeframe: Baseline to week 2, 4, 6, 8, 12Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Outcome measures
| Measure |
AIN457150 mg- Induction Period Only(IPO)
n=482 Participants
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
|
AIN457 300 mg - IPO
n=484 Participants
secukinumab- 2 x 150mg injections per dose
|
AIN457 150 mg - Fixed Interval (FI)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
|
AIN457 300 mg FI
2 s.c. secukinumab 150 mg injections
|
AIN457 150 mg- Start of Relapse (SoR)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
|
AIN457 300 mg- SoR
2 s.c. secukinumab 150 mg injections
|
|---|---|---|---|---|---|---|
|
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction)
Week 2 (n=463,471)
|
9.5 Percent of participants
|
13.8 Percent of participants
|
—
|
—
|
—
|
—
|
|
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction)
Week 4 (n=479,482)
|
23.2 Percent of participants
|
33.2 Percent of participants
|
—
|
—
|
—
|
—
|
|
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction)
Week 8 (n=479,482)
|
44.7 Percent of participants
|
52.1 Percent of participants
|
—
|
—
|
—
|
—
|
|
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction)
Week 12 (n=479,482)
|
53.4 Percent of participants
|
63.1 Percent of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Outcome measures
| Measure |
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
|
AIN457 300 mg - IPO
secukinumab- 2 x 150mg injections per dose
|
AIN457 150 mg - Fixed Interval (FI)
n=203 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
|
AIN457 300 mg FI
n=216 Participants
2 s.c. secukinumab 150 mg injections
|
AIN457 150 mg- Start of Relapse (SoR)
n=206 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
|
AIN457 300 mg- SoR
n=217 Participants
2 s.c. secukinumab 150 mg injections
|
|---|---|---|---|---|---|---|
|
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).
Week 16 (n=199,209,202,215)
|
—
|
—
|
59.8 Percent of participant
|
66.5 Percent of participant
|
58.4 Percent of participant
|
72.1 Percent of participant
|
|
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).
Week 20 (n=202,213,205,217)
|
—
|
—
|
57.4 Percent of participant
|
67.6 Percent of participant
|
58 Percent of participant
|
69.6 Percent of participant
|
|
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).
Week 24 (n=202,214,206,217)
|
—
|
—
|
58.4 Percent of participant
|
68.7 Percent of participant
|
53.9 Percent of participant
|
65.4 Percent of participant
|
|
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).
Week 28 (n=202,214,206,217)
|
—
|
—
|
57.9 Percent of participant
|
70.1 Percent of participant
|
47.6 Percent of participant
|
51.6 Percent of participant
|
|
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).
Week 32 (n=202,214,206,217)
|
—
|
—
|
57.9 Percent of participant
|
67.8 Percent of participant
|
37.9 Percent of participant
|
47.5 Percent of participant
|
|
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).
Week 36 (n=202,214,206,217)
|
—
|
—
|
58.4 Percent of participant
|
65 Percent of participant
|
39.8 Percent of participant
|
39.6 Percent of participant
|
|
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).
Week 40 (n=202,214,206,217)
|
—
|
—
|
55 Percent of participant
|
66.4 Percent of participant
|
35 Percent of participant
|
42.4 Percent of participant
|
|
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).
Week 44 (n=202,214,206,217)
|
—
|
—
|
59.9 Percent of participant
|
68.7 Percent of participant
|
31.6 Percent of participant
|
43.3 Percent of participant
|
|
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).
Week 48 (n=202,214,206,217)
|
—
|
—
|
54 Percent of participant
|
67.3 Percent of participant
|
32 Percent of participant
|
40.6 Percent of participant
|
|
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).
Week 52 (n=202,214,206,217)
|
—
|
—
|
56.4 Percent of participant
|
69.2 Percent of participant
|
31.1 Percent of participant
|
37.3 Percent of participant
|
SECONDARY outcome
Timeframe: Week 12 to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
Median time to relapse (weeks) from week 12. Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement
Outcome measures
| Measure |
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
|
AIN457 300 mg - IPO
secukinumab- 2 x 150mg injections per dose
|
AIN457 150 mg - Fixed Interval (FI)
n=203 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
|
AIN457 300 mg FI
n=216 Participants
2 s.c. secukinumab 150 mg injections
|
AIN457 150 mg- Start of Relapse (SoR)
n=206 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
|
AIN457 300 mg- SoR
n=217 Participants
2 s.c. secukinumab 150 mg injections
|
|---|---|---|---|---|---|---|
|
Median Time to Relapse (Weeks) From Week 12.
|
—
|
—
|
NA Number of weeks
not estimable due to insufficient events at the time of analysis
|
NA Number of weeks
not estimable due to insufficient events at the time of analysis
|
NA Number of weeks
not estimable due to insufficient events at the time of analysis
|
302 Number of weeks
Interval 302.0 to
not estimable due to insufficient events at the time of analysis
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set (FAS) - All patients to whom study treatment was assigned, only participants with evaluable data were included
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Outcome measures
| Measure |
AIN457150 mg- Induction Period Only(IPO)
n=64 Participants
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
|
AIN457 300 mg - IPO
n=74 Participants
secukinumab- 2 x 150mg injections per dose
|
AIN457 150 mg - Fixed Interval (FI)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
|
AIN457 300 mg FI
2 s.c. secukinumab 150 mg injections
|
AIN457 150 mg- Start of Relapse (SoR)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
|
AIN457 300 mg- SoR
2 s.c. secukinumab 150 mg injections
|
|---|---|---|---|---|---|---|
|
Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy
Week 12 IGA 0/1
|
42.2 Percent of participants
|
62.2 Percent of participants
|
—
|
—
|
—
|
—
|
|
Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy
Week 12 PASI 50
|
87.5 Percent of participants
|
90.5 Percent of participants
|
—
|
—
|
—
|
—
|
|
Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy
Week 12 PASI 75
|
68.8 Percent of participants
|
86.5 Percent of participants
|
—
|
—
|
—
|
—
|
|
Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy
Week 12 PASI 90
|
26.6 Percent of participants
|
56.8 Percent of participants
|
—
|
—
|
—
|
—
|
|
Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy
Week 12 PASI 100
|
6.3 Percent of participants
|
21.6 Percent of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Full analysis set (FAS) - All patients to whom study treatment was assigned, only participants with evaluable data were included
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Outcome measures
| Measure |
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
|
AIN457 300 mg - IPO
secukinumab- 2 x 150mg injections per dose
|
AIN457 150 mg - Fixed Interval (FI)
n=21 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
|
AIN457 300 mg FI
n=36 Participants
2 s.c. secukinumab 150 mg injections
|
AIN457 150 mg- Start of Relapse (SoR)
n=23 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
|
AIN457 300 mg- SoR
n=28 Participants
2 s.c. secukinumab 150 mg injections
|
|---|---|---|---|---|---|---|
|
Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy
Week 52 IGA 0/1
|
—
|
—
|
42.9 Percent of participants
|
66.7 Percent of participants
|
4.3 Percent of participants
|
14.3 Percent of participants
|
|
Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy
Week 52 PASI 50
|
—
|
—
|
81 Percent of participants
|
86.1 Percent of participants
|
60.9 Percent of participants
|
75 Percent of participants
|
|
Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy
Week 52 PASI 75
|
—
|
—
|
47.6 Percent of participants
|
77.8 Percent of participants
|
21.7 Percent of participants
|
32.1 Percent of participants
|
|
Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy
Week 52 PASI 90
|
—
|
—
|
33.3 Percent of participants
|
66.7 Percent of participants
|
13 Percent of participants
|
7.1 Percent of participants
|
|
Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy
Week 52 PASI 100
|
—
|
—
|
28.6 Percent of participants
|
52.8 Percent of participants
|
0 Percent of participants
|
3.6 Percent of participants
|
SECONDARY outcome
Timeframe: Week 16, 20, 24,28,32,36,40,44,48,and Week 52Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Outcome measures
| Measure |
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
|
AIN457 300 mg - IPO
secukinumab- 2 x 150mg injections per dose
|
AIN457 150 mg - Fixed Interval (FI)
n=203 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
|
AIN457 300 mg FI
n=216 Participants
2 s.c. secukinumab 150 mg injections
|
AIN457 150 mg- Start of Relapse (SoR)
n=206 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
|
AIN457 300 mg- SoR
n=217 Participants
2 s.c. secukinumab 150 mg injections
|
|---|---|---|---|---|---|---|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 50 Visit 0
|
—
|
—
|
1.5 Percent of participants
|
0.9 Percent of participants
|
0.5 Percent of participants
|
0.5 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 50 Visit 1
|
—
|
—
|
1 Percent of participants
|
0.5 Percent of participants
|
1.5 Percent of participants
|
0.5 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 50 Visit 2
|
—
|
—
|
2.5 Percent of participants
|
0.5 Percent of participants
|
3.4 Percent of participants
|
0.5 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 50 Visit 3
|
—
|
—
|
0.5 Percent of participants
|
1.9 Percent of participants
|
3.4 Percent of participants
|
0.5 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 50 Visit 4
|
—
|
—
|
1.5 Percent of participants
|
2.8 Percent of participants
|
4.4 Percent of participants
|
1.8 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 50 Visit 5
|
—
|
—
|
3.4 Percent of participants
|
0.5 Percent of participants
|
2.4 Percent of participants
|
1.8 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 50 Visit 6
|
—
|
—
|
2.5 Percent of participants
|
0.5 Percent of participants
|
4.9 Percent of participants
|
0.9 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 50 Visit 7
|
—
|
—
|
3 Percent of participants
|
3.2 Percent of participants
|
6.8 Percent of participants
|
5.5 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 50 Visit 8
|
—
|
—
|
3 Percent of participants
|
1.9 Percent of participants
|
10.2 Percent of participants
|
12.4 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 50 Visit 9
|
—
|
—
|
8.4 Percent of participants
|
7.9 Percent of participants
|
8.7 Percent of participants
|
16.6 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 50 Visit 10
|
—
|
—
|
72.9 Percent of participants
|
79.6 Percent of participants
|
53.9 Percent of participants
|
59 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 75 Visit 0
|
—
|
—
|
4.9 Percent of participants
|
3.2 Percent of participants
|
3.9 Percent of participants
|
2.8 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 75 Visit 1
|
—
|
—
|
5.9 Percent of participants
|
2.8 Percent of participants
|
6.8 Percent of participants
|
2.3 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 75 Visit 2
|
—
|
—
|
5.4 Percent of participants
|
2.8 Percent of participants
|
8.3 Percent of participants
|
4.1 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 75 Visit 3
|
—
|
—
|
3 Percent of participants
|
3.2 Percent of participants
|
7.8 Percent of participants
|
6.9 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 75 Visit 4
|
—
|
—
|
4.9 Percent of participants
|
1.9 Percent of participants
|
11.2 Percent of participants
|
8.3 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 75 Visit 5
|
—
|
—
|
3.4 Percent of participants
|
1.9 Percent of participants
|
10.7 Percent of participants
|
10.6 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 75 Visit 6
|
—
|
—
|
4.9 Percent of participants
|
1.9 Percent of participants
|
11.7 Percent of participants
|
8.3 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 75 Visit 7
|
—
|
—
|
4.4 Percent of participants
|
3.7 Percent of participants
|
9.2 Percent of participants
|
11.1 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 75 Visit 8
|
—
|
—
|
2.5 Percent of participants
|
4.2 Percent of participants
|
9.7 Percent of participants
|
18.4 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 75 Visit 9
|
—
|
—
|
7.4 Percent of participants
|
8.8 Percent of participants
|
10.7 Percent of participants
|
15.2 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 75 Visit 10
|
—
|
—
|
53.2 Percent of participants
|
65.7 Percent of participants
|
10.2 Percent of participants
|
12 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 90 Visit 0
|
—
|
—
|
24.6 Percent of participants
|
12 Percent of participants
|
23.8 Percent of participants
|
15.7 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 90 Visit 1
|
—
|
—
|
4.4 Percent of participants
|
5.1 Percent of participants
|
15 Percent of participants
|
7.8 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 90 Visit 2
|
—
|
—
|
2.5 Percent of participants
|
3.7 Percent of participants
|
8.3 Percent of participants
|
12 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 90 Visit 3
|
—
|
—
|
5.4 Percent of participants
|
4.2 Percent of participants
|
6.8 Percent of participants
|
11.1 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 90 Visit 4
|
—
|
—
|
4.4 Percent of participants
|
2.3 Percent of participants
|
11.2 Percent of participants
|
11.1 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 90 Visit 5
|
—
|
—
|
3.9 Percent of participants
|
1.4 Percent of participants
|
8.7 Percent of participants
|
6.5 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 90 Visit 6
|
—
|
—
|
3.4 Percent of participants
|
5.1 Percent of participants
|
9.7 Percent of participants
|
8.8 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 90 Visit 7
|
—
|
—
|
3.9 Percent of participants
|
4.6 Percent of participants
|
7.3 Percent of participants
|
10.6 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 90 Visit 8
|
—
|
—
|
5.4 Percent of participants
|
6.5 Percent of participants
|
2.9 Percent of participants
|
8.3 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 90 Visit 9
|
—
|
—
|
13.8 Percent of participants
|
13.4 Percent of participants
|
2.9 Percent of participants
|
3.7 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 90 Visit 10
|
—
|
—
|
28.1 Percent of participants
|
41.7 Percent of participants
|
3.4 Percent of participants
|
4.6 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 100 Visit 0
|
—
|
—
|
53.2 Percent of participants
|
41.2 Percent of participants
|
65 Percent of participants
|
51.2 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 100 Visit 1
|
—
|
—
|
5.9 Percent of participants
|
6.5 Percent of participants
|
9.7 Percent of participants
|
7.8 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 100 Visit 2
|
—
|
—
|
5.9 Percent of participants
|
4.2 Percent of participants
|
6.3 Percent of participants
|
12.4 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 100 Visit 3
|
—
|
—
|
3.4 Percent of participants
|
4.6 Percent of participants
|
7.3 Percent of participants
|
8.8 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 100 Visit 4
|
—
|
—
|
3.4 Percent of participants
|
2.3 Percent of participants
|
6.3 Percent of participants
|
6.9 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 100 Visit 5
|
—
|
—
|
3 Percent of participants
|
5.6 Percent of participants
|
2.9 Percent of participants
|
6.5 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 100 Visit 6
|
—
|
—
|
4.9 Percent of participants
|
5.1 Percent of participants
|
1 Percent of participants
|
1.8 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 100 Visit 7
|
—
|
—
|
4.4 Percent of participants
|
3.7 Percent of participants
|
0.5 Percent of participants
|
2.3 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 100 Visit 8
|
—
|
—
|
2.5 Percent of participants
|
5.6 Percent of participants
|
0 Percent of participants
|
0.9 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 100 Visit 9
|
—
|
—
|
4.4 Percent of participants
|
7.9 Percent of participants
|
0 Percent of participants
|
0.5 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI 100 Visit 10
|
—
|
—
|
8.9 Percent of participants
|
13.4 Percent of participants
|
1 Percent of participants
|
0.9 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
IGA mod 2011 0 or 1 response Visit 0
|
—
|
—
|
19.2 Percent of participants
|
11.6 Percent of participants
|
20.4 Percent of participants
|
12 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
IGA mod 2011 0 or 1 response Visit 1
|
—
|
—
|
5.4 Percent of participants
|
3.7 Percent of participants
|
10.2 Percent of participants
|
6.5 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
IGA mod 2011 0 or 1 response Visit 2
|
—
|
—
|
2 Percent of participants
|
3.7 Percent of participants
|
9.7 Percent of participants
|
7.4 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
IGA mod 2011 0 or 1 response Visit 3
|
—
|
—
|
5.4 Percent of participants
|
5.1 Percent of participants
|
9.2 Percent of participants
|
10.6 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
IGA mod 2011 0 or 1 response Visit 4
|
—
|
—
|
3.9 Percent of participants
|
3.2 Percent of participants
|
8.3 Percent of participants
|
12 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
IGA mod 2011 0 or 1 response Visit 5
|
—
|
—
|
3.4 Percent of participants
|
1.9 Percent of participants
|
10.2 Percent of participants
|
13.8 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
IGA mod 2011 0 or 1 response Visit 6
|
—
|
—
|
6.4 Percent of participants
|
4.6 Percent of participants
|
9.2 Percent of participants
|
7.8 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
IGA mod 2011 0 or 1 response Visit 7
|
—
|
—
|
6.4 Percent of participants
|
3.7 Percent of participants
|
7.8 Percent of participants
|
10.1 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
IGA mod 2011 0 or 1 response Visit 8
|
—
|
—
|
5.9 Percent of participants
|
2.8 Percent of participants
|
5.8 Percent of participants
|
8.3 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
IGA mod 2011 0 or 1 response Visit 9
|
—
|
—
|
6.4 Percent of participants
|
12.5 Percent of participants
|
3.9 Percent of participants
|
6 Percent of participants
|
|
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
IGA mod 2011 0 or 1 response Visit 10
|
—
|
—
|
35.5 Percent of participants
|
47.2 Percent of participants
|
5.3 Percent of participants
|
5.5 Percent of participants
|
SECONDARY outcome
Timeframe: week 16, 20, 24,28,32,36,40,44,48,and Week 52Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
The number of secukinumab injections needed for participants to regain PASI 75 response from the start of relapse after week 12
Outcome measures
| Measure |
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
|
AIN457 300 mg - IPO
secukinumab- 2 x 150mg injections per dose
|
AIN457 150 mg - Fixed Interval (FI)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
|
AIN457 300 mg FI
2 s.c. secukinumab 150 mg injections
|
AIN457 150 mg- Start of Relapse (SoR)
n=176 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
|
AIN457 300 mg- SoR
n=185 Participants
2 s.c. secukinumab 150 mg injections
|
|---|---|---|---|---|---|---|
|
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
SoR: one, Regain PASI 75 Injection 0 (n=97,128)
|
—
|
—
|
—
|
—
|
4.1 percent of participants
|
0.8 percent of participants
|
|
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
SoR: one, Regain PASI 75 Injection 1 (n=97,128)
|
—
|
—
|
—
|
—
|
40.2 percent of participants
|
0 percent of participants
|
|
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
SoR: one, Regain PASI 75 Injection 2 (n=97,128)
|
—
|
—
|
—
|
—
|
27.8 percent of participants
|
45.3 percent of participants
|
|
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
SoR: one, Regain PASI 75 Injection 3 (n=97,128)
|
—
|
—
|
—
|
—
|
11.3 percent of participants
|
0 percent of participants
|
|
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
SoR: one, Regain PASI 75 Injection 4 (n=97,128)
|
—
|
—
|
—
|
—
|
6.2 percent of participants
|
31.3 percent of participants
|
|
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
SoR: one, Regain PASI 75 Injection 5 (n=97,128)
|
—
|
—
|
—
|
—
|
4.1 percent of participants
|
0 percent of participants
|
|
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
SoR: one, Regain PASI 75 Injection 6 (n=97,128)
|
—
|
—
|
—
|
—
|
4.1 percent of participants
|
14.1 percent of participants
|
|
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
SoR: one, Regain PASI 75 Injection 7 (n=97,128)
|
—
|
—
|
—
|
—
|
1 percent of participants
|
0 percent of participants
|
|
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
SoR: one, Regain PASI 75 Injection 8 (n=97,128)
|
—
|
—
|
—
|
—
|
1 percent of participants
|
3.1 percent of participants
|
|
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
SoR: one, Regain PASI 75 Injection 10 (n=97,128)
|
—
|
—
|
—
|
—
|
0 percent of participants
|
3.9 percent of participants
|
|
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
SoR: one, Regain PASI 75 Injection 12 (n=97,128)
|
—
|
—
|
—
|
—
|
0 percent of participants
|
1.6 percent of participants
|
|
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
SoR: Two, Regain PASI 75 Injection 0 (n=21,36)
|
—
|
—
|
—
|
—
|
0 percent of participants
|
5.6 percent of participants
|
|
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
SoR: Two, Regain PASI 75 Injection 1 (n=21,36)
|
—
|
—
|
—
|
—
|
47.6 percent of participants
|
0 percent of participants
|
|
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
SoR: Two, Regain PASI 75 Injection 2 (n=21,36)
|
—
|
—
|
—
|
—
|
42.9 percent of participants
|
58.3 percent of participants
|
|
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
SoR: Two, Regain PASI 75 Injection 3 (n=21,36)
|
—
|
—
|
—
|
—
|
4.8 percent of participants
|
0 percent of participants
|
|
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
SoR: Two, Regain PASI 75 Injection 4 (n=21,36)
|
—
|
—
|
—
|
—
|
0 percent of participants
|
19.4 percent of participants
|
|
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
SoR: Two, Regain PASI 75 Injection 6 (n=21,36)
|
—
|
—
|
—
|
—
|
4.8 percent of participants
|
8.3 percent of participants
|
|
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
SoR: Two, Regain PASI 75 Injection 8 (n=21,36)
|
—
|
—
|
—
|
—
|
0 percent of participants
|
8.3 percent of participants
|
|
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
SoR: Three, Regain PASI 75 Injection 2 (n=0,4)
|
—
|
—
|
—
|
—
|
NA percent of participants
No evaluable participants
|
100 percent of participants
|
SECONDARY outcome
Timeframe: Baseline, weeks 12, 24, 52 and 60Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to week 12, 24, 52 and 8 weeks after treatment at week 60
Outcome measures
| Measure |
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
|
AIN457 300 mg - IPO
secukinumab- 2 x 150mg injections per dose
|
AIN457 150 mg - Fixed Interval (FI)
n=203 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
|
AIN457 300 mg FI
n=216 Participants
2 s.c. secukinumab 150 mg injections
|
AIN457 150 mg- Start of Relapse (SoR)
n=206 Participants
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
|
AIN457 300 mg- SoR
n=217 Participants
2 s.c. secukinumab 150 mg injections
|
|---|---|---|---|---|---|---|
|
Number of Participants Developing Anti-secukinumab Antibodies
|
—
|
—
|
2 Number of participants
|
1 Number of participants
|
1 Number of participants
|
1 Number of participants
|
Adverse Events
INDUCTION-AIN457 150mg
Serious events: 8 serious events
Other events: 190 other events
Deaths: 0 deaths
INDUCTION-AIN457 300mg
Serious events: 10 serious events
Other events: 178 other events
Deaths: 0 deaths
ENTIRE-AIN457 150mg
Serious events: 12 serious events
Other events: 134 other events
Deaths: 0 deaths
ENTIRE-AIN457 300mg
Serious events: 18 serious events
Other events: 137 other events
Deaths: 0 deaths
ENTIRE-AIN457 150 mg SoR
Serious events: 12 serious events
Other events: 120 other events
Deaths: 0 deaths
ENTIRE-AIN457 300 mg SoR
Serious events: 14 serious events
Other events: 126 other events
Deaths: 0 deaths
FOLLOW UP-AIN457 150mg IPO
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
FOLLOW UP-AIN457 300mg IPO
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
FOLLOW UP-AIN457 150 mg
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
FOLLOW UP-AIN457 300 mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
FOLLOW UP-AIN457 150 mg SoR
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
FOLLOW UP-AIN457 300 mg SoR
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
INDUCTION-AIN457 150mg
n=482 participants at risk
INDUCTION-AIN457 150mg
|
INDUCTION-AIN457 300mg
n=484 participants at risk
INDUCTION-AIN457 300mg
|
ENTIRE-AIN457 150mg
n=203 participants at risk
ENTIRE-AIN457 150mg
|
ENTIRE-AIN457 300mg
n=217 participants at risk
ENTIRE-AIN457 300mg
|
ENTIRE-AIN457 150 mg SoR
n=205 participants at risk
ENTIRE-AIN457 150 mg SoR
|
ENTIRE-AIN457 300 mg SoR
n=217 participants at risk
ENTIRE-AIN457 300 mg SoR
|
FOLLOW UP-AIN457 150mg IPO
n=27 participants at risk
FOLLOW UP-AIN457 150mg IPO
|
FOLLOW UP-AIN457 300mg IPO
n=23 participants at risk
FOLLOW UP-AIN457 300mg IPO
|
FOLLOW UP-AIN457 150 mg
n=40 participants at risk
FOLLOW UP-AIN457 150 mg
|
FOLLOW UP-AIN457 300 mg
n=39 participants at risk
FOLLOW UP-AIN457 300 mg
|
FOLLOW UP-AIN457 150 mg SoR
n=39 participants at risk
FOLLOW UP-AIN457 150 mg SoR
|
FOLLOW UP-AIN457 300 mg SoR
n=35 participants at risk
FOLLOW UP-AIN457 300 mg SoR
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/482
|
0.21%
1/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.21%
1/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Cardiac disorders
AORTIC VALVE INCOMPETENCE
|
0.00%
0/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/482
|
0.21%
1/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/35
|
|
Cardiac disorders
PALPITATIONS
|
0.21%
1/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Congenital, familial and genetic disorders
FIBROUS DYSPLASIA OF BONE
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Congenital, familial and genetic disorders
HYDROCELE
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Ear and labyrinth disorders
VESTIBULAR DISORDER
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.21%
1/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/482
|
0.21%
1/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
General disorders
GENERALISED OEDEMA
|
0.21%
1/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Hepatobiliary disorders
HEPATIC CIRRHOSIS
|
0.21%
1/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Hepatobiliary disorders
HEPATITIS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Hepatobiliary disorders
HEPATOTOXICITY
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Hepatobiliary disorders
LIVER INJURY
|
0.00%
0/482
|
0.21%
1/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Hepatobiliary disorders
PORTAL HYPERTENSION
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
ABSCESS BACTERIAL
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
ABSCESS OF SALIVARY GLAND
|
0.00%
0/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
APPENDICITIS
|
0.21%
1/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
2.5%
1/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
CHRONIC TONSILLITIS
|
0.00%
0/482
|
0.21%
1/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
GROIN ABSCESS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
HELICOBACTER GASTRITIS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
HEPATITIS B
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
3.7%
1/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
OOPHORITIS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
PHARYNGEAL ABSCESS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/482
|
0.00%
0/484
|
0.49%
1/203
|
0.46%
1/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.00%
0/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
SEPSIS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/35
|
|
Infections and infestations
TONSILLITIS BACTERIAL
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
VULVAL ABSCESS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.00%
0/482
|
0.21%
1/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/482
|
0.21%
1/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.00%
0/482
|
0.21%
1/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
PANCREATIC INJURY
|
0.00%
0/482
|
0.21%
1/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
POST-TRAUMATIC PAIN
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
SPINAL CORD INJURY
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.00%
0/482
|
0.21%
1/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.92%
2/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Investigations
URINE ANALYSIS ABNORMAL
|
0.21%
1/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Metabolism and nutrition disorders
GOUT
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
CHONDROMALACIA
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
FRACTURE NONUNION
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/482
|
0.21%
1/484
|
0.00%
0/203
|
0.92%
2/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN BREAST NEOPLASM
|
0.00%
0/482
|
0.21%
1/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PITUITARY TUMOUR BENIGN
|
0.00%
0/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Nervous system disorders
CENTRAL NERVOUS SYSTEM INFLAMMATION
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
2.5%
1/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Nervous system disorders
HAEMORRHAGIC STROKE
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Nervous system disorders
MULTIPLE SCLEROSIS
|
0.00%
0/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/482
|
0.21%
1/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Nervous system disorders
VASCULAR HEADACHE
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Psychiatric disorders
ALCOHOL ABUSE
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Psychiatric disorders
ALCOHOL WITHDRAWAL SYNDROME
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Psychiatric disorders
ALCOHOLISM
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Psychiatric disorders
DEPRESSION
|
0.21%
1/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Psychiatric disorders
PANIC ATTACK
|
0.21%
1/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Renal and urinary disorders
CALCULUS URETERIC
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Renal and urinary disorders
IGA NEPHROPATHY
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/35
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/482
|
0.21%
1/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Renal and urinary disorders
RENAL COLIC
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Renal and urinary disorders
RENAL TUBULAR NECROSIS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/35
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.00%
0/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Reproductive system and breast disorders
VARICOCELE
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Reproductive system and breast disorders
VULVA CYST
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.21%
1/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.00%
0/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
DERMAL CYST
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
PEMPHIGUS
|
0.00%
0/482
|
0.21%
1/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY REACTION
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
PUSTULAR PSORIASIS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Vascular disorders
FEMORAL ARTERY OCCLUSION
|
0.21%
1/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Vascular disorders
GRANULOMATOSIS WITH POLYANGIITIS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Vascular disorders
PERIPHERAL ARTERY STENOSIS
|
0.21%
1/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
Other adverse events
| Measure |
INDUCTION-AIN457 150mg
n=482 participants at risk
INDUCTION-AIN457 150mg
|
INDUCTION-AIN457 300mg
n=484 participants at risk
INDUCTION-AIN457 300mg
|
ENTIRE-AIN457 150mg
n=203 participants at risk
ENTIRE-AIN457 150mg
|
ENTIRE-AIN457 300mg
n=217 participants at risk
ENTIRE-AIN457 300mg
|
ENTIRE-AIN457 150 mg SoR
n=205 participants at risk
ENTIRE-AIN457 150 mg SoR
|
ENTIRE-AIN457 300 mg SoR
n=217 participants at risk
ENTIRE-AIN457 300 mg SoR
|
FOLLOW UP-AIN457 150mg IPO
n=27 participants at risk
FOLLOW UP-AIN457 150mg IPO
|
FOLLOW UP-AIN457 300mg IPO
n=23 participants at risk
FOLLOW UP-AIN457 300mg IPO
|
FOLLOW UP-AIN457 150 mg
n=40 participants at risk
FOLLOW UP-AIN457 150 mg
|
FOLLOW UP-AIN457 300 mg
n=39 participants at risk
FOLLOW UP-AIN457 300 mg
|
FOLLOW UP-AIN457 150 mg SoR
n=39 participants at risk
FOLLOW UP-AIN457 150 mg SoR
|
FOLLOW UP-AIN457 300 mg SoR
n=35 participants at risk
FOLLOW UP-AIN457 300 mg SoR
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.00%
0/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/35
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
2.5%
1/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Eye disorders
CATARACT
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/35
|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/482
|
0.62%
3/484
|
1.5%
3/203
|
2.3%
5/217
|
1.5%
3/205
|
1.4%
3/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Gastrointestinal disorders
ABDOMINAL TENDERNESS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
3.7%
1/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
0.41%
2/482
|
0.21%
1/484
|
0.00%
0/203
|
0.92%
2/217
|
0.49%
1/205
|
0.00%
0/217
|
3.7%
1/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/482
|
0.41%
2/484
|
0.00%
0/203
|
1.4%
3/217
|
0.98%
2/205
|
0.00%
0/217
|
0.00%
0/27
|
4.3%
1/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.5%
7/482
|
1.7%
8/484
|
3.0%
6/203
|
3.2%
7/217
|
3.9%
8/205
|
4.6%
10/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.41%
2/482
|
0.83%
4/484
|
2.5%
5/203
|
1.8%
4/217
|
0.00%
0/205
|
0.92%
2/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Gastrointestinal disorders
HYPERCHLORHYDRIA
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/35
|
|
Gastrointestinal disorders
NAUSEA
|
2.1%
10/482
|
0.83%
4/484
|
2.5%
5/203
|
1.4%
3/217
|
2.4%
5/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/35
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.62%
3/482
|
0.00%
0/484
|
2.0%
4/203
|
0.46%
1/217
|
2.0%
4/205
|
0.92%
2/217
|
0.00%
0/27
|
4.3%
1/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Gastrointestinal disorders
VOMITING
|
0.41%
2/482
|
0.62%
3/484
|
0.99%
2/203
|
2.3%
5/217
|
0.49%
1/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
General disorders
ASTHENIA
|
0.21%
1/482
|
0.62%
3/484
|
0.49%
1/203
|
0.00%
0/217
|
0.98%
2/205
|
1.4%
3/217
|
0.00%
0/27
|
0.00%
0/23
|
2.5%
1/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.21%
1/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
2.5%
1/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
General disorders
INJECTION SITE PAIN
|
0.62%
3/482
|
0.83%
4/484
|
0.00%
0/203
|
1.8%
4/217
|
1.5%
3/205
|
2.3%
5/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
General disorders
OEDEMA PERIPHERAL
|
0.83%
4/482
|
0.83%
4/484
|
2.0%
4/203
|
1.4%
3/217
|
0.98%
2/205
|
1.4%
3/217
|
3.7%
1/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
General disorders
PYREXIA
|
0.62%
3/482
|
0.00%
0/484
|
2.0%
4/203
|
2.3%
5/217
|
2.4%
5/205
|
0.92%
2/217
|
0.00%
0/27
|
0.00%
0/23
|
5.0%
2/40
|
0.00%
0/39
|
7.7%
3/39
|
0.00%
0/35
|
|
Infections and infestations
BRONCHITIS
|
0.62%
3/482
|
1.2%
6/484
|
5.4%
11/203
|
3.2%
7/217
|
0.49%
1/205
|
3.2%
7/217
|
3.7%
1/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.92%
2/217
|
3.7%
1/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
FOLLICULITIS
|
0.62%
3/482
|
0.62%
3/484
|
0.99%
2/203
|
2.8%
6/217
|
1.5%
3/205
|
2.8%
6/217
|
3.7%
1/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
GASTROENTERITIS
|
1.0%
5/482
|
0.41%
2/484
|
3.4%
7/203
|
2.3%
5/217
|
2.0%
4/205
|
2.3%
5/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
HERPES ZOSTER
|
0.62%
3/482
|
0.21%
1/484
|
1.5%
3/203
|
0.46%
1/217
|
0.49%
1/205
|
0.92%
2/217
|
0.00%
0/27
|
4.3%
1/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
INFLUENZA
|
1.2%
6/482
|
1.2%
6/484
|
4.4%
9/203
|
2.8%
6/217
|
2.4%
5/205
|
3.7%
8/217
|
3.7%
1/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/35
|
|
Infections and infestations
NASOPHARYNGITIS
|
10.0%
48/482
|
9.5%
46/484
|
18.2%
37/203
|
16.6%
36/217
|
15.6%
32/205
|
19.4%
42/217
|
0.00%
0/27
|
4.3%
1/23
|
2.5%
1/40
|
0.00%
0/39
|
0.00%
0/39
|
2.9%
1/35
|
|
Infections and infestations
ORAL HERPES
|
0.62%
3/482
|
0.41%
2/484
|
0.99%
2/203
|
0.92%
2/217
|
2.0%
4/205
|
0.92%
2/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
PERIODONTITIS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.98%
2/205
|
0.92%
2/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
2.9%
1/35
|
|
Infections and infestations
PHARYNGITIS
|
0.83%
4/482
|
1.9%
9/484
|
3.9%
8/203
|
5.5%
12/217
|
0.98%
2/205
|
3.2%
7/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
PHARYNGITIS BACTERIAL
|
0.21%
1/482
|
0.21%
1/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
2.3%
5/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
RHINITIS
|
1.0%
5/482
|
0.62%
3/484
|
2.0%
4/203
|
2.8%
6/217
|
2.0%
4/205
|
1.8%
4/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
SINUSITIS
|
1.0%
5/482
|
0.62%
3/484
|
1.5%
3/203
|
2.8%
6/217
|
3.4%
7/205
|
1.8%
4/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
3.5%
17/482
|
3.5%
17/484
|
7.9%
16/203
|
7.4%
16/217
|
5.4%
11/205
|
6.5%
14/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
5.1%
2/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/482
|
0.62%
3/484
|
1.5%
3/203
|
1.8%
4/217
|
0.00%
0/205
|
2.3%
5/217
|
0.00%
0/27
|
0.00%
0/23
|
2.5%
1/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
2.5%
1/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.41%
2/482
|
0.41%
2/484
|
0.49%
1/203
|
0.00%
0/217
|
0.49%
1/205
|
0.46%
1/217
|
0.00%
0/27
|
4.3%
1/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
2.9%
1/35
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.83%
4/482
|
0.62%
3/484
|
2.0%
4/203
|
0.46%
1/217
|
2.4%
5/205
|
1.4%
3/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
1.0%
5/482
|
0.00%
0/484
|
1.5%
3/203
|
0.46%
1/217
|
2.0%
4/205
|
0.00%
0/217
|
0.00%
0/27
|
8.7%
2/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Metabolism and nutrition disorders
DYSLIPIDAEMIA
|
1.0%
5/482
|
0.41%
2/484
|
0.99%
2/203
|
0.46%
1/217
|
2.9%
6/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
1.0%
5/482
|
1.0%
5/484
|
1.5%
3/203
|
2.3%
5/217
|
1.5%
3/205
|
0.92%
2/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/482
|
0.00%
0/484
|
0.99%
2/203
|
0.46%
1/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
4.3%
1/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
0.41%
2/482
|
0.41%
2/484
|
0.99%
2/203
|
2.8%
6/217
|
0.98%
2/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.41%
2/482
|
0.00%
0/484
|
0.99%
2/203
|
0.00%
0/217
|
1.5%
3/205
|
0.00%
0/217
|
0.00%
0/27
|
4.3%
1/23
|
0.00%
0/40
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
1.9%
9/482
|
1.9%
9/484
|
3.9%
8/203
|
5.1%
11/217
|
5.9%
12/205
|
6.0%
13/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.1%
10/482
|
0.83%
4/484
|
5.9%
12/203
|
4.1%
9/217
|
4.4%
9/205
|
3.2%
7/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.21%
1/482
|
0.21%
1/484
|
1.5%
3/203
|
0.46%
1/217
|
1.5%
3/205
|
0.46%
1/217
|
0.00%
0/27
|
4.3%
1/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
1.2%
6/482
|
0.41%
2/484
|
2.5%
5/203
|
1.8%
4/217
|
2.9%
6/205
|
0.92%
2/217
|
0.00%
0/27
|
0.00%
0/23
|
2.5%
1/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
PSORIATIC ARTHROPATHY
|
0.83%
4/482
|
0.21%
1/484
|
2.5%
5/203
|
0.92%
2/217
|
2.9%
6/205
|
0.92%
2/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/35
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.46%
1/217
|
0.98%
2/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/35
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SEBORRHOEIC KERATOSIS
|
0.21%
1/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
4.3%
1/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Nervous system disorders
HEADACHE
|
4.6%
22/482
|
3.5%
17/484
|
6.9%
14/203
|
5.1%
11/217
|
6.8%
14/205
|
5.1%
11/217
|
3.7%
1/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
2.9%
1/35
|
|
Nervous system disorders
PARAESTHESIA
|
0.21%
1/482
|
0.21%
1/484
|
0.99%
2/203
|
0.92%
2/217
|
0.49%
1/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
2.9%
1/35
|
|
Psychiatric disorders
INSOMNIA
|
1.9%
9/482
|
0.21%
1/484
|
3.0%
6/203
|
0.46%
1/217
|
1.5%
3/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
2.5%
1/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Renal and urinary disorders
DYSURIA
|
0.21%
1/482
|
0.00%
0/484
|
0.49%
1/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/35
|
|
Renal and urinary disorders
GLYCOSURIA
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
4.3%
1/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Renal and urinary disorders
KETONURIA
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
4.3%
1/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
2.1%
10/482
|
2.1%
10/484
|
6.4%
13/203
|
5.1%
11/217
|
3.9%
8/205
|
3.7%
8/217
|
0.00%
0/27
|
0.00%
0/23
|
2.5%
1/40
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.62%
3/482
|
1.4%
7/484
|
1.5%
3/203
|
4.6%
10/217
|
1.5%
3/205
|
3.2%
7/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
1.2%
6/482
|
0.62%
3/484
|
2.5%
5/203
|
0.46%
1/217
|
0.00%
0/205
|
1.4%
3/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.21%
1/482
|
0.62%
3/484
|
0.00%
0/203
|
2.3%
5/217
|
2.4%
5/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.41%
2/482
|
0.21%
1/484
|
1.5%
3/203
|
2.3%
5/217
|
2.0%
4/205
|
1.4%
3/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.21%
1/482
|
1.2%
6/484
|
0.00%
0/203
|
3.7%
8/217
|
0.49%
1/205
|
3.2%
7/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.21%
1/482
|
0.41%
2/484
|
0.49%
1/203
|
0.92%
2/217
|
0.49%
1/205
|
0.92%
2/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
ERYTHRODERMIC PSORIASIS
|
0.21%
1/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.49%
1/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
5.0%
2/40
|
7.7%
3/39
|
10.3%
4/39
|
14.3%
5/35
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
0.00%
0/482
|
0.21%
1/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
4.1%
20/482
|
2.5%
12/484
|
5.9%
12/203
|
6.0%
13/217
|
8.3%
17/205
|
2.8%
6/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
2.6%
1/39
|
5.1%
2/39
|
2.9%
1/35
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.21%
1/482
|
1.4%
7/484
|
0.00%
0/203
|
1.4%
3/217
|
0.49%
1/205
|
2.8%
6/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
2.6%
1/39
|
2.6%
1/39
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
PUSTULAR PSORIASIS
|
0.00%
0/482
|
0.21%
1/484
|
0.00%
0/203
|
0.46%
1/217
|
0.00%
0/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
5.1%
2/39
|
0.00%
0/39
|
5.7%
2/35
|
|
Skin and subcutaneous tissue disorders
SEBORRHOEIC DERMATITIS
|
0.83%
4/482
|
0.41%
2/484
|
2.5%
5/203
|
2.8%
6/217
|
1.5%
3/205
|
0.46%
1/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
0.00%
0/482
|
0.00%
0/484
|
0.00%
0/203
|
0.00%
0/217
|
0.00%
0/205
|
0.00%
0/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.62%
3/482
|
0.83%
4/484
|
3.0%
6/203
|
0.92%
2/217
|
0.49%
1/205
|
1.8%
4/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
|
Vascular disorders
HYPERTENSION
|
2.3%
11/482
|
2.3%
11/484
|
4.4%
9/203
|
7.8%
17/217
|
4.4%
9/205
|
5.5%
12/217
|
0.00%
0/27
|
0.00%
0/23
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/39
|
0.00%
0/35
|
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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
- Publication restrictions are in place
Restriction type: OTHER