Trial Outcomes & Findings for Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year (NCT NCT01365455)
NCT ID: NCT01365455
Last Updated: 2021-01-05
Results Overview
A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis. 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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
738 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-01-05
Participant Flow
Not all patients that completed Maintenance Period continued in the follow-up Period. Many patients from Maintence rolled into CAIN457A2302E1 study
Participant milestones
| Measure |
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Induction Period
STARTED
|
245
|
245
|
248
|
0
|
0
|
|
Induction Period
COMPLETED
|
230
|
238
|
232
|
0
|
0
|
|
Induction Period
NOT COMPLETED
|
15
|
7
|
16
|
0
|
0
|
|
Maintenance Period
STARTED
|
230
|
238
|
18
|
109
|
105
|
|
Maintenance Period
COMPLETED
|
201
|
215
|
15
|
100
|
92
|
|
Maintenance Period
NOT COMPLETED
|
29
|
23
|
3
|
9
|
13
|
|
Follow-up Period
STARTED
|
58
|
47
|
18
|
0
|
0
|
|
Follow-up Period
COMPLETED
|
58
|
47
|
18
|
0
|
0
|
|
Follow-up Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Induction Period
Adverse Event
|
5
|
3
|
4
|
0
|
0
|
|
Induction Period
Lack of Efficacy
|
1
|
1
|
0
|
0
|
0
|
|
Induction Period
Pregnancy
|
0
|
1
|
0
|
0
|
0
|
|
Induction Period
Protocol deviation
|
0
|
1
|
1
|
0
|
0
|
|
Induction Period
Subject/guardian decision
|
9
|
1
|
8
|
0
|
0
|
|
Induction Period
Lost to Follow-up
|
0
|
0
|
3
|
0
|
0
|
|
Maintenance Period
Adverse Event
|
12
|
5
|
1
|
2
|
4
|
|
Maintenance Period
Lack of Efficacy
|
10
|
2
|
0
|
2
|
2
|
|
Maintenance Period
Lost to Follow-up
|
2
|
4
|
0
|
0
|
3
|
|
Maintenance Period
Non-compliance with study treatment
|
0
|
0
|
0
|
1
|
0
|
|
Maintenance Period
Physician Decision
|
0
|
1
|
0
|
0
|
1
|
|
Maintenance Period
Pregnancy
|
0
|
4
|
0
|
0
|
2
|
|
Maintenance Period
Protocol deviation
|
1
|
1
|
0
|
0
|
0
|
|
Maintenance Period
Subject/guardian decision
|
4
|
6
|
2
|
4
|
1
|
Baseline Characteristics
Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year
Baseline characteristics by cohort
| Measure |
AIN457 150 mg
n=245 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=248 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
Total
n=738 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.9 years
STANDARD_DEVIATION 13.33 • n=5 Participants
|
44.9 years
STANDARD_DEVIATION 13.46 • n=7 Participants
|
45.4 years
STANDARD_DEVIATION 12.63 • n=5 Participants
|
45.1 years
STANDARD_DEVIATION 13.13 • n=4 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
229 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
168 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
509 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis. 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).
Outcome measures
| Measure |
AIN457 150 mg
n=243 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=246 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks
|
71.6 Percentage of participants
|
81.6 Percentage of participants
|
4.5 Percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
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. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. IGA score of 0 or 1 as an indicator of efficacy.
Outcome measures
| Measure |
AIN457 150 mg
n=244 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=246 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1
|
51.2 Percentage of Participants
|
65.3 Percentage of Participants
|
2.4 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
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 90 was defined as participants who achievied ≥ 90% improvement from baseline.
Outcome measures
| Measure |
AIN457 150 mg
n=243 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=246 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a PASI (Psoriasis Area and Severity Index) Score of 90 or Better at Week 12
|
39.1 Percentage of Participants
|
59.2 Percentage of Participants
|
1.2 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 and 52 weeksPopulation: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
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).
Outcome measures
| Measure |
AIN457 150 mg
n=245 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=248 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Number of Participants That Maintained the Psoriasis Area and Severity Index (PASI) 75 Response at 52 Weeks of Treatment for Participants Who Were PASI 75 Responders at Week 12
PASI 75 response at Week 12 (n=243, 245, 246)
|
174 number of participants
|
200 number of participants
|
11 number of participants
|
—
|
—
|
|
Number of Participants That Maintained the Psoriasis Area and Severity Index (PASI) 75 Response at 52 Weeks of Treatment for Participants Who Were PASI 75 Responders at Week 12
Maintained PASI 75 response at Wk 52(n=174,200,11)
|
126 number of participants
|
161 number of participants
|
NA number of participants
After W12: Efficacy was not focus for PBO group and therefore no data was provided at Week 52
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 and 52 weeksPopulation: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
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. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
Outcome measures
| Measure |
AIN457 150 mg
n=245 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=248 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Number of Participants That Maintained the IGA Mod 2011 0 or 1 Response at 52 Weeks of Treatment for Participants Who Were IGA Mod 2011 0 or 1 Responders at Week 12
IGA mod2011 0or1 response at Wk 12(n=244,245,246)
|
125 number of participants
|
160 number of participants
|
6 number of participants
|
—
|
—
|
|
Number of Participants That Maintained the IGA Mod 2011 0 or 1 Response at 52 Weeks of Treatment for Participants Who Were IGA Mod 2011 0 or 1 Responders at Week 12
Maintained IGAmod2011 0or1 resp atWk52 n=125,160,6
|
74 number of participants
|
119 number of participants
|
NA number of participants
After W12: Efficacy was not focus for PBO group and therefore no data was provided at Week 52
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. A reduction in score from baseline shows efficacy. Each question has a score of 0 (no symptoms) up to 10 (Severe symptoms)
Outcome measures
| Measure |
AIN457 150 mg
n=245 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=248 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo
itching (n=86,79,84)
|
-4.86 Scores on a Scale
Standard Error 0.299
|
-545 Scores on a Scale
Standard Error 0.276
|
-0.22 Scores on a Scale
Standard Error 0.260
|
—
|
—
|
|
Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo
pain (n=86,79,84)
|
-3.92 Scores on a Scale
Standard Error 0.337
|
-4.59 Scores on a Scale
Standard Error 0.322
|
0.06 Scores on a Scale
Standard Error 0.246
|
—
|
—
|
|
Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo
scaling (n=86,79,84)
|
-4.74 Scores on a Scale
Standard Error 0.307
|
-5.49 Scores on a Scale
Standard Error 0.289
|
-0.11 Scores on a Scale
Standard Error 0.248
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1,2,3,4,8,12,Population: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
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 (max). 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 |
AIN457 150 mg
n=245 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=247 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 1 IGA 0/1 (n=244,245,246)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 1 PASI 75 (n=243,245,246)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 1 PASI 50 (n=243,245,246)
|
2.1 Percentage of participants
|
4.5 Percentage of participants
|
0.4 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 1 PASI 90 (n=243,245,246)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 1 PASI 100 (n=243,245,246)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 2 IGA 0/1 n=244,245,246)
|
1.2 Percentage of participants
|
4.5 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 2 PASI 75 (n=243,245,246)
|
0.8 Percentage of participants
|
4.1 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 2 PASI 50 (n=243,245,246)
|
18.5 Percentage of participants
|
28.2 Percentage of participants
|
3.3 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 2 PASI 90 (n=243,245,246)
|
0.0 Percentage of participants
|
0.8 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 2 PASI 100 (n=243,245,246)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 3 IGA 0/1( n=244,245,246)
|
6.6 Percentage of participants
|
11.0 Percentage of participants
|
0.4 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 3 PASI 75 (n=243,245,246)
|
8.2 Percentage of participants
|
15.5 Percentage of participants
|
1.2 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 3 PASI 50 (n=243,245,246)
|
41.2 Percentage of participants
|
53.1 Percentage of participants
|
4.9 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 3 PASI 90 (n=243,245,246)
|
0.8 Percentage of participants
|
2.9 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 3 PASI 100 (n=243,245,246)
|
0.0 Percentage of participants
|
0.8 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 4 IGA 0/1( n=244,245,246)
|
17.2 Percentage of participants
|
26.1 Percentage of participants
|
1.2 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 4 PASI 75 (n=243,245,246)
|
24.3 Percentage of participants
|
38.0 Percentage of participants
|
0.8 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 4 PASI 50 (n=243,245,246)
|
63.0 Percentage of participants
|
74.7 Percentage of participants
|
7.3 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 4 PASI 90 (n=243,245,246)
|
5.8 Percentage of participants
|
10.6 Percentage of participants
|
0.4 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 4 PASI 100 (n=243,245,246)
|
0.8 Percentage of participants
|
3.7 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 8 IGA 0/1( n=244,245,246)
|
42.2 Percentage of participants
|
60.0 Percentage of participants
|
1.6 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 8 PASI 75 (n=243,245,246)
|
61.7 Percentage of participants
|
76.7 Percentage of participants
|
2.8 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 8 PASI 50 (n=243,245,246)
|
88.5 Percentage of participants
|
92.2 Percentage of participants
|
9.3 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 8 PASI 90 (n=243,245,246)
|
28.8 Percentage of participants
|
47.8 Percentage of participants
|
1.2 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 8 PASI 100 (n=243,245,246)
|
8.2 Percentage of participants
|
16.7 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 12 IGA 0/1( n=244,245,246)
|
51.2 Percentage of participants
|
65.3 Percentage of participants
|
2.4 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 12 PASI 75 (n=243,245,246)
|
71.6 Percentage of participants
|
81.6 Percentage of participants
|
4.5 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 12 PASI 50 (n=243,245,246)
|
83.5 Percentage of participants
|
90.6 Percentage of participants
|
8.9 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 12 PASI 90 (n=243,245,246)
|
39.1 Percentage of participants
|
59.2 Percentage of participants
|
1.2 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
Week 12 PASI 100 (n=243,245,246)
|
12.8 Percentage of participants
|
28.6 Percentage of participants
|
0.8 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 13,14,15,16,20,24,28,32,36,40,44,48,52Population: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
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 (max). 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 |
AIN457 150 mg
n=245 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=18 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
n=108 Participants
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
n=105 Participants
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 13 IGA 0/1 (n=244,245,18, 108, 104)
|
51.6 Percentage of participants
|
66.9 Percentage of participants
|
33.3 Percentage of participants
|
0.9 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 13 PASI 75 (n=243,245,18, 108, 104)
|
70.8 Percentage of participants
|
79.6 Percentage of participants
|
55.6 Percentage of participants
|
2.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 13 PASI 50 (n=243,245,18, 108, 104)
|
81.5 Percentage of participants
|
87.3 Percentage of participants
|
77.8 Percentage of participants
|
12.0 Percentage of participants
|
13.5 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 13 PASI 90 (n=243,245,18, 108, 104)
|
44.9 Percentage of participants
|
60.8 Percentage of participants
|
22.2 Percentage of participants
|
0.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 13 PASI 100 (n=243,245,18, 108, 104)
|
14.0 Percentage of participants
|
30.2 Percentage of participants
|
11.1 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 14 IGA 0/1 (n=244,245,18, 108, 104)
|
55.3 Percentage of participants
|
74.7 Percentage of participants
|
33.3 Percentage of participants
|
4.6 Percentage of participants
|
10.6 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 14 PASI 75 (n=243,245,18, 108, 104)
|
72.0 Percentage of participants
|
86.1 Percentage of participants
|
55.6 Percentage of participants
|
7.4 Percentage of participants
|
14.4 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 14 PASI 50 (n=243,245,18, 108, 104)
|
83.1 Percentage of participants
|
91.4 Percentage of participants
|
83.3 Percentage of participants
|
34.3 Percentage of participants
|
38.5 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 14 PASI 90 (n=243,245,18, 108, 104)
|
48.6 Percentage of participants
|
68.2 Percentage of participants
|
27.8 Percentage of participants
|
0.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 14 PASI 100 (n=243,245,18, 108, 104)
|
16.5 Percentage of participants
|
35.5 Percentage of participants
|
11.1 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 15 IGA 0/1 (n=244,245,18, 108, 104)
|
57.4 Percentage of participants
|
75.1 Percentage of participants
|
33.3 Percentage of participants
|
13.0 Percentage of participants
|
19.2 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 15 PASI 75 (n=243,245,18, 108, 104)
|
75.3 Percentage of participants
|
87.8 Percentage of participants
|
55.6 Percentage of participants
|
13.9 Percentage of participants
|
26.9 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 15 PASI 50 (n=243,245,18, 108, 104)
|
86.4 Percentage of participants
|
92.2 Percentage of participants
|
72.2 Percentage of participants
|
55.6 Percentage of participants
|
66.3 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 15 PASI 90 (n=243,245,18, 108, 104)
|
51.0 Percentage of participants
|
68.6 Percentage of participants
|
27.8 Percentage of participants
|
2.8 Percentage of participants
|
6.7 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 15 PASI 100 (n=243,245,18, 108, 104)
|
19.8 Percentage of participants
|
40.8 Percentage of participants
|
11.1 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 16 IGA 0/1 (n=244,245,18, 108, 104)
|
58.2 Percentage of participants
|
73.5 Percentage of participants
|
38.9 Percentage of participants
|
25.9 Percentage of participants
|
30.8 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 16 PASI 75 (n=243,245,18, 108, 104)
|
77.4 Percentage of participants
|
86.1 Percentage of participants
|
61.1 Percentage of participants
|
33.3 Percentage of participants
|
47.1 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 16 PASI 50 (n=243,245,18, 108, 104)
|
87.2 Percentage of participants
|
91.4 Percentage of participants
|
77.8 Percentage of participants
|
68.5 Percentage of participants
|
81.7 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 16 PASI 90 (n=243,245,18, 108, 104)
|
53.5 Percentage of participants
|
69.8 Percentage of participants
|
33.3 Percentage of participants
|
10.2 Percentage of participants
|
15.4 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 16 PASI 100 (n=243,245,18, 108, 104)
|
21.0 Percentage of participants
|
41.6 Percentage of participants
|
22.2 Percentage of participants
|
0.9 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 20 IGA 0/1 (n=244,245,18, 108, 104)
|
57.4 Percentage of participants
|
74.7 Percentage of participants
|
38.9 Percentage of participants
|
51.9 Percentage of participants
|
55.8 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 20 PASI 75 (n=243,245,18, 108, 104)
|
77.0 Percentage of participants
|
86.9 Percentage of participants
|
72.2 Percentage of participants
|
66.7 Percentage of participants
|
75.0 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 20 PASI 50 (n=243,245,18, 108, 104)
|
89.3 Percentage of participants
|
92.7 Percentage of participants
|
88.9 Percentage of participants
|
87.0 Percentage of participants
|
91.3 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 20 PASI 90 (n=243,245,18, 108, 104)
|
51.9 Percentage of participants
|
69.8 Percentage of participants
|
38.9 Percentage of participants
|
38.0 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 20 PASI 100 (n=243,245,18, 108, 104)
|
21.8 Percentage of participants
|
43.3 Percentage of participants
|
16.7 Percentage of participants
|
5.6 Percentage of participants
|
19.2 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 24 IGA 0/1 (n=244,245,18, 108, 104)
|
58.2 Percentage of participants
|
71.4 Percentage of participants
|
50.0 Percentage of participants
|
57.4 Percentage of participants
|
72.1 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 24 PASI 75 (n=243,245,18, 108, 104)
|
77.8 Percentage of participants
|
85.7 Percentage of participants
|
66.7 Percentage of participants
|
76.9 Percentage of participants
|
81.7 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 24 PASI 50 (n=243,245,18, 108, 104)
|
86.8 Percentage of participants
|
91.0 Percentage of participants
|
88.9 Percentage of participants
|
91.7 Percentage of participants
|
93.3 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 24 PASI 90 (n=243,245,18, 108, 104)
|
54.7 Percentage of participants
|
70.2 Percentage of participants
|
38.9 Percentage of participants
|
50.9 Percentage of participants
|
62.5 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 24 PASI 100 (n=243,245,18, 108, 104)
|
23.9 Percentage of participants
|
42.4 Percentage of participants
|
16.7 Percentage of participants
|
16.7 Percentage of participants
|
26.0 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 28 IGA 0/1 (n=244,245,18, 108, 104)
|
53.7 Percentage of participants
|
68.6 Percentage of participants
|
50.0 Percentage of participants
|
61.1 Percentage of participants
|
76.0 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 28 PASI 75 (n=243,245,18, 108, 104)
|
72.4 Percentage of participants
|
82.9 Percentage of participants
|
72.2 Percentage of participants
|
74.1 Percentage of participants
|
87.5 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 28 PASI 50 (n=243,245,18, 108, 104)
|
84.4 Percentage of participants
|
90.2 Percentage of participants
|
83.3 Percentage of participants
|
91.7 Percentage of participants
|
93.3 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 28 PASI 90 (n=243,245,18, 108, 104)
|
53.1 Percentage of participants
|
68.6 Percentage of participants
|
50.0 Percentage of participants
|
50.0 Percentage of participants
|
71.2 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 28 PASI 100 (n=243,245,18, 108, 104)
|
24.3 Percentage of participants
|
43.3 Percentage of participants
|
16.7 Percentage of participants
|
24.1 Percentage of participants
|
33.7 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 32 IGA 0/1 (n=244,245,18, 108, 104)
|
50.8 Percentage of participants
|
68.2 Percentage of participants
|
44.4 Percentage of participants
|
57.4 Percentage of participants
|
76.0 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 32 PASI 75 (n=243,245,18, 108, 104)
|
72.0 Percentage of participants
|
81.2 Percentage of participants
|
61.1 Percentage of participants
|
75.0 Percentage of participants
|
89.4 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 32 PASI 50 (n=243,245,18, 108, 104)
|
86.4 Percentage of participants
|
88.6 Percentage of participants
|
77.8 Percentage of participants
|
88.9 Percentage of participants
|
94.2 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 32 PASI 90 (n=243,245,18, 108, 104)
|
48.1 Percentage of participants
|
68.2 Percentage of participants
|
44.4 Percentage of participants
|
50.9 Percentage of participants
|
70.2 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 32 PASI 100 (n=243,245,18, 108, 104)
|
22.2 Percentage of participants
|
43.7 Percentage of participants
|
16.7 Percentage of participants
|
22.2 Percentage of participants
|
39.4 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 36 IGA 0/1 (n=244,245,18, 108, 104)
|
48.0 Percentage of participants
|
66.9 Percentage of participants
|
38.9 Percentage of participants
|
60.2 Percentage of participants
|
70.2 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 36 PASI 75 (n=243,245,18, 108, 104)
|
67.5 Percentage of participants
|
79.2 Percentage of participants
|
61.1 Percentage of participants
|
73.1 Percentage of participants
|
86.5 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 36 PASI 50 (n=243,245,18, 108, 104)
|
80.2 Percentage of participants
|
86.9 Percentage of participants
|
88.9 Percentage of participants
|
88.9 Percentage of participants
|
89.4 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 36 PASI 90 (n=243,245,18, 108, 104)
|
44.4 Percentage of participants
|
67.3 Percentage of participants
|
44.4 Percentage of participants
|
52.8 Percentage of participants
|
64.4 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 36 PASI 100 (n=243,245,18, 108, 104)
|
22.2 Percentage of participants
|
42.4 Percentage of participants
|
16.7 Percentage of participants
|
25.0 Percentage of participants
|
43.3 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 40 IGA 0/1 (n=244,245,18, 108, 104)
|
47.1 Percentage of participants
|
64.9 Percentage of participants
|
44.4 Percentage of participants
|
57.4 Percentage of participants
|
69.2 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 40 PASI 75 (n=243,245,18, 108, 104)
|
65.4 Percentage of participants
|
76.7 Percentage of participants
|
66.7 Percentage of participants
|
69.4 Percentage of participants
|
81.7 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 40 PASI 50 (n=243,245,18, 108, 104)
|
78.6 Percentage of participants
|
84.9 Percentage of participants
|
83.3 Percentage of participants
|
88.0 Percentage of participants
|
88.5 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 48 PASI 50 (n=243,245,18, 108, 104)
|
77.4 Percentage of participants
|
84.9 Percentage of participants
|
83.3 Percentage of participants
|
86.1 Percentage of participants
|
83.7 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 40 PASI 90 (n=243,245,18, 108, 104)
|
44.0 Percentage of participants
|
64.9 Percentage of participants
|
44.4 Percentage of participants
|
50.9 Percentage of participants
|
65.4 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 40 PASI 100 (n=243,245,18, 108, 104)
|
21.0 Percentage of participants
|
40.8 Percentage of participants
|
27.8 Percentage of participants
|
24.1 Percentage of participants
|
42.3 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 44 IGA 0/1 (n=244,245,18, 108, 104)
|
44.3 Percentage of participants
|
60.4 Percentage of participants
|
44.4 Percentage of participants
|
57.4 Percentage of participants
|
72.1 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 44 PASI 75 (n=243,245,18, 108, 104)
|
63.4 Percentage of participants
|
79.2 Percentage of participants
|
61.1 Percentage of participants
|
68.5 Percentage of participants
|
79.8 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 44 PASI 50 (n=243,245,18, 108, 104)
|
77.4 Percentage of participants
|
84.5 Percentage of participants
|
83.3 Percentage of participants
|
89.8 Percentage of participants
|
89.4 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 44 PASI 90 (n=243,245,18, 108, 104)
|
42.8 Percentage of participants
|
61.2 Percentage of participants
|
38.9 Percentage of participants
|
47.2 Percentage of participants
|
66.3 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 44 PASI 100 (n=243,245,18, 108, 104)
|
21.8 Percentage of participants
|
37.1 Percentage of participants
|
11.1 Percentage of participants
|
23.1 Percentage of participants
|
38.5 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 48 PASI 75 (n=243,245,18, 108, 104)
|
62.1 Percentage of participants
|
77.6 Percentage of participants
|
66.7 Percentage of participants
|
68.5 Percentage of participants
|
76.9 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 48 PASI 90 (n=243,245,18, 108, 104)
|
39.5 Percentage of participants
|
63.7 Percentage of participants
|
38.9 Percentage of participants
|
45.4 Percentage of participants
|
63.5 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 52 PASI 75 (n=243,245,18, 108, 104)
|
86.8 Percentage of participants
|
94.3 Percentage of participants
|
66.7 Percentage of participants
|
88.0 Percentage of participants
|
73.1 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 52 PASI 100 (n=243,245,18, 108, 104)
|
41.2 Percentage of participants
|
62.0 Percentage of participants
|
11.1 Percentage of participants
|
36.1 Percentage of participants
|
43.3 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 48 IGA 0/1 (n=244,245,18, 108, 104)
|
41.4 Percentage of participants
|
62.9 Percentage of participants
|
27.8 Percentage of participants
|
50.0 Percentage of participants
|
69.2 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 48 PASI 100 (n=243,245,18, 108, 104)
|
22.2 Percentage of participants
|
40.4 Percentage of participants
|
11.1 Percentage of participants
|
20.4 Percentage of participants
|
37.5 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 52 IGA 0/1 (n=244,245,18, 108, 104)
|
73.4 Percentage of participants
|
87.3 Percentage of participants
|
38.9 Percentage of participants
|
76.9 Percentage of participants
|
66.3 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 52 PASI 50(n=243,245,18, 108, 104)
|
91.8 Percentage of participants
|
95.9 Percentage of participants
|
83.3 Percentage of participants
|
96.3 Percentage of participants
|
81.7 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
Week 52 PASI 90 (n=243,245,18, 108, 104)
|
73.3 Percentage of participants
|
84.5 Percentage of participants
|
33.3 Percentage of participants
|
66.7 Percentage of participants
|
62.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1,2,3,4,8,12,Population: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
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 |
AIN457 150 mg
n=245 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=247 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Mean Percent Change From Baseline in PASI Scores up to Week 12 - Induction Period
Week 4 (n=243,245,245)
|
-55.73 Percent Change
Standard Deviation 24.252
|
-64.61 Percent Change
Standard Deviation 22.080
|
-8.89 Percent Change
Standard Deviation 28.165
|
—
|
—
|
|
Mean Percent Change From Baseline in PASI Scores up to Week 12 - Induction Period
Week 8 (n=243,245,245)
|
-76.35 Percent Change
Standard Deviation 20.427
|
-82.98 Percent Change
Standard Deviation 19.331
|
-8.15 Percent Change
Standard Deviation 32.755
|
—
|
—
|
|
Mean Percent Change From Baseline in PASI Scores up to Week 12 - Induction Period
Week 1 (n=243,243,242)
|
-12.08 Percent Change
Standard Deviation 19.225
|
-17.50 Percent Change
Standard Deviation 17.317
|
-3.70 Percent Change
Standard Deviation 14.756
|
—
|
—
|
|
Mean Percent Change From Baseline in PASI Scores up to Week 12 - Induction Period
Week 2 (n=243,245,243)
|
-28.61 Percent Change
Standard Deviation 21.982
|
-36.51 Percent Change
Standard Deviation 21.850
|
-5.63 Percent Change
Standard Deviation 23.616
|
—
|
—
|
|
Mean Percent Change From Baseline in PASI Scores up to Week 12 - Induction Period
Week 3 (n=243,245,243)
|
-42.79 Percent Change
Standard Deviation 23.695
|
-51.59 Percent Change
Standard Deviation 22.415
|
-8.62 Percent Change
Standard Deviation 25.785
|
—
|
—
|
|
Mean Percent Change From Baseline in PASI Scores up to Week 12 - Induction Period
Week 12 (n=243,245,245)
|
-80.87 Percent Change
Standard Deviation 20.512
|
-87.72 Percent Change
Standard Deviation 17.729
|
-5.89 Percent Change
Standard Deviation 36.606
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 13,14,15,16,20,24,28,32,36,40,44,48,52Population: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
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 |
AIN457 150 mg
n=245 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=18 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
n=108 Participants
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
n=105 Participants
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52
Week 14 (n=243,245,18,107,102)
|
-84.47 Percent change
Standard Deviation 18.832
|
-90.83 Percent change
Standard Deviation 15.013
|
-68.74 Percent change
Standard Deviation 30.225
|
-39.20 Percent change
Standard Deviation 26.228
|
-41.97 Percent change
Standard Deviation 28.809
|
|
Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52
Week 16 (n=243,245,18,107,103)
|
-85.20 Percent change
Standard Deviation 19.213
|
-91.37 Percent change
Standard Deviation 15.367
|
-73.38 Percent change
Standard Deviation 28.051
|
-62.19 Percent change
Standard Deviation 23.591
|
-70.15 Percent change
Standard Deviation 20.686
|
|
Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52
Week 20 (n=243,245,18,107,103)
|
-85.75 Percent change
Standard Deviation 17.904
|
-90.86 Percent change
Standard Deviation 16.263
|
-80.57 Percent change
Standard Deviation 22.454
|
-77.75 Percent change
Standard Deviation 20.587
|
-84.53 Percent change
Standard Deviation 16.030
|
|
Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52
Week 48(n=243,245,18,107,103)
|
-79.78 Percent change
Standard Deviation 26.471
|
-89.35 Percent change
Standard Deviation 17.281
|
-79.54 Percent change
Standard Deviation 21.506
|
-83.40 Percent change
Standard Deviation 18.736
|
-88.44 Percent change
Standard Deviation 18.083
|
|
Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52
Week 52 (n=243,245,18,107,103)
|
-79.74 Percent change
Standard Deviation 26.524
|
-88.42 Percent change
Standard Deviation 19.132
|
-79.64 Percent change
Standard Deviation 22.169
|
-82.14 Percent change
Standard Deviation 18.554
|
-87.66 Percent change
Standard Deviation 20.615
|
|
Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52
Week 32 (n=243,245,18,107,103)
|
-83.98 Percent change
Standard Deviation 21.887
|
-89.90 Percent change
Standard Deviation 17.775
|
-75.94 Percent change
Standard Deviation 25.879
|
-84.26 Percent change
Standard Deviation 20.622
|
-91.09 Percent change
Standard Deviation 13.240
|
|
Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52
Week 13 (n=243,245,18,102,96)
|
-83.12 Percent change
Standard Deviation 19.313
|
-89.55 Percent change
Standard Deviation 15.935
|
-63.10 Percent change
Standard Deviation 36.827
|
-21.03 Percent change
Standard Deviation 28.240
|
-21.66 Percent change
Standard Deviation 29.891
|
|
Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52
Week 15 (n=243,245,18,107,103)
|
-84.67 Percent change
Standard Deviation 19.407
|
-91.40 Percent change
Standard Deviation 14.769
|
-67.15 Percent change
Standard Deviation 32.972
|
-51.78 Percent change
Standard Deviation 23.561
|
-57.77 Percent change
Standard Deviation 23.166
|
|
Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52
Week 24 (n=243,245,18,107,103)
|
-85.46 Percent change
Standard Deviation 20.240
|
-90.83 Percent change
Standard Deviation 16.652
|
-78.06 Percent change
Standard Deviation 25.062
|
-83.19 Percent change
Standard Deviation 18.635
|
-89.20 Percent change
Standard Deviation 13.969
|
|
Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52
Week 28 (n=243,245,18,107,103)
|
-84.72 Percent change
Standard Deviation 20.417
|
-90.15 Percent change
Standard Deviation 17.600
|
-79.55 Percent change
Standard Deviation 23.943
|
-84.07 Percent change
Standard Deviation 19.819
|
-91.24 Percent change
Standard Deviation 11.849
|
|
Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52
Week 36(n=243,245,18,107,103)
|
-81.87 Percent change
Standard Deviation 25.048
|
-90.04 Percent change
Standard Deviation 17.981
|
-78.37 Percent change
Standard Deviation 24.608
|
-83.68 Percent change
Standard Deviation 20.328
|
-89.97 Percent change
Standard Deviation 16.373
|
|
Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52
Week 40(n=243,245,18,107,103)
|
-81.37 Percent change
Standard Deviation 25.395
|
-89.62 Percent change
Standard Deviation 17.385
|
-78.32 Percent change
Standard Deviation 24.770
|
-82.83 Percent change
Standard Deviation 20.762
|
-89.76 Percent change
Standard Deviation 17.029
|
|
Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52
Week 44 (n=243,245,18,107,103)
|
-80.81 Percent change
Standard Deviation 25.651
|
-88.97 Percent change
Standard Deviation 17.804
|
-79.96 Percent change
Standard Deviation 22.354
|
-83.44 Percent change
Standard Deviation 18.277
|
-89.37 Percent change
Standard Deviation 17.176
|
SECONDARY outcome
Timeframe: Baseline, Week 1,2,3,4,8,12,Population: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
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 |
AIN457 150 mg
n=245 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=247 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 2 (n=244,245,244) almost clear
|
1.2 Percentage of participants
|
4.5 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 2 (n=244,245,244) moderate
|
57.0 Percentage of participants
|
55.5 Percentage of participants
|
59.8 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 3 (n=244,245,244) moderate
|
49.2 Percentage of participants
|
40.4 Percentage of participants
|
58.6 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 3 (n=244,245,244) severe
|
10.2 Percentage of participants
|
5.3 Percentage of participants
|
34.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 4 (n=244,245,246) clear
|
0.4 Percentage of participants
|
3.7 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 4 (n=244,245,246) almost clear
|
16.8 Percentage of participants
|
22.9 Percentage of participants
|
1.6 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 4 (n=244,245,246) mild
|
40.2 Percentage of participants
|
43.7 Percentage of participants
|
7.3 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 8 (n=244,245,246) almost clear
|
32.0 Percentage of participants
|
39.6 Percentage of participants
|
1.6 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 8 (n=244,245,246) mild
|
38.9 Percentage of participants
|
29.0 Percentage of participants
|
8.1 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 8 (n=244,245,246) moderate
|
16.4 Percentage of participants
|
10.2 Percentage of participants
|
53.3 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 8 (n=244,245,246) severe
|
2.5 Percentage of participants
|
0.8 Percentage of participants
|
37.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 12 (n=244,245,246) clear
|
16.4 Percentage of participants
|
32.2 Percentage of participants
|
0.8 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 12 (n=244,245,246) almost clear
|
38.5 Percentage of participants
|
36.3 Percentage of participants
|
1.6 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 12 (n=244,245,246) mild
|
29.1 Percentage of participants
|
23.3 Percentage of participants
|
6.5 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 12 (n=244,245,246) moderate
|
14.8 Percentage of participants
|
6.9 Percentage of participants
|
55.3 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 12 (n=244,245,246) severe
|
1.2 Percentage of participants
|
1.2 Percentage of participants
|
35.8 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 3 (n=244,245,244) almost clear
|
6.6 Percentage of participants
|
9.8 Percentage of participants
|
0.4 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 3 (n=244,245,244) mild
|
34.0 Percentage of participants
|
43.3 Percentage of participants
|
7.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 1 (n=244,243,243) clear
|
0.0 Percentage of participants
19.225
|
0.0 Percentage of participants
17.317
|
0.0 Percentage of participants
14.756
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 1 (n=244,243,243) almost clear
|
0.0 Percentage of participants
21.982
|
0.0 Percentage of participants
21.850
|
0.0 Percentage of participants
23.616
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 1 (n=244,243,243) mild
|
6.6 Percentage of participants
23.695
|
9.1 Percentage of participants
22.415
|
4.1 Percentage of participants
25.785
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 1 (n=244,243,243) moderate
|
66.4 Percentage of participants
24.252
|
68.7 Percentage of participants
22.080
|
60.9 Percentage of participants
28.165
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 1 (n=244,243,243) severe
|
27.0 Percentage of participants
|
22.2 Percentage of participants
|
35.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 2 (n=244,245,244) clear
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 2 (n=244,245,244) mild
|
23.0 Percentage of participants
|
27.8 Percentage of participants
|
5.3 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 2 (n=244,245,244) severe
|
18.9 Percentage of participants
|
12.2 Percentage of participants
|
34.8 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 3 (n=244,245,244) clear
|
0.0 Percentage of participants
|
1.2 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 4 (n=244,245,246) moderate
|
37.3 Percentage of participants
|
26.5 Percentage of participants
|
58.1 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 4 (n=244,245,246) severe
|
5.3 Percentage of participants
|
3.3 Percentage of participants
|
32.9 Percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
Week 8 (n=244,245,246) clear
|
10.2 Percentage of participants
|
20.4 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 13,14,15,16,20,24,28,32,36,40,44,48,52Population: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
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 |
AIN457 150 mg
n=245 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=18 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
n=108 Participants
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
n=105 Participants
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 44 (n=244,245,18,108,103) severe
|
2.0 Percentage of participants
|
0.8 Percentage of participants
|
5.6 Percentage of participants
|
2.8 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 48 (n=244,245,18,108,103) clear
|
27.0 Percentage of participants
|
44.5 Percentage of participants
|
11.1 Percentage of participants
|
25.9 Percentage of participants
|
43.7 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 44 (n=244,245,18,108,103) clear
|
27.5 Percentage of participants
|
42.9 Percentage of participants
|
5.6 Percentage of participants
|
25.9 Percentage of participants
|
40.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 52 (n=244,245,18,108,103) moderate
|
16.0 Percentage of participants
|
11.4 Percentage of participants
|
27.8 Percentage of participants
|
15.7 Percentage of participants
|
11.7 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 40 (n=244,245,18,108,103) clear
|
28.7 Percentage of participants
|
46.1 Percentage of participants
|
22.2 Percentage of participants
|
25.9 Percentage of participants
|
44.7 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 40 (n=244,245,18,108,103) almost clear
|
25.8 Percentage of participants
|
25.3 Percentage of participants
|
22.2 Percentage of participants
|
34.3 Percentage of participants
|
31.1 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 40 (n=244,245,18,108,103) mild
|
25.0 Percentage of participants
|
17.1 Percentage of participants
|
27.8 Percentage of participants
|
21.3 Percentage of participants
|
11.7 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 40 (n=244,245,18,108,103) moderate
|
18.4 Percentage of participants
|
10.2 Percentage of participants
|
16.7 Percentage of participants
|
15.7 Percentage of participants
|
11.7 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 40 (n=244,245,18,108,103) severe
|
2.0 Percentage of participants
|
1.2 Percentage of participants
|
11.1 Percentage of participants
|
2.8 Percentage of participants
|
1.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 44 (n=244,245,18,108,103) mild
|
25.4 Percentage of participants
|
20.4 Percentage of participants
|
22.2 Percentage of participants
|
20.4 Percentage of participants
|
8.7 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 44 (n=244,245,18,108,103) moderate
|
20.1 Percentage of participants
|
11.8 Percentage of participants
|
27.8 Percentage of participants
|
17.6 Percentage of participants
|
11.7 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 44 (n=244,245,18,108,103) almost clear
|
25.0 Percentage of participants
|
24.1 Percentage of participants
|
38.9 Percentage of participants
|
33.3 Percentage of participants
|
36.9 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 48 (n=244,245,18,108,103) almost clear
|
22.1 Percentage of participants
|
25.3 Percentage of participants
|
16.7 Percentage of participants
|
28.7 Percentage of participants
|
34.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 48 (n=244,245,18,108,103) mild
|
27.9 Percentage of participants
|
16.3 Percentage of participants
|
50.0 Percentage of participants
|
27.8 Percentage of participants
|
9.7 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 48 (n=244,245,18,108,103) moderate
|
20.1 Percentage of participants
|
12.7 Percentage of participants
|
16.7 Percentage of participants
|
14.8 Percentage of participants
|
11.7 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 48 (n=244,245,18,108,103) severe
|
2.9 Percentage of participants
|
1.2 Percentage of participants
|
5.6 Percentage of participants
|
2.8 Percentage of participants
|
1.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 52 (n=244,245,18,108,103) clear
|
25.8 Percentage of participants
|
43.3 Percentage of participants
|
11.1 Percentage of participants
|
21.3 Percentage of participants
|
44.7 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 52 (n=244,245,18,108,103) almost clear
|
24.2 Percentage of participants
|
24.1 Percentage of participants
|
27.8 Percentage of participants
|
31.5 Percentage of participants
|
29.1 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 52 (n=244,245,18,108,103) mild
|
29.1 Percentage of participants
|
19.6 Percentage of participants
|
27.8 Percentage of participants
|
28.7 Percentage of participants
|
12.6 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 52 (n=244,245,18,108,103) severe
|
4.9 Percentage of participants
|
1.6 Percentage of participants
|
5.6 Percentage of participants
|
2.8 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 13 (n=244,245,18,103,96) clear
|
17.6 Percentage of participants
19.313
|
38.0 Percentage of participants
15.935
|
11.1 Percentage of participants
36.827
|
0.0 Percentage of participants
28.240
|
0.0 Percentage of participants
29.891
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 13 (n=244,245,18,103,96) almost clear
|
40.6 Percentage of participants
18.832
|
35.9 Percentage of participants
15.013
|
22.2 Percentage of participants
30.225
|
1.0 Percentage of participants
26.228
|
2.1 Percentage of participants
28.809
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 13 (n=244,245,18,103,96) mild
|
27.0 Percentage of participants
19.407
|
19.2 Percentage of participants
14.769
|
27.8 Percentage of participants
32.972
|
15.5 Percentage of participants
23.561
|
14.6 Percentage of participants
23.166
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 13 (n=244,245,18,103,96) moderate
|
12.7 Percentage of participants
19.213
|
6.5 Percentage of participants
15.367
|
27.8 Percentage of participants
28.051
|
61.2 Percentage of participants
23.591
|
59.4 Percentage of participants
20.686
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 13 (n=244,245,18,103,96) severe
|
2.0 Percentage of participants
17.904
|
0.4 Percentage of participants
16.263
|
11.1 Percentage of participants
22.454
|
22.3 Percentage of participants
20.587
|
24.0 Percentage of participants
16.030
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 14 (n=244,245,18,108,102) clear
|
19.3 Percentage of participants
20.240
|
41.6 Percentage of participants
16.652
|
16.7 Percentage of participants
25.062
|
0.0 Percentage of participants
18.635
|
0.0 Percentage of participants
13.969
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 14 (n=244,245,18,108,102)almost clear
|
42.3 Percentage of participants
20.417
|
36.7 Percentage of participants
17.600
|
16.7 Percentage of participants
23.943
|
4.6 Percentage of participants
19.819
|
10.8 Percentage of participants
11.849
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 14 (n=244,245,18,108,102) mild
|
25.0 Percentage of participants
21.887
|
13.5 Percentage of participants
17.775
|
33.3 Percentage of participants
25.879
|
30.6 Percentage of participants
20.622
|
27.5 Percentage of participants
13.240
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 14 (n=244,245,18,108,102)moderate
|
12.3 Percentage of participants
25.048
|
7.3 Percentage of participants
17.981
|
22.2 Percentage of participants
24.608
|
56.5 Percentage of participants
20.328
|
50.0 Percentage of participants
16.373
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 14 (n=244,245,18,108,102)severe
|
1.2 Percentage of participants
25.395
|
0.8 Percentage of participants
17.385
|
11.1 Percentage of participants
24.770
|
8.3 Percentage of participants
20.762
|
11.8 Percentage of participants
17.029
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 15 (n=244,245,18,108,103) clear
|
22.1 Percentage of participants
25.651
|
45.3 Percentage of participants
17.804
|
11.1 Percentage of participants
22.354
|
0.0 Percentage of participants
18.277
|
1.9 Percentage of participants
17.176
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 15 (n=244,245,18,108,103) almost clear
|
38.9 Percentage of participants
26.471
|
33.9 Percentage of participants
17.281
|
22.2 Percentage of participants
21.506
|
13.9 Percentage of participants
18.736
|
17.5 Percentage of participants
18.083
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 15 (n=244,245,18,108,103) mild
|
27.5 Percentage of participants
26.524
|
14.7 Percentage of participants
19.132
|
33.3 Percentage of participants
22.169
|
38.9 Percentage of participants
18.554
|
39.8 Percentage of participants
20.615
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 15 (n=244,245,18,108,103) moderate
|
10.2 Percentage of participants
|
5.3 Percentage of participants
|
22.2 Percentage of participants
|
42.6 Percentage of participants
|
35.9 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 15 (n=244,245,18,108,103) severe
|
1.2 Percentage of participants
|
0.8 Percentage of participants
|
11.1 Percentage of participants
|
4.6 Percentage of participants
|
4.9 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 16 (n=244,245,18,108,103) clear
|
23.8 Percentage of participants
|
47.3 Percentage of participants
|
22.2 Percentage of participants
|
0.0 Percentage of participants
|
6.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 16 (n=244,245,18,108,103) almost clear
|
37.7 Percentage of participants
|
30.6 Percentage of participants
|
16.7 Percentage of participants
|
0.0 Percentage of participants
|
24.3 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 16 (n=244,245,18,108,103) mild
|
26.6 Percentage of participants
|
15.9 Percentage of participants
|
27.8 Percentage of participants
|
7.4 Percentage of participants
|
39.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 16 (n=244,245,18,108,103) moderate
|
10.7 Percentage of participants
|
5.3 Percentage of participants
|
22.2 Percentage of participants
|
57.4 Percentage of participants
|
26.2 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 16 (n=244,245,18,108,103) severe
|
1.2 Percentage of participants
|
0.8 Percentage of participants
|
11.1 Percentage of participants
|
35.2 Percentage of participants
|
2.9 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 20 (n=244,245,18,108,103) clear
|
23.8 Percentage of participants
|
46.1 Percentage of participants
|
16.7 Percentage of participants
|
0.0 Percentage of participants
|
26.2 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 20 (n=244,245,18,108,103) almost clear
|
37.3 Percentage of participants
|
31.8 Percentage of participants
|
22.2 Percentage of participants
|
1.0 Percentage of participants
|
31.1 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 20 (n=244,245,18,108,103) mild
|
26.2 Percentage of participants
|
14.3 Percentage of participants
|
33.3 Percentage of participants
|
15.5 Percentage of participants
|
32.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 20 (n=244,245,18,108,103) moderate
|
11.5 Percentage of participants
|
7.3 Percentage of participants
|
16.7 Percentage of participants
|
61.2 Percentage of participants
|
10.7 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 20 (n=244,245,18,108,103) severe
|
1.2 Percentage of participants
|
0.4 Percentage of participants
|
11.1 Percentage of participants
|
22.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 24 (n=244,245,18,108,103) clear
|
27.0 Percentage of participants
|
46.5 Percentage of participants
|
16.7 Percentage of participants
|
0.0 Percentage of participants
|
32.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 24 (n=244,245,18,108,103) almost clear
|
35.7 Percentage of participants
|
29.0 Percentage of participants
|
33.3 Percentage of participants
|
4.6 Percentage of participants
|
41.7 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 24 (n=244,245,18,108,103) mild
|
24.6 Percentage of participants
|
15.1 Percentage of participants
|
22.2 Percentage of participants
|
30.6 Percentage of participants
|
20.4 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 24 (n=244,245,18,108,103) moderate
|
10.7 Percentage of participants
|
7.8 Percentage of participants
|
16.7 Percentage of participants
|
56.5 Percentage of participants
|
5.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 24 (n=244,245,18,108,103) severe
|
2.0 Percentage of participants
|
1.6 Percentage of participants
|
11.1 Percentage of participants
|
8.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 28 (n=244,245,18,108,103) clear
|
26.6 Percentage of participants
|
46.5 Percentage of participants
|
11.1 Percentage of participants
|
0.0 Percentage of participants
|
38.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 28 (n=244,245,18,108,103) almost clear
|
32.8 Percentage of participants
|
26.5 Percentage of participants
|
38.9 Percentage of participants
|
13.9 Percentage of participants
|
40.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 28 (n=244,245,18,108,103) mild
|
25.8 Percentage of participants
|
16.7 Percentage of participants
|
16.7 Percentage of participants
|
38.9 Percentage of participants
|
14.6 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 28 (n=244,245,18,108,103) moderate
|
12.7 Percentage of participants
|
9.4 Percentage of participants
|
27.8 Percentage of participants
|
42.6 Percentage of participants
|
5.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 28 (n=244,245,18,108,103) severe
|
2.0 Percentage of participants
|
0.8 Percentage of participants
|
5.6 Percentage of participants
|
4.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 32 (n=244,245,18,108,103) clear
|
26.2 Percentage of participants
|
46.5 Percentage of participants
|
16.7 Percentage of participants
|
29.6 Percentage of participants
|
42.7 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 32 (n=244,245,18,108,103) almost clear
|
30.3 Percentage of participants
|
26.5 Percentage of participants
|
27.8 Percentage of participants
|
30.6 Percentage of participants
|
35.9 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 32 (n=244,245,18,108,103) mild
|
27.0 Percentage of participants
|
16.7 Percentage of participants
|
27.8 Percentage of participants
|
22.2 Percentage of participants
|
13.6 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 32 (n=244,245,18,108,103) moderate
|
14.3 Percentage of participants
|
9.0 Percentage of participants
|
22.2 Percentage of participants
|
14.8 Percentage of participants
|
7.8 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 32 (n=244,245,18,108,103) severe
|
2.0 Percentage of participants
|
1.2 Percentage of participants
|
5.6 Percentage of participants
|
2.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 36 (n=244,245,18,108,103) clear
|
28.3 Percentage of participants
|
46.5 Percentage of participants
|
11.1 Percentage of participants
|
28.7 Percentage of participants
|
45.6 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 36 (n=244,245,18,108,103) almost clear
|
27.0 Percentage of participants
|
26.9 Percentage of participants
|
27.8 Percentage of participants
|
33.3 Percentage of participants
|
29.1 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 36 (n=244,245,18,108,103) mild
|
25.4 Percentage of participants
|
16.7 Percentage of participants
|
33.3 Percentage of participants
|
18.5 Percentage of participants
|
16.5 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 36 (n=244,245,18,108,103) moderate
|
16.8 Percentage of participants
|
8.2 Percentage of participants
|
16.7 Percentage of participants
|
16.7 Percentage of participants
|
8.7 Percentage of participants
|
|
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
Week 36 (n=244,245,18,108,103) severe
|
2.5 Percentage of participants
|
1.6 Percentage of participants
|
11.1 Percentage of participants
|
2.8 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
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 (max). 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 75 was defined as participants achieving ≥ 75% improvement from baseline.
Outcome measures
| Measure |
AIN457 150 mg
n=245 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=247 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Time to PASI 75 Response up to 12 Weeks
|
57 days
Interval 55.0 to 85.0
|
57 days
Interval 29.0 to 59.0
|
NA days
median could not be calculated because less than 50% of the participants achieved PASI 75
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4,8, 12Population: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.
Outcome measures
| Measure |
AIN457 150 mg
n=245 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=247 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Induction Period
Week 4 (238, 236,235)
|
38.1 percent change
Standard Deviation 95.93 • Interval 55.0 to 85.0
|
57.1 percent change
Standard Deviation 234.10 • Interval 29.0 to 59.0
|
6.3 percent change
Standard Deviation 59.30
|
—
|
—
|
|
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Induction Period
Week 8 (241, 242,241)
|
52.3 percent change
Standard Deviation 142.28
|
72.7 percent change
Standard Deviation 306.36
|
6.3 percent change
Standard Deviation 65.47
|
—
|
—
|
|
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Induction Period
Week 12 (242, 242,242)
|
58.5 percent change
Standard Deviation 158.66
|
76.3 percent change
Standard Deviation 281.48
|
5.4 percent change
Standard Deviation 67.60
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12, 24, 36, 52Population: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.
Outcome measures
| Measure |
AIN457 150 mg
n=245 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=18 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
n=108 Participants
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
n=105 Participants
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Maintenance Period
Week 12 (242, 242,18, 108, 104)
|
58.5 Percent Change
Standard Deviation 158.66
|
76.3 Percent Change
Standard Deviation 281.48
|
37.7 Percent Change
Standard Deviation 83.41
|
-0.1 Percent Change
Standard Deviation 38.95
|
3.3 Percent Change
Standard Deviation 79.45
|
|
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Maintenance Period
Week 24 (242, 242,18, 108, 97)
|
55.8 Percent Change
Standard Deviation 140.46
|
78.0 Percent Change
Standard Deviation 299.91
|
48.1 Percent Change
Standard Deviation 92.06
|
28.1 Percent Change
Standard Deviation 55.71
|
39.7 Percent Change
Standard Deviation 80.03
|
|
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Maintenance Period
Week 36 (242, 242,18, 108, 100)
|
55.1 Percent Change
Standard Deviation 129.87
|
80.5 Percent Change
Standard Deviation 300.89
|
45.3 Percent Change
Standard Deviation 77.11
|
28.5 Percent Change
Standard Deviation 60.39
|
43.8 Percent Change
Standard Deviation 100.57
|
|
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Maintenance Period
Week 52 (242, 242,18, 108,100)
|
54.3 Percent Change
Standard Deviation 128.86
|
76.9 Percent Change
Standard Deviation 299.07
|
43.9 Percent Change
Standard Deviation 81.50
|
28.3 Percent Change
Standard Deviation 60.68
|
41.3 Percent Change
Standard Deviation 95.90
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8 & 12Population: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Outcome measures
| Measure |
AIN457 150 mg
n=245 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=247 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Percentage Changes in the Dermatology Life Quality Index (DLQI) During Induction Period
Week 4 (n=237,236,232)
|
-55.0 Percent Change
Interval -58.9 to -50.7
|
-62.5 Percent Change
Interval -66.7 to -58.6
|
-5.0 Percent Change
Interval -10.1 to 0.0
|
—
|
—
|
|
Percentage Changes in the Dermatology Life Quality Index (DLQI) During Induction Period
Week 8 (n=241,242,239)
|
-73.1 Percent Change
Interval -76.7 to -69.2
|
-81.5 Percent Change
Interval -84.4 to -79.0
|
-8.3 Percent Change
Interval -13.3 to -2.6
|
—
|
—
|
|
Percentage Changes in the Dermatology Life Quality Index (DLQI) During Induction Period
Week 12 (n=242,242,240)
|
-77.8 Percent Change
Interval -81.3 to -75.0
|
-86.4 Percent Change
Interval -88.9 to -83.3
|
-9.1 Percent Change
Interval -15.6 to -3.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12,24, 36 & 52Population: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Outcome measures
| Measure |
AIN457 150 mg
n=245 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=18 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
n=108 Participants
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
n=105 Participants
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Percentage Changes in the Dermatology Life Quality Index (DLQI) During Maintenance Period
Week 12 (242,242,17,108,104)
|
-77.8 Percent Change
Interval -81.3 to -75.0
|
-86.4 Percent Change
Interval -88.9 to -83.3
|
-58.3 Percent Change
Interval -80.0 to -41.7
|
-7.1 Percent Change
Interval -16.7 to 3.4
|
-4.4 Percent Change
Interval -13.9 to 3.4
|
|
Percentage Changes in the Dermatology Life Quality Index (DLQI) During Maintenance Period
Week 24 (242,242,17,108,97)
|
-83.3 Percent Change
Interval -87.5 to -79.4
|
-89.6 Percent Change
Interval -92.5 to -86.0
|
-76.6 Percent Change
Interval -88.9 to -59.6
|
-83.3 Percent Change
Interval -87.5 to -76.7
|
-83.3 Percent Change
Interval -89.9 to -76.6
|
|
Percentage Changes in the Dermatology Life Quality Index (DLQI) During Maintenance Period
Week 36 (242,242,17,108,100)
|
-78.6 Percent Change
Interval -83.3 to -75.0
|
-91.7 Percent Change
Interval -94.2 to -88.9
|
-77.9 Percent Change
Interval -93.3 to -47.2
|
-78.5 Percent Change
Interval -85.7 to -66.7
|
-90.0 Percent Change
Interval -93.3 to -82.7
|
|
Percentage Changes in the Dermatology Life Quality Index (DLQI) During Maintenance Period
Week 52 (242,242,17,108,100)
|
-76.5 Percent Change
Interval -80.6 to -72.3
|
-88.9 Percent Change
Interval -92.3 to -85.7
|
-64.4 Percent Change
Interval -83.3 to -12.5
|
-75.0 Percent Change
Interval -82.8 to -66.2
|
-88.9 Percent Change
Interval -92.9 to -82.9
|
SECONDARY outcome
Timeframe: Week 4, 8, 12Population: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Outcome measures
| Measure |
AIN457 150 mg
n=245 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=247 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Induction Period
Week 4 (238, 237, 235)
|
17.6 Percentage of Participants
|
23.6 Percentage of Participants
|
6.4 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Induction Period
Week 8 (242,243,241)
|
39.7 Percentage of Participants
|
48.1 Percentage of Participants
|
10.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Induction Period
Week 12 (243,243,243)
|
46.1 Percentage of Participants
|
58.8 Percentage of Participants
|
10.3 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12,24,36, & 52Population: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Outcome measures
| Measure |
AIN457 150 mg
n=245 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=18 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
n=108 Participants
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
n=105 Participants
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Maintenance Period
Week 12 (243,243,18,108,105)
|
46.1 Percentage of Participants
|
58.8 Percentage of Participants
|
27.8 Percentage of Participants
|
10.2 Percentage of Participants
|
8.6 Percentage of Participants
|
|
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Maintenance Period
Week 24 (243,243,18,108,98)
|
54.7 Percentage of Participants
|
64.6 Percentage of Participants
|
50.0 Percentage of Participants
|
53.7 Percentage of Participants
|
67.3 Percentage of Participants
|
|
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Maintenance Period
Week 36 (243,243,18,108,101)
|
51.9 Percentage of Participants
|
68.7 Percentage of Participants
|
50.0 Percentage of Participants
|
56.5 Percentage of Participants
|
69.3 Percentage of Participants
|
|
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Maintenance Period
Week 52 (243,243,18,108,101)
|
48.6 Percentage of Participants
|
66.3 Percentage of Participants
|
22.2 Percentage of Participants
|
52.8 Percentage of Participants
|
67.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
PASI is an assessment of lesion severity \& affected area into a single score:0(no disease)to 72(max. disease).Body is divided into 4 areas for scoring(head,arms,trunk,legs)each area is scored separately \& then added for final PASI.For each area, % of skin involved is estimated:0(0%)to 6(90-100%)\& severity is estimated by clinical signs, erythema,induration \& desquamation;scale 0(none) to 4(max). 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 75, 90 is patients achieving≥75%or90% improvement from baseline.The IGA mod 2011 scale is static, exclusively to the patients disease at assessment,\& not with any of the patient's previous disease states at other visits.The scores are:0=clear,1=almost clear,2= mild,3=moderate\&4=severe.Response variables PASI 75,90, IGA mod 2011 0 or 1 response at wk 12 was scored versus previous psoriasis systemic therapy \& response to previous biologic systemic therapy by treatment
Outcome measures
| Measure |
AIN457 150 mg
n=245 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=247 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving PASI 75, PASI 90 and IGA Mod 2011 0 or 1 Response at Week 12 by Previous Exposure to Biologic Systemic Therapy or Anti-TNF-α Therapy and Failed to Respond to a Previous Biologic or Anti-TNF-α Therapy Psoriasis Therapy
IGA 0/1 biologic (29, 19, 24)
|
41.4 Percentage of participants
|
57.9 Percentage of participants
|
4.2 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 75, PASI 90 and IGA Mod 2011 0 or 1 Response at Week 12 by Previous Exposure to Biologic Systemic Therapy or Anti-TNF-α Therapy and Failed to Respond to a Previous Biologic or Anti-TNF-α Therapy Psoriasis Therapy
PASI 75 biologic (29, 19, 24)
|
48.3 Percentage of participants
|
57.9 Percentage of participants
|
12.5 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 75, PASI 90 and IGA Mod 2011 0 or 1 Response at Week 12 by Previous Exposure to Biologic Systemic Therapy or Anti-TNF-α Therapy and Failed to Respond to a Previous Biologic or Anti-TNF-α Therapy Psoriasis Therapy
PASI 90 biologic (29, 19, 24)
|
24.1 Percentage of participants
|
31.6 Percentage of participants
|
4.2 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 75, PASI 90 and IGA Mod 2011 0 or 1 Response at Week 12 by Previous Exposure to Biologic Systemic Therapy or Anti-TNF-α Therapy and Failed to Respond to a Previous Biologic or Anti-TNF-α Therapy Psoriasis Therapy
IGA 0/1 anti-TNF-α therapy (18,17,21)
|
50.0 Percentage of participants
|
64.7 Percentage of participants
|
4.8 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 75, PASI 90 and IGA Mod 2011 0 or 1 Response at Week 12 by Previous Exposure to Biologic Systemic Therapy or Anti-TNF-α Therapy and Failed to Respond to a Previous Biologic or Anti-TNF-α Therapy Psoriasis Therapy
PASI 75 anti-TNF-α therapy (18,17,21)
|
55.6 Percentage of participants
|
64.7 Percentage of participants
|
14.3 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 75, PASI 90 and IGA Mod 2011 0 or 1 Response at Week 12 by Previous Exposure to Biologic Systemic Therapy or Anti-TNF-α Therapy and Failed to Respond to a Previous Biologic or Anti-TNF-α Therapy Psoriasis Therapy
PASI 90 anti-TNF-α therapy (18,17,21)
|
33.3 Percentage of participants
|
35.3 Percentage of participants
|
4.8 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
The development of anti-secunimubab anti-bodies would decrease a participant's ability to respond to secukinumab treatment.
Outcome measures
| Measure |
AIN457 150 mg
n=245 Participants
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
AIN457 300 mg
n=245 Participants
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
|
Placebo
n=247 Participants
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
|
|---|---|---|---|---|---|
|
Number of Participants Who Developed Anti-secukinumab Antibodies
|
2 participants
|
0 participants
|
0 participants
|
—
|
—
|
Adverse Events
INDUCTION-AIN457 150mg
Serious events: 4 serious events
Other events: 108 other events
Deaths: 0 deaths
INDUCTION-AIN457 300mg
Serious events: 6 serious events
Other events: 102 other events
Deaths: 0 deaths
INDUCTION-Placebo
Serious events: 4 serious events
Other events: 77 other events
Deaths: 0 deaths
ENTIRE-AIN457 150mg
Serious events: 15 serious events
Other events: 172 other events
Deaths: 0 deaths
ENTIRE-AIN457 300mg
Serious events: 17 serious events
Other events: 161 other events
Deaths: 0 deaths
ENTIRE-Any AIN457 150mg
Serious events: 19 serious events
Other events: 228 other events
Deaths: 0 deaths
ENTIRE-Any AIN457 300mg
Serious events: 19 serious events
Other events: 229 other events
Deaths: 0 deaths
ENTIRE-Placebo
Serious events: 5 serious events
Other events: 85 other events
Deaths: 0 deaths
FOLLOW UP-Any AIN457 150mg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
FOLLOW UP-Any AIN457 300mg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
FOLLOW UP-Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
INDUCTION-AIN457 150mg
n=245 participants at risk
INDUCTION-AIN457 150mg
|
INDUCTION-AIN457 300mg
n=245 participants at risk
INDUCTION-AIN457 300mg
|
INDUCTION-Placebo
n=247 participants at risk
INDUCTION-Placebo
|
ENTIRE-AIN457 150mg
n=245 participants at risk
ENTIRE-AIN457 150mg
|
ENTIRE-AIN457 300mg
n=245 participants at risk
ENTIRE-AIN457 300mg
|
ENTIRE-Any AIN457 150mg
n=353 participants at risk
ENTIRE-Any AIN457 150mg
|
ENTIRE-Any AIN457 300mg
n=349 participants at risk
ENTIRE-Any AIN457 300mg
|
ENTIRE-Placebo
n=247 participants at risk
ENTIRE-Placebo
|
FOLLOW UP-Any AIN457 150mg
n=58 participants at risk
FOLLOW UP-Any AIN457 150mg
|
FOLLOW UP-Any AIN457 300mg
n=47 participants at risk
FOLLOW UP-Any AIN457 300mg
|
FOLLOW UP-Placebo
n=18 participants at risk
FOLLOW UP-Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
HAEMORRHAGIC ANAEMIA
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.41%
1/245
|
0.28%
1/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Cardiac disorders
ARRHYTHMIA
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.41%
1/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.41%
1/245
|
0.28%
1/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.41%
1/245
|
0.28%
1/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Ear and labyrinth disorders
SUDDEN HEARING LOSS
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA OBSTRUCTIVE
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/247
|
0.41%
1/245
|
0.41%
1/245
|
0.28%
1/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Gastrointestinal disorders
INTESTINAL HAEMORRHAGE
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
General disorders
ASTHENIA
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
General disorders
HERNIA
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/245
|
0.00%
0/245
|
0.40%
1/247
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/353
|
0.00%
0/349
|
0.40%
1/247
|
1.7%
1/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/247
|
0.41%
1/245
|
0.41%
1/245
|
0.28%
1/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/245
|
0.00%
0/245
|
0.40%
1/247
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/353
|
0.00%
0/349
|
0.40%
1/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.82%
2/245
|
0.00%
0/353
|
0.57%
2/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Infections and infestations
UROSEPSIS
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
COMMINUTED FRACTURE
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
LARYNGEAL INJURY
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
MULTIPLE INJURIES
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
PULMONARY CONTUSION
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
WOUND
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
ELECTROLYTE IMBALANCE
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
HYPOPROTEINAEMIA
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.41%
1/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.41%
1/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN NEOPLASM OF SKIN
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/353
|
0.00%
0/349
|
0.40%
1/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER
|
0.41%
1/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
FOLLICULAR THYROID CANCER
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID CANCER
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Nervous system disorders
CAROTID ARTERY DISSECTION
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Psychiatric disorders
ALCOHOL WITHDRAWAL SYNDROME
|
0.00%
0/245
|
0.00%
0/245
|
0.40%
1/247
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/353
|
0.00%
0/349
|
0.40%
1/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Psychiatric disorders
HALLUCINATION, AUDITORY
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.41%
1/245
|
0.28%
1/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Psychiatric disorders
PANIC ATTACK
|
0.00%
0/245
|
0.00%
0/245
|
0.40%
1/247
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/353
|
0.00%
0/349
|
0.40%
1/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Renal and urinary disorders
OBSTRUCTIVE UROPATHY
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY MASS
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.41%
1/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.00%
0/245
|
0.00%
0/245
|
0.40%
1/247
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/353
|
0.00%
0/349
|
0.40%
1/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Surgical and medical procedures
ABORTION INDUCED
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
2.1%
1/47
|
0.00%
0/18
|
|
Vascular disorders
AORTIC ANEURYSM
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Vascular disorders
AORTIC THROMBOSIS
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
Other adverse events
| Measure |
INDUCTION-AIN457 150mg
n=245 participants at risk
INDUCTION-AIN457 150mg
|
INDUCTION-AIN457 300mg
n=245 participants at risk
INDUCTION-AIN457 300mg
|
INDUCTION-Placebo
n=247 participants at risk
INDUCTION-Placebo
|
ENTIRE-AIN457 150mg
n=245 participants at risk
ENTIRE-AIN457 150mg
|
ENTIRE-AIN457 300mg
n=245 participants at risk
ENTIRE-AIN457 300mg
|
ENTIRE-Any AIN457 150mg
n=353 participants at risk
ENTIRE-Any AIN457 150mg
|
ENTIRE-Any AIN457 300mg
n=349 participants at risk
ENTIRE-Any AIN457 300mg
|
ENTIRE-Placebo
n=247 participants at risk
ENTIRE-Placebo
|
FOLLOW UP-Any AIN457 150mg
n=58 participants at risk
FOLLOW UP-Any AIN457 150mg
|
FOLLOW UP-Any AIN457 300mg
n=47 participants at risk
FOLLOW UP-Any AIN457 300mg
|
FOLLOW UP-Placebo
n=18 participants at risk
FOLLOW UP-Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.82%
2/245
|
1.2%
3/245
|
0.00%
0/247
|
2.4%
6/245
|
1.2%
3/245
|
1.7%
6/353
|
0.86%
3/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
5.6%
1/18
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.41%
1/245
|
0.41%
1/245
|
0.40%
1/247
|
1.6%
4/245
|
2.0%
5/245
|
1.1%
4/353
|
1.4%
5/349
|
0.40%
1/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.6%
4/245
|
2.0%
5/245
|
1.2%
3/247
|
3.7%
9/245
|
4.5%
11/245
|
2.8%
10/353
|
4.6%
16/349
|
1.6%
4/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.41%
1/245
|
0.41%
1/245
|
0.00%
0/247
|
2.4%
6/245
|
0.82%
2/245
|
1.7%
6/353
|
1.1%
4/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/245
|
1.2%
3/245
|
0.00%
0/247
|
0.41%
1/245
|
2.0%
5/245
|
0.85%
3/353
|
1.4%
5/349
|
0.40%
1/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Gastrointestinal disorders
NAUSEA
|
2.4%
6/245
|
0.41%
1/245
|
2.4%
6/247
|
2.9%
7/245
|
0.82%
2/245
|
2.3%
8/353
|
0.86%
3/349
|
3.2%
8/247
|
0.00%
0/58
|
2.1%
1/47
|
0.00%
0/18
|
|
Gastrointestinal disorders
TOOTHACHE
|
1.2%
3/245
|
0.82%
2/245
|
0.81%
2/247
|
3.3%
8/245
|
1.6%
4/245
|
2.3%
8/353
|
1.4%
5/349
|
0.81%
2/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Gastrointestinal disorders
VOMITING
|
0.82%
2/245
|
2.0%
5/245
|
0.81%
2/247
|
1.2%
3/245
|
2.4%
6/245
|
1.1%
4/353
|
2.0%
7/349
|
1.6%
4/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
General disorders
FATIGUE
|
3.3%
8/245
|
0.82%
2/245
|
0.81%
2/247
|
3.7%
9/245
|
1.2%
3/245
|
2.8%
10/353
|
0.86%
3/349
|
0.81%
2/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
1.2%
3/245
|
2.0%
5/245
|
1.2%
3/247
|
6.1%
15/245
|
4.5%
11/245
|
4.8%
17/353
|
4.0%
14/349
|
1.2%
3/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Infections and infestations
ABSCESS LIMB
|
0.41%
1/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
5.6%
1/18
|
|
Infections and infestations
BRONCHITIS
|
0.82%
2/245
|
1.2%
3/245
|
0.40%
1/247
|
2.9%
7/245
|
4.5%
11/245
|
2.3%
8/353
|
4.9%
17/349
|
0.81%
2/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Infections and infestations
FOLLICULITIS
|
1.6%
4/245
|
0.82%
2/245
|
0.81%
2/247
|
4.1%
10/245
|
2.4%
6/245
|
3.4%
12/353
|
2.6%
9/349
|
0.81%
2/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Infections and infestations
FURUNCLE
|
0.41%
1/245
|
0.82%
2/245
|
0.00%
0/247
|
2.0%
5/245
|
1.6%
4/245
|
1.4%
5/353
|
1.1%
4/349
|
0.40%
1/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Infections and infestations
GASTROENTERITIS
|
0.41%
1/245
|
0.82%
2/245
|
0.40%
1/247
|
2.4%
6/245
|
1.6%
4/245
|
2.0%
7/353
|
2.0%
7/349
|
0.40%
1/247
|
0.00%
0/58
|
0.00%
0/47
|
5.6%
1/18
|
|
Infections and infestations
INFLUENZA
|
1.6%
4/245
|
0.41%
1/245
|
0.81%
2/247
|
3.3%
8/245
|
2.9%
7/245
|
2.3%
8/353
|
2.9%
10/349
|
1.2%
3/247
|
1.7%
1/58
|
2.1%
1/47
|
0.00%
0/18
|
|
Infections and infestations
NASOPHARYNGITIS
|
9.4%
23/245
|
9.0%
22/245
|
7.7%
19/247
|
21.6%
53/245
|
18.4%
45/245
|
19.5%
69/353
|
16.3%
57/349
|
8.1%
20/247
|
1.7%
1/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/245
|
1.2%
3/245
|
0.81%
2/247
|
1.6%
4/245
|
2.4%
6/245
|
1.7%
6/353
|
2.3%
8/349
|
0.81%
2/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Infections and infestations
OTITIS MEDIA
|
0.00%
0/245
|
1.2%
3/245
|
0.40%
1/247
|
0.41%
1/245
|
2.4%
6/245
|
0.57%
2/353
|
1.7%
6/349
|
0.40%
1/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Infections and infestations
PERIODONTITIS
|
0.82%
2/245
|
0.41%
1/245
|
0.40%
1/247
|
1.2%
3/245
|
2.0%
5/245
|
0.85%
3/353
|
2.0%
7/349
|
0.40%
1/247
|
0.00%
0/58
|
0.00%
0/47
|
5.6%
1/18
|
|
Infections and infestations
PHARYNGITIS
|
0.82%
2/245
|
1.2%
3/245
|
0.00%
0/247
|
3.3%
8/245
|
2.9%
7/245
|
2.5%
9/353
|
2.6%
9/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Infections and infestations
RHINITIS
|
0.82%
2/245
|
0.82%
2/245
|
0.40%
1/247
|
1.2%
3/245
|
2.4%
6/245
|
1.1%
4/353
|
2.0%
7/349
|
0.40%
1/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Infections and infestations
TINEA PEDIS
|
0.82%
2/245
|
0.82%
2/245
|
0.00%
0/247
|
1.6%
4/245
|
2.4%
6/245
|
2.3%
8/353
|
2.9%
10/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.1%
10/245
|
3.7%
9/245
|
0.00%
0/247
|
11.4%
28/245
|
10.6%
26/245
|
10.2%
36/353
|
9.2%
32/349
|
0.81%
2/247
|
1.7%
1/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.82%
2/245
|
1.6%
4/245
|
0.81%
2/247
|
2.4%
6/245
|
3.3%
8/245
|
2.0%
7/353
|
3.2%
11/349
|
0.81%
2/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/353
|
0.29%
1/349
|
0.00%
0/247
|
0.00%
0/58
|
2.1%
1/47
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.82%
2/245
|
2.0%
5/245
|
0.40%
1/247
|
2.0%
5/245
|
2.0%
5/245
|
1.4%
5/353
|
2.0%
7/349
|
0.40%
1/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
0.82%
2/245
|
0.82%
2/245
|
0.00%
0/247
|
0.82%
2/245
|
2.0%
5/245
|
0.85%
3/353
|
2.0%
7/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
0.41%
1/245
|
0.41%
1/245
|
0.00%
0/247
|
0.82%
2/245
|
2.9%
7/245
|
0.85%
3/353
|
2.3%
8/349
|
0.40%
1/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
1.2%
3/245
|
1.6%
4/245
|
0.00%
0/247
|
2.9%
7/245
|
2.4%
6/245
|
2.3%
8/353
|
2.0%
7/349
|
0.40%
1/247
|
0.00%
0/58
|
2.1%
1/47
|
0.00%
0/18
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/245
|
0.00%
0/245
|
0.40%
1/247
|
0.41%
1/245
|
0.00%
0/245
|
0.28%
1/353
|
0.29%
1/349
|
0.40%
1/247
|
0.00%
0/58
|
2.1%
1/47
|
0.00%
0/18
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
2.0%
5/245
|
0.57%
2/353
|
1.4%
5/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
0.41%
1/245
|
1.2%
3/245
|
0.81%
2/247
|
3.3%
8/245
|
2.4%
6/245
|
3.7%
13/353
|
2.6%
9/349
|
0.81%
2/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/247
|
0.82%
2/245
|
2.0%
5/245
|
1.1%
4/353
|
2.0%
7/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
2.4%
6/245
|
0.82%
2/245
|
2.8%
7/247
|
3.7%
9/245
|
3.7%
9/245
|
3.7%
13/353
|
4.0%
14/349
|
3.2%
8/247
|
0.00%
0/58
|
2.1%
1/47
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.2%
3/245
|
0.82%
2/245
|
1.6%
4/247
|
2.9%
7/245
|
2.9%
7/245
|
2.5%
9/353
|
2.6%
9/349
|
1.6%
4/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/245
|
0.00%
0/245
|
0.00%
0/247
|
0.41%
1/245
|
0.00%
0/245
|
0.57%
2/353
|
0.00%
0/349
|
0.00%
0/247
|
0.00%
0/58
|
2.1%
1/47
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.41%
1/245
|
0.41%
1/245
|
1.6%
4/247
|
1.6%
4/245
|
2.0%
5/245
|
1.4%
5/353
|
1.4%
5/349
|
1.6%
4/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
1.2%
3/245
|
1.6%
4/245
|
0.81%
2/247
|
2.4%
6/245
|
2.9%
7/245
|
2.3%
8/353
|
2.3%
8/349
|
1.2%
3/247
|
1.7%
1/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
PSORIATIC ARTHROPATHY
|
0.41%
1/245
|
0.00%
0/245
|
1.2%
3/247
|
1.6%
4/245
|
2.4%
6/245
|
1.4%
5/353
|
2.0%
7/349
|
1.6%
4/247
|
3.4%
2/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Nervous system disorders
HEADACHE
|
5.3%
13/245
|
4.9%
12/245
|
2.8%
7/247
|
7.8%
19/245
|
9.0%
22/245
|
6.8%
24/353
|
8.6%
30/349
|
4.0%
10/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/245
|
0.41%
1/245
|
0.00%
0/247
|
2.4%
6/245
|
0.41%
1/245
|
2.3%
8/353
|
0.57%
2/349
|
0.40%
1/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Psychiatric disorders
INSOMNIA
|
1.2%
3/245
|
0.00%
0/245
|
0.00%
0/247
|
2.4%
6/245
|
0.00%
0/245
|
2.8%
10/353
|
0.57%
2/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.82%
2/245
|
1.6%
4/245
|
1.2%
3/247
|
1.2%
3/245
|
4.5%
11/245
|
1.4%
5/353
|
4.6%
16/349
|
1.2%
3/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
4.1%
10/245
|
1.6%
4/245
|
1.2%
3/247
|
4.5%
11/245
|
2.9%
7/245
|
3.4%
12/353
|
3.4%
12/349
|
1.2%
3/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.00%
0/245
|
1.2%
3/245
|
0.00%
0/247
|
0.82%
2/245
|
2.0%
5/245
|
0.57%
2/353
|
1.7%
6/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.00%
0/245
|
0.82%
2/245
|
0.40%
1/247
|
0.41%
1/245
|
2.9%
7/245
|
0.28%
1/353
|
3.2%
11/349
|
0.40%
1/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.82%
2/245
|
1.2%
3/245
|
0.00%
0/247
|
2.9%
7/245
|
2.9%
7/245
|
3.1%
11/353
|
2.6%
9/349
|
0.00%
0/247
|
0.00%
0/58
|
2.1%
1/47
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
3.7%
9/245
|
4.5%
11/245
|
2.4%
6/247
|
5.3%
13/245
|
5.7%
14/245
|
4.2%
15/353
|
5.4%
19/349
|
2.4%
6/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
1.6%
4/245
|
0.00%
0/245
|
2.8%
7/247
|
2.9%
7/245
|
0.41%
1/245
|
2.3%
8/353
|
0.86%
3/349
|
3.2%
8/247
|
3.4%
2/58
|
2.1%
1/47
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
1.2%
3/245
|
1.2%
3/245
|
0.00%
0/247
|
3.3%
8/245
|
3.3%
8/245
|
2.5%
9/353
|
2.6%
9/349
|
0.00%
0/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
|
Vascular disorders
HYPERTENSION
|
3.7%
9/245
|
0.00%
0/245
|
1.2%
3/247
|
6.5%
16/245
|
4.5%
11/245
|
5.9%
21/353
|
4.3%
15/349
|
1.2%
3/247
|
0.00%
0/58
|
0.00%
0/47
|
0.00%
0/18
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial
- Publication restrictions are in place
Restriction type: OTHER