Trial Outcomes & Findings for Secukinumab in Tumor Necrosis Factor (TNF) - Inadequate Response (IR) Psoriasis Participants. (NCT NCT01961609)
NCT ID: NCT01961609
Last Updated: 2019-03-18
Results Overview
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 75 is defined as participants achieving ≥ 75% improvement from baseline.
COMPLETED
PHASE3
235 participants
16 weeks
2019-03-18
Participant Flow
This study consisted of 3 periods: initiation, maintenance 1 and maintenance 2. During the initiation period, participants received secukinumab 150 mg or 300 mg for 16 weeks.
For both maintenance periods 1 and 2, after 16 weeks and 48 weeks, respectively, responders at both the 150 mg and 300 mg doses continued on their initiation doses during maintenance periods 1 and 2. Non-responders at 150 mg were uptitrated to 300 mg. Non-responders at 300 mg returned to routine treatment under the care of their usual clinician.
Participant milestones
| Measure |
Secukinumab (AIN457) 300 mg
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
Secukinumab (AIN457) 150 mg
Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 \& 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician.
|
Secukinumab (AIN457) 150 mg - 300 mg (Maintanence Period 1)
Non-responders at secukinumab 150mg from the initiation period were uptitrated to secukinumab 300 mg at week 16.
|
Secukinumab (AIN457) 150 mg - 300 mg (Maintenance Period 2)
Non-responders at secukinumab 150 mg from maintenance 1 period were uptitrated to secukinumab 300 mg at week 48.
|
|---|---|---|---|---|
|
Initiation
STARTED
|
119
|
116
|
0
|
0
|
|
Initiation
Safety Set
|
118
|
115
|
0
|
0
|
|
Initiation
Full Analysis Set
|
118
|
115
|
0
|
0
|
|
Initiation
COMPLETED
|
107
|
103
|
0
|
0
|
|
Initiation
NOT COMPLETED
|
12
|
13
|
0
|
0
|
|
Maintenance 1 (Weeks 17 - 48)
STARTED
|
107
|
66
|
37
|
0
|
|
Maintenance 1 (Weeks 17 - 48)
Full Analysis Set
|
107
|
66
|
37
|
0
|
|
Maintenance 1 (Weeks 17 - 48)
Safety Set
|
107
|
66
|
37
|
0
|
|
Maintenance 1 (Weeks 17 - 48)
COMPLETED
|
84
|
55
|
18
|
0
|
|
Maintenance 1 (Weeks 17 - 48)
NOT COMPLETED
|
23
|
11
|
19
|
0
|
|
Maintanence 2 (Weeks 49 - 72)
STARTED
|
83
|
31
|
16
|
24
|
|
Maintanence 2 (Weeks 49 - 72)
Safety Set
|
83
|
31
|
16
|
24
|
|
Maintanence 2 (Weeks 49 - 72)
Full Analysis Set
|
83
|
31
|
16
|
24
|
|
Maintanence 2 (Weeks 49 - 72)
COMPLETED
|
71
|
25
|
12
|
17
|
|
Maintanence 2 (Weeks 49 - 72)
NOT COMPLETED
|
12
|
6
|
4
|
7
|
Reasons for withdrawal
| Measure |
Secukinumab (AIN457) 300 mg
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
Secukinumab (AIN457) 150 mg
Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 \& 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician.
|
Secukinumab (AIN457) 150 mg - 300 mg (Maintanence Period 1)
Non-responders at secukinumab 150mg from the initiation period were uptitrated to secukinumab 300 mg at week 16.
|
Secukinumab (AIN457) 150 mg - 300 mg (Maintenance Period 2)
Non-responders at secukinumab 150 mg from maintenance 1 period were uptitrated to secukinumab 300 mg at week 48.
|
|---|---|---|---|---|
|
Initiation
Missing
|
3
|
2
|
0
|
0
|
|
Initiation
Protocol deviation
|
1
|
0
|
0
|
0
|
|
Initiation
Death
|
0
|
1
|
0
|
0
|
|
Initiation
Administrative problems
|
1
|
0
|
0
|
0
|
|
Initiation
Withdrawal by Subject
|
1
|
2
|
0
|
0
|
|
Initiation
Lack of Efficacy
|
2
|
1
|
0
|
0
|
|
Initiation
Abnormal lab values
|
0
|
1
|
0
|
0
|
|
Initiation
Adverse Event
|
3
|
5
|
0
|
0
|
|
Initiation
Randomized but not treated
|
1
|
1
|
0
|
0
|
|
Maintenance 1 (Weeks 17 - 48)
Reason for discontinuation is missing
|
1
|
0
|
3
|
0
|
|
Maintenance 1 (Weeks 17 - 48)
Protocol deviation
|
3
|
0
|
1
|
0
|
|
Maintenance 1 (Weeks 17 - 48)
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
|
Maintenance 1 (Weeks 17 - 48)
Lack of Efficacy
|
13
|
4
|
10
|
0
|
|
Maintenance 1 (Weeks 17 - 48)
Adverse Event
|
6
|
6
|
3
|
0
|
|
Maintenance 1 (Weeks 17 - 48)
Abnormal laboratory value
|
0
|
0
|
1
|
0
|
|
Maintanence 2 (Weeks 49 - 72)
Reason for discontinuation is missing
|
7
|
5
|
0
|
4
|
|
Maintanence 2 (Weeks 49 - 72)
Protocol deviation
|
0
|
0
|
1
|
0
|
|
Maintanence 2 (Weeks 49 - 72)
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Maintanence 2 (Weeks 49 - 72)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Maintanence 2 (Weeks 49 - 72)
Lack of Efficacy
|
3
|
0
|
3
|
1
|
|
Maintanence 2 (Weeks 49 - 72)
Adverse Event
|
1
|
0
|
0
|
2
|
Baseline Characteristics
Secukinumab in Tumor Necrosis Factor (TNF) - Inadequate Response (IR) Psoriasis Participants.
Baseline characteristics by cohort
| Measure |
Secukinumab (AIN457) 300 mg
n=119 Participants
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
Secukinumab (AIN457) 150 mg
n=116 Participants
Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 \& 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician.
|
Total
n=235 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.6 Years
STANDARD_DEVIATION 11.63 • n=5 Participants
|
44.6 Years
STANDARD_DEVIATION 11.73 • n=7 Participants
|
45.6 Years
STANDARD_DEVIATION 11.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).
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 75 is defined as participants achieving ≥ 75% improvement from baseline.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=118 Participants
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
Secukinumab (AIN457) 300 mg Subgroup 2
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 300 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
Secukinumab (AIN457) 150 mg Subgroup 1
Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
|
Secukinumab (AIN457) 150 mg Subgroup 2
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 150 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
|---|---|---|---|---|---|---|
|
Percentage of Secukinumab 300 mg Participants Achieving PASI 75 at 16 Weeks
|
65.3 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).
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 75 is defined as participants achieving ≥ 75% improvement from baseline.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=115 Participants
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
Secukinumab (AIN457) 300 mg Subgroup 2
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 300 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
Secukinumab (AIN457) 150 mg Subgroup 1
Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
|
Secukinumab (AIN457) 150 mg Subgroup 2
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 150 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
|---|---|---|---|---|---|---|
|
Percentage of Secukinumab 150 mg Participants Achieving PASI 75 at 16 Weeks
|
44.3 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).
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 75 is defined as participants achieving ≥ 75% improvement from baseline.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=14 Participants
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
Secukinumab (AIN457) 300 mg Subgroup 2
n=44 Participants
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 300 mg Subgroup 3
n=44 Participants
All participants who have tried and failed more than one anti-TNFalpha therapies
|
Secukinumab (AIN457) 150 mg Subgroup 1
n=18 Participants
Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
|
Secukinumab (AIN457) 150 mg Subgroup 2
n=42 Participants
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 150 mg Subgroup 3
n=37 Participants
All participants who have tried and failed more than one anti-TNFalpha therapies
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving PASI 75 According to 3 Key Participant Subgroups (Primary Inadequate Response (IR), Secondary IR and IR After More Than One Anti-TNFalpha Therapies) at 16 Weeks
|
71.4 Percentage of participants
|
70.5 Percentage of participants
|
47.7 Percentage of participants
|
38.9 Percentage of participants
|
61.9 Percentage of participants
|
32.4 Percentage of participants
|
SECONDARY outcome
Timeframe: 2 ,4, 8, 12 and 16 WeeksPopulation: The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).
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 75 is defined as participants achieving ≥ 75% improvement from baseline.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=118 Participants
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
Secukinumab (AIN457) 300 mg Subgroup 2
n=115 Participants
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 300 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
Secukinumab (AIN457) 150 mg Subgroup 1
Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
|
Secukinumab (AIN457) 150 mg Subgroup 2
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 150 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieiving PASI 75 - Initiation Period
Week 2
|
1.7 Percentage of participants
|
2.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieiving PASI 75 - Initiation Period
Week 4
|
27.1 Percentage of participants
|
18.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieiving PASI 75 - Initiation Period
Week 8
|
60.2 Percentage of participants
|
40.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieiving PASI 75 - Initiation Period
Week 12
|
61.9 Percentage of participants
|
52.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieiving PASI 75 - Initiation Period
Week 16
|
65.3 Percentage of participants
|
44.3 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 16, 24 and 48 WeeksPopulation: The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).
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 75 is defined as participants achieving ≥ 75% improvement from baseline.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=107 Participants
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
Secukinumab (AIN457) 300 mg Subgroup 2
n=66 Participants
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 300 mg Subgroup 3
n=37 Participants
All participants who have tried and failed more than one anti-TNFalpha therapies
|
Secukinumab (AIN457) 150 mg Subgroup 1
Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
|
Secukinumab (AIN457) 150 mg Subgroup 2
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 150 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieiving PASI 75 - Maintenance 1 Period
Week 48
|
52.3 Percentage of participants
|
39.4 Percentage of participants
|
8.1 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieiving PASI 75 - Maintenance 1 Period
Week 16
|
72.0 Percentage of participants
|
75.8 Percentage of participants
|
2.7 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieiving PASI 75 - Maintenance 1 Period
Week 24
|
61.7 Percentage of participants
|
68.2 Percentage of participants
|
13.5 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 48 and 72 WeeksPopulation: The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).
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 75 is defined as participants achieving ≥ 75% improvement from baseline.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=83 Participants
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
Secukinumab (AIN457) 300 mg Subgroup 2
n=31 Participants
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 300 mg Subgroup 3
n=16 Participants
All participants who have tried and failed more than one anti-TNFalpha therapies
|
Secukinumab (AIN457) 150 mg Subgroup 1
n=24 Participants
Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
|
Secukinumab (AIN457) 150 mg Subgroup 2
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 150 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieiving PASI 75 - Maintenance 2 Period
Week 48
|
65.1 Percentage of participants
|
80.6 Percentage of participants
|
18.8 Percentage of participants
|
4.2 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieiving PASI 75 - Maintenance 2 Period
Week 72
|
65.1 Percentage of participants
|
58.1 Percentage of participants
|
25.0 Percentage of participants
|
37.5 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 2, 4, 8, 12, 16 WeeksPopulation: The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=118 Participants
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
Secukinumab (AIN457) 300 mg Subgroup 2
n=115 Participants
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 300 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
Secukinumab (AIN457) 150 mg Subgroup 1
Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
|
Secukinumab (AIN457) 150 mg Subgroup 2
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 150 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period
PASI 50, week 2
|
28.0 Percentage of participants
|
25.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period
PASI 50, week 4
|
63.6 Percentage of participants
|
57.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period
PASI 50, week 8
|
84.7 Percentage of participants
|
67.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period
PASI 50, week 12
|
82.2 Percentage of participants
|
69.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period
PASI 50, week 16
|
82.2 Percentage of participants
|
65.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period
PASI 90, week 2
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period
PASI 90, week 4
|
6.8 Percentage of participants
|
4.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period
PASI 90, week 8
|
25.4 Percentage of participants
|
20.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period
PASI 90, week 12
|
38.1 Percentage of participants
|
25.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period
PASI 90, week 16
|
41.5 Percentage of participants
|
20.0 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 16, 24 and 48 WeeksPopulation: The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=107 Participants
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
Secukinumab (AIN457) 300 mg Subgroup 2
n=66 Participants
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 300 mg Subgroup 3
n=37 Participants
All participants who have tried and failed more than one anti-TNFalpha therapies
|
Secukinumab (AIN457) 150 mg Subgroup 1
Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
|
Secukinumab (AIN457) 150 mg Subgroup 2
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 150 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period
PASI 50, week 24
|
80.4 Percentage of participants
|
89.4 Percentage of participants
|
54.1 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period
PASI 50, week 48
|
70.1 Percentage of participants
|
65.2 Percentage of participants
|
32.4 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period
PASI 50, week 16
|
89.7 Percentage of participants
|
95.5 Percentage of participants
|
24.3 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period
PASI 90, week 16
|
45.8 Percentage of participants
|
34.8 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period
PASI 90, week 24
|
39.3 Percentage of participants
|
37.9 Percentage of participants
|
2.7 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period
PASI 90, week 48
|
31.8 Percentage of participants
|
18.2 Percentage of participants
|
5.4 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 48 and 72 WeeksPopulation: The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=83 Participants
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
Secukinumab (AIN457) 300 mg Subgroup 2
n=31 Participants
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 300 mg Subgroup 3
n=16 Participants
All participants who have tried and failed more than one anti-TNFalpha therapies
|
Secukinumab (AIN457) 150 mg Subgroup 1
n=24 Participants
Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
|
Secukinumab (AIN457) 150 mg Subgroup 2
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 150 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period
PASI 50, week 48
|
88.0 Percentage of participants
|
96.8 Percentage of participants
|
75.0 Percentage of participants
|
50.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period
PASI 50, week 72
|
74.7 Percentage of participants
|
80.6 Percentage of participants
|
37.5 Percentage of participants
|
70.8 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period
PASI 90, week 48
|
41.0 Percentage of participants
|
38.7 Percentage of participants
|
12.5 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period
PASI 90, week 72
|
38.6 Percentage of participants
|
22.6 Percentage of participants
|
18.8 Percentage of participants
|
16.7 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).
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 75 is defined as participants achieving ≥ 75% improvement from baseline.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=58 Participants
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
Secukinumab (AIN457) 300 mg Subgroup 2
n=60 Participants
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 300 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
Secukinumab (AIN457) 150 mg Subgroup 1
Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
|
Secukinumab (AIN457) 150 mg Subgroup 2
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 150 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Have Failed on One Anti-TNFα Achieving PASI 75 (Subgroups 1 and 2 Combined) at 16 Weeks
|
70.7 Percentage of participants
|
55.0 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: The full analysis set was analyzed.
PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. 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.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=118 Participants
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
Secukinumab (AIN457) 300 mg Subgroup 2
n=115 Participants
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 300 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
Secukinumab (AIN457) 150 mg Subgroup 1
Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
|
Secukinumab (AIN457) 150 mg Subgroup 2
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 150 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving NICE Continuation Criteria (PASI 75 or PASI 50 Plus a 5 Point Improvement in DLQI) at 16 Weeks
|
81.4 Percentage of participants
|
60.9 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 12, and week 16Population: The full analysis set was considered for the analysis. Only participants who had both baseline and post baseline measurements for a given time point were analyzed for that time point.
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. 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 change from baseline indicates improvement.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=118 Participants
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
Secukinumab (AIN457) 300 mg Subgroup 2
n=115 Participants
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 300 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
Secukinumab (AIN457) 150 mg Subgroup 1
Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
|
Secukinumab (AIN457) 150 mg Subgroup 2
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 150 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Scores - Initiation Period
Week 12, initiation
|
-15.6 score on a scale
Standard Deviation 7.49
|
-13.2 score on a scale
Standard Deviation 7.36
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Scores - Initiation Period
Week 16, initiation
|
-16.1 score on a scale
Standard Deviation 6.80
|
-12.3 score on a scale
Standard Deviation 7.68
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16, 24 and 48 weeksPopulation: The full analysis set was considered for the analysis. Only participants who had both baseline and post baseline measurements for a given time point were analyzed for that time point.
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. 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 change from baseline indicates improvement.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=107 Participants
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
Secukinumab (AIN457) 300 mg Subgroup 2
n=66 Participants
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 300 mg Subgroup 3
n=37 Participants
All participants who have tried and failed more than one anti-TNFalpha therapies
|
Secukinumab (AIN457) 150 mg Subgroup 1
Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
|
Secukinumab (AIN457) 150 mg Subgroup 2
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 150 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 1 Period
Week 16, maintenance 1
|
-16.3 score on a scale
Standard Deviation 6.67
|
-15.9 score on a scale
Standard Deviation 6.31
|
-6.1 score on a scale
Standard Deviation 5.86
|
—
|
—
|
—
|
|
Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 1 Period
Week 24, maintenance 1
|
-15.7 score on a scale
Standard Deviation 7.25
|
-14.4 score on a scale
Standard Deviation 6.73
|
-8.7 score on a scale
Standard Deviation 6.01
|
—
|
—
|
—
|
|
Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 1 Period
Week 48, maintenance 1
|
-16.2 score on a scale
Standard Deviation 8.06
|
-11.5 score on a scale
Standard Deviation 8.14
|
-9.8 score on a scale
Standard Deviation 6.76
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 48 and 72 weeksPopulation: The full analysis set was considered for the analysis. Only participants who had both baseline and post baseline measurements for a given time point were analyzed for that time point.
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. 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 change from baseline indicates improvement.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=83 Participants
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
Secukinumab (AIN457) 300 mg Subgroup 2
n=31 Participants
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 300 mg Subgroup 3
n=16 Participants
All participants who have tried and failed more than one anti-TNFalpha therapies
|
Secukinumab (AIN457) 150 mg Subgroup 1
n=24 Participants
Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
|
Secukinumab (AIN457) 150 mg Subgroup 2
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 150 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 2 Period
Week 48, maintenance 2
|
-17.2 score on a scale
Standard Deviation 7.33
|
-14.7 score on a scale
Standard Deviation 6.19
|
-11.5 score on a scale
Standard Deviation 5.98
|
-7.7 score on a scale
Standard Deviation 8.80
|
—
|
—
|
|
Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 2 Period
Week 72, maintenance 2
|
-17.0 score on a scale
Standard Deviation 7.27
|
-13.0 score on a scale
Standard Deviation 5.62
|
-11.3 score on a scale
Standard Deviation 4.77
|
-15.0 score on a scale
Standard Deviation 8.76
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 12 and 16 weeksPopulation: The full analysis set was considered for the analysis. Only participants with measurements at each given time point were analyzed for that time point.
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.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=118 Participants
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
Secukinumab (AIN457) 300 mg Subgroup 2
n=115 Participants
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 300 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
Secukinumab (AIN457) 150 mg Subgroup 1
Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
|
Secukinumab (AIN457) 150 mg Subgroup 2
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 150 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
|---|---|---|---|---|---|---|
|
Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Initiation Period
Week 12, initiation
|
76.25 percent change
Standard Deviation 18.612
|
72.92 percent change
Standard Deviation 20.004
|
—
|
—
|
—
|
—
|
|
Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Initiation Period
Week 16, initiation
|
76.30 percent change
Standard Deviation 21.580
|
75.25 percent change
Standard Deviation 19.100
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16, 24 and 48 weeksPopulation: The full analysis set was considered for the analysis. Only participants with measurements at each given time point were analyzed for that time point.
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.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=107 Participants
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
Secukinumab (AIN457) 300 mg Subgroup 2
n=66 Participants
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 300 mg Subgroup 3
n=37 Participants
All participants who have tried and failed more than one anti-TNFalpha therapies
|
Secukinumab (AIN457) 150 mg Subgroup 1
Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
|
Secukinumab (AIN457) 150 mg Subgroup 2
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 150 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
|---|---|---|---|---|---|---|
|
Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 1 Period
Week 16, maintenance 1
|
77.33 percent change
Standard Deviation 20.665
|
80.48 percent change
Standard Deviation 16.099
|
67.03 percent change
Standard Deviation 20.657
|
—
|
—
|
—
|
|
Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 1 Period
Week 24, maintenance 1
|
79.16 percent change
Standard Deviation 18.587
|
80.05 percent change
Standard Deviation 16.345
|
69.14 percent change
Standard Deviation 19.587
|
—
|
—
|
—
|
|
Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 1 Period
Week 48, maintenance 1
|
77.73 percent change
Standard Deviation 21.598
|
76.07 percent change
Standard Deviation 20.413
|
70.37 percent change
Standard Deviation 18.038
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 48 and 72 weeksPopulation: The full analysis set was considered for the analysis. Only participants with measurements at each given time point were analyzed for that time point.
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.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=83 Participants
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
Secukinumab (AIN457) 300 mg Subgroup 2
n=31 Participants
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 300 mg Subgroup 3
n=16 Participants
All participants who have tried and failed more than one anti-TNFalpha therapies
|
Secukinumab (AIN457) 150 mg Subgroup 1
n=24 Participants
Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
|
Secukinumab (AIN457) 150 mg Subgroup 2
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
|
Secukinumab (AIN457) 150 mg Subgroup 3
All participants who have tried and failed more than one anti-TNFalpha therapies
|
|---|---|---|---|---|---|---|
|
Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 2 Period
Week 48, maintenance 2 (n=79,30,16,24)
|
80.22 percent change
Standard Deviation 19.200
|
83.87 percent change
Standard Deviation 11.337
|
74.50 percent change
Standard Deviation 14.855
|
67.63 percent change
Standard Deviation 24.912
|
—
|
—
|
|
Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 2 Period
Week 72, maintenance 2 (n=73,26,12,21)
|
78.24 percent change
Standard Deviation 19.792
|
80.88 percent change
Standard Deviation 17.635
|
77.67 percent change
Standard Deviation 16.615
|
79.67 percent change
Standard Deviation 18.680
|
—
|
—
|
Adverse Events
Secukinumab (AIN457) 150mg
Secukinumab (AIN457) 300mg
Serious adverse events
| Measure |
Secukinumab (AIN457) 150mg
n=115 participants at risk
Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 \& 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician.
|
Secukinumab (AIN457) 300mg
n=179 participants at risk
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/115
|
0.56%
1/179
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/115
|
0.56%
1/179
|
|
Cardiac disorders
Myocardial infarction
|
1.7%
2/115
|
0.00%
0/179
|
|
Gastrointestinal disorders
Abdominal pain
|
0.87%
1/115
|
0.00%
0/179
|
|
Gastrointestinal disorders
Diarrhoea
|
0.87%
1/115
|
0.00%
0/179
|
|
Gastrointestinal disorders
Food poisoning
|
0.87%
1/115
|
0.00%
0/179
|
|
Gastrointestinal disorders
Nausea
|
0.87%
1/115
|
0.56%
1/179
|
|
Gastrointestinal disorders
Pancreatitis
|
0.87%
1/115
|
0.00%
0/179
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
2/115
|
0.00%
0/179
|
|
General disorders
Chills
|
0.00%
0/115
|
0.56%
1/179
|
|
General disorders
Electrocution
|
0.87%
1/115
|
0.00%
0/179
|
|
General disorders
Malaise
|
0.87%
1/115
|
0.00%
0/179
|
|
General disorders
Peripheral swelling
|
0.00%
0/115
|
0.56%
1/179
|
|
General disorders
Pyrexia
|
0.00%
0/115
|
0.56%
1/179
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.87%
1/115
|
0.00%
0/179
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.87%
1/115
|
0.00%
0/179
|
|
Infections and infestations
Cellulitis
|
0.00%
0/115
|
0.56%
1/179
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/115
|
1.1%
2/179
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/115
|
0.56%
1/179
|
|
Infections and infestations
Lower respiratory tract infection
|
0.87%
1/115
|
1.1%
2/179
|
|
Infections and infestations
Pneumonia
|
1.7%
2/115
|
0.56%
1/179
|
|
Infections and infestations
Sepsis
|
0.00%
0/115
|
0.56%
1/179
|
|
Infections and infestations
Skin infection
|
0.00%
0/115
|
0.56%
1/179
|
|
Infections and infestations
Tonsillitis
|
0.87%
1/115
|
0.00%
0/179
|
|
Infections and infestations
Urinary tract infection
|
0.87%
1/115
|
0.00%
0/179
|
|
Infections and infestations
Vulval abscess
|
0.87%
1/115
|
0.00%
0/179
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/115
|
0.56%
1/179
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/115
|
0.56%
1/179
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/115
|
0.56%
1/179
|
|
Investigations
Blood creatinine increased
|
0.00%
0/115
|
0.56%
1/179
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/115
|
0.56%
1/179
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/115
|
0.56%
1/179
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/115
|
0.56%
1/179
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/115
|
0.56%
1/179
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/115
|
0.56%
1/179
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/115
|
0.56%
1/179
|
|
Nervous system disorders
Alcoholic seizure
|
0.00%
0/115
|
0.56%
1/179
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/115
|
1.1%
2/179
|
|
Nervous system disorders
Drug withdrawal convulsions
|
0.00%
0/115
|
0.56%
1/179
|
|
Nervous system disorders
Headache
|
0.00%
0/115
|
0.56%
1/179
|
|
Nervous system disorders
Hypoaesthesia
|
0.87%
1/115
|
0.00%
0/179
|
|
Nervous system disorders
Migraine
|
0.87%
1/115
|
0.00%
0/179
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/115
|
0.56%
1/179
|
|
Renal and urinary disorders
Glomerulonephritis proliferative
|
0.00%
0/115
|
0.56%
1/179
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/115
|
0.56%
1/179
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/115
|
1.1%
2/179
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/115
|
0.56%
1/179
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.87%
1/115
|
0.00%
0/179
|
|
Social circumstances
Pregnancy of partner
|
0.00%
0/115
|
0.56%
1/179
|
|
Vascular disorders
Diabetic macroangiopathy
|
0.00%
0/115
|
0.56%
1/179
|
Other adverse events
| Measure |
Secukinumab (AIN457) 150mg
n=115 participants at risk
Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 \& 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician.
|
Secukinumab (AIN457) 300mg
n=179 participants at risk
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
|
|---|---|---|
|
Eye disorders
Dry eye
|
2.6%
3/115
|
2.8%
5/179
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
3/115
|
2.2%
4/179
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.87%
1/115
|
2.8%
5/179
|
|
Gastrointestinal disorders
Diarrhoea
|
12.2%
14/115
|
8.9%
16/179
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
7/115
|
3.9%
7/179
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/115
|
2.2%
4/179
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.87%
1/115
|
2.8%
5/179
|
|
Gastrointestinal disorders
Nausea
|
1.7%
2/115
|
10.6%
19/179
|
|
Gastrointestinal disorders
Toothache
|
2.6%
3/115
|
1.1%
2/179
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
6/115
|
6.7%
12/179
|
|
General disorders
Chest discomfort
|
2.6%
3/115
|
0.00%
0/179
|
|
General disorders
Fatigue
|
7.8%
9/115
|
4.5%
8/179
|
|
General disorders
Influenza like illness
|
7.0%
8/115
|
3.9%
7/179
|
|
Immune system disorders
Seasonal allergy
|
2.6%
3/115
|
3.4%
6/179
|
|
Infections and infestations
Cellulitis
|
0.00%
0/115
|
2.2%
4/179
|
|
Infections and infestations
Conjunctivitis
|
1.7%
2/115
|
3.9%
7/179
|
|
Infections and infestations
Ear infection
|
6.1%
7/115
|
3.9%
7/179
|
|
Infections and infestations
Folliculitis
|
0.87%
1/115
|
2.2%
4/179
|
|
Infections and infestations
Gastroenteritis
|
2.6%
3/115
|
1.7%
3/179
|
|
Infections and infestations
Influenza
|
4.3%
5/115
|
5.0%
9/179
|
|
Infections and infestations
Lower respiratory tract infection
|
5.2%
6/115
|
7.8%
14/179
|
|
Infections and infestations
Nasopharyngitis
|
23.5%
27/115
|
29.1%
52/179
|
|
Infections and infestations
Oral candidiasis
|
1.7%
2/115
|
3.9%
7/179
|
|
Infections and infestations
Oral herpes
|
5.2%
6/115
|
2.8%
5/179
|
|
Infections and infestations
Otitis externa
|
2.6%
3/115
|
1.1%
2/179
|
|
Infections and infestations
Pharyngitis
|
0.87%
1/115
|
2.8%
5/179
|
|
Infections and infestations
Sinusitis
|
2.6%
3/115
|
6.7%
12/179
|
|
Infections and infestations
Tinea pedis
|
0.87%
1/115
|
2.2%
4/179
|
|
Infections and infestations
Tonsillitis
|
3.5%
4/115
|
1.7%
3/179
|
|
Infections and infestations
Upper respiratory tract infection
|
7.0%
8/115
|
5.0%
9/179
|
|
Infections and infestations
Urinary tract infection
|
3.5%
4/115
|
5.6%
10/179
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.2%
6/115
|
6.1%
11/179
|
|
Infections and infestations
Vulvovaginal candidiasis
|
5.2%
6/115
|
4.5%
8/179
|
|
Injury, poisoning and procedural complications
Contusion
|
1.7%
2/115
|
2.2%
4/179
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
2/115
|
3.9%
7/179
|
|
Injury, poisoning and procedural complications
Joint injury
|
2.6%
3/115
|
1.7%
3/179
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/115
|
2.2%
4/179
|
|
Investigations
Alanine aminotransferase increased
|
1.7%
2/115
|
3.4%
6/179
|
|
Investigations
Aspartate aminotransferase increased
|
0.87%
1/115
|
2.8%
5/179
|
|
Investigations
Blood creatine phosphokinase increased
|
2.6%
3/115
|
3.4%
6/179
|
|
Investigations
Blood glucose increased
|
3.5%
4/115
|
1.7%
3/179
|
|
Investigations
Blood triglycerides increased
|
1.7%
2/115
|
2.2%
4/179
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.87%
1/115
|
3.9%
7/179
|
|
Investigations
Lipase increased
|
0.87%
1/115
|
3.4%
6/179
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.6%
3/115
|
0.00%
0/179
|
|
Metabolism and nutrition disorders
Gout
|
2.6%
3/115
|
0.56%
1/179
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
3.5%
4/115
|
1.1%
2/179
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
9/115
|
10.6%
19/179
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.5%
4/115
|
1.1%
2/179
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
8/115
|
8.9%
16/179
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.6%
3/115
|
5.0%
9/179
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.5%
4/115
|
2.2%
4/179
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
2.6%
3/115
|
0.00%
0/179
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.87%
1/115
|
4.5%
8/179
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.87%
1/115
|
2.8%
5/179
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
3/115
|
6.1%
11/179
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
3.5%
4/115
|
0.00%
0/179
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/115
|
5.0%
9/179
|
|
Nervous system disorders
Dizziness
|
1.7%
2/115
|
5.0%
9/179
|
|
Nervous system disorders
Headache
|
23.5%
27/115
|
15.6%
28/179
|
|
Nervous system disorders
Lethargy
|
2.6%
3/115
|
2.8%
5/179
|
|
Nervous system disorders
Migraine
|
3.5%
4/115
|
1.1%
2/179
|
|
Nervous system disorders
Paraesthesia
|
2.6%
3/115
|
1.1%
2/179
|
|
Psychiatric disorders
Depression
|
5.2%
6/115
|
2.2%
4/179
|
|
Psychiatric disorders
Insomnia
|
0.87%
1/115
|
2.8%
5/179
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.6%
11/115
|
11.2%
20/179
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.87%
1/115
|
2.2%
4/179
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.6%
3/115
|
2.2%
4/179
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.8%
9/115
|
16.2%
29/179
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/115
|
2.2%
4/179
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.6%
3/115
|
2.8%
5/179
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/115
|
2.2%
4/179
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
2.6%
3/115
|
1.1%
2/179
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.6%
3/115
|
2.2%
4/179
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
2.6%
3/115
|
0.56%
1/179
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
13.0%
15/115
|
15.6%
28/179
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.5%
4/115
|
3.4%
6/179
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.6%
3/115
|
0.56%
1/179
|
|
Vascular disorders
Hypertension
|
7.0%
8/115
|
3.9%
7/179
|
Additional Information
Study Director
Novartis Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER