Plaque-type Psoriasis
Conditions
Keywords
Psoriasis, Moderate to Severe Plaque-type Psoriasis, Skin condition, skin disease, itching condition, psoriasis vulgaris, relapsing/remitting psoriasis, immune-mediated systemic disease, skin lesions, red skin lesions, scaly patches, papules, plaques, itching
Brief summary
The purpose of this study was to demonstrate efficacy of autoinjector administered secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.
Interventions
DRUGPlacebo
2 injections of placebo to secukinumab 150mg per dose
Secukinumab 150mg: 1 injection of 150 mg secukinumab and 1 injection of placebo to secukinumab 150mg per dose. After Week 52 database lock, study is open label so only 1 injection of secukinumab 150mg per dose were administered
Secukinumab 300mg (2 injections of 150mg secukinumab per dose)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Moderate and severe plaque-type psoriasis diagnosed for at least 6 months. * Severity of psoriasis disease meeting all of the following three criteria: * Psoriasis Area and Severity Index (PASI) score of 12 or greater * Investigator's Global Assessment (IGA) score of 3 or greater * Total body surface area (BSA) affected of 10% or greater * Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.
Exclusion criteria
* Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate). * Current drug-induced psoriasis. * Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor. * Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject. * Hematological abnormalities. * History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis. * History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years. * Pregnant or nursing (lactating) women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response | 12 weeks | Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis. PASI score was based on assessment of the head, trunk, upper limbs and lower limbs for erythema, thickening (plaque elevation, induration), and scaling (desquamation). PASI scores can range from 0, corresponding to no signs of psoriasis, up to a theoretical maximum of 72.0. PASI-based secondary variables included absolute PASI score, response rates for PASI 75. PASI 50 and PASI 90 were defined as ≥ 50% and ≥ 90% improvement from Baseline in PASI score, respectively, while PASI 100 response corresponded to complete clearing of psoriasis (PASI = 0). IGA mod 2011 was used to evaluate the overall severity of psoriatic disease, with scores ranging from 0 (clear) to 4 (severe). Treatment success was defined as achievement of IGA mod 2011 0 or 1 score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Possible Use-related Hazards | Week 1 | To assess potential use-related hazards with the secukinumab autoinjector for the subject. |
| Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | Week 12 | The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10; 0 corresponds to worst experience while 10 corresponds to best experience. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit. |
| Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Absolute change from baseline at week 48 | The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10; 0 corresponds to worst experience while 10 corresponds to best experience. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit. |
| Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Induction Period | Week 12 | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. |
| Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 12 up to Week 52 | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. |
| Absolute Change From Baseline for PASI Score - Induction Period | Baseline, Week 12 | PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4) |
| Absolute Change From Baseline for PASI Score Over Time up to Week 52 - Maintenance Period (Observed Data) | Baseline, Week 52 | Psoriasis Area and Severity Index (PASI): Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4). |
| Percentage of Participants in Each IGA Mod 2011 Category - Induction Period | Week 12 | 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 |
| Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Week 52 | The Investigators' Global Assessment (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. |
| Percentages of Subjects With Successful Self-administration of Study Drug at Week 1 | Week 1 | To assess the subject's ability to follow instructions for use with the secukinumab autoinjector |
| Change From Baseline in EQ-5D Over Time up to Week 52 - Maintenance Period | Week 52 | ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example confined to bed) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state). |
| Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score - Induction Period | Baseline, up to Week 12 | The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. A negative median percent change from baseline indicates improvement. |
| Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52 - Maintenance Period | Baseline, Week 52 | The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. A negative median percent change from baseline indicates improvement. |
| Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12 - Induction Period | Week 12 | The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. |
| Percentages of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52 - (Maintenance) | Week 52 | The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. |
| Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | Week 160 | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. |
| Absolute Change From Baseline for PASI Score After Week 52 (Observed Data) | Week 160 | PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4). |
| Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Week 160 | 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. |
| Number of Participants Developing Treatment-emergent Anti-secukinumab Antibodies | Baseline and at Week 12, 24, 52, 100, 148, 196, 208, and 216 | The development of anti-secunimubab anti-bodies decreases a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to week 216. |
| Change From Baseline in EQ-5D up to Week 12 - Induction Period | Week 12 | ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example confined to bed) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state). |
Countries
Canada, Estonia, France, Germany, United States
Participant flow
Recruitment details
59 placebo subjects completed induction phase. These 59 entered maintenance phase. Of those, 28 were assigned to 150mg AIN457 and 28 were assigned to 300 mg AIN457, while 3 remained with PLC treatment.
Pre-assignment details
A total of 220 patients were screened at 39 study centers, and 182 patients were randomized at 38 study centers to 3 balanced groups.
Participants by arm
| Arm | Count |
|---|---|
| AIN457 150 mg Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing. | 61 |
| AIN457 300 mg Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing. | 60 |
| Placebo placebo secukinumab (2 s.c. injections) at each dosing | 61 |
| Total | 182 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Extension Period | Adverse Event | 4 | 3 | 2 | 1 | 0 |
| Extension Period | Lack of Efficacy | 7 | 0 | 2 | 1 | 0 |
| Extension Period | Lost to Follow-up | 1 | 0 | 1 | 0 | 0 |
| Extension Period | Physician Decision | 1 | 0 | 0 | 1 | 0 |
| Extension Period | study terminated by sponsor | 33 | 50 | 17 | 23 | 0 |
| Extension Period | technical problems | 0 | 1 | 2 | 1 | 0 |
| Extension Period | Withdrawal by Subject | 1 | 0 | 1 | 1 | 0 |
| Follow-up Period | Withdrawal by Subject | 1 | 0 | 0 | 0 | 1 |
| Induction Period | Adverse Event | 1 | 0 | 0 | 0 | 1 |
| Induction Period | Lack of Efficacy | 0 | 0 | 0 | 0 | 1 |
| Induction Period | Physician Decision | 1 | 0 | 0 | 0 | 0 |
| Induction Period | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 |
| Maintenance Period | Adverse Event | 1 | 0 | 0 | 0 | 0 |
| Maintenance Period | Lack of Efficacy | 4 | 1 | 0 | 0 | 0 |
| Maintenance Period | Lost to Follow-up | 1 | 1 | 0 | 0 | 1 |
| Maintenance Period | Physician Decision | 0 | 0 | 0 | 0 | 1 |
| Maintenance Period | Withdrawal by Subject | 2 | 0 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | AIN457 150 mg | AIN457 300 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 43.9 years STANDARD_DEVIATION 14.41 | 46.6 years STANDARD_DEVIATION 14.23 | 43.7 years STANDARD_DEVIATION 12.74 | 44.7 years STANDARD_DEVIATION 13.8 |
| Sex: Female, Male Female | 20 Participants | 14 Participants | 23 Participants | 57 Participants |
| Sex: Female, Male Male | 41 Participants | 46 Participants | 38 Participants | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 35 / 61 | 37 / 60 | 30 / 61 | 81 / 89 | 81 / 88 | 31 / 61 |
| serious Total, serious adverse events | 3 / 61 | 1 / 60 | 1 / 61 | 18 / 89 | 16 / 88 | 1 / 61 |
Outcome results
Primary
Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response
Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis. PASI score was based on assessment of the head, trunk, upper limbs and lower limbs for erythema, thickening (plaque elevation, induration), and scaling (desquamation). PASI scores can range from 0, corresponding to no signs of psoriasis, up to a theoretical maximum of 72.0. PASI-based secondary variables included absolute PASI score, response rates for PASI 75. PASI 50 and PASI 90 were defined as ≥ 50% and ≥ 90% improvement from Baseline in PASI score, respectively, while PASI 100 response corresponded to complete clearing of psoriasis (PASI = 0). IGA mod 2011 was used to evaluate the overall severity of psoriatic disease, with scores ranging from 0 (clear) to 4 (severe). Treatment success was defined as achievement of IGA mod 2011 0 or 1 score.
Time frame: 12 weeks
Population: Full Analysis Set (FAS) comprises of all patients to whom study treatment has been assigned.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg | Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response | PASI 75 | 71.7 Percentages of participants |
| AIN457 150 mg | Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response | IGA 0/1 | 53.3 Percentages of participants |
| AIN457 300 mg | Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response | PASI 75 | 86.7 Percentages of participants |
| AIN457 300 mg | Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response | IGA 0/1 | 73.3 Percentages of participants |
| Placebo | Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response | PASI 75 | 3.3 Percentages of participants |
| Placebo | Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response | IGA 0/1 | 0.0 Percentages of participants |
Comparison: Response criterion: IGA 0/1p-value: <0.000195% CI: [36.6, 67.7]Fisher Exact
Comparison: Response Criterion: IGA 0/1p-value: <0.000195% CI: [58.8, 83.9]Fisher Exact
Comparison: Response criterion: PASI 75p-value: <0.000195% CI: [53.1, 79.8]Fisher Exact
Comparison: Response criterion: PASI 75p-value: <0.000195% CI: [70.7, 91.7]Fisher Exact
Secondary
Absolute Change From Baseline for PASI Score After Week 52 (Observed Data)
PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4).
Time frame: Week 160
Population: Full analysis set (FAS).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AIN457 150 mg | Absolute Change From Baseline for PASI Score After Week 52 (Observed Data) | -18.7 Units on a scale | Standard Deviation 5.66 |
| AIN457 300 mg | Absolute Change From Baseline for PASI Score After Week 52 (Observed Data) | -15.9 Units on a scale | Standard Deviation 4.58 |
| Placebo | Absolute Change From Baseline for PASI Score After Week 52 (Observed Data) | -12.7 Units on a scale | Standard Deviation 8.08 |
| Placebo - AIN457 300 mg | Absolute Change From Baseline for PASI Score After Week 52 (Observed Data) | -18.1 Units on a scale | Standard Deviation 5.49 |
Secondary
Absolute Change From Baseline for PASI Score - Induction Period
PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)
Time frame: Baseline, Week 12
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AIN457 150 mg | Absolute Change From Baseline for PASI Score - Induction Period | -15.52 Units on a scale | Standard Deviation 7.841 |
| AIN457 300 mg | Absolute Change From Baseline for PASI Score - Induction Period | -16.67 Units on a scale | Standard Deviation 6.552 |
| Placebo | Absolute Change From Baseline for PASI Score - Induction Period | -1.26 Units on a scale | Standard Deviation 6.621 |
Secondary
Absolute Change From Baseline for PASI Score Over Time up to Week 52 - Maintenance Period (Observed Data)
Psoriasis Area and Severity Index (PASI): Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4).
Time frame: Baseline, Week 52
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AIN457 150 mg | Absolute Change From Baseline for PASI Score Over Time up to Week 52 - Maintenance Period (Observed Data) | -18.3 Units on a scale | Standard Deviation 6.75 |
| AIN457 300 mg | Absolute Change From Baseline for PASI Score Over Time up to Week 52 - Maintenance Period (Observed Data) | -16.4 Units on a scale | Standard Deviation 5.99 |
| Placebo | Absolute Change From Baseline for PASI Score Over Time up to Week 52 - Maintenance Period (Observed Data) | -15.2 Units on a scale | Standard Deviation 5.85 |
| Placebo - AIN457 300 mg | Absolute Change From Baseline for PASI Score Over Time up to Week 52 - Maintenance Period (Observed Data) | -18.8 Units on a scale | Standard Deviation 5.59 |
Secondary
Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12
The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10; 0 corresponds to worst experience while 10 corresponds to best experience. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Time frame: Week 12
Population: Safety Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 150 mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | Self confidence | 1.76 Score | Standard Deviation 1.763 |
| AIN457 150 mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | Feelings about injections | 0.94 Score | Standard Deviation 2.19 |
| AIN457 150 mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | Satisfaction with self-injection | 2.74 Score | Standard Deviation 2.741 |
| AIN457 300 mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | Self confidence | 1.68 Score | Standard Deviation 1.901 |
| AIN457 300 mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | Feelings about injections | 1.13 Score | Standard Deviation 1.796 |
| AIN457 300 mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | Satisfaction with self-injection | 2.63 Score | Standard Deviation 2.361 |
| Placebo | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | Feelings about injections | 0.93 Score | Standard Deviation 1.887 |
| Placebo | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | Satisfaction with self-injection | 1.71 Score | Standard Deviation 2.679 |
| Placebo | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | Self confidence | 1.00 Score | Standard Deviation 2.098 |
Secondary
Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48
The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10; 0 corresponds to worst experience while 10 corresponds to best experience. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Time frame: Absolute change from baseline at week 48
Population: Safety set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 150 mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Feelings about injections | 0.92 Score | Standard Deviation 1.853 |
| AIN457 150 mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Self confidence | 1.88 Score | Standard Deviation 1.926 |
| AIN457 150 mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Satisfaction with self-injection | 2.93 Score | Standard Deviation 2.853 |
| AIN457 300 mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Self confidence | 1.86 Score | Standard Deviation 2.052 |
| AIN457 300 mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Feelings about injections | 1.34 Score | Standard Deviation 2.336 |
| AIN457 300 mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Satisfaction with self-injection | 2.50 Score | Standard Deviation 2.121 |
| Placebo | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Satisfaction with self-injection | 2.29 Score | Standard Deviation 2.65 |
| Placebo | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Feelings about injections | 1.43 Score | Standard Deviation 2.049 |
| Placebo | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Self confidence | 1.17 Score | Standard Deviation 3.033 |
| Placebo - AIN457 300 mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Feelings about injections | 0.73 Score | Standard Deviation 1.45 |
| Placebo - AIN457 300 mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Self confidence | 1.70 Score | Standard Deviation 2.145 |
| Placebo - AIN457 300 mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Satisfaction with self-injection | 1.98 Score | Standard Deviation 2.853 |
| Placebo | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Self confidence | 0.00 Score | Standard Deviation 3.536 |
| Placebo | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Feelings about injections | 0.42 Score | Standard Deviation 1.768 |
| Placebo | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Satisfaction with self-injection | 2.50 Score | Standard Deviation 0 |
Secondary
Change From Baseline in EQ-5D Over Time up to Week 52 - Maintenance Period
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example confined to bed) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state).
Time frame: Week 52
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AIN457 150 mg | Change From Baseline in EQ-5D Over Time up to Week 52 - Maintenance Period | 16.8 unit on a scale | Standard Deviation 20.34 |
| AIN457 300 mg | Change From Baseline in EQ-5D Over Time up to Week 52 - Maintenance Period | 17.4 unit on a scale | Standard Deviation 20.38 |
| Placebo | Change From Baseline in EQ-5D Over Time up to Week 52 - Maintenance Period | 12.9 unit on a scale | Standard Deviation 28.45 |
| Placebo - AIN457 300 mg | Change From Baseline in EQ-5D Over Time up to Week 52 - Maintenance Period | 9.9 unit on a scale | Standard Deviation 10.94 |
| Placebo | Change From Baseline in EQ-5D Over Time up to Week 52 - Maintenance Period | 10.0 unit on a scale | Standard Deviation 9 |
Secondary
Change From Baseline in EQ-5D up to Week 12 - Induction Period
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example confined to bed) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state).
Time frame: Week 12
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AIN457 150 mg | Change From Baseline in EQ-5D up to Week 12 - Induction Period | 13.5 unit on a scale | Standard Deviation 19.63 |
| AIN457 300 mg | Change From Baseline in EQ-5D up to Week 12 - Induction Period | 15.3 unit on a scale | Standard Deviation 19.8 |
| Placebo | Change From Baseline in EQ-5D up to Week 12 - Induction Period | -0.5 unit on a scale | Standard Deviation 14.89 |
Secondary
Number of Participants Developing Treatment-emergent Anti-secukinumab Antibodies
The development of anti-secunimubab anti-bodies decreases a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to week 216.
Time frame: Baseline and at Week 12, 24, 52, 100, 148, 196, 208, and 216
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150 mg | Number of Participants Developing Treatment-emergent Anti-secukinumab Antibodies | 1 Number of participants |
| AIN457 300 mg | Number of Participants Developing Treatment-emergent Anti-secukinumab Antibodies | 2 Number of participants |
| Placebo | Number of Participants Developing Treatment-emergent Anti-secukinumab Antibodies | 0 Number of participants |
| Placebo - AIN457 300 mg | Number of Participants Developing Treatment-emergent Anti-secukinumab Antibodies | 0 Number of participants |
| Placebo | Number of Participants Developing Treatment-emergent Anti-secukinumab Antibodies | 0 Number of participants |
Secondary
Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score - Induction Period
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. A negative median percent change from baseline indicates improvement.
Time frame: Baseline, up to Week 12
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AIN457 150 mg | Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score - Induction Period | -83.3 percent change |
| AIN457 300 mg | Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score - Induction Period | -86.8 percent change |
| Placebo | Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score - Induction Period | -17.9 percent change |
Secondary
Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52 - Maintenance Period
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. A negative median percent change from baseline indicates improvement.
Time frame: Baseline, Week 52
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AIN457 150 mg | Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52 - Maintenance Period | -90.9 Percent change |
| AIN457 300 mg | Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52 - Maintenance Period | -91.2 Percent change |
| Placebo | Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52 - Maintenance Period | -78.5 Percent change |
| Placebo - AIN457 300 mg | Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52 - Maintenance Period | -97.7 Percent change |
| Placebo | Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52 - Maintenance Period | -53.7 Percent change |
Secondary
Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12 - Induction Period
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.
Time frame: Week 12
Population: Full analysis set (FAS)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150 mg | Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12 - Induction Period | 59.3 Percentage of participants |
| AIN457 300 mg | Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12 - Induction Period | 74.6 Percentage of participants |
| Placebo | Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12 - Induction Period | 15.3 Percentage of participants |
Secondary
Percentage of Participants in Each IGA Mod 2011 Category - Induction Period
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
Time frame: Week 12
Population: Full Analysis Set (FAS) - All patients to whom study treatment was assigned.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg | Percentage of Participants in Each IGA Mod 2011 Category - Induction Period | moderate | 15.0 Percentages of participants |
| AIN457 150 mg | Percentage of Participants in Each IGA Mod 2011 Category - Induction Period | mild | 25.0 Percentages of participants |
| AIN457 150 mg | Percentage of Participants in Each IGA Mod 2011 Category - Induction Period | clear | 18.3 Percentages of participants |
| AIN457 150 mg | Percentage of Participants in Each IGA Mod 2011 Category - Induction Period | almost clear | 35.0 Percentages of participants |
| AIN457 150 mg | Percentage of Participants in Each IGA Mod 2011 Category - Induction Period | severe | 6.7 Percentages of participants |
| AIN457 300 mg | Percentage of Participants in Each IGA Mod 2011 Category - Induction Period | mild | 18.3 Percentages of participants |
| AIN457 300 mg | Percentage of Participants in Each IGA Mod 2011 Category - Induction Period | clear | 30.0 Percentages of participants |
| AIN457 300 mg | Percentage of Participants in Each IGA Mod 2011 Category - Induction Period | almost clear | 45.0 Percentages of participants |
| AIN457 300 mg | Percentage of Participants in Each IGA Mod 2011 Category - Induction Period | moderate | 6.7 Percentages of participants |
| AIN457 300 mg | Percentage of Participants in Each IGA Mod 2011 Category - Induction Period | severe | 0.0 Percentages of participants |
| Placebo | Percentage of Participants in Each IGA Mod 2011 Category - Induction Period | severe | 31.1 Percentages of participants |
| Placebo | Percentage of Participants in Each IGA Mod 2011 Category - Induction Period | moderate | 60.7 Percentages of participants |
| Placebo | Percentage of Participants in Each IGA Mod 2011 Category - Induction Period | clear | 0.0 Percentages of participants |
| Placebo | Percentage of Participants in Each IGA Mod 2011 Category - Induction Period | mild | 8.2 Percentages of participants |
| Placebo | Percentage of Participants in Each IGA Mod 2011 Category - Induction Period | almost clear | 0.0 Percentages of participants |
Secondary
Percentage of Subjects With Possible Use-related Hazards
To assess potential use-related hazards with the secukinumab autoinjector for the subject.
Time frame: Week 1
Population: Safety set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg | Percentage of Subjects With Possible Use-related Hazards | Swallowing of material debris observed | 0 Percentages of participants |
| AIN457 150 mg | Percentage of Subjects With Possible Use-related Hazards | Needle stick in a critical area | 0 Percentages of participants |
| AIN457 150 mg | Percentage of Subjects With Possible Use-related Hazards | Allergic reaction to devise material | 0 Percentages of participants |
| AIN457 150 mg | Percentage of Subjects With Possible Use-related Hazards | Less than full dose administered | 0 Percentages of participants |
| AIN457 150 mg | Percentage of Subjects With Possible Use-related Hazards | Needle stick in non-critical area | 0 Percentages of participants |
| AIN457 150 mg | Percentage of Subjects With Possible Use-related Hazards | Pain due to bent needle | 0 Percentages of participants |
| AIN457 150 mg | Percentage of Subjects With Possible Use-related Hazards | Any other problem | 0 Percentages of participants |
| AIN457 150 mg | Percentage of Subjects With Possible Use-related Hazards | Any breakage of the device | 0 Percentages of participants |
| AIN457 150 mg | Percentage of Subjects With Possible Use-related Hazards | Any part of the device swallowed | 0 Percentages of participants |
| AIN457 300 mg | Percentage of Subjects With Possible Use-related Hazards | Any breakage of the device | 0 Percentages of participants |
| AIN457 300 mg | Percentage of Subjects With Possible Use-related Hazards | Swallowing of material debris observed | 0 Percentages of participants |
| AIN457 300 mg | Percentage of Subjects With Possible Use-related Hazards | Needle stick in a critical area | 0 Percentages of participants |
| AIN457 300 mg | Percentage of Subjects With Possible Use-related Hazards | Any other problem | 5.1 Percentages of participants |
| AIN457 300 mg | Percentage of Subjects With Possible Use-related Hazards | Less than full dose administered | 1.7 Percentages of participants |
| AIN457 300 mg | Percentage of Subjects With Possible Use-related Hazards | Any part of the device swallowed | 0 Percentages of participants |
| AIN457 300 mg | Percentage of Subjects With Possible Use-related Hazards | Allergic reaction to devise material | 0 Percentages of participants |
| AIN457 300 mg | Percentage of Subjects With Possible Use-related Hazards | Pain due to bent needle | 0 Percentages of participants |
| AIN457 300 mg | Percentage of Subjects With Possible Use-related Hazards | Needle stick in non-critical area | 0 Percentages of participants |
| Placebo | Percentage of Subjects With Possible Use-related Hazards | Less than full dose administered | 0 Percentages of participants |
| Placebo | Percentage of Subjects With Possible Use-related Hazards | Pain due to bent needle | 0 Percentages of participants |
| Placebo | Percentage of Subjects With Possible Use-related Hazards | Needle stick in a critical area | 0 Percentages of participants |
| Placebo | Percentage of Subjects With Possible Use-related Hazards | Needle stick in non-critical area | 0 Percentages of participants |
| Placebo | Percentage of Subjects With Possible Use-related Hazards | Any part of the device swallowed | 0 Percentages of participants |
| Placebo | Percentage of Subjects With Possible Use-related Hazards | Allergic reaction to devise material | 0 Percentages of participants |
| Placebo | Percentage of Subjects With Possible Use-related Hazards | Any breakage of the device | 0 Percentages of participants |
| Placebo | Percentage of Subjects With Possible Use-related Hazards | Swallowing of material debris observed | 0 Percentages of participants |
| Placebo | Percentage of Subjects With Possible Use-related Hazards | Any other problem | 0 Percentages of participants |
Secondary
Percentages of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52 - (Maintenance)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.
Time frame: Week 52
Population: Full Analysis Set (FAS) - All patients to whom study treatment was assigned.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150 mg | Percentages of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52 - (Maintenance) | 66.1 Percentage of participants |
| AIN457 300 mg | Percentages of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52 - (Maintenance) | 70.0 Percentage of participants |
| Placebo | Percentages of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52 - (Maintenance) | 57.1 Percentage of participants |
| Placebo - AIN457 300 mg | Percentages of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52 - (Maintenance) | 85.7 Percentage of participants |
| Placebo | Percentages of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52 - (Maintenance) | 0.0 Percentage of participants |
Secondary
Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data)
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.
Time frame: Week 160
Population: Full analysis set (FAS).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg | Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | almost clear Week 160 | 18.8 Percentages of participants |
| AIN457 150 mg | Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | clear Week 160 | 25.0 Percentages of participants |
| AIN457 150 mg | Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | severe Week 160 | 0.0 Percentages of participants |
| AIN457 150 mg | Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | mild Week 160 | 31.3 Percentages of participants |
| AIN457 150 mg | Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | moderate Week 160 | 25.0 Percentages of participants |
| AIN457 300 mg | Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | mild Week 160 | 20.8 Percentages of participants |
| AIN457 300 mg | Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | moderate Week 160 | 16.7 Percentages of participants |
| AIN457 300 mg | Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | severe Week 160 | 4.2 Percentages of participants |
| AIN457 300 mg | Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | almost clear Week 160 | 12.5 Percentages of participants |
| AIN457 300 mg | Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | clear Week 160 | 45.8 Percentages of participants |
| Placebo | Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | almost clear Week 160 | 0.0 Percentages of participants |
| Placebo | Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | clear Week 160 | 20.0 Percentages of participants |
| Placebo | Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | mild Week 160 | 50.0 Percentages of participants |
| Placebo | Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | moderate Week 160 | 20.0 Percentages of participants |
| Placebo | Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | severe Week 160 | 10.0 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | moderate Week 160 | 13.3 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | almost clear Week 160 | 13.3 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | clear Week 160 | 60.0 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | mild Week 160 | 6.7 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | severe Week 160 | 6.7 Percentages of participants |
Secondary
Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data)
The Investigators' Global Assessment (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.
Time frame: Week 52
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg | Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Moderate | 11.8 Percentages of participants |
| AIN457 150 mg | Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Almost clear | 29.4 Percentages of participants |
| AIN457 150 mg | Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Severe | 3.9 Percentages of participants |
| AIN457 150 mg | Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Mild | 19.6 Percentages of participants |
| AIN457 150 mg | Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Clear | 35.3 Percentages of participants |
| AIN457 300 mg | Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Mild | 19.0 Percentages of participants |
| AIN457 300 mg | Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Moderate | 6.9 Percentages of participants |
| AIN457 300 mg | Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Severe | 3.4 Percentages of participants |
| AIN457 300 mg | Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Almost clear | 31.0 Percentages of participants |
| AIN457 300 mg | Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Clear | 39.7 Percentages of participants |
| Placebo | Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Mild | 24.0 Percentages of participants |
| Placebo | Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Clear | 40.0 Percentages of participants |
| Placebo | Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Almost clear | 16.0 Percentages of participants |
| Placebo | Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Moderate | 20.0 Percentages of participants |
| Placebo | Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Severe | 0.0 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Moderate | 3.6 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Almost clear | 21.4 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Clear | 64.3 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Mild | 10.7 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) | Severe | 0.0 Percentages of participants |
Secondary
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data)
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Time frame: Week 160
Population: Full analysis set (FAS). Results after Week 160 and beyond cannot be interpreted meaningfully due to low number of evaluable patients at these visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | PASI 90 Week 160 | 62.5 Percentages of participants |
| AIN457 150 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | PASI 75 Week 160 | 93.8 Percentages of participants |
| AIN457 150 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | PASI 100 (n=16, 24, 10, 15) Week 160 | 31.3 Percentages of participants |
| AIN457 150 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | PASI 50 Week 160 | 100.0 Percentages of participants |
| AIN457 150 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | IGA 0/1 Week 160 | 43.8 Percentages of participants |
| AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | PASI 50 Week 160 | 100.0 Percentages of participants |
| AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | PASI 90 Week 160 | 70.8 Percentages of participants |
| AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | PASI 100 (n=16, 24, 10, 15) Week 160 | 45.8 Percentages of participants |
| AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | PASI 75 Week 160 | 87.5 Percentages of participants |
| AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | IGA 0/1 Week 160 | 58.3 Percentages of participants |
| Placebo | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | PASI 50 Week 160 | 70.0 Percentages of participants |
| Placebo | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | IGA 0/1 Week 160 | 20.0 Percentages of participants |
| Placebo | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | PASI 75 Week 160 | 70.0 Percentages of participants |
| Placebo | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | PASI 90 Week 160 | 40.0 Percentages of participants |
| Placebo | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | PASI 100 (n=16, 24, 10, 15) Week 160 | 20.0 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | PASI 90 Week 160 | 73.3 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | PASI 75 Week 160 | 86.7 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | IGA 0/1 Week 160 | 73.3 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | PASI 50 Week 160 | 100.0 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) | PASI 100 (n=16, 24, 10, 15) Week 160 | 60.0 Percentages of participants |
Secondary
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Induction Period
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Time frame: Week 12
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Induction Period | PASI 100 | 16.7 Percentages of participants |
| AIN457 150 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Induction Period | PASI 50 | 78.3 Percentages of participants |
| AIN457 150 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Induction Period | PASI 90 | 40.0 Percentages of participants |
| AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Induction Period | PASI 100 | 26.7 Percentages of participants |
| AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Induction Period | PASI 50 | 96.7 Percentages of participants |
| AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Induction Period | PASI 90 | 55.0 Percentages of participants |
| Placebo | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Induction Period | PASI 100 | 0.0 Percentages of participants |
| Placebo | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Induction Period | PASI 50 | 8.2 Percentages of participants |
| Placebo | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Induction Period | PASI 90 | 0.0 Percentages of participants |
Secondary
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data)
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Time frame: Week 12 up to Week 52
Population: Full Analysis Set (FAS). Results after Week 160 and beyond cannot be interpreted meaningfully due to low number of evaluable patients at these visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 52 IGA 0/1 | 64.7 Percentages of participants |
| AIN457 150 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 52 PASI 75 | 82.4 Percentages of participants |
| AIN457 150 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 52 PASI 100 | 35.3 Percentages of participants |
| AIN457 150 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 52 PASI 90 | 62.7 Percentages of participants |
| AIN457 150 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 52 PASI 50 | 96.1 Percentages of participants |
| AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 52 PASI 75 | 82.8 Percentages of participants |
| AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 52 PASI 100 | 39.7 Percentages of participants |
| AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 52 PASI 90 | 65.5 Percentages of participants |
| AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 52 PASI 50 | 94.8 Percentages of participants |
| AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 52 IGA 0/1 | 70.7 Percentages of participants |
| Placebo | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 52 IGA 0/1 | 56.0 Percentages of participants |
| Placebo | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 52 PASI 90 | 52.0 Percentages of participants |
| Placebo | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 52 PASI 50 | 88.0 Percentages of participants |
| Placebo | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 52 PASI 75 | 76.0 Percentages of participants |
| Placebo | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 52 PASI 100 | 40.0 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 52 PASI 100 | 64.3 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 52 IGA 0/1 | 85.7 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 52 PASI 75 | 96.4 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 52 PASI 50 | 100.0 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) | Week 52 PASI 90 | 89.3 Percentages of participants |
Secondary
Percentages of Subjects With Successful Self-administration of Study Drug at Week 1
To assess the subject's ability to follow instructions for use with the secukinumab autoinjector
Time frame: Week 1
Population: Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were analyzed according to treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150 mg | Percentages of Subjects With Successful Self-administration of Study Drug at Week 1 | 100 Percentages of participants |
| AIN457 300 mg | Percentages of Subjects With Successful Self-administration of Study Drug at Week 1 | 100 Percentages of participants |
| Placebo | Percentages of Subjects With Successful Self-administration of Study Drug at Week 1 | 100 Percentages of participants |