Moderate to Severe Plaque-type Psoriasis
Conditions
Keywords
Psoriasis
Brief summary
The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.
Interventions
After the data base lock of week 52 data has been performed, subjects will receive secukinumab 150 mg treatment as open label for the remainder of the extension treatment period
After the data base lock of week 52 data has been performed, subjects will receive secukinumab 300 mg treatment as open label for the remainder of the extension treatment period
DRUGplacebo
Subjects who were on placebo at Week 52 cannot continue in the extension treatment period
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis at Week 12 Measure: PASI 75 (Psoriasis Area and Severity Index) Response. | 12 weeks | A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis |
| Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) With a 0 or 1 Response at Week 12 | 12 weeks | The IGA scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit. IGA has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Potential Use Related Hazards at Week 1 | Week 1 | To assess potential use-related hazards with the secukinumab PFS for the subject |
| Percentage 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 PFS |
| Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Induction) With Non-responder Imputation | 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. |
| Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data) | 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. |
| Percent of Responders With Investigator's Global Assessment (IGA) Mod 2011 Score of 0 or 1, (Maintenance; Observed Data) | Week 52 | 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 at Week 12, (Induction) | 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; Observed Data) | Week 52 | 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) |
| Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction) | Week 12 | The IGA mod 2011 category 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 |
| Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Week 52 | The IGA mod 2011 category 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 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. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit. |
| Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Over Time up to Week 52, (Maintenance) | 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) |
| Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score, (Induction) | Baseline and 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. This result was reflected in the percentage change from baseline at Week 12, higher reductions (improvements) in DLQI scores (median treatment difference). |
| Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52, (Maintenance) | Baseline and 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. This result was reflected in the percentage change from baseline at Week 12, higher reductions (improvements) in DLQI scores (median treatment difference). |
| Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12, (Induction) | 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 |
| Percentage 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 |
| Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52 | Week 172 | 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. |
| Absolute Change From Baseline for PASI Score After Week 52, (Observed Data) | Week 172 | 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) |
| Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Week 172 | The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe. The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe |
| Number of Participants Developing Treatment Emergent Anti-secukinumab Antibodies, Immunogenicity | Baseline and at Week 12, 24, 52, 100, 148, and 196, 204 | The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to 8 weeks after last treatment |
| Change From Baseline in EQ-5D at Week 12 (Induction) | 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) |
| Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Baseline, 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. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit. |
Countries
Canada, Estonia, France, Germany, United States
Participant flow
Recruitment details
Study terminated by Sponsor refers to the fact that - as per protocol - patients had to stop participating in the study in a given country where Secukinumab became available following approval.
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 | 59 |
| AIN457 300 mg Patients received two secukinumab 150 mg s.c. injections at each dosing | 59 |
| Placebo Patients received placebo secukinumab (2 s.c. injections) at each dosing | 59 |
| Total | 177 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Extension | Adverse Event | 1 | 2 | 1 | 1 | 0 |
| Extension | Lack of Efficacy | 7 | 6 | 3 | 0 | 0 |
| Extension | Lost to Follow-up | 2 | 1 | 2 | 0 | 0 |
| Extension | Protocol deviation | 1 | 0 | 0 | 0 | 0 |
| Extension | Study terminated by sponsor | 32 | 33 | 16 | 20 | 0 |
| Extension | Subject/guardian decision | 1 | 9 | 1 | 0 | 0 |
| Extension | Technical Problems | 1 | 0 | 0 | 1 | 0 |
| Follow-Up Period | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 |
| Follow-Up Period | Subject / guardian decision | 3 | 1 | 1 | 1 | 0 |
| Induction Period | Adverse Event | 0 | 1 | 0 | 0 | 1 |
| Induction Period | Death | 1 | 0 | 0 | 0 | 0 |
| Induction Period | Lost to Follow-up | 0 | 2 | 0 | 0 | 0 |
| Induction Period | Subject / guardian decision | 0 | 0 | 0 | 0 | 2 |
| Maintenance Period | Adverse Event | 1 | 1 | 0 | 0 | 0 |
| Maintenance Period | Death | 0 | 0 | 0 | 1 | 0 |
| Maintenance Period | Lack of Efficacy | 6 | 1 | 3 | 0 | 0 |
| Maintenance Period | Lost to Follow-up | 2 | 0 | 0 | 1 | 0 |
| Maintenance Period | Physician Decision | 0 | 0 | 1 | 0 | 0 |
| Maintenance Period | Subject / guardian decision | 1 | 2 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | AIN457 150 mg | AIN457 300 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 46 Years STANDARD_DEVIATION 15.09 | 45.1 Years STANDARD_DEVIATION 12.57 | 46.5 Years STANDARD_DEVIATION 14.14 | 45.9 Years STANDARD_DEVIATION 13.91 |
| Sex: Female, Male Female | 19 Participants | 21 Participants | 20 Participants | 60 Participants |
| Sex: Female, Male Male | 40 Participants | 38 Participants | 39 Participants | 117 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 29 / 59 | 24 / 59 | 22 / 59 | 70 / 88 | 74 / 86 |
| serious Total, serious adverse events | 1 / 59 | 3 / 59 | 1 / 59 | 10 / 88 | 10 / 86 |
Outcome results
Primary
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis at Week 12 Measure: PASI 75 (Psoriasis Area and Severity Index) Response.
A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis
Time frame: 12 weeks
Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150 mg | Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis at Week 12 Measure: PASI 75 (Psoriasis Area and Severity Index) Response. | 69.5 Percentage of participants |
| AIN457 300 mg | Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis at Week 12 Measure: PASI 75 (Psoriasis Area and Severity Index) Response. | 75.9 Percentage of participants |
| Placebo | Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis at Week 12 Measure: PASI 75 (Psoriasis Area and Severity Index) Response. | 0 Percentage of participants |
p-value: <0.0001Fisher Exact
p-value: <0.0001Fisher Exact
Primary
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) With a 0 or 1 Response at Week 12
The IGA scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit. IGA has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe
Time frame: 12 weeks
Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150 mg | Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) With a 0 or 1 Response at Week 12 | 52.5 Percentage of Participants |
| AIN457 300 mg | Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) With a 0 or 1 Response at Week 12 | 69 Percentage of Participants |
| Placebo | Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) With a 0 or 1 Response at Week 12 | 0 Percentage of Participants |
p-value: <0.0001Fisher Exact
p-value: <0.0001Fisher 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 172
Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AIN457 150 mg | Absolute Change From Baseline for PASI Score After Week 52, (Observed Data) | -18 Units on a scale | Standard Deviation 6.97 |
| AIN457 300 mg | Absolute Change From Baseline for PASI Score After Week 52, (Observed Data) | -18.7 Units on a scale | Standard Deviation 8.36 |
| Placebo | Absolute Change From Baseline for PASI Score After Week 52, (Observed Data) | -14.7 Units on a scale | Standard Deviation 5.97 |
| Placebo-AIN457 300mg | Absolute Change From Baseline for PASI Score After Week 52, (Observed Data) | -19.4 Units on a scale | Standard Deviation 9.02 |
Secondary
Absolute Change From Baseline for PASI Score at Week 12, (Induction)
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 12
Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AIN457 150 mg | Absolute Change From Baseline for PASI Score at Week 12, (Induction) | -16.33 Units on a scale | Standard Deviation 8.49 |
| AIN457 300 mg | Absolute Change From Baseline for PASI Score at Week 12, (Induction) | -17.90 Units on a scale | Standard Deviation 8.74 |
| Placebo | Absolute Change From Baseline for PASI Score at Week 12, (Induction) | 0.50 Units on a scale | Standard Deviation 7.22 |
Secondary
Absolute Change From Baseline for PASI Score Over Time up to Week 52, (Maintenance; 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 52
Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AIN457 150 mg | Absolute Change From Baseline for PASI Score Over Time up to Week 52, (Maintenance; Observed Data) | -16.9 Units on a scale | Standard Deviation 8.27 |
| AIN457 300 mg | Absolute Change From Baseline for PASI Score Over Time up to Week 52, (Maintenance; Observed Data) | -18.7 Units on a scale | Standard Deviation 8.48 |
| Placebo | Absolute Change From Baseline for PASI Score Over Time up to Week 52, (Maintenance; Observed Data) | -15.2 Units on a scale | Standard Deviation 5.38 |
| Placebo-AIN457 300mg | Absolute Change From Baseline for PASI Score Over Time up to Week 52, (Maintenance; Observed Data) | -20 Units on a scale | Standard Deviation 7.96 |
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. 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: 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 | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 150 mg | Absolute Change From Baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | Self confidence | 1.10 Score | Standard Deviation 2.331 |
| AIN457 150 mg | Absolute Change From Baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | Feelings about injections | 1.07 Score | Standard Deviation 1.912 |
| AIN457 150 mg | Absolute Change From Baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | Satisfaction with self-injection | 1.64 Score | Standard Deviation 2.163 |
| AIN457 300 mg | Absolute Change From Baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | Self confidence | 1.08 Score | Standard Deviation 2.197 |
| AIN457 300 mg | Absolute Change From Baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | Feelings about injections | 0.85 Score | Standard Deviation 1.685 |
| AIN457 300 mg | Absolute Change From Baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | Satisfaction with self-injection | 1.62 Score | Standard Deviation 2.667 |
| Placebo | Absolute Change From Baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | Feelings about injections | 0.57 Score | Standard Deviation 1.509 |
| Placebo | Absolute Change From Baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | Satisfaction with self-injection | 1.32 Score | Standard Deviation 2.629 |
| Placebo | Absolute Change From Baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | Self confidence | 1.26 Score | Standard Deviation 2.009 |
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. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Time frame: Baseline, week 48
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 | 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 | 0.93 Score | Standard Deviation 1.752 |
| AIN457 150 mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Satisfaction, self-injection | 1.92 Score | Standard Deviation 2.239 |
| AIN457 150 mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Self-confidence | 1.63 Score | Standard Deviation 3.173 |
| AIN457 300 mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Feelings about injections | 1.01 Score | Standard Deviation 2.103 |
| AIN457 300 mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Satisfaction, self-injection | 2.15 Score | Standard Deviation 2.673 |
| AIN457 300 mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Self-confidence | 1.24 Score | Standard Deviation 2.4 |
| Placebo | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Self-confidence | 0.97 Score | Standard Deviation 1.811 |
| Placebo | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Feelings about injections | 0.63 Score | Standard Deviation 1.449 |
| Placebo | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Satisfaction, self-injection | 1.90 Score | Standard Deviation 3.25 |
| Placebo-AIN457 300mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Feelings about injections | 0.76 Score | Standard Deviation 1.321 |
| Placebo-AIN457 300mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Satisfaction, self-injection | 0.54 Score | Standard Deviation 1.84 |
| Placebo-AIN457 300mg | Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 | Self-confidence | 0.94 Score | Standard Deviation 1.521 |
Secondary
Change From Baseline in EQ-5D at Week 12 (Induction)
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) - All patients to whom study treatment was assigned
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AIN457 150 mg | Change From Baseline in EQ-5D at Week 12 (Induction) | 12.1 Units on a scale | Standard Deviation 24.03 |
| AIN457 300 mg | Change From Baseline in EQ-5D at Week 12 (Induction) | 11.2 Units on a scale | Standard Deviation 18.02 |
| Placebo | Change From Baseline in EQ-5D at Week 12 (Induction) | 0.8 Units on a scale | Standard Deviation 16.12 |
Secondary
Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Over Time up to Week 52, (Maintenance)
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) - All patients to whom study treatment was assigned
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AIN457 150 mg | Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Over Time up to Week 52, (Maintenance) | 11.4 Units on a scale | Standard Deviation 24.79 |
| AIN457 300 mg | Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Over Time up to Week 52, (Maintenance) | 13.5 Units on a scale | Standard Deviation 15.69 |
| Placebo | Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Over Time up to Week 52, (Maintenance) | 12.2 Units on a scale | Standard Deviation 15.05 |
| Placebo-AIN457 300mg | Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Over Time up to Week 52, (Maintenance) | 19.7 Units on a scale | Standard Deviation 17.16 |
Secondary
Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Score 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. This result was reflected in the percentage change from baseline at Week 12, higher reductions (improvements) in DLQI scores (median treatment difference).
Time frame: Baseline and week 52
Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AIN457 150 mg | Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52, (Maintenance) | -71.4 Percent change |
| AIN457 300 mg | Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52, (Maintenance) | -90.5 Percent change |
| Placebo | Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52, (Maintenance) | -91.7 Percent change |
| Placebo-AIN457 300mg | Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52, (Maintenance) | -97.2 Percent change |
Secondary
Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score, (Induction)
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. This result was reflected in the percentage change from baseline at Week 12, higher reductions (improvements) in DLQI scores (median treatment difference).
Time frame: Baseline and week 12
Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AIN457 150 mg | Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score, (Induction) | -78.6 Percent change |
| AIN457 300 mg | Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score, (Induction) | -85.0 Percent change |
| Placebo | Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score, (Induction) | -16.7 Percent change |
Secondary
Number of Participants Developing Treatment Emergent Anti-secukinumab Antibodies, Immunogenicity
The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to 8 weeks after last treatment
Time frame: Baseline and at Week 12, 24, 52, 100, 148, and 196, 204
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150 mg | Number of Participants Developing Treatment Emergent Anti-secukinumab Antibodies, Immunogenicity | 3 Number of participants |
| AIN457 300 mg | Number of Participants Developing Treatment Emergent Anti-secukinumab Antibodies, Immunogenicity | 0 Number of participants |
| Placebo | Number of Participants Developing Treatment Emergent Anti-secukinumab Antibodies, Immunogenicity | 0 Number of participants |
| Placebo-AIN457 300mg | Number of Participants Developing Treatment Emergent Anti-secukinumab Antibodies, Immunogenicity | 0 Number of participants |
| Placebo | Number of Participants Developing Treatment Emergent Anti-secukinumab Antibodies, Immunogenicity | 0 Number of participants |
Secondary
Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data)
The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe. The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe
Time frame: Week 172
Population: Full analysis set (FAS) - All patients to whom study treatment was assigned. Results after Week 172 and beyond cannot be interpreted meaningfully due to low number of evaluable patients at these visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg | Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Moderate | 1 Number of participants |
| AIN457 150 mg | Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Almost clear | 3 Number of participants |
| AIN457 150 mg | Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Severe | 0 Number of participants |
| AIN457 150 mg | Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Mild | 16 Number of participants |
| AIN457 150 mg | Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Clear | 7 Number of participants |
| AIN457 300 mg | Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Mild | 6 Number of participants |
| AIN457 300 mg | Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Moderate | 7 Number of participants |
| AIN457 300 mg | Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Severe | 0 Number of participants |
| AIN457 300 mg | Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Almost clear | 4 Number of participants |
| AIN457 300 mg | Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Clear | 15 Number of participants |
| Placebo | Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Mild | 3 Number of participants |
| Placebo | Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Clear | 7 Number of participants |
| Placebo | Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Almost clear | 1 Number of participants |
| Placebo | Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Moderate | 1 Number of participants |
| Placebo | Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Severe | 1 Number of participants |
| Placebo-AIN457 300mg | Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Moderate | 4 Number of participants |
| Placebo-AIN457 300mg | Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Almost clear | 2 Number of participants |
| Placebo-AIN457 300mg | Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Clear | 7 Number of participants |
| Placebo-AIN457 300mg | Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Mild | 6 Number of participants |
| Placebo-AIN457 300mg | Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) | Severe | 0 Number of participants |
Secondary
Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction)
The IGA mod 2011 category 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 | Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction) | moderate | 14 Number of participants |
| AIN457 150 mg | Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction) | mild | 12 Number of participants |
| AIN457 150 mg | Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction) | clear | 6 Number of participants |
| AIN457 150 mg | Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction) | almost clear | 26 Number of participants |
| AIN457 150 mg | Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction) | severe | 1 Number of participants |
| AIN457 300 mg | Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction) | mild | 9 Number of participants |
| AIN457 300 mg | Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction) | clear | 26 Number of participants |
| AIN457 300 mg | Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction) | almost clear | 17 Number of participants |
| AIN457 300 mg | Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction) | moderate | 5 Number of participants |
| AIN457 300 mg | Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction) | severe | 1 Number of participants |
| Placebo | Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction) | severe | 24 Number of participants |
| Placebo | Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction) | moderate | 34 Number of participants |
| Placebo | Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction) | clear | 0 Number of participants |
| Placebo | Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction) | mild | 1 Number of participants |
| Placebo | Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction) | almost clear | 0 Number of participants |
Secondary
Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After 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.
Time frame: Week 172
Population: Full analysis set (FAS) - All patients to whom study treatment was assigned. Results after Week 172 and beyond cannot be interpreted meaningfully due to low number of evaluable patients at these visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg | Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52 | Week 172 PASI 75 | 26 Number of participants |
| AIN457 150 mg | Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52 | Week 172 PASI 50 | 27 Number of participants |
| AIN457 150 mg | Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52 | Week 172 PASI 90 | 14 Number of participants |
| AIN457 150 mg | Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52 | Week 172 PASI 100 | 6 Number of participants |
| AIN457 300 mg | Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52 | Week 172 PASI 50 | 32 Number of participants |
| AIN457 300 mg | Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52 | Week 172 PASI 90 | 21 Number of participants |
| AIN457 300 mg | Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52 | Week 172 PASI 100 | 16 Number of participants |
| AIN457 300 mg | Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52 | Week 172 PASI 75 | 25 Number of participants |
| Placebo | Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52 | Week 172 PASI 90 | 9 Number of participants |
| Placebo | Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52 | Week 172 PASI 50 | 12 Number of participants |
| Placebo | Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52 | Week 172 PASI 100 | 6 Number of participants |
| Placebo | Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52 | Week 172 PASI 75 | 9 Number of participants |
| Placebo-AIN457 300mg | Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52 | Week 172 PASI 100 | 7 Number of participants |
| Placebo-AIN457 300mg | Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52 | Week 172 PASI 50 | 18 Number of participants |
| Placebo-AIN457 300mg | Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52 | Week 172 PASI 75 | 17 Number of participants |
| Placebo-AIN457 300mg | Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52 | Week 172 PASI 90 | 11 Number of participants |
Secondary
Number of Subjects With Potential Use Related Hazards at Week 1
To assess potential use-related hazards with the secukinumab PFS for the subject
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 | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg | Number of Subjects With Potential Use Related Hazards at Week 1 | Needle stick in a critical area | 0 Number of participants |
| AIN457 150 mg | Number of Subjects With Potential Use Related Hazards at Week 1 | Any part of the device swallowed | 0 Number of participants |
| AIN457 150 mg | Number of Subjects With Potential Use Related Hazards at Week 1 | Allergic reaction to device material | 0 Number of participants |
| AIN457 150 mg | Number of Subjects With Potential Use Related Hazards at Week 1 | Less than full dose administered | 1 Number of participants |
| AIN457 150 mg | Number of Subjects With Potential Use Related Hazards at Week 1 | Any other problem | 1 Number of participants |
| AIN457 150 mg | Number of Subjects With Potential Use Related Hazards at Week 1 | Pain due to bent needle | 0 Number of participants |
| AIN457 150 mg | Number of Subjects With Potential Use Related Hazards at Week 1 | Swallowing of material debris observed | 0 Number of participants |
| AIN457 150 mg | Number of Subjects With Potential Use Related Hazards at Week 1 | Needle stick in non-critical area | 0 Number of participants |
| AIN457 150 mg | Number of Subjects With Potential Use Related Hazards at Week 1 | Any breakage of the device | 0 Number of participants |
| AIN457 300 mg | Number of Subjects With Potential Use Related Hazards at Week 1 | Any part of the device swallowed | 0 Number of participants |
| AIN457 300 mg | Number of Subjects With Potential Use Related Hazards at Week 1 | Needle stick in non-critical area | 0 Number of participants |
| AIN457 300 mg | Number of Subjects With Potential Use Related Hazards at Week 1 | Any other problem | 0 Number of participants |
| AIN457 300 mg | Number of Subjects With Potential Use Related Hazards at Week 1 | Less than full dose administered | 0 Number of participants |
| AIN457 300 mg | Number of Subjects With Potential Use Related Hazards at Week 1 | Any breakage of the device | 0 Number of participants |
| AIN457 300 mg | Number of Subjects With Potential Use Related Hazards at Week 1 | Needle stick in a critical area | 0 Number of participants |
| AIN457 300 mg | Number of Subjects With Potential Use Related Hazards at Week 1 | Allergic reaction to device material | 0 Number of participants |
| AIN457 300 mg | Number of Subjects With Potential Use Related Hazards at Week 1 | Swallowing of material debris observed | 0 Number of participants |
| AIN457 300 mg | Number of Subjects With Potential Use Related Hazards at Week 1 | Pain due to bent needle | 0 Number of participants |
| Placebo | Number of Subjects With Potential Use Related Hazards at Week 1 | Less than full dose administered | 0 Number of participants |
| Placebo | Number of Subjects With Potential Use Related Hazards at Week 1 | Needle stick in a critical area | 0 Number of participants |
| Placebo | Number of Subjects With Potential Use Related Hazards at Week 1 | Needle stick in non-critical area | 1 Number of participants |
| Placebo | Number of Subjects With Potential Use Related Hazards at Week 1 | Any part of the device swallowed | 0 Number of participants |
| Placebo | Number of Subjects With Potential Use Related Hazards at Week 1 | Allergic reaction to device material | 0 Number of participants |
| Placebo | Number of Subjects With Potential Use Related Hazards at Week 1 | Pain due to bent needle | 0 Number of participants |
| Placebo | Number of Subjects With Potential Use Related Hazards at Week 1 | Any breakage of the device | 0 Number of participants |
| Placebo | Number of Subjects With Potential Use Related Hazards at Week 1 | Swallowing of material debris observed | 0 Number of participants |
| Placebo | Number of Subjects With Potential Use Related Hazards at Week 1 | Any other problem | 0 Number of participants |
Secondary
Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12, (Induction)
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) - All patients to whom study treatment was assigned
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150 mg | Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12, (Induction) | 54.4 Percentage of participants |
| AIN457 300 mg | Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12, (Induction) | 54.7 Percentage of participants |
| Placebo | Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12, (Induction) | 7.4 Percentage of participants |
Secondary
Percentage 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 | Percentage of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52, (Maintenance) | 48.3 Percentage of participants |
| AIN457 300 mg | Percentage of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52, (Maintenance) | 62.5 Percentage of participants |
| Placebo | Percentage of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52, (Maintenance) | 62.1 Percentage of participants |
| Placebo-AIN457 300mg | Percentage of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52, (Maintenance) | 76.9 Percentage of participants |
Secondary
Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data)
The IGA mod 2011 category 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) - All patients to whom study treatment was assigned
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg | Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Mild | 18.4 Percentage of participants |
| AIN457 150 mg | Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Severe | 4.1 Percentage of participants |
| AIN457 150 mg | Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Clear | 36.7 Percentage of participants |
| AIN457 150 mg | Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Moderate | 26.5 Percentage of participants |
| AIN457 150 mg | Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Almost clear | 14.3 Percentage of participants |
| AIN457 300 mg | Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Mild | 19.2 Percentage of participants |
| AIN457 300 mg | Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Almost clear | 23.1 Percentage of participants |
| AIN457 300 mg | Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Severe | 0 Percentage of participants |
| AIN457 300 mg | Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Clear | 48.1 Percentage of participants |
| AIN457 300 mg | Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Moderate | 9.6 Percentage of participants |
| Placebo | Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Almost clear | 20 Percentage of participants |
| Placebo | Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Severe | 4 Percentage of participants |
| Placebo | Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Moderate | 20 Percentage of participants |
| Placebo | Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Mild | 4 Percentage of participants |
| Placebo | Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Clear | 52 Percentage of participants |
| Placebo-AIN457 300mg | Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Severe | 0 Percentage of participants |
| Placebo-AIN457 300mg | Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Clear | 44 Percentage of participants |
| Placebo-AIN457 300mg | Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Almost clear | 48 Percentage of participants |
| Placebo-AIN457 300mg | Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Mild | 4 Percentage of participants |
| Placebo-AIN457 300mg | Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) | Moderate | 4 Percentage of participants |
Secondary
Percentage 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 PFS
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 | Percentage of Subjects With Successful Self Administration of Study Drug at Week 1 | 100 Percentage of participants |
| AIN457 300 mg | Percentage of Subjects With Successful Self Administration of Study Drug at Week 1 | 100 Percentage of participants |
| Placebo | Percentage of Subjects With Successful Self Administration of Study Drug at Week 1 | 100 Percentage of participants |
Secondary
Percent of Responders With Investigator's Global Assessment (IGA) Mod 2011 Score of 0 or 1, (Maintenance; 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 52
Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150 mg | Percent of Responders With Investigator's Global Assessment (IGA) Mod 2011 Score of 0 or 1, (Maintenance; Observed Data) | 51 Percentage of participants |
| AIN457 300 mg | Percent of Responders With Investigator's Global Assessment (IGA) Mod 2011 Score of 0 or 1, (Maintenance; Observed Data) | 71.2 Percentage of participants |
| Placebo | Percent of Responders With Investigator's Global Assessment (IGA) Mod 2011 Score of 0 or 1, (Maintenance; Observed Data) | 72 Percentage of participants |
| Placebo-AIN457 300mg | Percent of Responders With Investigator's Global Assessment (IGA) Mod 2011 Score of 0 or 1, (Maintenance; Observed Data) | 92 Percentage of participants |
Secondary
Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Induction) With Non-responder Imputation
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.
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 | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Induction) With Non-responder Imputation | Week 12 PASI 90 | 45.8 Percentage of participants |
| AIN457 150 mg | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Induction) With Non-responder Imputation | Week 12 PASI 50 | 86.4 Percentage of participants |
| AIN457 150 mg | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Induction) With Non-responder Imputation | Week 12 PASI 100 | 8.5 Percentage of participants |
| AIN457 300 mg | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Induction) With Non-responder Imputation | Week 12 PASI 90 | 60.3 Percentage of participants |
| AIN457 300 mg | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Induction) With Non-responder Imputation | Week 12 PASI 50 | 87.9 Percentage of participants |
| AIN457 300 mg | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Induction) With Non-responder Imputation | Week 12 PASI 100 | 43.1 Percentage of participants |
| Placebo | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Induction) With Non-responder Imputation | Week 12 PASI 50 | 5.1 Percentage of participants |
| Placebo | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Induction) With Non-responder Imputation | Week 12 PASI 100 | 0 Percentage of participants |
| Placebo | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Induction) With Non-responder Imputation | Week 12 PASI 90 | 0 Percentage of participants |
Secondary
Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; 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.
Time frame: Week 52
Population: Full analysis set (FAS) - All patients to whom study treatment was assigned
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data) | Week 52 PASI 75 | 71.4 Percentage of participants |
| AIN457 150 mg | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data) | Week 52 PASI 50 | 89.8 Percentage of participants |
| AIN457 150 mg | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data) | Week 52 PASI 90 | 59.2 Percentage of participants |
| AIN457 150 mg | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data) | Week 52 PASI 100 | 36.7 Percentage of participants |
| AIN457 300 mg | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data) | Week 52 PASI 50 | 96.2 Percentage of participants |
| AIN457 300 mg | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data) | Week 52 PASI 90 | 69.2 Percentage of participants |
| AIN457 300 mg | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data) | Week 52 PASI 100 | 48.1 Percentage of participants |
| AIN457 300 mg | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data) | Week 52 PASI 75 | 84.6 Percentage of participants |
| Placebo | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data) | Week 52 PASI 90 | 64.0 Percentage of participants |
| Placebo | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data) | Week 52 PASI 50 | 84.0 Percentage of participants |
| Placebo | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data) | Week 52 PASI 100 | 52.0 Percentage of participants |
| Placebo | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data) | Week 52 PASI 75 | 72.0 Percentage of participants |
| Placebo-AIN457 300mg | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data) | Week 52 PASI 100 | 44.0 Percentage of participants |
| Placebo-AIN457 300mg | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data) | Week 52 PASI 50 | 100.0 Percentage of participants |
| Placebo-AIN457 300mg | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data) | Week 52 PASI 75 | 96.0 Percentage of participants |
| Placebo-AIN457 300mg | Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data) | Week 52 PASI 90 | 76.0 Percentage of participants |