Psoriasis
Conditions
Keywords
Chronic plaque psoriasis
Brief summary
This study was designed to prove and quantify the hypothesis that secukinumab is effective, safe and well tolerated in the treatment of moderate to severe chronic plaque-type psoriasis in patients who are inadequate responders to anti-TNFα therapy in a United Kingdom (UK) and Republic of Ireland) specific population.
Detailed description
There is no clear evidence or guidelines on appropriate treatment once a patient with moderate/severe psoriasis has failed to respond to anti-TNFα therapy, whether a single anti-TNFα therapy failure or multiple anti-TNFα therapy failures. Numerous double-blind, double-dummy, randomised, parallel-group, active and placebo controlled studies have already been designed and run for the Phase III secukinumab clinical development program, in accordance with Health Authorities guidelines and feedback, including Food and Drug Administration (FDA) and European Medicines Agency (EMA). None of these specifically studied patients who have failed to respond to anti-TNFα therapy as defined by National Institute for Health and Care Excellence (NICE) guidelines. Therefore, this study utilises a pragmatic, open-label, non-comparator design, which has been shown to be appropriate in similar studies looking at anti-TNFα therapy in patients failing on other therapies (Papp et al. 2012; Strober et al. 2011), to answer the question of whether secukinumab is an appropriate choice in patients who have failed to respond to anti-TNFα therapy (TNF-IR) per NICE definitions, whether a single anti-TNFα therapy failure or multiple anti-TNFα therapy failures.
Interventions
BIOLOGICALSecukinumab (AIN457)
Secukinumab was supplied in 150mg pre-filled syringes.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent must be obtained before any assessment is performed 2. Aged at least 18 years at screening 3. Chronic plaque-type psoriasis diagnosed for at least 6 months prior to screening 4. Moderate to severe disease severity: * PASI ≥10 and * DLQI \>10 5. Failed to respond to systemic therapies including cyclosporine and/or methotrexate and/or PUVA (or is intolerant and/or has a contraindication to these) 6. Previously treated with at least one anti-TNFα for moderate or severe psoriasis but is a primary or secondary non-responder 7. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Key
Exclusion criteria
1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) 2. Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) 3. Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids (CS), UV therapy). Washout periods detailed in the protocol must be adhered to. 4. Ongoing use of other non-psoriasis prohibited treatments. Washout periods detailed in the protocol have to be adhered to. All other prior non-psoriasis concomitant treatments must be on a stable dose for at least four weeks before initiation of study drug. 5. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor 6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/mL) 7. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they use 2 (two) effective forms of contraception during the study and for 16 weeks after stopping treatment. 8. Men with a female partner of child bearing potential defined as all women physiologically capable of becoming pregnant unless they use 1 (one) effective form of contraception during the study and for 16 weeks after stopping treatment. 9. Active systemic infections during the last two weeks (exception: common cold) prior to initiation of study drug and any infections that reoccur on a regular basis; investigator discretion should be used regarding patients who have travelled or recently resided in areas of endemic mycoses, such as histoplasmosis, coccidioidomycosis or blastomycosis and for patients with underlying conditions that may predispose them to infection, such as advanced or poorly controlled diabetes 10. History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold test (QFT) at screening. Patients with a positive QFT test may participate in the study if further work up establishes conclusively that the patient has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to UK guidelines. 11. Known infection with HIV, hepatitis B or hepatitis C at screening or at initiation of study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Secukinumab 300 mg Participants Achieving PASI 75 at 16 Weeks | 16 weeks | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving PASI 75 According to 3 Key Participant Subgroups (Primary Inadequate Response (IR), Secondary IR and IR After More Than One Anti-TNFalpha Therapies) at 16 Weeks | 16 Weeks | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. |
| Percentage of Participants Achieiving PASI 75 - Initiation Period | 2 ,4, 8, 12 and 16 Weeks | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. |
| Percentage of Participants Achieiving PASI 75 - Maintenance 1 Period | 16, 24 and 48 Weeks | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. |
| Percentage of Participants Achieiving PASI 75 - Maintenance 2 Period | 48 and 72 Weeks | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. |
| Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | 2, 4, 8, 12, 16 Weeks | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively. |
| Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | 16, 24 and 48 Weeks | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively. |
| Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period | 48 and 72 Weeks | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively. |
| Percentage of Secukinumab 150 mg Participants Achieving PASI 75 at 16 Weeks | 16 Weeks | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. |
| Percentage of Participants Achieving NICE Continuation Criteria (PASI 75 or PASI 50 Plus a 5 Point Improvement in DLQI) at 16 Weeks | 16 Weeks | PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. |
| Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Scores - Initiation Period | Baseline, week 12, and week 16 | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change from baseline indicates improvement. |
| Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 1 Period | Baseline, 16, 24 and 48 weeks | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change from baseline indicates improvement. |
| Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 2 Period | Baseline, 48 and 72 weeks | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change from baseline indicates improvement. |
| Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Initiation Period | Baseline, 12 and 16 weeks | The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. |
| Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 1 Period | Baseline, 16, 24 and 48 weeks | The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. |
| Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 2 Period | Baseline, 48 and 72 weeks | The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. |
| Percentage of Participants Who Have Failed on One Anti-TNFα Achieving PASI 75 (Subgroups 1 and 2 Combined) at 16 Weeks | 16 Weeks | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. |
Countries
Ireland, United Kingdom
Participant flow
Recruitment details
This study consisted of 3 periods: initiation, maintenance 1 and maintenance 2. During the initiation period, participants received secukinumab 150 mg or 300 mg for 16 weeks.
Pre-assignment details
For both maintenance periods 1 and 2, after 16 weeks and 48 weeks, respectively, responders at both the 150 mg and 300 mg doses continued on their initiation doses during maintenance periods 1 and 2. Non-responders at 150 mg were uptitrated to 300 mg. Non-responders at 300 mg returned to routine treatment under the care of their usual clinician.
Participants by arm
| Arm | Count |
|---|---|
| Secukinumab (AIN457) 300 mg Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 & 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. | 119 |
| Secukinumab (AIN457) 150 mg Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician. | 116 |
| Total | 235 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Initiation | Abnormal lab values | 0 | 1 | 0 | 0 |
| Initiation | Administrative problems | 1 | 0 | 0 | 0 |
| Initiation | Adverse Event | 3 | 5 | 0 | 0 |
| Initiation | Death | 0 | 1 | 0 | 0 |
| Initiation | Lack of Efficacy | 2 | 1 | 0 | 0 |
| Initiation | Missing | 3 | 2 | 0 | 0 |
| Initiation | Protocol deviation | 1 | 0 | 0 | 0 |
| Initiation | Randomized but not treated | 1 | 1 | 0 | 0 |
| Initiation | Withdrawal by Subject | 1 | 2 | 0 | 0 |
| Maintanence 2 (Weeks 49 - 72) | Adverse Event | 1 | 0 | 0 | 2 |
| Maintanence 2 (Weeks 49 - 72) | Lack of Efficacy | 3 | 0 | 3 | 1 |
| Maintanence 2 (Weeks 49 - 72) | Lost to Follow-up | 1 | 0 | 0 | 0 |
| Maintanence 2 (Weeks 49 - 72) | Protocol deviation | 0 | 0 | 1 | 0 |
| Maintanence 2 (Weeks 49 - 72) | Reason for discontinuation is missing | 7 | 5 | 0 | 4 |
| Maintanence 2 (Weeks 49 - 72) | Withdrawal by Subject | 0 | 1 | 0 | 0 |
| Maintenance 1 (Weeks 17 - 48) | Abnormal laboratory value | 0 | 0 | 1 | 0 |
| Maintenance 1 (Weeks 17 - 48) | Adverse Event | 6 | 6 | 3 | 0 |
| Maintenance 1 (Weeks 17 - 48) | Lack of Efficacy | 13 | 4 | 10 | 0 |
| Maintenance 1 (Weeks 17 - 48) | Protocol deviation | 3 | 0 | 1 | 0 |
| Maintenance 1 (Weeks 17 - 48) | Reason for discontinuation is missing | 1 | 0 | 3 | 0 |
| Maintenance 1 (Weeks 17 - 48) | Withdrawal by Subject | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Secukinumab (AIN457) 300 mg | Secukinumab (AIN457) 150 mg | Total |
|---|---|---|---|
| Age, Continuous | 46.6 Years STANDARD_DEVIATION 11.63 | 44.6 Years STANDARD_DEVIATION 11.73 | 45.6 Years STANDARD_DEVIATION 11.7 |
| Sex: Female, Male Female | 51 Participants | 52 Participants | 103 Participants |
| Sex: Female, Male Male | 68 Participants | 64 Participants | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 88 / 115 | 152 / 179 |
| serious Total, serious adverse events | 14 / 115 | 24 / 179 |
Outcome results
Primary
Percentage of Secukinumab 300 mg Participants Achieving PASI 75 at 16 Weeks
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline.
Time frame: 16 weeks
Population: The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secukinumab (AIN457) 300 mg | Percentage of Secukinumab 300 mg Participants Achieving PASI 75 at 16 Weeks | 65.3 Percentage of participants |
p-value: <0.000199.375% CI: [52.4, 76.7]two-sided binomial exact test
Secondary
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Scores - Initiation Period
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change from baseline indicates improvement.
Time frame: Baseline, week 12, and week 16
Population: The full analysis set was considered for the analysis. Only participants who had both baseline and post baseline measurements for a given time point were analyzed for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab (AIN457) 300 mg | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Scores - Initiation Period | Week 12, initiation | -15.6 score on a scale | Standard Deviation 7.49 |
| Secukinumab (AIN457) 300 mg | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Scores - Initiation Period | Week 16, initiation | -16.1 score on a scale | Standard Deviation 6.8 |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Scores - Initiation Period | Week 12, initiation | -13.2 score on a scale | Standard Deviation 7.36 |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Scores - Initiation Period | Week 16, initiation | -12.3 score on a scale | Standard Deviation 7.68 |
Secondary
Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 1 Period
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change from baseline indicates improvement.
Time frame: Baseline, 16, 24 and 48 weeks
Population: The full analysis set was considered for the analysis. Only participants who had both baseline and post baseline measurements for a given time point were analyzed for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab (AIN457) 300 mg | Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 1 Period | Week 24, maintenance 1 | -15.7 score on a scale | Standard Deviation 7.25 |
| Secukinumab (AIN457) 300 mg | Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 1 Period | Week 16, maintenance 1 | -16.3 score on a scale | Standard Deviation 6.67 |
| Secukinumab (AIN457) 300 mg | Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 1 Period | Week 48, maintenance 1 | -16.2 score on a scale | Standard Deviation 8.06 |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 1 Period | Week 24, maintenance 1 | -14.4 score on a scale | Standard Deviation 6.73 |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 1 Period | Week 16, maintenance 1 | -15.9 score on a scale | Standard Deviation 6.31 |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 1 Period | Week 48, maintenance 1 | -11.5 score on a scale | Standard Deviation 8.14 |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 1 Period | Week 16, maintenance 1 | -6.1 score on a scale | Standard Deviation 5.86 |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 1 Period | Week 48, maintenance 1 | -9.8 score on a scale | Standard Deviation 6.76 |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 1 Period | Week 24, maintenance 1 | -8.7 score on a scale | Standard Deviation 6.01 |
Secondary
Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 2 Period
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change from baseline indicates improvement.
Time frame: Baseline, 48 and 72 weeks
Population: The full analysis set was considered for the analysis. Only participants who had both baseline and post baseline measurements for a given time point were analyzed for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab (AIN457) 300 mg | Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 2 Period | Week 48, maintenance 2 | -17.2 score on a scale | Standard Deviation 7.33 |
| Secukinumab (AIN457) 300 mg | Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 2 Period | Week 72, maintenance 2 | -17.0 score on a scale | Standard Deviation 7.27 |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 2 Period | Week 72, maintenance 2 | -13.0 score on a scale | Standard Deviation 5.62 |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 2 Period | Week 48, maintenance 2 | -14.7 score on a scale | Standard Deviation 6.19 |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 2 Period | Week 48, maintenance 2 | -11.5 score on a scale | Standard Deviation 5.98 |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 2 Period | Week 72, maintenance 2 | -11.3 score on a scale | Standard Deviation 4.77 |
| Secukinumab (AIN457) 150 mg Subgroup 1 | Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 2 Period | Week 48, maintenance 2 | -7.7 score on a scale | Standard Deviation 8.8 |
| Secukinumab (AIN457) 150 mg Subgroup 1 | Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 2 Period | Week 72, maintenance 2 | -15.0 score on a scale | Standard Deviation 8.76 |
Secondary
Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Initiation Period
The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score.
Time frame: Baseline, 12 and 16 weeks
Population: The full analysis set was considered for the analysis. Only participants with measurements at each given time point were analyzed for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab (AIN457) 300 mg | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Initiation Period | Week 12, initiation | 76.25 percent change | Standard Deviation 18.612 |
| Secukinumab (AIN457) 300 mg | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Initiation Period | Week 16, initiation | 76.30 percent change | Standard Deviation 21.58 |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Initiation Period | Week 12, initiation | 72.92 percent change | Standard Deviation 20.004 |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Initiation Period | Week 16, initiation | 75.25 percent change | Standard Deviation 19.1 |
Secondary
Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 1 Period
The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score.
Time frame: Baseline, 16, 24 and 48 weeks
Population: The full analysis set was considered for the analysis. Only participants with measurements at each given time point were analyzed for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab (AIN457) 300 mg | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 1 Period | Week 24, maintenance 1 | 79.16 percent change | Standard Deviation 18.587 |
| Secukinumab (AIN457) 300 mg | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 1 Period | Week 16, maintenance 1 | 77.33 percent change | Standard Deviation 20.665 |
| Secukinumab (AIN457) 300 mg | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 1 Period | Week 48, maintenance 1 | 77.73 percent change | Standard Deviation 21.598 |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 1 Period | Week 24, maintenance 1 | 80.05 percent change | Standard Deviation 16.345 |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 1 Period | Week 16, maintenance 1 | 80.48 percent change | Standard Deviation 16.099 |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 1 Period | Week 48, maintenance 1 | 76.07 percent change | Standard Deviation 20.413 |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 1 Period | Week 16, maintenance 1 | 67.03 percent change | Standard Deviation 20.657 |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 1 Period | Week 48, maintenance 1 | 70.37 percent change | Standard Deviation 18.038 |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 1 Period | Week 24, maintenance 1 | 69.14 percent change | Standard Deviation 19.587 |
Secondary
Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 2 Period
The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score.
Time frame: Baseline, 48 and 72 weeks
Population: The full analysis set was considered for the analysis. Only participants with measurements at each given time point were analyzed for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab (AIN457) 300 mg | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 2 Period | Week 48, maintenance 2 (n=79,30,16,24) | 80.22 percent change | Standard Deviation 19.2 |
| Secukinumab (AIN457) 300 mg | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 2 Period | Week 72, maintenance 2 (n=73,26,12,21) | 78.24 percent change | Standard Deviation 19.792 |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 2 Period | Week 72, maintenance 2 (n=73,26,12,21) | 80.88 percent change | Standard Deviation 17.635 |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 2 Period | Week 48, maintenance 2 (n=79,30,16,24) | 83.87 percent change | Standard Deviation 11.337 |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 2 Period | Week 48, maintenance 2 (n=79,30,16,24) | 74.50 percent change | Standard Deviation 14.855 |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 2 Period | Week 72, maintenance 2 (n=73,26,12,21) | 77.67 percent change | Standard Deviation 16.615 |
| Secukinumab (AIN457) 150 mg Subgroup 1 | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 2 Period | Week 48, maintenance 2 (n=79,30,16,24) | 67.63 percent change | Standard Deviation 24.912 |
| Secukinumab (AIN457) 150 mg Subgroup 1 | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 2 Period | Week 72, maintenance 2 (n=73,26,12,21) | 79.67 percent change | Standard Deviation 18.68 |
Secondary
Percentage of Participants Achieiving PASI 75 - Initiation 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 75 is defined as participants achieving ≥ 75% improvement from baseline.
Time frame: 2 ,4, 8, 12 and 16 Weeks
Population: The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieiving PASI 75 - Initiation Period | Week 8 | 60.2 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieiving PASI 75 - Initiation Period | Week 12 | 61.9 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieiving PASI 75 - Initiation Period | Week 16 | 65.3 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieiving PASI 75 - Initiation Period | Week 2 | 1.7 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieiving PASI 75 - Initiation Period | Week 4 | 27.1 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieiving PASI 75 - Initiation Period | Week 4 | 18.3 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieiving PASI 75 - Initiation Period | Week 2 | 2.6 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieiving PASI 75 - Initiation Period | Week 12 | 52.2 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieiving PASI 75 - Initiation Period | Week 8 | 40.0 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieiving PASI 75 - Initiation Period | Week 16 | 44.3 Percentage of participants |
Secondary
Percentage of Participants Achieiving PASI 75 - Maintenance 1 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 75 is defined as participants achieving ≥ 75% improvement from baseline.
Time frame: 16, 24 and 48 Weeks
Population: The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieiving PASI 75 - Maintenance 1 Period | Week 48 | 52.3 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieiving PASI 75 - Maintenance 1 Period | Week 24 | 61.7 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieiving PASI 75 - Maintenance 1 Period | Week 16 | 72.0 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieiving PASI 75 - Maintenance 1 Period | Week 24 | 68.2 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieiving PASI 75 - Maintenance 1 Period | Week 16 | 75.8 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieiving PASI 75 - Maintenance 1 Period | Week 48 | 39.4 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Percentage of Participants Achieiving PASI 75 - Maintenance 1 Period | Week 16 | 2.7 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Percentage of Participants Achieiving PASI 75 - Maintenance 1 Period | Week 48 | 8.1 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Percentage of Participants Achieiving PASI 75 - Maintenance 1 Period | Week 24 | 13.5 Percentage of participants |
Secondary
Percentage of Participants Achieiving PASI 75 - Maintenance 2 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 75 is defined as participants achieving ≥ 75% improvement from baseline.
Time frame: 48 and 72 Weeks
Population: The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieiving PASI 75 - Maintenance 2 Period | Week 48 | 65.1 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieiving PASI 75 - Maintenance 2 Period | Week 72 | 65.1 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieiving PASI 75 - Maintenance 2 Period | Week 72 | 58.1 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieiving PASI 75 - Maintenance 2 Period | Week 48 | 80.6 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Percentage of Participants Achieiving PASI 75 - Maintenance 2 Period | Week 48 | 18.8 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Percentage of Participants Achieiving PASI 75 - Maintenance 2 Period | Week 72 | 25.0 Percentage of participants |
| Secukinumab (AIN457) 150 mg Subgroup 1 | Percentage of Participants Achieiving PASI 75 - Maintenance 2 Period | Week 48 | 4.2 Percentage of participants |
| Secukinumab (AIN457) 150 mg Subgroup 1 | Percentage of Participants Achieiving PASI 75 - Maintenance 2 Period | Week 72 | 37.5 Percentage of participants |
Secondary
Percentage of Participants Achieving NICE Continuation Criteria (PASI 75 or PASI 50 Plus a 5 Point Improvement in DLQI) at 16 Weeks
PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.
Time frame: 16 Weeks
Population: The full analysis set was analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving NICE Continuation Criteria (PASI 75 or PASI 50 Plus a 5 Point Improvement in DLQI) at 16 Weeks | 81.4 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving NICE Continuation Criteria (PASI 75 or PASI 50 Plus a 5 Point Improvement in DLQI) at 16 Weeks | 60.9 Percentage of participants |
Secondary
Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation 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 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively.
Time frame: 2, 4, 8, 12, 16 Weeks
Population: The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI 50, week 8 | 84.7 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI 50, week 2 | 28.0 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI 50, week 4 | 63.6 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI 50, week 12 | 82.2 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI 50, week 16 | 82.2 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI 90, week 2 | 0 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI 90, week 4 | 6.8 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI 90, week 8 | 25.4 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI 90, week 12 | 38.1 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI 90, week 16 | 41.5 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI 90, week 8 | 20.0 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI 90, week 2 | 0 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI 50, week 2 | 25.2 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI 90, week 16 | 20.0 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI 50, week 4 | 57.4 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI 50, week 8 | 67.8 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI 90, week 4 | 4.3 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI 50, week 12 | 69.6 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI 90, week 12 | 25.2 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI 50, week 16 | 65.2 Percentage of participants |
Secondary
Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 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 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively.
Time frame: 16, 24 and 48 Weeks
Population: The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | PASI 50, week 16 | 89.7 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | PASI 50, week 24 | 80.4 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | PASI 90, week 48 | 31.8 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | PASI 50, week 48 | 70.1 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | PASI 90, week 16 | 45.8 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | PASI 90, week 24 | 39.3 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | PASI 90, week 16 | 34.8 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | PASI 90, week 24 | 37.9 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | PASI 50, week 48 | 65.2 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | PASI 50, week 16 | 95.5 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | PASI 90, week 48 | 18.2 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | PASI 50, week 24 | 89.4 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | PASI 90, week 48 | 5.4 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | PASI 50, week 16 | 24.3 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | PASI 50, week 48 | 32.4 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | PASI 90, week 16 | 0 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | PASI 90, week 24 | 2.7 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | PASI 50, week 24 | 54.1 Percentage of participants |
Secondary
Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 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 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively.
Time frame: 48 and 72 Weeks
Population: The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period | PASI 50, week 48 | 88.0 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period | PASI 50, week 72 | 74.7 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period | PASI 90, week 48 | 41.0 Percentage of participants |
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period | PASI 90, week 72 | 38.6 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period | PASI 50, week 72 | 80.6 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period | PASI 90, week 48 | 38.7 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period | PASI 90, week 72 | 22.6 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period | PASI 50, week 48 | 96.8 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period | PASI 90, week 48 | 12.5 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period | PASI 50, week 72 | 37.5 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period | PASI 90, week 72 | 18.8 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period | PASI 50, week 48 | 75.0 Percentage of participants |
| Secukinumab (AIN457) 150 mg Subgroup 1 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period | PASI 90, week 72 | 16.7 Percentage of participants |
| Secukinumab (AIN457) 150 mg Subgroup 1 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period | PASI 50, week 72 | 70.8 Percentage of participants |
| Secukinumab (AIN457) 150 mg Subgroup 1 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period | PASI 50, week 48 | 50.0 Percentage of participants |
| Secukinumab (AIN457) 150 mg Subgroup 1 | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period | PASI 90, week 48 | 0 Percentage of participants |
Secondary
Percentage of Participants Achieving PASI 75 According to 3 Key Participant Subgroups (Primary Inadequate Response (IR), Secondary IR and IR After More Than One Anti-TNFalpha Therapies) at 16 Weeks
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline.
Time frame: 16 Weeks
Population: The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secukinumab (AIN457) 300 mg | Percentage of Participants Achieving PASI 75 According to 3 Key Participant Subgroups (Primary Inadequate Response (IR), Secondary IR and IR After More Than One Anti-TNFalpha Therapies) at 16 Weeks | 71.4 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Achieving PASI 75 According to 3 Key Participant Subgroups (Primary Inadequate Response (IR), Secondary IR and IR After More Than One Anti-TNFalpha Therapies) at 16 Weeks | 70.5 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 3 | Percentage of Participants Achieving PASI 75 According to 3 Key Participant Subgroups (Primary Inadequate Response (IR), Secondary IR and IR After More Than One Anti-TNFalpha Therapies) at 16 Weeks | 47.7 Percentage of participants |
| Secukinumab (AIN457) 150 mg Subgroup 1 | Percentage of Participants Achieving PASI 75 According to 3 Key Participant Subgroups (Primary Inadequate Response (IR), Secondary IR and IR After More Than One Anti-TNFalpha Therapies) at 16 Weeks | 38.9 Percentage of participants |
| Secukinumab (AIN457) 150 mg Subgroup 2 | Percentage of Participants Achieving PASI 75 According to 3 Key Participant Subgroups (Primary Inadequate Response (IR), Secondary IR and IR After More Than One Anti-TNFalpha Therapies) at 16 Weeks | 61.9 Percentage of participants |
| Secukinumab (AIN457) 150 mg Subgroup 3 | Percentage of Participants Achieving PASI 75 According to 3 Key Participant Subgroups (Primary Inadequate Response (IR), Secondary IR and IR After More Than One Anti-TNFalpha Therapies) at 16 Weeks | 32.4 Percentage of participants |
Secondary
Percentage of Participants Who Have Failed on One Anti-TNFα Achieving PASI 75 (Subgroups 1 and 2 Combined) at 16 Weeks
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline.
Time frame: 16 Weeks
Population: The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secukinumab (AIN457) 300 mg | Percentage of Participants Who Have Failed on One Anti-TNFα Achieving PASI 75 (Subgroups 1 and 2 Combined) at 16 Weeks | 70.7 Percentage of participants |
| Secukinumab (AIN457) 300 mg Subgroup 2 | Percentage of Participants Who Have Failed on One Anti-TNFα Achieving PASI 75 (Subgroups 1 and 2 Combined) at 16 Weeks | 55.0 Percentage of participants |
Secondary
Percentage of Secukinumab 150 mg Participants Achieving PASI 75 at 16 Weeks
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline.
Time frame: 16 Weeks
Population: The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secukinumab (AIN457) 300 mg | Percentage of Secukinumab 150 mg Participants Achieving PASI 75 at 16 Weeks | 44.3 Percentage of participants |