Psoriatic Arthritis
Conditions
Keywords
Psoriatic arthritis, AIN457, PsA, ACR, CASPAR, PASDAS, secukinumab, autoinjector
Brief summary
The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis factor alpha (TNFα) therapy.
Interventions
BIOLOGICALSecukinumab
Secukinumab 150 mg provided in a 1 mL autoinjector (1 autoinjector for 150 mg dose, 2 autoinjectors for 300 mg dose)
BIOLOGICALPlacebo
Secukinumab placebo provided in 1 mL autoinjector
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria. * Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative. * Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis. * Inadequate control of symptoms with NSAID.
Exclusion criteria
* Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process. * Subjects taking high potency opioid analgesics. * Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor. * Ongoing use of prohibited psoriasis treatments / medications. * Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα. * Previous treatment with any cell-depleting therapies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Achieving American College of Rheumatology 20 (ACR20) Response Criteria on Secukinumab Versus Placebo at Week 24 | Week 24 | A patient will be considered as improved according the ACR20 criteria if she/he has at least 20% decrease in the swollen and tender joint count, and at least 20% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant \[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing hsCRP) in Subjects Treated With Secukinumab Versus Placebo at Week 24 | Week 24 | DAS28-CRP is a measure of disease activity based on 28-Swollen and Tender Joint Count \[proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2)\], CRP, and the Patient's Global Assessment of disease activity. Values range from 2.0 to 10.0 where higher values mean a higher disease activity. DAS28-CRP \< 2.6 is interpreted as remission. |
| Proportion of Subjects Achieving a Psoriatic Area and Severity Index 75 (PASI75) Response in Subjects on Secukinumab Versus Placebo at Week 24 | Week 24 | PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI75 represents an improvement in the PASI score of at least 75% as compared with baseline. |
| Change From Baseline in Physical Function Component of the Short-form Health Survey (SF-36-PCS) in Subjects Treated With Secukinumab Versus Placebo at Week 24 | Week 24 | SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value. |
| Percentage of Subjects Achieving a Psoriatic Area and Severity Index 90 (PASI90) Response in Subjects Treated With Secukinumab Versus Placebo at Week 24 | Week 24 | PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI90 represents an improvement in the PASI score of at least 90% as compared with baseline. |
| Proportion of Patients Achieving American College of Rheumatology 50 (ACR50) Response Criteria on Secukinumab Versus Placebo at Week 24 | Week 24 | A patient will be considered as improved according the ACR50 criteria if she/he has at least 50% decreases in the swollen and tender joint count, and at least 50% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant \[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\] |
| Proportion of Patients With Dactylitis at Week 24 in the Subset of Patients Who Had Dactylitis at Baseline | Week 24 | The presence of dactylitis was assessed by dactylitis count (number of fingers and toes with dactylitis, with a range of 0-20). If dactylitis is present with any finger or toe, the patient is counted as a patient with dactylitis. |
| Proportion of Patients With Enthesitis at Week 24 in the Subset of Patients Who Had Enthesitis at Baseline | Week 24 | The presence of Enthesitis was assessed using a validated enthesitis index that uses 6 sites for evaluation of enthesitis: lateral epicondyle humerus L + R, proximal achilles L + R and medial condyle femur. If enthesitis is present at any of the 6 sites, the subject is counted as a subject with enthesitis. |
| Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC) | From first dose of study treatment to last study visit, up to 3 years | Analysis of frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC). |
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) in Subjects Treated With Secukinumab Versus Placebo at Week 24 | Week 24 | The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. In this trial, only the disability dimension was used. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Within each of the 8 categories, only the item indicating the most severe impairment contributes to the category score. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from baseline indicates improvement. |
Countries
Australia, Bulgaria, Canada, Czechia, Germany, Italy, Netherlands, Puerto Rico, Russia, Spain, Switzerland, United Kingdom, United States
Participant flow
Recruitment details
Patients were randomized to 1 of 3 treatment arms (1:1:1) and planned to be treated for 156 weeks. Placebo non-responders had the option to be re-randomized at Week 16 and placebo responders had the option to be re-randomized at Week 24. Thus, of the 137 original placebo patients 64 were re-randomized to AIN457 150 mg and 65 to AIN457 300 mg.
Pre-assignment details
A screening period (SCR) running up to 10 weeks before randomization was used to assess eligibility.
Participants by arm
| Arm | Count |
|---|---|
| AIN457 150 mg 1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4. | 138 |
| AIN457 300 mg 2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4. | 139 |
| Placebo Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4. | 137 |
| Total | 414 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 10 | 15 | 4 | 5 | 4 |
| Overall Study | Death | 3 | 0 | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 11 | 11 | 7 | 4 | 2 |
| Overall Study | Lost to Follow-up | 5 | 2 | 0 | 1 | 1 |
| Overall Study | Physician Decision | 4 | 1 | 0 | 1 | 0 |
| Overall Study | Pregnancy | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Subject Guardian Decision | 11 | 6 | 4 | 4 | 1 |
| Overall Study | Technical Problems | 3 | 1 | 3 | 1 | 0 |
Baseline characteristics
| Characteristic | AIN457 150 mg | AIN457 300 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 16 Participants | 19 Participants | 47 Participants |
| Age, Categorical Between 18 and 65 years | 126 Participants | 123 Participants | 118 Participants | 367 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 3 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 6 Participants | 0 Participants | 11 Participants |
| Race/Ethnicity, Customized White | 129 Participants | 130 Participants | 133 Participants | 392 Participants |
| Sex: Female, Male Female | 77 Participants | 72 Participants | 78 Participants | 227 Participants |
| Sex: Female, Male Male | 61 Participants | 67 Participants | 59 Participants | 187 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 202 | 0 / 284 | 4 / 406 | 0 / 137 |
| other Total, other adverse events | 153 / 202 | 201 / 284 | 320 / 406 | 65 / 137 |
| serious Total, serious adverse events | 42 / 202 | 35 / 284 | 76 / 406 | 9 / 137 |
Outcome results
Primary
Proportion of Patients Achieving American College of Rheumatology 20 (ACR20) Response Criteria on Secukinumab Versus Placebo at Week 24
A patient will be considered as improved according the ACR20 criteria if she/he has at least 20% decrease in the swollen and tender joint count, and at least 20% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant \[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\]
Time frame: Week 24
Population: The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AIN457 150 mg | Proportion of Patients Achieving American College of Rheumatology 20 (ACR20) Response Criteria on Secukinumab Versus Placebo at Week 24 | 58 Participants |
| AIN457 300 mg | Proportion of Patients Achieving American College of Rheumatology 20 (ACR20) Response Criteria on Secukinumab Versus Placebo at Week 24 | 67 Participants |
| Placebo | Proportion of Patients Achieving American College of Rheumatology 20 (ACR20) Response Criteria on Secukinumab Versus Placebo at Week 24 | 22 Participants |
Secondary
Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing hsCRP) in Subjects Treated With Secukinumab Versus Placebo at Week 24
DAS28-CRP is a measure of disease activity based on 28-Swollen and Tender Joint Count \[proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2)\], CRP, and the Patient's Global Assessment of disease activity. Values range from 2.0 to 10.0 where higher values mean a higher disease activity. DAS28-CRP \< 2.6 is interpreted as remission.
Time frame: Week 24
Population: The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AIN457 150 mg | Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing hsCRP) in Subjects Treated With Secukinumab Versus Placebo at Week 24 | -1.24 Unit on a scale | Standard Error 0.095 |
| AIN457 300 mg | Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing hsCRP) in Subjects Treated With Secukinumab Versus Placebo at Week 24 | -1.56 Unit on a scale | Standard Error 0.093 |
| Placebo | Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing hsCRP) in Subjects Treated With Secukinumab Versus Placebo at Week 24 | -0.64 Unit on a scale | Standard Error 0.127 |
Secondary
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) in Subjects Treated With Secukinumab Versus Placebo at Week 24
The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. In this trial, only the disability dimension was used. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Within each of the 8 categories, only the item indicating the most severe impairment contributes to the category score. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from baseline indicates improvement.
Time frame: Week 24
Population: The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AIN457 150 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) in Subjects Treated With Secukinumab Versus Placebo at Week 24 | -0.27 Unit on a scale | Standard Error 0.043 |
| AIN457 300 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) in Subjects Treated With Secukinumab Versus Placebo at Week 24 | -0.38 Unit on a scale | Standard Error 0.042 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) in Subjects Treated With Secukinumab Versus Placebo at Week 24 | -0.17 Unit on a scale | Standard Error 0.055 |
Secondary
Change From Baseline in Physical Function Component of the Short-form Health Survey (SF-36-PCS) in Subjects Treated With Secukinumab Versus Placebo at Week 24
SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
Time frame: Week 24
Population: The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 150 mg | Change From Baseline in Physical Function Component of the Short-form Health Survey (SF-36-PCS) in Subjects Treated With Secukinumab Versus Placebo at Week 24 | Mental Component Summary (MCS) | 1.68 Unit on a scale | Standard Error 0.837 |
| AIN457 150 mg | Change From Baseline in Physical Function Component of the Short-form Health Survey (SF-36-PCS) in Subjects Treated With Secukinumab Versus Placebo at Week 24 | Physical Component Summary (PCS) | 3.42 Unit on a scale | Standard Error 0.6 |
| AIN457 300 mg | Change From Baseline in Physical Function Component of the Short-form Health Survey (SF-36-PCS) in Subjects Treated With Secukinumab Versus Placebo at Week 24 | Mental Component Summary (MCS) | 4.41 Unit on a scale | Standard Error 0.822 |
| AIN457 300 mg | Change From Baseline in Physical Function Component of the Short-form Health Survey (SF-36-PCS) in Subjects Treated With Secukinumab Versus Placebo at Week 24 | Physical Component Summary (PCS) | 6.46 Unit on a scale | Standard Error 0.59 |
| Placebo | Change From Baseline in Physical Function Component of the Short-form Health Survey (SF-36-PCS) in Subjects Treated With Secukinumab Versus Placebo at Week 24 | Mental Component Summary (MCS) | -0.10 Unit on a scale | Standard Error 1.142 |
| Placebo | Change From Baseline in Physical Function Component of the Short-form Health Survey (SF-36-PCS) in Subjects Treated With Secukinumab Versus Placebo at Week 24 | Physical Component Summary (PCS) | 2.94 Unit on a scale | Standard Error 0.83 |
Secondary
Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC)
Analysis of frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC).
Time frame: From first dose of study treatment to last study visit, up to 3 years
Population: Safety Set, based on Final Analysis. All subjects who took at least one dose of study treatment during the treatment period. A subject with multiple adverse events within a primary system organ class was counted only once in the total row. Deaths up to 28 days after the last dose are included. Only descriptive analysis done.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AIN457 150 mg | Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC) | AEs by Primary System Organ Class (SOC) | 176 Participants |
| AIN457 150 mg | Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC) | SAEs by Primary System Organ Class (SOC) | 42 Participants |
| AIN457 150 mg | Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC) | Deaths by Primary System Organ Class (SOC) | 4 Participants |
| AIN457 300 mg | Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC) | AEs by Primary System Organ Class (SOC) | 230 Participants |
| AIN457 300 mg | Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC) | SAEs by Primary System Organ Class (SOC) | 35 Participants |
| AIN457 300 mg | Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC) | Deaths by Primary System Organ Class (SOC) | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC) | AEs by Primary System Organ Class (SOC) | 363 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC) | Deaths by Primary System Organ Class (SOC) | 4 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC) | SAEs by Primary System Organ Class (SOC) | 76 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC) | AEs by Primary System Organ Class (SOC) | 81 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC) | SAEs by Primary System Organ Class (SOC) | 9 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC) | Deaths by Primary System Organ Class (SOC) | 0 Participants |
Secondary
Percentage of Subjects Achieving a Psoriatic Area and Severity Index 90 (PASI90) Response in Subjects Treated With Secukinumab Versus Placebo at Week 24
PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI90 represents an improvement in the PASI score of at least 90% as compared with baseline.
Time frame: Week 24
Population: The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AIN457 150 mg | Percentage of Subjects Achieving a Psoriatic Area and Severity Index 90 (PASI90) Response in Subjects Treated With Secukinumab Versus Placebo at Week 24 | 25 Participants |
| AIN457 300 mg | Percentage of Subjects Achieving a Psoriatic Area and Severity Index 90 (PASI90) Response in Subjects Treated With Secukinumab Versus Placebo at Week 24 | 21 Participants |
| Placebo | Percentage of Subjects Achieving a Psoriatic Area and Severity Index 90 (PASI90) Response in Subjects Treated With Secukinumab Versus Placebo at Week 24 | 4 Participants |
Secondary
Proportion of Patients Achieving American College of Rheumatology 50 (ACR50) Response Criteria on Secukinumab Versus Placebo at Week 24
A patient will be considered as improved according the ACR50 criteria if she/he has at least 50% decreases in the swollen and tender joint count, and at least 50% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant \[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\]
Time frame: Week 24
Population: The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AIN457 150 mg | Proportion of Patients Achieving American College of Rheumatology 50 (ACR50) Response Criteria on Secukinumab Versus Placebo at Week 24 | 26 Participants |
| AIN457 300 mg | Proportion of Patients Achieving American College of Rheumatology 50 (ACR50) Response Criteria on Secukinumab Versus Placebo at Week 24 | 48 Participants |
| Placebo | Proportion of Patients Achieving American College of Rheumatology 50 (ACR50) Response Criteria on Secukinumab Versus Placebo at Week 24 | 12 Participants |
Secondary
Proportion of Patients With Dactylitis at Week 24 in the Subset of Patients Who Had Dactylitis at Baseline
The presence of dactylitis was assessed by dactylitis count (number of fingers and toes with dactylitis, with a range of 0-20). If dactylitis is present with any finger or toe, the patient is counted as a patient with dactylitis.
Time frame: Week 24
Population: The Dactylitis subset of the Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value at Baseline and post-basline, was considered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AIN457 150 mg | Proportion of Patients With Dactylitis at Week 24 in the Subset of Patients Who Had Dactylitis at Baseline | 22 Participants |
| AIN457 300 mg | Proportion of Patients With Dactylitis at Week 24 in the Subset of Patients Who Had Dactylitis at Baseline | 24 Participants |
| Placebo | Proportion of Patients With Dactylitis at Week 24 in the Subset of Patients Who Had Dactylitis at Baseline | 31 Participants |
Secondary
Proportion of Patients With Enthesitis at Week 24 in the Subset of Patients Who Had Enthesitis at Baseline
The presence of Enthesitis was assessed using a validated enthesitis index that uses 6 sites for evaluation of enthesitis: lateral epicondyle humerus L + R, proximal achilles L + R and medial condyle femur. If enthesitis is present at any of the 6 sites, the subject is counted as a subject with enthesitis.
Time frame: Week 24
Population: The Enthesitis subset of the Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value at Baseline and post-basline, was considered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AIN457 150 mg | Proportion of Patients With Enthesitis at Week 24 in the Subset of Patients Who Had Enthesitis at Baseline | 60 Participants |
| AIN457 300 mg | Proportion of Patients With Enthesitis at Week 24 in the Subset of Patients Who Had Enthesitis at Baseline | 53 Participants |
| Placebo | Proportion of Patients With Enthesitis at Week 24 in the Subset of Patients Who Had Enthesitis at Baseline | 83 Participants |
Secondary
Proportion of Subjects Achieving a Psoriatic Area and Severity Index 75 (PASI75) Response in Subjects on Secukinumab Versus Placebo at Week 24
PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI75 represents an improvement in the PASI score of at least 75% as compared with baseline.
Time frame: Week 24
Population: The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AIN457 150 mg | Proportion of Subjects Achieving a Psoriatic Area and Severity Index 75 (PASI75) Response in Subjects on Secukinumab Versus Placebo at Week 24 | 34 Participants |
| AIN457 300 mg | Proportion of Subjects Achieving a Psoriatic Area and Severity Index 75 (PASI75) Response in Subjects on Secukinumab Versus Placebo at Week 24 | 29 Participants |
| Placebo | Proportion of Subjects Achieving a Psoriatic Area and Severity Index 75 (PASI75) Response in Subjects on Secukinumab Versus Placebo at Week 24 | 6 Participants |