Psoriatic Arthritis
Conditions
Keywords
Extension study, psoriatic arthritis, pre-filled syringe
Brief summary
This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time.
Interventions
DRUGSecukinumab
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a messenger protein in the body) called Interleukin 17 (IL-17).
DRUGPlacebo
Placebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed * Subjects must have participated in core study CAIN457F2306, and must have completed the entire treatment period * Subjects must be deemed by the investigator to benefit from continued secukinumab therapy
Exclusion criteria
* Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab * Any subject who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms * Pregnant or nursing (lactating) women * Women of child-bearing potential, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., 20 weeks in EU) Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | weeks 116, 128, 140, 156, 180, 208, 232 and 260 | Proportion of subjects with a positive clinical response to treatment (individual improvement) in disease activity according to ACR20 criteria if he/she has at least 20% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures: * Patient's assessment of Psoriatic Arthritis (PsA) pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Subject self-assessed disability (Health-Assessment Questionnaire \[HAQ-DI\] score) * Acute phase reactant (hsCRP or ESR) |
| Proportion of Subjects Who Reached ACR50 | weeks 116, 128, 140, 156, 180, 208, 232 and 260 | Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR50 criteria if he/she has at least 50% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures: * Patient's assessment of PsA pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Subject self-assessed disability (Health-Assessment Questionnaire \[HAQ-DI\] score) * Acute phase reactant (hsCRP or ESR) |
| Proportion of Subjects Who Reached ACR70 | weeks 116, 128, 140, 156, 180, 208, 232 and 260 | Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR70 criteria if he/she has at least 70% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:- Patient's assessment of PsA pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Subject self-assessed disability (Health-Assessment Questionnaire \[HAQ-DI\] score) * Acute phase reactant (hsCRP or ESR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Achieving Low Disease Activity | weeks 116, 128, 140, 156, 180, 208, 232 and 260 | Percentage of subjects achieving low disease activity (DAS28 ≤ 3.2). The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | weeks 116, 128, 140, 156, 180, 208, 232 and 260 | Changes from baseline in score of the disability assessment component of the HAQ (Health Assessment Questionnaire - Disability Index). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. Health Assessment Questionnaire - Disability Index (HAQ-DI) ranges from 0 (no disability) to 3 (very severe disability) |
| Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | weeks 116, 128, 140, 156, 180, 208, 232 and 260 | Percentage of subjects achieving disease remission (DAS28\<2.6). The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission |
| Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | weeks 116, 128, 140, 156, 180, 208, 232 and 260 | Percentage of subjects with improvements from baseline in HAQ-DI meeting or exceeding minimal clinically important difference (MCID=0.3). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. |
| Change From Baseline in Disease Activity Score-CRP (DAS28) | weeks 116, 128, 140, 156, 180, 208, 232 and 260 | Changes in DAS28 (utilizing hsCRP) from baseline up to Month 60. The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. This measure represents change in scores - not the actual scores. DAS28 is a combined measure of disease activity based on the following formula: DAS28-CRP = 0.56\*TJC28\^0.5 + 0.28\*SJC28\^0.5 + 0.36\*ln(CRP+1) + 0.014\*PGA + 0.96 The greater the score is, the more the disease activity exists. Remission is defined as DAS28-CRP \< 2.6 Low disease activity is defined as DAS28-CRP \< 3.2 The minimum value can be 0.96 (not applicable in our study due to the inclusion/exclusion criteria regarding tender, swollen joints). There is no maximum expected value for this score |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Czechia, Germany, Israel, Italy, Philippines, Poland, Russia, Singapore, Slovakia, Thailand, United Kingdom, United States
Participant flow
Recruitment details
The extension FAS (N=457) comprised all patients enrolled in the extension with at least 1 post baseline efficacy assessment during the extension study. 3 patients signed the ICF but had no efficacy assessments during the extension study and were not included in extension FAS.
Pre-assignment details
Of the 457 patients in the extension FAS, 380 (83.2%) completed 260 weeks of treatment (84.4% in the secukinumab 10 mg/kg-75 mg group, 82.0% in the secukinumab 10 mg/kg-150 mg group, 85.1% in the placebo-secukinumab 75 mg group and 81.3% in the placebo-secukinumab 150 mg group)
Participants by arm
| Arm | Count |
|---|---|
| Secukinumab 75mg Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator | 147 |
| Secukinumab 150mg Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator | 161 |
| Placebo - AIN457A 75mg Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1.0 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg. Participants also received secukinumab 75mg from week 16/24. Patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator | 74 |
| Placebo - AIN457 150mg Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg. Participants also received secukinumab 150 mg from week 16/24. patients may have been escalated to 300mg or 300 mg as judged appropriate by investigator | 75 |
| Total | 457 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 7 | 6 | 2 | 3 |
| Overall Study | Death | 1 | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 1 | 2 | 2 | 2 |
| Overall Study | Lost to Follow-up | 1 | 1 | 1 | 3 |
| Overall Study | non-compliance with treatment | 1 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 2 | 1 | 0 | 1 |
| Overall Study | Pregnancy | 0 | 2 | 1 | 0 |
| Overall Study | Technical problems | 2 | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 15 | 4 | 4 |
Baseline characteristics
| Characteristic | Secukinumab 75mg | Secukinumab 150mg | Placebo - AIN457A 75mg | Placebo - AIN457 150mg | Total |
|---|---|---|---|---|---|
| Age, Customized <65 | 132 Count of Participants | 145 Count of Participants | 72 Count of Participants | 71 Count of Participants | 420 Count of Participants |
| Age, Customized >=65 | 15 Count of Participants | 16 Count of Participants | 2 Count of Participants | 4 Count of Participants | 37 Count of Participants |
| Age, Customized >=75 | 1 Count of Participants | 0 Count of Participants | 1 Count of Participants | 0 Count of Participants | 2 Count of Participants |
| Race/Ethnicity, Customized Asian | 27 Count of participants | 29 Count of participants | 23 Count of participants | 16 Count of participants | 95 Count of participants |
| Race/Ethnicity, Customized Black or African American | 1 Count of participants | 1 Count of participants | 0 Count of participants | 0 Count of participants | 2 Count of participants |
| Race/Ethnicity, Customized Other | 1 Count of participants | 1 Count of participants | 0 Count of participants | 1 Count of participants | 3 Count of participants |
| Race/Ethnicity, Customized White | 118 Count of participants | 130 Count of participants | 51 Count of participants | 58 Count of participants | 357 Count of participants |
| Sex: Female, Male Female | 81 Participants | 83 Participants | 40 Participants | 38 Participants | 242 Participants |
| Sex: Female, Male Male | 66 Participants | 78 Participants | 34 Participants | 37 Participants | 215 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 | 3 / 292 | 3 / 473 | 0 / 165 | 0 / 202 |
| other Total, other adverse events | 197 / 292 | 264 / 473 | 47 / 165 | 63 / 202 |
| serious Total, serious adverse events | 48 / 292 | 96 / 473 | 10 / 165 | 11 / 202 |
Outcome results
Primary
Proportion of Subjects Who Reached ACR50
Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR50 criteria if he/she has at least 50% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures: * Patient's assessment of PsA pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Subject self-assessed disability (Health-Assessment Questionnaire \[HAQ-DI\] score) * Acute phase reactant (hsCRP or ESR)
Time frame: weeks 116, 128, 140, 156, 180, 208, 232 and 260
Population: Extension FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Secukinumab 75mg | Proportion of Subjects Who Reached ACR50 | week 208 | 44.9 percentage of participants |
| Secukinumab 75mg | Proportion of Subjects Who Reached ACR50 | week 232 | 49.6 percentage of participants |
| Secukinumab 75mg | Proportion of Subjects Who Reached ACR50 | week 260 | 51.2 percentage of participants |
| Secukinumab 75mg | Proportion of Subjects Who Reached ACR50 | week 128 | 43.7 percentage of participants |
| Secukinumab 75mg | Proportion of Subjects Who Reached ACR50 | week 156 | 39.2 percentage of participants |
| Secukinumab 75mg | Proportion of Subjects Who Reached ACR50 | week 180 | 43.1 percentage of participants |
| Secukinumab 75mg | Proportion of Subjects Who Reached ACR50 | week 116 | 43.4 percentage of participants |
| Secukinumab 75mg | Proportion of Subjects Who Reached ACR50 | week 140 | 41.7 percentage of participants |
| Secukinumab 150mg | Proportion of Subjects Who Reached ACR50 | week 116 | 51.0 percentage of participants |
| Secukinumab 150mg | Proportion of Subjects Who Reached ACR50 | week 156 | 56.1 percentage of participants |
| Secukinumab 150mg | Proportion of Subjects Who Reached ACR50 | week 232 | 53.4 percentage of participants |
| Secukinumab 150mg | Proportion of Subjects Who Reached ACR50 | week 140 | 48.7 percentage of participants |
| Secukinumab 150mg | Proportion of Subjects Who Reached ACR50 | week 180 | 45.7 percentage of participants |
| Secukinumab 150mg | Proportion of Subjects Who Reached ACR50 | week 128 | 52.9 percentage of participants |
| Secukinumab 150mg | Proportion of Subjects Who Reached ACR50 | week 260 | 52.7 percentage of participants |
| Secukinumab 150mg | Proportion of Subjects Who Reached ACR50 | week 208 | 46.9 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subjects Who Reached ACR50 | week 140 | 51.4 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subjects Who Reached ACR50 | week 232 | 53.0 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subjects Who Reached ACR50 | week 116 | 49.3 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subjects Who Reached ACR50 | week 128 | 56.5 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subjects Who Reached ACR50 | week 156 | 52.1 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subjects Who Reached ACR50 | week 180 | 52.2 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subjects Who Reached ACR50 | week 208 | 52.9 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subjects Who Reached ACR50 | week 260 | 60.6 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subjects Who Reached ACR50 | week 140 | 44.4 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subjects Who Reached ACR50 | week 128 | 53.5 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subjects Who Reached ACR50 | week 260 | 50.0 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subjects Who Reached ACR50 | week 232 | 50.8 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subjects Who Reached ACR50 | week 116 | 47.2 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subjects Who Reached ACR50 | week 156 | 47.3 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subjects Who Reached ACR50 | week 208 | 53.0 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subjects Who Reached ACR50 | week 180 | 50.8 percentage of participants |
Primary
Proportion of Subjects Who Reached ACR70
Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR70 criteria if he/she has at least 70% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:- Patient's assessment of PsA pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Subject self-assessed disability (Health-Assessment Questionnaire \[HAQ-DI\] score) * Acute phase reactant (hsCRP or ESR)
Time frame: weeks 116, 128, 140, 156, 180, 208, 232 and 260
Population: Extension FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Secukinumab 75mg | Proportion of Subjects Who Reached ACR70 | week 128 | 24.6 percentage of participants |
| Secukinumab 75mg | Proportion of Subjects Who Reached ACR70 | week 140 | 27.3 percentage of participants |
| Secukinumab 75mg | Proportion of Subjects Who Reached ACR70 | week 208 | 25.7 percentage of participants |
| Secukinumab 75mg | Proportion of Subjects Who Reached ACR70 | week 232 | 35.4 percentage of participants |
| Secukinumab 75mg | Proportion of Subjects Who Reached ACR70 | week 180 | 27.0 percentage of participants |
| Secukinumab 75mg | Proportion of Subjects Who Reached ACR70 | week 156 | 25.9 percentage of participants |
| Secukinumab 75mg | Proportion of Subjects Who Reached ACR70 | week 116 | 23.8 percentage of participants |
| Secukinumab 75mg | Proportion of Subjects Who Reached ACR70 | week 260 | 33.9 percentage of participants |
| Secukinumab 150mg | Proportion of Subjects Who Reached ACR70 | week 116 | 30.1 percentage of participants |
| Secukinumab 150mg | Proportion of Subjects Who Reached ACR70 | week 180 | 31.2 percentage of participants |
| Secukinumab 150mg | Proportion of Subjects Who Reached ACR70 | week 208 | 31.0 percentage of participants |
| Secukinumab 150mg | Proportion of Subjects Who Reached ACR70 | week 128 | 31.0 percentage of participants |
| Secukinumab 150mg | Proportion of Subjects Who Reached ACR70 | week 260 | 37.4 percentage of participants |
| Secukinumab 150mg | Proportion of Subjects Who Reached ACR70 | week 140 | 28.3 percentage of participants |
| Secukinumab 150mg | Proportion of Subjects Who Reached ACR70 | week 232 | 32.1 percentage of participants |
| Secukinumab 150mg | Proportion of Subjects Who Reached ACR70 | week 156 | 32.9 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subjects Who Reached ACR70 | week 208 | 32.4 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subjects Who Reached ACR70 | week 232 | 37.9 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subjects Who Reached ACR70 | week 128 | 34.8 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subjects Who Reached ACR70 | week 140 | 33.3 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subjects Who Reached ACR70 | week 116 | 28.2 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subjects Who Reached ACR70 | week 156 | 26.0 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subjects Who Reached ACR70 | week 260 | 37.9 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subjects Who Reached ACR70 | week 180 | 31.3 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subjects Who Reached ACR70 | week 260 | 33.9 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subjects Who Reached ACR70 | week 116 | 29.2 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subjects Who Reached ACR70 | week 128 | 23.9 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subjects Who Reached ACR70 | week 140 | 27.8 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subjects Who Reached ACR70 | week 156 | 27.0 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subjects Who Reached ACR70 | week 180 | 27.7 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subjects Who Reached ACR70 | week 208 | 28.8 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subjects Who Reached ACR70 | week 232 | 34.4 percentage of participants |
Primary
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
Proportion of subjects with a positive clinical response to treatment (individual improvement) in disease activity according to ACR20 criteria if he/she has at least 20% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures: * Patient's assessment of Psoriatic Arthritis (PsA) pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Subject self-assessed disability (Health-Assessment Questionnaire \[HAQ-DI\] score) * Acute phase reactant (hsCRP or ESR)
Time frame: weeks 116, 128, 140, 156, 180, 208, 232 and 260
Population: Extension Full Analysis Set (extension FAS) is comprised all patients enrolled in the extension study who had at least one post baseline assessment of efficacy during the extension period. Patients were analyzed according to the treatment they were assigned.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Secukinumab 75mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 180 | 73.0 percentage of participants |
| Secukinumab 75mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 156 | 64.3 percentage of participants |
| Secukinumab 75mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 140 | 69.8 percentage of participants |
| Secukinumab 75mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 260 | 77.2 percentage of participants |
| Secukinumab 75mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 232 | 79.5 percentage of participants |
| Secukinumab 75mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 208 | 72.8 percentage of participants |
| Secukinumab 75mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 128 | 69.7 percentage of participants |
| Secukinumab 75mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 116 | 71.3 percentage of participants |
| Secukinumab 150mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 156 | 76.1 percentage of participants |
| Secukinumab 150mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 116 | 73.9 percentage of participants |
| Secukinumab 150mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 128 | 72.9 percentage of participants |
| Secukinumab 150mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 140 | 71.1 percentage of participants |
| Secukinumab 150mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 180 | 72.5 percentage of participants |
| Secukinumab 150mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 208 | 66.9 percentage of participants |
| Secukinumab 150mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 232 | 69.5 percentage of participants |
| Secukinumab 150mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 260 | 67.9 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 128 | 76.8 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 156 | 75.3 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 180 | 74.6 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 208 | 75.0 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 116 | 73.2 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 260 | 78.8 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 232 | 83.3 percentage of participants |
| Placebo - AIN457A 75mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 140 | 79.2 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 156 | 67.6 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 140 | 69.4 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 128 | 74.6 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 180 | 67.7 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 116 | 73.6 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 260 | 77.4 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 232 | 80.3 percentage of participants |
| Placebo - AIN457 150mg | Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | week 208 | 68.2 percentage of participants |
Secondary
Change From Baseline in Disease Activity Score-CRP (DAS28)
Changes in DAS28 (utilizing hsCRP) from baseline up to Month 60. The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. This measure represents change in scores - not the actual scores. DAS28 is a combined measure of disease activity based on the following formula: DAS28-CRP = 0.56\*TJC28\^0.5 + 0.28\*SJC28\^0.5 + 0.36\*ln(CRP+1) + 0.014\*PGA + 0.96 The greater the score is, the more the disease activity exists. Remission is defined as DAS28-CRP \< 2.6 Low disease activity is defined as DAS28-CRP \< 3.2 The minimum value can be 0.96 (not applicable in our study due to the inclusion/exclusion criteria regarding tender, swollen joints). There is no maximum expected value for this score
Time frame: weeks 116, 128, 140, 156, 180, 208, 232 and 260
Population: Extension FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab 75mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 128 | -2.013 change in scores | Standard Deviation 1.3446 |
| Secukinumab 75mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 140 | -2.074 change in scores | Standard Deviation 1.3224 |
| Secukinumab 75mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 260 | -2.112 change in scores | Standard Deviation 1.2664 |
| Secukinumab 75mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 156 | -1.844 change in scores | Standard Deviation 1.4923 |
| Secukinumab 75mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 232 | -2.225 change in scores | Standard Deviation 1.257 |
| Secukinumab 75mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 208 | -2.042 change in scores | Standard Deviation 1.2907 |
| Secukinumab 75mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 180 | -2.058 change in scores | Standard Deviation 1.376 |
| Secukinumab 75mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 116 | -2.044 change in scores | Standard Deviation 1.3382 |
| Secukinumab 150mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 116 | -1.904 change in scores | Standard Deviation 1.3165 |
| Secukinumab 150mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 232 | -2.046 change in scores | Standard Deviation 1.259 |
| Secukinumab 150mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 180 | -1.937 change in scores | Standard Deviation 1.2674 |
| Secukinumab 150mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 260 | -2.074 change in scores | Standard Deviation 1.3146 |
| Secukinumab 150mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 140 | -1.912 change in scores | Standard Deviation 1.2246 |
| Secukinumab 150mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 156 | -1.942 change in scores | Standard Deviation 1.3195 |
| Secukinumab 150mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 128 | -1.962 change in scores | Standard Deviation 1.29 |
| Secukinumab 150mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 208 | -1.767 change in scores | Standard Deviation 1.4574 |
| Placebo - AIN457A 75mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 116 | -2.282 change in scores | Standard Deviation 1.2732 |
| Placebo - AIN457A 75mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 260 | -2.506 change in scores | Standard Deviation 1.3774 |
| Placebo - AIN457A 75mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 180 | -2.327 change in scores | Standard Deviation 1.2339 |
| Placebo - AIN457A 75mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 208 | -2.344 change in scores | Standard Deviation 1.3351 |
| Placebo - AIN457A 75mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 232 | -2.611 change in scores | Standard Deviation 1.3247 |
| Placebo - AIN457A 75mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 140 | -2.412 change in scores | Standard Deviation 1.3059 |
| Placebo - AIN457A 75mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 128 | -2.333 change in scores | Standard Deviation 1.2815 |
| Placebo - AIN457A 75mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 156 | -2.109 change in scores | Standard Deviation 1.3188 |
| Placebo - AIN457 150mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 260 | -2.099 change in scores | Standard Deviation 1.2466 |
| Placebo - AIN457 150mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 116 | -1.853 change in scores | Standard Deviation 1.2737 |
| Placebo - AIN457 150mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 128 | -2.031 change in scores | Standard Deviation 1.329 |
| Placebo - AIN457 150mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 140 | -1.830 change in scores | Standard Deviation 1.3136 |
| Placebo - AIN457 150mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 156 | -1.743 change in scores | Standard Deviation 1.363 |
| Placebo - AIN457 150mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 180 | -1.867 change in scores | Standard Deviation 1.459 |
| Placebo - AIN457 150mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 208 | -1.862 change in scores | Standard Deviation 1.4708 |
| Placebo - AIN457 150mg | Change From Baseline in Disease Activity Score-CRP (DAS28) | week 232 | -2.286 change in scores | Standard Deviation 1.2102 |
Secondary
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Changes from baseline in score of the disability assessment component of the HAQ (Health Assessment Questionnaire - Disability Index). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. Health Assessment Questionnaire - Disability Index (HAQ-DI) ranges from 0 (no disability) to 3 (very severe disability)
Time frame: weeks 116, 128, 140, 156, 180, 208, 232 and 260
Population: Extension FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab 75mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 180 | -0.4617 change in scores | Standard Deviation 0.61472 |
| Secukinumab 75mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 140 | -0.4448 change in scores | Standard Deviation 0.61406 |
| Secukinumab 75mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 156 | -0.4236 change in scores | Standard Deviation 0.61896 |
| Secukinumab 75mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 260 | -0.4821 change in scores | Standard Deviation 0.6117 |
| Secukinumab 75mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 232 | -0.4710 change in scores | Standard Deviation 0.60931 |
| Secukinumab 75mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 128 | -0.4171 change in scores | Standard Deviation 0.61192 |
| Secukinumab 75mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 116 | -0.4537 change in scores | Standard Deviation 0.60617 |
| Secukinumab 75mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 208 | -0.4463 change in scores | Standard Deviation 0.5713 |
| Secukinumab 150mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 140 | -0.4713 change in scores | Standard Deviation 0.58791 |
| Secukinumab 150mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 116 | -0.4592 change in scores | Standard Deviation 0.56155 |
| Secukinumab 150mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 128 | -0.4619 change in scores | Standard Deviation 0.55835 |
| Secukinumab 150mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 156 | -0.4266 change in scores | Standard Deviation 0.57491 |
| Secukinumab 150mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 180 | -0.4305 change in scores | Standard Deviation 0.59901 |
| Secukinumab 150mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 208 | -0.3857 change in scores | Standard Deviation 0.59304 |
| Secukinumab 150mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 232 | -0.4122 change in scores | Standard Deviation 0.60461 |
| Secukinumab 150mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 260 | -0.4036 change in scores | Standard Deviation 0.58334 |
| Placebo - AIN457A 75mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 128 | -0.5143 change in scores | Standard Deviation 0.55599 |
| Placebo - AIN457A 75mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 116 | -0.5642 change in scores | Standard Deviation 0.56722 |
| Placebo - AIN457A 75mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 260 | -0.5038 change in scores | Standard Deviation 0.61039 |
| Placebo - AIN457A 75mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 208 | -0.5531 change in scores | Standard Deviation 0.62622 |
| Placebo - AIN457A 75mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 140 | -0.4635 change in scores | Standard Deviation 0.56037 |
| Placebo - AIN457A 75mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 232 | -0.5777 change in scores | Standard Deviation 0.6693 |
| Placebo - AIN457A 75mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 156 | -0.5068 change in scores | Standard Deviation 0.62548 |
| Placebo - AIN457A 75mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 180 | -0.5698 change in scores | Standard Deviation 0.65258 |
| Placebo - AIN457 150mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 156 | -0.3159 change in scores | Standard Deviation 0.73507 |
| Placebo - AIN457 150mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 232 | -0.3952 change in scores | Standard Deviation 0.72115 |
| Placebo - AIN457 150mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 180 | -0.3538 change in scores | Standard Deviation 0.71246 |
| Placebo - AIN457 150mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 208 | -0.3447 change in scores | Standard Deviation 0.74745 |
| Placebo - AIN457 150mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 116 | -0.4115 change in scores | Standard Deviation 0.66721 |
| Placebo - AIN457 150mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 260 | -0.3730 change in scores | Standard Deviation 0.71306 |
| Placebo - AIN457 150mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 140 | -0.3507 change in scores | Standard Deviation 0.69221 |
| Placebo - AIN457 150mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 128 | -0.3750 change in scores | Standard Deviation 0.69661 |
Secondary
Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)
Percentage of subjects with improvements from baseline in HAQ-DI meeting or exceeding minimal clinically important difference (MCID=0.3). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities.
Time frame: weeks 116, 128, 140, 156, 180, 208, 232 and 260
Population: Extension FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Secukinumab 75mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 116 | 53.1 percentage of participants |
| Secukinumab 75mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 128 | 52.8 percentage of participants |
| Secukinumab 75mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 140 | 55.4 percentage of participants |
| Secukinumab 75mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 156 | 52.8 percentage of participants |
| Secukinumab 75mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 180 | 56.9 percentage of participants |
| Secukinumab 75mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 208 | 53.3 percentage of participants |
| Secukinumab 75mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 232 | 55.2 percentage of participants |
| Secukinumab 75mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 260 | 55.6 percentage of participants |
| Secukinumab 150mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 208 | 50.0 percentage of participants |
| Secukinumab 150mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 180 | 51.5 percentage of participants |
| Secukinumab 150mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 128 | 51.9 percentage of participants |
| Secukinumab 150mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 260 | 48.9 percentage of participants |
| Secukinumab 150mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 232 | 48.9 percentage of participants |
| Secukinumab 150mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 156 | 52.3 percentage of participants |
| Secukinumab 150mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 140 | 52.3 percentage of participants |
| Secukinumab 150mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 116 | 52.3 percentage of participants |
| Placebo - AIN457A 75mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 232 | 59.1 percentage of participants |
| Placebo - AIN457A 75mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 140 | 56.9 percentage of participants |
| Placebo - AIN457A 75mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 156 | 60.8 percentage of participants |
| Placebo - AIN457A 75mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 180 | 61.2 percentage of participants |
| Placebo - AIN457A 75mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 208 | 59.4 percentage of participants |
| Placebo - AIN457A 75mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 260 | 59.1 percentage of participants |
| Placebo - AIN457A 75mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 116 | 63.9 percentage of participants |
| Placebo - AIN457A 75mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 128 | 57.1 percentage of participants |
| Placebo - AIN457 150mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 140 | 48.6 percentage of participants |
| Placebo - AIN457 150mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 156 | 44.6 percentage of participants |
| Placebo - AIN457 150mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 128 | 54.9 percentage of participants |
| Placebo - AIN457 150mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 116 | 50.0 percentage of participants |
| Placebo - AIN457 150mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 180 | 47.7 percentage of participants |
| Placebo - AIN457 150mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 260 | 53.2 percentage of participants |
| Placebo - AIN457 150mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 232 | 52.5 percentage of participants |
| Placebo - AIN457 150mg | Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | week 208 | 48.5 percentage of participants |
Secondary
Percentage of Subjects Achieving Disease Remission (DAS28<2.6)
Percentage of subjects achieving disease remission (DAS28\<2.6). The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission
Time frame: weeks 116, 128, 140, 156, 180, 208, 232 and 260
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Secukinumab 75mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 116 | 52.4 percentage of participants |
| Secukinumab 75mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 128 | 54.6 percentage of participants |
| Secukinumab 75mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 140 | 58.6 percentage of participants |
| Secukinumab 75mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 156 | 48.6 percentage of participants |
| Secukinumab 75mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 180 | 54.7 percentage of participants |
| Secukinumab 75mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 208 | 56.5 percentage of participants |
| Secukinumab 75mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 232 | 64.3 percentage of participants |
| Secukinumab 75mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 260 | 55.0 percentage of participants |
| Secukinumab 150mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 208 | 52.1 percentage of participants |
| Secukinumab 150mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 180 | 53.3 percentage of participants |
| Secukinumab 150mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 128 | 49.4 percentage of participants |
| Secukinumab 150mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 260 | 58.3 percentage of participants |
| Secukinumab 150mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 232 | 61.4 percentage of participants |
| Secukinumab 150mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 156 | 52.6 percentage of participants |
| Secukinumab 150mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 140 | 46.7 percentage of participants |
| Secukinumab 150mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 116 | 50.3 percentage of participants |
| Placebo - AIN457A 75mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 232 | 65.1 percentage of participants |
| Placebo - AIN457A 75mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 140 | 55.6 percentage of participants |
| Placebo - AIN457A 75mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 156 | 43.8 percentage of participants |
| Placebo - AIN457A 75mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 180 | 49.3 percentage of participants |
| Placebo - AIN457A 75mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 208 | 55.2 percentage of participants |
| Placebo - AIN457A 75mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 260 | 64.6 percentage of participants |
| Placebo - AIN457A 75mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 116 | 47.9 percentage of participants |
| Placebo - AIN457A 75mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 128 | 55.1 percentage of participants |
| Placebo - AIN457 150mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 140 | 51.4 percentage of participants |
| Placebo - AIN457 150mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 156 | 46.6 percentage of participants |
| Placebo - AIN457 150mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 128 | 57.1 percentage of participants |
| Placebo - AIN457 150mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 116 | 45.8 percentage of participants |
| Placebo - AIN457 150mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 180 | 58.6 percentage of participants |
| Placebo - AIN457 150mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 260 | 66.1 percentage of participants |
| Placebo - AIN457 150mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 232 | 69.5 percentage of participants |
| Placebo - AIN457 150mg | Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | week 208 | 53.0 percentage of participants |
Secondary
Percentage of Subjects Achieving Low Disease Activity
Percentage of subjects achieving low disease activity (DAS28 ≤ 3.2). The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission
Time frame: weeks 116, 128, 140, 156, 180, 208, 232 and 260
Population: Extension FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Secukinumab 75mg | Percentage of Subjects Achieving Low Disease Activity | week 116 | 70.3 percentage of participants |
| Secukinumab 75mg | Percentage of Subjects Achieving Low Disease Activity | week 128 | 69.5 percentage of participants |
| Secukinumab 75mg | Percentage of Subjects Achieving Low Disease Activity | week 140 | 72.9 percentage of participants |
| Secukinumab 75mg | Percentage of Subjects Achieving Low Disease Activity | week 156 | 63.4 percentage of participants |
| Secukinumab 75mg | Percentage of Subjects Achieving Low Disease Activity | week 180 | 71.2 percentage of participants |
| Secukinumab 75mg | Percentage of Subjects Achieving Low Disease Activity | week 208 | 71.7 percentage of participants |
| Secukinumab 75mg | Percentage of Subjects Achieving Low Disease Activity | week 232 | 75.2 percentage of participants |
| Secukinumab 75mg | Percentage of Subjects Achieving Low Disease Activity | week 260 | 74.4 percentage of participants |
| Secukinumab 150mg | Percentage of Subjects Achieving Low Disease Activity | week 208 | 65.8 percentage of participants |
| Secukinumab 150mg | Percentage of Subjects Achieving Low Disease Activity | week 180 | 70.1 percentage of participants |
| Secukinumab 150mg | Percentage of Subjects Achieving Low Disease Activity | week 128 | 69.9 percentage of participants |
| Secukinumab 150mg | Percentage of Subjects Achieving Low Disease Activity | week 260 | 75.0 percentage of participants |
| Secukinumab 150mg | Percentage of Subjects Achieving Low Disease Activity | week 232 | 73.5 percentage of participants |
| Secukinumab 150mg | Percentage of Subjects Achieving Low Disease Activity | week 156 | 67.9 percentage of participants |
| Secukinumab 150mg | Percentage of Subjects Achieving Low Disease Activity | week 140 | 66.0 percentage of participants |
| Secukinumab 150mg | Percentage of Subjects Achieving Low Disease Activity | week 116 | 64.7 percentage of participants |
| Placebo - AIN457A 75mg | Percentage of Subjects Achieving Low Disease Activity | week 232 | 79.4 percentage of participants |
| Placebo - AIN457A 75mg | Percentage of Subjects Achieving Low Disease Activity | week 140 | 75.0 percentage of participants |
| Placebo - AIN457A 75mg | Percentage of Subjects Achieving Low Disease Activity | week 156 | 61.6 percentage of participants |
| Placebo - AIN457A 75mg | Percentage of Subjects Achieving Low Disease Activity | week 180 | 65.7 percentage of participants |
| Placebo - AIN457A 75mg | Percentage of Subjects Achieving Low Disease Activity | week 208 | 67.2 percentage of participants |
| Placebo - AIN457A 75mg | Percentage of Subjects Achieving Low Disease Activity | week 260 | 76.9 percentage of participants |
| Placebo - AIN457A 75mg | Percentage of Subjects Achieving Low Disease Activity | week 116 | 70.4 percentage of participants |
| Placebo - AIN457A 75mg | Percentage of Subjects Achieving Low Disease Activity | week 128 | 75.4 percentage of participants |
| Placebo - AIN457 150mg | Percentage of Subjects Achieving Low Disease Activity | week 140 | 65.3 percentage of participants |
| Placebo - AIN457 150mg | Percentage of Subjects Achieving Low Disease Activity | week 156 | 58.9 percentage of participants |
| Placebo - AIN457 150mg | Percentage of Subjects Achieving Low Disease Activity | week 128 | 68.6 percentage of participants |
| Placebo - AIN457 150mg | Percentage of Subjects Achieving Low Disease Activity | week 116 | 63.9 percentage of participants |
| Placebo - AIN457 150mg | Percentage of Subjects Achieving Low Disease Activity | week 180 | 68.8 percentage of participants |
| Placebo - AIN457 150mg | Percentage of Subjects Achieving Low Disease Activity | week 260 | 77.4 percentage of participants |
| Placebo - AIN457 150mg | Percentage of Subjects Achieving Low Disease Activity | week 232 | 84.7 percentage of participants |
| Placebo - AIN457 150mg | Percentage of Subjects Achieving Low Disease Activity | week 208 | 71.2 percentage of participants |