Psoriatic Arthritis
Conditions
Keywords
PsA, ACR, CASPAR, inflammatory arthritis, spondylitis
Brief summary
To demonstrate that the efficacy of secukinumab 300 mg at Week 16 was superior to placebo in adult patients with active PsA based on the proportion of patients achieving an American College of Rheumatology 20 (ACR20) response.
Detailed description
Treatment Period 1 was defined as the period from Randomization through Week 16 (prior to the Week 16 dose). At the start of placebo-controlled Treatment Period 1, patients were randomized via Interactive Response Technology (IRT) in a 2:2:1 ratio to 1 of 3 treatment groups. Group 1- Secukinumab 300 mg: secukinumab 300 mg (2 s.c. injections of the 150-mg dose) once weekly for 5 weeks (at Baseline, Weeks 1, 2, 3, and 4), followed by dosing every 4 weeks. Group 2- Secukinumab 150 mg: secukinumab 150 mg (1 s.c. injection of the 150-mg dose and 1 s.c. injection of placebo) once weekly for 5 weeks (at Baseline, Weeks 1, 2, 3, and 4), followed by dosing every 4 weeks. Group 3- Placebo: placebo (2 s.c. injections of 150 mg secukinumab placebo per dose) once per week for 5 weeks (at Baseline, Weeks 1, 2, 3, and 4), followed by dosing every 4 weeks. At each study treatment visit 2 s.c. injections in the form of prefilled syringes (PFS) were administered. This was necessary to maintain the blind, as secukinumab in PFS is available in either 1.0 mL (150 mg) or 2 x 1.0 mL (300 mg). Placebo to secukinumab was also available in 1.0 mL to match the active drug. Rescue medication was not allowed before completion of Week 16 assessments. Treatment Period 2 patients receiving secukinumab 300 mg (Group 1) continued to receive the same dose up to Week 48. At Weeks 16, 28, and 40 patients on secukinumab 150 mg (Group 2) were classified as responders (≥20% improvement from BL in both tender and swollen joint counts) or nonresponders. * At Weeks 16, 28, and 40 patients on secukinumab 150 mg (Group 2) who were responders continued to receive secukinumab 150 mg (1.0 mL) plus placebo (1.0 mL) every 4 weeks until next evaluation of responder status at Weeks 28 or 40. * Patients who did not meet the responder criteria at Week 16, 28, or 40 started receiving secukinumab 300 mg s.c. every 4 weeks and continued this dose up to Week 48. * Patients on placebo (Group 3) regardless of their responder status started receiving secukinumab 300 mg s.c. every 4 weeks from Week 16 up to Week 48.
Interventions
150 mg x 2 s.c. injection
150 mg s.c. injection
OTHERPlacebo
Placebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Study design displays results combined as two or more Arms/Groups. Patients assigned to Placebo arm in Treatment Period 1 (TP1) may have switched to Secukinumab 300mg in Treatment Period 2 (TP2). Summaries by group were performed cumulatively by actual treatment received (as follows) for every visit until Week 16 groups in Treatment Period 1: · Secukinumab 300mg (Group 1) · Secukinumab 150mg (Group 2) · Placebo (Group 3) For entire treatment period, summaries by treatment group were performed cumulatively by the actual treatment received (as follows) for every visit til Week 52, including patients who switched at Weeks 16, 28, 40. For safety variables · Any Secukinumab 150 mg (Group 2) · Any Secukinumab 300mg (Group 1) · Any Secukinumab (Group 3) Hence, participants who received Placebo in TP1 were combined with participants who received Any Secukinumab in Group 3 and Any Secukinumab 300mg in Group 1 in TP2. Safety is presented for the ENTIRE period, including TP1 and TP2
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or non-pregnant, non-lactating female patients at least 18 years of age * Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each) * Rheumatoid factor and/or anti-CCP antibodies negative at screening * A target skin psoriatic lesion and a PASI score of 1 or greater
Exclusion criteria
* Chest X-ray with evidence of ongoing infectious or malignant process * Patients who ever received biologic immunomodulating agents including those targeting TNFα, IL-6 and IL-12/23 investigational or approved
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients Achieving American College of Rheumatology Score of at Least 20% (ACR20) Response Criteria on Secukinumab 300 mg and 150 mg vs. Placebo at Week 16 | 16 Weeks | A patient was considered as improved according to the ACR20 criteria if she/he had at least 20% improvement in two of the following measures:Tender joint count, Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity, Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR). Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Week 16 (Combined SPARCC and LEI) | 16 Weeks | Statistical analysis (logistic regression) of presence of enthesitis (Combined SPARCC and LEI) by visit - in treatment period 1 (non-responder imputation) (Combined SPARCC and LEI Subset) Enthesitis, also called enthesopathy, is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. |
| Percentage of Patients Achieving ACR70 Response Criteria on Secukinumab 300 or 150 mg vs. Placebo at Week 16 | 16 Weeks | A patient was considered as improved according the ACR70 criteria if she/he had at least 70% improvement in the two of the following measures: Tender joint count, Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR) Statistical analysis (logistic regression) of ACR70 response by visit - in treatment period 1 (non-responder imputation) Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. |
| Percentage of Patients Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 | 16 Weeks | A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis. |
| Percentage of Patients Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 | 16 Weeks | A 90% reduction in the Psoriasis Area and Severity Index score (PASI 90) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis. |
| Percentage of Patients Achieving a PASI100 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 | 16 Weeks | A 100% reduction in the Psoriasis Area and Severity Index score (PASI 100) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis. Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. |
| Change From Baseline to Week 16 in DAS28-CRP | baseline, 16 weeks | DAS-CRP uses the C-Reactive Protein (CRP) value. Disease Activity Score (DAS28-CRP) values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS28-CRP below the value of 2.6 is interpreted as Remission. DAS28-CRP uses 28 different joints for its calculation: proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2) With the above mentioned parameters. Least squares mean (LSM), Least squares mean (LSM) treatment difference, 95% confidence interval (CI) for treatment difference, and p-values are from an analysis of covariance (ANCOVA) model with treatment (3 treatment groups), baseline DAS28-CRP score, methotrexate usage at baseline (yes, no), and body weight(kg) as explanatory variables. |
| Change From Baseline to Week 16 in HAQ-DI | 16 Weeks | The Health assessment questionnaire disability index (HAQ-DI) is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled). |
| Percentage of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Week 16 | Week 16 | The percent of patients in the Dactylitis Subset with dactylitis in the secukinumab 300 mg group at Week 16. Dactylitis is severe inflammation of the finger and toe joints. Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. |
| Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline (SPARCC) at Week 16 | 16 Weeks | Enthesitis, also called enthesopathy, is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. |
| Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Week 16 (LEI) | 16 Weeks | Enthesitis, also called enthesopathy, is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. LEI=Leeds Enthesitis Index |
| Percentage of Patients Achieving ACR50 Response Criteria on Secukinumab 300 or 150 mg vs. Placebo at Week 16 | 16 Weeks | A patient was considered as improved according the ACR50 criteria if she/he had at least 50% improvement in the two of the following measures: Tender joint count, Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR) Statistical analysis (logistic regression) of ACR50 response by visit - in treatment period 1 (non-responder imputation) (Full Analysis Set) Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | up to 52 weeks | Exploratory |
| Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | up to 52 weeks | Exploratory |
| Number and Percentage of Patients With Minimal Disease Activity Response by Visit in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | up to 52 weeks | Exploratory |
| Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | up to 52 weeks | Exploratory |
| Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | up to 52 weeks | Exploratory |
| Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | up to 52 weeks | Exploratory The ACR20 is a composite measure defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP) |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Of 349 patients screened for the study, 271 passed screening and 258 were randomized (103 to secukinumab 300 mg, 103 to secukinumab 150 mg, and 52 to placebo). A higher percentage of patients in the secukinumab 300 mg group completed Period 1 (94.2%) than in the secukinumab 150 mg (90.3%) or placebo (88.5%) groups.
Pre-assignment details
This was a 2-Period study in which participants were randomized to one of three treatment groups (i.e., secukinumab 300mg s.c. injection, secukinumab 1500mg s.c. injection and placebo s.c. injection) in Period 1 and then some participants switched to Arms/Groups Group 4, Group 5, and Group 6, in Period 2.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 secukinumab 300mg s.c. injection | 103 |
| Group 2 secukinumab 150 mg s.c. injection | 103 |
| Group 3 Placebo s.c. injection | 52 |
| Total | 258 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Period 1 | Adverse Event | 1 | 1 | 0 | 0 | 0 | 0 |
| Period 1 | Death | 0 | 0 | 1 | 0 | 0 | 0 |
| Period 1 | Lost to Follow-up | 2 | 1 | 0 | 0 | 0 | 0 |
| Period 1 | Protocol Violation | 0 | 0 | 2 | 0 | 0 | 0 |
| Period 1 | Withdrawal by Subject | 1 | 1 | 0 | 0 | 0 | 0 |
| Period 1 | Withdrawal of Informed Consent | 2 | 7 | 3 | 0 | 0 | 0 |
| Period 2 | Adverse Event | 5 | 0 | 0 | 0 | 1 | 0 |
| Period 2 | Lack of Efficacy | 1 | 0 | 0 | 1 | 0 | 1 |
| Period 2 | Lost to Follow-up | 3 | 0 | 0 | 0 | 2 | 0 |
| Period 2 | Physician Decision | 1 | 0 | 0 | 1 | 1 | 0 |
| Period 2 | Pregnancy | 0 | 0 | 0 | 2 | 0 | 0 |
| Period 2 | Technical problems | 1 | 0 | 0 | 1 | 0 | 0 |
| Period 2 | Withdrawal by Subject | 2 | 0 | 0 | 0 | 2 | 2 |
| Period 2 | Withdrawal of Informed Consent | 1 | 0 | 0 | 2 | 2 | 3 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| Age, Continuous | 51.9 years STANDARD_DEVIATION 12.56 | 51.3 years STANDARD_DEVIATION 14.58 | 53.1 years STANDARD_DEVIATION 12.67 | 52.2 years STANDARD_DEVIATION 80.86 |
| Age, Customized ≥18-<40 | 20 Participants | 20 Participants | 8 Participants | 48 Participants |
| Age, Customized ≥40-<65 | 65 Participants | 61 Participants | 35 Participants | 161 Participants |
| Age, Customized ≥65-<75 | 14 Participants | 18 Participants | 9 Participants | 41 Participants |
| Age, Customized ≥75 | 4 Participants | 4 Participants | 0 Participants | 8 Participants |
| Race/Ethnicity, Customized Asian | 9 Participants | 10 Participants | 1 Participants | 20 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 2 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Caucasian | 88 Participants | 88 Participants | 45 Participants | 221 Participants |
| Race/Ethnicity, Customized Native American | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 50 Participants | 47 Participants | 29 Participants | 126 Participants |
| Sex: Female, Male Male | 53 Participants | 56 Participants | 23 Participants | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 191 | 0 / 103 | 1 / 52 |
| other Total, other adverse events | 66 / 191 | 35 / 103 | 12 / 52 |
| serious Total, serious adverse events | 15 / 191 | 4 / 103 | 3 / 52 |
Outcome results
Primary
Percent of Patients Achieving American College of Rheumatology Score of at Least 20% (ACR20) Response Criteria on Secukinumab 300 mg and 150 mg vs. Placebo at Week 16
A patient was considered as improved according to the ACR20 criteria if she/he had at least 20% improvement in two of the following measures:Tender joint count, Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity, Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR). Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables.
Time frame: 16 Weeks
Population: The Full Analysis Set (FAS) includes all patients assigned study medication. Patients inappropriately randomized (e.g., IRT was called in error for randomization of a screen failed patient) were excluded from analysis set. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Percent of Patients Achieving American College of Rheumatology Score of at Least 20% (ACR20) Response Criteria on Secukinumab 300 mg and 150 mg vs. Placebo at Week 16 | 51.46 percentage of participants |
| Group 2 | Percent of Patients Achieving American College of Rheumatology Score of at Least 20% (ACR20) Response Criteria on Secukinumab 300 mg and 150 mg vs. Placebo at Week 16 | 36.89 percentage of participants |
| Group 3 | Percent of Patients Achieving American College of Rheumatology Score of at Least 20% (ACR20) Response Criteria on Secukinumab 300 mg and 150 mg vs. Placebo at Week 16 | 23.08 percentage of participants |
Comparison: secukinumab 300mg s.c. injection, 16 weeksp-value: 0.001195% CI: [1.65, 7.45]Regression, Logistic
Comparison: secukinumab 150 mg s.c. injection, 16 weeksp-value: 0.096195% CI: [0.89, 4.15]Regression, Logistic
Secondary
Change From Baseline to Week 16 in DAS28-CRP
DAS-CRP uses the C-Reactive Protein (CRP) value. Disease Activity Score (DAS28-CRP) values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS28-CRP below the value of 2.6 is interpreted as Remission. DAS28-CRP uses 28 different joints for its calculation: proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2) With the above mentioned parameters. Least squares mean (LSM), Least squares mean (LSM) treatment difference, 95% confidence interval (CI) for treatment difference, and p-values are from an analysis of covariance (ANCOVA) model with treatment (3 treatment groups), baseline DAS28-CRP score, methotrexate usage at baseline (yes, no), and body weight(kg) as explanatory variables.
Time frame: baseline, 16 weeks
Population: The Full Analysis Set (FAS) includes all patients assigned study medication. Patients inappropriately randomized (e.g., IRT was called in error for randomization of a screen failed patient) were excluded from analysis set. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Change From Baseline to Week 16 in DAS28-CRP | -1.39 scores on a scale | Standard Deviation 0.12 |
| Group 2 | Change From Baseline to Week 16 in DAS28-CRP | -1.18 scores on a scale | Standard Deviation 0.125 |
| Group 3 | Change From Baseline to Week 16 in DAS28-CRP | -0.35 scores on a scale | Standard Deviation 0.17 |
Comparison: secukinumab 150 mg s.c. injectionp-value: <0.000195% CI: [-1.24, -0.43]ANCOVA
Comparison: secukinumab 300mg s.c. injection, 16 weeksp-value: <0.000195% CI: [-1.45, -0.65]ANCOVA
Secondary
Change From Baseline to Week 16 in HAQ-DI
The Health assessment questionnaire disability index (HAQ-DI) is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).
Time frame: 16 Weeks
Population: The Full Analysis Set (FAS) includes all patients assigned study medication. Patients inappropriately randomized (e.g., IRT was called in error for randomization of a screen failed patient) were excluded from analysis set. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Group 1 | Change From Baseline to Week 16 in HAQ-DI | -0.32 scores on a scale |
| Group 2 | Change From Baseline to Week 16 in HAQ-DI | -0.24 scores on a scale |
| Group 3 | Change From Baseline to Week 16 in HAQ-DI | -0.11 scores on a scale |
Comparison: secukinumab 300mg s.c. injectionp-value: 0.010795% CI: [-0.37, -0.05]ANCOVA
p-value: 0.110995% CI: [-0.3, 0.03]ANCOVA
Secondary
Percentage of Patients Achieving ACR50 Response Criteria on Secukinumab 300 or 150 mg vs. Placebo at Week 16
A patient was considered as improved according the ACR50 criteria if she/he had at least 50% improvement in the two of the following measures: Tender joint count, Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR) Statistical analysis (logistic regression) of ACR50 response by visit - in treatment period 1 (non-responder imputation) (Full Analysis Set) Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables.
Time frame: 16 Weeks
Population: The Full Analysis Set (FAS) includes all patients assigned study medication. Patients inappropriately randomized (e.g., IRT was called in error for randomization of a screen failed patient) were excluded from analysis set. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Patients Achieving ACR50 Response Criteria on Secukinumab 300 or 150 mg vs. Placebo at Week 16 | 28.16 percentage of participants |
| Group 2 | Percentage of Patients Achieving ACR50 Response Criteria on Secukinumab 300 or 150 mg vs. Placebo at Week 16 | 24.27 percentage of participants |
| Group 3 | Percentage of Patients Achieving ACR50 Response Criteria on Secukinumab 300 or 150 mg vs. Placebo at Week 16 | 5.77 percentage of participants |
Comparison: secukinumab 300mg s.c. injection, week 16p-value: 0.003895% CI: [1.81, 21.88]Regression, Logistic
Comparison: secukinumab 150 mg s.c. injection, week 16p-value: 0.014995% CI: [1.36, 16.77]Regression, Logistic
Secondary
Percentage of Patients Achieving ACR70 Response Criteria on Secukinumab 300 or 150 mg vs. Placebo at Week 16
A patient was considered as improved according the ACR70 criteria if she/he had at least 70% improvement in the two of the following measures: Tender joint count, Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR) Statistical analysis (logistic regression) of ACR70 response by visit - in treatment period 1 (non-responder imputation) Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables.
Time frame: 16 Weeks
Population: The Full Analysis Set (FAS) includes all patients assigned study medication. Patients inappropriately randomized (e.g., IRT was called in error for randomization of a screen failed patient) were excluded from analysis set. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Patients Achieving ACR70 Response Criteria on Secukinumab 300 or 150 mg vs. Placebo at Week 16 | 17.48 percentage of participants |
| Group 2 | Percentage of Patients Achieving ACR70 Response Criteria on Secukinumab 300 or 150 mg vs. Placebo at Week 16 | 10.68 percentage of participants |
| Group 3 | Percentage of Patients Achieving ACR70 Response Criteria on Secukinumab 300 or 150 mg vs. Placebo at Week 16 | 1.92 percentage of participants |
Comparison: secukinumab 300mg s.c. injection, week 16p-value: 0.024395% CI: [1.36, 81.3]Regression, Logistic
Comparison: secukinumab 150 mg s.c. injection, week 16p-value: 0.11295% CI: [0.67, 43.64]Regression, Logistic
Secondary
Percentage of Patients Achieving a PASI100 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16
A 100% reduction in the Psoriasis Area and Severity Index score (PASI 100) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis. Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables.
Time frame: 16 Weeks
Population: Psoriasis Subset: The psoriasis subset comprises patients having Body Surface Area (BSA) \>= 3% at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Patients Achieving a PASI100 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 | 25.32 percentage of participants |
| Group 2 | Percentage of Patients Achieving a PASI100 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 | 18.07 percentage of participants |
| Group 3 | Percentage of Patients Achieving a PASI100 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 | 2.33 percentage of participants |
Comparison: secukinumab 300 mg s.c. injection, week 16p-value: 0.010795% CI: [1.86, 111.53]Regression, Logistic
Comparison: secukinumab 150 mg s.c. injection, week 16p-value: 0.030795% CI: [1.24, 77.9]Regression, Logistic
Secondary
Percentage of Patients Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16
A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis.
Time frame: 16 Weeks
Population: Psoriasis Subset: The psoriasis subset comprises patients having Body Surface Area (BSA) \>= 3% at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Patients Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 | 64.56 percentage of participants |
| Group 2 | Percentage of Patients Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 | 54.22 percentage of participants |
| Group 3 | Percentage of Patients Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 | 16.28 percentage of participants |
Comparison: secukinumab 300 mg s.c. injection, week 16p-value: <0.000195% CI: [3.73, 24.16]Regression, Logistic
Comparison: secukinumab 150 mg s.c. injection, week 16p-value: 0.000195% CI: [2.51, 16.24]Regression, Logistic
Secondary
Percentage of Patients Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16
A 90% reduction in the Psoriasis Area and Severity Index score (PASI 90) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis.
Time frame: 16 Weeks
Population: Psoriasis Subset: The psoriasis subset comprises patients having Body Surface Area (BSA) \>= 3% at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Patients Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 | 49.37 percentage of participants |
| Group 2 | Percentage of Patients Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 | 36.14 percentage of participants |
| Group 3 | Percentage of Patients Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 | 9.3 percentage of participants |
Comparison: secukinumab 300 mg s.c. injection, week 16p-value: <0.000195% CI: [3.19, 30.45]Regression, Logistic
Comparison: secukinumab 150 mg s.c. injection, week 16p-value: 0.004395% CI: [1.68, 16.21]Regression, Logistic
Secondary
Percentage of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Week 16
The percent of patients in the Dactylitis Subset with dactylitis in the secukinumab 300 mg group at Week 16. Dactylitis is severe inflammation of the finger and toe joints. Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables.
Time frame: Week 16
Population: Dactylitis Subset: The Dactylitis Subset comprises patients who have LDI \>= 1 at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Week 16 | 53.06 percent of participants |
| Group 2 | Percentage of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Week 16 | 44.23 percent of participants |
| Group 3 | Percentage of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Week 16 | 65.22 percent of participants |
Comparison: secukinumab 300 mg s.c. injection, 16 weeksp-value: 0.33395% CI: [0.22, 1.68]Regression, Logistic
Comparison: secukinumab 150 mg s.c. injection, 16 weeksp-value: 0.084195% CI: [0.14, 1.13]Regression, Logistic
Secondary
Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline (SPARCC) at Week 16
Enthesitis, also called enthesopathy, is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables.
Time frame: 16 Weeks
Population: Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC) subset. The SPARCC Subset is comprised of patients who have SPARCC \>= 1 at baseline. Score range is 0-16 sites where a higher indicates more enthesitis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline (SPARCC) at Week 16 | 63.89 percentage of participants |
| Group 2 | Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline (SPARCC) at Week 16 | 57.89 percentage of participants |
| Group 3 | Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline (SPARCC) at Week 16 | 76.92 percentage of participants |
Comparison: secukinumab 300mg s.c. injection, 16 weeksp-value: 0.161895% CI: [0.21, 1.3]Regression, Logistic
Comparison: secukinumab 150mg s.c. injection, 16 weeksp-value: 0.089895% CI: [0.19, 1.13]Regression, Logistic
Secondary
Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Week 16 (Combined SPARCC and LEI)
Statistical analysis (logistic regression) of presence of enthesitis (Combined SPARCC and LEI) by visit - in treatment period 1 (non-responder imputation) (Combined SPARCC and LEI Subset) Enthesitis, also called enthesopathy, is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables.
Time frame: 16 Weeks
Population: Combined SPARCC and LEI Subset: The LEI and SPARCC Subset comprises patients who have an enthesitis score \>= 1 when sites from LEI and SPARCC are assessed together at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Week 16 (Combined SPARCC and LEI) | 62.16 percentage of participants |
| Group 2 | Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Week 16 (Combined SPARCC and LEI) | 59.21 percentage of participants |
| Group 3 | Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Week 16 (Combined SPARCC and LEI) | 82.05 percentage of participants |
Comparison: secukinumab 300mg s.c. injection, 16 weeksp-value: 0.033895% CI: [0.13, 0.92]Regression, Logistic
Comparison: secukinumab 150mg s.c. injection, 16 weeksp-value: 0.035995% CI: [0.14, 0.93]Regression, Logistic
Secondary
Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Week 16 (LEI)
Enthesitis, also called enthesopathy, is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. LEI=Leeds Enthesitis Index
Time frame: 16 Weeks
Population: LEI subset: The LEI Subset comprises patients who have LEI \>= 1 at baseline. LEI uses 6 sites for evaluation of enthesitis, so the range is 0-6 withy a higher number indicating more arthritis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Week 16 (LEI) | 56.06 percentage of participants |
| Group 2 | Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Week 16 (LEI) | 52.24 percentage of participants |
| Group 3 | Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Week 16 (LEI) | 82.35 percentage of participants |
Comparison: secukinumab 300mg s.c. injection, 16 weeksp-value: 0.012595% CI: [0.09, 0.75]Regression, Logistic
Comparison: secukinumab 150mg s.c. injection, 16 weeksp-value: 0.008695% CI: [0.09, 0.7]Regression, Logistic
Other Pre-specified
Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation)
Exploratory The ACR20 is a composite measure defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP)
Time frame: up to 52 weeks
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 | Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 16 | 51.46 percentage of participants |
| Group 1 | Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 1 | 17.48 percentage of participants |
| Group 1 | Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 52 | 47.57 percentage of participants |
| Group 2 | Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 16 | 72.00 percentage of participants |
| Group 2 | Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 1 | 8.00 percentage of participants |
| Group 2 | Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 52 | 68.00 percentage of participants |
| Group 3 | Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 16 | 4.76 percentage of participants |
| Group 3 | Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 1 | 4.76 percentage of participants |
| Group 3 | Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 52 | 28.57 percentage of participants |
| Group 4 | Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 1 | 5.83 percentage of participants |
| Group 4 | Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 52 | 44.66 percentage of participants |
| Group 4 | Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 16 | 36.89 percentage of participants |
| Group 5 | Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 16 | 23.08 percentage of participants |
| Group 5 | Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 1 | 1.92 percentage of participants |
| Group 5 | Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 52 | 42.31 percentage of participants |
Other Pre-specified
Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation)
Exploratory
Time frame: up to 52 weeks
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR50 - week 52 | 32.04 percentage of participants |
| Group 1 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR70 - week 16 | 17.48 percentage of participants |
| Group 1 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR50 - week 16 | 28.16 percentage of participants |
| Group 1 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR50 - week 1 | 2.91 percentage of participants |
| Group 1 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR70 - week 52 | 21.36 percentage of participants |
| Group 2 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR70 - week 16 | 22.00 percentage of participants |
| Group 2 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR50 - week 16 | 46.00 percentage of participants |
| Group 2 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR70 - week 52 | 28.00 percentage of participants |
| Group 2 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR50 - week 52 | 48.00 percentage of participants |
| Group 3 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR50 - week 52 | 14.29 percentage of participants |
| Group 3 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR50 - week 16 | 4.76 percentage of participants |
| Group 3 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR50 - week 1 | 2.38 percentage of participants |
| Group 3 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR70 - week 52 | 4.76 percentage of participants |
| Group 4 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR70 - week 52 | 15.53 percentage of participants |
| Group 4 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR50 - week 16 | 24.27 percentage of participants |
| Group 4 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR70 - week 16 | 10.68 percentage of participants |
| Group 4 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR50 - week 1 | .97 percentage of participants |
| Group 4 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR50 - week 52 | 29.13 percentage of participants |
| Group 5 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR70 - week 52 | 5.77 percentage of participants |
| Group 5 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR50 - week 16 | 5.77 percentage of participants |
| Group 5 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR70 - week 16 | 1.92 percentage of participants |
| Group 5 | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | ACR50 - week 52 | 17.31 percentage of participants |
Other Pre-specified
Number and Percentage of Patients With Minimal Disease Activity Response by Visit in Entire Treatment Period (up to Week 52) (Non-responder Imputation)
Exploratory
Time frame: up to 52 weeks
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 | Number and Percentage of Patients With Minimal Disease Activity Response by Visit in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 16 | 36.36 percentage of participants |
| Group 1 | Number and Percentage of Patients With Minimal Disease Activity Response by Visit in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 52 | 26.21 percentage of participants |
| Group 1 | Number and Percentage of Patients With Minimal Disease Activity Response by Visit in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 1 | 0.97 percentage of participants |
| Group 2 | Number and Percentage of Patients With Minimal Disease Activity Response by Visit in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 16 | 69.70 percentage of participants |
| Group 2 | Number and Percentage of Patients With Minimal Disease Activity Response by Visit in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 52 | 42.00 percentage of participants |
| Group 3 | Number and Percentage of Patients With Minimal Disease Activity Response by Visit in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 16 | 25.93 percentage of participants |
| Group 3 | Number and Percentage of Patients With Minimal Disease Activity Response by Visit in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 52 | 14.29 percentage of participants |
| Group 4 | Number and Percentage of Patients With Minimal Disease Activity Response by Visit in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 16 | 44.78 percentage of participants |
| Group 4 | Number and Percentage of Patients With Minimal Disease Activity Response by Visit in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 52 | 26.21 percentage of participants |
| Group 5 | Number and Percentage of Patients With Minimal Disease Activity Response by Visit in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 52 | 3.85 percentage of participants |
| Group 5 | Number and Percentage of Patients With Minimal Disease Activity Response by Visit in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 16 | 26.47 percentage of participants |
Other Pre-specified
Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation)
Exploratory
Time frame: up to 52 weeks
Population: Psoriasis subset~The psoriasis subset comprises patients having Body Surface Area (BSA) \>= 3% at baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI90 - week 1 | 1.27 percentage of participants |
| Group 1 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI90 - week 16 | 49.37 percentage of participants |
| Group 1 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI75 - week 16 | 64.56 percentage of participants |
| Group 1 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI75 - week 1 | 8.86 percentage of participants |
| Group 1 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI100 - week 52 | 31.65 percentage of participants |
| Group 1 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI90- week 52 | 48.10 percentage of participants |
| Group 1 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI75 - week 52 | 67.09 percentage of participants |
| Group 1 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI100 - week 16 | 25.32 percentage of participants |
| Group 2 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI90 - week 16 | 60.00 percentage of participants |
| Group 2 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI100 - week 16 | 37.50 percentage of participants |
| Group 2 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI75 - week 1 | 7.5 percentage of participants |
| Group 2 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI75 - week 16 | 80.00 percentage of participants |
| Group 2 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI75 - week 52 | 77.50 percentage of participants |
| Group 2 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI90- week 52 | 67.50 percentage of participants |
| Group 2 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI100 - week 52 | 55.00 percentage of participants |
| Group 3 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI75 - week 16 | 38.24 percentage of participants |
| Group 3 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI75 - week 52 | 52.94 percentage of participants |
| Group 3 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI90 - week 1 | 2.94 percentage of participants |
| Group 3 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI100 - week 52 | 26.47 percentage of participants |
| Group 3 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI75 - week 1 | 11.76 percentage of participants |
| Group 3 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI90 - week 16 | 17.65 percentage of participants |
| Group 3 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI90- week 52 | 35.29 percentage of participants |
| Group 4 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI75 - week 52 | 59.04 percentage of participants |
| Group 4 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI75 - week 16 | 54.22 percentage of participants |
| Group 4 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI90 - week 16 | 36.14 percentage of participants |
| Group 4 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI75 - week 1 | 8.43 percentage of participants |
| Group 4 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI100 - week 52 | 37.35 percentage of participants |
| Group 4 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI90- week 52 | 46.99 percentage of participants |
| Group 4 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI100 - week 16 | 18.07 percentage of participants |
| Group 4 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI90 - week 1 | 1.2 percentage of participants |
| Group 5 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI90 - week 1 | 1 percentage of participants |
| Group 5 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI75 - week 16 | 16.28 percentage of participants |
| Group 5 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI100 - week 1 | 2.33 percentage of participants |
| Group 5 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI90- week 52 | 44.19 percentage of participants |
| Group 5 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI100 - week 52 | 32.56 percentage of participants |
| Group 5 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI100 - week 16 | 2.33 percentage of participants |
| Group 5 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI90 - week 16 | 9.30 percentage of participants |
| Group 5 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI75 - week 52 | 53.49 percentage of participants |
| Group 5 | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | PASI75 - week 1 | 4.65 percentage of participants |
Other Pre-specified
Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation)
Exploratory
Time frame: up to 52 weeks
Population: Dactylitis Subset~The Dactylitis Subset comprised patients who had LDI ≥1 at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 | Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 1 | 42.72 percentage of participants |
| Group 1 | Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 52 | 10.68 percentage of participants |
| Group 1 | Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 16 | 25.24 percentage of participants |
| Group 2 | Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 16 | 24.00 percentage of participants |
| Group 2 | Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 1 | 42.00 percentage of participants |
| Group 2 | Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 52 | 6.00 percentage of participants |
| Group 3 | Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 16 | 26.19 percentage of participants |
| Group 3 | Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 1 | 35.71 percentage of participants |
| Group 3 | Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 52 | 11.90 percentage of participants |
| Group 4 | Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 1 | 40.78 percentage of participants |
| Group 4 | Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 52 | 7.77 percentage of participants |
| Group 4 | Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 16 | 22.33 percentage of participants |
| Group 5 | Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 16 | 28.85 percentage of participants |
| Group 5 | Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 1 | 32.69 percentage of participants |
| Group 5 | Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 52 | 9.62 percentage of participants |
Other Pre-specified
Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation)
Exploratory
Time frame: up to 52 weeks
Population: Leeds Enthesitis Index (LEI) Subset:~The LEI Subset comprised patients who had LEI ≥1 at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 | Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 16 | 56.06 percentage of participants |
| Group 1 | Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 1 | 84.85 percentage of participants |
| Group 1 | Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 52 | 53.03 percentage of participants |
| Group 2 | Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 52 | 36.36 percentage of participants |
| Group 2 | Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 1 | 66.67 percentage of participants |
| Group 2 | Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 16 | 24.24 percentage of participants |
| Group 3 | Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 16 | 77.78 percentage of participants |
| Group 3 | Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 1 | 88.89 percentage of participants |
| Group 3 | Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 52 | 66.67 percentage of participants |
| Group 4 | Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 1 | 77.61 percentage of participants |
| Group 4 | Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 52 | 53.73 percentage of participants |
| Group 4 | Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 16 | 52.24 percentage of participants |
| Group 5 | Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 52 | 61.76 percentage of participants |
| Group 5 | Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 16 | 82.35 percentage of participants |
| Group 5 | Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | week 1 | 79.41 percentage of participants |