Moderate to Severe Plaque-type Psoriasis
Conditions
Keywords
Psoriasis, inflammatory skin disease, scaly patches, secukinumab (AIN457), Psoriasis Area and Severity Index (PASI), Investigator Global Assessment (IGA) mod 2011
Brief summary
This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) were eligible to join this extension study. This extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab were used.
Interventions
Secukinumab is a new type of psoriasis medication called 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). IL-17 is believed to be partly responsible for inflammation (pain, swelling, redness). Researchers believe that IL-17 causes symptoms of plaque-type psoriasis like plaques and scales. A product that targets IL-17 therefore may help to relieve these symptoms and conditions.
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
Key Inclusion Criteria: Completed the full study treatment period of 52 weeks in preceding phase III studies, and have been receiving secukinumab treatment during the maintenance phase of the preceding phase III studies, and show at least a partial response (PASI 50 or better) at Week 52 of the preceding phase III studies. Written informed consent form. Key
Exclusion criteria
A protocol deviation in either of the preceding phase III studies which according to the investigator prevented the meaningful analysis of the extension study for the individual subject. Ongoing use of prohibited psoriasis or non-psoriasis treatments. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\>10 mIU/mL). Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68 | At week 68 (16 weeks after week 52) | The primary variable was the cumulative rate of patients who lost PASI 75 response up to Week 68 (time=0 being defined as Week 52). Loss of PASI 75 response was analyzed by means of a survival analysis defining loss of PASI 75 response as failure. The term cumulative rate corresponded to 1 minus the survival function within this survival analysis, and the cumulative rate and the survival functions were dependent on time t. PASI 75 response: patients achieving ≥ 75% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 75 responders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Week 52, Week 104, Week 156, week 208, week 260 | Psoriasis Area and Severity Index (PASI) scoring system: The average degree of severity of each sign in each of the four body regions was assigned a score of 0-4. The area covered by lesions on each body region was estimated as a percentage of the total area of that particular body region. |
| Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period | Week 52, 104, and 156 | The improvement (decrease from baseline) in PASI total scores observed at Week 52. Perc. change = 100 x Abs. change /Base. (Abs. change = Post - Base) For each post-baseline visit only patients with a value at both baseline and the respective post-baseline visit are included. |
| Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period | Week 52, Week 104, Week 156, week 208, week 260 | Perc. change = 100 x Abs. change /Base. (Abs. change = Post - Base) For each post-baseline visit only patients with a value at both baseline and the respective post-baseline visit are included. |
| Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Week 52 (baseline), 104, and 156 | Investigator Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0: Clear (No signs of psoriasis. Post-inflammatory hyperpigmentation could be Present). Score 1: Almost clear (Normal to pink coloration of lesions; no thickening; no to minimal focal scaling), Score 2: Mild (Pink to light red coloration; just detectable to mild thickening; predominantly fine scaling). Score 3: Moderate (Dull bright red, clearly distinguishable erythema; clearly distinguishable to moderate thickening; moderate scaling). Score 4: Severe (Bright to deep dark red coloration; severe thickening with hard edges; severe /coarse scaling covering almost all or all lesions). Patients in the placebo groups were not evaluable after re-treatment with Secukinumab |
| Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Week 52, Week 104, Week 156, week 208, week 260 | Investigator's Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions) |
| Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period | Week 52, Week 104, Week 156, week 208, week 260 | Investigator's Global Assessment (IGA) mod 2011 0/1. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions) Based on this scale, a patient was considered as IGA mod 2011 0/1 responder if the patient achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline. |
| Percent of Participants With Loss of IGA Mod 2011 0 or 1 Response Over Time for Subjects With IGA Mod 2011 0 or 1 Response at Week 52 - Randomized Withdrawal Period | Week 68 | Summary for loss of IGA mod 2011 0 or 1 response over time for patients with response at Week 52. time = 0 refers to Week 52 |
| Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse | up to week 260 | PASI 75 response since reinitiating treatment after relapse. time = 0 refers to Week 52 |
| Percent of Participants With IGA Mod 0 or 1 Response - Treatment Period for Re-treated After Relapse | up to week 260 | IGA mod 2011 0 or 1 response since reinitiating treatment after relapse for subjects with IGA 0 or 1 response at week 52 and not have IGA 0 or 1 response at relapse. time = 0 refers to Week 52 |
| Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period | up to week 156 | Time 0 = week 52 |
| Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Week 52, 104, and 156 | Psoriasis Area and Severity Index (PASI) 75 responder at week 52. Patients in the placebo groups were not evaluable after re-treatment with Secukinumab. PASI 75 Responders: patients with a PASI 75 response (patients achieving ≥75% improvement \[reduction\] in PASI score compared to baseline of the core study). PASI 50 response: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 50 responders. PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 90 responders. PASI 100 response/remission: complete clearing of psoriasis (PASI=0) |
| Percent of Participants With Rebound After Last Injection | up to week 68 | Rebound: PASI increases to \> 125% of baseline (where baseline is the PASI at the randomization of the core study) or presence of new pustular psoriasis, new erythrodermic psoriasis or more inflammatory psoriasis occurring within 8 Weeks of stopping therapy (after the last dose of study treatment received). Rebound like event (RLE) was defined as increase of PASI of \> 125% from baseline value or occurrence of new pustular, new erythrodermic or more inflammatory psoriasis any time after stopping therapy (last treatment administered) up to Week 68. Rebound was evaluated for the patients randomized to the placebo groups in the extension study; hence these patients received the last dose of secukinumab during the core studies. |
| Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156 | Dermatology Life Quality Index (DLQI) scores range from 0 to 30. Lower absolute scores on DLQI indicate better/improved health-related quality-of life impairment. |
| Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period | Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156 | Dermatology Life Quality Index (DLQI) scores range from 0 to 30. Lower absolute scores on DLQI indicate better/improved health-related quality-of life impairment. |
| EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156 | EQ-5D: EuroQOL 5-Dimension Health Status Questionnaire. The EQ-5D© is a generic instrument to assess each patient's health status. It provides a simple descriptive profile and a single index value for health status. The EQ visual analog scale records the respondent's self-rated health on a vertical scale where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents. |
| EQ-5D Health State Assessment (Observed Value) - Entire Study Period | week 64, 76, 88, 104, 116, 128, 140, and 156 | EQ-5D: EuroQOL 5-Dimension Health Status Questionnaire. The EQ-5D© is a generic instrument to assess each patient's health status. It provides a simple descriptive profile and a single index value for health status. The EQ visual analog scale records the respondent's self-rated health on a vertical scale where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents. |
| Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Week 52-156 | CTCAE: common terminology criteria for adverse events. A subject with multiple variable measurements is counted only once under the worst condition. LLN = lower limit of normal. IR=incidence rate per 100 subject years |
| Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | approximately 4 years | CTCAE: common terminology criteria for adverse events. A subject with multiple variable measurements is counted only once under the worst condition. LLN = lower limit of normal. |
| Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | Week 52 - 156 | QTcB: QT interval corrected using Bazett's formula QTcF: QT interval corrected using Fridericia's formula A patient with multiple variable measurements is counted only once under the worst condition. IR=incidence rate per 100 subject years. |
| Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | Approximately 4 years | QTcB: QT interval corrected using Bazett's formula QTcF: QT interval corrected using Fridericia's formula A patient with multiple variable measurements is counted only once under the worst condition. |
| Percent of Participants With Relapse After Last Injection | up to week 16 | Relapse: when the achieved maximal PASI improvement from baseline of core study was reduced by \>50%. Time 0 = week 52 |
Countries
Argentina, Australia, Belgium, Canada, Colombia, Estonia, Finland, France, Germany, Guatemala, Hungary, Iceland, Israel, Italy, Japan, Latvia, Lithuania, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
Among the 1146 patients who completed the screening phase, 995 PASI 75 responder at week 52 patients were randomized in a double blind fashion to either active treatment or placebo & entered the randomized withdrawal period and 151 partial responders at week 52 patients entered treatment period of the Extension.
Pre-assignment details
1366 patients who completed the core studies (CAIN457A2302 or CAIN457A2303) and provided consent for participation in the extension study were screened, and 1146 (83.9%) completed the screening phase and entered the extension.
Participants by arm
| Arm | Count |
|---|---|
| AIN457 150 mg -Randomized Withdrawal Period PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg | 301 |
| AIN457 300 mg -Randomized Withdrawal Period PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg | 363 |
| AIN457 150 mg Placebo - Randomized Withdrawal Period PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo | 150 |
| AIN457 300 mg Placebo - Randomized Withdrawal Period PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo | 181 |
| AIN457 150 mg - Partial Responders PASI 50 responders / PASI 75 non responders at Week 52, treated with AIN 150 mg in core and extension study | 98 |
| AIN457 300 mg - Partial Responders PASI 50 responders / PASI 75 non responders at Week 52, treated with AIN 300 mg in core and extension study | 53 |
| Total | 1,146 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Status at Week 156 | Adverse Event | 9 | 11 | 1 | 3 | 4 | 2 |
| Status at Week 156 | Lack of Efficacy | 1 | 0 | 1 | 4 | 10 | 5 |
| Status at Week 156 | Lost to Follow-up | 4 | 4 | 0 | 1 | 4 | 1 |
| Status at Week 156 | Moved to treatment period ≤ wk 156 | 86 | 44 | 131 | 145 | 0 | 0 |
| Status at Week 156 | Non-compliance with study treatement | 0 | 1 | 0 | 1 | 0 | 1 |
| Status at Week 156 | Physician Decision | 0 | 3 | 1 | 0 | 0 | 0 |
| Status at Week 156 | Pregnancy | 2 | 3 | 0 | 0 | 0 | 0 |
| Status at Week 156 | Protocol Violation | 3 | 1 | 2 | 2 | 0 | 0 |
| Status at Week 156 | Technical problems | 3 | 1 | 0 | 1 | 0 | 0 |
| Status at Week 156 | Withdrawal by Subject | 9 | 10 | 4 | 9 | 20 | 6 |
| Status at Week 68 | Adverse Event | 3 | 2 | 1 | 0 | 0 | 0 |
| Status at Week 68 | Lack of Efficacy | 1 | 0 | 0 | 0 | 0 | 0 |
| Status at Week 68 | Lost to Follow-up | 1 | 1 | 0 | 0 | 0 | 0 |
| Status at Week 68 | Moved to treatment period ≤ wk 68 | 30 | 13 | 60 | 46 | 0 | 0 |
| Status at Week 68 | Non-compliance with study treatment | 1 | 0 | 0 | 1 | 0 | 0 |
| Status at Week 68 | Protocol Violation | 2 | 0 | 1 | 1 | 0 | 0 |
| Status at Week 68 | Technical problems | 1 | 0 | 0 | 1 | 0 | 0 |
| Status at Week 68 | Withdrawal by Subject | 0 | 1 | 1 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | AIN457 150 mg Placebo - Randomized Withdrawal Period | AIN457 300 mg Placebo - Randomized Withdrawal Period | AIN457 150 mg - Partial Responders | AIN457 300 mg -Randomized Withdrawal Period | AIN457 300 mg - Partial Responders | AIN457 150 mg -Randomized Withdrawal Period | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 47.1 years STANDARD_DEVIATION 13.34 | 45.4 years STANDARD_DEVIATION 13.09 | 46.8 years STANDARD_DEVIATION 12.78 | 45.8 years STANDARD_DEVIATION 12.92 | 48.5 years STANDARD_DEVIATION 11.98 | 45.9 years STANDARD_DEVIATION 12.93 | 46.2 years STANDARD_DEVIATION 12.84 |
| Race/Ethnicity, Customized Asian | 22 participants | 24 participants | 17 participants | 50 participants | 8 participants | 52 participants | 173 participants |
| Race/Ethnicity, Customized Black | 2 participants | 3 participants | 4 participants | 4 participants | 1 participants | 4 participants | 18 participants |
| Race/Ethnicity, Customized Caucasian | 115 participants | 136 participants | 73 participants | 276 participants | 42 participants | 213 participants | 855 participants |
| Race/Ethnicity, Customized Native American | 9 participants | 15 participants | 2 participants | 23 participants | 2 participants | 24 participants | 75 participants |
| Race/Ethnicity, Customized Other | 1 participants | 1 participants | 1 participants | 7 participants | 0 participants | 7 participants | 17 participants |
| Race/Ethnicity, Customized Pacific Islander | 0 participants | 1 participants | 1 participants | 2 participants | 0 participants | 1 participants | 5 participants |
| Race/Ethnicity, Customized Unknown | 1 participants | 1 participants | 0 participants | 1 participants | 0 participants | 0 participants | 3 participants |
| Sex: Female, Male Female | 45 Participants | 62 Participants | 28 Participants | 102 Participants | 10 Participants | 83 Participants | 330 Participants |
| Sex: Female, Male Male | 105 Participants | 119 Participants | 70 Participants | 261 Participants | 43 Participants | 218 Participants | 816 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 545 | 2 / 890 | 2 / 1,113 | 0 / 150 | 0 / 181 |
| other Total, other adverse events | 386 / 545 | 679 / 890 | 889 / 1,113 | 75 / 150 | 86 / 181 |
| serious Total, serious adverse events | 61 / 545 | 143 / 890 | 198 / 1,113 | 4 / 150 | 13 / 181 |
Outcome results
Primary
Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68
The primary variable was the cumulative rate of patients who lost PASI 75 response up to Week 68 (time=0 being defined as Week 52). Loss of PASI 75 response was analyzed by means of a survival analysis defining loss of PASI 75 response as failure. The term cumulative rate corresponded to 1 minus the survival function within this survival analysis, and the cumulative rate and the survival functions were dependent on time t. PASI 75 response: patients achieving ≥ 75% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 75 responders.
Time frame: At week 68 (16 weeks after week 52)
Population: Full analysis set (FAS): patients from randomized set with at least 1 post baseline efficacy assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68 | 49.8 Cummulative rate |
| AIN457 300 mg -Randomized Withdrawal Period | Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68 | 25.4 Cummulative rate |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68 | 74.3 Cummulative rate |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68 | 64.7 Cummulative rate |
Comparison: The following hypotheses were tested for 52 weeks≤ t ≤68 weeks~* H1: p1(t) - p0,1(t) = 0 versus HA1: p1(t)- p0,1(t) ≥ 0,~* H2: p2(t) - p0,2(t) = 0 versus HA2: p2(t) - p0,2(t) ≥ 0,p-value: <0.000195% CI: [0.22, 0.42]Log Rank
Comparison: The following hypotheses were tested for 52 weeks≤ t ≤68 weeks~* H1: p1(t) - p0,1(t) = 0 versus HA1: p1(t)- p0,1(t) ≥ 0,~* H2: p2(t) - p0,2(t) = 0 versus HA2: p2(t) - p0,2(t) ≥ 0,p-value: <0.000195% CI: [0.14, 0.29]Log Rank
Secondary
Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period
CTCAE: common terminology criteria for adverse events. A subject with multiple variable measurements is counted only once under the worst condition. LLN = lower limit of normal. IR=incidence rate per 100 subject years
Time frame: Week 52-156
Population: Safety set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Lymphocytes (<LLN-0.8x10e9 /L) | 6.4 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Leukocytes (< 3.0 - 2.0 x 10E9/L) | 1.4 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Leukocytes (< 2.0 - 1.0 x 10E9/L) | 0.2 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Leukocytes (< 1.0 x 10E9/L) | 0.0 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Leukocytes (< LLN - 3.0 x 10E9/L) | 7.0 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Lymphocytes (<0.8-0.5x10e9 /L) | 3.0 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Lymphocytes (<0.5-0.2 x 10e9 /L) | 0.2 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Lymphocytes (<0.2x10e9 /L) | 0.0 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Neutrophils (<LLN-1.5x10e9 /L) | 5.9 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Neutrophils (<1.5-1.0x10e9 /L) | 1.4 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Neutrophils (<1.0 - 0.5x10e9 /L) | 0.9 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Neutrophils (<0.5x10e9 /L) | 0.0 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Platelets (LLN-75 x10e9 /L) | 3.3 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Platelets (<75-50 x 10e9 /L) | 0.2 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Platelets (<50-25 x 10e9 /L) | 0.0 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Platelets (<25x10e9 /L) | 0.0 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Lymphocytes (<0.8-0.5x10e9 /L) | 1.8 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Neutrophils (<LLN-1.5x10e9 /L) | 5.6 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Platelets (<25x10e9 /L) | 0.2 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Neutrophils (<0.5x10e9 /L) | 0.0 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Platelets (<50-25 x 10e9 /L) | 0.0 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Neutrophils (<1.5-1.0x10e9 /L) | 1.8 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Leukocytes (< 2.0 - 1.0 x 10E9/L) | 0.0 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Neutrophils (<1.0 - 0.5x10e9 /L) | 0.5 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Lymphocytes (<LLN-0.8x10e9 /L) | 6.1 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Lymphocytes (<0.5-0.2 x 10e9 /L) | 0.0 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Leukocytes (< 1.0 x 10E9/L) | 0.0 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Leukocytes (< 3.0 - 2.0 x 10E9/L) | 0.8 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Platelets (LLN-75 x10e9 /L) | 3.1 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Lymphocytes (<0.2x10e9 /L) | 0.0 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Platelets (<75-50 x 10e9 /L) | 0.2 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Leukocytes (< LLN - 3.0 x 10E9/L) | 4.9 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Lymphocytes (<0.8-0.5x10e9 /L) | 6.3 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Lymphocytes (<LLN-0.8x10e9 /L) | 4.9 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Platelets (<75-50 x 10e9 /L) | 0.0 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Lymphocytes (<0.5-0.2 x 10e9 /L) | 0.0 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Lymphocytes (<0.2x10e9 /L) | 0.0 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Platelets (<25x10e9 /L) | 0.0 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Neutrophils (<LLN-1.5x10e9 /L) | 8.7 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Neutrophils (<1.5-1.0x10e9 /L) | 2.4 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Platelets (<50-25 x 10e9 /L) | 0.0 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Neutrophils (<1.0 - 0.5x10e9 /L) | 0.0 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Neutrophils (<0.5x10e9 /L) | 0.0 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Leukocytes (< LLN - 3.0 x 10E9/L) | 7.2 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Leukocytes (< 3.0 - 2.0 x 10E9/L) | 0.0 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Platelets (LLN-75 x10e9 /L) | 2.4 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Leukocytes (< 2.0 - 1.0 x 10E9/L) | 0.0 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Leukocytes (< 1.0 x 10E9/L) | 0.0 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Platelets (<25x10e9 /L) | 0.0 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Lymphocytes (<0.2x10e9 /L) | 0.0 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Leukocytes (< 2.0 - 1.0 x 10E9/L) | 0.0 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Leukocytes (< LLN - 3.0 x 10E9/L) | 8.6 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Platelets (<75-50 x 10e9 /L) | 0.0 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Lymphocytes (<0.5-0.2 x 10e9 /L) | 0.0 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Platelets (LLN-75 x10e9 /L) | 5.4 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Leukocytes (< 3.0 - 2.0 x 10E9/L) | 0.0 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Lymphocytes (<LLN-0.8x10e9 /L) | 6.0 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Neutrophils (<1.5-1.0x10e9 /L) | 0.0 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Lymphocytes (<0.8-0.5x10e9 /L) | 3.4 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Neutrophils (<1.0 - 0.5x10e9 /L) | 0.0 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Platelets (<50-25 x 10e9 /L) | 0.0 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Neutrophils (<LLN-1.5x10e9 /L) | 11.3 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Leukocytes (< 1.0 x 10E9/L) | 0.0 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Neutrophils (<0.5x10e9 /L) | 0.0 IR |
Secondary
Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period
CTCAE: common terminology criteria for adverse events. A subject with multiple variable measurements is counted only once under the worst condition. LLN = lower limit of normal.
Time frame: approximately 4 years
Population: Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were be analyzed according to treatment received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Leukocytes (<3.0-2.0 x 10e9 /L) | 10 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Neutrophils (<1.0 - 0.5x10e9 /L,) | 7 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Lymphocytes (<0.5-0.2 x 10e9 /L, n=545,864,1075) | 1 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Leukocytes (<LLN-3.0x10e9 /L) | 55 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Neutrophils (<1.5-1.0x10e9 /L) | 12 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Lymphocytes (<0.2x10e9 /L, n=545,864,1075) | 0 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Platelets (<75-50x10e9 /L,) | 2 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Neutrophils (<LLN-1.5x10e9 /L) | 54 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Leukocytes (<2.0-1.0x10e9 /L) | 1 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Leukocytes (<1.0x10e9 /L) | 0 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Platelets (<25x10e9 /L) | 0 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Platelets (LLN-75x10e9 /L) | 24 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Lymphocytes (<LLN-0.8x10e9 /L) | 47 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Platelets (<50-25 x 10e9 /L) | 0 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Neutrophils (<0.5x10e9 /L) | 0 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Lymphocytes (<0.8-0.5x10e9 /L) | 18 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Leukocytes (<3.0-2.0 x 10e9 /L) | 7 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Leukocytes (<LLN-3.0x10e9 /L) | 59 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Leukocytes (<2.0-1.0x10e9 /L) | 0 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Leukocytes (<1.0x10e9 /L) | 0 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Lymphocytes (<LLN-0.8x10e9 /L) | 61 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Lymphocytes (<0.8-0.5x10e9 /L) | 28 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Lymphocytes (<0.5-0.2 x 10e9 /L, n=545,864,1075) | 1 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Lymphocytes (<0.2x10e9 /L, n=545,864,1075) | 0 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Neutrophils (<LLN-1.5x10e9 /L) | 69 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Neutrophils (<1.5-1.0x10e9 /L) | 20 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Neutrophils (<1.0 - 0.5x10e9 /L,) | 4 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Neutrophils (<0.5x10e9 /L) | 0 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Platelets (LLN-75x10e9 /L) | 39 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Platelets (<75-50x10e9 /L,) | 2 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Platelets (<50-25 x 10e9 /L) | 0 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Platelets (<25x10e9 /L) | 1 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Neutrophils (<1.0 - 0.5x10e9 /L,) | 11 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Lymphocytes (<LLN-0.8x10e9 /L) | 108 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Platelets (<25x10e9 /L) | 1 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Neutrophils (<0.5x10e9 /L) | 0 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Leukocytes (<1.0x10e9 /L) | 0 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Platelets (<50-25 x 10e9 /L) | 0 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Platelets (LLN-75x10e9 /L) | 63 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Leukocytes (<3.0-2.0 x 10e9 /L) | 17 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Lymphocytes (<0.2x10e9 /L, n=545,864,1075) | 0 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Leukocytes (<2.0-1.0x10e9 /L) | 1 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Neutrophils (<LLN-1.5x10e9 /L) | 123 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Lymphocytes (<0.5-0.2 x 10e9 /L, n=545,864,1075) | 2 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Platelets (<75-50x10e9 /L,) | 4 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Neutrophils (<1.5-1.0x10e9 /L) | 32 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Lymphocytes (<0.8-0.5x10e9 /L) | 46 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | Leukocytes (<LLN-3.0x10e9 /L) | 114 Participants |
Secondary
Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period
QTcB: QT interval corrected using Bazett's formula QTcF: QT interval corrected using Fridericia's formula A patient with multiple variable measurements is counted only once under the worst condition. IR=incidence rate per 100 subject years.
Time frame: Week 52 - 156
Population: Safety set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcB>450 msec | 10.5 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcB change from baseline>30 ms | 15.6 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcF>500 msec | 0.0 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcB>480 msec | 0.7 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcF>480 msec | 0.5 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcB change from baseline>60 ms | 0.7 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcB>500 msec | 0.2 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | PR>250 msec | 0.2 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcF change from baseline>60 ms | 0.2 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcF>450 msec | 3.6 IR |
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcF change from baseline>30 ms | 6.9 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcF>450 msec | 3.0 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcF change from baseline>30 ms | 6.8 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcF>480 msec | 0.2 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcF>500 msec | 0.0 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcB>500 msec | 0.2 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | PR>250 msec | 0.0 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcB change from baseline>30 ms | 14.3 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcF change from baseline>60 ms | 0.2 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcB change from baseline>60 ms | 0.8 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcB>480 msec | 1.1 IR |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcB>450 msec | 9.4 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcF change from baseline>60 ms | 0.0 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcB>450 msec | 11.3 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcB>480 msec | 0.0 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcB>500 msec | 0.0 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcB change from baseline>30 ms | 21.6 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcB change from baseline>60 ms | 0.0 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcF>450 msec | 2.6 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcF>480 msec | 0.0 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcF>500 msec | 0.0 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcF change from baseline>30 ms | 7.9 IR |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | PR>250 msec | 0.0 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcF>450 msec | 4.7 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | PR>250 msec | 0.0 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcF change from baseline>30 ms | 9.5 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcB change from baseline>60 ms | 0.0 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcB change from baseline>30 ms | 15.7 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcB>500 msec | 0.0 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcF change from baseline>60 ms | 0.0 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcB>480 msec | 0.0 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcB>450 msec | 14.1 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcF>500 msec | 0.0 IR |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period | QTcF>480 msec | 0.9 IR |
Secondary
Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period
QTcB: QT interval corrected using Bazett's formula QTcF: QT interval corrected using Fridericia's formula A patient with multiple variable measurements is counted only once under the worst condition.
Time frame: Approximately 4 years
Population: Safety set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcB changes from baseline>30 ms | 124 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcF>450 msec (n=545,838,1043) | 35 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcF changes from baseline>30 ms | 69 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcB changes from baseline>60 ms | 7 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcB>450 msec | 86 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcB>480 msec | 8 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcF>500 msec | 0 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | PR>250 msec | 4 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcF changes from baseline>60 ms | 1 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcF>480 msec | 3 Participants |
| AIN457 150 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcB>500 msec | 1 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcF>480 msec | 6 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcF>450 msec (n=545,838,1043) | 67 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcF changes from baseline>30 ms | 127 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcF changes from baseline>60 ms | 3 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcB>450 msec | 159 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | PR>250 msec | 5 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcB changes from baseline>30 ms | 223 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcB changes from baseline>60 ms | 19 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcF>500 msec | 1 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcB>480 msec | 23 Participants |
| AIN457 300 mg -Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcB>500 msec | 2 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | PR>250 msec | 8 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcB>500 msec | 3 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcB>480 msec | 30 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcB>450 msec | 218 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcB changes from baseline>30 ms | 316 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcB changes from baseline>60 ms | 25 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcF>500 msec | 1 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcF>480 msec | 8 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcF changes from baseline>30 ms | 184 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcF changes from baseline>60 ms | 4 Participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period | QTcF>450 msec (n=545,838,1043) | 93 Participants |
Secondary
EQ-5D Health State Assessment (Observed Value) - Entire Study Period
EQ-5D: EuroQOL 5-Dimension Health Status Questionnaire. The EQ-5D© is a generic instrument to assess each patient's health status. It provides a simple descriptive profile and a single index value for health status. The EQ visual analog scale records the respondent's self-rated health on a vertical scale where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.
Time frame: week 64, 76, 88, 104, 116, 128, 140, and 156
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Entire Study Period | Week 64 | -1.33 Percent change | Standard Deviation 22.506 |
| AIN457 150 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Entire Study Period | Week 76 | -1.99 Percent change | Standard Deviation 22.339 |
| AIN457 150 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Entire Study Period | Week 88 | -0.66 Percent change | Standard Deviation 24.558 |
| AIN457 150 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Entire Study Period | Week 104 | -4.15 Percent change | Standard Deviation 27.823 |
| AIN457 150 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Entire Study Period | Week 116 | -1.19 Percent change | Standard Deviation 21.022 |
| AIN457 150 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Entire Study Period | Week 128 | -2.85 Percent change | Standard Deviation 23.584 |
| AIN457 150 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Entire Study Period | Week 140 | 0.09 Percent change | Standard Deviation 20.814 |
| AIN457 150 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Entire Study Period | Week 156 | 2.13 Percent change | Standard Deviation 32.326 |
| AIN457 300 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Entire Study Period | Week 156 | 1.19 Percent change | Standard Deviation 21.548 |
| AIN457 300 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Entire Study Period | Week 64 | 1.44 Percent change | Standard Deviation 26.815 |
| AIN457 300 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Entire Study Period | Week 116 | 1.21 Percent change | Standard Deviation 23.681 |
| AIN457 300 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Entire Study Period | Week 76 | 2.10 Percent change | Standard Deviation 28.493 |
| AIN457 300 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Entire Study Period | Week 140 | -0.44 Percent change | Standard Deviation 18.504 |
| AIN457 300 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Entire Study Period | Week 88 | 1.45 Percent change | Standard Deviation 28.269 |
| AIN457 300 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Entire Study Period | Week 128 | 1.93 Percent change | Standard Deviation 27.84 |
| AIN457 300 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Entire Study Period | Week 104 | 0.65 Percent change | Standard Deviation 23.454 |
Secondary
EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period
EQ-5D: EuroQOL 5-Dimension Health Status Questionnaire. The EQ-5D© is a generic instrument to assess each patient's health status. It provides a simple descriptive profile and a single index value for health status. The EQ visual analog scale records the respondent's self-rated health on a vertical scale where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.
Time frame: Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 64 | 0.03 Percent change | Standard Deviation 21.603 |
| AIN457 150 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 156 | 2.53 Percent change | Standard Deviation 34.259 |
| AIN457 150 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 88 | 0.07 Percent change | Standard Deviation 21.421 |
| AIN457 150 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 128 | 2.06 Percent change | Standard Deviation 33.078 |
| AIN457 150 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 76 | 0.79 Percent change | Standard Deviation 25.605 |
| AIN457 150 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 140 | 1.20 Percent change | Standard Deviation 25.801 |
| AIN457 150 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 104 | 2.37 Percent change | Standard Deviation 24.075 |
| AIN457 150 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 116 | 2.12 Percent change | Standard Deviation 31.724 |
| AIN457 300 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 104 | 1.57 Percent change | Standard Deviation 23.941 |
| AIN457 300 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 128 | 3.17 Percent change | Standard Deviation 29.615 |
| AIN457 300 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 116 | 2.06 Percent change | Standard Deviation 24.814 |
| AIN457 300 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 76 | 2.76 Percent change | Standard Deviation 29.715 |
| AIN457 300 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 140 | 0.71 Percent change | Standard Deviation 18.151 |
| AIN457 300 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 88 | 2.15 Percent change | Standard Deviation 29.702 |
| AIN457 300 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 64 | 2.09 Percent change | Standard Deviation 28.358 |
| AIN457 300 mg -Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 156 | 2.23 Percent change | Standard Deviation 22.581 |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 128 | -5.59 Percent change | Standard Deviation 21.756 |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 64 | -9.58 Percent change | Standard Deviation 20.339 |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 76 | -13.73 Percent change | Standard Deviation 23.295 |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 88 | -10.24 Percent change | Standard Deviation 26.026 |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 104 | -2.81 Percent change | Standard Deviation 27.303 |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 116 | -4.82 Percent change | Standard Deviation 20.921 |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 140 | -5.90 Percent change | Standard Deviation 27.335 |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 156 | 3.68 Percent change | Standard Deviation 26.836 |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 88 | -14.67 Percent change | Standard Deviation 27.975 |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 76 | -9.27 Percent change | Standard Deviation 35.302 |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 156 | -7.60 Percent change | Standard Deviation 20.683 |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 140 | -8.86 Percent change | Standard Deviation 18.344 |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 64 | -5.57 Percent change | Standard Deviation 27.889 |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 128 | -5.97 Percent change | Standard Deviation 13.207 |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 116 | -3.44 Percent change | Standard Deviation 11.846 |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 104 | -9.65 Percent change | Standard Deviation 17.794 |
Secondary
Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period
Investigator's Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions)
Time frame: Week 52, Week 104, Week 156, week 208, week 260
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 260 - severe | 0 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 208 - severe | 1 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 52 - clear | 56 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 52 - almost clear | 38 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 52 - mild | 44 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 52 - moderate | 26 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 52 - severe | 0 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 104 - clear | 47 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 104 - almost clear | 16 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 104 - mild | 17 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 104 - moderate | 19 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 104 - severe | 5 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 156 - clear | 37 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 156 - almost clear | 13 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 156 - mild | 11 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 156 - moderate | 8 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 156 - severe | 0 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 208 - clear | 33 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 208 - almost clear | 14 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 208 - mild | 7 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 208 - moderate | 3 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 260 - clear | 27 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 260 - almost clear | 12 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 260 - mild | 8 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 260 - moderate | 4 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 208 - mild | 88 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 156 - almost clear | 90 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 260 - severe | 4 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 260 - moderate | 53 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 52 - clear | 188 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 156 - mild | 91 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 52 - almost clear | 123 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 208 - severe | 5 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 52 - mild | 71 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 156 - moderate | 61 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 52 - moderate | 32 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 260 - mild | 66 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 52 - severe | 2 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 156 - severe | 3 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 104 - clear | 154 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 260 - clear | 97 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 104 - almost clear | 85 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 208 - clear | 102 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 104 - mild | 80 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 208 - moderate | 47 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 104 - moderate | 51 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 208 - almost clear | 81 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 104 - severe | 7 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 260 - almost clear | 65 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Wk 156 - clear | 116 Number of participants |
Secondary
Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period
Investigator Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0: Clear (No signs of psoriasis. Post-inflammatory hyperpigmentation could be Present). Score 1: Almost clear (Normal to pink coloration of lesions; no thickening; no to minimal focal scaling), Score 2: Mild (Pink to light red coloration; just detectable to mild thickening; predominantly fine scaling). Score 3: Moderate (Dull bright red, clearly distinguishable erythema; clearly distinguishable to moderate thickening; moderate scaling). Score 4: Severe (Bright to deep dark red coloration; severe thickening with hard edges; severe /coarse scaling covering almost all or all lesions). Patients in the placebo groups were not evaluable after re-treatment with Secukinumab
Time frame: Week 52 (baseline), 104, and 156
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 52 - clear | 95 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 156 - almost clear | 42 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 104 - moderate | 47 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 52 - mild | 75 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 104 - severe | 7 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 156 - clear | 48 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 52 - moderate | 14 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 52 - almost clear | 113 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 156 - moderate | 59 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 52 - severe | 0 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 104 - clear | 66 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 156 - mild | 88 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 104 - almost clear | 62 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 156 - severe | 2 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 104 - mild | 78 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 104 - mild | 64 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 156 - almost clear | 87 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 52 - severe | 1 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 104 - moderate | 33 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 52 - almost clear | 121 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 156 - clear | 115 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 156 - mild | 78 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 104 - severe | 5 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 52 - mild | 44 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 104 - almost clear | 84 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 156 - severe | 1 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 156 - moderate | 43 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 104 - clear | 152 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 52 - moderate | 9 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 52 - clear | 188 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 104 - mild | 9 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 52 - clear | 56 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 52 - almost clear | 56 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 52 - mild | 33 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 52 - moderate | 4 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 52 - severe | 1 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 104 - clear | 3 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 104 - almost clear | 5 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 104 - moderate | 3 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 104 - severe | 0 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 156 - clear | 2 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 156 - almost clear | 2 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 156 - mild | 2 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 156 - moderate | 4 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 156 - severe | 0 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 104 - almost clear | 9 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 52 - almost clear | 63 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 156 - almost clear | 3 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 104 - clear | 4 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 52 - severe | 0 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 52 - clear | 94 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 156 - mild | 5 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 52 - moderate | 1 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 52 - mild | 22 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 156 - severe | 1 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 104 - severe | 2 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 104 - moderate | 10 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 156 - moderate | 2 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 156 - clear | 4 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Wk 104 - mild | 9 Number of participants |
Secondary
Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period
Dermatology Life Quality Index (DLQI) scores range from 0 to 30. Lower absolute scores on DLQI indicate better/improved health-related quality-of life impairment.
Time frame: Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period | week 156 | 47 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period | Week 104 | 66 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period | Week 208 | 41 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period | week 260 | 42 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period | Week 52 (baseline) | 95 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period | week 260 | 174 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period | Week 52 (baseline) | 299 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period | Week 104 | 254 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period | week 156 | 225 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period | Week 208 | 207 Number of participants |
Secondary
Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data)
Dermatology Life Quality Index (DLQI) scores range from 0 to 30. Lower absolute scores on DLQI indicate better/improved health-related quality-of life impairment.
Time frame: Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 64 | 170 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 116 | 141 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 88 | 157 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 76 | 163 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 156 | 119 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 52 (baseline) | 196 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 128 | 139 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 104 | 146 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 140 | 126 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 88 | 247 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 140 | 229 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 52 (baseline) | 281 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 64 | 265 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 76 | 256 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 104 | 237 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 116 | 230 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 128 | 222 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 156 | 215 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 64 | 59 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 88 | 18 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 52 (baseline) | 109 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 104 | 10 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 116 | 6 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 140 | 4 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 156 | 5 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 128 | 4 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 76 | 26 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 64 | 90 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 116 | 9 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 88 | 24 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 76 | 38 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 128 | 10 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 52 (baseline) | 142 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 104 | 14 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 140 | 7 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 156 | 8 Number of participants |
Secondary
Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period
Investigator's Global Assessment (IGA) mod 2011 0/1. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions) Based on this scale, a patient was considered as IGA mod 2011 0/1 responder if the patient achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline.
Time frame: Week 52, Week 104, Week 156, week 208, week 260
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period | Wk 104 | 63 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period | Wk 208 | 47 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period | Wk 156 | 50 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period | Wk 260 | 39 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period | Wk 52 | 94 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period | Wk 260 | 162 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period | Wk 52 | 311 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period | Wk 104 | 239 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period | Wk 156 | 206 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period | Wk 208 | 183 Number of participants |
Secondary
Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period
Psoriasis Area and Severity Index (PASI) scoring system: The average degree of severity of each sign in each of the four body regions was assigned a score of 0-4. The area covered by lesions on each body region was estimated as a percentage of the total area of that particular body region.
Time frame: Week 52, Week 104, Week 156, week 208, week 260
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 104 - PASI 75 | 76 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 104 - PASI 90 | 62 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 52 - PASI 50 | 164 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 52 - PASI 75 | 121 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 52 - PASI 90 | 85 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 52 - PASI 100 | 54 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 104 - PASI 50 | 99 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 104 - PASI 100 | 46 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 156 - PASI 50 | 67 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 156 - PASI | 63 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 156 - PASI 90 | 52 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 156 - PASI 100 | 37 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 208 - PASI 50 | 58 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 208 - PASI 75 | 55 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 208 - PASI 90 | 51 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 208 - PASI 100 | 33 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 260 - PASI 50 | 51 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 260 - PASI 75 | 49 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 260 - PASI 90 | 37 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 260 - PASI 100 | 26 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 260 - PASI 75 | 231 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 104 - PASI 75 | 314 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 156 - PASI 90 | 211 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 208 - PASI 100 | 104 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 52 - PASI 50 | 416 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 156 - PASI 100 | 118 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 52 - PASI 75 | 361 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 260 - PASI 100 | 100 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 52 - PASI 90 | 303 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 208 - PASI 50 | 316 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 52 - PASI 100 | 191 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 260 - PASI 50 | 279 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 104 - PASI 50 | 359 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 104 - PASI 90 | 243 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 208 - PASI 75 | 269 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 104 - PASI 100 | 153 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 260 - PASI 90 | 179 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 156 - PASI 50 | 351 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 208 - PASI 90 | 194 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Wk 156 - PASI | 297 Number of participants |
Secondary
Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period
Psoriasis Area and Severity Index (PASI) 75 responder at week 52. Patients in the placebo groups were not evaluable after re-treatment with Secukinumab. PASI 75 Responders: patients with a PASI 75 response (patients achieving ≥75% improvement \[reduction\] in PASI score compared to baseline of the core study). PASI 50 response: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 50 responders. PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 90 responders. PASI 100 response/remission: complete clearing of psoriasis (PASI=0)
Time frame: Week 52, 104, and 156
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 156 - PASI 100 | 47 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 156 - PASI 90 (n=239, 324, 10,15) | 101 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 52 - PASI 90 | 190 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 52 - PASI 50 | 297 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 156 - PASI 50 | 230 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 104 - PASI 75 | 209 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 52 - PASI 100 | 93 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 104 - PASI 100 | 65 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 156 - PASI 75 | 183 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 104 - IGA 0/1 | 128 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 104 - PASI 90 | 125 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 52 - PASI 75 | 296 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 156 - IGA 0/1 | 90 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 104 - PASI 50 | 254 Number of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 52 - IGA 0/1 | 208 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 104 - PASI 50 | 329 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 104 - PASI 75 | 299 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 52 - IGA 0/1 | 309 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 104 - PASI 90 | 240 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 52 - PASI 50 | 363 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 104 - PASI 100 | 151 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 156 - PASI 90 (n=239, 324, 10,15) | 207 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 52 - PASI 75 | 361 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 156 - PASI 100 | 117 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 52 - PASI 90 | 303 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 156 - PASI 75 | 287 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 52 - PASI 100 | 191 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 104 - IGA 0/1 | 236 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 156 - PASI 50 | 322 Number of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 156 - IGA 0/1 | 202 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 156 - IGA 0/1 | 4 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 52 - PASI 100 | 54 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 52 - PASI 50 | 149 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 52 - PASI 75 | 149 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 52 - PASI 90 | 105 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 104 - IGA 0/1 | 8 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 104 - PASI 50 | 19 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 104 - PASI 75 | 15 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 104 - PASI 90 | 6 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 104 - PASI 100 | 4 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 52 - IGA 0/1 | 112 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 156 - PASI 50 | 10 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 156 - PASI 75 | 6 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 156 - PASI 90 (n=239, 324, 10,15) | 4 Number of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 156 - PASI 100 | 2 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 156 - PASI 90 (n=239, 324, 10,15) | 7 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 52 - IGA 0/1 | 157 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 156 - PASI 50 | 15 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 52 - PASI 100 | 96 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 52 - PASI 90 | 156 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 156 - IGA 0/1 | 7 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 156 - PASI 75 | 13 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 52 - PASI 75 | 179 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 52 - PASI 50 | 180 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 104 - PASI 90 | 13 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 104 - PASI 75 | 21 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 156 - PASI 100 | 5 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 104 - PASI 100 | 6 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 104 - PASI 50 | 28 Number of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Wk 104 - IGA 0/1 | 13 Number of participants |
Secondary
Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period
Perc. change = 100 x Abs. change /Base. (Abs. change = Post - Base) For each post-baseline visit only patients with a value at both baseline and the respective post-baseline visit are included.
Time frame: Week 52, Week 104, Week 156, week 208, week 260
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period | Wk 104 | -85.97 Percent change in PASI score | Standard Deviation 18.811 |
| AIN457 150 mg -Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period | Wk 208 | -95.71 Percent change in PASI score | Standard Deviation 7.868 |
| AIN457 150 mg -Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period | Wk 156 | -93.03 Percent change in PASI score | Standard Deviation 12.338 |
| AIN457 150 mg -Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period | Wk 260 | -93.65 Percent change in PASI score | Standard Deviation 9.959 |
| AIN457 150 mg -Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period | Wk 52 | -85.93 Percent change in PASI score | Standard Deviation 14.815 |
| AIN457 300 mg -Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period | Wk 260 | -88.08 Percent change in PASI score | Standard Deviation 14.983 |
| AIN457 300 mg -Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period | Wk 52 | -91.82 Percent change in PASI score | Standard Deviation 11.889 |
| AIN457 300 mg -Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period | Wk 104 | -88.86 Percent change in PASI score | Standard Deviation 16.151 |
| AIN457 300 mg -Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period | Wk 156 | -87.78 Percent change in PASI score | Standard Deviation 15.114 |
| AIN457 300 mg -Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period | Wk 208 | -88.25 Percent change in PASI score | Standard Deviation 14.496 |
Secondary
Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period
The improvement (decrease from baseline) in PASI total scores observed at Week 52. Perc. change = 100 x Abs. change /Base. (Abs. change = Post - Base) For each post-baseline visit only patients with a value at both baseline and the respective post-baseline visit are included.
Time frame: Week 52, 104, and 156
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period | Week 52 (baseline) | -92.31 Percent change in PASI score | Standard Deviation 7.878 |
| AIN457 150 mg -Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period | Week 156 | -83.32 Percent change in PASI score | Standard Deviation 17.341 |
| AIN457 150 mg -Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period | Week 104 | -85.88 Percent change in PASI score | Standard Deviation 14.631 |
| AIN457 300 mg -Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period | Week 52 (baseline) | -95.98 Percent change in PASI score | Standard Deviation 6.638 |
| AIN457 300 mg -Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period | Week 156 | -90.50 Percent change in PASI score | Standard Deviation 11.66 |
| AIN457 300 mg -Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period | Week 104 | -91.51 Percent change in PASI score | Standard Deviation 13.221 |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period | Week 104 | -82.67 Percent change in PASI score | Standard Deviation 15.568 |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period | Week 52 (baseline) | -92.88 Percent change in PASI score | Standard Deviation 8.435 |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period | Week 156 | -79.77 Percent change in PASI score | Standard Deviation 15.172 |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period | Week 52 (baseline) | -96.16 Percent change in PASI score | Standard Deviation 6.03 |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period | Week 156 | -86.35 Percent change in PASI score | Standard Deviation 15.602 |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period | Week 104 | -78.04 Percent change in PASI score | Standard Deviation 20.986 |
Secondary
Percent of Participants With IGA Mod 0 or 1 Response - Treatment Period for Re-treated After Relapse
IGA mod 2011 0 or 1 response since reinitiating treatment after relapse for subjects with IGA 0 or 1 response at week 52 and not have IGA 0 or 1 response at relapse. time = 0 refers to Week 52
Time frame: up to week 260
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | Percent of Participants With IGA Mod 0 or 1 Response - Treatment Period for Re-treated After Relapse | 0 to <=4 wks (n=96,123) | 12.5 Percent of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Percent of Participants With IGA Mod 0 or 1 Response - Treatment Period for Re-treated After Relapse | >12 to <=16 wks (n=40,32) | 75.0 Percent of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Percent of Participants With IGA Mod 0 or 1 Response - Treatment Period for Re-treated After Relapse | >84 to <=88 wks (n=7,4) | 87.9 Percent of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Percent of Participants With IGA Mod 0 or 1 Response - Treatment Period for Re-treated After Relapse | 0 to <=4 wks (n=96,123) | 28.1 Percent of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Percent of Participants With IGA Mod 0 or 1 Response - Treatment Period for Re-treated After Relapse | >12 to <=16 wks (n=40,32) | 83.5 Percent of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Percent of Participants With IGA Mod 0 or 1 Response - Treatment Period for Re-treated After Relapse | >84 to <=88 wks (n=7,4) | 90.8 Percent of participants |
Secondary
Percent of Participants With Loss of IGA Mod 2011 0 or 1 Response Over Time for Subjects With IGA Mod 2011 0 or 1 Response at Week 52 - Randomized Withdrawal Period
Summary for loss of IGA mod 2011 0 or 1 response over time for patients with response at Week 52. time = 0 refers to Week 52
Time frame: Week 68
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | Percent of Participants With Loss of IGA Mod 2011 0 or 1 Response Over Time for Subjects With IGA Mod 2011 0 or 1 Response at Week 52 - Randomized Withdrawal Period | 38.1 Percent of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Percent of Participants With Loss of IGA Mod 2011 0 or 1 Response Over Time for Subjects With IGA Mod 2011 0 or 1 Response at Week 52 - Randomized Withdrawal Period | 33.4 Percent of participants |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Percent of Participants With Loss of IGA Mod 2011 0 or 1 Response Over Time for Subjects With IGA Mod 2011 0 or 1 Response at Week 52 - Randomized Withdrawal Period | 82.1 Percent of participants |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Percent of Participants With Loss of IGA Mod 2011 0 or 1 Response Over Time for Subjects With IGA Mod 2011 0 or 1 Response at Week 52 - Randomized Withdrawal Period | 65.5 Percent of participants |
Secondary
Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse
PASI 75 response since reinitiating treatment after relapse. time = 0 refers to Week 52
Time frame: up to week 260
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse | 0 to <=4 wks | 38.5 Percent of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse | >12 to <=16 wks (n=21,13) | 91.2 Percent of participants |
| AIN457 150 mg -Randomized Withdrawal Period | Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse | >80 to <=84 wks (n=2,1) | 96.8 Percent of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse | 0 to <=4 wks | 51.0 Percent of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse | >12 to <=16 wks (n=21,13) | 95.1 Percent of participants |
| AIN457 300 mg -Randomized Withdrawal Period | Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse | >80 to <=84 wks (n=2,1) | 98.8 Percent of participants |
Secondary
Percent of Participants With Rebound After Last Injection
Rebound: PASI increases to \> 125% of baseline (where baseline is the PASI at the randomization of the core study) or presence of new pustular psoriasis, new erythrodermic psoriasis or more inflammatory psoriasis occurring within 8 Weeks of stopping therapy (after the last dose of study treatment received). Rebound like event (RLE) was defined as increase of PASI of \> 125% from baseline value or occurrence of new pustular, new erythrodermic or more inflammatory psoriasis any time after stopping therapy (last treatment administered) up to Week 68. Rebound was evaluated for the patients randomized to the placebo groups in the extension study; hence these patients received the last dose of secukinumab during the core studies.
Time frame: up to week 68
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | Percent of Participants With Rebound After Last Injection | Rebound (<8 wks after last inj.; n=108,320) | 8.3 Percent of participants with rebound |
| AIN457 150 mg -Randomized Withdrawal Period | Percent of Participants With Rebound After Last Injection | RLE (< 12 wks after last inj., n=110,326) | 11.8 Percent of participants with rebound |
| AIN457 300 mg -Randomized Withdrawal Period | Percent of Participants With Rebound After Last Injection | Rebound (<8 wks after last inj.; n=108,320) | 6.6 Percent of participants with rebound |
| AIN457 300 mg -Randomized Withdrawal Period | Percent of Participants With Rebound After Last Injection | RLE (< 12 wks after last inj., n=110,326) | 9.5 Percent of participants with rebound |
Secondary
Percent of Participants With Relapse After Last Injection
Relapse: when the achieved maximal PASI improvement from baseline of core study was reduced by \>50%. Time 0 = week 52
Time frame: up to week 16
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | Percent of Participants With Relapse After Last Injection | 0 to <=4 wks (n=158,415) | 7.2 Percent of participants with relapse |
| AIN457 150 mg -Randomized Withdrawal Period | Percent of Participants With Relapse After Last Injection | >12 to <=16 wks (n=66,208) | 34.0 Percent of participants with relapse |
| AIN457 300 mg -Randomized Withdrawal Period | Percent of Participants With Relapse After Last Injection | 0 to <=4 wks (n=158,415) | 2.0 Percent of participants with relapse |
| AIN457 300 mg -Randomized Withdrawal Period | Percent of Participants With Relapse After Last Injection | >12 to <=16 wks (n=66,208) | 28.4 Percent of participants with relapse |
Secondary
Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period
Time 0 = week 52
Time frame: up to week 156
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150 mg -Randomized Withdrawal Period | Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period | 0 to <=4 wks (n=286,353,150,180) | 0.3 Percent of participants with relapses |
| AIN457 150 mg -Randomized Withdrawal Period | Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period | >12 to <=16 wks (n=297,363,124,160) | 3.1 Percent of participants with relapses |
| AIN457 150 mg -Randomized Withdrawal Period | Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period | >92 to <=96 wks (n=188,292,11,15) | 21.5 Percent of participants with relapses |
| AIN457 150 mg -Randomized Withdrawal Period | Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period | >104 to <=108 wks (n=156,297,8,9) | 21.9 Percent of participants with relapses |
| AIN457 300 mg -Randomized Withdrawal Period | Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period | >104 to <=108 wks (n=156,297,8,9) | 9.4 Percent of participants with relapses |
| AIN457 300 mg -Randomized Withdrawal Period | Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period | >92 to <=96 wks (n=188,292,11,15) | 9.4 Percent of participants with relapses |
| AIN457 300 mg -Randomized Withdrawal Period | Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period | >12 to <=16 wks (n=297,363,124,160) | 2.2 Percent of participants with relapses |
| AIN457 300 mg -Randomized Withdrawal Period | Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period | 0 to <=4 wks (n=286,353,150,180) | 0.3 Percent of participants with relapses |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period | >92 to <=96 wks (n=188,292,11,15) | 88.1 Percent of participants with relapses |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period | >104 to <=108 wks (n=156,297,8,9) | 88.1 Percent of participants with relapses |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period | >12 to <=16 wks (n=297,363,124,160) | 19.8 Percent of participants with relapses |
| AIN457 150 mg Placebo - Randomized Withdrawal Period | Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period | 0 to <=4 wks (n=286,353,150,180) | 0.0 Percent of participants with relapses |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period | >12 to <=16 wks (n=297,363,124,160) | 12.1 Percent of participants with relapses |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period | 0 to <=4 wks (n=286,353,150,180) | 0.0 Percent of participants with relapses |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period | >104 to <=108 wks (n=156,297,8,9) | 86.1 Percent of participants with relapses |
| AIN457 300 mg Placebo - Randomized Withdrawal Period | Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period | >92 to <=96 wks (n=188,292,11,15) | 86.1 Percent of participants with relapses |