Enthesitis Related Arthritis, Juvenile Psoriatic Arthritis
Conditions
Keywords
JIA, JPsA, ERA, Secukinumab, ILAR, Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis
Brief summary
Optional open label, roll over extension study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic Arthritis (JIA) subtypes of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA).
Detailed description
This study is an extension of a previous core study (NCT03031782 \[CAIN457F2304\]) aiming to assess the long-term efficacy, safety, and tolerability of secukinumab treatment in patients who completed the core study and chose to participate in the extension study. The primary objective was to gather comprehensive data on the efficacy and safety of secukinumab over an extended period. At Week 104 of the core study, all eligible patients could opt to roll over to the extension study and continue receiving secukinumab at either 75 mg or 150 mg, as they were at the Week 100 visit of the core study. The treatment involved subcutaneous injections using pre-filled syringes (PFS). The duration of patient participation could range from a minimum of one year to a maximum of four years, or until one of the following conditions was met: the drug was locally approved, marketed, and reimbursed, secukinumab could be provided free of charge to patients in compliance with local guidelines, or a maximum of 4 years study duration. During the extension study (starting from Week 108), to maintain a high proportion of clinically meaningful response during the entire duration of the extension study, the dosing options available, at the Investigator's discretion, were as follows: * The dose could be escalated from 75 mg to 150 mg for patients whose signs and symptoms were not fully controlled with the current dose of 75 mg and might improve with a higher dose as judged by the investigator * Further, the dose could be escalated to 300 mg for patients weighing 50 kg and over currently on the 150 mg dose whose signs and symptoms were not fully controlled and might improve further with an increase in dose as judged by the investigator * Dose escalation from secukinumab 75 mg to 300 mg had to be done in two steps (first 150 mg then 300 mg if the patient weighed 50 kg or over and based on the investigator's judgement), also considering the gap between the two escalations to review the response
Interventions
DRUGSecukinumab
Secukinumab solution for subcutaneous injections was provided in PFS. Initially, participants continued to receive secukinumab at either 75 mg (in 0.5mL) or 150 mg (in 1mL) every 4 weeks, consistent with their dosage at the Week 100 visit of the core study. The dose could be escalated from 75 mg to 150 mg for patients whose signs and symptoms were not fully controlled, as judged by the investigator, with the current 75 mg dose. Furthermore, the dose could also be escalated to 300 mg every 4 weeks for patients weighing 50kg and over who were currently on the 150 mg dose and whose signs and symptoms were not well-controlled, as judged by the investigator. The dose escalation from secukinumab 75 mg to 300 mg was to be implemented in two steps (first 150 mg and then 300 mg based on the investigator's judgment). At each study treatment time point, one or two subcutaneous injections in the form of PFS were administered.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label
Eligibility
Sex/Gender
ALL
Age
2 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Patients had to have participated in the core study CAIN457F2304 and completed the entire treatment period up to and including Week 104. * Patients had to be deemed by the investigator to benefit from continued secukinumab therapy. Key
Exclusion criteria
* Patients with plans for administration of live vaccines during the extension study period were excluded. * Patients taking any other concomitant biologic immunomodulating agent(s) except secukinumab were excluded. * Patients who were deemed not to be benefiting from the study treatment based on lack of improvement or worsening of their symptoms were excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JIA ACR response criteria consisted of 6 core criteria: * Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). * Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). * Functional ability (CHAQ: Childhood Health Assessment Questionnaire): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain. It ranged from 0 (no disability) to 3 (very severe disability). * Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. * Number of joints with limited range of motion, ranging from 0 to 69. * Index of inflammation: C-reactive Protein (CRP) levels The JIA ACR 30 response was achieved if 3 of any 6 core set variables improved by at least 30% from baseline of the core study, and no more than 1 variable worsening more than 30% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With JIA ACR 70 Response | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JIA ACR response criteria consisted of 6 core criteria: * Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). * Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). * Functional ability (CHAQ): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain (0 \[no disability\] to 3 \[very severe disability\]). * Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. * Number of joints with limited range of motion, ranging from 0 to 69. * Index of inflammation: CRP levels The JIA ACR 70 responses were achieved if 3 of any 6 core set variables improved by at least 70%, from baseline of the core study, and no more than 1 variable worsening \> 30% |
| Percentage of Participants With JIA ACR 90 Response | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JIA ACR response criteria consisted of 6 core criteria: * Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). * Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). * Functional ability (CHAQ): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain (0 \[no disability\] to 3 \[very severe disability\]). * Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. * Number of joints with limited range of motion, ranging from 0 to 69. * Index of inflammation: CRP levels The JIA ACR 90 responses were achieved if 3 of any 6 core set variables improved by at least 90% from baseline of the core study, and no more than 1 variable worsening \> 30% |
| Percentage of Participants With JIA ACR 100 Response | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JIA ACR response criteria consisted of 6 core criteria: * Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). * Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). * Functional ability (CHAQ): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain (0 \[no disability\] to 3 \[very severe disability\]). * Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. * Number of joints with limited range of motion, ranging from 0 to 69. * Index of inflammation: CRP levels The JIA ACR 100 responses were achieved if 3 of any 6 core set variables improved with 100% from baseline of the core study, and no more than 1 variable worsening \> 30% |
| Number of Participants With Inactive Disease Status | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | Inactive disease status was confirmed in a patient when all the following conditions were met: * No joints with active arthritis * No uveitis * CRP value within normal limits for the laboratory where tested or, if elevated, not attributable to JIA * Physician's global assessment of disease activity score ≤ 10mm * Duration of morning stiffness attributable to JIA lasting ≥15 minutes. |
| Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JIA ACR response criteria consisted of 6 core criteria, one of which was the physician global assessment of disease activity. this assessment was conducted using a 100 mm VAS score, where 0 represented the best disease activity and 100 the worst. The change from baseline of the core study of the physician global assessment of disease activity was measured, with a negative change indicating improvement. |
| Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JIA ACR response criteria included six core components, one of which was the parent's or patients' global assessment of overall well-being. This assessment was conducted using a 100 mm VAS score, where 0 represented very well and 100 very poor. The change from baseline of the core study in the parent's or patients' global assessment of overall well-being was measured, with a negative change indicating improvement |
| Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JIA ACR response criteria included six core components, one of which was the functional ability, measured by the CHAQ. The CHAQ questionnaire consisted of 30 questions across 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each domain was scored on a 4-point scale, and the total score was calculated as the average of the scores for each domain. The total score ranged from 0 (no disability) to 3 (very severe disability). The change from baseline of the core study in the CHAQ was measured, with a negative change indicating improvement. |
| Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JIA ACR response criteria included six core components, one of which was the number of joints with active arthritis. This was determined using the ACR definition, which identifies active arthritis as any joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion or tenderness not due to deformity. The active joint count ranged from 0 to 73. The change from baseline of the core study in the number of active joints was measured, with a negative change indicating improvement. |
| Percentage of Participants With JIA ACR 50 Response | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JIA ACR response criteria consisted of 6 core criteria: * Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). * Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). * Functional ability (CHAQ): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain (0 \[no disability\] to 3 \[very severe disability\]). * Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. * Number of joints with limited range of motion, ranging from 0 to 69. * Index of inflammation: CRP levels The JIA ACR 50 responses were achieved if 3 of any 6 core set variables improved by at least 50% from baseline of the core study, and no more than 1 variable worsening \> 30% |
| Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JIA ACR response criteria included six core components, one of which was CRP levels, an inflammation biomarker. Serum concentrations of CRP were determined, and the change from baseline of the core study was assessed, with negative changes indicating improvement. |
| Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JADAS-27 was used for assessment of disease activity, and it included 4 measures: * Physician global assessment of disease activity (VAS range: 0 to 10; where 0=very good and 100=very poor) * Parent/participant global assessment of well-being (VAS range: 0 to 10; 0=very well and 100=very poor) * Count of joints with active disease (range: 0 to 27; where 0= no disease activity and 27= maximum disease activity) * Index of inflammation determined by CRP concentration, calculated as: (CRP (mg/l) -10)/10. Before calculation, CRP values \<10 mg/l were converted to 10 and CRP values \>110 mg/l were converted to 110. The normalized scale ranged from 0 to 10; where 0= no disease activity and 10= maximum disease activity. JADAS-27 score was calculated as the sum of the score of its 4 components, ranging from 0 to 57 where 0= no disease activity and 57= maximum disease activity. The change from baseline of the core study was assessed. A negative change from baseline indicated improvement. |
| Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JADAS-27 was used for assessment of disease activity, and it included 4 measures: * Physician global assessment of disease activity (VAS range: 0 to 10; where 0=very good and 100=very poor) * Parent/participant global assessment of well-being (VAS range: 0 to 10; 0=very well and 100=very poor) * Count of joints with active disease (range: 0 to 71; where 0= no disease activity and 71= maximum disease activity) * Index of inflammation determined by CRP concentration, calculated as: (CRP (mg/l) -10)/10. Before calculation, CRP values \<10 mg/l were converted to 10 and CRP values \>110 mg/l were converted to 110. The normalized scale ranged from 0 to 10; where 0= no disease activity and 10= maximum disease activity. JADAS-27 score was calculated as the sum of the score of its 4 components, ranging from 0 to 101 where 0= no disease activity and 101= maximum disease activity. The change from baseline of the core study was assessed. A negative change from baseline indicated improvement. |
| Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The following 16 entheseal sites were assessed for the presence or absence of tenderness (enthesitis) on each side of the body: * Anterior Entheses: Greater trochanter of the Femur; Medial condyle of the femur; Lateral condyle of the femur * Posterior Entheses: Greater tuberosity of humerus; medial epicondyle of humerus; lateral epicondyle of humerus, Achilles tendon; and calcaneal insertion of the plantar fascia. Tenderness on examination was recorded as either present (1) or absent (0) for each of the 16 sites, The total enthesitis count ranged from 0 to 16. The change from baseline of the core study was assessed. A negative change from baseline indicated improvement |
| Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The dactylitis count was the number of fingers and toes presenting with swelling and inflammation. Swelling and inflammation on examination was recorded as either present (1) or absent (0) for each of the 20 sites, The total dactylitis count ranged from 0 to 20. The change from baseline of the core study was assessed. A negative change from baseline indicated improvement |
| Serum Concentrations of Secukinumab Over Time | Pre-dose at Week 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | Serum concentration of secukinumab over time. Blood samples for pharmacokinetics were taken pre-dose at the scheduled time points. |
| Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) of Secukinumab | From baseline of the core study up to Week 312. Study week is defined with respect to the core study. | Number of participants with treatment-emergent Anti-Drug Antibodies (ADAs) of secukinumab. Blood samples were collected for immunogenicity (anti-AIN457 antibodies) assessments. |
| Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JIA ACR response criteria included six core components, one of which was the number of joints with limited range of motion. A total of 69 joints were assessed for limitation of motion. The change from baseline of the core study in the number of joints with limited range of motion was measured, with a negative change indicating improvement. |
Countries
Belgium, Germany, Italy, Poland, Russia, South Africa, Spain, Turkey (Türkiye), United States
Participant flow
Recruitment details
Participants were recruited in 24 centers across 9 countries
Pre-assignment details
One participant enrolled with planned treatment secukinumab 150 mg discontinued the study before receiving study treatment due to physician decision
Participants by arm
| Arm | Count |
|---|---|
| Group 1- Secukinumab 75 mg Participants were planned to initially receive secukinumab 75mg subcutaneously once every four weeks. If the signs and symptoms of the participants were not adequately controlled with the 75mg dose, as determined by the investigator, the dose could be escalated to 150mg subcutaneously. For patients weighing 50kg and over, the dose could further be escalated to 300mg subcutaneously every four weeks. The dose escalation from secukinumab 75mg subcutaneously to 300mg subcutaneously was to be implemented in two steps, with the first step being an increase to 150mg subcutaneously, followed by another escalation to 300mg subcutaneously, based on the judgement of the investigator. | 19 |
| Group 2 - Secukinumab 150 mg Participants were planned to initially receive secukinumab 150mg subcutaneously once every four weeks. If the signs and symptoms of the participants were not adequately controlled with the 150mg dose, as determined by the investigator, the dose could be escalated to 300mg subcutaneously. | 35 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Guardian decision | 1 | 0 |
| Overall Study | Lack of Efficacy | 2 | 4 |
| Overall Study | Physician Decision | 1 | 4 |
| Overall Study | Post study access to treatment | 3 | 11 |
| Overall Study | Subject Decision | 2 | 4 |
Baseline characteristics
| Characteristic | Group 1- Secukinumab 75 mg | Group 2 - Secukinumab 150 mg | Total |
|---|---|---|---|
| Age, Continuous | 9.5 Years STANDARD_DEVIATION 3.49 | 14.1 Years STANDARD_DEVIATION 2.02 | 12.5 Years STANDARD_DEVIATION 3.4 |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 19 Participants | 33 Participants | 52 Participants |
| Sex: Female, Male Female | 8 Participants | 10 Participants | 18 Participants |
| Sex: Female, Male Male | 11 Participants | 25 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 43 | 0 / 16 | 0 / 54 |
| other Total, other adverse events | 15 / 19 | 28 / 43 | 11 / 16 | 43 / 54 |
| serious Total, serious adverse events | 0 / 19 | 4 / 43 | 0 / 16 | 4 / 54 |
Outcome results
Primary
Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response
The JIA ACR response criteria consisted of 6 core criteria: * Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). * Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). * Functional ability (CHAQ: Childhood Health Assessment Questionnaire): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain. It ranged from 0 (no disability) to 3 (very severe disability). * Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. * Number of joints with limited range of motion, ranging from 0 to 69. * Index of inflammation: C-reactive Protein (CRP) levels The JIA ACR 30 response was achieved if 3 of any 6 core set variables improved by at least 30% from baseline of the core study, and no more than 1 variable worsening more than 30%
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Population: Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1- Secukinumab 75 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 104 | 100 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 116 | 100 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 128 | 100 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 140 | 100 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 156 | 94.7 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 180 | 94.7 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 208 | 100 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 232 | 94.1 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 260 | 92.9 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 284 | 100 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 308 | 100 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 312 | 90.0 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 312 | 100 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 104 | 100 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 208 | 100 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 260 | 96.2 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 116 | 96.9 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 180 | 97.0 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 308 | 100 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 128 | 100 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 232 | 100 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 156 | 100 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 140 | 100 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 284 | 95.7 Percentage of Participants |
| Total Secukinumab Dose | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 140 | 100 Percentage of Participants |
| Total Secukinumab Dose | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 156 | 98.1 Percentage of Participants |
| Total Secukinumab Dose | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 284 | 97.3 Percentage of Participants |
| Total Secukinumab Dose | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 180 | 96.2 Percentage of Participants |
| Total Secukinumab Dose | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 208 | 100 Percentage of Participants |
| Total Secukinumab Dose | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 232 | 97.7 Percentage of Participants |
| Total Secukinumab Dose | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 308 | 100 Percentage of Participants |
| Total Secukinumab Dose | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 104 | 100 Percentage of Participants |
| Total Secukinumab Dose | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 116 | 98.9 Percentage of Participants |
| Total Secukinumab Dose | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 260 | 95.0 Percentage of Participants |
| Total Secukinumab Dose | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 128 | 100 Percentage of Participants |
| Total Secukinumab Dose | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Week 312 | 95.5 Percentage of Participants |
Secondary
Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels
The JIA ACR response criteria included six core components, one of which was CRP levels, an inflammation biomarker. Serum concentrations of CRP were determined, and the change from baseline of the core study was assessed, with negative changes indicating improvement.
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Population: Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 116 | -11.201 milligram (mg) / liter (L) | Standard Deviation 40.1619 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 156 | -13.622 milligram (mg) / liter (L) | Standard Deviation 34.4677 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 140 | -15.867 milligram (mg) / liter (L) | Standard Deviation 36.7306 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 308 | -21.052 milligram (mg) / liter (L) | Standard Deviation 53.0822 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 180 | -16.131 milligram (mg) / liter (L) | Standard Deviation 38.0479 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 104 | -15.238 milligram (mg) / liter (L) | Standard Deviation 38.068 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 312 | -25.915 milligram (mg) / liter (L) | Standard Deviation 55.0448 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 208 | -16.907 milligram (mg) / liter (L) | Standard Deviation 40.1651 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 284 | -19.974 milligram (mg) / liter (L) | Standard Deviation 47.7822 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 128 | -15.027 milligram (mg) / liter (L) | Standard Deviation 40.3989 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 232 | -15.015 milligram (mg) / liter (L) | Standard Deviation 41.4765 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 260 | -18.746 milligram (mg) / liter (L) | Standard Deviation 48.0621 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 232 | -20.365 milligram (mg) / liter (L) | Standard Deviation 38.9746 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 260 | -20.715 milligram (mg) / liter (L) | Standard Deviation 42.7106 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 284 | -15.530 milligram (mg) / liter (L) | Standard Deviation 59.2045 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 308 | -21.458 milligram (mg) / liter (L) | Standard Deviation 47.6825 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 312 | -27.892 milligram (mg) / liter (L) | Standard Deviation 53.5661 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 140 | -21.211 milligram (mg) / liter (L) | Standard Deviation 37.0123 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 156 | -21.325 milligram (mg) / liter (L) | Standard Deviation 37.3081 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 116 | -21.795 milligram (mg) / liter (L) | Standard Deviation 37.5991 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 180 | -20.788 milligram (mg) / liter (L) | Standard Deviation 36.9842 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 104 | -19.788 milligram (mg) / liter (L) | Standard Deviation 36.292 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 208 | -20.694 milligram (mg) / liter (L) | Standard Deviation 38.1014 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 128 | -21.446 milligram (mg) / liter (L) | Standard Deviation 38.287 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 312 | -26.993 milligram (mg) / liter (L) | Standard Deviation 52.939 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 104 | -18.187 milligram (mg) / liter (L) | Standard Deviation 36.6322 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 116 | -17.848 milligram (mg) / liter (L) | Standard Deviation 38.5218 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 128 | -19.088 milligram (mg) / liter (L) | Standard Deviation 38.7812 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 140 | -19.325 milligram (mg) / liter (L) | Standard Deviation 36.6347 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 156 | -18.510 milligram (mg) / liter (L) | Standard Deviation 36.148 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 180 | -19.086 milligram (mg) / liter (L) | Standard Deviation 37.0716 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 208 | -19.303 milligram (mg) / liter (L) | Standard Deviation 38.4978 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 232 | -18.298 milligram (mg) / liter (L) | Standard Deviation 39.5668 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 260 | -20.026 milligram (mg) / liter (L) | Standard Deviation 44.0482 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 284 | -17.212 milligram (mg) / liter (L) | Standard Deviation 54.5096 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels | Week 308 | -21.290 milligram (mg) / liter (L) | Standard Deviation 49.0532 |
Secondary
Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ)
The JIA ACR response criteria included six core components, one of which was the functional ability, measured by the CHAQ. The CHAQ questionnaire consisted of 30 questions across 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each domain was scored on a 4-point scale, and the total score was calculated as the average of the scores for each domain. The total score ranged from 0 (no disability) to 3 (very severe disability). The change from baseline of the core study in the CHAQ was measured, with a negative change indicating improvement.
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Population: Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 104 | -0.599 Score on a Scale | Standard Deviation 0.549 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 116 | -0.605 Score on a Scale | Standard Deviation 0.5469 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 128 | -0.647 Score on a Scale | Standard Deviation 0.5196 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 140 | -0.590 Score on a Scale | Standard Deviation 0.4809 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 156 | -0.645 Score on a Scale | Standard Deviation 0.5275 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 180 | -0.658 Score on a Scale | Standard Deviation 0.5541 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 208 | -0.667 Score on a Scale | Standard Deviation 0.4832 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 232 | -0.610 Score on a Scale | Standard Deviation 0.5411 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 260 | -0.741 Score on a Scale | Standard Deviation 0.5035 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 284 | -0.777 Score on a Scale | Standard Deviation 0.5052 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 308 | -0.865 Score on a Scale | Standard Deviation 0.4811 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 312 | -0.888 Score on a Scale | Standard Deviation 0.505 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 312 | -1.000 Score on a Scale | Standard Deviation 0.6077 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 104 | -0.636 Score on a Scale | Standard Deviation 0.5967 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 208 | -0.625 Score on a Scale | Standard Deviation 0.5293 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 260 | -0.649 Score on a Scale | Standard Deviation 0.6205 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 116 | -0.617 Score on a Scale | Standard Deviation 0.5811 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 180 | -0.625 Score on a Scale | Standard Deviation 0.5779 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 308 | -0.794 Score on a Scale | Standard Deviation 0.6311 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 128 | -0.685 Score on a Scale | Standard Deviation 0.557 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 232 | -0.681 Score on a Scale | Standard Deviation 0.5825 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 156 | -0.644 Score on a Scale | Standard Deviation 0.5763 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 140 | -0.648 Score on a Scale | Standard Deviation 0.5638 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 284 | -0.652 Score on a Scale | Standard Deviation 0.6329 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 140 | -0.627 Score on a Scale | Standard Deviation 0.5318 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 156 | -0.644 Score on a Scale | Standard Deviation 0.5537 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 284 | -0.699 Score on a Scale | Standard Deviation 0.5837 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 180 | -0.637 Score on a Scale | Standard Deviation 0.5641 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 208 | -0.640 Score on a Scale | Standard Deviation 0.5082 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 232 | -0.653 Score on a Scale | Standard Deviation 0.5615 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 308 | -0.823 Score on a Scale | Standard Deviation 0.5655 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 104 | -0.623 Score on a Scale | Standard Deviation 0.5754 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 116 | -0.613 Score on a Scale | Standard Deviation 0.5631 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 260 | -0.681 Score on a Scale | Standard Deviation 0.5773 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 128 | -0.672 Score on a Scale | Standard Deviation 0.5388 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Week 312 | -0.949 Score on a Scale | Standard Deviation 0.5532 |
Secondary
Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis
The JIA ACR response criteria included six core components, one of which was the number of joints with active arthritis. This was determined using the ACR definition, which identifies active arthritis as any joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion or tenderness not due to deformity. The active joint count ranged from 0 to 73. The change from baseline of the core study in the number of active joints was measured, with a negative change indicating improvement.
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Population: Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 104 | -8.4 Joints | Standard Deviation 11.03 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 116 | -8.4 Joints | Standard Deviation 11.48 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 128 | -8.7 Joints | Standard Deviation 11.81 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 140 | -8.4 Joints | Standard Deviation 11.81 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 156 | -8.1 Joints | Standard Deviation 9.77 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 180 | -8.3 Joints | Standard Deviation 11.66 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 208 | -7.0 Joints | Standard Deviation 6.12 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 232 | -7.4 Joints | Standard Deviation 8.48 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 260 | -7.9 Joints | Standard Deviation 10.14 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 284 | -8.4 Joints | Standard Deviation 11.61 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 308 | -8.0 Joints | Standard Deviation 9.7 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 312 | -8.9 Joints | Standard Deviation 11.59 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 312 | -7.5 Joints | Standard Deviation 5.14 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 104 | -6.9 Joints | Standard Deviation 5.26 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 208 | -6.7 Joints | Standard Deviation 5.38 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 260 | -7.5 Joints | Standard Deviation 5.57 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 116 | -6.6 Joints | Standard Deviation 4.5 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 180 | -7.0 Joints | Standard Deviation 5.69 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 308 | -6.5 Joints | Standard Deviation 4.52 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 128 | -7.3 Joints | Standard Deviation 5.35 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 232 | -7.0 Joints | Standard Deviation 5.68 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 156 | -7.1 Joints | Standard Deviation 5.61 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 140 | -7.0 Joints | Standard Deviation 5.44 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 284 | -7.0 Joints | Standard Deviation 5.57 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 140 | -7.5 Joints | Standard Deviation 8.17 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 156 | -7.5 Joints | Standard Deviation 7.32 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 284 | -7.5 Joints | Standard Deviation 8.25 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 180 | -7.5 Joints | Standard Deviation 8.29 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 208 | -6.8 Joints | Standard Deviation 5.6 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 232 | -7.1 Joints | Standard Deviation 6.8 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 308 | -7.1 Joints | Standard Deviation 7.01 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 104 | -7.4 Joints | Standard Deviation 7.72 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 116 | -7.3 Joints | Standard Deviation 7.79 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 260 | -7.7 Joints | Standard Deviation 7.36 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 128 | -7.8 Joints | Standard Deviation 8.24 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Week 312 | -8.1 Joints | Standard Deviation 8.48 |
Secondary
Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion
The JIA ACR response criteria included six core components, one of which was the number of joints with limited range of motion. A total of 69 joints were assessed for limitation of motion. The change from baseline of the core study in the number of joints with limited range of motion was measured, with a negative change indicating improvement.
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Population: Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 104 | -5.5 Joints | Standard Deviation 6.2 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 116 | -5.4 Joints | Standard Deviation 6.24 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 128 | -5.5 Joints | Standard Deviation 6.41 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 140 | -5.7 Joints | Standard Deviation 6.31 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 156 | -5.2 Joints | Standard Deviation 5.68 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 180 | -5.3 Joints | Standard Deviation 6.37 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 208 | -5.1 Joints | Standard Deviation 5.61 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 232 | -4.5 Joints | Standard Deviation 5.42 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 260 | -5.2 Joints | Standard Deviation 6.47 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 284 | -5.1 Joints | Standard Deviation 5.72 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 308 | -5.2 Joints | Standard Deviation 5.46 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 312 | -5.3 Joints | Standard Deviation 6.77 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 312 | -6.3 Joints | Standard Deviation 3.62 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 104 | -5.3 Joints | Standard Deviation 4.23 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 208 | -5.3 Joints | Standard Deviation 3.92 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 260 | -5.9 Joints | Standard Deviation 3.93 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 116 | -5.7 Joints | Standard Deviation 4.19 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 180 | -5.5 Joints | Standard Deviation 4.83 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 308 | -5.8 Joints | Standard Deviation 3.05 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 128 | -6.0 Joints | Standard Deviation 4.6 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 232 | -5.6 Joints | Standard Deviation 3.93 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 156 | -4.3 Joints | Standard Deviation 8.19 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 140 | -6.0 Joints | Standard Deviation 4.99 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 284 | -6.0 Joints | Standard Deviation 3.88 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 140 | -5.9 Joints | Standard Deviation 5.43 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 156 | -4.6 Joints | Standard Deviation 7.32 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 284 | -5.7 Joints | Standard Deviation 4.61 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 180 | -5.4 Joints | Standard Deviation 5.38 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 208 | -5.2 Joints | Standard Deviation 4.56 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 232 | -5.2 Joints | Standard Deviation 4.53 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 308 | -5.5 Joints | Standard Deviation 4.14 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 104 | -5.4 Joints | Standard Deviation 4.96 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 116 | -5.6 Joints | Standard Deviation 4.99 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 260 | -5.7 Joints | Standard Deviation 4.9 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 128 | -5.8 Joints | Standard Deviation 5.28 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion | Week 312 | -5.8 Joints | Standard Deviation 5.17 |
Secondary
Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being
The JIA ACR response criteria included six core components, one of which was the parent's or patients' global assessment of overall well-being. This assessment was conducted using a 100 mm VAS score, where 0 represented very well and 100 very poor. The change from baseline of the core study in the parent's or patients' global assessment of overall well-being was measured, with a negative change indicating improvement
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Population: Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 128 | -46.8 Score on a Scale | Standard Deviation 25.02 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 284 | -51.6 Score on a Scale | Standard Deviation 24.97 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 140 | -41.1 Score on a Scale | Standard Deviation 27.57 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 308 | -49.8 Score on a Scale | Standard Deviation 24.23 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 312 | -48.9 Score on a Scale | Standard Deviation 28.45 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 104 | -47.1 Score on a Scale | Standard Deviation 25.9 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 156 | -46.1 Score on a Scale | Standard Deviation 25.41 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 116 | -45.4 Score on a Scale | Standard Deviation 25.7 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 180 | -45.5 Score on a Scale | Standard Deviation 27.24 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 208 | -47.6 Score on a Scale | Standard Deviation 25.7 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 232 | -39.6 Score on a Scale | Standard Deviation 27.23 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 260 | -44.8 Score on a Scale | Standard Deviation 34.52 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 232 | -43.4 Score on a Scale | Standard Deviation 28.2 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 260 | -42.8 Score on a Scale | Standard Deviation 29.31 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 128 | -39.1 Score on a Scale | Standard Deviation 26.69 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 156 | -39.2 Score on a Scale | Standard Deviation 27.15 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 284 | -43.2 Score on a Scale | Standard Deviation 31.23 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 208 | -40.3 Score on a Scale | Standard Deviation 28.13 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 104 | -38.6 Score on a Scale | Standard Deviation 27.74 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 308 | -48.5 Score on a Scale | Standard Deviation 31.93 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 140 | -38.7 Score on a Scale | Standard Deviation 27.06 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 180 | -39.8 Score on a Scale | Standard Deviation 27.48 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 312 | -53.5 Score on a Scale | Standard Deviation 30.31 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 116 | -37.7 Score on a Scale | Standard Deviation 26.39 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 312 | -51.4 Score on a Scale | Standard Deviation 28.87 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 104 | -41.6 Score on a Scale | Standard Deviation 27.17 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 116 | -40.5 Score on a Scale | Standard Deviation 26.15 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 140 | -38.7 Score on a Scale | Standard Deviation 27.06 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 156 | -41.8 Score on a Scale | Standard Deviation 26.49 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 180 | -41.9 Score on a Scale | Standard Deviation 27.27 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 208 | -43.0 Score on a Scale | Standard Deviation 27.23 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 232 | -41.9 Score on a Scale | Standard Deviation 27.57 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 260 | -43.5 Score on a Scale | Standard Deviation 30.8 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 284 | -46.4 Score on a Scale | Standard Deviation 28.96 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 308 | -49.1 Score on a Scale | Standard Deviation 28.53 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Week 128 | -41.8 Score on a Scale | Standard Deviation 26.11 |
Secondary
Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity
The JIA ACR response criteria consisted of 6 core criteria, one of which was the physician global assessment of disease activity. this assessment was conducted using a 100 mm VAS score, where 0 represented the best disease activity and 100 the worst. The change from baseline of the core study of the physician global assessment of disease activity was measured, with a negative change indicating improvement.
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Population: Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 104 | -40.0 Score on a Scale | Standard Deviation 18.39 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 116 | -40.3 Score on a Scale | Standard Deviation 18.42 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 128 | -40.4 Score on a Scale | Standard Deviation 18.55 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 140 | -39.0 Score on a Scale | Standard Deviation 16.75 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 156 | -39.7 Score on a Scale | Standard Deviation 17.09 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 180 | -38.5 Score on a Scale | Standard Deviation 18.2 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 208 | -39.0 Score on a Scale | Standard Deviation 17.06 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 232 | -38.4 Score on a Scale | Standard Deviation 18.2 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 260 | -37.6 Score on a Scale | Standard Deviation 28.75 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 284 | -43.6 Score on a Scale | Standard Deviation 18.96 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 308 | -43.8 Score on a Scale | Standard Deviation 18.76 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 312 | -44.2 Score on a Scale | Standard Deviation 26.58 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 312 | -47.4 Score on a Scale | Standard Deviation 22.05 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 104 | -42.2 Score on a Scale | Standard Deviation 20.43 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 208 | -41.8 Score on a Scale | Standard Deviation 19.45 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 260 | -45.4 Score on a Scale | Standard Deviation 20.74 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 116 | -41.1 Score on a Scale | Standard Deviation 20.35 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 180 | -38.9 Score on a Scale | Standard Deviation 21.71 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 308 | -40.3 Score on a Scale | Standard Deviation 20.51 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 128 | -41.9 Score on a Scale | Standard Deviation 21.33 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 232 | -42.9 Score on a Scale | Standard Deviation 20.86 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 156 | -40.8 Score on a Scale | Standard Deviation 20.72 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 140 | -42.4 Score on a Scale | Standard Deviation 19.18 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 284 | -42.8 Score on a Scale | Standard Deviation 20.53 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 140 | -41.2 Score on a Scale | Standard Deviation 18.26 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 156 | -40.4 Score on a Scale | Standard Deviation 19.5 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 284 | -43.1 Score on a Scale | Standard Deviation 19.68 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 180 | -38.8 Score on a Scale | Standard Deviation 20.31 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 208 | -40.8 Score on a Scale | Standard Deviation 18.48 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 232 | -41.1 Score on a Scale | Standard Deviation 19.78 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 308 | -41.7 Score on a Scale | Standard Deviation 19.53 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 104 | -41.4 Score on a Scale | Standard Deviation 19.59 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 116 | -40.8 Score on a Scale | Standard Deviation 19.46 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 260 | -42.7 Score on a Scale | Standard Deviation 23.78 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 128 | -41.3 Score on a Scale | Standard Deviation 20.17 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Week 312 | -46.0 Score on a Scale | Standard Deviation 23.67 |
Secondary
Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count
The dactylitis count was the number of fingers and toes presenting with swelling and inflammation. Swelling and inflammation on examination was recorded as either present (1) or absent (0) for each of the 20 sites, The total dactylitis count ranged from 0 to 20. The change from baseline of the core study was assessed. A negative change from baseline indicated improvement
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Population: Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 104 | -1.3 Dactylitis count | Standard Deviation 1.94 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 116 | -1.5 Dactylitis count | Standard Deviation 2.04 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 128 | -1.8 Dactylitis count | Standard Deviation 2.39 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 140 | -1.6 Dactylitis count | Standard Deviation 2.42 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 156 | -1.6 Dactylitis count | Standard Deviation 2.23 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 180 | -1.8 Dactylitis count | Standard Deviation 2.41 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 208 | -1.6 Dactylitis count | Standard Deviation 2.42 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 232 | -1.5 Dactylitis count | Standard Deviation 2.42 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 260 | -1.2 Dactylitis count | Standard Deviation 2.04 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 284 | -1.2 Dactylitis count | Standard Deviation 2.13 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 308 | -0.9 Dactylitis count | Standard Deviation 1.7 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 312 | -1.1 Dactylitis count | Standard Deviation 1.83 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 312 | -0.2 Dactylitis count | Standard Deviation 0.39 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 104 | -0.4 Dactylitis count | Standard Deviation 1.97 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 208 | -0.3 Dactylitis count | Standard Deviation 0.87 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 260 | -0.3 Dactylitis count | Standard Deviation 0.84 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 116 | -0.5 Dactylitis count | Standard Deviation 2.05 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 180 | 0.0 Dactylitis count | Standard Deviation 4.15 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 308 | 0.1 Dactylitis count | Standard Deviation 0.56 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 128 | -0.5 Dactylitis count | Standard Deviation 2.23 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 232 | -0.4 Dactylitis count | Standard Deviation 0.88 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 156 | -0.7 Dactylitis count | Standard Deviation 2.07 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 140 | -0.6 Dactylitis count | Standard Deviation 2.09 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 284 | -0.3 Dactylitis count | Standard Deviation 0.95 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 140 | -1.0 Dactylitis count | Standard Deviation 2.24 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 156 | -1.0 Dactylitis count | Standard Deviation 2.15 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 284 | -0.6 Dactylitis count | Standard Deviation 1.52 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 180 | -0.6 Dactylitis count | Standard Deviation 3.71 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 208 | -0.8 Dactylitis count | Standard Deviation 1.7 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 232 | -0.8 Dactylitis count | Standard Deviation 1.7 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 308 | -0.3 Dactylitis count | Standard Deviation 1.22 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 104 | -0.7 Dactylitis count | Standard Deviation 1.99 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 116 | -0.9 Dactylitis count | Standard Deviation 2.08 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 260 | -0.6 Dactylitis count | Standard Deviation 1.43 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 128 | -0.9 Dactylitis count | Standard Deviation 2.35 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count | Week 312 | -0.6 Dactylitis count | Standard Deviation 1.29 |
Secondary
Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count
The following 16 entheseal sites were assessed for the presence or absence of tenderness (enthesitis) on each side of the body: * Anterior Entheses: Greater trochanter of the Femur; Medial condyle of the femur; Lateral condyle of the femur * Posterior Entheses: Greater tuberosity of humerus; medial epicondyle of humerus; lateral epicondyle of humerus, Achilles tendon; and calcaneal insertion of the plantar fascia. Tenderness on examination was recorded as either present (1) or absent (0) for each of the 16 sites, The total enthesitis count ranged from 0 to 16. The change from baseline of the core study was assessed. A negative change from baseline indicated improvement
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Population: Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 104 | -2.5 Enthesitis count | Standard Deviation 2.57 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 116 | -2.4 Enthesitis count | Standard Deviation 2.36 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 128 | -2.4 Enthesitis count | Standard Deviation 2.43 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 140 | -2.5 Enthesitis count | Standard Deviation 2.36 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 156 | -2.7 Enthesitis count | Standard Deviation 3.03 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 180 | -2.6 Enthesitis count | Standard Deviation 2.59 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 208 | -2.4 Enthesitis count | Standard Deviation 2.81 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 232 | -2.5 Enthesitis count | Standard Deviation 2.85 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 260 | -2.5 Enthesitis count | Standard Deviation 3.54 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 284 | -2.9 Enthesitis count | Standard Deviation 3.05 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 308 | -3.2 Enthesitis count | Standard Deviation 3.07 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 312 | -2.5 Enthesitis count | Standard Deviation 2.32 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 312 | -2.1 Enthesitis count | Standard Deviation 1.44 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 104 | -2.3 Enthesitis count | Standard Deviation 2.3 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 208 | -2.3 Enthesitis count | Standard Deviation 2.56 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 260 | -2.0 Enthesitis count | Standard Deviation 1.36 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 116 | -2.3 Enthesitis count | Standard Deviation 2.5 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 180 | -2.5 Enthesitis count | Standard Deviation 2.54 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 308 | -2.1 Enthesitis count | Standard Deviation 1.25 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 128 | -2.3 Enthesitis count | Standard Deviation 1.97 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 232 | -2.0 Enthesitis count | Standard Deviation 2.28 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 156 | -2.5 Enthesitis count | Standard Deviation 2.36 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 140 | -2.7 Enthesitis count | Standard Deviation 2.43 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 284 | -2.0 Enthesitis count | Standard Deviation 1.52 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 140 | -2.6 Enthesitis count | Standard Deviation 2.38 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 156 | -2.2 Enthesitis count | Standard Deviation 2.62 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 284 | -2.4 Enthesitis count | Standard Deviation 2.21 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 180 | -2.5 Enthesitis count | Standard Deviation 2.53 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 208 | 2.53 Enthesitis count | Standard Deviation 2.63 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 232 | -2.2 Enthesitis count | Standard Deviation 2.49 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 308 | -2.5 Enthesitis count | Standard Deviation 2.21 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 104 | -2.4 Enthesitis count | Standard Deviation 2.37 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 116 | -2.4 Enthesitis count | Standard Deviation 2.42 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 260 | -2.2 Enthesitis count | Standard Deviation 2.37 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 128 | -2.3 Enthesitis count | Standard Deviation 2.13 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count | Week 312 | -2.3 Enthesitis count | Standard Deviation 1.86 |
Secondary
Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27)
The JADAS-27 was used for assessment of disease activity, and it included 4 measures: * Physician global assessment of disease activity (VAS range: 0 to 10; where 0=very good and 100=very poor) * Parent/participant global assessment of well-being (VAS range: 0 to 10; 0=very well and 100=very poor) * Count of joints with active disease (range: 0 to 27; where 0= no disease activity and 27= maximum disease activity) * Index of inflammation determined by CRP concentration, calculated as: (CRP (mg/l) -10)/10. Before calculation, CRP values \<10 mg/l were converted to 10 and CRP values \>110 mg/l were converted to 110. The normalized scale ranged from 0 to 10; where 0= no disease activity and 10= maximum disease activity. JADAS-27 score was calculated as the sum of the score of its 4 components, ranging from 0 to 57 where 0= no disease activity and 57= maximum disease activity. The change from baseline of the core study was assessed. A negative change from baseline indicated improvement.
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Population: Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 104 | -14.436 Score on a Scale | Standard Deviation 7.2274 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 116 | -13.984 Score on a Scale | Standard Deviation 7.9693 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 128 | -14.478 Score on a Scale | Standard Deviation 7.7217 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 140 | -14.050 Score on a Scale | Standard Deviation 7.6609 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 156 | -14.027 Score on a Scale | Standard Deviation 6.1256 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 180 | -14.235 Score on a Scale | Standard Deviation 7.6622 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 208 | -13.501 Score on a Scale | Standard Deviation 5.7531 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 232 | -13.064 Score on a Scale | Standard Deviation 6.3732 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 260 | -13.454 Score on a Scale | Standard Deviation 8.9326 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 284 | -15.358 Score on a Scale | Standard Deviation 7.3767 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 308 | -14.437 Score on a Scale | Standard Deviation 6.4218 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 312 | -15.310 Score on a Scale | Standard Deviation 8.3332 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 312 | -17.122 Score on a Scale | Standard Deviation 8.2219 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 104 | -13.731 Score on a Scale | Standard Deviation 7.4131 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 208 | -13.869 Score on a Scale | Standard Deviation 7.379 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 260 | -15.096 Score on a Scale | Standard Deviation 7.979 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 116 | -13.632 Score on a Scale | Standard Deviation 7.0546 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 180 | -13.737 Score on a Scale | Standard Deviation 7.519 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 308 | -14.647 Score on a Scale | Standard Deviation 8.3114 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 128 | -14.277 Score on a Scale | Standard Deviation 7.3964 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 232 | -14.669 Score on a Scale | Standard Deviation 7.641 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 156 | -14.158 Score on a Scale | Standard Deviation 7.4052 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 140 | -14.104 Score on a Scale | Standard Deviation 7.3246 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 284 | -14.445 Score on a Scale | Standard Deviation 8.4302 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 140 | -14.085 Score on a Scale | Standard Deviation 7.3683 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 156 | -14.111 Score on a Scale | Standard Deviation 6.9032 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 284 | -14.791 Score on a Scale | Standard Deviation 7.955 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 180 | -13.919 Score on a Scale | Standard Deviation 7.5002 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 208 | -13.734 Score on a Scale | Standard Deviation 6.7665 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 232 | -14.049 Score on a Scale | Standard Deviation 7.1443 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 308 | -14.560 Score on a Scale | Standard Deviation 7.4623 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 104 | -13.979 Score on a Scale | Standard Deviation 7.2876 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 116 | -13.763 Score on a Scale | Standard Deviation 7.3314 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 260 | -14.521 Score on a Scale | Standard Deviation 8.2484 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 128 | -14.348 Score on a Scale | Standard Deviation 7.4314 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | Week 312 | -16.298 Score on a Scale | Standard Deviation 8.1255 |
Secondary
Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71)
The JADAS-27 was used for assessment of disease activity, and it included 4 measures: * Physician global assessment of disease activity (VAS range: 0 to 10; where 0=very good and 100=very poor) * Parent/participant global assessment of well-being (VAS range: 0 to 10; 0=very well and 100=very poor) * Count of joints with active disease (range: 0 to 71; where 0= no disease activity and 71= maximum disease activity) * Index of inflammation determined by CRP concentration, calculated as: (CRP (mg/l) -10)/10. Before calculation, CRP values \<10 mg/l were converted to 10 and CRP values \>110 mg/l were converted to 110. The normalized scale ranged from 0 to 10; where 0= no disease activity and 10= maximum disease activity. JADAS-27 score was calculated as the sum of the score of its 4 components, ranging from 0 to 101 where 0= no disease activity and 101= maximum disease activity. The change from baseline of the core study was assessed. A negative change from baseline indicated improvement.
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Population: Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 104 | -17.962 Score on a Scale | Standard Deviation 13.277 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 116 | -17.510 Score on a Scale | Standard Deviation 14.0289 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 128 | -18.595 Score on a Scale | Standard Deviation 14.2989 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 140 | -17.384 Score on a Scale | Standard Deviation 13.8172 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 156 | -17.448 Score on a Scale | Standard Deviation 11.6294 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 180 | -17.709 Score on a Scale | Standard Deviation 13.9552 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 208 | -16.723 Score on a Scale | Standard Deviation 8.8183 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 232 | -16.005 Score on a Scale | Standard Deviation 10.7335 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 260 | -17.239 Score on a Scale | Standard Deviation 13.8602 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 284 | -19.144 Score on a Scale | Standard Deviation 13.7107 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 308 | -18.520 Score on a Scale | Standard Deviation 12.0126 |
| Group 1- Secukinumab 75 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 312 | -19.810 Score on a Scale | Standard Deviation 14.3124 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 312 | -19.622 Score on a Scale | Standard Deviation 9.0748 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 104 | -16.503 Score on a Scale | Standard Deviation 9.0939 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 208 | -16.675 Score on a Scale | Standard Deviation 9.0536 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 260 | -18.019 Score on a Scale | Standard Deviation 9.7594 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 116 | -16.226 Score on a Scale | Standard Deviation 8.2331 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 180 | -16.556 Score on a Scale | Standard Deviation 9.4998 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 308 | -17.000 Score on a Scale | Standard Deviation 9.1449 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 128 | -17.083 Score on a Scale | Standard Deviation 9.1148 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 232 | -17.262 Score on a Scale | Standard Deviation 9.3685 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 156 | -16.855 Score on a Scale | Standard Deviation 9.1102 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 140 | -16.861 Score on a Scale | Standard Deviation 9.0858 |
| Group 2 - Secukinumab 150 mg | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 284 | -17.141 Score on a Scale | Standard Deviation 10.3338 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 140 | -17.046 Score on a Scale | Standard Deviation 10.854 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 156 | -17.072 Score on a Scale | Standard Deviation 9.9946 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 284 | -17.899 Score on a Scale | Standard Deviation 11.5806 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 180 | -16.977 Score on a Scale | Standard Deviation 11.2105 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 208 | -16.693 Score on a Scale | Standard Deviation 8.8753 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 232 | -16.776 Score on a Scale | Standard Deviation 9.8143 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 308 | -17.629 Score on a Scale | Standard Deviation 10.2499 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 104 | -17.016 Score on a Scale | Standard Deviation 10.6497 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 116 | -16.704 Score on a Scale | Standard Deviation 10.6429 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 260 | -17.746 Score on a Scale | Standard Deviation 11.1907 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 128 | -17.619 Score on a Scale | Standard Deviation 11.098 |
| Total Secukinumab Dose | Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 312 | -19.707 Score on a Scale | Standard Deviation 11.4427 |
Secondary
Number of Participants With Inactive Disease Status
Inactive disease status was confirmed in a patient when all the following conditions were met: * No joints with active arthritis * No uveitis * CRP value within normal limits for the laboratory where tested or, if elevated, not attributable to JIA * Physician's global assessment of disease activity score ≤ 10mm * Duration of morning stiffness attributable to JIA lasting ≥15 minutes.
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Population: Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1- Secukinumab 75 mg | Number of Participants With Inactive Disease Status | Week 104 | 63.2 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Number of Participants With Inactive Disease Status | Week 116 | 68.4 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Number of Participants With Inactive Disease Status | Week 128 | 66.7 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Number of Participants With Inactive Disease Status | Week 140 | 72.2 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Number of Participants With Inactive Disease Status | Week 156 | 68.4 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Number of Participants With Inactive Disease Status | Week 180 | 68.4 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Number of Participants With Inactive Disease Status | Week 208 | 61.1 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Number of Participants With Inactive Disease Status | Week 232 | 70.6 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Number of Participants With Inactive Disease Status | Week 260 | 71.4 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Number of Participants With Inactive Disease Status | Week 284 | 78.6 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Number of Participants With Inactive Disease Status | Week 308 | 83.3 Percentage of Participants |
| Group 1- Secukinumab 75 mg | Number of Participants With Inactive Disease Status | Week 312 | 70.0 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Number of Participants With Inactive Disease Status | Week 312 | 75.0 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Number of Participants With Inactive Disease Status | Week 104 | 65.7 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Number of Participants With Inactive Disease Status | Week 208 | 67.7 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Number of Participants With Inactive Disease Status | Week 260 | 65.4 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Number of Participants With Inactive Disease Status | Week 116 | 71.9 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Number of Participants With Inactive Disease Status | Week 180 | 54.5 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Number of Participants With Inactive Disease Status | Week 308 | 82.4 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Number of Participants With Inactive Disease Status | Week 128 | 64.5 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Number of Participants With Inactive Disease Status | Week 232 | 66.7 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Number of Participants With Inactive Disease Status | Week 156 | 72.7 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Number of Participants With Inactive Disease Status | Week 140 | 63.6 Percentage of Participants |
| Group 2 - Secukinumab 150 mg | Number of Participants With Inactive Disease Status | Week 284 | 78.3 Percentage of Participants |
| Total Secukinumab Dose | Number of Participants With Inactive Disease Status | Week 140 | 66.7 Percentage of Participants |
| Total Secukinumab Dose | Number of Participants With Inactive Disease Status | Week 156 | 71.2 Percentage of Participants |
| Total Secukinumab Dose | Number of Participants With Inactive Disease Status | Week 284 | 78.4 Percentage of Participants |
| Total Secukinumab Dose | Number of Participants With Inactive Disease Status | Week 180 | 59.6 Percentage of Participants |
| Total Secukinumab Dose | Number of Participants With Inactive Disease Status | Week 208 | 65.3 Percentage of Participants |
| Total Secukinumab Dose | Number of Participants With Inactive Disease Status | Week 232 | 68.2 Percentage of Participants |
| Total Secukinumab Dose | Number of Participants With Inactive Disease Status | Week 308 | 82.8 Percentage of Participants |
| Total Secukinumab Dose | Number of Participants With Inactive Disease Status | Week 104 | 64.8 Percentage of Participants |
| Total Secukinumab Dose | Number of Participants With Inactive Disease Status | Week 116 | 70.6 Percentage of Participants |
| Total Secukinumab Dose | Number of Participants With Inactive Disease Status | Week 260 | 67.5 Percentage of Participants |
| Total Secukinumab Dose | Number of Participants With Inactive Disease Status | Week 128 | 65.3 Percentage of Participants |
| Total Secukinumab Dose | Number of Participants With Inactive Disease Status | Week 312 | 72.7 Percentage of Participants |
Secondary
Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) of Secukinumab
Number of participants with treatment-emergent Anti-Drug Antibodies (ADAs) of secukinumab. Blood samples were collected for immunogenicity (anti-AIN457 antibodies) assessments.
Time frame: From baseline of the core study up to Week 312. Study week is defined with respect to the core study.
Population: Participants who enrolled in the extension study and received at least one dose of study treatment with immunogenicity (anti-AIN457 antibodies) measurements of secukinumab in both the core and extension study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1- Secukinumab 75 mg | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) of Secukinumab | 0 Participants |
| Group 2 - Secukinumab 150 mg | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) of Secukinumab | 6 Participants |
| Total Secukinumab Dose | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) of Secukinumab | 6 Participants |
Secondary
Percentage of Participants With JIA ACR 100 Response
The JIA ACR response criteria consisted of 6 core criteria: * Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). * Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). * Functional ability (CHAQ): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain (0 \[no disability\] to 3 \[very severe disability\]). * Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. * Number of joints with limited range of motion, ranging from 0 to 69. * Index of inflammation: CRP levels The JIA ACR 100 responses were achieved if 3 of any 6 core set variables improved with 100% from baseline of the core study, and no more than 1 variable worsening \> 30%
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Population: Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 100 Response | Week 104 | 63.2 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 100 Response | Week 116 | 63.2 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 100 Response | Week 128 | 66.7 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 100 Response | Week 140 | 66.7 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 100 Response | Week 156 | 63.2 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 100 Response | Week 180 | 57.9 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 100 Response | Week 208 | 72.2 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 100 Response | Week 232 | 58.8 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 100 Response | Week 260 | 71.4 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 100 Response | Week 284 | 78.6 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 100 Response | Week 308 | 91.7 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 100 Response | Week 312 | 80.0 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 100 Response | Week 312 | 75.0 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 100 Response | Week 104 | 57.1 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 100 Response | Week 208 | 58.1 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 100 Response | Week 260 | 65.4 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 100 Response | Week 116 | 62.5 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 100 Response | Week 180 | 54.5 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 100 Response | Week 308 | 76.5 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 100 Response | Week 128 | 54.8 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 100 Response | Week 232 | 63.0 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 100 Response | Week 156 | 60.6 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 100 Response | Week 140 | 57.6 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 100 Response | Week 284 | 78.3 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 100 Response | Week 140 | 60.8 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 100 Response | Week 156 | 61.5 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 100 Response | Week 284 | 78.4 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 100 Response | Week 180 | 55.8 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 100 Response | Week 208 | 63.3 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 100 Response | Week 232 | 61.4 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 100 Response | Week 308 | 82.8 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 100 Response | Week 104 | 59.3 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 100 Response | Week 116 | 62.7 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 100 Response | Week 260 | 67.5 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 100 Response | Week 128 | 59.2 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 100 Response | Week 312 | 77.3 Percentage of participants |
Secondary
Percentage of Participants With JIA ACR 50 Response
The JIA ACR response criteria consisted of 6 core criteria: * Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). * Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). * Functional ability (CHAQ): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain (0 \[no disability\] to 3 \[very severe disability\]). * Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. * Number of joints with limited range of motion, ranging from 0 to 69. * Index of inflammation: CRP levels The JIA ACR 50 responses were achieved if 3 of any 6 core set variables improved by at least 50% from baseline of the core study, and no more than 1 variable worsening \> 30%
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Population: Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 50 Response | Week 104 | 94.7 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 50 Response | Week 116 | 100 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 50 Response | Week 128 | 94.4 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 50 Response | Week 140 | 100 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 50 Response | Week 156 | 94.7 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 50 Response | Week 180 | 94.7 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 50 Response | Week 208 | 100 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 50 Response | Week 232 | 94.1 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 50 Response | Week 260 | 92.9 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 50 Response | Week 284 | 100 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 50 Response | Week 308 | 100 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 50 Response | Week 312 | 90.0 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 50 Response | Week 312 | 100 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 50 Response | Week 104 | 94.3 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 50 Response | Week 208 | 90.3 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 50 Response | Week 260 | 96.2 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 50 Response | Week 116 | 93.8 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 50 Response | Week 180 | 93.9 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 50 Response | Week 308 | 100 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 50 Response | Week 128 | 93.5 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 50 Response | Week 232 | 96.3 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 50 Response | Week 156 | 87.9 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 50 Response | Week 140 | 90.9 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 50 Response | Week 284 | 95.7 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 50 Response | Week 140 | 94.1 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 50 Response | Week 156 | 90.4 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 50 Response | Week 284 | 97.3 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 50 Response | Week 180 | 94.2 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 50 Response | Week 208 | 93.9 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 50 Response | Week 232 | 95.5 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 50 Response | Week 308 | 100 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 50 Response | Week 104 | 94.4 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 50 Response | Week 116 | 96.1 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 50 Response | Week 260 | 95.0 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 50 Response | Week 128 | 93.9 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 50 Response | Week 312 | 95.5 Percentage of participants |
Secondary
Percentage of Participants With JIA ACR 70 Response
The JIA ACR response criteria consisted of 6 core criteria: * Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). * Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). * Functional ability (CHAQ): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain (0 \[no disability\] to 3 \[very severe disability\]). * Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. * Number of joints with limited range of motion, ranging from 0 to 69. * Index of inflammation: CRP levels The JIA ACR 70 responses were achieved if 3 of any 6 core set variables improved by at least 70%, from baseline of the core study, and no more than 1 variable worsening \> 30%
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Population: Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 70 Response | Week 104 | 94.7 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 70 Response | Week 116 | 94.7 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 70 Response | Week 128 | 94.4 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 70 Response | Week 140 | 88.9 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 70 Response | Week 156 | 94.7 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 70 Response | Week 180 | 89.5 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 70 Response | Week 208 | 94.4 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 70 Response | Week 232 | 88.2 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 70 Response | Week 260 | 92.9 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 70 Response | Week 284 | 100 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 70 Response | Week 308 | 100 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 70 Response | Week 312 | 90.0 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 70 Response | Week 312 | 83.3 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 70 Response | Week 104 | 82.9 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 70 Response | Week 208 | 90.3 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 70 Response | Week 260 | 96.2 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 70 Response | Week 116 | 90.6 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 70 Response | Week 180 | 81.8 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 70 Response | Week 308 | 100 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 70 Response | Week 128 | 90.3 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 70 Response | Week 232 | 85.2 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 70 Response | Week 156 | 84.8 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 70 Response | Week 140 | 84.8 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 70 Response | Week 284 | 95.7 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 70 Response | Week 140 | 86.3 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 70 Response | Week 156 | 88.5 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 70 Response | Week 284 | 97.3 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 70 Response | Week 180 | 84.6 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 70 Response | Week 208 | 91.8 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 70 Response | Week 232 | 86.4 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 70 Response | Week 308 | 100 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 70 Response | Week 104 | 87.0 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 70 Response | Week 116 | 92.2 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 70 Response | Week 260 | 95.0 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 70 Response | Week 128 | 91.8 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 70 Response | Week 312 | 86.4 Percentage of participants |
Secondary
Percentage of Participants With JIA ACR 90 Response
The JIA ACR response criteria consisted of 6 core criteria: * Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). * Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). * Functional ability (CHAQ): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain (0 \[no disability\] to 3 \[very severe disability\]). * Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. * Number of joints with limited range of motion, ranging from 0 to 69. * Index of inflammation: CRP levels The JIA ACR 90 responses were achieved if 3 of any 6 core set variables improved by at least 90% from baseline of the core study, and no more than 1 variable worsening \> 30%
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Population: Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 90 Response | Week 104 | 84.2 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 90 Response | Week 116 | 73.7 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 90 Response | Week 128 | 83.3 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 90 Response | Week 140 | 83.3 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 90 Response | Week 156 | 73.7 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 90 Response | Week 180 | 84.2 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 90 Response | Week 208 | 77.8 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 90 Response | Week 232 | 76.5 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 90 Response | Week 260 | 71.4 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 90 Response | Week 284 | 85.7 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 90 Response | Week 308 | 91.7 Percentage of participants |
| Group 1- Secukinumab 75 mg | Percentage of Participants With JIA ACR 90 Response | Week 312 | 80.0 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 90 Response | Week 312 | 83.3 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 90 Response | Week 104 | 74.3 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 90 Response | Week 208 | 71.0 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 90 Response | Week 260 | 84.6 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 90 Response | Week 116 | 75.0 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 90 Response | Week 180 | 69.7 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 90 Response | Week 308 | 88.2 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 90 Response | Week 128 | 77.4 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 90 Response | Week 232 | 81.5 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 90 Response | Week 156 | 75.8 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 90 Response | Week 140 | 72.7 Percentage of participants |
| Group 2 - Secukinumab 150 mg | Percentage of Participants With JIA ACR 90 Response | Week 284 | 95.7 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 90 Response | Week 140 | 76.5 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 90 Response | Week 156 | 75.0 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 90 Response | Week 284 | 91.9 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 90 Response | Week 180 | 75.0 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 90 Response | Week 208 | 73.5 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 90 Response | Week 232 | 79.5 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 90 Response | Week 308 | 89.7 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 90 Response | Week 104 | 77.8 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 90 Response | Week 116 | 74.5 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 90 Response | Week 260 | 80.0 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 90 Response | Week 128 | 79.6 Percentage of participants |
| Total Secukinumab Dose | Percentage of Participants With JIA ACR 90 Response | Week 312 | 81.8 Percentage of participants |
Secondary
Serum Concentrations of Secukinumab Over Time
Serum concentration of secukinumab over time. Blood samples for pharmacokinetics were taken pre-dose at the scheduled time points.
Time frame: Pre-dose at Week 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Population: Participants who enrolled in the extension study and received at least one dose of study treatment with quantifiable pharmacokinetic (PK) measurements of secukinumab. Participants with dose escalations were not included in the analysis post up-titration.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1- Secukinumab 75 mg | Serum Concentrations of Secukinumab Over Time | Week 208 | 20.5 microgram (ug)/milliliter (mL) | Standard Deviation 6.82 |
| Group 1- Secukinumab 75 mg | Serum Concentrations of Secukinumab Over Time | Week 312 | 14.6 microgram (ug)/milliliter (mL) | Standard Deviation 4.79 |
| Group 1- Secukinumab 75 mg | Serum Concentrations of Secukinumab Over Time | Week 260 | 16.0 microgram (ug)/milliliter (mL) | Standard Deviation 6.94 |
| Group 1- Secukinumab 75 mg | Serum Concentrations of Secukinumab Over Time | Week 232 | 19.7 microgram (ug)/milliliter (mL) | Standard Deviation 7.06 |
| Group 1- Secukinumab 75 mg | Serum Concentrations of Secukinumab Over Time | Week 128 | 21.4 microgram (ug)/milliliter (mL) | Standard Deviation 8.57 |
| Group 1- Secukinumab 75 mg | Serum Concentrations of Secukinumab Over Time | Week 308 | 12.5 microgram (ug)/milliliter (mL) | Standard Deviation 5.31 |
| Group 1- Secukinumab 75 mg | Serum Concentrations of Secukinumab Over Time | Week 180 | 21.0 microgram (ug)/milliliter (mL) | Standard Deviation 10.4 |
| Group 1- Secukinumab 75 mg | Serum Concentrations of Secukinumab Over Time | Week 156 | 20.8 microgram (ug)/milliliter (mL) | Standard Deviation 8.76 |
| Group 1- Secukinumab 75 mg | Serum Concentrations of Secukinumab Over Time | Week 284 | 13.5 microgram (ug)/milliliter (mL) | Standard Deviation 7.99 |
| Group 2 - Secukinumab 150 mg | Serum Concentrations of Secukinumab Over Time | Week 232 | 24.2 microgram (ug)/milliliter (mL) | Standard Deviation 11.6 |
| Group 2 - Secukinumab 150 mg | Serum Concentrations of Secukinumab Over Time | Week 128 | 26.4 microgram (ug)/milliliter (mL) | Standard Deviation 9.78 |
| Group 2 - Secukinumab 150 mg | Serum Concentrations of Secukinumab Over Time | Week 156 | 26.6 microgram (ug)/milliliter (mL) | Standard Deviation 11.6 |
| Group 2 - Secukinumab 150 mg | Serum Concentrations of Secukinumab Over Time | Week 180 | 25.2 microgram (ug)/milliliter (mL) | Standard Deviation 9.28 |
| Group 2 - Secukinumab 150 mg | Serum Concentrations of Secukinumab Over Time | Week 208 | 26.7 microgram (ug)/milliliter (mL) | Standard Deviation 11.4 |
| Group 2 - Secukinumab 150 mg | Serum Concentrations of Secukinumab Over Time | Week 260 | 25.4 microgram (ug)/milliliter (mL) | Standard Deviation 8.99 |
| Group 2 - Secukinumab 150 mg | Serum Concentrations of Secukinumab Over Time | Week 284 | 27.5 microgram (ug)/milliliter (mL) | Standard Deviation 7.48 |
| Group 2 - Secukinumab 150 mg | Serum Concentrations of Secukinumab Over Time | Week 308 | 27.5 microgram (ug)/milliliter (mL) | Standard Deviation 14.7 |
| Group 2 - Secukinumab 150 mg | Serum Concentrations of Secukinumab Over Time | Week 312 | 25.4 microgram (ug)/milliliter (mL) | Standard Deviation 18.5 |
| Total Secukinumab Dose | Serum Concentrations of Secukinumab Over Time | Week 180 | 23.7 microgram (ug)/milliliter (mL) | Standard Deviation 9.75 |
| Total Secukinumab Dose | Serum Concentrations of Secukinumab Over Time | Week 128 | 24.8 microgram (ug)/milliliter (mL) | Standard Deviation 9.58 |
| Total Secukinumab Dose | Serum Concentrations of Secukinumab Over Time | Week 284 | 21.7 microgram (ug)/milliliter (mL) | Standard Deviation 10.3 |
| Total Secukinumab Dose | Serum Concentrations of Secukinumab Over Time | Week 156 | 24.3 microgram (ug)/milliliter (mL) | Standard Deviation 10.8 |
| Total Secukinumab Dose | Serum Concentrations of Secukinumab Over Time | Week 312 | 19.5 microgram (ug)/milliliter (mL) | Standard Deviation 13.4 |
| Total Secukinumab Dose | Serum Concentrations of Secukinumab Over Time | Week 232 | 22.5 microgram (ug)/milliliter (mL) | Standard Deviation 10.2 |
| Total Secukinumab Dose | Serum Concentrations of Secukinumab Over Time | Week 208 | 24.3 microgram (ug)/milliliter (mL) | Standard Deviation 10.2 |
| Total Secukinumab Dose | Serum Concentrations of Secukinumab Over Time | Week 308 | 18.8 microgram (ug)/milliliter (mL) | Standard Deviation 12.4 |
| Total Secukinumab Dose | Serum Concentrations of Secukinumab Over Time | Week 260 | 21.5 microgram (ug)/milliliter (mL) | Standard Deviation 9.32 |