Trial Outcomes & Findings for AScalate: Treat-to-target in Axial Spondyloarthritis (NCT NCT03906136)
NCT ID: NCT03906136
Last Updated: 2025-04-29
Results Overview
Assessment of SpondyloArthritis International Society criteria (ASAS) consists of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 0 - 10 in at least three of the four ASAS domains and no worsening at all in the remaining domain. A score of 0 indicates less severity; a score of 10 indicates more severity. Percentage was calculated from a logistic regression model: logit(proportion) = treatment + baseline quick C-reactive protein (CRP) + baseline weight.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
304 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2025-04-29
Participant Flow
The study included an 8-week Screening period.
Participant milestones
| Measure |
Treat-to-Target (T2T)
Treat To Target approach with secukinumab as first line biologic
|
Standard-of-care (SOC)
Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations
|
|---|---|---|
|
Overall Study
STARTED
|
155
|
149
|
|
Overall Study
COMPLETED
|
143
|
138
|
|
Overall Study
NOT COMPLETED
|
12
|
11
|
Reasons for withdrawal
| Measure |
Treat-to-Target (T2T)
Treat To Target approach with secukinumab as first line biologic
|
Standard-of-care (SOC)
Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
7
|
4
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
7
|
Baseline Characteristics
AScalate: Treat-to-target in Axial Spondyloarthritis
Baseline characteristics by cohort
| Measure |
Treat-to-Target (T2T)
n=155 Participants
Participants received secukinumab at a dose of 150 milligrams (mg) as subcutaneous (s.c.) injection at 150 mg dose at Baseline, Week 1, 2, 3, 4 and 8. From Week 12, only responders continued to receive 4-weekly doses until Week 32 if they maintained the response. In the event these patients experienced a loss of response from Week 24, they were escalated to secukinumab 300 mg s.c. every 4 weeks until Week 32.
Patients who were non-responders at Week 12 received 4-weekly secukinumab 300 mg s.c. until Week 24. From Week 24, only responders continued to receive 4-weekly secukinumab 300 mg s.c. until Week 32. Patients who were non-responders to secukinumab 300 mg at Week 24 received biweekly adalimumab biosimilar 40 mg s.c. until Week 34.
|
Standard-of-care (SOC)
n=149 Participants
Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
149 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
293 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
40.0 Years
STANDARD_DEVIATION 12.03 • n=5 Participants
|
38.6 Years
STANDARD_DEVIATION 12.17 • n=7 Participants
|
39.3 Years
STANDARD_DEVIATION 12.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
128 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
26 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization. Data represent the number of patients with non-missing response at the specified visit.
Assessment of SpondyloArthritis International Society criteria (ASAS) consists of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 0 - 10 in at least three of the four ASAS domains and no worsening at all in the remaining domain. A score of 0 indicates less severity; a score of 10 indicates more severity. Percentage was calculated from a logistic regression model: logit(proportion) = treatment + baseline quick C-reactive protein (CRP) + baseline weight.
Outcome measures
| Measure |
Treat-to-Target (T2T)
n=144 Participants
Treat To Target approach with secukinumab as first line biologic
|
Standard-of-care (SOC)
n=139 Participants
Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations
|
|---|---|---|
|
Percentage of Patients Achieving an ASAS40 Response at Week 24
|
40.1 Percentage of participants
|
49.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization. Data represent the number of patients with non-missing response at the specified visit.
Assessment of SpondyloArthritis International Society criteria (ASAS) consists of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 0 - 10 in at least three of the four ASAS domains and no worsening at all in the remaining domain. A score of 0 indicates less severity; a score of 10 indicates more severity. Percentage was calculated from a logistic regression model: logit(proportion) = treatment + baseline quick C-reactive protein (CRP) + baseline weight.
Outcome measures
| Measure |
Treat-to-Target (T2T)
n=147 Participants
Treat To Target approach with secukinumab as first line biologic
|
Standard-of-care (SOC)
n=143 Participants
Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations
|
|---|---|---|
|
Percentage of Patients Achieving an ASAS40 Response at Week 12
|
34.0 Percentage of participants
|
46.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization. Data represent the number of patients with non-missing response at the specified visit.
Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 0 - 10 in at least three of the four ASAS domains and no worsening at all in the remaining domain. A score of 0 indicates less severity; a score of 10 indicates more severity. Percentage was calculated from a logistic regression model: logit(proportion) = treatment + baseline quick C-reactive protein (CRP) + baseline weight.
Outcome measures
| Measure |
Treat-to-Target (T2T)
n=147 Participants
Treat To Target approach with secukinumab as first line biologic
|
Standard-of-care (SOC)
n=143 Participants
Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations
|
|---|---|---|
|
Percentage of Patients Achieving ASAS20 Response
Week 12 n=147,143
|
51.8 Percentage of participants
|
60.1 Percentage of participants
|
|
Percentage of Patients Achieving ASAS20 Response
Week 24 n=144,139
|
62.1 Percentage of participants
|
65.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization. Data represent the number of patients with non-missing response at the specified visit.
Assessment of SpondyloArthritis International Society criteria (ASAS): 6 domains (4 main; 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (CRP, acute phase reactant). ASAS partial remission: a value not above 2 units in each of the four main domains on a scale of 10. Higher score on VAS = higher severity. Percentage calculated from a logistic regression model: logit(proportion) = treatment + baseline quick CRP + baseline weight.
Outcome measures
| Measure |
Treat-to-Target (T2T)
n=149 Participants
Treat To Target approach with secukinumab as first line biologic
|
Standard-of-care (SOC)
n=143 Participants
Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations
|
|---|---|---|
|
Percentage of Patients Achieving ASAS Partial Remission
Week 24 n=146,139
|
22.8 Percentage of participants
|
28.5 Percentage of participants
|
|
Percentage of Patients Achieving ASAS Partial Remission
Week 12 n=149, 143
|
18.2 Percentage of participants
|
29.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization. Data represent the number of patients with non-missing response at the specified visit.
Parameters used for the ASDAS include spinal pain (Bath Ankylosing Spondylitis Disease Activity Index, BASDAI question 2), the patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and C-reactive Protein or Erythrocyte Sedimentation Rate). The 3 values selected to separate disease activity states were \< 1.3 between inactive disease and low disease activity, \< 2.1 between low disease activity and high disease activity, and \> 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores were a change of ≥ 1.1 unit for "minimal clinically important improvement" and a change of ≥ 2.0 units for "major improvement". Percentage was calculated from a logistic regression model: logit(proportion) = treatment + baseline ASDAS + baseline weight.
Outcome measures
| Measure |
Treat-to-Target (T2T)
n=151 Participants
Treat To Target approach with secukinumab as first line biologic
|
Standard-of-care (SOC)
n=141 Participants
Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations
|
|---|---|---|
|
Percentage of Patients Meeting the Ankylosing Spondylitis Disease Activity Score (ASDAS) Definition of Inactive Disease
Week 12 n=151,141
|
19.8 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Patients Meeting the Ankylosing Spondylitis Disease Activity Score (ASDAS) Definition of Inactive Disease
Week 24 n=146,136
|
18.8 Percentage of participants
|
33.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization. Data represent the number of patients with non-missing response at the specified visit.
Parameters used for the ASDAS include spinal pain (Bath Ankylosing Spondylitis Disease Activity Index, BASDAI question 2), the patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and C-reactive Protein or Erythrocyte Sedimentation Rate). The 3 values selected to separate disease activity states were \< 1.3 between inactive disease and low disease activity, \< 2.1 between low disease activity and high disease activity, and \> 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores were a change of ≥ 1.1 unit for "minimal clinically important improvement" and a change of ≥ 2.0 units for "major improvement". Percentage was calculated from a logistic regression model: logit(proportion) = treatment + baseline ASDAS + baseline weight.
Outcome measures
| Measure |
Treat-to-Target (T2T)
n=151 Participants
Treat To Target approach with secukinumab as first line biologic
|
Standard-of-care (SOC)
n=141 Participants
Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations
|
|---|---|---|
|
Percentage of Patients With ASDAS Major Improvement
Week 12 n=151,141
|
19.8 Percentage of participants
|
25.6 Percentage of participants
|
|
Percentage of Patients With ASDAS Major Improvement
Week 24 n=146,136
|
18.6 Percentage of participants
|
27.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization. Data represent the number of patients with non-missing response at the specified visit.
Parameters used for the ASDAS include spinal pain (Bath Ankylosing Spondylitis Disease Activity Index, BASDAI question 2), the patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and C-reactive Protein or Erythrocyte Sedimentation Rate). The 3 values selected to separate disease activity states were \< 1.3 between inactive disease and low disease activity, \< 2.1 between low disease activity and high disease activity, and \> 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores were a change of ≥ 1.1 unit for "minimal clinically important improvement" and a change of ≥ 2.0 units for "major improvement". Percentage was calculated from a logistic regression model: logit(proportion) = treatment + baseline ASDAS + baseline weight.
Outcome measures
| Measure |
Treat-to-Target (T2T)
n=151 Participants
Treat To Target approach with secukinumab as first line biologic
|
Standard-of-care (SOC)
n=141 Participants
Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations
|
|---|---|---|
|
Percentage of Patients With ASDAS Low Disease Activity
Week 12 n=151,141
|
46.5 Percentage of participants
|
57.7 Percentage of participants
|
|
Percentage of Patients With ASDAS Low Disease Activity
Week 24 n=146,136
|
52.4 Percentage of participants
|
57.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization.
The BASDAI consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of the disease. BASDAI 50 response is defined as at least 50% improvement (decrease) in total BASDAI score.
Outcome measures
| Measure |
Treat-to-Target (T2T)
n=155 Participants
Treat To Target approach with secukinumab as first line biologic
|
Standard-of-care (SOC)
n=149 Participants
Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations
|
|---|---|---|
|
Percentage of Patients Achieving the Bath Ankylosing Spondylitis Disease Activity Index Response 50% (BASDAI 50) at Week 12 and Week 24
Week 12
|
38.0 Percentage of participants
|
42.0 Percentage of participants
|
|
Percentage of Patients Achieving the Bath Ankylosing Spondylitis Disease Activity Index Response 50% (BASDAI 50) at Week 12 and Week 24
Week 24
|
42.5 Percentage of participants
|
42.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization.
The Bath Ankylosing Spondylitis Functional Index (BASFI) is a set of 10 questions designed to determine the degree of functional limitation in those patients with AS. The 10 questions were chosen with major input from patients with AS. The first 8 questions consider activities related to functional anatomy. The final 2 questions assess the patients' ability to cope with everyday life. A 0 through 10 scale (captured as a continuous VAS) is used to answer the questions. The mean of the 10 scales gives the BASFI score - a value between 0 and 10. A higher score on the VAS signifies higher severity.
Outcome measures
| Measure |
Treat-to-Target (T2T)
n=155 Participants
Treat To Target approach with secukinumab as first line biologic
|
Standard-of-care (SOC)
n=149 Participants
Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations
|
|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
Week 12
|
-1.69 Scores on a scale
Interval -2.01 to -1.37
|
-1.99 Scores on a scale
Interval -2.31 to 1.66
|
|
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
Week 24
|
-1.97 Scores on a scale
Interval -2.28 to 1.65
|
-2.33 Scores on a scale
Interval -2.66 to 2.01
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization.
BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement.
Outcome measures
| Measure |
Treat-to-Target (T2T)
n=155 Participants
Treat To Target approach with secukinumab as first line biologic
|
Standard-of-care (SOC)
n=149 Participants
Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations
|
|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
Week 12
|
-0.32 Scores on a scale
Interval -0.44 to -0.2
|
-0.38 Scores on a scale
Interval -0.5 to -0.27
|
|
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
Week 24
|
-0.41 Scores on a scale
Interval -0.55 to -0.27
|
-0.35 Scores on a scale
Interval -0.5 to -0.21
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization.
Chest expansion is measured as the cervical rotation angle (in degrees).
Outcome measures
| Measure |
Treat-to-Target (T2T)
n=155 Participants
Treat To Target approach with secukinumab as first line biologic
|
Standard-of-care (SOC)
n=149 Participants
Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations
|
|---|---|---|
|
Change From Baseline in Chest Expansion
Week 12
|
0.46 degrees
Interval -0.54 to 1.46
|
1.35 degrees
Interval 0.33 to 2.38
|
|
Change From Baseline in Chest Expansion
Week 24
|
0.47 degrees
Interval 0.05 to 0.88
|
0.57 degrees
Interval 0.14 to 1.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization.
The Ankylosing Spondylitis Quality of Life scores (ASQoL) is a self-administered questionnaire designed to assess health-related quality of life in adult patients with Ankylosing Spondylitis. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each "yes" response and no points for each "no" response resulting in overall scores that range from 0 (least severity) to 18 (highest severity). As such, lower score indicate better quality of life. Items include an assessment of mobility/energy, self-care and mood/emotion. The recall period is "at the moment," and the measure requires approximately 6 minutes to complete.
Outcome measures
| Measure |
Treat-to-Target (T2T)
n=155 Participants
Treat To Target approach with secukinumab as first line biologic
|
Standard-of-care (SOC)
n=149 Participants
Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations
|
|---|---|---|
|
Change From Baseline in the ASQoL (Ankylosing Spondylitis Quality of Life Instrument)
Week 12
|
-3.52 Scores on a scale
Interval -4.13 to 2.91
|
-3.39 Scores on a scale
Interval -4.02 to 2.76
|
|
Change From Baseline in the ASQoL (Ankylosing Spondylitis Quality of Life Instrument)
Week 24
|
-4.21 Scores on a scale
Interval -4.88 to 3.53
|
-3.84 Scores on a scale
Interval -4.53 to 3.15
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization.
The ASAS-HI is a disease-specific questionnaire that was developed based on the comprehensive International Classification of Functioning, Disability and Health Core Set (also known as the ICF Core Set) for AS. The ASAS HI is a linear composite measure and contains 17 items (dichotomous response option: "I agree" and "I do not agree"), which cover most of the ICF Core Set. The ASAS HI contains items addressing categories of pain, emotional functions, sleep, sexual function, mobility, self-care, and community life. The total sum of the ASAS HI ranges from 0 to 17, with a lower score indicating a better health status. In addition, the Environmental Factor (EF) Item Set contains items addressing categories of support/relationships, attitudes and health services. The EF Item Set contains 9 dichotomous items with an identical response option but without a sum score because of its multidimensional nature.
Outcome measures
| Measure |
Treat-to-Target (T2T)
n=155 Participants
Treat To Target approach with secukinumab as first line biologic
|
Standard-of-care (SOC)
n=149 Participants
Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations
|
|---|---|---|
|
Change From Baseline in ASAS-HI (Ankylosing Spondyloarthritis International Society Health Index)
Week 12
|
-2.55 Scores on a scale
Interval -3.05 to 2.05
|
-2.81 Scores on a scale
Interval -3.32 to 2.3
|
|
Change From Baseline in ASAS-HI (Ankylosing Spondyloarthritis International Society Health Index)
Week 24
|
-3.24 Scores on a scale
Interval -3.77 to 2.72
|
-3.07 Scores on a scale
Interval -3.61 to 2.54
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization.
The patient's global assessment of disease activity was performed using a 100 mm (visual analog scale) VAS, ranging from not severe (0 mm) to very severe (100 mm), in response to the question, "How active was your disease on average during the last week?" A higher score indicates more disease activity.
Outcome measures
| Measure |
Treat-to-Target (T2T)
n=155 Participants
Treat To Target approach with secukinumab as first line biologic
|
Standard-of-care (SOC)
n=149 Participants
Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations
|
|---|---|---|
|
Change From Baseline in Global Disease Assessment (Patient)
Week 12
|
-2.95 Scores on a scale
Interval -3.38 to 2.52
|
-3.12 Scores on a scale
Interval -3.56 to 2.68
|
|
Change From Baseline in Global Disease Assessment (Patient)
Week 24
|
-3.27 Scores on a scale
Interval -3.69 to 2.85
|
-3.48 Scores on a scale
Interval -3.92 to 3.05
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization.
The physician's global assessment of disease activity was performed using a 100 mm VAS, ranging from not severe (0 mm) to very severe (100 mm), in response to the question, "Considering all the ways the disease affects your patient, draw a line on the scale for how well his or her condition is today." To enhance objectivity, the physician must not be aware of the specific patient's global assessment of disease activity when performing his own assessment on that patient. A higher score indicates more disease activity.
Outcome measures
| Measure |
Treat-to-Target (T2T)
n=155 Participants
Treat To Target approach with secukinumab as first line biologic
|
Standard-of-care (SOC)
n=149 Participants
Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations
|
|---|---|---|
|
Change From Baseline in Global Disease Assessment (Physician)
Week 12
|
-32.46 Scores on a scale
Interval -35.98 to 28.94
|
-36.96 Scores on a scale
Interval -40.6 to 33.31
|
|
Change From Baseline in Global Disease Assessment (Physician)
Week 24
|
-35.81 Scores on a scale
Interval -39.34 to 32.28
|
-38.54 Scores on a scale
Interval -42.19 to 34.89
|
Adverse Events
Secukinumab 150 mg
Serious events: 10 serious events
Other events: 69 other events
Deaths: 0 deaths
Secukinumab 300 mg
Serious events: 4 serious events
Other events: 38 other events
Deaths: 0 deaths
Adalimumab 40 mg
Serious events: 5 serious events
Other events: 35 other events
Deaths: 0 deaths
Other Treatment
Serious events: 8 serious events
Other events: 36 other events
Deaths: 0 deaths
Overall
Serious events: 16 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Secukinumab 150 mg
n=190 participants at risk
Secukinumab 150 mg
|
Secukinumab 300 mg
n=92 participants at risk
Secukinumab 300 mg
|
Adalimumab 40 mg
n=116 participants at risk
Adalimumab 40 mg
|
Other Treatment
n=128 participants at risk
Other treatment included concomitant and rescue medications other than study drugs.
|
Overall
n=303 participants at risk
Overall
|
|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.53%
1/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
1.1%
1/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.33%
1/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
Cardiac disorders
Coronary artery disease
|
0.53%
1/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
1.1%
1/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.33%
1/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
Cardiac disorders
Tachycardia
|
0.53%
1/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.33%
1/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.53%
1/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.33%
1/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
Immune system disorders
Immunisation reaction
|
0.53%
1/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.86%
1/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.33%
1/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.53%
1/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.33%
1/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.78%
1/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.33%
1/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.86%
1/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.78%
1/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.33%
1/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
1.1%
2/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.86%
1/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
1.6%
2/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.66%
2/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.78%
1/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.33%
1/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.53%
1/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
1.1%
1/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.33%
1/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.86%
1/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.78%
1/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.33%
1/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.86%
1/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.78%
1/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.33%
1/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.53%
1/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
1.1%
1/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.33%
1/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.78%
1/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.33%
1/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
Other adverse events
| Measure |
Secukinumab 150 mg
n=190 participants at risk
Secukinumab 150 mg
|
Secukinumab 300 mg
n=92 participants at risk
Secukinumab 300 mg
|
Adalimumab 40 mg
n=116 participants at risk
Adalimumab 40 mg
|
Other Treatment
n=128 participants at risk
Other treatment included concomitant and rescue medications other than study drugs.
|
Overall
n=303 participants at risk
Overall
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.4%
16/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
9.8%
9/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
6.9%
8/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
8.6%
11/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
7.9%
24/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
Gastrointestinal disorders
Nausea
|
6.3%
12/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
6.5%
6/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
2.6%
3/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
5.5%
7/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
4.6%
14/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
General disorders
Fatigue
|
3.7%
7/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
3.3%
3/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
5.2%
6/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
3.9%
5/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
4.0%
12/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
Infections and infestations
Nasopharyngitis
|
12.6%
24/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
14.1%
13/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
6.0%
7/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
7.8%
10/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
10.2%
31/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
Infections and infestations
Respiratory tract infection
|
5.3%
10/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
3.3%
3/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
2.6%
3/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
2.3%
3/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
3.3%
10/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
10/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
6.5%
6/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
5.2%
6/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
2.3%
3/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
4.0%
12/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
7/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
6.5%
6/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
2.6%
3/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
0.00%
0/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
2.6%
8/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
|
Nervous system disorders
Headache
|
6.3%
12/190 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
7.6%
7/92 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
6.0%
7/116 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
4.7%
6/128 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
5.9%
18/303 • Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
The safety set included all patients who received at least one dose of study treatment. AEs are reported according to the actual treatment received when AE started. As Secukinumab 150 mg could also had been provided in the Standard-of-Care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER