Trial Outcomes & Findings for Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA (NCT NCT04156620)
NCT ID: NCT04156620
Last Updated: 2024-06-18
Results Overview
ASAS40 is ≥ 40% and an absolute improvement from baseline of ≥20 units (range 0-100) in ≥ 3 of the following 4 domains: back pain \[10 cm visual analogue scale (VAS)\], patient global assessment of disease activity (10 cm VAS), physical function (BASFI; range 0-100) and inflammation (mean score of items 5 and 6 of the BASDAI; both 10 cm VAS) without any worsening in the remaining domain. ASAS consists of 6 domains (4 main and 2 additional): 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) measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the BAS Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the BAS Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
527 participants
Primary outcome timeframe
Baseline to Week 16
Results posted on
2024-06-18
Participant Flow
769 participants were screened for the study and 527 participants were randomized. However, one participant was mis-randomized and discontinued prior to dosing and is not included in the table below.
Participant milestones
| Measure |
AIN457 6 mg/kg - 3 mg/kg i.v.
Participants received AIN457 (secukinumab) 6 mg/kg i.v. at baseline, followed by AIN457 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52)
|
Placebo - AIN457 3 mg/kg i.v.
Participants received i.v. placebo at baseline visit, Weeks 4, 8, and 12, followed by AIN457 (secukinumab) 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52)
|
|---|---|---|
|
Overall Study
STARTED
|
264
|
262
|
|
Overall Study
Completed Period 1
|
255
|
253
|
|
Overall Study
Started Period 2
|
255
|
251
|
|
Overall Study
Completed Period 2
|
233
|
235
|
|
Overall Study
COMPLETED
|
227
|
233
|
|
Overall Study
NOT COMPLETED
|
37
|
29
|
Reasons for withdrawal
| Measure |
AIN457 6 mg/kg - 3 mg/kg i.v.
Participants received AIN457 (secukinumab) 6 mg/kg i.v. at baseline, followed by AIN457 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52)
|
Placebo - AIN457 3 mg/kg i.v.
Participants received i.v. placebo at baseline visit, Weeks 4, 8, and 12, followed by AIN457 (secukinumab) 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52)
|
|---|---|---|
|
Overall Study
Adverse event - TP 1
|
5
|
2
|
|
Overall Study
Lost to follow-up TP 1
|
1
|
1
|
|
Overall Study
Progressive disease - TP 1
|
0
|
1
|
|
Overall Study
Subject decision - TP 1
|
3
|
5
|
|
Overall Study
Adverse event - TP 2
|
5
|
6
|
|
Overall Study
Death - TP 2
|
1
|
0
|
|
Overall Study
Lost to follow-up - TP 2
|
5
|
2
|
|
Overall Study
Physician decision - TP 2
|
4
|
2
|
|
Overall Study
Pregnancy - TP 2
|
1
|
1
|
|
Overall Study
Subject decision - TP 2
|
11
|
9
|
|
Overall Study
New therapy for study indication - TP 2
|
1
|
0
|
Baseline Characteristics
Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA
Baseline characteristics by cohort
| Measure |
AIN457 6 mg/kg - 3 mg/kg i.v.
n=264 Participants
Participants received AIN457 (secukinumab) 6 mg/kg i.v. at baseline, followed by AIN457 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52)
|
Placebo - AIN457 3 mg/kg i.v.
n=262 Participants
Participants received i.v. placebo at baseline visit, Weeks 4, 8, and 12, followed by AIN457 (secukinumab) 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52)
|
Total
n=526 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 65 years
|
253 Participants
n=99 Participants
|
257 Participants
n=107 Participants
|
510 Participants
n=206 Participants
|
|
Age, Customized
65 - 75 years
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Customized
>= 75 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
183 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
165 Participants
n=99 Participants
|
178 Participants
n=107 Participants
|
343 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
180 Participants
n=99 Participants
|
179 Participants
n=107 Participants
|
359 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
59 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
17 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Disease condition
Ankylosing spondylitis
|
208 Participants
n=99 Participants
|
205 Participants
n=107 Participants
|
413 Participants
n=206 Participants
|
|
Disease condition
Non-radiographic axial spondylarthritis
|
56 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Weight
|
77.61 kg
STANDARD_DEVIATION 18.006 • n=99 Participants
|
78.08 kg
STANDARD_DEVIATION 18.444 • n=107 Participants
|
77.85 kg
STANDARD_DEVIATION 18.210 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set with missing responses for any reason imputed as non-responders.
ASAS40 is ≥ 40% and an absolute improvement from baseline of ≥20 units (range 0-100) in ≥ 3 of the following 4 domains: back pain \[10 cm visual analogue scale (VAS)\], patient global assessment of disease activity (10 cm VAS), physical function (BASFI; range 0-100) and inflammation (mean score of items 5 and 6 of the BASDAI; both 10 cm VAS) without any worsening in the remaining domain. ASAS consists of 6 domains (4 main and 2 additional): 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) measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the BAS Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the BAS Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant).
Outcome measures
| Measure |
AIN457 6 mg/kg - 3 mg/kg i.v.
n=264 Participants
Participants received AIN457 (secukinumab) 6 mg/kg i.v. at baseline, followed by AIN457 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52)
|
Placebo - AIN457 3 mg/kg i.v.
n=262 Participants
Participants received i.v. placebo at baseline visit, Weeks 4, 8, and 12, followed by AIN457 (secukinumab) 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52)
|
|---|---|---|
|
Percentage of Participants Who Achieved an ASAS40 (Assessment of SpondyloArthritis International Society Criteria)
|
40.85 percentage of participants
Interval 34.94 to 46.76
|
22.94 percentage of participants
Interval 17.86 to 28.02
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set with missing responses for any reason imputed as non-responders.
ASDAS-CRP was utilized to assess disease activity status. Parameters used for the ASDAS included: total back pain (BASDAI question 2), patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and CRP in mg/L. Disease activity states: inactive disease, moderate disease activity, high disease activity, and very high disease activity. The three values selected to separate these states are: \< 1.3 between inactive disease and moderate disease activity; \< 2.1 between moderate disease activity and high disease activity; and \> 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores are a change of ≥ 1.1 unit for "minimal clinically important improvement" and a change of ≥ 2.0 units for "major improvement" .
Outcome measures
| Measure |
AIN457 6 mg/kg - 3 mg/kg i.v.
n=264 Participants
Participants received AIN457 (secukinumab) 6 mg/kg i.v. at baseline, followed by AIN457 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52)
|
Placebo - AIN457 3 mg/kg i.v.
n=262 Participants
Participants received i.v. placebo at baseline visit, Weeks 4, 8, and 12, followed by AIN457 (secukinumab) 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52)
|
|---|---|---|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Major Improvement
|
27.99 percentage of participants
Interval 22.86 to 33.12
|
7.54 percentage of participants
Interval 4.44 to 10.64
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set
BASDAI consists of a 0 through 10 scale (0 indicating no problem and 10 indicating the worst problem, captured as a continuous VAS), which was used to answer six questions pertaining to the five major symptoms of AS: fatigue, spinal pain, peripheral joint pain / swelling,, areas of localized tenderness (enthesitis, or inflammation of tendons and ligaments), morning stiffness duration, morning stiffness severity. To give each symptom equal weight, the mean of the two scores relating to morning stiffness is taken into account (questions 5 and 6). The resulting 0 to 10 score is added to the scores for questions 1 through 4. The resulting 0 to 50 score is divided by 5 to give a final 0 10 BASDAI score.
Outcome measures
| Measure |
AIN457 6 mg/kg - 3 mg/kg i.v.
n=253 Participants
Participants received AIN457 (secukinumab) 6 mg/kg i.v. at baseline, followed by AIN457 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52)
|
Placebo - AIN457 3 mg/kg i.v.
n=247 Participants
Participants received i.v. placebo at baseline visit, Weeks 4, 8, and 12, followed by AIN457 (secukinumab) 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52)
|
|---|---|---|
|
The Change From Baseline in Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
|
-2.70 scores on a scale
Standard Error 0.144
|
-1.69 scores on a scale
Standard Error 0.144
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set with missing responses for any reason imputed as non-responders.
The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains. A higher score on the VAS signifies higher severity. ASAS consists of 6 domains (4 main and 2 additional): 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) measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the BAS Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the BAS Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant).
Outcome measures
| Measure |
AIN457 6 mg/kg - 3 mg/kg i.v.
n=264 Participants
Participants received AIN457 (secukinumab) 6 mg/kg i.v. at baseline, followed by AIN457 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52)
|
Placebo - AIN457 3 mg/kg i.v.
n=262 Participants
Participants received i.v. placebo at baseline visit, Weeks 4, 8, and 12, followed by AIN457 (secukinumab) 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52)
|
|---|---|---|
|
Percentage of Participants Who Achieved an ASAS 5/6 (Assessment of Spondylarthritis International Society Criteria)
|
43.92 Percentage of participaants
Interval 37.94 to 49.9
|
21.77 Percentage of participaants
Interval 16.77 to 26.77
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set
The BASFI is a set of 10 questions designed to determine the degree of functional limitation in subjects with AS. The questions were chosen on the basis of predominant input from subjects with AS. The first eight questions consider activities related to functional anatomy. The final two questions assess the subjects' ability to cope with everyday life. A 0-10 scale (captured as a continuous VAS) is used to answer the questions. The BASFI score is the mean of the ten scales - a value between 0 and 10.
Outcome measures
| Measure |
AIN457 6 mg/kg - 3 mg/kg i.v.
n=253 Participants
Participants received AIN457 (secukinumab) 6 mg/kg i.v. at baseline, followed by AIN457 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52)
|
Placebo - AIN457 3 mg/kg i.v.
n=247 Participants
Participants received i.v. placebo at baseline visit, Weeks 4, 8, and 12, followed by AIN457 (secukinumab) 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52)
|
|---|---|---|
|
The Change From Baseline in Total Bath Ankylosing Spondylitis Functional Index (BASFI)
|
-2.33 scores on a scale
Standard Error 0.147
|
-1.39 scores on a scale
Standard Error 0.148
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set
The Short Form-36 Physical Component Summary (SF-36 PCS) is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of eight subscales (domains) that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role- Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed. The eight domains are based on a scale from 0-100 while PCS and MCS are norm-based scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of functioning. A positive change from baseline score indicates an improvement.
Outcome measures
| Measure |
AIN457 6 mg/kg - 3 mg/kg i.v.
n=254 Participants
Participants received AIN457 (secukinumab) 6 mg/kg i.v. at baseline, followed by AIN457 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52)
|
Placebo - AIN457 3 mg/kg i.v.
n=247 Participants
Participants received i.v. placebo at baseline visit, Weeks 4, 8, and 12, followed by AIN457 (secukinumab) 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52)
|
|---|---|---|
|
The Change From Baseline in Short Form-36 Physical Component Summary (SF-36 PCS)
|
7.70 scores on a scale
Standard Error 0.473
|
4.69 scores on a scale
Standard Error 0.473
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set
The ASQoL is a self-administered questionnaire designed to assess health-related quality of life in adult subjects with AS. 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 scores indicate better quality of life. Items include an assessment of mobility/energy, self care and mood/emotion. The recall period is "at the moment".
Outcome measures
| Measure |
AIN457 6 mg/kg - 3 mg/kg i.v.
n=254 Participants
Participants received AIN457 (secukinumab) 6 mg/kg i.v. at baseline, followed by AIN457 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52)
|
Placebo - AIN457 3 mg/kg i.v.
n=247 Participants
Participants received i.v. placebo at baseline visit, Weeks 4, 8, and 12, followed by AIN457 (secukinumab) 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52)
|
|---|---|---|
|
The Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQol)
|
-4.65 scores on a scale
Standard Error 0.291
|
-2.88 scores on a scale
Standard Error 0.290
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set
This assessment (laboratory assessment) was performed in order to identify the presence of inflammation, to determine its severity and to monitor the response to treatment. Exponentially transformed LSM, the geometric mean ratio of post-baseline/baseline. A value \<1 indicates a reduced CRP
Outcome measures
| Measure |
AIN457 6 mg/kg - 3 mg/kg i.v.
n=246 Participants
Participants received AIN457 (secukinumab) 6 mg/kg i.v. at baseline, followed by AIN457 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52)
|
Placebo - AIN457 3 mg/kg i.v.
n=248 Participants
Participants received i.v. placebo at baseline visit, Weeks 4, 8, and 12, followed by AIN457 (secukinumab) 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52)
|
|---|---|---|
|
The Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)
|
0.39 ratio
Standard Error 1.063
|
0.89 ratio
Standard Error 1.062
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set with missing responses for any reason imputed as non-responders.
The ASAS Response Criteria (ASAS20) is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain. A higher score on the VAS signifies higher severity. ASAS consists of 6 domains (4 main and 2 additional): 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) measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the BAS Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the BAS Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant).
Outcome measures
| Measure |
AIN457 6 mg/kg - 3 mg/kg i.v.
n=264 Participants
Participants received AIN457 (secukinumab) 6 mg/kg i.v. at baseline, followed by AIN457 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52)
|
Placebo - AIN457 3 mg/kg i.v.
n=262 Participants
Participants received i.v. placebo at baseline visit, Weeks 4, 8, and 12, followed by AIN457 (secukinumab) 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52)
|
|---|---|---|
|
Percentage of Participants Who Achieved an ASAS20 (Assessment of SpondyloArthritis International Society Criteria)
|
63.94 percentage of participants
Interval 58.19 to 69.7
|
40.53 percentage of participants
Interval 34.62 to 46.44
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set with missing responses for any reason imputed as non-responders.
ASDAS-CRP was utilized to assess disease activity status. Parameters used for the ASDAS included: total back pain (BASDAI question 2), patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and CRP in mg/L. Disease activity states: inactive disease, moderate disease activity, high disease activity, and very high disease activity. The three values selected to separate these states are: \< 1.3 between inactive disease and moderate disease activity; \< 2.1 between moderate disease activity and high disease activity; and \> 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores are a change of ≥ 1.1 unit for "minimal clinically important improvement" and a change of ≥ 2.0 units for "major improvement"
Outcome measures
| Measure |
AIN457 6 mg/kg - 3 mg/kg i.v.
n=264 Participants
Participants received AIN457 (secukinumab) 6 mg/kg i.v. at baseline, followed by AIN457 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52)
|
Placebo - AIN457 3 mg/kg i.v.
n=262 Participants
Participants received i.v. placebo at baseline visit, Weeks 4, 8, and 12, followed by AIN457 (secukinumab) 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52)
|
|---|---|---|
|
The Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease.
|
15.66 percentage of participants
Interval 11.53 to 19.78
|
3.08 percentage of participants
Interval 1.0 to 5.15
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set with missing responses for any reason imputed as non-responders.
ASAS partial remission criteria are defined as a value not above 2 units in each of the four main ASAS domains on a scale of 0-10. ASAS consists of 6 domains (4 main and 2 additional): 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) measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the BAS Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the BAS Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant).
Outcome measures
| Measure |
AIN457 6 mg/kg - 3 mg/kg i.v.
n=264 Participants
Participants received AIN457 (secukinumab) 6 mg/kg i.v. at baseline, followed by AIN457 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52)
|
Placebo - AIN457 3 mg/kg i.v.
n=262 Participants
Participants received i.v. placebo at baseline visit, Weeks 4, 8, and 12, followed by AIN457 (secukinumab) 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52)
|
|---|---|---|
|
Percentage of Participants Who Achieved ASAS20 (Assessment of Spondylarthritis International Society Criteria) Partial Remission.
|
14.76 percentage of participants
Interval 10.49 to 19.03
|
4.20 percentage of participants
Interval 1.77 to 6.63
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set
The PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denoted a healthier sleep quality.
Outcome measures
| Measure |
AIN457 6 mg/kg - 3 mg/kg i.v.
n=249 Participants
Participants received AIN457 (secukinumab) 6 mg/kg i.v. at baseline, followed by AIN457 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52)
|
Placebo - AIN457 3 mg/kg i.v.
n=246 Participants
Participants received i.v. placebo at baseline visit, Weeks 4, 8, and 12, followed by AIN457 (secukinumab) 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52)
|
|---|---|---|
|
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI)
|
-2.42 scores on a scale
Standard Error 0.222
|
-1.76 scores on a scale
Standard Error 0.221
|
Adverse Events
Any AIN457
Serious events: 32 serious events
Other events: 172 other events
Deaths: 1 deaths
Placebo Until Week 16
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Any AIN457
n=517 participants at risk
Participants received secukinumab (AIN457) 6 mg/kg i.v. at baseline, followed by secukinumab 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52); placebo participants who switched at Week 16 received secukinumab 3 mg/kg i.v. every four weeks starting at Week 16 through Week 48 (exposure through Week 52)
|
Placebo Until Week 16
n=261 participants at risk
Participants received i.v. placebo at baseline visit), Weeks 4, 8, and 12 , followed by the administration of secukinumab 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Cardiac disorders
Myocardial infarction
|
0.39%
2/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Cardiac disorders
Tachycardia
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Eye disorders
Choroiditis
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.39%
2/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Gastrointestinal disorders
Colitis
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.39%
2/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
General disorders
Chest pain
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
General disorders
Non-cardiac chest pain
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.38%
1/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Immune system disorders
Drug hypersensitivity
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Infections and infestations
Anal abscess
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Infections and infestations
Appendicitis
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Infections and infestations
Cellulitis
|
0.39%
2/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Infections and infestations
Dengue fever
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Infections and infestations
Pneumonia
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Infections and infestations
Sepsis
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.38%
1/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.38%
1/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Investigations
Weight decreased
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seminoma
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Psychiatric disorders
Depression suicidal
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.38%
1/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.19%
1/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.00%
0/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
Other adverse events
| Measure |
Any AIN457
n=517 participants at risk
Participants received secukinumab (AIN457) 6 mg/kg i.v. at baseline, followed by secukinumab 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52); placebo participants who switched at Week 16 received secukinumab 3 mg/kg i.v. every four weeks starting at Week 16 through Week 48 (exposure through Week 52)
|
Placebo Until Week 16
n=261 participants at risk
Participants received i.v. placebo at baseline visit), Weeks 4, 8, and 12 , followed by the administration of secukinumab 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
18/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
1.9%
5/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Gastrointestinal disorders
Nausea
|
2.3%
12/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.77%
2/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Infections and infestations
COVID-19
|
12.6%
65/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
3.8%
10/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
32/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
2.7%
7/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Infections and infestations
Pharyngitis
|
2.5%
13/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.38%
1/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Infections and infestations
Rhinitis
|
2.1%
11/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.77%
2/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
22/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
2.3%
6/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
11/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.38%
1/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.9%
20/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
0.38%
1/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
|
Nervous system disorders
Headache
|
3.3%
17/517 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
3.4%
9/261 • Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Any subjects randomized to Placebo were counted under 'Placebo' before being switched to AIN457 and under 'Any AIN457' after being switched to AIN457. It was pre-specified in the Study Protocol to monitor/assess Adverse Events irrespective of AIN457 dose level.
|
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 (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER