Trial Outcomes & Findings for Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing Spondylitis (NCT NCT02896127)
NCT ID: NCT02896127
Last Updated: 2020-12-30
Results Overview
ASAS20 response is defined as an improvement of ≥20% and ≥1 units on a scale of 10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
458 participants
Primary outcome timeframe
Week 16
Results posted on
2020-12-30
Participant Flow
The majority of subjects completed 52 weeks of treatment. After Week 16 all participants originally assigned to placebo switched to AIN457 150 mg s.c. Four out of the 153 assigned to the placebo group discontinued before Week 16.
All patients independent of completer status were asked to enter follow up whenever they exited the study no matter at what time in their participation. Moreover, not all participants who completed Week 52 entered the follow up period and some did not complete follow-up. Therefore, the number of participants who started the follow-up period is not equal to the number of participants who completed the previous period.
Participant milestones
| Measure |
Secukinumab
AIN457 150 mg s.c.
|
Placebo
Placebo s.c.
|
|---|---|---|
|
COMPLETED WEEK 52
STARTED
|
305
|
153
|
|
COMPLETED WEEK 52
COMPLETED
|
278
|
142
|
|
COMPLETED WEEK 52
NOT COMPLETED
|
27
|
11
|
|
COMPLETED POST-TREATMENT FOLLOW UP
STARTED
|
280
|
139
|
|
COMPLETED POST-TREATMENT FOLLOW UP
COMPLETED
|
276
|
134
|
|
COMPLETED POST-TREATMENT FOLLOW UP
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Secukinumab
AIN457 150 mg s.c.
|
Placebo
Placebo s.c.
|
|---|---|---|
|
COMPLETED WEEK 52
Adverse Event
|
9
|
2
|
|
COMPLETED WEEK 52
Lack of Efficacy
|
2
|
3
|
|
COMPLETED WEEK 52
Lost to Follow-up
|
0
|
1
|
|
COMPLETED WEEK 52
Physician Decision
|
1
|
1
|
|
COMPLETED WEEK 52
Pregnancy
|
2
|
0
|
|
COMPLETED WEEK 52
Withdrawal by Subject
|
12
|
4
|
|
COMPLETED WEEK 52
Technical problems
|
1
|
0
|
|
COMPLETED POST-TREATMENT FOLLOW UP
Withdrawal by Subject
|
2
|
3
|
|
COMPLETED POST-TREATMENT FOLLOW UP
Lost to Follow-up
|
0
|
1
|
|
COMPLETED POST-TREATMENT FOLLOW UP
Physician Decision
|
1
|
0
|
|
COMPLETED POST-TREATMENT FOLLOW UP
Pregnancy
|
1
|
0
|
|
COMPLETED POST-TREATMENT FOLLOW UP
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Randomized Analysis Set
Baseline characteristics by cohort
| Measure |
Secukinumab
n=305 Participants
AIN457 150 mg s.c.
|
Placebo
n=153 Participants
Placebo s.c.
|
Total
n=458 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Randomized Analysis Set
|
0 Participants
n=7 Participants • Randomized Analysis Set
|
0 Participants
n=5 Participants • Randomized Analysis Set
|
|
Age, Categorical
Between 18 and 65 years
|
303 Participants
n=5 Participants • Randomized Analysis Set
|
152 Participants
n=7 Participants • Randomized Analysis Set
|
455 Participants
n=5 Participants • Randomized Analysis Set
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants • Randomized Analysis Set
|
1 Participants
n=7 Participants • Randomized Analysis Set
|
3 Participants
n=5 Participants • Randomized Analysis Set
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants • FAS
|
21 Participants
n=7 Participants • FAS
|
74 Participants
n=5 Participants • FAS
|
|
Sex: Female, Male
Male
|
252 Participants
n=5 Participants • FAS
|
132 Participants
n=7 Participants • FAS
|
384 Participants
n=5 Participants • FAS
|
|
Race/Ethnicity, Customized
Asian
|
239 participants
n=5 Participants • FAS
|
130 participants
n=7 Participants • FAS
|
369 participants
n=5 Participants • FAS
|
|
Race/Ethnicity, Customized
White
|
64 participants
n=5 Participants • FAS
|
23 participants
n=7 Participants • FAS
|
87 participants
n=5 Participants • FAS
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants • FAS
|
0 participants
n=7 Participants • FAS
|
2 participants
n=5 Participants • FAS
|
PRIMARY outcome
Timeframe: Week 16Population: Full Analysis Set (FAS) was comprised of all subjects from the randomized set to whom study treatment had been assigned. Following the intent-to-treat principle, subjects were evaluated according to the treatment assigned to at randomization, but actual stratum, if stratified randomization was used.
ASAS20 response is defined as an improvement of ≥20% and ≥1 units on a scale of 10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain
Outcome measures
| Measure |
Secukinumab
n=305 Participants
AIN457 150 mg s.c.
|
Placebo
n=153 Participants
Placebo s.c.
|
|---|---|---|
|
The Proportion of Participants Who Achieve an ASAS 20 Response (Assessment of SpondyloArthritis International Society Criteria)
|
178 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: The secondary outcome analysis occurred only at Week 16. Thus, while data were collected beyond week 16, they were not part of the secondary outcomes.Population: Full Analysis Set (FAS)
ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain The number analyzed for some of continuous outcome variables are the number of participants for whom the specific outcome data were available. Thus the number for these variables differs from the FAS.
Outcome measures
| Measure |
Secukinumab
n=294 Participants
AIN457 150 mg s.c.
|
Placebo
n=146 Participants
Placebo s.c.
|
|---|---|---|
|
The Proportion of Participants Who Achieve an ASAS40 Response
|
138 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Change from baseline to Week 16. The secondary outcome analysis occurred only at Week 16. Thus, while data were collected beyond week 16, they were not part of the secondary outcomes.Population: FAS
hsCRP is measured as a marker of inflammation from blood samples during the study The number analyzed for some of continuous outcome variables are the number of participants for whom the specific outcome data were available. Thus the number for these variables differs from the FAS.
Outcome measures
| Measure |
Secukinumab
n=295 Participants
AIN457 150 mg s.c.
|
Placebo
n=146 Participants
Placebo s.c.
|
|---|---|---|
|
Change in hsCRP Over Time
|
-11.78 mg/l
Standard Deviation 22.919
|
-0.79 mg/l
Standard Deviation 20.023
|
SECONDARY outcome
Timeframe: Week 16: The secondary outcome analysis occurred only at Week 16. Thus, while data were collected beyond week 16, they were not part of the secondary outcomes.Population: FAS
The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains The number analyzed for some of continuous outcome variables are the number of participants for whom the specific outcome data were available. Thus the number for these variables differs from the FAS.
Outcome measures
| Measure |
Secukinumab
n=295 Participants
AIN457 150 mg s.c.
|
Placebo
n=146 Participants
Placebo s.c.
|
|---|---|---|
|
Percentage of Participants Who Achieve an ASAS 5/6 at Week 16
|
50.5 percentage of participants
Interval 44.7 to 56.3
|
19.2 percentage of participants
Interval 13.3 to 26.7
|
SECONDARY outcome
Timeframe: The secondary outcome analysis occurred only at Week 16. Thus, while data were collected beyond week 16, they were not part of the secondary outcomes.Population: FAS
The BASDAI or Bath Ankylosing Spondylitis Disease Activity Index 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 AS The number analyzed for some of continuous outcome variables are the number of participants for whom the specific outcome data were available. Thus the number for these variables differs from the FAS.
Outcome measures
| Measure |
Secukinumab
n=295 Participants
AIN457 150 mg s.c.
|
Placebo
n=149 Participants
Placebo s.c.
|
|---|---|---|
|
Participants With BASDAI Response at 16 Weeks
|
41.7 percent of participants
Interval 36.0 to 47.6
|
22.6 percent of participants
Interval 16.3 to 30.4
|
SECONDARY outcome
Timeframe: The secondary outcome analysis occurred only at Week 16. Thus, while data were collected beyond week 16, they were not part of the secondary outcomes.Population: FAS
The Physical Component Summary (PCS) SF-36 is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions The number analyzed for some of continuous outcome variables are the number of participants for whom the specific outcome data were available. Thus the number for these variables differs from the FAS.
Outcome measures
| Measure |
Secukinumab
n=301 Participants
AIN457 150 mg s.c.
|
Placebo
n=149 Participants
Placebo s.c.
|
|---|---|---|
|
Change in Short Form (36) - PCS Responders (Improvement of >= 2.5 Points) at Week 16
|
71.8 percent of participants
Interval 66.3 to 76.7
|
61.1 percent of participants
Interval 52.7 to 68.8
|
SECONDARY outcome
Timeframe: change from baseline to Week 16Population: FAS
The Ankylosing Spondylitis Quality of Life (ASQoL) is an instrument to assess health-related quality of life among adult patients with Ankylosing Spondylitis. Each statement on the ASQoL is given a score of "1" or "0". A score of "1" is given where the item is affirmed, indicating adverse QoL. All item scores are summed to give a total score or index. Scores can range from 0 (good QoL) to 18 (poor QoL).
Outcome measures
| Measure |
Secukinumab
n=305 Participants
AIN457 150 mg s.c.
|
Placebo
n=153 Participants
Placebo s.c.
|
|---|---|---|
|
Change in ASQoL Score Over Time
|
-4.6 scores
Standard Deviation 4.98
|
-2.6 scores
Standard Deviation 4.28
|
SECONDARY outcome
Timeframe: Week 16Population: FAS
The The Assessment in SpondyloArthritis International Society (ASAS) partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 10 The number analyzed for some of continuous outcome variables are the number of participants for whom the specific outcome data were available. Thus the number for these variables differs from the FAS.
Outcome measures
| Measure |
Secukinumab
n=294 Participants
AIN457 150 mg s.c.
|
Placebo
n=146 Participants
Placebo s.c.
|
|---|---|---|
|
The Proportion of Patients Who Achieve an ASAS Partial Remission
|
17.7 percent of participants
Interval 13.6 to 22.6
|
7.5 percent of participants
Interval 4.0 to 13.4
|
Adverse Events
Any AIN457 150 mg
Serious events: 33 serious events
Other events: 282 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Any AIN457 150 mg
n=453 participants at risk
This arm includes all patients who received at least 1 dose of study drug.
|
Placebo
n=153 participants at risk
All patients randomized to placebo from baseline up to week 16.
|
|---|---|---|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Congenital, familial and genetic disorders
Bronchogenic cyst
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Eye disorders
Iridocyclitis
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Eye disorders
Uveitis
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Gastrointestinal disorders
Appendix disorder
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
General disorders
Cyst
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Infections and infestations
Anal abscess
|
0.66%
3/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Infections and infestations
Appendicitis
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Infections and infestations
Chronic sinusitis
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Infections and infestations
Perineal abscess
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.44%
2/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.65%
1/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Infections and infestations
Tonsillitis
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Injury, poisoning and procedural complications
Electric injury
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.65%
1/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Nervous system disorders
Lacunar infarction
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Nervous system disorders
Optic neuritis
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.65%
1/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Psychiatric disorders
Confusional state
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Psychiatric disorders
Schizophrenia
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.44%
2/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal cyst
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.22%
1/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
Other adverse events
| Measure |
Any AIN457 150 mg
n=453 participants at risk
This arm includes all patients who received at least 1 dose of study drug.
|
Placebo
n=153 participants at risk
All patients randomized to placebo from baseline up to week 16.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.3%
15/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.65%
1/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
35/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
3.9%
6/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Gastrointestinal disorders
Mouth ulceration
|
4.0%
18/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
1.3%
2/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
General disorders
Fatigue
|
2.6%
12/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
5.3%
24/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
2.0%
3/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Infections and infestations
Nasopharyngitis
|
10.2%
46/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
6.5%
10/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Infections and infestations
Pharyngitis
|
3.1%
14/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.65%
1/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Infections and infestations
Upper respiratory tract infection
|
32.0%
145/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
19.0%
29/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Infections and infestations
Urinary tract infection
|
3.5%
16/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
3.3%
5/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
24/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
2.0%
3/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Investigations
Aspartate aminotransferase increased
|
2.2%
10/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
1.3%
2/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Investigations
Protein urine present
|
2.4%
11/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Investigations
White blood cell count decreased
|
3.8%
17/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
2.6%
12/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.65%
1/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.7%
26/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.65%
1/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
13/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
3.3%
5/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
7/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
2.6%
4/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Nervous system disorders
Dizziness
|
1.1%
5/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
2.6%
4/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
10/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
2.0%
3/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.0%
18/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
1.3%
2/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
10/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
0.00%
0/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
|
Vascular disorders
Hypertension
|
2.4%
11/453 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
2.0%
3/153 • Adverse events were collected from first dose of study treatment until end of study treatment up to week 52
An adverse event (AE) is any sign or symptom that occurs during the study treatment period. Patients randomized to placebo at baseline are reported under Placebo up for AEs starting before switching to Secukinumab. Starting from Week 16 onwards, all patients on placebo still in the study were re-assigned to secukinumab and AEs starting after this switch will be counted in the Any AIN457 150 mg group.
|
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 publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER