Trial Outcomes & Findings for Study of Efficacy and Safety of Secukinumab in Psoriatic Arthritis and Axial Spondyloarthritis Patients With Active Enthesitis Including One Achilles Tendon Site (NCT NCT02771210)
NCT ID: NCT02771210
Last Updated: 2021-05-03
Results Overview
Number (%) of patients with resolution of Achilles tendon enthesitis (affected foot) as assessed by respective subcomponent of Leeds enthesitis index (LEI) at Week 24. The primary analysis was performed via a logistic regression model with the factors treatment, country, and stratification factor diagnosis (PsA or axSpA); patients with a missing assessment were considered as responders if they had already met the response criterion at the time of last assessment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
204 participants
Primary outcome timeframe
Week 24
Results posted on
2021-05-03
Participant Flow
304 patients were screened. Of these, 94 patients discontinued during screening phase, 6 patients were re-screened and 204 patients completed the screening phase and were randomized in the trial.
A total of 175 patients (85.8%) completed treatment period 1 (up to Week 24); 29 patients (14.2%) discontinued study treatment in treatment period 1. A total of 170 patients (83.3%) completed treatment period 2 (up to Week 52); 5 patients (2.5%) discontinued in treatment period 2.
Participant milestones
| Measure |
Secukinumab
Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
Placebo
Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
|---|---|---|
|
Period 1
STARTED
|
102
|
102
|
|
Period 1
COMPLETED
|
91
|
84
|
|
Period 1
NOT COMPLETED
|
11
|
18
|
|
Period 2
STARTED
|
91
|
84
|
|
Period 2
COMPLETED
|
89
|
81
|
|
Period 2
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Secukinumab
Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
Placebo
Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
|---|---|---|
|
Period 1
Adverse Event
|
5
|
3
|
|
Period 1
Lack of Efficacy
|
3
|
6
|
|
Period 1
Lost to Follow-up
|
2
|
0
|
|
Period 1
Physician Decision
|
0
|
1
|
|
Period 1
Withdrawal by Subject
|
0
|
3
|
|
Period 1
Withdrawal of informed consent
|
1
|
5
|
|
Period 2
Adverse Event
|
1
|
0
|
|
Period 2
Lack of Efficacy
|
0
|
1
|
|
Period 2
Withdrawal by Subject
|
1
|
0
|
|
Period 2
Withdrawal of informed consent
|
0
|
2
|
Baseline Characteristics
Study of Efficacy and Safety of Secukinumab in Psoriatic Arthritis and Axial Spondyloarthritis Patients With Active Enthesitis Including One Achilles Tendon Site
Baseline characteristics by cohort
| Measure |
Secukinumab
n=102 Participants
Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
Placebo
n=102 Participants
Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
97 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
47.8 Years
STANDARD_DEVIATION 11.33 • n=5 Participants
|
47.7 Years
STANDARD_DEVIATION 11.02 • n=7 Participants
|
47.7 Years
STANDARD_DEVIATION 11.18 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
58 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
44 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
99 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Full analysis set (FAS) included all patients to whom study medication had been assigned.
Number (%) of patients with resolution of Achilles tendon enthesitis (affected foot) as assessed by respective subcomponent of Leeds enthesitis index (LEI) at Week 24. The primary analysis was performed via a logistic regression model with the factors treatment, country, and stratification factor diagnosis (PsA or axSpA); patients with a missing assessment were considered as responders if they had already met the response criterion at the time of last assessment.
Outcome measures
| Measure |
Secukinumab
n=102 Participants
Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
Placebo
n=102 Participants
Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
|---|---|---|
|
Number (%) of Patients With Resolution of Achilles Tendon Enthesitis
|
43 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set (FAS)
Mean change of heel pain from baseline to Week 24 measured by Numeric Rating Scale (NRS) ranging from 0 to 10, with 0 representing no pain and 10 representing worst pain (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Outcome measures
| Measure |
Secukinumab
n=87 Participants
Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
Placebo
n=85 Participants
Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
|---|---|---|
|
Mean Change of Heel Pain
|
-2.8 Scores on a scale
Standard Deviation 2.99
|
-1.9 Scores on a scale
Standard Deviation 2.69
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set (FAS)
Number (%) of patients with an improvement of bone marrow edema from baseline to Week 24 as assessed by the respective subcomponent of the Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS) in the affected foot.
Outcome measures
| Measure |
Secukinumab
n=44 Participants
Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
Placebo
n=36 Participants
Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
|---|---|---|
|
Number (%) of Patients With Improvement of Bone Marrow Edema
|
17 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set (FAS)
Number (%) of patients with resolution of enthesitis as assessed by the Leeds enthesitis index (LEI) at Week 24.
Outcome measures
| Measure |
Secukinumab
n=102 Participants
Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
Placebo
n=102 Participants
Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
|---|---|---|
|
Number (%) of Patients With Resolution of Enthesitis as Assessed by LEI
|
31 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set (FAS)
Mean change of physician's global assessment (PhGA) of disease activity from baseline to Week 24 measured by Visual Analog Scale (VAS) ranging from 0 to 100, with 0 representing not severe and 100 representing very severe.
Outcome measures
| Measure |
Secukinumab
n=88 Participants
Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
Placebo
n=85 Participants
Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
|---|---|---|
|
Mean Change of Physician's Global Assessment of Disease Activity
|
-34.88 mm
Standard Deviation 25.927
|
-18.93 mm
Standard Deviation 26.257
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set (FAS)
Mean change of patient's global assessment (PGA) of disease activity from baseline to Week 24 measured by Visual Analog Scale (VAS) ranging from 0 to 100, with 0 representing not severe and 100 representing very severe.
Outcome measures
| Measure |
Secukinumab
n=82 Participants
Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
Placebo
n=80 Participants
Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
|---|---|---|
|
Mean Change of Patient's Global Assessment of Disease Activity
|
-25.87 mm
Standard Deviation 31.108
|
-16.61 mm
Standard Deviation 29.235
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set (FAS)
Mean change of physician's assessment of heel enthesopathy activity from baseline to Week 24 measured by Visual Analog Scale (VAS) ranging from 0 to 100, with 0 representing not severe and 100 representing very severe.
Outcome measures
| Measure |
Secukinumab
n=88 Participants
Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
Placebo
n=85 Participants
Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
|---|---|---|
|
Mean Change of Physician's Assessment of Heel Enthesopathy Activity
|
-38.40 mm
Standard Deviation 24.244
|
-25.19 mm
Standard Deviation 25.250
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set (FAS)
Mean change of patient's assessment of heel enthesopathy activity from baseline to Week 24 measured by Visual Analog Scale (VAS) ranging from 0 to 100, with 0 representing not severe and 100 representing very severe.
Outcome measures
| Measure |
Secukinumab
n=86 Participants
Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
Placebo
n=84 Participants
Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
|---|---|---|
|
Mean Change of Patient's Assessment of Heel Enthesopathy Activity
|
-31.05 mm
Standard Deviation 29.135
|
-20.77 mm
Standard Deviation 30.417
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set (FAS)
Mean change in Short Form-36 (SF-36) v2 as an indicator of overall health status The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability
Outcome measures
| Measure |
Secukinumab
n=87 Participants
Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
Placebo
n=85 Participants
Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
|---|---|---|
|
Mean Change in Short Form-36 (SF-36) v2
|
8.29 scores on a scale
Standard Deviation 9.759
|
5.28 scores on a scale
Standard Deviation 7.285
|
SECONDARY outcome
Timeframe: Weeks 24 and 52Population: Full analysis set (FAS)
Percentage of patients with resolution of Achilles tendon enthesitis (affected foot) after switching from placebo to secukinumab at Week 24
Outcome measures
| Measure |
Secukinumab
n=102 Participants
Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
Placebo
n=102 Participants
Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
|---|---|---|
|
Percentage of Patients With Resolution of Achilles Tendon Enthesitis After Switching From Placebo to Secukinumab
Week 24
|
43 Participants
|
32 Participants
|
|
Percentage of Patients With Resolution of Achilles Tendon Enthesitis After Switching From Placebo to Secukinumab
Week 52
|
66 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: Change from week 24 to week 52Population: Full analysis set (FAS)
Mean change of heel pain after switching from placebo to secukinumab from Week 24 to week 52 measured by Numeric Rating Scale (NRS) ranging from 0 to 10, with 0 representing no pain and 10 representing worst pain (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Outcome measures
| Measure |
Secukinumab
n=80 Participants
Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
Placebo
n=79 Participants
Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
|---|---|---|
|
Mean Change of Heel Pain After Switching From Placebo to Secukinumab
|
-0.70 Scores on a scale
Standard Deviation 2.291
|
-1.43 Scores on a scale
Standard Deviation 2.251
|
Adverse Events
Secukinumab
Serious events: 7 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo-Secukinumab
Serious events: 6 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Secukinumab
n=102 participants at risk
Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
Placebo-Secukinumab
n=102 participants at risk
Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.98%
1/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
0.98%
1/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
|
Endocrine disorders
Goitre
|
0.00%
0/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
0.98%
1/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
0.98%
1/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.98%
1/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
0.98%
1/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
0.98%
1/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
|
Infections and infestations
Cellulitis
|
0.98%
1/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
0.00%
0/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
0.98%
1/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
0.98%
1/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
0.98%
1/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
0.98%
1/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.98%
1/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
0.00%
0/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.98%
1/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
0.00%
0/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.98%
1/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
0.00%
0/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
0.98%
1/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.98%
1/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
0.00%
0/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
|
Nervous system disorders
Migraine with aura
|
0.98%
1/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
0.00%
0/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
0.98%
1/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
Other adverse events
| Measure |
Secukinumab
n=102 participants at risk
Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
Placebo-Secukinumab
n=102 participants at risk
Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.8%
8/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
4.9%
5/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
|
Infections and infestations
Nasopharyngitis
|
12.7%
13/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
21.6%
22/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
6/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
4.9%
5/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
7/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
4.9%
5/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
|
Nervous system disorders
Headache
|
5.9%
6/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
|
9.8%
10/102 • Adverse events were collected from first dose of study treatment until end of study treatment at week 52
* Adverse Events (AEs) are any untoward signs or symptoms that occurred during the study treatment. * Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once. * Where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class 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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER