Trial Outcomes & Findings for Study of Secukinumab Compared to Fumaderm® in Adults With Moderate to Severe Psoriasis. (NCT NCT02474082)
NCT ID: NCT02474082
Last Updated: 2017-10-27
Results Overview
PASI score is an average degree of severity of signs in head \[H\], trunk \[T\], upper limbs \[U\] and lower limbs \[L\], assessed separately for erythema \[E\], thickening (plaque elevation, induration) \[I\], and scaling (desquamation) \[D\]. Area \[A\] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 75 responders were participants who achieved \>=75% improvement (reduction) in PASI score compared to baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
202 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2017-10-27
Participant Flow
A total of 202 (secukinumab: 105 and fumaric acid derivatives: 97) participants were randomized in the study out of which 200 (secukinumab: 105 and fumaric acid derivatives: 95) received treatment. 2 participants were discontinued from the study due to non-compliance with study treatment (1) and withdrawal of informed consent (1).
Participant milestones
| Measure |
Secukinumab
Participants were self-administered subcutaneously (s.c.) with a dose of 300 milligrams (mg) of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 centimeters (cm) around the navel).
|
Fumaric Acid (Initial and Maintenance Therapy)
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
97
|
|
Overall Study
Full Analysis Set (FAS)
|
105
|
95
|
|
Overall Study
COMPLETED
|
99
|
43
|
|
Overall Study
NOT COMPLETED
|
6
|
54
|
Reasons for withdrawal
| Measure |
Secukinumab
Participants were self-administered subcutaneously (s.c.) with a dose of 300 milligrams (mg) of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 centimeters (cm) around the navel).
|
Fumaric Acid (Initial and Maintenance Therapy)
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
32
|
|
Overall Study
Withdrawal of informed consent
|
1
|
11
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Dose tapering not achieved
|
0
|
4
|
|
Overall Study
Participant/guardian decision
|
1
|
2
|
|
Overall Study
Non-compliance with study treatment
|
0
|
2
|
|
Overall Study
Protocol deviation
|
0
|
1
|
Baseline Characteristics
Study of Secukinumab Compared to Fumaderm® in Adults With Moderate to Severe Psoriasis.
Baseline characteristics by cohort
| Measure |
Secukinumab
n=105 Participants
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
|
Fumaric Acid (Initial and Maintenance Therapy)
n=97 Participants
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
98 Participants
n=93 Participants
|
90 Participants
n=4 Participants
|
188 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 14.2 • n=93 Participants
|
42.4 years
STANDARD_DEVIATION 13.2 • n=4 Participants
|
42.8 years
STANDARD_DEVIATION 13.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
77 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
125 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: The analysis was performed in Full analysis set (FAS) population, defined as all randomized participants who received at least one dose of study drug.
PASI score is an average degree of severity of signs in head \[H\], trunk \[T\], upper limbs \[U\] and lower limbs \[L\], assessed separately for erythema \[E\], thickening (plaque elevation, induration) \[I\], and scaling (desquamation) \[D\]. Area \[A\] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 75 responders were participants who achieved \>=75% improvement (reduction) in PASI score compared to baseline.
Outcome measures
| Measure |
Secukinumab
n=105 Participants
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
|
Fumaric Acid (Initial and Maintenance Therapy)
n=95 Participants
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
|
|---|---|---|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 24
|
89.52 Percentage of participants
|
33.68 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24Population: The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for PASI 50 at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
PASI score is an average degree of severity of signs in head \[H\], trunk \[T\], upper limbs \[U\] and lower limbs \[L\], assessed separately for erythema \[E\], thickening (plaque elevation, induration) \[I\], and scaling (desquamation) \[D\]. Area \[A\] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 50 responders were participants who achieved \>=50% improvement (reduction) in PASI score compared to baseline.
Outcome measures
| Measure |
Secukinumab
n=105 Participants
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
|
Fumaric Acid (Initial and Maintenance Therapy)
n=95 Participants
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
|
|---|---|---|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 1
|
9.5 Percentage of participants
|
1.1 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 2
|
37.1 Percentage of participants
|
6.3 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 3
|
63.8 Percentage of participants
|
10.5 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 4
|
81.9 Percentage of participants
|
14.7 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 6
|
93.3 Percentage of participants
|
28.4 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 8)
|
96.2 Percentage of participants
|
41.1 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 12
|
97.1 Percentage of participants
|
56.8 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 16
|
98.1 Percentage of participants
|
60.0 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 20
|
98.1 Percentage of participants
|
61.1 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 24
|
98.1 Percentage of participants
|
61.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16 and 20Population: The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for PASI 75 at week 1, 2, 3, 4, 6, 8, 12, 16 and 20.
PASI score is an average degree of severity of signs in head \[H\], trunk \[T\], upper limbs \[U\] and lower limbs \[L\], assessed separately for erythema \[E\], thickening (plaque elevation, induration) \[I\], and scaling (desquamation) \[D\]. Area \[A\] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 75 responders were participants who achieved \>=75% improvement (reduction) in PASI score compared to baseline.
Outcome measures
| Measure |
Secukinumab
n=105 Participants
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
|
Fumaric Acid (Initial and Maintenance Therapy)
n=95 Participants
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
|
|---|---|---|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16 and 20
Week 1
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16 and 20
Week 2
|
5.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16 and 20
Week 3
|
24.8 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16 and 20
Week 4
|
47.6 Percentage of participants
|
1.1 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16 and 20
Week 6
|
69.5 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16 and 20
Week 8
|
80.0 Percentage of participants
|
8.4 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16 and 20
Week 12
|
87.6 Percentage of participants
|
21.1 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16 and 20
Week 16
|
88.6 Percentage of participants
|
27.4 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16 and 20
Week 20
|
88.6 Percentage of participants
|
36.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24Population: The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for PASI 90 at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
PASI score is an average degree of severity of signs in head \[H\], trunk \[T\], upper limbs \[U\] and lower limbs \[L\], assessed separately for erythema \[E\], thickening (plaque elevation, induration) \[I\], and scaling (desquamation) \[D\]. Area \[A\] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 90 responders were participants who achieved \>=90% improvement (reduction) in PASI score compared to baseline.
Outcome measures
| Measure |
Secukinumab
n=105 Participants
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
|
Fumaric Acid (Initial and Maintenance Therapy)
n=95 Participants
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
|
|---|---|---|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 1
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 2
|
1.9 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 3
|
2.9 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 4
|
17.1 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 6
|
32.4 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 8
|
46.7 Percentage of participants
|
1.1 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 12
|
63.8 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 16
|
68.6 Percentage of participants
|
8.4 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 20
|
75.2 Percentage of participants
|
14.7 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 24
|
75.2 Percentage of participants
|
18.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24Population: The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for PASI 100 at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
PASI score is an average degree of severity of signs in head \[H\], trunk \[T\], upper limbs \[U\] and lower limbs \[L\], assessed separately for erythema \[E\], thickening (plaque elevation, induration) \[I\], and scaling (desquamation) \[D\]. Area \[A\] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 100 responders were participants who achieved complete clearance of psoriasis (PASI=0).
Outcome measures
| Measure |
Secukinumab
n=105 Participants
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
|
Fumaric Acid (Initial and Maintenance Therapy)
n=95 Participants
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
|
|---|---|---|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 1
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 2
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 3
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 4
|
3.8 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 6
|
7.6 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 8
|
15.2 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 12
|
28.6 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 16
|
37.1 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 20
|
41.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 24
|
43.8 Percentage of participants
|
3.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24Population: The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for BSA at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
The Body surface area (BSA) affected by plaque-type psoriasis was the total of percentages of areas affected, including head, trunk, upper limbs and lower limbs. Each reported percentage was multiplied by its respective body region corresponding factor (head = 0.1, trunk = 0.3, upper limbs = 0.2, lower limbs = 0.4). The resulting four percentages were added to estimate the total BSA affected by plaque-type psoriasis.
Outcome measures
| Measure |
Secukinumab
n=105 Participants
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
|
Fumaric Acid (Initial and Maintenance Therapy)
n=95 Participants
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
|
|---|---|---|
|
Body Surface Area (BSA) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 1
|
23.8 Percentage of area
Standard Deviation 12.82
|
23.2 Percentage of area
Standard Deviation 14.11
|
|
Body Surface Area (BSA) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 2
|
20.1 Percentage of area
Standard Deviation 12.25
|
22.5 Percentage of area
Standard Deviation 14.37
|
|
Body Surface Area (BSA) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 3
|
17.0 Percentage of area
Standard Deviation 11.95
|
22.1 Percentage of area
Standard Deviation 14.33
|
|
Body Surface Area (BSA) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 4
|
13.0 Percentage of area
Standard Deviation 11.93
|
21.6 Percentage of area
Standard Deviation 14.12
|
|
Body Surface Area (BSA) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 6
|
9.8 Percentage of area
Standard Deviation 11.12
|
19.7 Percentage of area
Standard Deviation 13.52
|
|
Body Surface Area (BSA) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 8
|
7.6 Percentage of area
Standard Deviation 10.19
|
17.8 Percentage of area
Standard Deviation 12.65
|
|
Body Surface Area (BSA) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 12
|
5.2 Percentage of area
Standard Deviation 9.12
|
13.7 Percentage of area
Standard Deviation 11.60
|
|
Body Surface Area (BSA) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 16
|
3.7 Percentage of area
Standard Deviation 6.72
|
11.4 Percentage of area
Standard Deviation 11.52
|
|
Body Surface Area (BSA) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 20
|
2.6 Percentage of area
Standard Deviation 5.77
|
9.2 Percentage of area
Standard Deviation 11.87
|
|
Body Surface Area (BSA) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 24
|
2.9 Percentage of area
Standard Deviation 6.43
|
7.9 Percentage of area
Standard Deviation 9.92
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24Population: The analysis was performed on FAS population. Here 'number analyzed' signifies participants evaluable for NAPSI 50 at week 1, 2, 3, 4, 5, 6, 7,12,16, 20 and 24.
NAPSI was used to assess psoriatic nail involvement in participants with nail psoriasis. NAPSI score was calculated as total of nail matrix and nail bed score, ranging from 0-8 per nail. Total NAPSI score ranges from 0 to 80 for all fingernails. Each nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score of 0 - 4 for nail matrix and nail bed psoriasis 0-4 (0: for none, 1: for 1 quadrant, 2: for 2 quadrants, 3: for 3 quadrants, 4: for all 4 quadrants), based on presence of any feature of nail psoriasis in that quadrant. Nail matrix psoriasis feature includes: pitting, leukonychia red spots in lunula, crumbling. Nail bed psoriasis feature includes: onycholysis, splinter hemorrhages, subungual hyperkeratosis, "oil drop" (salmon patch dyschroma). NPASI 50 responders were participants who achieved \>=50% improvement (reduction) in NPASI score compared to baseline.
Outcome measures
| Measure |
Secukinumab
n=105 Participants
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
|
Fumaric Acid (Initial and Maintenance Therapy)
n=95 Participants
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
|
|---|---|---|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 1
|
1.8 Percentage of participants
|
4.1 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 2
|
3.6 Percentage of participants
|
8.2 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 3
|
5.4 Percentage of participants
|
10.2 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 4
|
7.1 Percentage of participants
|
12.2 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 6
|
19.6 Percentage of participants
|
10.2 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 8
|
23.2 Percentage of participants
|
8.2 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 12
|
41.1 Percentage of participants
|
12.2 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 16
|
51.8 Percentage of participants
|
10.2 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 20
|
62.5 Percentage of participants
|
18.4 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 24
|
67.9 Percentage of participants
|
18.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24Population: The analysis was performed on FAS population. Here 'number analyzed' signifies participants evaluable for NAPSI 75 at week 1, 2, 3, 4, 5, 6, 8,12,16, 20 and 24.
NAPSI was used to assess psoriatic nail involvement in participants with nail psoriasis. NAPSI score was calculated as total of nail matrix and nail bed score, ranging from 0-8 per nail. Total NAPSI score ranges from 0 to 80 for all fingernails. Each nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score of 0 - 4 for nail matrix and nail bed psoriasis 0-4 (0: for none, 1: for 1 quadrant, 2: for 2 quadrants, 3: for 3 quadrants, 4: for all 4 quadrants), based on presence of any feature of nail psoriasis in that quadrant. Nail matrix psoriasis feature includes: pitting, leukonychia red spots in lunula, crumbling. Nail bed psoriasis feature includes: onycholysis, splinter hemorrhages, subungual hyperkeratosis, "oil drop" (salmon patch dyschroma). NPASI 75 responders were participants who achieved \>=75% improvement (reduction) in NPASI score compared to baseline.
Outcome measures
| Measure |
Secukinumab
n=105 Participants
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
|
Fumaric Acid (Initial and Maintenance Therapy)
n=95 Participants
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
|
|---|---|---|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 3
|
5.4 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 4
|
7.1 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 6
|
8.9 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 8
|
17.9 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 12
|
28.6 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 16
|
30.4 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 20
|
44.6 Percentage of participants
|
6.1 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 24
|
53.6 Percentage of participants
|
4.1 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 1
|
1.8 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 2
|
1.8 Percentage of participants
|
2.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24Population: The analysis was performed on FAS population. Here 'number analyzed' signifies the participants evaluable for NAPSI 90 response at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
NAPSI was used to assess psoriatic nail involvement in participants with nail psoriasis. NAPSI score was calculated as total of nail matrix and nail bed score, ranging from 0-8 per nail. Total NAPSI score ranges from 0 to 80 for all fingernails. Each nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score of 0 - 4 for nail matrix and nail bed psoriasis 0-4 (0: for none, 1: for 1 quadrant, 2: for 2 quadrants, 3: for 3 quadrants, 4: for all 4 quadrants), based on presence of any feature of nail psoriasis in that quadrant. Nail matrix psoriasis feature includes: pitting, leukonychia red spots in lunula, crumbling. Nail bed psoriasis feature includes: onycholysis, splinter hemorrhages, subungual hyperkeratosis, "oil drop" (salmon patch dyschroma). NPASI 90 responders were participants who achieved \>=90% improvement (reduction) in NPASI score compared to baseline.
Outcome measures
| Measure |
Secukinumab
n=105 Participants
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
|
Fumaric Acid (Initial and Maintenance Therapy)
n=95 Participants
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
|
|---|---|---|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 1
|
1.8 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 2
|
1.8 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 3
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 4
|
3.6 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 6
|
3.6 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 8
|
7.1 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 12
|
14.3 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 16
|
21.4 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 20
|
26.8 Percentage of participants
|
4.1 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 24
|
35.7 Percentage of participants
|
4.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24Population: The analysis was performed on FAS population. Here 'number analyzed' signifies the participants evaluable for NAPSI 100 response at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
NAPSI was used to assess psoriatic nail involvement in participants with nail psoriasis. NAPSI score was calculated as total of nail matrix and nail bed score, ranging from 0-8 per nail. Total NAPSI score ranges from 0 to 80 for all fingernails. Each nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score of 0 - 4 for nail matrix and nail bed psoriasis 0-4 (0: for none, 1: for 1 quadrant, 2: for 2 quadrants, 3: for 3 quadrants, 4: for all 4 quadrants), based on presence of any feature of nail psoriasis in that quadrant. Nail matrix psoriasis feature includes: pitting, leukonychia red spots in lunula, crumbling. Nail bed psoriasis feature includes: onycholysis, splinter hemorrhages, subungual hyperkeratosis, "oil drop" (salmon patch dyschroma). NPASI 100 responders were participants who PASI 100 responders were participants who achieved complete clearance of psoriasis.
Outcome measures
| Measure |
Secukinumab
n=105 Participants
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
|
Fumaric Acid (Initial and Maintenance Therapy)
n=95 Participants
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
|
|---|---|---|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 1
|
1.8 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 2
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 3
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 4
|
3.6 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 6
|
3.6 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 8
|
5.4 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 12
|
10.7 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 16
|
19.6 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 20
|
19.6 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 24
|
23.2 Percentage of participants
|
2.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24Population: The analysis was performed in FAS population. Here 'number analyzed' signifies the participants evaluable for IGA mod 2011 at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
IGA mod 2011 is a global static severity rating scale referring exclusively to the participant's disease state at the time of the assessments and don't attempt comparison with participant's any previous disease states at baseline or visit. IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. Scores used were: 0/Clear: no signs of psoriasis, Post-inflammatory hyperpigmentation may be present; 1/almost clear: Normal to pink coloration of lesions/no thickening/no to minimal focal scaling; 2/Mild: Pink to light red coloration/just detectable to mild thickening/predominantly fine scaling; 3/Moderate: Dull bright red, clearly distinguishable erythema/clearly distinguishable to moderate thickening/moderate scaling; 4/Severe: Bright to deep dark red coloration/severe thickening with hard edges/severe or coarse scaling covering almost all or all lesions.
Outcome measures
| Measure |
Secukinumab
n=105 Participants
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
|
Fumaric Acid (Initial and Maintenance Therapy)
n=95 Participants
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
|
|---|---|---|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 12: Severe
|
0 Participants
|
2 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 16: Clear
|
38 Participants
|
0 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 16: Almost Clear
|
42 Participants
|
12 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 16: Mild
|
15 Participants
|
35 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 16: Moderate
|
4 Participants
|
11 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 16: Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 20: Clear
|
43 Participants
|
0 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 20: Almost Clear
|
36 Participants
|
17 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 20: Mild
|
18 Participants
|
24 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 20: Moderate
|
2 Participants
|
8 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 20: Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 24: Clear
|
45 Participants
|
4 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 24: Almost Clear
|
36 Participants
|
21 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 24: Mild
|
13 Participants
|
15 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 24: Moderate
|
5 Participants
|
7 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 24: Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 1: Mild
|
18 Participants
|
8 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 1: Clear
|
0 Participants
|
0 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 1: Almost Clear
|
0 Participants
|
0 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 1: Moderate
|
65 Participants
|
58 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 1: Severe
|
22 Participants
|
28 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 2: Clear
|
0 Participants
|
0 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 2: Almost Clear
|
6 Participants
|
0 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 2: Mild
|
38 Participants
|
15 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 2: Moderate
|
49 Participants
|
56 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 2: Severe
|
12 Participants
|
20 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 3: Clear
|
0 Participants
|
0 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 3: Almost Clear
|
14 Participants
|
1 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 3: Mild
|
51 Participants
|
18 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 3: Moderate
|
35 Participants
|
51 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 3: Severe
|
5 Participants
|
19 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 4: Clear
|
4 Participants
|
0 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 4: Almost Clear
|
31 Participants
|
1 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 4: Mild
|
46 Participants
|
21 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 4: Moderate
|
19 Participants
|
46 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 4: Severe
|
3 Participants
|
16 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 6: Clear
|
9 Participants
|
0 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 6: Almost Clear
|
42 Participants
|
2 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 6: Mild
|
39 Participants
|
26 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 6: Moderate
|
7 Participants
|
44 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 6: Severe
|
1 Participants
|
10 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 8: Clear
|
17 Participants
|
0 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 8: Almost Clear
|
52 Participants
|
4 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 8: Mild
|
29 Participants
|
32 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 8: Moderate
|
2 Participants
|
34 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 8: Severe
|
2 Participants
|
5 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 12: Clear
|
31 Participants
|
0 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 12: Almost Clear
|
49 Participants
|
11 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 12: Mild
|
19 Participants
|
35 Participants
|
|
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 12: Moderate
|
4 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24Population: The analysis was performed on FAS population.
The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe. IGA 0/1 responders: who achieved score of 0/1 and improved by at least 2 points on the IGA scale compared to baseline.
Outcome measures
| Measure |
Secukinumab
n=105 Participants
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
|
Fumaric Acid (Initial and Maintenance Therapy)
n=95 Participants
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
|
|---|---|---|
|
Percentage of Participants With IGA Mod. 2011 0/1-response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 1
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With IGA Mod. 2011 0/1-response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 2
|
5.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With IGA Mod. 2011 0/1-response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 3
|
13.3 Percentage of participants
|
1.1 Percentage of participants
|
|
Percentage of Participants With IGA Mod. 2011 0/1-response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 4
|
34.3 Percentage of participants
|
1.1 Percentage of participants
|
|
Percentage of Participants With IGA Mod. 2011 0/1-response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 6
|
50.5 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants With IGA Mod. 2011 0/1-response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 8
|
66.7 Percentage of participants
|
4.2 Percentage of participants
|
|
Percentage of Participants With IGA Mod. 2011 0/1-response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 12
|
77.1 Percentage of participants
|
12.6 Percentage of participants
|
|
Percentage of Participants With IGA Mod. 2011 0/1-response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 16
|
80.0 Percentage of participants
|
14.7 Percentage of participants
|
|
Percentage of Participants With IGA Mod. 2011 0/1-response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 20
|
79.0 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants With IGA Mod. 2011 0/1-response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 24
|
81.0 Percentage of participants
|
28.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24Population: The analysis was performed on FAS population. Here 'number analyzed' signifies the participants evaluable for DLQI at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral. The measure was self-administered and included domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. Each item had four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" was also a valid response and was scored as 0. The DLQI total score was a sum of the 10 questions. Scores ranged from 0 to 30, with higher scores indicating greater impairment in health related quality of life.
Outcome measures
| Measure |
Secukinumab
n=105 Participants
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
|
Fumaric Acid (Initial and Maintenance Therapy)
n=95 Participants
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
|
|---|---|---|
|
Dermatology Life Quality Index (DLQI) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 1
|
13.9 Score on a scale
Standard Deviation 5.86
|
16.3 Score on a scale
Standard Deviation 6.44
|
|
Dermatology Life Quality Index (DLQI) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 2
|
10.5 Score on a scale
Standard Deviation 6.22
|
15.3 Score on a scale
Standard Deviation 6.99
|
|
Dermatology Life Quality Index (DLQI) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 3
|
8.4 Score on a scale
Standard Deviation 5.96
|
14.6 Score on a scale
Standard Deviation 7.01
|
|
Dermatology Life Quality Index (DLQI) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 4
|
6.6 Score on a scale
Standard Deviation 5.13
|
13.8 Score on a scale
Standard Deviation 7.23
|
|
Dermatology Life Quality Index (DLQI) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 6
|
5.3 Score on a scale
Standard Deviation 5.79
|
12.4 Score on a scale
Standard Deviation 7.24
|
|
Dermatology Life Quality Index (DLQI) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 8
|
4.2 Score on a scale
Standard Deviation 4.75
|
11.0 Score on a scale
Standard Deviation 7.16
|
|
Dermatology Life Quality Index (DLQI) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 12
|
3.1 Score on a scale
Standard Deviation 4.41
|
8.8 Score on a scale
Standard Deviation 7.10
|
|
Dermatology Life Quality Index (DLQI) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 16
|
2.7 Score on a scale
Standard Deviation 3.95
|
6.8 Score on a scale
Standard Deviation 6.05
|
|
Dermatology Life Quality Index (DLQI) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 20
|
2.5 Score on a scale
Standard Deviation 3.84
|
5.9 Score on a scale
Standard Deviation 5.67
|
|
Dermatology Life Quality Index (DLQI) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 24
|
2.0 Score on a scale
Standard Deviation 3.58
|
5.4 Score on a scale
Standard Deviation 5.56
|
SECONDARY outcome
Timeframe: Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24Population: The analysis was performed on FAS population.
DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral. The measure was self-administered and included domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. Each item had four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" was also a valid response and was scored as 0. The DLQI total score was a sum of the 10 questions. Scores ranged from 0 to 30, with higher scores indicating greater impairment in health related quality of life. DLQI 0/1 response was the achievement of a DLQI score of 0 or 1.
Outcome measures
| Measure |
Secukinumab
n=105 Participants
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
|
Fumaric Acid (Initial and Maintenance Therapy)
n=95 Participants
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
|
|---|---|---|
|
Percentage of Participants With DLQI 0/1 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 1
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With DLQI 0/1 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 2
|
3.8 Percentage of participants
|
1.1 Percentage of participants
|
|
Percentage of Participants With DLQI 0/1 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 3
|
7.6 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With DLQI 0/1 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 4
|
19.0 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants With DLQI 0/1 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 6
|
30.5 Percentage of participants
|
4.2 Percentage of participants
|
|
Percentage of Participants With DLQI 0/1 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 8
|
40.0 Percentage of participants
|
6.3 Percentage of participants
|
|
Percentage of Participants With DLQI 0/1 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 12
|
57.1 Percentage of participants
|
10.5 Percentage of participants
|
|
Percentage of Participants With DLQI 0/1 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 16
|
59.0 Percentage of participants
|
14.7 Percentage of participants
|
|
Percentage of Participants With DLQI 0/1 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 20
|
64.8 Percentage of participants
|
15.8 Percentage of participants
|
|
Percentage of Participants With DLQI 0/1 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Week 24
|
71.4 Percentage of participants
|
25.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 4, 16 and 24Population: The analysis was performed on FAS population. Here 'number analyzed' signifies the participants evaluable for SF-36 response at week 4, 16 and 24
SF-36 is a generic indicator of health status for use in population surveys and evaluative studies of health policy. The SF-36 included 36 items in a Likert-type or forced-choice format measured on eight dimensions. The scores for each domain range from 0 to 100, with high scores indicating a better status. SF-36 responder is defined as subject reaching at least an improvement of minimum important difference (MID). The SF-36 measure dimensions and their MID includes: * Physical Functioning:4.3 * Role-Physical: 3.4 * Bodily Pain: 6.2 * General Health: 7.2 * Vitality: 6.2 * Social Functioning: 6.9 * Role-Emotional: 4.5 * Mental Health: 6.2 Two component scores and their MID which were derived from the above mentioned 8 domains includes-: * Physical component summary: 3.4 * Mental component summary: 4.6
Outcome measures
| Measure |
Secukinumab
n=105 Participants
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
|
Fumaric Acid (Initial and Maintenance Therapy)
n=95 Participants
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
|
|---|---|---|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Physical Component Summary Week 4
|
38.1 Percentage of participants
|
26.1 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Mental component summary Week 4
|
41.2 Percentage of participants
|
36.4 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Physical functioning scale Week 4
|
24.5 Percentage of participants
|
19.6 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Role physical scale Week 4
|
44.2 Percentage of participants
|
23.7 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Bodily pain scale Week 4
|
53.3 Percentage of participants
|
31.6 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
General health scale Week 4
|
32.4 Percentage of participants
|
21.1 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Vitality scale Week 4
|
31.7 Percentage of participants
|
20.4 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Social functioning scale Week 4
|
39.2 Percentage of participants
|
27.7 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Role emotional scale Week 4
|
41.3 Percentage of participants
|
34.7 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Mental health scale Week 4
|
33.3 Percentage of participants
|
32.6 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Physical Component Summary Week 16
|
52.6 Percentage of participants
|
39.8 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Mental component summary Week 16
|
63.9 Percentage of participants
|
46.6 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Physical functioning scale Week 16
|
36.3 Percentage of participants
|
31.5 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Role physical scale Week 16
|
52.9 Percentage of participants
|
36.6 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Bodily pain scale Week 16
|
63.8 Percentage of participants
|
45.3 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
General health scale Week 16
|
38.2 Percentage of participants
|
22.1 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Vitality scale Week 16
|
45.2 Percentage of participants
|
23.7 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Social functioning scale Week 16
|
57.8 Percentage of participants
|
41.5 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Role emotional scale Week 16
|
56.7 Percentage of participants
|
43.2 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Mental health scale Week 16
|
54.3 Percentage of participants
|
42.1 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Physical Component Summary Week 24
|
57.7 Percentage of participants
|
43.2 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Mental component summary Week 24
|
63.9 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Physical functioning scale Week 24
|
38.2 Percentage of participants
|
31.5 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Role physical scale Week 24
|
52.9 Percentage of participants
|
37.6 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Bodily pain scale Week 24
|
64.8 Percentage of participants
|
49.5 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
General health scale Week 24
|
41.2 Percentage of participants
|
21.1 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Vitality scale Week 24
|
48.1 Percentage of participants
|
29.0 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Social functioning scale Week 24
|
63.7 Percentage of participants
|
45.7 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Role emotional scale Week 24
|
54.8 Percentage of participants
|
41.1 Percentage of participants
|
|
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Mental health scale Week 24
|
53.3 Percentage of participants
|
38.9 Percentage of participants
|
Adverse Events
Secukinumab
Serious events: 4 serious events
Other events: 75 other events
Deaths: 0 deaths
Fumaric Acid (Initial and Maintenance Therapy)
Serious events: 4 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Secukinumab
n=105 participants at risk
Participants were self-administered subcutaneously (s.c.) with a dose of 300 milligrams (mg) of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 centimeters (cm) around the navel).
|
Fumaric Acid (Initial and Maintenance Therapy)
n=95 participants at risk
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
|
|---|---|---|
|
Gastrointestinal disorders
ANAL HAEMORRHAGE
|
0.00%
0/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
1.1%
1/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
1.1%
1/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
General disorders
ASTHENIA
|
0.95%
1/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
0.00%
0/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Infections and infestations
PILONIDAL CYST
|
0.00%
0/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
1.1%
1/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.95%
1/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
0.00%
0/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.95%
1/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
0.00%
0/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
0.95%
1/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
0.00%
0/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SMALL CELL LUNG CANCER
|
0.95%
1/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
0.00%
0/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Nervous system disorders
BRAIN OEDEMA
|
0.95%
1/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
0.00%
0/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.00%
0/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
2.1%
2/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Vascular disorders
THROMBOSIS
|
0.95%
1/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
0.00%
0/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
Other adverse events
| Measure |
Secukinumab
n=105 participants at risk
Participants were self-administered subcutaneously (s.c.) with a dose of 300 milligrams (mg) of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 centimeters (cm) around the navel).
|
Fumaric Acid (Initial and Maintenance Therapy)
n=95 participants at risk
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
|
|---|---|---|
|
Blood and lymphatic system disorders
EOSINOPHILIA
|
0.95%
1/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
17.9%
17/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
1.9%
2/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
5.3%
5/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.95%
1/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
5.3%
5/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
1.9%
2/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
24.2%
23/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.95%
1/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
6.3%
6/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.9%
2/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
11.6%
11/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
2.9%
3/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
38.9%
37/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Gastrointestinal disorders
DIARRHOEA
|
6.7%
7/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
50.5%
48/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
5.3%
5/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Gastrointestinal disorders
NAUSEA
|
2.9%
3/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
21.1%
20/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Gastrointestinal disorders
VOMITING
|
1.9%
2/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
7.4%
7/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
General disorders
FATIGUE
|
3.8%
4/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
6.3%
6/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Infections and infestations
NASOPHARYNGITIS
|
51.4%
54/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
42.1%
40/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.7%
6/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
3.2%
3/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.95%
1/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
6.3%
6/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
5.7%
6/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
4.2%
4/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Nervous system disorders
HEADACHE
|
14.3%
15/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
15.8%
15/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Renal and urinary disorders
HAEMATURIA
|
5.7%
6/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
3.2%
3/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
6.7%
7/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
8.4%
8/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Vascular disorders
FLUSHING
|
0.95%
1/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
35.8%
34/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Vascular disorders
HOT FLUSH
|
0.95%
1/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
7.4%
7/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
|
Vascular disorders
HYPERTENSION
|
5.7%
6/105 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
1.1%
1/95 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862 -778- 8300
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