Chronic Plaque Type Psoriasis
Conditions
Keywords
chronic plaque type psoriasis, secukinumab, ustekinumab, inflammatory skin disease, scaling
Brief summary
This study assessed efficacy of secukinumab, compared to ustekinumab, in patients that have plaque-type psoriasis
Interventions
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with moderate to severe plaque type psoriasis for at least 6 months before randomization * patients eligible for systemic therapy with inadequately controlled psoriasis
Exclusion criteria
* forms of sporiasis other than plaque type psoriasis * previous exposure to secukinumab, ustekinumab, or other biologic drugs targeting (IL)-17A or IL-17RA Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 | Week 16 | Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4 | Week 4 | Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). Speed of Onset was based on percentage PASI 75 responders and were defined as participants achieving ≥ 75% improvement at Week 4 |
| Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52 | Week 52 | Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 52 |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Denmark, Estonia, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Norway, Portugal, Slovakia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
Of the 676 patients who were randomized to the study, 571 patients completed the study (286 patients (84.9%) in the secukinumab group and 285 patients (84.1%) in the ustekinumab group. Efficacy Data up to 52 weeks and Safety Data included up to 104 weeks
Participants by arm
| Arm | Count |
|---|---|
| AIN457 300 mg patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive | 337 |
| Ustekinumab patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive | 339 |
| Total | 676 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 15 | 7 |
| Overall Study | Death | 0 | 2 |
| Overall Study | Lack of Efficacy | 6 | 1 |
| Overall Study | Lost to Follow-up | 9 | 10 |
| Overall Study | Non-compliance with study treatment | 0 | 2 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Pregnancy | 1 | 2 |
| Overall Study | Protocol deviation | 4 | 3 |
| Overall Study | Subject/guardian decision | 15 | 24 |
| Overall Study | Technical problems | 0 | 2 |
Baseline characteristics
| Characteristic | AIN457 300 mg | Ustekinumab | Total |
|---|---|---|---|
| Age, Continuous | 45.2 years STANDARD_DEVIATION 13.95 | 44.6 years STANDARD_DEVIATION 13.67 | 44.9 years STANDARD_DEVIATION 13.81 |
| Sex: Female, Male Female | 108 Participants | 87 Participants | 195 Participants |
| Sex: Female, Male Male | 229 Participants | 252 Participants | 481 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 270 / 335 | 246 / 336 |
| serious Total, serious adverse events | 41 / 335 | 32 / 336 |
Outcome results
Primary
Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16
Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 16
Time frame: Week 16
Population: Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 300 mg | Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 | 79.0 Percentage of Participants |
| Ustekinumab | Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 | 57.3 Percentage of Participants |
p-value: <0.000195% CI: [2.01, 4.02]Regression, Logistic
Secondary
Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52
Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 52
Time frame: Week 52
Population: Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 300 mg | Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52 | 74.9 percentage of participants |
| Ustekinumab | Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52 | 60.6 percentage of participants |
Secondary
Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4
Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). Speed of Onset was based on percentage PASI 75 responders and were defined as participants achieving ≥ 75% improvement at Week 4
Time frame: Week 4
Population: Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 300 mg | Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4 | 49.7 percentage of participants |
| Ustekinumab | Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4 | 20.6 percentage of participants |