Secukinumab targets a different interleukin and has potential to be used as alternative to existing treatments. This study will provide clinical data with respect to efficacy through Psoriasis Area and Severity Index (PASI) at 16 weeks, safety/tolerability of secukinumab and evaluate the impact of the treatment on quality of life and work productivity in subjects with moderate to severe plaque psoriasis in the Turkish population.
To demonstrate the efficacy of secukinumab in subjects with moderate to severe plaque psoriasis based on the percentage of PASI 90 responder patients at Week 16 as compared to baseline Evaluation of onset of efficacy measured by the percentage of patient achieving PASI 75 and PASI 90 at week 4 The efficacy of treatment using Investigator's Global Assessment modified 2011 (IGA mod 2011) at week 4 and week 16 Work productivity (measured with WPAI-PSO) at Week 16 Changes in quality of life measured with the Dermatology Life Quality Index (DLQI) at Week 16 Health assessment questionnaire -Disability index (HAQ-DI) in patients with psoriatic arthritis (PsA)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
"Secukinumab" "Cosentyx TM" 150 mg PFS (pre-filled syringe) containing for solution for s.c. injection will be applied as 2 units (300 mg dosage) per patient at each visit. First month: 300 mg injections/week, 4 weeks Starting from 4th week until Week 16, one injection/month
Percentage of PASI 90 responder patients at Week 16 as compared to baseline
The primary endpoint has been chosen as percentage of PASI 90 responder patients. PASI 90 is accepted as clear or almost clear of psoriatic lesions which are the ultimate goal of treatment in plaque psoriasis.
Time frame: 16 week
Evaluation of onset of efficacy measured by the percentage of patient achieving PASI 75 and PASI 90 at week 4
Patients, who achieved PASI 75 and PASI 90 response at week 4 will be counted by using frequencies and percentages (a subject is defined as a PASI 90 responder if the PASI score is reduced by 90% or more compared to baseline visit)
Time frame: 4 week
The efficacy of treatment using Investigator's Global Assessment modified 2011 (IGA mod 2011) at week 4 and week 16
Investigator's Global Assessment (IGA mod 2011) score will be explained by using descriptive statistics at week 4 and week 16. Change between week 4 and week 16 comparing to baseline
Time frame: 4 and 16 week
Work productivity (measured with WPAI-PSO) at Week 16
Work productivity (WPAI-PSO) at week 16 will be evaluated by using descriptive statistics at week 16. Changes at work productivity through the visits will be inspected by using Repeated Measures ANOVA test.
Time frame: 16 week
Changes in quality of life measured with the Dermatology Life Quality Index (DLQI) at Week 16
Changes in quality of life measured with Dermatology Life Quality Index (DLQI) through visits will be evaluated by using Repeated Measures ANOVA test.
Time frame: 16 week
Health assessment questionnaire -Disability index (HAQ-DI) in patients with psoriatic arthritis (PsA)
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Health Assessment Questionnaire-Disability Index (HAQ-DI) will be evaluated at all visits by using descriptive statistics. The change between visits will be evaluated by Repeated Measures ANOVA test.
Time frame: 16 week