Multicenter, non-interventional, cohort study in pediatric patients with moderate to severe plaque-type psoriasis. Retrospective data collection is planned at patients' inclusion.
This observational study will be performed at healthcare facilities treating pediatric psoriasis patients. The study population will consist of a representative group of pediatric patients with moderate-to-severe plaque psoriasis for whom routine treatment with secukinumab according to the approved national label is initiated during 4 to 16 weeks Retrospective data collection is planned at patients' inclusion. Prospective data collection will continue during follow-up routine visits until secukinumab discontinuation or maximum duration of follow-up for 104 weeks after index date.
Study Type
OBSERVATIONAL
Enrollment
199
There is no treatment allocation. Patients administered secukinumab by prescription will be enrolled
Novartis Investigative Site
Chelyabinsk, Russia
Novartis Investigative Site
Grozny, Russia
Novartis Investigative Site
Izhevsk, Russia
Drug survival rate of secukinumab
Drug survival is defined as time from the index date (defined as secukinumab treatment initiation) until discontinuation of secukinumab (defined as ≥2 missed consecutive doses with drug discontinuation proved by investigator in eCRF).
Time frame: 52 weeks
Secukinumab survival rates
Secukinumab survival rate is defined as proportion of patients who have not discontinued treatment due to reasons other than lack of efficacy.
Time frame: Week 24, week 52, and week 104 after the index date
Time to treatment discontinuation due to ineffectiveness
Time from index date to treatment discontinuation due to ineffectiveness
Time frame: Week 12, week 24, week 52, week 104
Proportion of patients achieving PASI 75 responses
Psoriasis Area and Severity Index (PASI) takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI 75 represents an improvement in the PASI score of at least 75% as compared with baseline.
Time frame: Baseline (study inclusion), week 24, week 52, and week 104 after the index date
Proportion of patients achieving PASI 90 responses
Psoriasis Area and Severity Index (PASI) takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI 90 represents an improvement in the PASI score of at least 90% as compared with baseline.
Time frame: Baseline (study inclusion), week 24, week 52, and week 104 after the index date
Proportion of patients achieving PASI 100 responses
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Novartis Investigative Site
Kazan', Russia
Novartis Investigative Site
Kemerovo, Russia
Novartis Investigative Site
Moscow, Russia
Novartis Investigative Site
Moscow, Russia
Novartis Investigative Site
Moscow, Russia
Novartis Investigative Site
Moscow, Russia
Novartis Investigative Site
Mytishchi, Russia
...and 6 more locations
Psoriasis Area and Severity Index (PASI) takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI 100 response corresponds to complete clearing of psoriasis (PASI = 0).
Time frame: Baseline (study inclusion), week 24, week 52, and week 104 after the index date
Proportion of patients achieving a physicians' global assessment (PGA) 0/1 response
Proportion of patients achieving a physicians' global assessment 0/1 response: clear/almost clear skin
Time frame: Baseline (study inclusion), week 24, week 52, and week 104 after the index date
Adverse events (AEs) of special interest
Adverse events (AEs) of special interest: Inflammatory Bowel Disease, malignancy, tuberculosis, serious infections, candidiasis, acute injection site reaction, immunogenicity
Time frame: Week 12, week 24, week 52, week 104 after the index date
Proportion of patients discontinued secukinumab by reason
Proportion of patients discontinued secukinumab by reason: * Lack of efficacy * Adverse events * Administrative reasons (no medication available in the hospital, etc.) * Lack of patient's adherence * Patient's or legal representative's wish * Other
Time frame: Week 12, week 24, week 52 and week 104
Drug survival rate
Drug survival is defined as time from the index date (defined as secukinumab treatment initiation) until discontinuation of secukinumab (defined as ≥2 missed consecutive doses with drug discontinuation proved by investigator in eCRF).
Time frame: 104 weeks