This study will assess the use of risankizumab in adult patients with moderate to severe chronic plaque psoriasis and compare risankizumab to other commonly used biologics.
Study Type
OBSERVATIONAL
Enrollment
2,759
Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 90
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.
Time frame: From Month 4 to 3 years
Time to first treatment change
Identify time to first treatment change including discontinuation, dose escalation and dosing interval shortening
Time frame: From Week 0 (Baseline) to first treatment change
Time to first treatment change rate
Time to first treatment change including discontinuation, dose escalation and dose interval shortening.
Time frame: At 1 year, 2 year, and 3 year
Percentage of participants who achieved Static Physicians Global Assessment (sPGA) 0/1 or sPGA 0
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. sPGA scores demonstrate overall psoriatic disease with a lower score indicating less body coverage. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the patient's previous disease states, whether at Baseline or at a previous visit.
Time frame: Monthly for up to 3 years
Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 75, 90, or 100
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. Each threshold will be analyzed separately.
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Emiliano Baccarini Priv Practice /ID# 218581
Lomas de Zamora, Buenos Aires, Argentina
Hospital Universitario Austral /ID# 217540
Pilar, Buenos Aires, Argentina
Stringa Dermatologia /ID# 218450
Ciudad Autonoma Buenos Aires, Buenos Aires F.D., Argentina
Private Office Cristina Echeverria /ID# 222082
Ciudad Autonoma Buenos Aires, Buenos Aires F.D., Argentina
Stat Research /ID# 217185
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Buenos Aires Skin /ID# 217657
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
CEDIC Centro de Investigaciones Clinicas /ID# 217184
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Instituto de Neumonologia y Dermatologia /ID# 217429
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Psoriahue Med Interdisciplinar /ID# 217182
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Professional Skin Care /ID# 218514
Buenos Aires, Argentina
...and 292 more locations
Time frame: Monthly for up to 3 years
Percentage of participants who achieved Absolute PASI<=5, <=3 or <=1
Used to assess the benefit of psoriasis therapy. Each threshold will be analyzed separately.
Time frame: Monthly for up to 3 years
Time to achieve sPGA 0/1 or sPGA 0
The sPGA is the assessment by the Investigator of the overall disease severity at the time of evaluation. The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores.
Time frame: Up to 3 years
Time to achieve PASI 75, 90,or 100
PASI 75, 90, or 100 defined as at least a 75%/ 90%/ 100% reduction in PASI relative to Week 0 (Baseline). Each threshold will be analyzed separately.
Time frame: Up to 3 years
Percentage of participants who achieve sPGA 0/1 or sPGA 0 at 4 Months and maintained the response status at 1 Year, 2 Years and 3 Years without increasing the dose or shortening the dose interval
Percentage of participants who achieve sPGA 0/1 or sPGA 0 at 4 Months and maintained the response status at 1 Year, 2 Years and 3 Years without increasing the dose or shortening the dose interval.
Time frame: At 4 months to 1 year, 2 years, and 3 years
Percentage of participants who achieved PASI 90 or PASI 100 at 4 Months and maintained the response status at 1 Year, 2 Years, and 3 Years without changing the indicated dose or dosing interval
Percentage of participants who achieved PASI 90 or PASI 100 demonstrating a 90 or 100% reduction in PASI at 4 Months and maintained the response status at 1 Year, 2 Years, and 3 Years without changing the indicated dose or dosing interval.
Time frame: At 4 months and 1 year, 2 years, and 3 years
Change in PASI
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.
Time frame: From Week 0 to up to 3 years
Change in Body Surface Area (BSA)
BSA can be used to quantify the severity of psoriasis. A decrease in BSA affected by psoriasis indicates improvement.
Time frame: From Week 0 to up to 3 years
Change in Dermatology Quality of Life Index (DLQI) Score
The Dermatology Life Quality Index (DLQI) is the most commonly used quality of life (QoL) assessment tool. The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status. Scores range from 0 (not relevant/not at all) to 3 (very much).
Time frame: From Week 0 to up to 3 years
Percentage of participants who achieve DLQI 0/1
The Dermatology Life Quality Index (DLQI) is the most commonly used quality of life (QoL) assessment tool. The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status. The higher the DLQI score, the more quality of life is impaired.
Time frame: Monthly for up to 3 years
Change in Treatment Satisfaction Questionnaire for Medication (TSQM) score
The Treatment Satisfaction Questionnaire for Medication (TSQM) is a widely used generic measure to assess treatment satisfaction with their medication. This is a 100-point scale with higher scores indicating greater satisfaction with medication and provides scores on four scales - side effects, effectiveness, convenience and global satisfaction.
Time frame: From Week 0 to up to 3 years