Regulatory Post-Marketing Surveillance in hidradenitis suppurativa, pediatric plaque psoriasis and JIA treated with Cosentyx®(secukinumab) in Korea
Adults 18 years of age and older with moderate to severe hidradenitis suppurativa who are or will be receiving Cosentyx within the scope of approved indication.
Patients who have agreed to participate in study (written informed consent)
Patients with moderate to severe plaque psoriasis between the ages of 6 and 18 years who are receiving or will receive Cosentyx within the scope of approved indication.
Patients with patient or guardian consent to participate in study (written informed consent)
Patients who are contraindicated according to national prescribing information
Patients participating in other interventional clinical trials
Patients who are receiving or will receive Cosentyx after the start of this study in routine clinical practice.
Cohort
Prospective
Secukinumab
DrugThis is a prospective observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
Number of participants having Adverse Events (AEs) and Serious Adverse Events (SAEs) within each indication
All AEs, regardless of severity or causality, will be collected from all participants enrolled in the study.
Proportion of paticipants achieving 50% reduction in hidradenitis suppurativa clinical response (HiSCR50) - HS participants
The HiSCR is a validated assessment tool developed for patients with hidradenitis suppurativa. It is a dichotomized clinical response assessment that measures the status of three types of lesions: abscesses, inflammatory nodules, and draining fistulas. HiSCR50 is defined as participants who have at least a 50% reduction in abscess and nodule count compared to baseline and no increase in the number of abscesses or draining tunnels.
Proportion of participants achieving a severity of 0 or 1 on the hidradenitis supurativa-physician's global assessment (HS-PGA) - HS participants
The HS-PGA is a global assessment of patients with hidradenitis suppurativa based on four clinical assessments \[number of abscesses, number of draining fistulas, number of inflammatory nodules, and presence/absence of non-inflammatory nodules\] to determine severity on a six-point scale, scores range from 0-5 based on the number of HS lesions ranges from clear to very severe.
Proportion of participants with a 55% or greater reduction in international hidradenitis suppurativa severity scoring system (IHS4-55) - HS participants
The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity. HS severity is calculated based on the number of lesions multiplied by their respective score: the IHS4 score (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + \[number of draining tunnels (fistulae/sinuses) multiplied by 4\]. HS4-55 is defined as participants who have at least a 55% reduction in IHS4 score compared to baseline.
Proportion of participants with a ≥30% reduction in Hidradenitis suppurativa-related skin pain numerical rating scale (NRS) - HS participants
The HS-related skin pain NRS is a numeric rating scale in which patients rate their pain at the time of the worst skin pain in the past 24 hours. The numeric rating scale is a fine-grained numeric version of a visual analogue scale (VAS) in which respondents select a number (0-10) that best reflects the intensity of their pain, ranging from 0 (no skin pain) to 10 (most severe skin pain)
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