Regulatory Post-Marketing Surveillance in Hidradenitis Suppurativa, Pediatric Plaque Psoriasis and JIA Treated With Cosentyx®(Secukinumab) in Korea

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.

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.

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.

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)

An HS flare is a new or substantial worsening of clinical signs or symptoms.

The Hurley stage is a grading system for classifying the severity of hidradenitis suppurativa. Stage I is defined as abscess formation (single or multiple), no sinus tracts or cicatrization/scarring, Stage II is defined as recurrent abscesses with sinus tracts and scarring, single or multiple separated lesions, and Stage III is defined as diffuse or almost diffuse involvement, or multiple interconnected sinus tracts and abscesses across the entire area.

The PASI is a composite index that combines the area of involvement of psoriatic lesions with the severity of the lesions. The PASI calculates the extent of redness/erythema, scaling, and thickness/thickness of psoriatic lesions and assesses their severity with a corresponding score. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.

The IGA mod 2011 score is used to determine the severity psoriasis symptoms. It reflects a subject's overall disease severity for the whole body. The scale includes 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.

A joint is classified as "active" when there is swelling, pain on movement, tenderness/pain on movement, and limitation of motion. It is also possible to classify a joint as "active" if only edema is present.

Using digital pressure, joints that feel tender or show pain when moved are considered tender joints, and their counts are totaled to determine the tender joint count (TJC).

A joint is classified as "active" when there is swelling, pain on movement, tenderness/pain on movement, and limitation of motion. It is also possible to classify a joint as "active" if only edema is present.

Swollen joint count SJC is determined by physical examination of joint counts that are classified as either swollen or not swollen.

The JADAS is a tool for assessing disease activity in Juvenile idiopathic arthritis that is composed of four items: joint count (number of active joints as assessed by a physician), physician global assessment of disease activity (VAS 0-10), parent/patient global assessment (VAS 0-10), and serum inflammatory markers (erythrocyte sedimentation rate (ESR)), which are scored separately and summed to calculate a score. The clinical JADAS (cJADAS) used in this study excludes serum inflammatory markers and is calculated by summing all the scores (0-10) obtained from each item, and the score is calculated from a minimum of 0 to a maximum of 30.

Treatment effect is evaluated by physician based on clinical judgement and/or laboratory test results and classified in four categories.

• Improved: improvement or maintenance of symptoms*, as determined by the investigator.
• Unchanged: No significant change from pre-initiation of the investigational drug is identified, which is not considered a maintenance effect*.
• Worsening: Symptoms are worse than before started taking the investigational drug.
• Unevaluable: Unable to evaluate due to lost to follow-up, etc. * Maintenance effect: When there is a significant risk of worsening of symptoms if the medication is discontinued, or when substitution with an existing medication continues to have an equivalent effect.