Long Term Observational Study to Collect in a Real-world populatIon Data on the Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe HS Within the Italian Population

Proportion of patients achieving 55% reduction in IHS4 (IHS4-55) stratified by dosing

The proportion of patients achieving 55% reduction in IHS4 (IHS4-55) stratified by dosing (q4w / q2w regimen), at 6 months, 1 and 1.5 years after initiation of secukinumab treatment. The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity. Determining IHS4 requires counting nodules, abscesses and draining tunnels/sinus tracts, which is easy to calculate. The IHS4 score is calculated as the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS

Time frame: 6 months, 1 and 1.5 years after initiation of secukinumab treatment

Proportion of patients achieving 75% reduction in IHS4 (IHS4-75) and 100% reduction in IHS4 (IHS4-100)

The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity. Determining IHS4 requires counting nodules, abscesses and draining tunnels/sinus tracts, which is easy to calculate. The IHS4 score is calculated as the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS

Time frame: 6 months, 1 and 1.5 years after initiation of secukinumab treatment

Proportion of patients achieving 50% reduction in HiSCR (HiSCR-50) and 75% reduction in HiSCR (HiSCR-75)

The Hidradenitis Suppurativa Clinical Response (HiSCR) is defined as a ≥ 50% reduction in total AN count (abscesses + inflammatory nodules), and no increase in abscesses or draining tunnels when compared with baseline.

Time frame: 6 months, 1 and 1.5 years after initiation of secukinumab treatment

Number, type, and localization of HS lesions

lesion spread is defined as total abscess and inflammatory nodule count (AN) or draining fistulae in a body region not seen at baseline

Time frame: baseline, 6 months, 1 and 1.5 years after initiation of secukinumab treatment

Change of total abscess and inflammatory nodule count

Time frame: 6 months, 1 and 1.5 years after initiation of secukinumab treatment

Proportion of patients receiving up-titration

Proportion of patients receiving up-titration (q4w-to-q2w) of secukinumab

Time frame: Within 6 months, 1 and 1.5 years after initiation of secukinumab treatment

Proportion of patients receiving down-titration

Proportion of patients receiving down-titration (q2w-to-q4w) of secukinumab

Time frame: within 6 months, 1 and 1.5 years after initiation of secukinumab treatment

Time to up-titration and down-titration

Time to up-titration (q4w-to-q2w) and down-titration (q2w-to-q4w) of secukinumab

Time frame: Up to 1.5 years

Proportion of patients switching from q4w to q2w treatment

Proportion of patients switching from q4w to q2w treatment with secukinumab after dose reduction.

Time frame: 6 months and 1.5 years after initiation of secukinumab treatment

Proportion of patients who receive more than one up- and/or down-titration

Proportion of patients who receive more than one up- and/or down-titration of secukinumab

Time frame: within 6 months, 1 and 1.5 years after initiation of secukinumab treatment

Demographics of adult patients with moderate or severe HS

Descriptive statistics will be performed

Time frame: Baseline

Proportion of patients achieving a 5-point reduction of Dermatology life quality index (DLQI) score.

The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week. Each item has four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score ranges from 0 to 30, with higher scores indicating greater HRQoL impairment

Time frame: 6 months, 1 and 1.5 years after initiation of secukinumab treatment

Change in DLQI score from baseline

The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week. Each item has four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score ranges from 0 to 30, with higher scores indicating greater HRQoL impairment

Time frame: Baseline, 6 months, 1 and 1.5 years after initiation of secukinumab

Clinical characteristics of adult patients with moderate to severe HS

Clinical characteristics of adult patients with HS moderate or severe

Time frame: Up to 1.5 years

Proportion of patients with new draining tunnel

Proportion of patients with new draining tunnel(s) (fistulae/sinuses)

Time frame: 6 months, 1 and 1.5 years after initiation of secukinumab treatment

Number of areas affected and proportion of patients with additional area involvement

Time frame: 6 months, 1 and 1.5 years after initiation of secukinumab treatment

Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab

Proportion of patient as per clinical practice

Time frame: Up to 1.5 years

Time of initiation of concomitant medications

Time of initiation of concomitant medications (after the initiation of secukinumab)

Time frame: Baseline, 6 months, 1 and 1.5 years after initiation of secukinumab treatment

Duration of treatment with concomitant medications

Duration of treatment with concomitant medications in a flexible dosing regimen of secukinumab

Time frame: Up to 1.5 years

Proportion of patients undergoing tapering of concomitant medications

Proportion of patients undergoing tapering of concomitant medications in a flexible dosing regimen of secukinumab.

Time frame: Baseline, 6 months, 1 and 1.5 years after initiation of secukinumab treatment

Number and type of surgical interventions

number and type of surgical interventions (minor and major surgical excision; inpatient, outpatient, or self-treatment at home) in a flexible dosing regimen of secukinumab (q4w and q2w)

Time frame: 6 months, 1 and 1.5 years after initiation of secukinumab

Reason for surgical intervention

Time frame: Up to 1.5 years after initiation of secukinumab

Duration of discontinuation/pause of secukinumab treatment before surgery

Time frame: Up to 1.5 years after initiation of secukinumab

Duration of discontinuation/pause of secukinumab treatment after surgery

Time frame: Up to 1.5 years after initiation of secukinumab

Reduction in the number of surgical procedures

Time frame: Up to 1.5 years after initiation of secukinumab

Identification of potential predictors using multivariable analysis

Time frame: Up to 1.5 years after initiation of secukinumab treatment

Descriptive statistics of pain

Descriptive statistics of pain (Numerical Skin Pain Rating Scale).

Time frame: 6 months, 1 and 1.5 years after initiation of secukinumab treatment

Proportion of patients achieving a 30% reduction of Pain Numerical Rating scale (NRS30)

The Numerical Skin Pain Rating Scale (NRS) is a scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her worst skin pain ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine).To assess this, the patient should concentrate on the worst pain that his/her skin lesions has generated during the previous 24 hours. NRS30 is a specific threshold used in the assessment of pain reduction in patients with HS. It is defined as a ≥30% and ≥2-point reduction in skin pain on the NRS.

Time frame: 6 months, 1 and 1.5 years after initiation of secukinumab treatment

Number of patients with secukinumab AEs in routine clinical practice

Number of patients with secukinumab adverse events (AEs) in routine clinical practice

Time frame: Up to 1.5 years after initiation of secukinumab treatment

Hospital Anxiety and Depression Scale [HADS] score

The HADS is a widely used screening tool that helps to identify possible or probable instances of anxiety and depression among patients in non-psychiatric hospital settings. It consists of 14 items, with 7 items related to anxiety (HADS-A) and 7 related to depression (HADS-D), collecting how the patient was feeling in the previous week. Each item is scored from 0 to 3, leading to a maximum score of 21 for each subscale. The HADS is beneficial because it excludes somatic symptoms, which might be caused by physical health problems rather than psychological conditions. It is a quick, reliable, and valid measure that can be self-administered, making it a practical tool for clinicians.

Time frame: 6 months, 1 and 1.5 years after secukinumab initiation

Healthcare Resource Utilization of adult patients with HS

describe Healthcare Resource Utilization of adult patients with HS 12 months before and 12 months after secukinumab treatment initiation with administrative claims data

Time frame: 2 months before and 12 months after secukinumab treatment initiation

Costs of HS covered by the Italian National Health System

Costs of HS covered by the Italian National Health System (Servizio Sanitario Nazionale, SSN) with administrative Claims data

Time frame: 12 months before and 12 months after secukinumab treatment initiation

Direct costs not covered by the SSN and indirect costs of HS

Direct costs not covered by the SSN and indirect costs of HS evaluated through a structured interview between physicians and patients.

Time frame: 12 months before and 12 months after secukinumab treatment initiation

Analysis on HS-related surgeries per patient and related direct costs covered by SSN

HS-related surgeries and estimate direct costs of HS-related surgeries covered by the SSN during the period from the date of first HS diagnosis to 12 months after secukinumab treatment initiation with administrative Claims data

Time frame: 12 months after secukinumab treatment initiation