The aim of this study is to evaluate the effectiveness of early treatment with secukinumab in patients with moderate-to-severe hidradenitis suppurativa (HS) and assess its impact on disease progression using data from multiple European data sources. All data will be sourced from existing non-interventional study primary data collection, registries, and hospital cohorts that captured information collected in routine clinical practice, prior to and independent of this study.
Study Type
OBSERVATIONAL
Enrollment
186
Proportion of Patients Achieving 55% Reduction From Baseline in International Hidradenitis Suppurativa Severity Scoring System (IHS4-55) at 6 and 12 Months
The International Hidradenitis Suppurativa Severity Scoring System (IHS4) is a validated measure of HS severity. Disease severity is calculated by weighting different lesion types as follows: the IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + (number of draining tunnels \[fistulae/sinuses\] × 4). A score of ≤3 indicates mild disease, a score of 4-10 indicates moderate disease, and a score of ≥11 indicates severe disease. In this study, treatment response is assessed using IHS4-55, defined as a proportion of patients achieving ≥55% reduction in IHS4 score compared to baseline.
Time frame: 6 and 12 months
Number and Percentage of Patients by Selected Demographic and Clinical Characteristics Overall and by Early and Late Treatment Group
Demographics and clinical characteristics (subject to availability in the data sources) include: * Age category * Sex * Body mass index (BMI) category * Smoking status * Other medical conditions * Family history of HS * Year of HS diagnosis * Year of secukinumab initiation * Hurley stage * Number of tunnels, nodules, abscesses * Prior surgeries and procedures * Prior treatment
Time frame: Baseline
Duration of HS
Time frame: Baseline
Mean Change From Baseline in IHS4 Score at 6 and 12 Months
The IHS4 is a validated measure of HS severity. Disease severity is calculated by weighting different lesion types as follows: the IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + (number of draining tunnels \[fistulae/sinuses\] × 4). A score of ≤3 indicates mild disease, a score of 4-10 indicates moderate disease, and a score of ≥11 indicates severe disease.
Time frame: Baseline, 6 and 12 months
Proportion of Patients Achieving 75% Reduction in IHS4 (IHS4-75) From Baseline at 6 and 12 Months
Novartis Pharmaceuticals
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The IHS4 is a validated measure of HS severity. Disease severity is calculated by weighting different lesion types as follows: the IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + (number of draining tunnels \[fistulae/sinuses\] × 4). A score of ≤3 indicates mild disease, a score of 4-10 indicates moderate disease, and a score of ≥11 indicates severe disease. IHS4-75 is defined as a proportion of patients achieving ≥ 75% reduction in IHS4 score at 6 and 12 months compared to baseline.
Time frame: 6 and 12 months
Proportion of Patients Achieving 100% Reduction in IHS4 (IHS4-100) From Baseline at 6 and 12 Months
The IHS4 is a validated measure of HS severity. Disease severity is calculated by weighting different lesion types as follows: the IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + (number of draining tunnels \[fistulae/sinuses\] × 4). A score of ≤3 indicates mild disease, a score of 4-10 indicates moderate disease, and a score of ≥11 indicates severe disease. IHS4-100 is defined as a proportion of patients achieving 100% reduction in IHS4 score at 6 and 12 months compared to baseline.
Time frame: 6 and 12 months
Mean Change in Number of Inflammatory Abscesses, Nodules, and Active Tunnels From Baseline at 6 and 12 Months
Time frame: Baseline, 6 and 12 months
Proportion of Patients Whose Disease Progresses From Baseline at 6 and 12 Months
Disease progression is defined as development of new tunnel(s) or development of new persistent HS lesions in an anatomical area not previously affected or increase in the number of persistent HS lesions in an affected anatomical region. Persistent lesions are defined as lesions sustained for ≥4 weeks.
Time frame: 6 and 12 months
Mean Number of Flares From Baseline at 6 and 12 Months
Flare is defined as an increase of at least 25% in AN (abscess and inflammatory nodule) count with a minimum increase of 2 AN relative to baseline.
Time frame: 6 and 12 months
Mean Change in Pain From Baseline at 6 and 12 Months
Patient-reported Numeric Rating Scale (NRS) skin pain score at 6 and/or 12 months, as recorded. The Skin Pain NRS is a tool used to measure patient reported skin pain severity. Patients rate their worst skin pain over the past 24 hours on a scale from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Baseline, 6 and 12 months
Proportion of Patients Achieving ≥30% Reduction in Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS30)
The Skin Pain NRS is a tool used to measure patient reported skin pain severity. Patients rate their worst skin pain over the past 24 hours on a scale from 0 (no pain) to 10 (worst pain imaginable). An NRS30 response is defined as a ≥30% reduction and ≥2-point decrease in skin pain score from baseline.
Time frame: 6 and 12 months
Proportion of Patients Who Required Surgery From Baseline at 6 and 12 Months
Any HS-related surgery (e.g., STEEP, wide excision, incision and drainage, deroofing) between baseline and at 6 and/or 12 months, as reported.
Time frame: 6 and 12 months
Proportion of Patients Achieving a 5-point Reduction of Their Dermatology Life Quality Index (DLQI) Questionnaire From Baseline at 6 and 12 Months
The DLQI is a questionnaire designed to measure the impact of skin disease on a patient's health-related quality of life. It contains 10 simple, self-administered items. Each item is scored on a 4-point scale (0 = not at all to 3 = very much). The total score ranges from 0 to 30, with higher scores indicating greater impairment in quality of life.
Time frame: 6 and 12 months