Early Secukinumab Treatment in Moderate to Severe Hidradenitis Suppurativa Patients: Early Action Reduces Long-term Yield in Hidradenitis Suppurativa (EARLY HS 2)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 186
- Primary Endpoint
- Proportion of Patients Achieving 55% Reduction From Baseline in International Hidradenitis Suppurativa Severity Scoring System (IHS4-55) at 6 and 12 Months
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with a documented diagnosis of HS (e.g., International Classification of Diseases, 10th Revision [ICD-10] code L73.2);
- •Age ≥18 years at index date;
- •Moderate-to-severe HS as per label;
- •Initiation of secukinumab treatment on or after the first HS diagnosis date;
- •And at least one follow-up assessment at 6 or 12 months after index date.
Exclusion Criteria
- •Patients who had major HS-related surgery (Skin-tissue-sparing Excision with Electrosurgical Peeling [STEEP] or wide excision) in the 12 months prior to index date;
- •Patients participating in interventional clinical trials at index date.
- •Other protocol-defined inclusion/exclusion criteria may apply.
Outcomes
Primary Outcomes
Proportion of Patients Achieving 55% Reduction From Baseline in International Hidradenitis Suppurativa Severity Scoring System (IHS4-55) at 6 and 12 Months
Time Frame: 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.
Secondary Outcomes
- Number and Percentage of Patients by Selected Demographic and Clinical Characteristics Overall and by Early and Late Treatment Group(Baseline)
- Duration of HS(Baseline)
- Mean Change From Baseline in IHS4 Score at 6 and 12 Months(Baseline, 6 and 12 months)
- Mean Change in Pain From Baseline at 6 and 12 Months(Baseline, 6 and 12 months)
- Proportion of Patients Achieving 75% Reduction in IHS4 (IHS4-75) From Baseline at 6 and 12 Months(6 and 12 months)
- Proportion of Patients Achieving 100% Reduction in IHS4 (IHS4-100) From Baseline at 6 and 12 Months(6 and 12 months)
- Mean Change in Number of Inflammatory Abscesses, Nodules, and Active Tunnels From Baseline at 6 and 12 Months(Baseline, 6 and 12 months)
- Proportion of Patients Whose Disease Progresses From Baseline at 6 and 12 Months(6 and 12 months)
- Mean Number of Flares From Baseline at 6 and 12 Months(6 and 12 months)
- Proportion of Patients Achieving ≥30% Reduction in Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS30)(6 and 12 months)
- Proportion of Patients Who Required Surgery From Baseline at 6 and 12 Months(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(6 and 12 months)