Hidradenitis Suppurativa
Conditions
Keywords
Hidradenitis Suppurativa, Secukinumab, Early treatment, Real-world evidence
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Achieving 55% Reduction From Baseline in International Hidradenitis Suppurativa Severity Scoring System (IHS4-55) at 6 and 12 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Patients by Selected Demographic and Clinical Characteristics Overall and by Early and Late Treatment Group | Baseline | 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 |
| Duration of HS | Baseline | — |
| Mean Change From Baseline in IHS4 Score at 6 and 12 Months | Baseline, 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. |
| Proportion of Patients Achieving 75% Reduction in IHS4 (IHS4-75) From Baseline at 6 and 12 Months | 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. IHS4-75 is defined as a proportion of patients achieving ≥ 75% reduction in IHS4 score at 6 and 12 months compared to baseline. |
| Proportion of Patients Achieving 100% Reduction in IHS4 (IHS4-100) From Baseline at 6 and 12 Months | 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. |
| 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 | 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. |
| Mean Number of Flares From Baseline at 6 and 12 Months | 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. |
| Mean Change in Pain From Baseline at 6 and 12 Months | Baseline, 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). |
| Proportion of Patients Achieving ≥30% Reduction in Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS30) | 6 and 12 months | 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. |
| Proportion of Patients Who Required Surgery From Baseline at 6 and 12 Months | 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. |
| 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 | 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. |
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed