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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Treatment Group | Adult patients with moderate to severe HS, having up to 1 active tunnel (draining or non-draining) or up to 4 inflammatory lesions (abscess/nodules) at date of first secukinumab administration for HS treatment. | ||
| Late Treatment Group | Adult patients with moderate to severe HS, having >1 active tunnel or >4 inflammatory lesions, at date of first secukinumab administration for HS treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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Adult patients with moderate-to-severe HS who initiated secukinumab treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Baseline |
| Duration of HS | 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. | Baseline, 6 and 12 months |
| Proportion of Patients Achieving 75% Reduction in IHS4 (IHS4-75) 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. IHS4-75 is defined as a proportion of patients achieving ≥ 75% reduction in IHS4 score at 6 and 12 months compared to baseline. | 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. | 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 | 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. | 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. | 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). | 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. | 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. | 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. | 6 and 12 months |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |