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The aim of this study is to assess the real-world effects of secukinumab in adult participants with moderate-to-severe Hidradenitis Suppurativa (HS), particularly focusing on its potential impact on coronary atherosclerotic plaque progression or stability. Participants will be enrolled at a single dermatology and cardiology center in Italy and will receive secukinumab as part of their routine clinical care
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab Cohort | Adult participants with a confirmed diagnosis of moderate-to-severe HS and either a very high cardiovascular risk with no detectable plaque at baseline or a documented coronary atherosclerotic plaque, who are initiating or receiving secukinumab as part of routine clinical care. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Lack of Clinically Significant Progression of Coronary Atherosclerotic Plaque Between Baseline and 12 Months, as Measured by PCCT | Lack of clinically significant progression is defined as follows: • For participants with established coronary atherosclerotic plaque at baseline: no ≥10% increase in total plaque volume (mm^3) • For participants with no detectable atherosclerotic plaque at baseline and a high risk of developing atherosclerotic cardiovascular disease (ASCVD): no new detectable plaque formation. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Participants With No Changes, Positive Changes, and Negative Changes in Coronary Artery Calcium (CAC) Score Between Baseline and 12 Months | CAC score will be assessed by the Agatston method via PCCT using the classification according to the CAC-Data and Reporting System (DRS) categories. Each category represents a progressively higher risk of cardiovascular disease. CAC-DRS categories:
|
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Inclusion criteria:
Adult participants aged ≥18 and ≤75 years.
Diagnosis of moderate-to-severe HS (International Hidradenitis Suppurativa Severity Score System [IHS4] ≥4).
Taking or planning to take secukinumab according to standard of care.
Participants eligible for coronary imaging by Photon-Counting Computed Tomography (PCCT) based on at least one of the following:
Signed Informed Consent Form (ICF), obtained from the participant or a legally authorized representative, prior to any study-related activities.
Exclusion criteria:
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Adult participants diagnosed with moderate-to-severe HS who receive secukinumab as part of their routine clinical care at a single dermatology and cardiology center in Italy.
| 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 to 12 months |
| Number and Percentage of Participants With No Changes, Positive Changes, and Negative Changes in the Densitometric Spectrum of the Coronary Atherosclerotic Plaque Between Baseline and 12 Months | The densitometric spectrum of the plaque, as measured by PCCT, will be assessed based on the Hounsfield Unit (HU)-defined categories:
| Baseline to 12 months |
| Number and Percentage of Participants With No Changes, Positive Changes, and Negative Changes in the Degree of Coronary Artery Lumen Stenosis Between Baseline and 12 Months | The degree of coronary artery lumen stenosis, as measured by PCCT, will be assessed based on the Society of Cardiovascular Computed Tomography (SCCT)-defined categories:
5. Occluded: 100% | Baseline to 12 months |
| Change in HS Severity, as Measured by IHS4, From Baseline to 6 Months and 12 Months | IHS4 is a score used to assess the severity of HS. Determining IHS4 score requires counting nodules, abscesses and draining tunnels/sinus tracts. A score of 3 or less signifies mild HS, a score of 4 to 10 signifies moderate HS, and a score of 11 or higher signifies severe HS. | Baseline to 6 months and 12 months |
| Percentage Change in Total Coronary Atherosclerotic Plaque Volume Between Baseline and 12 Months, as Assessed by PCCT | Baseline to 12 months |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |