Hidradenitis Suppurativa
Conditions
Keywords
Coronary Plaque, Cardiovascular Risk
Brief summary
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
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Adult participants aged ≥18 and ≤75 years. 2. Diagnosis of moderate-to-severe HS (International Hidradenitis Suppurativa Severity Score System \[IHS4\] ≥4). 3. Taking or planning to take secukinumab according to standard of care. 4. Participants eligible for coronary imaging by Photon-Counting Computed Tomography (PCCT) based on at least one of the following: 1. Evidence of coronary atherosclerotic plaque previously identified by imaging and receipt of stable, guideline-directed medical therapy. 2. Clinical indication as determined by a cardiologist. 3. Very high risk of developing cardiovascular diseases according to the Systematic Coronary Risk Evaluation 2 (SCORE2) and Systematic Coronary Risk Evaluation 2 - Older Persons (SCORE2-OP) risk models for moderate risk European regions (score ≥7.5% for participants \<50 years old, score ≥10% for participants 50-69 years old, and score ≥15% for participants ≥70 years old). 5. Signed Informed Consent Form (ICF), obtained from the participant or a legally authorized representative, prior to any study-related activities.
Exclusion criteria
1. Known history of previous Myocardial Infarction (MI), Acute Coronary Syndromes (ACS) or Transient Ischemic Attack (TIA) requiring urgent intervention/hospitalization in the last 6 months prior to enrollment. 2. Use of investigational cardiovascular or anti-inflammatory drugs. 3. Use of any other investigational drugs. 4. Chronic Kidney Disease (estimated Glomerular Filtration Rate \[eGFR\] \<30 mL/min). 5. Contraindications to perform PCCT (including allergies to contrast). 6. Other autoimmune systemic diseases or active neoplastic diseases. 7. Known history of Moderate to severe anemia. 8. Congestive Heart Failure (New York Heart Association \[NYHA\] Class III-IV). 9. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Lack of Clinically Significant Progression of Coronary Atherosclerotic Plaque Between Baseline and 12 Months, as Measured by PCCT | Baseline to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Participants With No Changes, Positive Changes, and Negative Changes in Coronary Artery Calcium (CAC) Score Between Baseline and 12 Months | Baseline to 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: * A0: 0 (no calcium) * A1: 1-99 (mild calcification) * A2: 100-299 (moderate calcification) * A3: ≥300 (moderate to severe calcification) |
| 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 | Baseline to 12 months | The densitometric spectrum of the plaque, as measured by PCCT, will be assessed based on the Hounsfield Unit (HU)-defined categories: * Lipidic plaque: \<30 HU * Fibro-lipidic plaque: 30-60 HU * Fibrotic plaque: 60-130 HU * Calcified plaque: \>130 HU |
| 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 | Baseline to 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: 1. Normal/Absence of Stenosis: 0% 2. Minimal: 1-24% 3. Mild: 25-49% 4. Moderate: 50-69% 5. Severe: 70-99% 5\. Occluded: 100% |
| Change in HS Severity, as Measured by IHS4, From Baseline to 6 Months and 12 Months | 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. |
| Percentage Change in Total Coronary Atherosclerotic Plaque Volume Between Baseline and 12 Months, as Assessed by PCCT | Baseline to 12 months | — |
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed