Early Secukinumab Treatment in Moderate to Severe Hidradenitis Suppurativa Patients: Early Action Reduces Long-term Yield in Hidradenitis Suppurativa (EARLY HS 2)

Objectif(s) de la recherche et intérêt pour la santé publique

Finalité de l'étude

Objectifs poursuivis

Domaines médicaux investigués

Bénéfices attendus

Hidradenitis suppurativa (HS) is a chronic, inflammatory systemic disease characterized by deep, painful, and recurrent nodules, abscesses, and draining or non draining tunnels.

HS severity ranges from mild to severe and can be assessed using several clinical tools, such as Hurley staging and the International Hidradenitis Suppurativa Severity Score System (IHS4) . There is increasing recognition of a potential ‘window of opportunity’ in HS in which early therapeutic intervention may interrupt inflammatory pathways and prevent progression.

Secukinumab, an interleukin17A inhibitor, has demonstrated rapid and sustained clinical efficacy in patients with moderate to severe HS, with responses maintained up to 52 weeks. Post hoc analyses indicate that patients with predominantly inflammatory nodules at baseline may benefit most from secukinumab, supporting the hypothesis that earlier use, prior to the development of extensive tunnelling, could yield superior clinical outcomes. Nonetheless, data specifically evaluating early versus late initiation of secukinumab in HS are absent.

The EARLY-HS 2 multicentre observational study aims to address this evidence gap by evaluating the effectiveness of early treatment with secukinumab in patients with moderate to severe HS and assessing its impact on disease progression using data from multiple European data sources.

Study objectives
Primary objective:
1. To compare the clinical response to secukinumab between early and late treatment initiation in HS patients.
Secondary objectives:
1. To describe the baseline demographic and clinical characteristics of the overall study population, and by early and late treatment groups.
2. To compare changes in HS disease severity between early and late treatment groups.
3. To compare higher levels of clinical response to secukinumab between early and late treatment groups.
4. To evaluate changes in inflammatory lesion burden; overall and in each affected anatomical area, between early and late treatment groups.
5. To assess disease progression as an individual measure and as a composite measure.
6. To compare flare frequency between early and late treatment groups.
7. To assess changes in patient-reported pain between early and late treatment groups.
8. To compare surgical interventions between early and late treatment groups; overall and by type of surgery.
9. To evaluate changes in patient-reported quality of life between early and late treatment groups.
Exploratory objectives:
1. To explore changes in comorbidity burden in early and late treatment groups.
2. To explore whether clinical response differs by secukinumab treatment discontinuation status among early and late treatment groups.
3. To explore longer-term clinical response in early and late treatment groups.

Setting and study population
The EARLY-HS 2 study will use retrospective data obtained from existing NIS PDC, registries, and hospital cohorts in Europe. The study population will comprise of adult (aged ≥18 years) men and women with moderate-to-severe HS who initiated secukinumab therapy.

Inclusion Criteria
• 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;
o According to the feasibility assessment, SPECTRA does not collect information on STEEP procedures. This exclusion criterion will therefore be adapted for SPECTRA to exclude patients who had wide excision surgery in the 12 months prior to index;
• Patients participating in interventional clinical trials at index date.