Hidradenitis Suppurativa (Acne Inversa), Hidradenitis Suppurativa (HS), Secukinumab
Conditions
Brief summary
This study aims to retrospectively analyze the efficacy and safety of secukinumab combined with surgery in treating moderate to severe HS in real-world clinical practice, providing clinical practioners with real-world evidence in HS treatment.
Detailed description
Hidradenitis suppurativa (HS) is a chronic, recurrent, and disabling inflammatory disease that occurs in apocrine distribution sites such as the axilla, groin, and perianal region with a worldwide prevalence of approximately 1.5% -4.6%.The pathogenesis is excessive activation of the Th17 type immune response mediated by IL-17, IL-23, resulting in abnormal keratinization of hair follicles, obstruction of sebaceous ducts, and bacterial infection, culminating in abscesses, sinus tracts, and scarring.Patients with moderate to severe HS (Hurley stage II-III) often suffer from a severe decline in their quality of life due to recurrent infections, pain, and dysfunction, and their risk of depression is markedly elevated.Traditional treatments such as antibiotics, glucocorticoids, surgical debridement have limited efficacy, and the recurrence rate of surgery alone is as high as 50% -70%.In recent years, the use of biologic agents such as TNF-α inhibitors has dramatically improved HS outcomes, but 30% to 40% of patients still have an inadequate response to TNF-α inhibitors. Accumulating evidence suggests that the IL-17 pathway plays a key role in HS pathogenesis, that IL-17A expression is upregulated in the skin lesions of HS patients and positively correlates with disease severity. The efficacy and safety of secukinumab in combination with surgery remain unclear.
Interventions
COMBINATION_PRODUCTSurgery combined with secukinumab
Surgery combined with secukinumab
Sponsors
Peking Union Medical College
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18 to 80 years old with moderate-severe (Hurley II-III) HS 2. The diagnosis of HS was confirmed by histopathological examination in the Department of Pathology of our hospital 3. Patients with HS who received secukinumab combined with surgery in the Department of Dermatologic Surgery of our hospital 4. Patients with complete clinical data followed up for at least 1 year
Exclusion criteria
1. Patients lost to follow-up 2. Patients with less than one year of follow-up 3. Patients who received additional adjuvant therapy during the follow-up period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HiSCR | week 52 | at least a 50% reduction in total AN count, with no increase in abscess count, and no increase in draining fistula count relative to baseline) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of inflammatory nodules | week 52 | Change in number of inflammatory nodules |
| Change in number of abscesses | week 52 | Change in number of abscesses |
| Change in number of sinus tracts | week 52 | Change in number of sinus tracts |
| HS related skin pain (NRS30) | week 52 | NRS30 is defined as at least a 30% reduction from baseline and at least a 2-unit reduction in patient's global assessment of skin pain at worst |
| Time to onset of action | week 52 | Time to onset of action |
| IHS4 | week 52 | the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4) |
| Changes in inflammatory markers | week 52 | white blood cells, erythrocyte sedimentation rate, C-reactive protein |
| DLQI | week 52 | Dermatology Life Quality Index |
| WPAI | week 52 | Work Productivity and Activity Impairment |
| Adverse effect and complications | week 52 | Adverse effect and complications |
| Duration of drug effect | week 52 | Duration of drug effect |
Countries
China
Contacts
Primary ContactYoujun ZHENG
Outcome results
None listed