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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate to severe hidradenitis suppurativa |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery combined with secukinumab | Combination Product | Surgery combined with secukinumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| HiSCR | 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) | week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| IHS4 | the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4) | week 52 |
| Change in number of inflammatory nodules |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged 18 to 80 years old with moderate-severe (Hurley II-III) HS
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Youjun ZHENG | Contact | 1+86 9943909917 | 19943909917@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Science and Peking Union Medical College | Recruiting | Nanjing | Jiangsu | 210042 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40023624 | Result | Fang V, Gupta R, Micheletti RG. Managing Hidradenitis Suppurativa with Biologics and Small Molecule Inhibitors. Dermatol Clin. 2025 Apr;43(2):231-245. doi: 10.1016/j.det.2024.12.008. Epub 2025 Jan 21. | |
| 40062409 | Result | Calabrese L, Cartocci A, Rubegni P, French LE, Kendziora B. Efficacy and safety of biologics for hidradenitis suppurativa: A network meta-analysis of phase III trials. J Eur Acad Dermatol Venereol. 2026 Apr;40(4):637-645. doi: 10.1111/jdv.20617. Epub 2025 Mar 10. |
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Change in number of inflammatory nodules
| week 52 |
| Change in number of abscesses | Change in number of abscesses | week 52 |
| Change in number of sinus tracts | Change in number of sinus tracts | week 52 |
| HS related skin pain (NRS30) | 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 | week 52 |
| Time to onset of action | Time to onset of action | week 52 |
| Duration of drug effect | Duration of drug effect | week 52 |
| Changes in inflammatory markers | white blood cells, erythrocyte sedimentation rate, C-reactive protein | week 52 |
| DLQI | Dermatology Life Quality Index | week 52 |
| WPAI | Work Productivity and Activity Impairment | week 52 |
| Adverse effect and complications | Adverse effect and complications | week 52 |
| 28027202 | Result | Kohorst JJ, Baum CL, Otley CC, Roenigk RK, Pemberton JH, Dozois EJ, Tran NV, Davis MD. Patient Satisfaction and Quality of Life Following Surgery for Hidradenitis Suppurativa. Dermatol Surg. 2017 Jan;43(1):125-133. doi: 10.1097/DSS.0000000000000942. |
| 39941581 | Result | Caliezi A, Rabufetti A, Hunger R, Wolf R, Seyed Jafari SM. Impact of Hidradenitis Suppurativa on Sexual Quality of Life. J Clin Med. 2025 Jan 30;14(3):910. doi: 10.3390/jcm14030910. |
| 38146560 | Result | Agnese ER, Tariche N, Sharma A, Gulati R. The Pathogenesis and Treatment of Hidradenitis Suppurativa. Cureus. 2023 Nov 25;15(11):e49390. doi: 10.7759/cureus.49390. eCollection 2023 Nov. |
| 22236226 | Result | Jemec GB. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012 Jan 12;366(2):158-64. doi: 10.1056/NEJMcp1014163. No abstract available. |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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