Efficacy and Safety of Secukinumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgery combined with secukinumab.
- Who it may be relevant to
- Registry conditions: Hidradenitis Suppurativa (HS), Hidradenitis Suppurativa (Acne Inversa), Secukinumab. Basic parameters: up to 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Secukinumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa: An Open-label Cohort Study in Real Clinical Practice
Overview
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 product Surgery combined with secukinumab
Surgery combined with secukinumab
Primary outcome measures
- HiSCR [Time frame: week 52]
Secondary outcome measures (11)
- IHS4 [Time frame: week 52]
- Change in number of inflammatory nodules [Time frame: week 52]
- Change in number of abscesses [Time frame: week 52]
- Change in number of sinus tracts [Time frame: week 52]
- HS related skin pain (NRS30) [Time frame: week 52]
- Time to onset of action [Time frame: week 52]
- Duration of drug effect [Time frame: week 52]
- Changes in inflammatory markers [Time frame: week 52]
- DLQI [Time frame: week 52]
- WPAI [Time frame: week 52]
- Adverse effect and complications [Time frame: week 52]
Eligibility criteria
Inclusion criteria
- Patients aged 18 to 80 years old with moderate-severe (Hurley II-III) HS
- The diagnosis of HS was confirmed by histopathological examination in the Department of Pathology of our hospital
- Patients with HS who received secukinumab combined with surgery in the Department of Dermatologic Surgery of our hospital
- Patients with complete clinical data followed up for at least 1 year
Exclusion criteria
- Patients lost to follow-up
- Patients with less than one year of follow-up
- Patients who received additional adjuvant therapy during the follow-up period
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Science a — Nanjing
Publications
- 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. PMID 40023624
- 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. PMID 40062409
- 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. PMID 28027202
- 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. PMID 39941581
- 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. PMID 38146560
- Jemec GB. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012 Jan 12;366(2):158-64. doi: 10.1056/NEJMcp1014163. No abstract available. PMID 22236226
Identifiers
NCT: NCT06926192 · 2025-KY-016