Real-World Evaluation of Secukinumab in Moderate-to-Severe Hidradenitis Suppurativa
Conditions: Hidradenitis Suppurativa (HS)
Sponsor: Peking Union Medical College

Real-World Evaluation of Secukinumab in Moderate-to-Severe
Hidradenitis Suppurativa
2025-06-30
Ethics Approval No. I-24PJ1844
Study Design
This single-center, prospective, observational study aimed to evaluate the
efficacy and safety of Secukinumab in treating moderate-to-severe hidradenitis
suppurativa (HS). The study was conducted from June 1, 2025, to June 1,
2026, and all participants were treated at the Department of Dermatology,
Peking Union Medical College Hospital. The study was approved by the
Clinical and Research Ethics Committee of the Chinese Academy of Medical
Sciences, Peking Union Medical College Hospital (Ethics Approval No.
I-24PJ1844). All procedures involving human participants adhered to the
Declaration of Helsinki. Written informed consent form was signed and
obtained from the participant.
Patient Selection
Participants were included based on the following criteria: age ≥18 years,
diagnosis of moderate-to-severe HS with Hurley stage II or III, Disease
duration of ≥6 months, presence of at least one draining tunnel or two
inflammatory nodules, inadequate response to prior treatments, such as
antibiotics, isotretinoin, or TNF inhibitors. Patients were excluded if they: active
infections (e.g., viral hepatitis, active tuberculosis), use of other biologics or
systemic immunosuppressants within the past three months, severe organ
dysfunction (e.g., hepatic or renal failure), any other conditions that might
affect study results. All participants provided informed consent after being fully
briefed on the study’s objectives and potential risks.
Treatment Regimen
Patients received secukinumab 300 mg weekly for five weeks, followed by 300
mg monthly subcutaneous injection.Depending on their individual presentation,
some patients also received concomitant medications, such as isotretinoin,
systemic antibiotics (e.g., clarithromycin, minocycline, rifampin), or topical
antibiotics. The decision to use concomitant medications, as well as the

specific drug choices and dosages, was based on the patient’s clinical needs
and physician discretion.
Efficacy and Safety Assessments
Treatment efficacy was evaluated through a comprehensive assessment
approach including objective
measures
and patient-reported
outcomes.
Disease severity was objectively measured using the International Hidradenitis
Suppurativa Severity Score System (IHS4), which quantifies disease activity
based on the weighted sum of inflammatory nodules (×1), abscesses (×2), and
draining tunnels (dT) (×4), as assessed by the physician. Treatment response
was determined using the Hidradenitis Suppurativa Clinical Response 50
(HiSCR50),
defined
as
a
≥50%
reduction
in
the
combined
count
of
inflammatory nodules and abscesses from baseline, without an increase in the
number of abscesses or draining tunnels at Week 12. During the treatment
with secukinumab, the patient also underwent ultrasound assessment and
examination. The assessment points were set at baseline, the 4th week, and
the 16th week. The evaluation indicators include the regression of nodules and
abscesses, the changes in sinus tracts, and the blood flow conditions around
the lesion.
Patient-reported outcomes were assessed using three validated instruments:
the Pain Numerical Rating Scale (NRS), where patients rated pain intensity
from 0 (no pain) to 10 (worst possible pain); the Hidradenitis Suppurativa
Quality of Life (HiSQOL) questionnaire, which evaluates the impact of HS on
daily life; and the Dermatology Life Quality Index (DLQI), which measures the
psychological and quality-of-life impact of skin conditions.
Throughout the study period, adverse events (AEs) were systematically
recorded, documenting their symptoms, severity, and duration. All AEs were
graded according to the Common Terminology Criteria for Adverse Events
(CTCAE) version 5.0.