This is a multicenter open-label mode of action study. Twenty patients with moderate to severe hidradenitis suppurativa will be treated with guselkumab 200 mg Q4W subcutaneously. Main objectie is to investigate changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab, in HS lesional skin. The total duration of the treatment period per subject is 16 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
See study arm description.
Erasmus MC, University Medical Center Rotterdam
Rotterdam, South Holland, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab.
Pangenomic gene expression profiling at week 0 and week 16 will be performed on skin biopsies to investigate changes in levels of cytokines in the skin.
Time frame: Week 0 and 16
Clinical efficacy - Inflammatory lesion count and Hidradenitis Suppurativa Clinical Response (HiSCR)
All inflammatory lesions on all affected body areas will be counted. Additionally, the HiSCR will be calculated from these counted lesions.
Time frame: Week 0, 4, 12, 16.
Clinical efficacy - International Hidradenitis Suppurativa Severity Score System (IHS4).
The IHS4 score will be calculated by multiplying the number of nodules by 1, the number of abscesses by 2 and the number of draining fistulas by 4 and adding up these three outcomes into a total score.
Time frame: Week 0, 4, 12, 16.
Patient reported outcomes - Patient Global Assessment
Patient will be asked to assess his or her skin disease activity with in 5 categories.
Time frame: Every four weeks
Patient reported outcomes - Itch Numeric Rating Scale
Patient will be asked to score his or her itch on numeric rating scale from 0 (no itch) to 10 (worst possible itch).
Time frame: Week 0, 4, 8, 12 and 16
Patient reported outcomes - Pain Numeric Rating Scale
Patient will be asked to score his or her pain on numeric rating scale from 0 (no pain) to 10 (worst possible pain).
Time frame: Week 0, 4, 8, 12 and 16
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Patient reported outcomes - Patient treatment satisfaction score
Patient will be asked to score his or her satisfaction about the treatment at baseline and at week 16 on a numeric rating scale from 0 (completely unsatisfied) to 10 (completely satisfied).
Time frame: Week 0 and 16
Patient reported outcomes - Dermatology Life Quality Index
A survey containing 10 questions regarding multiple aspects of the quality of life. Each question has 4 answer possibilities: 'not at all', 'a little', 'a lot' and 'very much'. These answers correspond with 0,1,2 or 3 points respectively. The total score can range from 0 to 30 points.
Time frame: Week 0, 4, 8, 12 and 16