An Open-Label Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum
Abstract
INTRODUCTION: Ixekizumab, a monoclonal antibody (MAB) targeting interleukin-17 (IL-17), represents a potential treatment avenue for pyoderma gangrenosum (PG) patients unresponsive to first-line therapies. The objective of this study was to determine the safety and efficacy of ixekizumab in PG.
METHODS: An open-label proof-of-concept study was performed on a cohort of 5 PG patients. Patients were intended to receive subcutaneous ixekizumab injections at baseline (160 mg) and 2-week intervals (80 mg) for 12 weeks. Objective measures including a 5-point investigator global assessment (IGA) and patient-reported outcomes (PRO) were assessed at baseline and completion. NanoString profiling was performed in pre- and post-treatment biopsy samples to assess for differential expression of genes associated with inflammation and immunity.
RESULTS: 5 patients were screened and consented, and 4 were enrolled. Unfortunately, the trial was terminated early due to serious adverse events in 3 patients. Total treatment duration was variable among patients (12, 6, and 2 weeks). Outcome assessments were performed at baseline and completion (mean (std dev)). Objective measures showed average increases in IGA (+0.33 (0.58)) and total ulcer surface area (SA) (+9.01 (7.27) cm2). No patients achieved target ulcer closure. PRO showed average decreases in patient global assessment (PGA) (-1.67 (2.08)), patient pain visual analog scale (VAS) (-0.83 (1.04)), and dermatology life quality index (DLQI) (-2.25 (6.55)). NanoString identified differential expression of 5 genes in response to ixekizumab treatment.
CONCLUSIONS: Due to the small sample size and early termination of this trial, the utility of ixekizumab and IL-17 inhibition in PG remains uncertain.
Keywords: pyoderma gangrenosum, ixekizumab, neutrophilic dermatoses
How to Cite:
Hansen, E., Milam, P., Callen, J. P. & Kaffenberger, B. H., (2026) “An Open-Label Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum”, Academic Dermatology 4(1), 1-16. doi: https://doi.org/10.18061/ad.5785
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