Ixekizumab improves secondary lesional signs, pain and sexual health in patients with moderate-to-severe genital psoriasis

Abstract

Background: Epithelial surface disruption in genital psoriatic lesions may manifest as erosions, fissures and/or ulcers, causing pain and significantly impacting a patient's sexual health.

Objective: To evaluate the impact of erosions, fissures and/or ulcers in genital psoriatic lesions on pain and sexual activity in patients with moderate-to-severe genital psoriasis (GenPs) and treatment responses to ixekizumab vs. placebo until Week 12.

Methods: This post hoc subgroup analysis of patients presenting with and without erosions, fissures and/or ulcers in genital lesions from a phase IIIb multicentre, randomized, double-blind, placebo-controlled study (IXORA-Q; NCT02718898) in 149 adults with moderate-to-severe GenPs treated with subcutaneous ixekizumab (80 mg every 2 weeks; n = 75) or placebo (n = 74) evaluated outcomes for clinician-rated GenPs severity (static Physician's Global Assessment of Genitalia; sPGA-G) and patient-reported genital pain and itch (Genital Psoriasis Symptoms Scale; GPSS) and sexual health (Genital Psoriasis Sexual Frequency Questionnaire; GenPs-SFQ).

Results: At baseline, 38% (n = 57) of patients presented with genital erosions, fissures and/or ulcers independent of overall body surface area involvement (<10% or ≥10%). These signs were associated with higher scores for disease severity (sPGA-G) and pain (GPSS) but not sexual health (GenPs-SFQ). Complete resolution of these signs was observed in 62% of ixekizumab-treated patients (25% for placebo) at Week 1 and 83% (21% for placebo) at Week 12. Patients treated with ixekizumab reported significant improvements in pain, itch, disease severity and sexual health over 12 weeks compared to placebo and irrespective of the presence/absence of genital erosions, fissures and/or ulcers at baseline.

Conclusion: Ixekizumab led to rapid and sustained resolution of erosions, fissures and/or ulcers and significant improvements in GenPs severity, genital pain and sexual health. Ixekizumab may help to improve the well-being of patients with GenPs.

Figure 1

The graphs show (a) complete resolution of genital erosions, fissures and/or ulcers by treatment group over 12 weeks in the subgroup of patients with these signs at baseline (Week 0), (b) the Static Physician's Global Assessment of Genitalia (sPGA‐G) (0,1) non‐responder imputation response rate over 12 weeks. *P < 0.01 vs. PBO in patients with genital erosions, fissures and/or ulcers (solid grey line); ‡P < 0.001 vs. PBO in patients without genital erosions, fissures and/or ulcers (dashed grey line) from logistic regression analysis, and (c) the Genital Psoriasis Sexual Frequency Questionnaire (GenPs‐SFQ) item 2 (0,1) response rate over 12 weeks in patients with and without genital erosions, fissures and/or ulcers at baseline by treatment group; non‐responder imputation, intention‐to‐treat population with baseline GenPs‐SFQ item 2 score ≥2. *P < 0.01 vs. PBO in patients with genital erosions, fissures and/or ulcers (solid grey line); †P < 0.01; ‡P < 0.001 vs. PBO in patients without genital erosions, fissures and/or ulcers (dashed grey line) from generalized linear model. IXE Q2W, ixekizumab 80 mg every 2 weeks; PBO, placebo.