Efficacy of Risankizumab in Patients with Genital Psoriasis: A Subgroup Analysis by Sex

Introduction: Genital psoriasis (PsO) is considered a high impact area and qualifies patients for systemic treatment. Patients with genital PsO often have increased disease burden and reduced quality of life. These effects may be compounded with concerns regarding engaging in sexual activity. The UnlIMMited clinical trial assesses efficacy and safety of risankizumab (RZB), an IL-23 inhibitor, in patients with genital or scalp PsO. Here we present efficacy results for patients with genital PsO in the UnlIMMited study stratified by sex. Materials and Methods: UnlIMMited (NCT05969223) is a phase 4, multicenter, randomized, double-blind, placebo-controlled study for adult patients with moderate-to-severe genital or scalp PsO. This analysis included patients with genital PsO (Study-G) who were originally randomized during the double-blind placebo-controlled period to receive 150 mg RZB at weeks 0 and 4. Beginning at week 16, patients entered the open-label extension and received 150 mg RZB every 12 weeks. Patients were stratified by self-reported sex, and efficacy outcomes were reported at week 52. Safety was not assessed in this analysis and has been previously reported. Efficacy outcomes included the static Physician’s Global Assessment – Genital (sPGA-G) 0/1 (clear/almost clear) or 0 (clear skin), clinically meaningful improvement in genital itch (assessed as ≥ 4 point reduction in itch from baseline genital PsO itch – numerical rating scale for patients with a baseline score ≥ 4), Genital PsO – Sexual Frequency Questionnaire (GenPs-SFQ) – item 2 0/1 (PsO symptoms never/rarely limit sexual activity frequency; 0 to 4 scale) in patients with a baseline score ≥ 2, Dermatology Life Quality Index (DLQI) 0/1 (no impact), total Genital PsO Symptom Sale (GPSS), and Patient’s Global Assessment of Genital PsO (PatGA-G) (0 = clear to 5 = very severe) in patients with a baseline score ≥ 2. Missing data was handled with non-responder imputation. Results: This analysis included 38 males and 16 females. sPGA-G 0/1 was achieved by 84.2% (32/38) of males and 75.0% (12/16) of females, while sPGA-G 0 was achieved by 73.7% (28/38) and 62.5% (10/16) of male and females, respectively. Clinically meaningful improvement in genital itch was reported by 85.7% (24/28) of males and 69.2% (9/13) of females. GenPS-SFQ Item 2 0/1 was achieved by 78.9% (15/19) of males and 75.0% (9/12) of females. DLQI 0/1 was achieved by 63.2% (24/38) of males and 43.8% (7/16) of females. A ≥ 2 point reduction from baseline in PatGA-G was reported by 78.8% (26/33) of males and 76.9% (10/13) of females. The mean total change from baseline GPSS was -35.5 for males and -35.9 in females. Conclusions: Across all endpoints patients with genital PsO, after 52 weeks of treatment with RZB, reported reduced signs and symptoms of genital PsO and improved quality of life, regardless of sex. Overall, RZB treatment demonstrated efficacy in the treatment of patients with genital PsO.