Efficacy and Safety of Ixekizumab in a Randomized, Double-Blinded, Placebo-Controlled Phase 3b Study of Patients with Moderate-to-Severe Genital Psoriasis
BACKGROUND: Genital psoriasis (GenPs) is a common, debilitating, and difficult to treat manifestation of plaque psoriasis. However, few controlled, interventional studies of GenPs exist. OBJECTIVE: To determine the efficacy of ixekizumab versus placebo in patients with moderate-to-severe GenPs with BSA>/=1%. METHODS: Subjects with moderate-to-severe GenPs (defined as a baseline static Physician's Global Assessment of Genitalia [sPGA-G] score of >/=3) with BSA>/=1% were randomized 1:1 to receive placebo (N=74) or the recommended dosing of ixekizumab (N=75). Major outcomes included the percentage of patients achieving 0 or 1 scores on the sPGA-G (primary endpoint), overall sPGA, GenPs Sexual Frequency Questionnaire (GenPs-SFQ) item 2, and a >/=3-point improvement from baseline on the GenPs itch numeric rating scale. RESULTS: At week 12, ixekizumab was superior to placebo on the sPGA-G 0/1 (73.3% versus 8.1%, p/=1%. The safety profile of ixekizumab was consistent with previous studies in moderate-to-severe plaque psoriasis. This article is protected by copyright. All rights reserved.
Ryan, C., Menter, A., Gottlieb, A., Fretzin, S., Osuntokun, O., Burge, R., Naegeli, A., Yang, F., Lin, C., Todd, K., Potts Bleakman, A., & IXORA-Q Study Group. (2018). Efficacy and Safety of Ixekizumab in a Randomized, Double-Blinded, Placebo-Controlled Phase 3b Study of Patients with Moderate-to-Severe Genital Psoriasis. The British Journal of Dermatology, 179 (4), 844-852. https://doi.org/10.1111/bjd.16736