Ixekizumab Results in Persistent Clinical Improvement in Moderate-to-Severe Genital Psoriasis During a 52 Week, Randomized, Placebo-Controlled, Phase 3 Clinical Trial

Abstract

Ixekizumab was efficacious in treating moderate-to-severe genital psoriasis over 12 weeks. We evaluated the long-term efficacy and safety of ixekizumab for up to 52 weeks. Patients were randomized to 80 mg ixekizumab every 2 weeks or to placebo through Week 12, then received 80 mg open-label ixekizumab every 4 weeks through Week 52. In patients initially randomized to ixekizumab, clear or almost clear genital skin was achieved for 73% of patients at Week 12 and 75% at Week 52. Persistent improvements were also observed for overall psoriasis, genital itch, and the impact of genital psoriasis on the frequency of sexual activity. The safety profile was consistent with studies of ixekizumab in patients with moderate-to-severe plaque psoriasis. Ixekizumab provided rapid and persistent improvements in the signs and symptoms of genital psoriasis for up to 52 weeks of treatment.

Keywords: IXORA-Q; clinical trial; genital psoriasis; itch; ixekizumab; sexual impact.

Fig. 1

Genital psoriasis severity during 52 weeks (NRI) of treatment in IXORA-Q. (a) Proportion of patients achieving a static Physician’s Global Assessment of Genitalia (sPGA-G) score of 0 or 1 at each post-baseline visit. (b) Proportion of patients achieving complete resolution of genital psoriasis (sPGA-G 0) at each post-baseline visit. (c) Proportion of patients achieving a sPGA-G 0/1 at Week 52 among patients with lower (1 to <10%) and higher (≥10%) body surface area involvement at baseline. (d) Proportion of patients achieving at least a 2-point improvement in the Patient’s Global Assessment of Genital Psoriasis among patients with a baseline score of ≥2. (a-d) Results are summarized for the placebo (PBO) population (all patients randomized to placebo at Week 0) through Week 12, the PBO/IXE Q4W population (all patients randomized to placebo at Week 0 who entered the open-label treatment period and received at least 1 dose of ixekizumab) from Weeks 12 to 52, and the IXE population (all patients randomized to ixekizumab at Week 0) through Week 52.

Fig. 2

Overall psoriasis during 52 weeks of treatment (nonresponder imputation) in IXORA-Q. (a) Proportion of patients achieving an overall static Physician’s Global Assessment (sPGA) score of 0 or 1 at each post-baseline visit. (b) Proportion of patients achieving complete resolution of overall psoriasis (sPGA 0) at each post-baseline visit. (a and b) Results are summarized for the PBO population (all patients randomized to placebo at Week 0) through Week 12, the PBO/IXE Q4W population (all patients randomized to placebo at Week 0 who entered the open-label treatment period and received at least one dose of ixekizumab) from Weeks 12 to 52, and IXE population (all patients randomized to ixekizumab at Week 0) through Week 52.

Fig. 3

Photographic examples of improvement in genital psoriasis during 52 weeks of treatment in IXORA-Q. (a) Photographs of the genital region of a female patient in the PBO/IXE Q4W population. (b) Photographs of the genital region of a male patient in the IXE population.

Fig. 4

Patient-reported outcomes during 52 weeks (nonresponder imputation) of treatment in IXORA-Q. (a) Proportion of patients achieving at least a 3-point improvement in the genital itch numeric rating scale (NRS) at each post-baseline visit among patients with a score of ≥3 at baseline. (b) Proportion of patients achieving at least a 4-point improvement in the genital itch NRS at each post-baseline visit among patients with a score of ≥4 at baseline. (c) Proportion of patients achieving a score of 0 or 1 in the genital psoriasis Sexual Frequency Questionnaire Item 2 (GenPs-SFQ Item 2), indicating genital psoriasis never or rarely limited the frequency of sexual activity, among patients with a score of ≥2 at baseline. (a-c) Results are summarized for the PBO population (all patients randomized to placebo at Week 0) through Week 12, the PBO/IXE Q4W population (all patients randomized to placebo at Week 0 who entered the open-label treatment period and received at least 1 dose of ixekizumab) from Weeks 12 to 52, and IXE population (all patients randomized to ixekizumab at Week 0) through Week 52.