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

Abstract

Genital skin is commonly affected among patients with psoriasis. Genital psoriasis can cause problems such as genital itch and pain, and have negative effects on mental, social, and sexual health. Ixekizumab, can provide significant relief of genital psoriasis within 12 weeks of starting treatment. This study showed that patients with genital psoriasis continue to have symptom relief after one year of treatment with ixekizumab. Ixekizumab was efficacious in treating moderate-tosevere 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.

Brodalumab for the treatment of moderate‐to‐severe plaque‐type psoriasis: a real‐life, retrospective 24‐week experience

“…After 12 weeks of brodalumab, sPGA‐G 0/1 was achieved by 16 of 18 patients (88.9%) and remained stable up to week 24 demonstrating its effectiveness. To our knowledge, no previous study has investigated sPGA‐G for brodalumab, although other anti‐IL17 molecules (i.e., ixekizumab) have demonstrated efficacy in genital psoriasis 36‐39 …”

Ixekizumab provides persistent improvements in health‐related quality of life and the sexual impact associated with moderate‐to‐severe genital psoriasis in adult patients during a 52‐week, randomised, placebo‐controlled, phase 3 clinical trial

“…Dosing could be increased if necessary to achieve or maintain satisfactory disease control. 6 Patients treated with IXE achieved persistent improvements in HRQoL, as measured by DLQI (0,1) and multiple domains of SF-36, and in the sexual impact of GenPs, at Week 12; these improvements persisted through Week 52. In the group that received IXE in both periods (IXE/IXE), the proportion of patients with GPSIS-Avoidance (1,2) response persisted through Week 52, with 80% (n = 24/30) achieving GPSIS-Avoidance (1,2).…”

“…4,5 Ixekizumab (IXE), a high-affinity monoclonal antibody selectively targeting interleukin-17A (IL-17A), is the only United States Food and Drug Administration-approved treatment for patients with moderate-to-severe plaque psoriasis that includes labelling information about successful treatment of patients with genital involvement. 6 In the IXORA-Q trial, IXE provided significant improvements in HRQoL and in the sexual impact of GenPs following 12 weeks of treatment. 7,8 Here, we report the persistence of these improvements through 52 weeks.Patient eligibility criteria have been previously published 6-8 ; 149 patients were enrolled in the induction period (Weeks 0-12); patients randomised to either placebo (PBO) or Ixekizumab (IXEQ2W); most had GPSIS-Impact scores of ≥3 (moderate-tovery high), nearly one-third of patients had GPSIS-Avoidance score of 5 (always avoid sexual activity due to GenPs).…”

Genital and Inverse/Intertriginous Psoriasis: An Updated Review of Therapies and Recommendations for Practical Management

“…Several papers have demonstrated significant improvement in genital lesion appearance, itch, sexual health, and quality of life in resistant genital psoriasis treated with ixekizumab. [49][50][51][52] A randomized, placebo-controlled, phase III clinical trial demonstrated the longterm efficacy and safety of ixekizumab for up to 52 weeks [51]. Patients received either ixekizumab 80 mg (n = 75) or placebo (n = 74) every 2 weeks up to week 12, then entered an openlabel period where all patients received ixekizumab 80 mg every 4 weeks up to week 52.…”