MedicalResearch.com Interview with:
Dr. Jennifer Cather MD
Medical Director at Modern Dermatology and Modern Research Associate
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Genital psoriasis can be an uncomfortable and burdensome condition that many people living with moderate-to-severe plaque psoriasis experience. Due to the significant impact, Lilly conducted a 12-week Phase 3b clinical trial with patients with moderate-to-severe genital psoriasis treated with ixekizumab, which found that patients had a greater decrease in the impact of their condition on sexual activity compared to placebo as early as one week.
Specifically, trial patients were randomized to receive ixekizumab (80 mg every two weeks, following a 160-mg starting dose) or placebo and researchers measured pre-specified patient-reported outcomes, including the Genital Psoriasis Sexual Impact Scale (GPSIS), which is composed of the Sexual Activity Avoidance (Avoidance) and Impact of Sexual Activity on Genital Psoriasis Symptoms (Impact) subscales. Patient-reported outcomes were also measured by the Sexual Frequency Questionnaire (SFQ) item 2, evaluating the impact of genital psoriasis on the frequency of sexual activity, and the Dermatology Life Quality Index (DLQI) item 9, evaluating the impact of skin symptoms on sexual difficulties.
At 12 weeks, patients reported the following outcomes:
- DLQI Item 9 0/1: 92.0 percent of patients treated with ixekizumab compared to 56.8 percent of patients treated with placebo reported no (0) or little (1) sexual difficulties caused by skin symptoms.
- SFQ Item 2 0/1: 78.4 percent of patients treated with ixekizumab compared to 21.4 percent of patients treated with placebo (reported the frequency of sexual activity was either never (0) or rarely (1) limited by genital psoriasis.
- GPSIS-Avoidance 1/2: 76.7 percent of patients treated with ixekizumab compared to 25.7 percent of patients treated with placebo reported never (1) or rarely (2) avoiding sexual activity due to genital psoriasis.
- GPSIS-Impact 1/2: 85.7 percent of patients treated with ixekizumab compared to 52.9 percent of patients treated with placebo reported worsening of genital psoriasis symptoms during or after sexual activity was very low/none at all (1) or low (2).
MedicalResearch.com: What should readers take away from your report?
Response: Over the course of their disease, up to 63 percent of psoriasis patients experience genital psoriasis, which can have a significant impact on a patients’ sexual health and experience. The findings presented at the American Academy of Dermatology annual meeting underscores positive patient-related outcomes for those living with this challenging disease, demonstrating that treatment with ixekizumab resulted in improvement in the impact of genital psoriasis on sexual activity.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Despite the availability of existing treatment options for psoriasis, there are still many people living with moderate-to-severe genital psoriasis looking for an option to decrease the impact of this difficult-to-treat condition. This research adds to the growing body of evidence supporting the use of ixekizumab and reinforces Lilly’s commitment to research underway evaluating ixekizumab for the treatment of genital psoriasis.
MedicalResearch.com: Is there anything else you would like to add?
Response: Over the last 18 years of my career, I’ve participated in multiple clinical drug trials, several of which have been new biologics approved for the treatment of psoriasis. Despite the field growing, we still have room for improvement in how we treat psoriasis and how we communicate it with our patients. It can be uncomfortable discussing sexual intimacy issues during a busy dermatology clinic day, though I find these conversations impactful and rewarding. In our clinic, we have an all hands-on deck policy—it doesn’t matter who patients feel most comfortable talking to in the clinic or on the phone, we are all here to help and support them.
Disclosure: Dr. Cather was a principal investigator in the ixekizumab Phase 3b clinical trial supported by Eli Lilly and Company, and is a consultant for AbbVie, Celgene, Eli Lilly and Company, Leo Pharma and Novartis.
Results from the Phase IIIb trial presented in an oral presentation at the annual meeting of the American Academy of Dermatology, took place February 16-20, in San Diego, Calif
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