Ixekizumab Effective for Genital Psoriasis, Improves Sexual Health

Caroline Helwick

October 31, 2017

SAN ANTONIO — Genital psoriasis is a disturbing condition, with half of patients in one study reporting a powerful negative effect on sexual activity and health. Treatment with ixekizumab, a biologic therapy that targets interleukin 17A, significantly improved multiple endpoints in an international phase IIIb study.

"Ixekizumab is an efficacious treatment for moderate to severe genital psoriasis, providing rapid clearance of genital skin. It improves genital itch and minimizes how often genital psoriasis limits the frequency of sexual activity," said Allison Potts Bleakman, PhD, principal clinical research scientist at Eli Lilly and Company, Indianapolis, Indiana.

Reporting these benefits here at the Sexual Medicine Society of North America (SMSNA) Fall 2017 Scientific Meeting, Dr Bleakman described the heavy physical and sexual burden of genital psoriasis.

"Genital psoriasis affects up to 63% of patients with plaque psoriasis, much more than people realize, and can have a significant impact on quality of life and sexual health," she said. To date, few data have been published on the efficacy of biologic therapy on genital involvement.

Patients in the current study reported multiple genital psoriasis symptoms. Itch and stinging/burning were the two most bothersome symptoms, and itch and discomfort the two most common ones.

"Importantly, nearly all patients reported genital psoriasis has an impact on their sexual health, and the majority reported impacts to their general well-being and activities," she said.

Study Details

The randomized, double-blinded, placebo-controlled phase IIIb study evaluated the effect of ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin 17A, compared with placebo on genital psoriasis and on genital psoriasis-related sexual function during 12 weeks of treatment.

The genital areas of interest were labia majora, labia minor, and perineum in women and penis, scrotum and perineum in men.

Overall, 149 patients with moderate to severe genital psoriasis were randomly assigned to either 80 mg ixekizumab (after a starting dose of 160 mg) or placebo every 2 weeks. The population was primarily male (76%), with a mean duration of psoriasis of about 12 years.

Primary and major secondary endpoints included the percentage of patients at week 12 achieving a 0 or 1 score in the 6-point static Physician's Global Assessment of Genitalia scale, a 0 or 1 score in the 6-point overall static Physician's Global Assessment scale, or an improvement of 3 or more points on the 11-point genital itch numeric rating scale for patients with a baseline score of at least 3. At baseline, the static Physician's Global Assessment (genital score) was 3.5 on the 6-point scale.

The sexual activity endpoint was a score of 0 or 1 on the 5-point sexual frequency questionnaire item 2 for patients with a baseline score of 2 or more. Sexual frequency questionnaire item 2 determines how genital psoriasis affects the frequency of sexual activity.

Ixekizumab Significantly Improved All Endpoints

Ixekizumab was superior to placebo for the primary and many secondary endpoints at week 12, and significant improvements vs placebo were observed as early as week 1, the authors said. At week 12, the following benefits were noted:

  • Achievement of clear or almost clear genital skin for 73% of ixekizumab-treated patients vs 8% of the placebo group (P < .001).

  • Clinically meaningful improvements in genital itch for 60% vs 8%, respectively (P < .001).

  • Little to no effect of genital psoriasis on frequency of sexual activity for 78% vs 21%, respectively (P < .001).

Frequencies of treatment-emergent adverse events through week 12 were 56.0% in the ixekizumab group and 44.6% in the placebo group. Mostly mild or moderate in severity, these included upper respiratory tract infections, injection site reactions, headache, oropharyngeal pain, and pruritus.

Significant Improvement in Sexual Health

Dr Bleakman also reported the effect on sexual health in greater detail, derived from in-depth semistructured interviews with 20 patients (mean age, 45 years; 55% women) with moderate to severe genital involvement. Patients reported having psoriasis for a mean time of 18 years and genital involvement for 7.5 years. More than 90% reported currently experiencing moderate to severe overall psoriasis and genital psoriasis.

"Our interviews were intended to elicit information about genital psoriasis symptoms and their impact," she said.

Overall, the most common symptoms were itch (100%), discomfort (100%), redness/erythema (95%), stinging/burning (95%), pain (85%), and scaling (75%). Of these, patients spontaneously reported itch and redness/erythema most frequently (90% and 50%, respectively), and on probing, reported discomfort (70%), stinging/burning (50%), pain (45%), and scaling (50%). In addition, cracking was spontaneously reported by 30% of patients.

Respondents said they were most bothered by itch (40%) and stinging/burning (40%) and indicated that symptom severity often depended on their activities and/or the weather.

These physical manifestations had consequences for sexual activity. During the qualitative interviews, 45% of patients said they were currently not sexually active. Most (90%) reported at least one effect of genital psoriasis on sexual health. The most common sexual effects were worsening of symptoms after sexual activity (80%), negative physical effects on sexual experience (80%), decreased sexual frequency (80%), avoidance of sexual relationships (75%), and reduced sexual desire (55%).

For half the patients, genital psoriasis affected satisfaction with their sex lives "quite a bit" (25%) or "very much" (25%). Effects on mood/emotion (95%), physical activities (70%), and daily activities (60%) were also reported.

"The burden of symptoms associated with genital psoriasis is considerable," Dr Bleakman concluded. "Nearly all patients reported at least one negative impact of genital psoriasis on sexual aspects of their quality of life."

Dr Bleakman encouraged clinicians to query any patient with psoriasis about genital involvement, as an effective treatment is available.

"Disabling" Condition

John Mulhall, MD, director of the Male Sexual and Reproductive Medicine Program at Memorial Sloan Kettering Cancer Center in New York City, commented that genital psoriasis can be a "disabling" condition for which treatments are very much needed.

"Imagine a young man, with perfect erectile function, who's met a nice girl, then must drop his pants and show this scaly stuff on his penis. While very dense plaques can be uncomfortable, just having to disclose this condition to a partner, in itself, is a barrier to sexual health," he said told Medscape Medical News.

"Anything you put in the way of comfortable, non-stress-inducing sexual activity can lead to erectile dysfunction, so these men are often referred to us with [erectile dysfunction] from their medical doctor. It's a complex situation," he commented.

Dr Mulhall indicated that this study is the first he has seen on the topic, and he predicted that ixekizumab could have a "direct impact on this population."

The study was funded by Eli Lilly and Company. Dr Bleakman is employed by the company. Dr Mulhall had no relevant disclosures.

Sexual Medicine Society of North America (SMSNA) Fall 2017 Scientific Meeting: Abstracts 012, 203, and 204. Presented October 27, 2017.

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